This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 9, is updated January 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.1]
[Page 417-422]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart A--Definitions
Sec. 381.1 Definitions.
(a) For the purposes of the regulations in this part, unless
otherwise required by the context, the singular form shall also import
the plural and the masculine form shall also import the feminine, and
vice versa.
(b) For the purposes of such regulations, unless otherwise required
by the context, the following terms shall be construed, respectively, to
mean:
Acceptable. "Acceptable" means suitable for the purpose intended
and acceptable to the Administrator.
Act. "Act" means the Poultry Products Inspection Act (71 Stat.
441, as amended by the Wholesome Poultry Products Act, 82 Stat. 791; 21
U.S.C. 451 et seq.).
Administrator. "Administrator" means the Administrator of the Food
Safety and Inspection Service of the Department or any other officer or
employee of the Department to whom there has heretofore been delegated,
or to whom there may hereafter be delegated the authority to act in his
stead.
Adulterated. "Adulterated" applies to any poultry product under
one or more of the following circumstances:
(i) If it bears or contains any poisonous or deleterious substance
which may render it injurious to health; but in case the substance is
not an added substance, such article shall not be considered adulterated
under this clause if the quantity of such substance in or on such
article does not ordinarily render it injurious to health;
(ii)(a) If it bears or contains (by reason of administration of any
substance to the live poultry or otherwise) any added poisonous or added
deleterious substance (other than one which is a pesticide chemical in
or on a raw agricultural commodity; a food additive; or a color
additive) which may, in the judgment of the Administrator, make such
article unfit for human food;
[[Page 418]]
(b) If it is, in whole or part, a raw agricultural commodity and
such commodity bears or contains a pesticide chemical which is unsafe
within the meaning of section 408 of the Federal Food, Drug, and
Cosmetic Act;
(c) If it bears or contains any food additive which is unsafe within
the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act;
(d) If it bears or contains any color additive which is unsafe
within the meaning of section 706 of the Federal Food, Drug, and
Cosmetic Act:
Provided, That an article which is not otherwise deemed adulterated
under paragraphs (b)(4)(ii) (b), (c), or (d) of this section shall
nevertheless be deemed adulterated if use of the pesticide chemical,
food additive, or color additive in or on such article is prohibited by
the regulations in this part in official establishments;
(iii) If it consists in whole or in part of any filthy, putrid, or
decomposed substance or is for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food;
(iv) If it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health;
(v) If it is, in whole or in part, the product of any poultry which
has died otherwise than by slaughter;
(vi) If its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
(vii) If it has been intentionally subjected to radiation, unless
the use of the radiation was in conformity with a regulation or
exemption in effect pursuant to section 409 of the Federal Food, Drug,
and Cosmetic Act; or
(viii) If any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or if any substance has been
substituted, wholly or in part therefor; or if damage or inferiority has
been concealed in any manner; or if any substance has been added thereto
or mixed or packed therewith so as to increase its bulk or weight, or
reduce its quality or strength, or make it appear better or of greater
value than it is.
Animal food. Any article intended for use as food for dogs, cats, or
other animals, derived wholly, or in part, from carcasses or parts or
products of the carcass of poultry, except that the term animal food as
used herein does not include (i) processed dry animal food or (ii)
livestock or poultry feeds manufactured from processed poultry
byproducts (such as poultry byproduct meal, hydrolyzed poultry feathers,
and hydrolyzed poultry byproducts aggregate).
Animal food manufacturer. "Animal Food Manufacturer" means any
person engaged in the business of manufacturing or processing animal
food.
Applicant. "Applicant" means any person who requests inspection
service, exemption, or other authorization under the regulations.
Biological residue. "Biological Residue" means any substance,
including metabolites, remaining in poultry at the time of slaughter or
in any of its tissues after slaughter, as the result of treatment or
exposure of the live poultry to a pesticide, organic compound, metallic
or other inorganic compound, hormone, hormone-like substance, growth
promoter, antibiotic, anthelmintic, tranquilizer, or other agent that
leaves a residue.
Capable of use as human food. The term "capable of use as human
food" applies to any carcass, or part or product of a carcass of any
poultry, unless it is denatured or otherwise identified as required by
the regulations, or it is naturally inedible by humans.
Carcass. This term means all parts, including viscera, of any
slaughtered poultry.
Circuit supervisor. This term refers to the official of the
Inspection Service who is assigned responsibility for supervising the
conduct of inspection at a specific group of official establishments.
Commerce. "Commerce" means commerce between any State, any
territory, or the District of Columbia, and any place outside thereof;
or within any territory not organized with a legislative body, or the
District of Columbia.
Consumer package. "Consumer package" means any container in which
a
[[Page 419]]
poultry product is enclosed for the purpose of display and sale to
household consumers.
Container. The term "container" includes any box, can, tin, cloth,
plastic, or any other receptacle, wrapper, or cover.
Department. "Department" means the United States Department of
Agriculture.
Edible. This term means that an article is intended for use as human
food.
Egg Products Inspection Act. "Egg Products Inspection Act" means
the Act so entitled, approved December 29, 1970 (84 Stat. 1620, 21
U.S.C. 1031 et seq.).
Federal Food, Drug, and Cosmetic Act. "Federal Food, Drug, and
Cosmetic Act" means the Act so entitled, approved June 25, 1938 (52
Stat. 1040), and acts amendatory thereof or supplementary thereto (21
U.S.C. 301 et seq.).
Federal Meat Inspection Act. "Federal Meat Inspection Act" means
the Act so entitled, approved March 4, 1907, 34 Stat. 1260, as amended
by the Wholesome Meat Act, 81 Stat. 584 (21 U.S.C. 601 et seq.).
Free from protruding pinfeathers. "Free from protruding
pinfeathers" means that the carcass is free from protruding pinfeathers
which are visible to an inspector during an examination of the carcass
at normal operating speeds. However, a carcass may be considered as
being free from protruding pinfeathers if it has a generally clean
appearance (especially on the breast), and if not more than an
occasional protruding pinfeather is in evidence during a more careful
examination of the carcass.
Giblets. "Giblets" means the liver from which the bile sac has
been removed, the heart from which the pericardial sac has been removed,
and the gizzard from which the lining and contents have been removed:
Provided, That each such organ has been properly trimmed and washed.
Immediate container. "Immediate container" includes any consumer
package; or any other container in which poultry products, not consumer
packaged, are packed.
Import Field Office (IFO). The office of the supervisor of import
inspection activities for a particular importing field area. The areas
are as follows:
IFO 1. Boston, MA--Covering the States of Massachusetts,
New York (excluding New York City), Connecticut, Rhode Island, Vermont,
New Hampshire, and Maine.
IFO 2. New York, NY--Covering the areas of New York City
and northern New Jersey.
IFO 3. Philadelphia, PA--Covering the State of Pennsylvania
and the area of southern New Jersey.
IFO 4. Baltimore, MD--Covering the States of Maryland,
Delaware, West Virginia, Virginia and Kentucky.
IFO 5. Charleston, SC--Covering the States of Tennessee,
North Carolina, South Carolina, Georgia, and Florida (excluding south
Florida).
IFO 6. Miami, FL--Covering the areas of southern Florida,
Puerto Rico and the Virgin Islands.
IFO 7. New Orleans, LA--Covering the States of Louisiana,
Mississippi, Alabama, Arkansas, Texas, Oklahoma, Kansas, New Mexico and
Colorado.
IFO 8. San Pedro, CA--Covering the States of Hawaii,
Arizona, Utah, Nevada, the area of southern California, American Samoa,
Guam, and the Northern Marianas.
IFO 9. Tacoma, WA--Covering the States of Washington,
Oregon, Idaho, Montana, Wyoming, North Dakota, South Dakota, Alaska, and
Nebraska, and the area of northern California.
IFO 10. Detroit, MI--Covering the States of Michigan,
Wisconsin, Minnesota, Iowa, Missouri, Illinois, Indiana and Ohio.
Import Supervisor. The official in charge of import inspection
activities within each of the import field offices.
Inedible. This term means any carcass or any part of a carcass that
is either naturally inedible by humans or is rendered unfit for human
food by reason of adulteration or denaturing.
Inspected for wholesomeness. This term means that the poultry
product so identified has been inspected and was found at the time of
such inspection to be not adulterated.
Inspection. "Inspection" means any inspection required by the
regulations to determine whether any poultry or poultry products comply
with the requirements of the Act and the regulations.
Inspection Service. "Inspection Service" means the organizational
unit within the Department having the responsibility for carrying out
the provisions of the Act.
[[Page 420]]
Inspection Service employee. This term refers to any employee of the
Inspection Service who is authorized to perform any function under the
regulations.
Inspection Service supervisor. This term refers to any employee of
the Inspection Service who is delegated authority to exercise
supervision over certain phases of the inspection program at a
designated level. \1\
---------------------------------------------------------------------------
\1\ Information identifying the employees who have been delegated
such authority at various levels may be obtained from an inspector or
from the Administrator, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250.
---------------------------------------------------------------------------
Inspector. "Inspector" means (a) an employee or official of the
U.S. Government authorized by the Administrator to inspect poultry and
poultry products under the authority of this Act, or (b) any employee or
official of the government of any State or Territory or the District of
Columbia authorized by the Administrator to inspect poultry and poultry
products under the authority of this Act, under an agreement entered
into between the Administrator and the appropriate State or other
agency.
Inspector in Charge. This term means the inspector primarily
responsible for the conduct of inspection at any particular official
establishment.
Label. This term applies to any display of written, printed, or
graphic matter upon any article or the immediate container (not
including package liners) of any article.
Labeling. This term applies to all labels and other written,
printed, or graphic matter (i) upon any article or any of its containers
or wrappers, or (ii) accompanying such article.
Misbranded. This term applies to any poultry product under one or
more of the following circumstances:
(i) If its labeling is false or misleading in any particular;
(ii) If it is offered for sale under the name of another food;
(iii) If it is an imitation of another food, unless its label bears,
in type of uniform size and prominence, the word "imitation" and
immediately thereafter, the name of the food imitated;
(iv) If its container is so made, formed, or filled as to be
misleading;
(v) If in a package or other container, unless it bears a label
showing:
(a) The name and place of business of the manufacturer, packer, or
distributor; and
(b) An accurate statement of the quantity of the contents in terms
of weight, measure, or numerical count; except as otherwise provided in
Sec. 381.121(a) with respect to the quantity of contents;
(vi) If any word, statement, or other information required by or
under authority of the Act to appear on the label or other labeling is
not prominently placed thereon with such conspicuousness (as compared
with other words, statements, designs, or devices, in the labeling) and
in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use;
(vii) If it purports to be or is represented as a food for which a
definition and standard of identity or composition is prescribed by the
regulations in subpart P of this part unless:
(a) It conforms to such definition and standard, and
(b) Its label bears the name of the food specified in the definition
and standard, and insofar as may be required by such regulations, the
common names of optional ingredients (other than spices, flavoring, and
coloring) present in such food.
(viii) If it purports to be or is represented as a food for which a
standard or standards of fill of container have been prescribed by
regulations of the Secretary, \2\ and falls below the standard of fill
of container applicable thereto, unless its label bears, in such manner
and form as such regulations specify, a statement that it falls below
such standard;
---------------------------------------------------------------------------
\2\ No such standards are currently in effect. However, Sec. 381.129
prohibits the use of false or misleading containers.
---------------------------------------------------------------------------
(ix) If it is not subject to the provisions of paragraph (b)(vii) of
this section, unless its label bears:
(a) The common or usual name of the food, if any there be, and
(b) In case it is fabricated from two or more ingredients, the
common or
[[Page 421]]
usual name of each ingredient, except as otherwise provided in
Sec. 381.118(c);
(x) If it purports to be or is represented for special dietary uses,
unless the label bears such information concerning its vitamin, mineral,
and other dietary properties as is required by Sec. 381.124;
(xi) If it bears or contains any artificial flavoring, artificial
coloring, or chemical preservative, unless it bears a label stating that
fact; except as otherwise provided in Sec. 381.119, or
(xii) If it fails to bear, directly thereon or on its containers,
when required by Sec. 381.123, the official inspection legend and the
official establishment number of the establishment where the product was
processed; and unrestricted by any of the foregoing; such other
information as the Administrator may require in the regulations to
assure that it will not have false or misleading labeling and that the
public will be informed of the manner of handling required to maintain
the article in a wholesome condition.
Nonfood compounds. Any substance proposed for use in official
establishments, the intended use of which will not result, directly or
indirectly, in the substance becoming a component or otherwise affecting
the characteristics of poultry or poultry products, excluding labeling
and packaging materials as covered in subpart N of this part.
Official certificate. This term means any certificate prescribed in
subpart M of this part relating to poultry or poultry products.
Official device. This term means any label or other device
prescribed in subpart M of this part for use in applying any official
mark.
Official establishment. "Official establishment" means any
establishment as determined by the Administrator at which inspection of
the slaughter of poultry, or the processing of poultry products, is
maintained pursuant to the regulations.
Official inspection legend. This term means the official inspection
mark prescribed in Sec. 381.96 or the official poultry identification
mark prescribed in Sec. 381.97, showing that an article was inspected
for wholesomeness and passed in accordance with the Act.
Official mark. This term means any symbol prescribed in subpart M of
this part to identify the status of any article or poultry under the
Act.
Packaging material. Any cloth, paper, plastic, metal, or other
material used to form a container, wrapper, label, or cover for poultry
products.
Pesticide chemical, food additive, color additive, raw agricultural
commodity. These terms shall have the same meanings for the purposes of
the Act and the regulations as under the Federal Food, Drug, and
Cosmetic Act.
Poultry. "Poultry" means any domesticated bird (chickens, turkeys,
ducks, geese, guineas, ratites, or squabs, also termed young pigeons
from one to about thirty days of age), whether live or dead.
Poultry product. (i) This term means any poultry carcass or part
thereof; or any product which is made wholly or in part from any poultry
carcass or part thereof, excepting those exempted from definition as a
poultry product in Sec. 381.15. Except where the context requires
otherwise (e.g., in paragraph (b)(42) of this section), this term is
limited to articles capable of use as human food.
(ii) Poultry food product. This term means any product capable of
use as human food which is made in part from any poultry carcass or part
thereof, excepting those exempted from definition as a poultry product
in Sec. 381.15.
Poultry products broker. "Poultry products broker" means any
person engaged in the business of buying or selling poultry products on
commission, or otherwise negotiating purchases or sales of such articles
other than for his own account or as an employee of another person.
Process. Process used as a verb means to conduct any operation or
combination of operations, whereby poultry is slaughtered, eviscerated,
canned, salted, stuffed, rendered, boned, cut up, or otherwise
manufactured or processed. The term "process" does not refer to
freezing of poultry products, except when freezing is incidental to
operations otherwise classed as "processing" under this paragraph.
[[Page 422]]
Process authority. A person or organization with expert knowledge in
poultry production process control and relevant regulations.
Process schedule. A written description of processing procedures,
consisting of any number of specific, distinct, and ordered operations
directly under control of the establishment employed in the manufacture
of a specific product, including the control, monitoring, verification,
validation, and corrective action activities associated with production.
Ready-to-cook poultry. "Ready-to-cook poultry" means any
slaughtered poultry free from protruding pinfeathers and vestigial
feathers (hair or down), from which the head, feet, crop, oil gland,
trachea, esophagus, entrails, and lungs have been removed, and from
which the mature reproductive organs and kidneys may have been removed,
and with or without the giblets, and which is suitable for cooking
without need of further processing. Ready-to-cook poultry also means any
cut-up or disjointed portion of poultry or other parts of poultry, such
as reproductive organs, head, or feet that are suitable for cooking
without need of further processing.
Regulations. "Regulations" means the provisions of this entire
part.
Renderer. "Renderer" means any person engaged in the business of
rendering carcasses, or parts or products of the carcasses, of poultry,
except rendering conducted under inspection or exemption pursuant to the
regulations.
Secretary. "Secretary" means the Secretary of Agriculture of the
United States or his delegate.
Shipping container. "Shipping container" means any container used
or intended for use in packaging the product packed in an immediate
container.
Slaughter. "Slaughter" means the act of killing poultry for human
food.
State. Except as otherwise provided in Sec. 381.220 "State" means
any State of the United States and the Commonwealth of Puerto Rico.
Supervision. This term means the controls, as prescribed in
instructions to Inspection Service employees, to be exercised by them
over particular operations to insure that such operations are conducted
in compliance with the Act and the regulations in this part.
Territory. The term "territory" means Guam, the Virgin Islands of
the United States, American Samoa, and any other territory or possession
of the United States, excluding the Canal Zone.
United States. This term means the States, the District of Columbia,
and the territories of the United States.
U.S. Condemned. This term means that the poultry carcass, or part or
product of a poultry carcass, so identified was inspected and found to
be adulterated and is condemned.
U.S. Detained. This term is applicable to poultry, poultry products,
and other articles which are held in official custody in accordance with
section 19 of the Act and Sec. 381.210, pending disposal as provided in
said section 19.
U.S. Refused Entry. This term means that the slaughtered poultry or
other poultry product so identified was presented for inspection for
entry into the United States and was found not to comply with the
requirements of the Act.
U.S. Rejected. This term means that the equipment or facility so
identified is prohibited from being used in the processing of any
poultry or poultry product until such equipment or facility is found by
an inspector to be sanitary and otherwise eligible for use under the
regulations.
U.S. Retained. This term means that the poultry or carcass, or part
or product of a carcass, of poultry so identified is held at an official
establishment by the inspection service for further determination as to
its disposal.
(c) For the purposes of the standard for cooked, smoked sausage
(Sec. 319.180 of this chapter), the term "poultry byproduct" means the
skin, fat, gizzard, heart, or liver, or any combination thereof, of any
poultry.
[37 FR 9706; May 16, 1972, as amended at 39 FR 4568, Feb. 5, 1974; 40 FR
42338, Sept. 12, 1975; 48 FR 6091, Feb. 10, 1983; 49 FR 2236, Jan. 19,
1984; 49 FR 3643, Jan. 30, 1984; 49 FR 47478, Dec. 5, 1984; 51 FR 37709,
Oct. 24, 1986; 64 FR 745, Jan. 6, 1999; 64 FR 56416, Oct. 20, 1999; 66
FR 1770, Jan. 9, 2001; 66 FR 22905, May 7, 2001; 67 FR 13258, Mar. 22,
2002]
[[Page 423]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.3]
[Page 423-424]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart B--Administration; Application of Inspection and Other
Requirements
Sec. 381.3 Administration.
(a) General authority to administer the Act has been delegated to
the Administrator (29 FR 16210, as amended; 37 FR 6327, 6505).
(b) The Administrator may in specific classes of cases waive for
limited periods any provisions of the regulations in order to permit
appropriate and necessary action in the event of a public health
emergency or to permit experimentation so that new procedures,
equipment, and processing techniques may be tested to facilitate
definite improvements: Provided, That such waivers of the provisions of
the regulations are not in conflict with the purposes or provisions of
the Act.
(c) Pursuant to section 6 of the Act, the Administrator believes
that, in establishments processing poultry products at which inspection
under the Act and regulations is required, the frequency with which and
the manner in which poultry products made from poultry previously
slaughtered and eviscerated in official establishments are reinspected
by Inspection Service employees should be based on considerations
relevant to effective regulation of poultry products and protection of
the health and welfare of consumers. In order to test procedures for use
in making such determinations and, in particular, for determining
whether and, if so, to what extent the intensity of inspection coverage
exceeds that which should be deemed necessary pursuant to section 6 of
the Act, the Administrator is initiating experimentation of a new system
of inspection for reviewing the performance of establishments and for
designing the supervision and other conditions and methods of inspection
coverage. For the period of such experimentation, the Administrator
shall identify establishments for review, and the frequency and the
manner of inspection by Inspection Service employees shall be determined
on the basis of the results of those reviews and be otherwise in
accordance with this section.
(d) The determinations referred to in paragraph (c) of this section
shall be made by the Inspection Service and shall reflect evaluations of
the performance and the characteristics of such establishments.
(1) In assessing the performance of an establishment, the following
factors are appropriate for consideration:
(i) The history of compliance with applicable regulatory
requirements by the person operating such establishment or by anyone
responsibly connected with the business operating such establishment, as
"responsibly connected" is defined in section 18(a) of the Act,
(ii) The competence of the person operating such establishment, as
indicated by:
(A) Knowledge of appropriate manufacturing practices and applicable
regulatory requirements,
(B) Demonstrated ability to apply such knowledge in a timely and
consistent manner, and
(C) Commitment to correcting deficiencies noted by Inspection
Service employees and otherwise assuring compliance with applicable
regulatory requirements, and
(iii) The procedures used in such establishment to control the
production process, environment, and resulting product in order to
assure and monitor compliance with the requirements of the Act and the
rules and regulations promulgated thereunder.
(2) In assessing the characteristics of an establishment, the
following factors are appropriate for consideration:
(i) The complexity of the processing operation(s) conducted at such
establishment,
(ii) The frequency with which each such operation is conducted at
such establishment,
(iii) The volume of product resulting from each such operation at
such establishment,
(iv) Whether and to what extent slaughter and evisceration
operations also are conducted at such establishment,
(v) What, if any, food products not regulated under this Act or the
Federal Meat Inspection Act also are processed at such establishment,
and
(vi) The size of such establishment.
(e)(1) For the period of experimentation described in paragraph (c)
of
[[Page 424]]
this section, the frequency of inspection by Inspection Service
employees of operations other than slaughter and evisceration may be
reduced in an establishment in which the procedures referred to therein
are being tested if and only if the evaluation of the performance of
such establishment described in paragraph (d)(1) indicates that there
are:
(i) No instances, documented in records compiled no earlier than 10
years before, of substantial and recent noncompliance with applicable
regulatory requirements (taking into account both the nature and
frequency of any such noncompliance), and
(ii) The competence and control procedures needed to assure and
monitor compliance with applicable regulatory requirements.
(2)(i) The frequency of Federal inspection and other conditions and
methods of inspection coverage in any establishment in which the
frequency of Federal inspection is reduced shall be based on:
(A) The evaluation of the characteristics of such establishment
described in paragraph (d)(2) of this section,\1\
---------------------------------------------------------------------------
\1\ These evaluations will be based upon guidelines developed by
FSIS and the complexity categorization in FSIS Directive 1030.2
(Documentation of Processing and Combination Assignments, 4/22/85). The
guidelines and Directive will be available for public inspection and
copying in the Policy Office, Room 3168, South Agriculture Building,
14th Street and Independence Avenue, SW., Washington, DC.
---------------------------------------------------------------------------
(B) The significance of potential public health consequences of
noncompliance, and
(C) The availability of Inspection Service employees.
(ii) To the extent that frequency of inspection or other conditions
and methods of inspection coverage are identified as conflicting with
provisions of the regulations in this part, the Administrator will waive
such provisions for the period of experimentation, in accordance with
paragraph (b) of this section.
[37 FR 9706, May 16, 1972, as amended at 52 FR 10033, Mar. 30, 1987]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.4]
[Page 424]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart B--Administration; Application of Inspection and Other
Requirements
Sec. 381.4 Inspection in accordance with methods prescribed or approved.
Inspection of poultry products shall be rendered pursuant to the
regulations and under such conditions and in accordance with such
methods as may be prescribed or approved by the Administrator.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.5]
[Page 424]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart B--Administration; Application of Inspection and Other
Requirements
Sec. 381.5 Publications.
Publications under the Act and the regulations shall be made in the
Federal Register and in such other media as the Administrator may
designate.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.6]
[Page 424]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart B--Administration; Application of Inspection and Other
Requirements
Sec. 381.6 Establishments requiring inspection.
Inspection under the regulations is required at:
(a) Every establishment, except as provided in Sec. 381.10 (a) and
(b) or Sec. 381.11, in which any poultry is slaughtered for
transportation or sale in commerce, or in which any poultry products are
wholly or in part, processed for transportation or sale in commerce, as
articles intended for use as human food;
(b) Every establishment, except as provided in Sec. 381.10 (a) and
(b), (c), or (d), or Sec. 381.11, within any State or organized
territory which is designated in Sec. 381.221 pursuant to section 5(c)
of the Act, at which any poultry is slaughtered or any poultry products
are processed, for use as human food solely for distribution within such
jurisdiction; and
(c) Except as provided in Sec. 381.10 (a) and (b), or (c), or
Sec. 381.11, every establishment designated by the Administrator
pursuant to section 5(c) of the Act as one producing adulterated poultry
products which would clearly endanger the public health.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.7]
[Page 424]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart B--Administration; Application of Inspection and Other
Requirements
Sec. 381.7 Coverage of all poultry and poultry products processed in official establishments.
All poultry and poultry products processed in an official
establishment shall be inspected, handled, processed, marked, and
labeled as required by the regulations.
[[Page 425]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.10]
[Page 425-432]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart C--Exemptions
Sec. 381.10 Exemptions for specified operations.
(a) The requirements of the Act and the regulations for inspection
of the processing of poultry and poultry products shall not apply to:
(1) Any retail dealer with respect to poultry products sold in
commerce directly to consumers in an individual retail store, if the
only processing operation performed by such retail dealer is the cutting
up of poultry products on the premises where such sales to consumers are
made: Provided, That such operation is conducted under such sanitary
standards, practices, and procedures as result in the preparation of
poultry products that are not adulterated: And provided further, That
the poultry products sold in commerce are derived from poultry inspected
and passed under the Act and such poultry products are not adulterated
or misbranded at the time of sale (except that the official inspection
legend shall not be used). (For the purposes of this subparagraph, a
retail dealer is any person who sells poultry products directly to
consumers as defined in paragraph (d)(2)(vi) of this section and whose
sales of poultry products to household consumers constitute, in terms of
dollar value, at least 75 percent of his total sales of poultry
products.)
(2) The slaughter of poultry, and the processing of poultry
products, by any person in any territory not organized with a
legislative body, solely for distribution within such territory:
Provided, That such poultry is sound and healthy and is slaughtered
under such sanitary standards, practices, and procedures as result in
the preparation of poultry products that are not adulterated: And
provided further, That the poultry products are not adulterated or
misbranded when so distributed (except that the official inspection
legend shall not be used).
(3) The slaughtering by any person of poultry of his own raising,
and the processing by him and transportation in commerce of the poultry
products exclusively for use by him and members of his household and his
nonpaying guests and employees: Provided, That in lieu of complying with
all the adulteration and misbranding provisions of the Act, such poultry
is healthy and is slaughtered and processed under such sanitary
standards, practices, and procedures as result in the preparation of
poultry products that are sound, clean, and fit for human food, and the
shipping containers of such poultry products bear the producer's name
and address and the statement "Exempted--P.L. 90-492."
(4) The custom slaughter by any person of poultry delivered by the
owner thereof for such slaughter, and the processing by such slaughterer
and transportation in commerce of the poultry products exclusively for
use, in the household of such owner, by him and members of his household
and his nonpaying guests and the employees: Provided, That such custom
slaughterer does not engage in the business of buying or selling any
poultry products capable of use as human food: And provided further,
That in lieu of complying with all the adulteration and misbranding
provisions of the Act, such poultry is healthy and is slaughtered and
processed under such sanitary standards, practices, and procedures as
result in the preparation of poultry products that are sound, clean and
fit for human food, and the shipping containers of such poultry products
bear the owner's name and address and the statement "Exempted--P.L. 90-
492."
(5) The slaughtering of sound and healthy poultry and processing of
poultry products therefrom in any State or territory or the District of
Columbia by any poultry producer on his own premises with respect to
poultry raised on his premises, and the distribution by any person
solely within such jurisdiction of the poultry products derived from
such operations: Provided, That (i) in lieu of complying with all the
adulteration provisions of the Act, such poultry is slaughtered and
otherwise processed and handled under such sanitary standards,
practices, and procedures as result in the preparation of poultry
products that are sound, clean, and fit for human food when so
distributed; (ii) such poultry products when so distributed, bear (in
lieu of labeling that would otherwise be required) the producer's name
and address and the
[[Page 426]]
statement "Exempted--P.L. 90-492" and such poultry products are not
otherwise misbranded; (iii) such producer and distributor do not engage
in the current calendar year in the business of buying or selling any
poultry or poultry products other than as specified in this paragraph
(a) (5) or (6) of this section; and (iv) neither such producer or
distributor slaughters or processes the products of more poultry than
allowed by paragraph (b) of this section.
(6) The slaughtering of sound and healthy poultry or the processing
of poultry products of such poultry in any State or territory or the
District of Columbia by any poultry producer or other person for
distribution by him solely within such jurisdiction directly to
household consumers, restaurants, hotels, and boardinghouses, for use in
their own dining rooms, or in the preparation of meals for sales direct
to consumers: Provided, That (i) in lieu of complying with all the
adulteration provisions of the Act, such poultry is slaughtered and
otherwise processed and handled under such sanitary standards,
practices, and procedures as result in the preparation of poultry
products that are sound, clean, and fit for human food when distributed
by such processor; (ii) such poultry products when so distributed bear
(in lieu of labeling that would otherwise be required) the processor's
name and address and the statement "Exempted--P.L. 90-492" and such
poultry products are not otherwise misbranded; (iii) such processor does
not engage in the current calendar year in the business of buying or
selling any poultry or poultry products other than as specified in this
paragraph (a) (6) or (5) of this section; and (iv) such processor does
not exceed the volume limitation prescribed in paragraph (b) of this
section.
(7) The operations and products of small enterprises (including
poultry producers) not exempted under paragraphs (a) (1) through (6) of
this section that are engaged in any State or territory or the District
of Columbia in slaughtering and/or cutting up poultry for distribution
as carcasses or parts thereof solely for distribution within such
jurisdiction; Provided, That (i) such poultry is sound and healthy when
slaughtered and is slaughtered and/or cut up and handled under such
sanitary standards, practices and procedures as result in the
preparation of poultry products that are not adulterated when so
distributed; and (ii) when so distributed, such poultry products are not
misbranded (except that the official inspection legend shall not be
used).
(b) No person qualifies for any exemption specified in paragraph
(a)(5), (6), or (7) of this section if, in the current calendar year,
such person:
(1) Slaughters or processes the products of more than 20,000
poultry, or
(2) Slaughters or processes poultry products at a facility used for
slaughtering or processing poultry products by any other person, except
when the Administrator grants such exemption after determining, upon
review of a person's application, that such an exemption will not impair
effectuating the purposes of the Act.
(c) The provisions of the Act and the regulations do not apply to
any poultry producer with respect to poultry, of his own raising on his
own farm, which he slaughters if:
(1) Such producer slaughters not more than 1,000 poultry during the
calendar year for which this exemption is being determined;
(2) Such poultry producer does not engage in buying or selling
poultry products other than those produced from poultry raised on his
own farm; and
(3) None of such poultry moves in "commerce" (as defined in
Sec. 381.1).
(d)(1) The requirements of the Act and the regulations for
inspection of the processing of poultry and poultry products do not
apply to operations of types traditionally and usually conducted at
retail stores and restaurants, when conducted at any retail store or
restaurant or similar-retail-type establishment for sale in normal
retail quantities or service of such articles to consumers at such
establishments.
(2) For the purposes of paragraph (d)(1) of this section:
(i) Operations of types traditionally and usually conducted at
retail stores and restaurants include any processing of poultry products
except canning of
[[Page 427]]
poultry products and except slaughtering of poultry unless such
slaughtering is conducted at a retail store with respect to live poultry
purchased by the consumer at the retail store and processed by the
retail store operator in accordance with the consumer's instructions.
(ii) A normal retail quantity is any quantity of a poultry product
purchased by a household consumer from a retail supplier that in the
aggregate does not exceed 75 pounds. A normal retail quantity sold by a
retail supplier to other than a household consumer is any quantity that
in the aggregate does not exceed 150 pounds.
(iii) A retail store is any place of business where:
(a) The sales of poultry products are made to consumers only;
(b) At least 75 percent, in terms of dollar value, of total sales of
product represents sales to household consumers and the total dollar
value of sales of product to consumers other than household consumers
does not exceed the dollar limitation per calendar year set by the
Administrator. This dollar limitation is a figure which will
automatically be adjusted during the first quarter of each calendar
year, upward or downward, whenever the Consumer Price Index, published
by the Bureau of Labor Statistics, Department of Labor, indicates a
change in the price of this same volume of product which exceeds $500.
Notice of the adjusted dollar limitation will be published in the
Federal Register. \1\
---------------------------------------------------------------------------
\1\ The dollar limitation currently in effect may be obtained by
contacting Director, Slaughter Inspection Standards and Procedures
Division, Technical Services, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250 (202) 447-3219.
---------------------------------------------------------------------------
(c) Only federally or State inspected and passed, or exempted (or,
as provided in Sec. 381.223, State or local agency inspected and passed
or exempted) poultry products are handled or used in the preparation of
any poultry products;
(d) No sale of poultry products is made in excess of a normal retail
quantity as defined in paragraph (d)(2)(ii) of this section; and
(e) The processing of poultry products for sale is limited to
traditional and usual operations as defined in paragraph (d)(2)(i) of
this section.
(iv) Restaurants. (a) A restaurant is any establishment where:
(1) Poultry products are processed only for sale or service in meals
or as entrees directly to individual consumers at such establishments;
(2) Only federally inspected and passed, or exempted (or, as
provided in Sec. 381.223, State or local agency inspected and passed or
exempted) poultry products are handled or used in the preparation of any
poultry products;
(3) No sale of poultry products is made in excess of a normal retail
quantity as defined in paragraph (d)(2)(ii) of this section; and
(4) The processing of poultry products is limited to traditional and
usual operations as defined in paragraph (d)(2)(i) of this section.
(b) The definition of a restaurant includes a caterer which delivers
or serves product in meals, or as entrees, only to individual consumers
and otherwise meets the requirements of this paragraph.
(c) For purposes of this paragraph, operations conducted as a
restaurant central kitchen facility shall be considered as being
conducted at a restaurant if the restaurant central kitchen prepares
poultry products that are ready to eat when they leave such facility
(i.e., no further cooking or other preparation is needed, except that
they may be reheated prior to serving if chilled during transportation),
transported directly to a receiving restaurant by its own employees,
without intervening transfer or storage, maintained in a safe,
unadulterated condition during transportation, and served in meals or as
entrees only to customers at restaurants, or through vending machines,
owned or operated by the same person that owns or operates such
facility, and which otherwise meets the requirement of this paragraph:
Provided, That the requirements of Secs. 381.175 through 381.178 of this
subchapter apply to such facility. Provided further, That the exempted
facility may be subject to inspection requirements under the Act for as
long as the Administrator deems necessary if the
[[Page 428]]
Administrator determines that the sanitary conditions or practices of
the facility or the processing procedures or methods at the facility are
such that any of its poultry products are rendered adulterated. When the
Administrator has made such determination and subjected a restaurant
central kitchen facility to such inspection requirements, the operator
of such facility shall be afforded an opportunity to dispute the
Administrator's determination in a hearing pursuant to rules of practice
which will be adopted for this proceeding.
(v) A similar retail-type establishment is any establishment which
is a combination retail store and restaurant; any delicatessen which
meets the requirements for a retail store or restaurant as prescribed in
paragraph (d)(2) (iii) or (iv) of this section; or other establishment
as determined by the Administrator in specific cases.
(vi) A consumer is any household consumer, hotel, or restaurant, or
similar institution as determined by the Administrator in specific
cases.
(3) Whenever any complaint is received by the Administrator from any
person alleging that any retail establishment or restaurant claiming
exemption under this paragraph (d) in any designated State or organized
territory listed in Sec. 381.221 that is also identified in Sec. 381.224
as a jurisdiction that does not have or is not exercising adequate
authority with respect to recordkeeping requirements, has been operated
in violation of the conditions prescribed in this paragraph (d) for such
exemption, and the Administrator, upon investigation of the complaint,
has reason to believe that any such violation has occurred, he shall so
notify the operator of the retail establishment or restaurant and afford
him reasonable opportunity to present his views informally with respect
to the matter. Thereafter, if the Administrator determines that such a
violation has occurred, and that a requirement that the operator keep
records concerning the operations of the retail establishment or
restaurant would effectuate the purposes of the Act, the Administrator
shall order the operator to maintain complete, accurate, and legible
records of his total monthly purchases and of his total monthly sales of
poultry and poultry products. Such records shall separately show total
sales to household consumers and total sales to other consumers, and
shall be maintained for the period prescribed in Sec. 381.177. If the
operator maintains copies of bills of lading, receiving and shipping
invoices, warehouse receipts, or similar documents which give the
information required herein, additional records are not required by this
subparagraph.
(4) The adulteration and misbranding provisions of the Act and the
regulations other than the requirement of the official inspection
legend, apply to articles which are exempted from inspection under this
paragraph (d).
(e)(1) The requirements of the Act and the regulations in this
subchapter for inspection of the preparation of products do not apply to
poultry pizzas containing poultry product ingredients which were
prepared, inspected, and passed in a cured or cooked form as ready-to-
eat (i.e., no further cooking or other preparation is needed) in
compliance with the requirements of the Act and these regulations; and
the poultry pizzas are to be served in public or private nonprofit
institutions, provided that the poultry pizzas are ready to eat (i.e.,
no further cooking or other preparation is needed, except that they may
be reheated prior to serving if chilled during transportation),
transported directly to the receiving institution by employees of the
preparing firm, receiving institution, or a food service management
company contracted to conduct food service at the public or private
nonprofit institution, without intervening transfer or storage.
(2) The definitions at Chapter 1, 1-102, except 1-102(z) and the
provisions of Chapters 2 through 8, except sections 2-102 (a) and (b),
2-302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506,
2-508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c),
5-203, and 6-105, Part IV, of the Food and Drug Administration's Food
Service Sanitation Manual (1976 Recommendations), DHEW Publication No.
(FDA) 78-2081, which is incorporated by reference,
[[Page 429]]
shall apply to the facilities and operations of businesses claiming this
exemption. (These materials are incorporated as they exist on the date
of approval. This incorporation by reference was approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies may be purchased from the Superintendent of
Documents, U.S. Government Printing Office, Washington, DC 20402. It is
also available for inspection at the Office of the Federal Register
Information Center, Suite 700, 800 North Capitol Street, NW.,
Washington, DC, or the FSIS Hearing Clerk, room 3171, South Building,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250.)
(3) Facilities and operations of businesses claiming this exemption
shall also conform to the following requirements:
(i) Manual cleaning and sanitizing. (A) For manual washing, rinsing
and sanitizing of utensils and equipment, a sink with not fewer than
three compartments shall be provided and used. Sink compartments shall
be large enough to permit the accommodation of the equipment and
utensils, and each compartment of the sink shall be supplied with hot
and cold potable running water. Fixed equipment and utensils and
equipment too large to be cleaned in sink compartments shall be washed
manually or cleaned through pressure spray methods.
(B) Drain boards or easily movable dish tables of adequate size
shall be provided for proper handling of soiled utensils prior to
washing and for cleaned utensils following sanitizing and shall be
located so as not to interfere with the proper use of the dishwashing
facilities.
(C) Equipment and utensils shall be preflushed or prescraped and,
when necessary, presoaked to remove gross food particles and soil.
(D) Except for fixed equipment and utensils too large to be cleaned
in sink compartments, manual washing, rinsing and sanitizing shall be
conducted in the following sequence:
(1) Sinks shall be cleaned prior to use.
(2) Equipment and utensils shall be thoroughly washed in the first
compartment with a hot detergent solution that is kept clean.
(3) Equipment and utensils shall be rinsed free of detergent and
abrasives with clean water in the second compartment.
(4) Equipment and utensils shall be sanitized in the third
compartment according to one of the methods prescribed in paragraph
(e)(3)(i)(E) (1) through (4) of this section.
(E) The food-contact surfaces of all equipment and utensils shall be
sanitized by:
(1) Immersion for at least \1/2\ minute in clean, hot water at a
temperature of at least 170 deg.F; or
(2) Immersion for at least 1 minute in a clean solution containing
at least 50 parts per million of available chlorine as a hypochlorite
and at a temperature of at least 75 deg.F; or
(3) Immersion for at least 1 minute in a clean solution containing
at least 12.5 parts per million of available iodine and having a pH not
higher than 5.0 and at a temperature of at least 75 deg.F; or
(4) Immersion in a clean solution containing any other chemical
sanitizing agent allowed under 21 CFR 178.1010 that will provide the
equivalent bactericidal effect of a solution containing at least 50
parts per million of available chlorine as a hypochlorite at a
temperature of at least 75 deg.F for 1 minute; or
(5) Treatment with steam free from materials or additives other than
those specified in 21 CFR 173.310 in the case of equipment too large to
sanitize by immersion, but in which steam can be confined; or
(6) Rinsing, spraying, or swabbing with a chemical sanitizing
solution of at least twice the strength required for that particular
sanitizing solution under paragraph (e)(3)(i)(E)(4) of this section in
the case of equipment too large to sanitize by immersion.
(F) When hot water is used for sanitizing, the following facilities
shall be provided and used:
(1) An integral heating device or fixture installed in, on, or under
the sanitizing compartment of the sink capable of maintaining the water
at a temperature of at least 170 deg.F; and
[[Page 430]]
(2) A numerically scaled indicating thermometer, accurate to
3 deg.F, convenient to the sink for frequent checks of
water temperature; and
(3) Dish baskets of such size and design to permit complete
immersion of the tableware, kitchenware, and equipment in the hot water.
(G) When chemicals are used for sanitization, they shall not have
concentrations higher than the maximum permitted under 21 CFR 178.1010
and a test kit or other device that accurately measures the parts per
million concentration of the solution shall be provided and used.
(ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing
may be done by spray-type or immersion dishwashing machines or by any
other type of machine or device if it is demonstrated that it thoroughly
cleans and sanitizes equipment and utensils. These machines and devices
shall be properly installed and maintained in good repair. Machines and
devices shall be operated in accordance with manufacturers'
instructions, and utensils and equipment placed in the machine shall be
exposed to all dishwashing cycles. Automatic detergent dispensers,
wetting agent dispensers, and liquid sanitizer injectors, if any, shall
be properly installed and maintained.
(B) The pressure of final rinse water supplied to spray-type
dishwashing machines shall not be less than 15 nor more than 25 pounds
per square inch measured in the water line immediately adjacent to the
final rinse control valve. A \1/4\-inch IPS valve shall be provided
immediately upstream from the final rinse control valve to permit
checking the flow pressure of the final rinse water.
(C) Machine or water line mounted numerically scaled indicating
thermometers, accurate to 3 deg.F, shall be provided to
indicate the temperature of the water in each tank of the machine and
the temperature of the final rinse water as it enters the manifold.
(D) Rinse water tanks shall be protected by baffles, curtains, or
other effective means to minimize the entry of wash water into the rinse
water. Conveyors in dishwashing machines shall be accurately timed to
assure proper exposure times in wash and rinse cycles in accordance with
manufacturers' specifications attached to the machines.
(E) Drain boards shall be provided and be of adequate size for the
proper handling of soiled utensils prior to washing and of cleaned
utensils following sanitization and shall be so located and constructed
as not to interfere with the proper use of the dishwashing facilities.
This does not preclude the use of easily movable dish tables for the
storage of soiled utensils or the use of easily movable dishtables for
the storage of clean utensils following sanitization.
(F) Equipment and utensils shall be flushed or scraped and, when
necessary, soaked to remove gross food particles and soil prior to being
washed in a dishwashing machine unless a prewashcycle is a part of the
dishwashing machine operation. Equipment and utensils shall be placed in
racks, trays, or baskets, or on conveyors, in a way that food-contact
surfaces are exposed to the unobstructed application of detergent wash
and clean rinse waters and that permits free draining.
(G) Machines (single-tank, stationary-rack, door-type machines and
spray-type glass washers) using chemicals for sanitization may be used:
Provided, That,
(1) The temperature of the wash water shall not be less than 120
deg.F.
(2) The wash water shall be kept clean.
(3) Chemicals added for sanitization purposes shall be automatically
dispensed.
(4) Utensils and equipment shall be exposed to the final chemical
sanitizing rinse in accordance with manufacturers' specifications for
time and concentration.
(5) The chemical sanitizing rinse water temperature shall be not
less than 75 deg.F nor less than the temperature specified by the
machine's manufacturer.
(6) Chemical sanitizers used shall meet the requirements of 21 CFR
178.1010.
(7) A test kit or other device that accurately measures the parts
per million concentration of the solution shall be available and used.
[[Page 431]]
(H) Machines using hot water for sanitizing may be used provided
that wash water and pumped rinse water shall be kept clean and water
shall be maintained at not less than the following temperatures:
(1) Single-tank, stationary-rack, dual-temperature machine:
Wash temperature..................................................150
deg.F
Final rinse temperature...........................................180
deg.F
(2) Single-tank, stationary-rack, single-temperature machine:
Wash temperature..................................................165
deg.F
Final rinse temperature...........................................165
deg.F
(3) Single-tank, conveyor machine:
Wash temperature..................................................160
deg.F
Final rinse temperature...........................................180
deg.F
(4) Multitank, conveyor machine:
Wash temperature..................................................150
deg.F
Pumped rinse temperature..........................................160
deg.F
Final rinse temperature...........................................180
deg.F
(5) Single-tank, pot, pan, and utensil washer (either stationary or
moving-rack):
Wash temperature..................................................140
deg.F
Final rinse temperature...........................................180
deg.F
(I) All dishwashing machines shall be thoroughly cleaned at least
once a day or more often when necessary to maintain them in a
satisfactory operating condition.
(iii) Steam. Steam used in contact with food or food-contact
surfaces shall be free from any materials or additives other than those
specified in 21 CFR 173.310.
(4) For purposes of this paragraph, the term "private nonprofit
institution" means "a corporation, and any community chest, fund, or
foundation, organized and operated exclusively for religious,
charitable, scientific, testing for public safety, literary, or
educational purposes, or to foster national or international amateur
sports competition (but only if no part of its activities involve the
provision of athletic facilities or equipment), or for the prevention of
cruelty to children or animals, no part of the net earnings of which
inures to the benefit of any private shareholder or individual, no
substantial part of the activities of which is carrying on propaganda,
or otherwise attempting, to influence legislation, and which does not
participate in, or intervene in (including the publishing or
distribution of statements), any political campaign on behalf of (or in
opposition to) any candidate for public office."
(5) The Administrator may withdraw or modify the exemption set forth
in Sec. 381.10(e)(1) for a particular establishment when he or she
determines that such action is necessary to ensure food safety and
public health. Before such action is taken, the owner or operator of the
particular establishment shall be notified, in writing, of the reasons
for the proposed action and shall be given an opportunity to respond, in
writing, to the Administrator within 20 days after notification of the
proposed action. The written notification shall be served on the owner
or operator of the establishment in the manner prescribed in section
1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)).
In those instances where there is conflict of any material fact, the
owner or operator of the establishment, upon request, shall be afforded
an opportunity for a hearing with respect to the disputed fact, in
accordance with rules of practice which shall be adopted for the
proceeding. However, such withdrawal or modification shall become
effective pending final determination in the proceeding when the
Administrator determines that an imminent threat to food safety or
public health exists, and that such action is, therefore, necessary to
protect the public health, interest or safety. Such withdrawal or
modification shall be effective upon oral or written notification,
whichever is earlier, to the owner or operator of the particular
establishment as promptly as circumstances permit. In the event of oral
notification, written confirmation shall be given to the owner or
operator of the establishment as promptly as circumstances permit. This
withdrawal or modification shall continue in effect pending the
completion of the proceeding and any judicial review thereof, unless
otherwise ordered by the Administrator.
[[Page 432]]
(6) The adulteration and misbranding provisions of the Act and the
regulations apply to articles which are exempted from inspection under
Sec. 381.10(e).
[37 FR 9706, May 16, 1972, as amended at 38 FR 16991, June 28, 1973; 45
FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 16, 1981; 48 FR 2959, Jan.
24, 1983; 51 FR 29909, Aug. 21, 1986; 53 FR 24679, June 30, 1988; 57 FR
34184, Aug. 3, 1992]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.11]
[Page 432]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart C--Exemptions
Sec. 381.11 Exemptions based on religious dietary laws.
(a) Any person who slaughters, processes, or otherwise handles
poultry or poultry products which have been or are to be processed as
required by recognized religious dietary laws may apply for exemption
from specific provisions of the Act or regulations which are in conflict
with such religious dietary laws. Any person desiring such an exemption
shall apply in writing to the Meat and Poultry Inspection Program, Food
Safety and Inspection Service, Department of Agriculture, Washington, DC
20250, setting forth the specific provisions of the Act and the
regulations from which exemption is sought and setting forth the
provisions of the religious dietary laws in support of the requested
exemption. In addition, the applicant for such an exemption shall submit
a statement from the clerical official having jurisdiction over the
enforcement of the religious dietary laws with respect to the poultry or
poultry products involved, which identifies the requirements of such
laws pertaining to the slaughter of the poultry and the processing or
other handling of the poultry products involved, and certifies that such
requirements are in conflict with specific provisions of the Act and
regulations from which the exemption is sought.
(b) The Administrator, upon a determination that an exemption should
be granted, will grant such exemption to the extent necessary to avoid
conflict with the religious requirements while still effectuating the
purposes of the Act. He may impose such conditions as to sanitary
standards, practices, and procedures in granting such exemption as he
deems necessary to effectuate the purposes of the Act. Any person who
processes poultry or poultry products under exemption from certain
requirements as provided in this section shall be subject to all of the
other applicable provisions of the Act and the regulations. Processing
plants shall meet the sanitary requirements set forth in this part and
unless exempted from inspection under the provisions of this subpart,
shall be required to qualify for inspection and operate as official
establishments. Slaughtered poultry which is prepared under an exemption
authorizing the sale of noneviscerated poultry in commerce shall be
individually identified with a label approved by the Administrator which
identifies the clerical official under whose supervision the poultry was
slaughtered.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.12]
[Page 432]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart C--Exemptions
Sec. 381.12 Effect of religious dietary laws exemptions on other persons.
Whenever a slaughterer or processor is granted an exemption under
Sec. 381.11 with respect to the slaughtering or processing of any
poultry or poultry products under this part, under specified conditions,
the sale, offer for sale, transportation and other handling in commerce
by any person of such poultry and poultry products in accordance with
such conditions is hereby authorized, except as restricted by the Act.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.13]
[Page 432-433]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart C--Exemptions
Sec. 381.13 Suspension or termination of exemptions.
(a) The Administrator may, by order, in accordance with the
applicable rules of practice suspend or terminate any exemption under
Sec. 381.10(a) with respect to any person whenever he finds that such
action will aid in effectuating the purposes of the Act. Failure to
comply with the conditions of the exemption, including, but not limited
to, failure to process poultry and poultry products under clean and
sanitary conditions may result in termination of an exemption, in
addition to any other penalties provided by law.
(b) Except as provided in Sec. 381.10(c), the Administrator may
extend the requirements of the Act to any establishment in any State or
organized territory at which poultry products are processed for
distribution solely within such jurisdiction if he determines in
accordance with the provisions of subparagraph 5(c)(1) of the Act that
the establishment is producing adulterated
[[Page 433]]
poultry products which would clearly endanger the public health.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.14]
[Page 433]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart C--Exemptions
Sec. 381.14 Inspection concerning purportedly exempted operations.
Inspectors of the Inspection Service are authorized to make
inspections in accordance with law to ascertain whether any of the
provisions of the Act or the regulations applying to producers,
retailers, or other persons purporting to be exempted from any
requirements under this subpart have been violated.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.15]
[Page 433-434]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart C--Exemptions
Sec. 381.15 Exemption from definition of "poultry product" of certain human food products containing poultry.
The following articles contain poultry ingredients only in a
relatively small proportion or historically have not been considered by
consumers as products of the poultry food industry. Therefore said
articles are exempted from the definition of "poultry product" and the
requirements of the Act and the regulations applicable to poultry
products, if they comply with the conditions specified in this section.
(a) Any human food product (in a consumer package) not provided for
in paragraph (c) of this section, if:
(1) It contains less than 2 percent cooked poultry meat (deboned
white or dark poultry meat, or both) and/or "Mechanically Separated
(Kind of Poultry)" as defined in Sec. 381.173;
(2) It contains less than 10 percent of cooked poultry skins,
giblets, or fat, separately, and less than 10 percent of cooked poultry
skins, giblets, fat, and meat (as meat is limited in paragraph (a)(1) of
this section) or "Mechanically Separated (Kind of Poultry)" as defined
in Sec. 381.173, in any combination;
(3) The poultry ingredients used in the product were prepared under
inspection as defined in Sec. 381.1, or were inspected under a foreign
inspection system approved under Sec. 381.196(b) and imported in
compliance with the Act and the regulations;
(4) The immediate container of the product bears a label which shows
the name of the product in accordance with this section; and
(5) The product is not represented as a poultry product. The
aforesaid percentages of ingredients shall be computed on the basis of
the moist, deboned, cooked poultry in the ready-to-serve product when
prepared according to the serving directions on the consumer package.
(b) Any human food product (in an institutional pack), not provided
for in paragraph (c) of this section, if:
(1) It is prepared for sale only to institutional users, such as
hotels, restaurants, and boardinghouses, for use as a soup base or
flavoring;
(2) It contains less than 15 percent cooked poultry meat (deboned
white or dark poultry meat or both) and/or "Mechanically Separated
(Kind of Poultry)" as defined in Sec. 381.173, computed on the basis of
the moist deboned, cooked poultry meat and/or "Mechanically Separated
(Kind of Poultry)" in such product; and
(3) It complies with the provisions of paragraphs (a)(3), (4), and
(5) of this section in all respects.
(c) Bouillon cubes, poultry broths, gravies, sauces, seasonings, and
flavorings if:
(1) They contain poultry meat and/or "Mechanically Separated (Kind
of Poultry)" as defined in Sec. 381.173 or poultry fat only in
condimental quantities;
(2) They comply with the provisions of paragraphs (a)(3), (4), and
(5) of this section in all respects; and
(3) In the case of poultry broth, it will not be used in the
processing of any poultry product in any official establishment.
(d) Fat capsules and sandwiches containing poultry products if they
comply with the provisions of paragraphs (a)(3), (4), and (5) of this
section in all respects.
(e) Products of the types specified in this section except those
specified in paragraphs (c) and (d) of this section will be deemed to be
represented as poultry products if the kind name of the poultry
(chicken, turkey, etc.) is used in the product name of the product
without appropriate qualification. For example, a consumer-packaged
noodle soup product containing less than 2 percent chicken meat on a
ready-to-serve basis may not be labeled "Chicken Noodle Soup" but,
when appropriate, could be labeled as "Chicken Flavored Noodle Soup."
Products exempted under this section are subject
[[Page 434]]
to the requirements of the Federal Food, Drug, and Cosmetic Act.
[37 FR 9706, May 16, 1972, as amended at 60 FR 55982, Nov. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.16]
[Page 434]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart D--Application for Inspection; Grant or Refusal of Inspection
Sec. 381.16 How application shall be made.
The operator of each establishment of the kind required by
Sec. 381.6 to have inspection shall make application to the
Administrator for inspection service. In cases of change of name,
ownership, or location, a new application shall be made.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.17]
[Page 434]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart D--Application for Inspection; Grant or Refusal of Inspection
Sec. 381.17 Filing of application.
Every application for inspection at any establishment shall be made
by the operator on a form furnished by the Meat and Poultry Inspection
Program, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250, and shall include all information
called for by that form, including the name of any subsidiary
corporation that will prepare any poultry product or conduct any other
operation at the establishment for which inspection is requested. The
applicant for inspection will be held responsible for compliance by all
its subsidiaries with the requirements of the regulations at such
establishments if inspection is granted. Processing of poultry products
and other operations at the establishment for which inspection is
granted may be conducted only by the applicant, except that such a
subsidiary of the grantee, may conduct such operations at such
establishment.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.18]
[Page 434]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart D--Application for Inspection; Grant or Refusal of Inspection
Sec. 381.18 Authority of applicant.
Any person applying for inspection service may be required at the
discretion of the Administrator to demonstrate that the operator of the
establishment authorized him to do so.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.20]
[Page 434]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart D--Application for Inspection; Grant or Refusal of Inspection
Sec. 381.20 Survey and grant of inspection.
(a) Before inspection is granted, FSIS shall survey the
establishment to determine if the construction and facilities of the
establishment are in accordance with the regulations. FSIS will grant
inspection, subject to Sec. 381.21, when these requirements are met.
(b) FSIS shall give notice in writing to each applicant granted
inspection and shall specify in the notice the establishment, including
the limits of the establishment's premises, to which the grant pertains.
[62 FR 45026, Aug. 25, 1997]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.21]
[Page 434-435]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart D--Application for Inspection; Grant or Refusal of Inspection
Sec. 381.21 Refusal of inspection.
(a) Any application for inspection in accordance with this part may
be denied or refused in accordance with the rules of practice in part
500 of this chapter.
(b)(1) Any applicant for inspection at an establishment where the
operations thereof may result in any discharge into the navigable waters
of the United States is required by subsection 21(b) of the Federal
Water Pollution Control Act, as amended, to provide the Administrator
with a certification as prescribed in said subsection that there is
reasonable assurance that such activity will be conducted in a manner
which will not violate the applicable water quality standards. No grant
of inspection can be issued after April 3, 1970 (the date of enactment
of the Water Quality Improvement Act), unless such certification has
been obtained, or is waived because of failure or refusal of the State,
interstate agency, or the Administrator of the Environmental Protection
Agency to act on a request for certification within 1 year after receipt
of such request. Further, upon receipt of an application for inspection
and a certification as required by subsection 21(b) of the Federal Water
Pollution Control Act, the Administrator (as defined in Sec. 381.1) is
required by paragraph (2) of said subsection to notify the Administrator
of the Environmental Protection Agency for proceedings in accordance
with that paragraph. No grant of inspection can be made until the
requirements of said paragraph (2) have been met.
(2) However, certification under subsection 21(b) of the Federal
Water Pollution Control Act is not initially required in connection with
an application for inspection granted after April 3, 1970, for
facilities existing or under construction on April 3, 1970, although
[[Page 435]]
certification for such facilities is required to be obtained within the
3-year period immediately following April 3, 1970. Failure to obtain
such certification or to meet the other requirements of subsection 21(b)
prior to April 3, 1973, will result in the termination of inspection at
such facilities on that date.
(3) Further, any application for inspection pending on April 3,
1970, and granted within 1 year thereafter shall not require
certification for 1 year following the grant of inspection but such
grant of inspection shall terminate at the end of 1 year after its
issuance unless prior thereto such certification has been obtained and
the other requirements of subsection 21(b) are met.
(4) In the case of any activity which will affect water quality but
for which there are no applicable water quality standards, no
certification is required prior to the grant of inspection but such
grant will be conditioned upon a requirement of compliance with the
purpose of the Federal Water Pollution Control Act as provided in
paragraph 21(b)(9) of said Act.
[37 FR 9706, May 16, 1972, as amended at 64 FR 66545, Nov. 29, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.22]
[Page 435]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart D--Application for Inspection; Grant or Refusal of Inspection
Sec. 381.22 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an establishment shall
have developed written sanitation Standard Operating Procedures, in
accordance with part 416 of this chapter.
(b) Before being granted Federal inspection, an establishment shall
have conducted a hazard analysis and developed and validated a HACCP
plan, in accordance with Secs. 417.2 and 417.4 of this chapter. A
conditional grant of inspection shall be issued for a period not to
exceed 90 days, during which period the establishment must validate its
HACCP plan.
(c) Before producing new product for distribution in commerce, an
establishment shall have conducted a hazard analysis and developed a
HACCP plan applicable to that product in accordance with Sec. 417.2 of
this chapter. During a period not to exceed 90 days after the date the
new product is produced for distribution in commerce, the establishment
shall validate its HACCP plan, in accordance with Sec. 417.4 of this
chapter.
[61 FR 38866, July 25, 1996]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.25]
[Page 435]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart E--Inauguration of Inspection; Official Establishment Numbers;
Separation of Establishments and Other Requirements; Withdrawal of
Inspection
Sec. 381.25 Official establishment numbers.
An official establishment number shall be assigned to each
establishment granted inspection service. Such number shall be used to
identify all containers of inspected poultry products prepared in the
establishment. An establishment shall not have more than one
establishment number.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.26]
[Page 435]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart E--Inauguration of Inspection; Official Establishment Numbers;
Separation of Establishments and Other Requirements; Withdrawal of
Inspection
Sec. 381.26 Separation of establishments.
Each official establishment shall be separate and distinct from any
other official establishment and from any unofficial establishment
except an establishment preparing meat products under the Federal Meat
Inspection Act or under State meat inspection. Further, doorways, or
other openings, may be permitted between establishments at the
discretion of the Administrator and under such conditions as he may
prescribe.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.27]
[Page 435]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart E--Inauguration of Inspection; Official Establishment Numbers;
Separation of Establishments and Other Requirements; Withdrawal of
Inspection
Sec. 381.27 Inauguration of service; notification concerning regulations; status of uninspected poultry products.
The inspector in charge or his supervisor shall, upon or prior to
the inauguration of service, inform the operator of the establishment of
the requirements of the regulations. If the establishment at the time
service is inaugurated contains any poultry product which has not been
inspected and marked in compliance with the regulations, its identity
shall be maintained, and it shall not be represented or dealt with as a
product which has been inspected. Such products may not be shipped in
commerce unless such products are eligible for such shipment under an
exemption from inspection under subpart C and comply with all
requirements of said subpart.
[[Page 436]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.28]
[Page 436]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart E--Inauguration of Inspection; Official Establishment Numbers;
Separation of Establishments and Other Requirements; Withdrawal of
Inspection
Sec. 381.28 Report of violations.
Each inspector, agent, representative, or employee of the Inspection
Service shall report, in the manner prescribed by the Administrator, all
violations of the Act and noncompliance with the regulations of which he
has knowledge.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.32]
[Page 436]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart F--Assignment and Authorities of Program Employees; Appeals
Sec. 381.32 Access to establishments.
Any duly authorized representative of the Secretary shall have
access at all reasonable times, by day or night, whether the
establishment is in operation or not, to the premises or any part
thereof of an establishment engaged in processing poultry or poultry
products for commerce, upon presentation of appropriate credentials.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.33]
[Page 436]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart F--Assignment and Authorities of Program Employees; Appeals
Sec. 381.33 Identification.
Each inspector will be furnished with a numbered official inspection
badge, which shall remain in his or her possession at all times, and
which shall be worn in such manner and at such times as the
Administrator may prescribe. This badge shall be sufficient
identification to entitle the inspector to admittance at all regular
entrances and to all parts of the establishment and premises to which
the inspector is assigned.
[59 FR 42156, Aug. 17, 1994]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.34]
[Page 436]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart F--Assignment and Authorities of Program Employees; Appeals
Sec. 381.34 Financial interest of inspectors.
(a) No inspector shall inspect any poultry or poultry product in
which he, his spouse, minor child, partner, organization in which he is
serving as officer, director, trustee, partner, or employee, or any
person with whom he is negotiating or has any arrangement concerning
prospective employment, is financially interested.
(b) All inspectors are subject to statutory restrictions with
respect to political activities; e.g., 5 U.S.C. 7324 and 1502.
(c) Violation of the provisions of paragraph (a) of this section or
the provisions of applicable statutes referenced in paragraph (b) of
this section will constitute grounds for dismissal in the case of
appointees and for revocation of licenses in the case of licensees.
(d) Inspectors are subject to all applicable provisions of law and
regulations and instructions of the Department and the Food Safety and
Inspection Service and other authority concerning employee
responsibilities and conduct. The setting forth of certain prohibitions
in this part in no way limits the applicability of such general or other
regulations or instructions.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.35]
[Page 436]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart F--Assignment and Authorities of Program Employees; Appeals
Sec. 381.35 Appeal inspections; how made.
Any person receiving inspection service may, if dissatisfied with
any decision of an inspector relating to any inspection, file an appeal
from such decision: Provided, That such appeal is filed within 48 hours
from the time the decision was made. Any such appeal from a decision of
an inspector shall be made to his immediate superior having jurisdiction
over the subject matter of the appeal, and such superior shall determine
whether the inspector's decision was correct. Review of such appeal
determination, when requested, shall be made by the immediate superior
of the employee of the Department making the appeal determination. The
cost of any such appeal shall be borne by the appellant if the
Administrator determines that the appeal is frivolous. The charges for
such frivolous appeal shall be at the rate of $9.28 per hour for the
time required to make the appeal inspection. The poultry or poultry
products involved in any appeal shall be identified by U.S. retained
tags and segregated in a manner approved by the inspector pending
completion of an appeal inspection.
[48 FR 11419, Mar. 18, 1983, as amended at 60 FR 67456, Dec. 29, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.36]
[Page 436-440]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart G--Facilities for Inspection; Overtime and Holiday Service;
Billing Establishments
Sec. 381.36 Facilities required.
(a) Inspector's Office. Office space, including, but not being
limited to furnishings, light, heat, and janitor service, shall be
provided rent free in the
[[Page 437]]
official establishment, for the use of Government personnel for official
purposes. The room or space set apart for this purpose must meet the
approval of the Inspection Service and be conveniently located, properly
ventilated, and provided with lockers or file cabinets suitable for the
protection and storage of supplies and with facilities suitable for
inspectors to change clothing. At the discretion of the Administrator,
small plants requiring the services of less than one full-time inspector
need not furnish facilities for Program employees as prescribed in this
section, where adequate facilities exist in a nearby convenient
location. Each official establishment shall provide commercial laundry
service for inspectors' outer work clothing, or disposable outer work
garments designed for one-time use, or uniform rental service garments
which are laundered by the rental service.
(b) Facilities for ante mortem inspection. A suspect pen is required
for adequate ratite inspection.
(c) Facilities for the Streamlined Inspection System (SIS). The
following requirements for lines operating under SIS are in addition to
the normal requirements to obtain a grant of inspection. The
requirements for SIS in Sec. 381.76(b) also apply.
(1) The following provisions shall apply to every inspection
station:
(i) The conveyor line shall be level for the entire length of the
inspection station. The vertical distance from the bottom of the
shackles to the top of the adjustable platform (paragraph (c)(1)(iv) of
this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 4 feet along the conveyor line for
the inspector, and 4 feet for the establishment helper. A total of at
least 8 feet along the conveyor line shall be supplied for one
inspection station and 16 feet for two-inspection stations.
(iii) Selectors or "kickouts" shall be installed in establishments
with two inspection stations on a line so each inspector will receive
birds on 12-inch centers with no intervening birds to impede inspection.
The selector must move the bird to the edge of the trough for the
inspector and establishment helper. The selectors must be smooth,
steady, and consistent in moving the birds parallel and through the
inspection station. Birds shall be selected and released smoothly to
avoid swinging when entering the inspection station.
(iv) Each inspector's station shall have a platform that is slip-
resistant and can be safely accessed by the inspector. The platform
shall be designed so that it can be easily and rapidly adjusted for a
minimum of 14 inches vertically while standing on the platform. The
platform shall be a minimum length of 4 feet and have a minimum width of
2 feet; the platform shall be designed with a 42-inch high rail on the
back side and with \1/2\-inch foot bumpers on both sides and front to
allow safe working conditions. The platform must have a safe lift
mechanism and be large enough for the inspector to sit on a stool and to
change stations during breaks or station rotation.
(v) Conveyor line stop/start switches shall be located within easy
reach of each inspector.
(vi) A trough or other facilities shall extend beneath the conveyor
at all places where processing operations are conducted from the point
where the carcass is opened to the point where the trimming has been
performed. The trough must be of sufficient width to preclude trimmings,
drippage, and debris from accumulating on the floor or platforms. The
clearance between the suspended carcasses and the trough must be
sufficient to preclude contamination of carcasses by splash.
(vii) A minimum of 200-footcandles of shadow-free lighting with a
minimum color rendering index value of 85 where the birds are inspected
to facilitate inspection.
(viii) Online handrinsing facilities with a continuous flow of water
must be provided for and within easy reach of each inspector and each
establishment helper. The hand-contact element must be rinsed
automatically with a sufficient volume of water to remove all fat,
tissue, debris, and other extraneous material from the hand contact
element after each use. Both hot and cold running water shall be
available at each inspection station on the eviscerating line and shall
be delivered
[[Page 438]]
through a suitable mixing device controlled by the inspector.
Alternatively, water for hand washing shall be delivered to such
inspection stations at a minimum temperature of 65 degrees F.
(ix) Hangback racks shall be provided for and positioned within easy
reach of the establishment helpers.
(x) Each inspection station shall be provided with receptacles for
condemned carcasses and parts. Such receptacles shall comply with the
performance standards in Sec. 416.3(c) of this chapter.
(2) The following provisions shall apply only to prechill and
postchill reinspection stations:
(i) Floor space shall consist of a minimum of 3 feet along each
conveyor line and after each chiller to allow carcasses to be removed
for evaluation. The space shall be level and protected from all traffic
and overhead obstructions.
(ii) The vertical distance from the bottom of the shackles to the
floor shall not be less than 48 inches.
(iii) A table, at least 2 feet wide, 2 feet deep, and 3 feet high
designed to be readily cleanable and drainable shall be provided for
reinspecting the sampled birds.
(iv) A minimum of 200-footcandles of shadow-free lighting with a
minimum color rendering index of 85 on the table surface shall be
provided.
(v) A separate clip board holder shall be provided for holding the
recording sheets.
(vi) Handwashing facilities shall be provided for and shall be
within easy access of persons working at the stations.
(vii) Hangback racks designed to hold 10 carcasses shall be provided
for and positioned within easy reach of the person at the station.
(d) Facilities for the New Line Speed (NELS) inspection system. The
following requirements for lines operating under the NELS inspection
system are in addition to the normal requirements to obtain a grant of
inspection and to the requirements for NELS in Sec. 381.76 (b) and (c).
(1) The following provisions shall apply to every inspection
station:
(i) The conveyor line shall be level for the entire length of the
inspection station. The vertical distance from the bottom of the
shackles to the top of the adjustable platform (paragraph (d)(1)(iv) of
this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 6 feet along the conveyor line for
the establishment employee presenting the birds, 4 feet for the
inspector, and 4 feet for the establishment helper. A total of at least
42 feet along the conveyor line shall be supplied for three inspection
stations.
(iii) Selectors or "kickouts" shall be installed so the three
inspection stations will receive birds on 18-inch centers with no
intervening birds to impede inspection. The selector must move the bird
to the end of the trough for the presenter, inspector, and establishment
helper. The selectors must be smooth, steady, and consistent in moving
the birds parallel and through the inspection station. Birds shall be
selected and released smoothly to avoid splashing the mirror (paragraph
(d)(1)(vii) of this section) and swinging when entering the inspection
station. Guide bars shall not extend in front of the inspection station
mirror to avoid obstructing the inspector's view.
(iv) Each inspector's station shall have an easily and rapidly
adjustable platform, with a minimum of 14 inches of vertical adjustment,
which covers the entire length of the station (4 feet) and has a minimum
width of 2 feet. The platform shall be designed with a 42-inch high rail
on the back side and with \1/2\-inch foot bumpers on both sides and
front to allow safe working conditions.
(v) Conveyor line stop/start switches shall be located within easy
reach of each inspector.
(vi) A trough shall extend beneath the conveyor at all places where
processing operations are conducted from the point where the carcass is
opened to the point where the trimming has been performed. The trough
must be of sufficient width to preclude trimmings, drippage, and debris
from accumulating on the floor or platforms. The clearance between the
suspended carcasses and the trough must be sufficient to preclude
contamination of carcasses by splash.
[[Page 439]]
(vii) A distortion-free mirror, at least 3 feet wide and 2 feet
high, shall be mounted at each inspection station so that it can be
adjusted between 5 and 15 inches behind the shackles, tilt up and down,
tilt from side to side, and be raised and lowered. The mirror shall be
positioned in relation to the inspection platform so that the inspector
can position himself/herself opposite it 8 to 12 inches from the
downstream edge. The mirror must be maintained abrasion free.
(viii) A minimum of 200-footcandles of shadow-free lighting with
minimum color rendering index value of 85 \1\ where the birds are
inspected to facilitate inspection. A light shall also be positioned
above and slightly in front of the mirror to facilitate the illumination
of the bird and mirror surfaces.
---------------------------------------------------------------------------
\1\ This requirement may be met by deluxe cool white type of
fluorescent lighting.
---------------------------------------------------------------------------
(ix) "One-line" handrinsing facilities with a continuous flow of
water shall be provided for and within easy reach of each inspector and
each establishment presenter and helper.
(x) Hangback racks shall be provided for and positioned within easy
reach of the establishment helpers.
(xi) Each inspection station shall be provided with receptacle for
condemned carcasses and parts. Such receptacles shall comply with the
performance standards in Sec. 416.3(c) of this chapter.
(2) The following provisions shall apply only to the reinspection
station:
(i) Floor space shall consist of 6 feet along the conveyor line. The
space shall be level and protected from all traffic and overhead
obstructions.
(ii) The vertical distance from the bottom of the shackles to the
floor shall not be less than 48 inches.
(iii) A table, at least 3 feet wide and 2 feet deep, shall be
provided for reinspecting the sample birds.
(iv) A minimum of 200-footcandles of shows free lighting with a
minimum color rendering index of 85 \1\ on the table surface.
(v) A separate clip board holder shall be provided for holding the
recording sheets.
(vi) Handwashing facilities shall be provided for and shall be
within easy reach of persons working at the station.
(vii) Hangback racks designed to hold 10 carcasses shall be provided
for and positioned within easy reach of the person at the station.
(e) Facilities for the New Turkey Inspection (NTI) System. The
following requirements for lines operating under the NTI System are in
addition to the normal requirements to obtain a grant of inspection and
to the requirements for the NTI System in Sec. 381.76 (b) and (c).
(1) The following provisions apply to every inspection station:
(i) The conveyor line must be level for the entire length of the
inspection station. The vertical distance from the bottom of the
shackles to the top of the adjustable platform (paragraph (e)(1)(iii) of
this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 8 feet along the conveyor line; at
least 4 feet for the inspector, and at least 4 feet for the
establishment helper.
(iii) The inspector's station shall have an easily and rapidly
adjustable platform with a minimum width of 2 feet which covers the
entire length of the station (4 feet). The platform must adjust
vertically a minimum of 14 inches, and must have a 42-inch rail on the
back side and \1/2\-inch foot bumpers on the sides and the front to
allow safe working conditions.
(iv) Conveyor line stop/start switches shall be located within easy
reach of each inspector.
(v) A trough or other facilities shall extend beneath the conveyor
at all places where processing operations are conducted from the point
where the carcass is opened to the point where the trimming has been
performed. The trough must be wide enough to prevent trimmings,
drippage, and debris from accumulation on the floor or platforms. The
clearance between suspended carcasses and the trough must be sufficient
to prevent contamination of carcasses by splash.
(vi) A minimum of 200 foot-candles of shadow-free lighting with a
minimum
[[Page 440]]
color rendering index value of 85 \1\ where the birds are inspected to
facilitate inspection is required. The minimum lighting requirement for
inspection stations in Sec. 381.52(b) shall not apply.
---------------------------------------------------------------------------
\1\ This requirement may be met by deluxe cool white fluorescent
lighting.
---------------------------------------------------------------------------
(vii) On-line handrinsing facilities with a continuous flow of water
shall be provided for and within easy reach of each inspector and each
establishment helper.
(viii) Hangback racks shall be provided for and within easy reach of
the establishment helper.
(ix) Each inspection station shall be provided with receptacles for
condemned carcasses and parts. Such receptacles shall comply with the
performance standards in Sec. 416.3(c) of this chapter.
(2) The following provisions shall apply only to the reinspection
station:
(i) Floor space shall consist of a minimum of 3 feet along the
conveyor line so carcasses can be removed from each line for evaluation.
The space shall be level and protected from all traffic and overhead
obstructions.
(ii) The vertical distance from the bottom of the shackles to the
floor must not be less than 48 inches.
(iii) A table at least 3 feet wide and 2 feet deep designed to be
readily cleanable and drainable shall be provided for reinspecting the
sampled birds.
(iv) A minimum of 200 foot-candles of shadow-free lighting with a
minimum color rendering index of 85 \1\ at the table surface is
required.
(v) A clipboard holder shall be provided for holding the recording
sheets.
(vi) Handwashing facilities shall be provided for and within easy
reach of persons working at the station.
(vii) Hangback racks designed to hold 10 carcasses shall be provided
for and positioned within easy reach of the person at this station.
[37 FR 9706, May 16, 1972, as amended at 38 FR 9794, Apr. 20, 1973; 47
FR 23434, May 28, 1982; 49 FR 42554, Oct. 23, 1984; 50 FR 37512, Sept.
16, 1985; 52 FR 39209, Oct. 21, 1987; 64 FR 56416, Oct. 20, 1999; 66 FR
22905, May 7, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.37]
[Page 440-441]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart G--Facilities for Inspection; Overtime and Holiday Service;
Billing Establishments
Sec. 381.37 Schedule of operations.
(a) No operations requiring inspection shall be conducted except
under the supervision of an Inspection Service employee. All
eviscerating of poultry and further processing shall be done with
reasonable speed, considering the official establishment's facilities.
(b) A shift is a regularly scheduled operating period, exclusive of
mealtime. One lunch period is the only official authorized interruption
in the inspector's tour of duty once it begins. Lunch periods may be 30
minutes, 45 minutes, or in any case may not exceed one hour in duration.
Once established, the lunch period must remain relatively constant as to
time and duration. Lunch periods for inspectors shall not, except as
provided herein, occur prior to 4 hours after the beginning of scheduled
operations nor later than 5 hours after operations begin. In plants
where a company rest break of not less than 30 minutes is regularly
observed, approximately midpoint between start of work and the lunch
period, and the inspector is allowed this time to meet his personal
needs, the lunch period may be scheduled as long as 5\1/2\ hours after
the beginning of scheduled operations.
(c) Official establishments, importers, and exporters shall be
provided inspection service, without charge, up to 8 hours per shift
during the basic workweek subject to the provisions of Sec. 381.38:
Provided, That any additional shifts meet requirements as determined by
the Administrator or his designee. The basic workweek shall consist of 5
consecutive 8-hour days within the administrative workweek Sunday
through Saturday, excluding the lunch period; except that, when
possible, the Department shall schedule the basic workweek so as to
consist of 5 consecutive 8-hour days Monday through Friday, excluding
lunch period. The Department may depart from the basic workweek in those
cases where maintaining such a schedule would seriously handicap the
Department in carrying out its functions. These provisions are
applicable to all official establishments except in certain cases as
provided in Sec. 381.145(h) of this subchapter.
[[Page 441]]
(d)(1) Each official establishment shall submit a work schedule to
the area supervisor for approval. In consideration of whether the
approval of an establishment work schedule shall be given, the area
supervisor shall take in account the efficient and effective use of
inspection personnel. The work schedule must specify the workweek, daily
clock hours of operation, and lunch periods for all departments of the
establishment requiring inspection.
(2) Establishments shall maintain consistent work schedules. Any
request by an establishment for a change in its work schedule involving
changes in the workweek or an addition or elimination of shifts shall be
submitted to the area supervisor at least 2 weeks in advance of the
proposed change. Frequent requests for change shall not be approved:
Provided, however, Minor deviations from a daily operating schedule may
be approved by the inspector in charge if such request is received on
the day preceding the day of change.
(3) Requests for inspection service outside an approved work
schedule shall be made as early in the day as possible for overtime work
to be performed within that same workday; or made prior to the end of
the day's operation when such a request will result in overtime service
at the start of the following day: Provided, That an inspector may be
recalled to his assignment after the completion of his daily tour of
duty under the provisions of Sec. 381.39(b).
[40 FR 45800, Oct. 3, 1975, as amended at 40 FR 50719, Oct. 31, 1975; 41
FR 15401, Apr. 13, 1976; 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept.
11, 1986]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.38]
[Page 441]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart G--Facilities for Inspection; Overtime and Holiday Service;
Billing Establishments
Sec. 381.38 Overtime and holiday inspection service.
(a) The management of an official establishment, an importer, or an
exporter shall reimburse the Program, at the rate specified in
Sec. 391.3, for the cost of the inspection service furnished on any
holiday specified in paragraph (b) of this section; or for more than 8
hours on any day, or more than 40 hours in any administrative workweek
Sunday through Saturday.
(b) Holidays for Federal employees shall be New Year's Day, January
1; Birthday of Martin Luther King, Jr., the third Monday in January;
Washington's Birthday, the third Monday in February; Memorial Day, the
last Monday in May; Independence Day, July 4; Labor Day, the first
Monday in September; Columbus Day, the second Monday in October;
Veterans' Day, November 11; Thanksgiving Day, the fourth Thursday in
November; Christmas Day, December 25. When any of the above-listed
holidays falls outside the basic workweek, the nearest workday within
that week shall be the holiday.
[40 FR 45801, Oct. 3, 1975, as amended at 43 FR 51754, Nov. 7, 1978; 50
FR 51513, Dec. 18, 1985; 52 FR 5, Jan. 2, 1987; 53 FR 13398, Apr. 22,
1988; 54 FR 6390, Feb. 10, 1989]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.39]
[Page 441]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart G--Facilities for Inspection; Overtime and Holiday Service;
Billing Establishments
Sec. 381.39 Basis of billing for overtime and holiday services.
(a) Each recipient of overtime or holiday inspection service, or
both, shall be billed as provided for in Sec. 381.38(a) and at the rate
specified in Sec. 391.3, in increments of quarter hours. For billing
purposes, 8 or more minutes shall be considered a full quarter hour.
Billing will be for each quarter hour of service rendered by each
Inspection Service employee.
(b) Official establishments, importers, or exporters requesting and
receiving the services of an Inspection Service employee after he has
completed his day's assignment and left the premises, or called back to
duty during any overtime or holiday period, shall be billed for a
minimum of 2 hours overtime or holiday inspection service at the
established rate.
(c) Bills are payable upon receipt and become delinquent 30 days
from the date of the bill. Overtime or holiday inspection will not be
performed for anyone having a delinquent account.
[40 FR 45801, Oct. 3, 1975, as amended at 54 FR 6390, Feb. 10, 1989]
Subpart H [Reserved]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.65]
[Page 441-442]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart I--Operating Procedures
Sec. 381.65 Operations and procedures, generally.
(a) Operations and procedures involving the processing, other
handling, or storing of any poultry product must be
[[Page 442]]
strictly in accord with clean and sanitary practices and must be
conducted in a manner that will result in sanitary processing, proper
inspection, and the production of poultry and poultry products that are
not adulterated.
(b) Poultry must be slaughtered in accordance with good commercial
practices in a manner that will result in thorough bleeding of the
carcasses and ensure that breathing has stopped prior to scalding. Blood
from the killing operation must be confined to a relatively small area.
(c) When thawing frozen ready-to-cook poultry in water, the
establishment must use methods that prevent adulteration of, or net
weight gain by, the poultry.
(d) The water used in washing the poultry must be permitted to drain
freely from the body cavity.
(e) Poultry carcasses contaminated with visible fecal material shall
be prevented from entering the chilling tank.
(f) Detached ova may be collected for human food and handled only in
accordance with 9 CFR 590.44 and may leave the establishment only to be
moved to an official egg product processing plant for processing. Ova
from condemned carcasses must be condemned and treated as required in
Sec. 381.95.
[66 FR 1771, Jan. 9, 2001; 66 FR 19714, Apr. 17, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.66]
[Page 442-443]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart I--Operating Procedures
Sec. 381.66 Temperatures and chilling and freezing procedures.
(a) General. Temperatures and procedures that are necessary for
chilling and freezing ready-to-cook poultry, including all edible
portions thereof, must be in accordance with operating procedures that
ensure the prompt removal of the animal heat, preserve the condition and
wholesomeness of the poultry, and assure that the products are not
adulterated.
(b) General chilling requirements, except for ratites. (1) All
poultry that is slaughtered and eviscerated in the official
establishment shall be chilled immediately after processing so that the
internal temperature is reduced to 40 deg.F. or less, as provided in
paragraph (b)(2) of this section unless such poultry is to be frozen or
cooked immediately at the official establishment. Eviscerated poultry to
be shipped from the establishment in packaged form shall be maintained
at 40 deg.F. or less, except that during further processing and
packaging operations, the internal temperature may rise to a maximum of
55 deg.F.: Provided, That immediately after packaging, the poultry is
placed under refrigeration at a temperature that will promptly lower the
internal temperature of the product to 40 deg.F. or less, or the
poultry is placed in a freezer. Poultry which is to be held at the plant
in packaged form in excess of 24 hours shall be held in a room at a
temperature of 36 deg.F. or less.
(2) Major portions of poultry carcasses, as defined in
Sec. 381.170(b)(22), and poultry carcasses shall be chilled to 40
deg.F. or lower within the following specified times:
------------------------------------------------------------------------
Time
Weight of carcass (hours)
------------------------------------------------------------------------
Under 4 pounds............................................... 4
4 to 8 pounds................................................ 6
Over 8 pounds................................................ 8
------------------------------------------------------------------------
(c) Ice and water chilling. (1) Only ice produced from potable water
may be used for ice and water chilling, except that water and ice used
for chilling may be reused in accordance with Sec. 416.2(g). The ice
must be handled and stored in a sanitary manner.
(2)(i) Poultry chilling equipment must be operated in a manner
consistent with meeting the applicable pathogen reduction performance
standards for raw poultry products as set forth in Sec. 381.94 and the
provisions of the establishment's HACCP plan.
(ii) Major portions of poultry carcasses, as defined in
Sec. 381.170(b)(22), may be chilled in water and ice.
(3) Previously chilled poultry carcasses and major portions must be
maintained constantly at 40 deg.F or below until removed from the vats
or tanks for immediate packaging. Such products may be removed from the
vats or tanks prior to being cooled to 40 deg.F or below, for freezing
or cooling in the official establishment. Such products must not be
packed until after they have been chilled to 40 deg.F or below, except
when the packaging will be followed immediately by freezing at the
official establishment.
[[Page 443]]
(4) Giblets must be chilled to 40 deg.F or below within 2 hours
from the time they are removed from the inedible viscera, except that
when they are cooled with the carcass, the requirements of paragraph
(b)(2) of this section must apply. Any of the acceptable methods of
chilling the poultry carcass may be followed in cooling giblets.
(d) Water absorption and retention. (1) Poultry washing, chilling,
and draining practices and procedures must be such as will minimize
water absorption and retention at time of packaging.
(2) The establishment must provide scales, weights, identification
devices, and other supplies necessary to conduct water tests.
(e) Air chilling. In air chilling ready-to-cook poultry, the
internal temperature of the carcasses shall be reduced to 40 deg.F. or
less within 16 hours.
(f) Freezing. (1) Ready-to-cook poultry which is to be or is labeled
with descriptive terms such as "fresh frozen," "quick frozen" or
"frozen fresh" or any other term implying a rapid change from a fresh
state to a frozen state shall be placed into a freezer within 48 hours
after initial chilling in accordance with paragraph (b) of this section.
During this period, if such poultry is not immediately placed into a
freezer after chilling and packaging, it shall be held at 36 deg.F. or
lower.
(2) Ready-to-cook poultry shall be frozen in a manner so as to bring
the internal temperature of the birds at the center of the package to 0
deg.F. or below within 72 hours from the time of entering the freezer.
Such procedures shall not apply to raw poultry product described in
Sec. 381.129(b)(6)(i) of this subchapter.
(3) Upon written request, and under such conditions as may be
prescribed by the Administrator, in specific cases, ready-to-cook
poultry which is to be frozen immediately may be moved from the official
establishment prior to freezing: Provided, That the plant and freezer
are so located and such necessary arrangements are made that the
Inspection Service will have access to the freezing room and adequate
opportunity to determine compliance with the time and temperature
requirements specified in paragraph (f)(2) of this section.
(4) Warm packaged ready-to-cook poultry which is to be chilled by
immediate entry into a freezer within the official establishment shall
within 2 hours from time of slaughter be placed in a plate freezer or a
freezer with a functioning circulating air system where a temperature of
-10 deg.F. or lower is maintained.
(5) Frozen poultry shall be held under conditions which will
maintain the product in a solidly frozen state with temperature
maintained as constant as possible under good commercial practice.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4568, 4569, Feb. 5, 1974;
40 FR 42338, Sept. 12, 1975; 49 FR 9411, Mar. 13, 1984; 60 FR 44412,
Aug. 25, 1995; 63 FR 48960, Sept. 11, 1998; 66 FR 1771, Jan. 9, 2001; 66
FR 19714, Apr. 17, 2001; 66 FR 22905, May 7, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.67]
[Page 443-444]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart I--Operating Procedures
Sec. 381.67 Young chicken and squab slaughter inspection rate maximums under traditional inspection procedure.
The maximum number of birds to be inspected by each inspector per
minute under the traditional inspection procedure for the different
young chicken and squab slaughter line configurations are specified in
the following table. These maximum rates will not be exceeded. The
inspector in charge will be responsible for reducing production line
rates where in the inspector's judgment the prescribed inspection
procedure cannot be adequately performed within the time available,
either because the birds are not presented by the official establishment
in such a manner that the carcasses, including both internal and
external surfaces and all organs, are readily accessible for inspection,
or because the health conditions of a particular flock dictate a need
for a more extended inspection procedure. The standards in 381.170(a) of
this part specify which classes of birds constitute young chickens and
squabs. Section 381.76(b) specifies when either the traditional
inspection procedure or the modified traditional inspection procedure
can or must be used.
[[Page 444]]
Maximum Production Line Rates--Chickens and Squabs-Traditional
Inspection Procedures
------------------------------------------------------------------------
Birds per
Number of inspector
Line configuration \1\ inspection per
stations minute
------------------------------------------------------------------------
6-1.............................................. 1 25
12-1............................................. 2 23
12-2............................................. 2 21
18-1............................................. 3 19
18-2............................................. 3 19
18-3............................................. 3 18
24-1............................................. 4 16\1/2\
24-2............................................. 4 16
24-4............................................. 4 15\1/2\
------------------------------------------------------------------------
\1\ Birds are suspended on the slaughter line at 6-inch intervals. The
first number indicates the interval in inches between the birds that
each inspector examines. The second number indicates how many of the
birds presented, the inspector is to inspect, i.e., "1" means
inspect every bird. "4" means inspect every fourth bird, etc.
[47 FR 23435, May 28, 1982, as amended at 66 FR 22905, May 7, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.68]
[Page 444]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart I--Operating Procedures
Sec. 381.68 Maximum inspection rates--New turkey inspection system.
(a) The maximum inspection rates for one inspector New Turkey
Inspection (NTI-1) and two inspector New Turkey Inspection (NTI-2) are
listed in the table below. These line speeds are for lines using
standard 9-inch shackles on 12-inch centers with birds hung on every
shackle and opened with J-type or Bar-type opening cuts. Maximum rates
for those establishments having varying configurations will be
established by the Administrator but will not exceed those in the table.
Neither the rates in the table nor those established for establishments
with varying configurations shall be exceeded under any circumstances.
(b) There are two categories of turkeys for determining inspection
rates, "light turkeys" and "heavy turkeys". Light turkeys are all
turkeys weighing less than 16 pounds. Heavy turkeys are all turkeys
weighing 16 pounds or more. The weights refer to the bird at the point
of post-mortem inspection, with blood, feathers and feet removed.
(c) The inspector in charge may reduce inspection line rates when in
his/her judgment the prescribed inspection procedure cannot be
adequately performed within the time available because the health
conditions of a particular flock dictate a need for a more extended
inspection.
Maximum Turkey Inspection Rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Birds/Minute
----------------------------------------------------------------------------------------
Line Number of J-Type Bar-Type
Inspection system configuration inspectors ----------------------------------------------------------------------------------------
(<16) (16)\1\ (<) (16)\1\)
light heavy light heavy
--------------------------------------------------------------------------------------------------------------------------------------------------------
NTI-1.............................. 12-1 1 32 30 25 21
NTI-2.............................. \2\ 24-2 2 51 41 45 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This weight refers to the bird at the point of post-mortem inspection, without blood, feathers, or feet.
\2\ The turkeys are suspended on the slaughter line at 12-inch intervals, with two inspectors each looking at alternating birds at 24-inch intervals.
[50 FR 37512, Sept. 16, 1985]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.70]
[Page 444-445]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart J--Ante Mortem Inspection
Sec. 381.70 Ante mortem inspection; when required; extent.
(a) An ante mortem inspection of poultry shall, where and to the
extent considered necessary by the Administrator and under such
instructions as he may issue from time to time, be made of poultry on
the day of slaughter in any official establishment.
(b) The examination and inspection of ratites will be on the day of
slaughter, except:
(1) When it is necessary for humane reasons to slaughter an injured
animal at night or on a Sunday or holiday, and the FSIS veterinary
medical officer cannot be obtained; or
(2) In low volume establishments, when ante mortem inspection cannot
be done on the day of slaughter, and the birds to be slaughtered have
received ante mortem inspection in the
[[Page 445]]
last 24 hours, provided the establishment has an identification and
control system over birds that have received ante mortem inspection.
[37 FR 9706, May 16, 1972, as amended at 66 FR 22906, May 7, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.71]
[Page 445]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart J--Ante Mortem Inspection
Sec. 381.71 Condemnation on ante mortem inspection.
(a) Birds plainly showing on ante mortem inspection any disease or
condition, that under Secs. 381.80 to 381.93, inclusive, would cause
condemnation of their carcasses on post mortem inspection, shall be
condemned. Birds which on ante mortem inspection are condemned shall not
be dressed, nor shall they be conveyed into any department of the
official establishment where poultry products are prepared or held.
Poultry which has been condemned on ante mortem inspection and has been
killed or died otherwise shall under the supervision of an inspector of
the Inspection Service, be disposed of as provided in Sec. 381.95.
(b) Dead-on-arrival ratites and ratites condemned on ante mortem
inspection will be tagged "U.S. Condemned" by an establishment
employee under FSIS supervision and disposed of by one of the methods
prescribed in Sec. 381.95.
(c) All seriously crippled ratites and non-ambulatory ratites,
commonly termed "downers," shall be identified as "U.S. Suspects."
(d) Ratites exhibiting signs of drug or chemical poisoning shall be
withheld from slaughter.
(e) Ratites identified as "U.S. Suspects" or "U.S. Condemned"
may be set aside for treatment. The "U.S. Suspect" or "U.S.
Condemned" identification device will be removed by an establishment
employee under FSIS supervision following treatment if the bird is found
to be free of disease. Such a bird found to have recovered from the
condition for which it was treated may be released for slaughter or for
purposes other than slaughter, provided that in the latter instance
permission is first obtained from the local, State, or Federal sanitary
official having jurisdiction over movement of such birds.
(f) When it is necessary for humane reasons to slaughter an injured
ratite at night or Sunday or a holiday, and the Agency veterinary
medical officer cannot be obtained, the carcass and all parts shall be
kept for inspection, with the head and all viscera except the
gastrointestinal tract held by the natural attachment. If all parts are
not so kept for inspection, the carcass shall be condemned. If on
inspection of a carcass slaughtered in the absence of an inspector, any
lesion or other evidence is found indicating that the bird was sick or
diseased, or affected with any other condition requiring condemnation of
the animal on ante mortem inspection, or if there is lacking evidence of
the condition that rendered emergency slaughter necessary, the carcass
shall be condemned. Ratites that are sick, dying, or that have been
treated with a drug or chemical and presented for slaughter before the
required withdrawal period, are not covered by emergency slaughter
provisions.
[37 FR 9706, May 16, 1972, as amended at 66 FR 22906, May 7, 2001; 67 FR
13258, Mar. 22, 2002]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.72]
[Page 445-446]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart J--Ante Mortem Inspection
Sec. 381.72 Segregation of suspects on ante mortem inspection.
(a) All birds, except ratites, that on ante mortem inspection do not
plainly show, but are suspected of being affected with, any disease or
condition that under Secs. 381.80 to 381.93 of this Part may cause
condemnation in whole or in part on post mortem inspection, shall be
segregated from the other poultry and held for separate slaughter,
evisceration, and post mortem inspection. The inspector shall be
notified when such segregated lots are presented for post mortem
inspection, and inspection of such birds shall be conducted separately.
Such procedure for the correlation of ante mortem and post mortem
findings by the inspector, as may be prescribed or approved by the
Administrator, shall be carried out.
(b) All ratites showing symptoms of disease will be segregated,
individually tagged as "U.S. Suspects" by establishment personnel
under FSIS supervision with a serially numbered metal or plastic leg
band or tag bearing the term "U.S. Suspect," and held for further
examination by an FSIS veterinarian. Depending upon the findings of the
veterinarian's examination, these birds
[[Page 446]]
will either be passed for regular slaughter, slaughtered as suspects,
withheld from slaughter, or condemned on ante mortem. Those ratites
affected with conditions that would be readily detected on post mortem
inspection need not be individually tagged on ante mortem inspection
with the "U.S. Suspect" tag provided that such ratites are segregated
and otherwise handled as "U.S. Suspects." All ratites identified as
"U.S. Condemned" shall be tagged by establishment personnel, under
FSIS supervision, with a serially numbered metal or plastic leg band or
tag bearing the term "U.S. Condemned."
[66 FR 22906, May 7, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.73]
[Page 446]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart J--Ante Mortem Inspection
Sec. 381.73 Quarantine of diseased poultry.
If live poultry, which is affected by any contagious disease which
is transmissible to man, is brought into an official establishment, such
poultry shall be segregated. The slaughtering of such poultry shall be
deferred and the poultry shall be dealt with in one of the following
ways:
(a) If it is determined by a veterinary inspector that further
handling of the poultry will not create a health hazard, the lot shall
be slaughtered separately, subject to ante mortem and post mortem
inspection pursuant to the regulations.
(b) If it is determined by a veterinary inspector that further
handling of the poultry will create a health hazard, such poultry may be
released for treatment under the control of an appropriate State or
Federal agency. If the circumstances are such that release for treatment
is impracticable, a careful bird-by-bird ante mortem inspection shall be
made, and all birds found to be, or which are suspected of being,
affected with a contagious disease transmissible to man shall be
condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.74]
[Page 446]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart J--Ante Mortem Inspection
Sec. 381.74 Poultry suspected of having biological residues.
When any poultry at an official establishment is suspected of having
been treated with or exposed to any substance that may impart a
biological residue that would make their edible tissues adulterated,
they shall, at the option of the operator of the establishment, be
processed at the establishment and the carcasses and all parts thereof
retained under U.S. Retained tags, pending final disposition in
accordance with Sec. 381.80, of this part, and other provisions in
subpart K; or they shall be slaughtered at the establishment and buried
or incinerated in a manner satisfactory to the inspector. Alternatively,
such poultry may be returned to the grower, if further holding is likely
to result in their not being adulterated by reason of any residue. The
Inspection Service will notify the other Federal and State agencies
concerned of such action. To aid in determining the amount of residue
present in the poultry, officials of the Inspection Service may permit
the slaughter of any such poultry for the purpose of collecting tissues
for analysis of the residue. Such analysis may include the use of
inplant screening procedures designed to detect the presence of
antimicrobial residues in any species of poultry.
[47 FR 41336, Sept. 20, 1982]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.75]
[Page 446]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart J--Ante Mortem Inspection
Sec. 381.75 Poultry used for research.
(a) No poultry used in any research investigation involving an
experimental biological product, drug, or chemical shall be eligible for
slaughter at an official establishment unless the operator of such
establishment, the sponsor of the investigation, or the investigator has
submitted to the Inspection Service, or the Veterinary Biologics unit of
Veterinary Services, Animal and Plant Health Inspection Service of the
Department or the Environmental Protection Agency, or the Food and Drug
Administration of the Department of Health, Education, and Welfare, data
or a summary evaluation of the data which demonstrates that the use of
such biological product, drug, or chemical will not result in the
products of such poultry being adulterated, and the Administrator has
approved such slaughter.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]
[[Page 447]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.76]
[Page 447-457]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.76 Post-mortem inspection, when required; extent; traditional, Streamlined Inspection System (SIS), New Line Speed (NELS) Inspection System and the
New Turkey Inspection (NTI) System; rate of inspection.
(a) A post-mortem inspection shall be made on a bird-by-bird basis
on all poultry eviscerated in an official establishment. No viscera or
any part thereof shall be removed from any poultry processed in any
official establishment, except at the time of post-mortem inspection,
unless their identify with the rest of the carcass is maintained in a
manner satisfactory to the inspector until such inspection is made. Each
carcass to be eviscerated shall be opened so as to expose the organs and
the body cavity for proper examination by the inspector and shall be
prepared immediately after inspection as ready-to-cook poultry. If a
carcass is frozen, it shall be thoroughly thawed before being opened for
examination by the inspector. Each carcass, or all parts comprising such
carcass, shall be examined by the inspector, except for parts that are
not needed for inspection purposes and are not intended for human food
and are condemned.
(b)(1) There are five systems of post-mortem inspection: Streamlined
Inspection System (SIS) and the New Line Speed (NELS) Inspection System,
both of which shall be used only for broilers and cornish game hens; the
New Turkey Inspection (NTI) System, which shall be used only for
turkeys; Traditional Inspection; and Ratite Inspection.
(i) The SIS shall be used only for broilers and cornish game hens
if:
(a) The Administrator determines that SIS will increase inspector
efficiency; or
(b) The operator requests SIS and the Administrator determines that
the system will result in no loss of inspection efficiency.
(ii) The NELS Inspection System shall be used only for broilers and
cornish game hens if:
(a) The operator requests the NELS Inspection System, and
(b) The Administrator determines that the establishment has the
intent and capability to operate at line speeds greater than 70 birds
per minute, and meets all the facility requirements in Sec. 381.36(d).
(iii) The NTI System shall be used only for turkeys if:
(a) The operator requests it, and
(b) The Administrator determines that the establishment meets all
the facility requirements in Sec. 381.36(e).
(iv) Traditional inspection shall be used for turkeys when the NTI
System is not used. For other classes of poultry, Traditional Inspection
shall be used when neither the SIS nor the NELS Inspection System is
used.
(2) The requirements of paragraph (a) of this section are applicable
to all four inspection systems.
(3) The following requirements are applicable to SIS:
(i) Definitions. For purposes of this paragraph, the following
definitions shall apply:
(a) Cumulative sum (CUSUM). A statistical concept used by the
establishment and monitored by the inspector whereby compliance is
determined based on sample results collected over a period of time. For
purposes of determining compliance with the finished product standards,
the CUSUM is equal to the sum of prior test results plus the weighted
result of the current test minus the tolerance, with the condition that
the resulting CUSUM cannot go below zero.
(b) Tolerance number. A weighted measure that equates to product
being produced at a national product quality level. See Table 2.
(c) Action number. A level reached by the CUSUM where the process is
out of control and product action is required by the establishment or
the inspector. See Table 2.
(d) "Start number". A value halfway between zero and the action
number. The start number is used to determine the starting CUSUM for the
first subgroup of a shift and to reset the CUSUM value if the CUSUM is
equal to or greater than the action number. See Table 2.
[[Page 448]]
(e) Subgroup. A 10-bird sample collected before product enters the
chiller and after product leaves the chiller.
(f) Subgroup absolute limit. The tolerance number plus 5. See Table
2.
(g) Prechill testing. Testing conducted by the establishment to
determine the CUSUM on consecutive 10-bird subgroup samples collected
prior to product entering the chilling system.
(h) Postchill testing. Testing conducted by the establishment to
determine the CUSUM on consecutive 10-bird subgroup samples collected as
the product leaves the chilling system.
(i) Rework. Reprocessing the product to correct the condition or
conditions causing the nonconformances listed in Table 1.
(ii) General. (a) Under SIS, one inspector inspects the outside,
inside, and viscera of each bird. There may be two inspectors on one
processing line, each inspecting every other bird. For the establishment
to run its processing line(s) at maximum speed, optimal conditions must
be maintained so that inspection may be conducted efficiently. The
inspector in charge determines the speed at which each processing line
may be operated to permit inspection. A variety of conditions may affect
this determination including the health of each flock and the manner in
which birds are being presented to the inspector for inspection.
(b) SIS may be performed by one inspector (SIS-1) or two inspectors
(SIS-2). SIS-1 requires that the establishment provide one inspection
station for each line and adequate reinspection facilities so carcasses
can be removed from each line for evaluation. The maximum line speed for
SIS-1 is 35 birds per minute. SIS-2 requires that the establishment
provide two inspection stations for each line and adequate reinspection
facilities so carcasses can be removed from each line for evaluation.
The maximum line speed for SIS-2 is 70 birds per minute.
(c) Under all inspection systems, including SIS, inspectors conduct
post-mortem inspection and look for a number of conditions, as specified
elsewhere in this subpart, which may indicate adulteration. Adulterated
product is condemned and destroyed, except that carcasses and parts
which may be made unadulterated by reprocessing (reworking) may be so
reprocessed under the supervision of an inspector and reinspected. Under
SIS, inspectors also reinspect product by sampling finished birds (both
before and after chilling) for nonconformances with finished product
standards (see Table 1). If such nonconformances are present at certain
statistical levels, it may indicate process difficulties requiring
corrective action by the establishment. If the establishment does not
take adequate corrective action, the inspector shall initiate corrective
actions such as conducting closer post-mortem inspections and requiring
reprocessing and reinspection of previously processed carcasses and
parts. Thus, SIS is conducted in two phases--a post-mortem inspection
phase and a reinspection phase. The following paragraphs describe the
inspection requirements (not addressed elsewhere in this subpart) under
each.
(iii) Post-mortem inspection. (a) Facilities: Each inspection
station must comply with the facility requirements in Sec. 381.36(c).
(b) Presentation: Each inspector shall be flanked by an
establishment employee assigned to be the inspector's helper. The one
inspector on the SIS-1 line shall be presented every bird. Each
inspector on the SIS-2 line shall be presented every other bird on the
line. An establishment employee shall present each bird to the inspector
properly eviscerated with the back side toward the inspector and the
viscera uniformly trailing or leading. Each inspector shall inspect the
inside, viscera, and outside of all birds presented.
(c) Disposition: The inspector shall determine which birds shall be
salvaged, reprocessed, condemned, retained for disposition by the
veterinarian, or allowed to proceed down the line as a passed bird
subject to trim and reinspection. Carcasses with certain defects not
requiring condemnation of the entire carcass shall be passed by the
inspector, but shall be subject to reinspection to ensure the physical
removal of the defects. The helper, under the supervision of the
inspector, shall mark such carcasses for trim when the defects are not
readily observable. Trimming of birds passed
[[Page 449]]
subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after all giblets are
harvested and prior to reinspection.
(iv) Reinspection. (a) Facilities: Reinspection stations are
required at both the prechill and postchill locations. The Agency will
determine the number of stations needed in those establishments having
more than one processing line or more than one chiller. One or more
prechill reinspection stations shall be conveniently located at the end
of the line or lines prior to chilling. One or more postchill stations
must be conveniently located at the end of the chiller or chillers. The
prechill and postchill reinspection stations must meet the following
provisions:
(1) Floor space shall consist of 3 feet along each conveyor line.
The space shall be level and protected from all traffic and overhead
obstructions.
(2) A table at least 2 feet wide and 2 feet deep and 3 feet in
height designed to be readily cleanable and drainable shall be provided
for reinspecting the sampled birds.
(3) A minimum of 200 foot-candles of shadow-free lighting with a
minimum color rendering index of 85 on the table surface.
(4) A separate clip board holder shall be provided for holding the
recording sheets.
(5) Hangback racks designed to hold 10 carcasses shall be provided
for and positioned within easy reach of the person at the station.
(b) Disposition: An inspector shall monitor the establishment's
application of the Finished Product Standards program and shall take
corrective action including retaining product to prevent adulterated
product from leaving the establishment when the inspector determines
that the establishment has failed to apply the program as prescribed in
paragraph (b)(3)(iv)(c) of this section).
(c) Finished Product Standards: Finished Product Standards (FPS) are
criteria applied to processed birds before and after chill to ensure
that the product being produced is consistently wholesome and
unadulterated. These criteria consist of nonconformances (listed in
Table 1), the incidence of which is determined from 10 bird subgroup
samples, reduced to a CUSUM number, and measured against the standards
(Table 2). The standards are applied to permit the Agency to estimate
when the production process is in control and when it is out of control.
The establishment is responsible for maintaining FPS which, in turn, is
monitored by the inspector. FPS is applied in two separate parts. The
first is called prechill testing. It is designed to ensure that the
slaughter and evisceration procedures are in control. Compliance is
measured by determining the CUSUM on consecutive 10-bird subgroup
samples collected prior to product entering the chilling system. The
second part of the FPS is called postchill testing. It is designed to
monitor the production through the chill system to ensure that it meets
the postchill FPS. This test is independent of the prechill test.
Compliance is measured by determining the CUSUM on consecutive 10-bird
subgroup samples as they exit the chilling system. When the system is
operating within compliance, the establishment applies the FPS to
product samples at the prechill reinspection station. Testing time and
time between tests are such that birds represented by the test are still
within the chiller. If an out-of-compliance condition is found, the
product leaving the chiller is segregated for rework and retested before
it may proceed into commerce. A second 10 bird subgroup sample of the
birds is taken after they leave the chiller to ensure that the product
meets the postchill FPS. Since the product is closer to the end of
processing, the controls on releasing reworked product are stricter than
controls under prechill testing, again to ensure that no adulterated
product enters into commerce.
(d) Prechill testing. The prechill FPS have been divided into
processing and trim categories. The processing category is designed to
monitor the output of the dressing and evisceration
[[Page 450]]
procedures. The trim category monitors the establishment's ability to
remove unwholesome lesions and conditions from inspected and passed
carcasses. Each category is monitored independently of the other
category using a separate CUSUM for each category.
(1) Actions to be taken when the process is in control. If the CUSUM
is less than the action number and the subgroup absolute limit is not
exceeded, the process is judged to be in control.
(i) Establishment Actions. The establishment shall:
(A) Randomly select and record subgroup sampling times for each
production unit of time before product reaches the prechill reinspection
station on the production line. In no case shall the time between tests
exceed 1 hour of production time.
(B) Conduct a 10-bird subgroup test at a random time on each poultry
slaughter line. These times are preselected by the establishment and
available to the inspector prior to the start of the shift/day's
operations. All 10 samples of the subgroup shall be collected at the
random time.
(C) Obtain the weighted value of each nonconformance by multiplying
the number recorded for each nonconformance by the "factor" in Table
1, sum the total of all the nonconformances, and calculate the CUSUM
value for that test.
(ii) Inspector Actions. The inspector shall:
(A) Select random times for monitoring subgroup tests for each half-
shift on the evisceration line. In establishments that have multiple
evisceration lines on a production shift, monitor all lines of product
at the random times.
(B) Collect the subgroup samples to be monitored at preselected
times. All 10 samples of the subgroup shall be collected at the random
time selected in paragraph (b)(3)(iv)(d)(1)(ii)(A) of this section.
(C) Conduct the 10-bird monitoring subgroup test.
(2) Actions to be taken when the subgroup absolute limit is
exceeded. If either an inspector or establishment subgroup test exceeds
the subgroup absolute limit of tolerance plus 5 (T+5), the establishment
shall determine if any of the immediate past 5 plant prechill subgroups
for that category (processing or trim) resulted in a CUSUM above the
start number.
(i) If all of the past 5 plant prechill subgroups are at or below
the start number, the establishment shall immediately conduct a retest
subgroup on that category of prechill to determine sample validity. If
retest subgroup total equals tolerance or less, the establishment
resumes random time testing. If the retest subgroup total exceeds
tolerance, the establishment shall proceed as if CUSUM reaches the
action number and shall begin process actions as set forth in paragraph
(b)(3)(iv)(d)(4) of this section. In either case, the prechill retest
results will be used to calculate CUSUM.
(ii) If any of the past 5 plant prechill subgroups resulted in a
CUSUM above the start number, the establishment shall proceed as if
CUSUM reaches the action number and shall begin process actions as set
forth in paragraph (b)(3)(iv)(d)(4) of this section.
(3) Actions to be taken when a trimmable lesion/condition is found.
If either inspection or plant monitoring finds any trimmable lesion or
condition as specified in item B(7) of Table 1 during a prechill
subgroup test, the establishment shall immediately conduct an additional
prechill subgroup test for the same trimmable lesion/condition category.
This is a requirement on the subgroup testing for the prechill trim
nonconformance that is in addition to the CUSUM test described in
paragraph (b)(3)(iv)(d)(1) of this section.
(i) If no additional item in the same category is found on retest,
the establishment shall resume random time sampling.
(ii) If an additional item in the same category is found on retest,
the establishment shall proceed as if CUSUM reaches the action number
and shall initiate corrective action set forth in paragraph
(b)(3)(iv)(d)(4) of this section for this category only.
(4) Actions to be taken when the CUSUM reaches the action number.
Once CUSUM reaches the action number, the process is judged to be not in
control.
(i) Establishment Actions. The establishment shall:
[[Page 451]]
(A) Immediately notify the inspector in charge and the production
supervisor responsible for the affected evisceration line.
(B) Suspend random time prechill testing of the affected
nonconformance category (processing or trim). Suspend random time
postchill subgroup testing when the processing category is the affected
nonconformance category.
(C) Conduct subgroup retests on carcasses leaving the chill system.
Apply the prechill criteria in Table 1 (A) or (B), depending upon which
category caused the action, and apply prechill Finished Product
Standards as listed in Table 2 to determine product compliance. In no
case shall the time between retests exceed 30 minutes of production
time. Apply prechill standard criteria at the postchill location after
notifying the establishment's production supervisor. If any of these
subgroup retests on product leaving the chill system result in a
subgroup total exceeding tolerance, identify for rework subsequent
product at the postchill location. All noncomplying product will be
brought into compliance prior to release into commerce. Product from the
chiller will continue accumulating for rework until a subsequent
subgroup test results in a subgroup total equal to or less than
tolerance.
(D) Conduct additional subgroup tests at the prechill reinspection
station to determine the adequacy of production corrective action. If
the prechill tests results in a subgroup total exceeding the tolerance,
notify the production supervisor. The number of additional tests at the
postchill reinspection station using prechill standards is increased as
required to include the product in the chiller represented by this
additional prechill test.
(E) After two consecutive additional prechill subgroup tests result
in subgroup totals equal to or less than tolerance:
-- Resume random time prechill subgroup testing as set forth in
actions to be taken when the process is in control at paragraph
(b)(3)(iv)(d)(1) of this section.
-- Identify product entering the chill system that will mark the end
of the retest action upon arrival at the postchill sampling location.
Such identification may include tagging or empty space in chillers,
depending upon the establishment's identification method.
-- Once all product identified as needing retesting has arrived at
the postchill sampling location, random time postchill FPS testing
resumes.
-- If two consecutive additional prechill subgroup tests demonstrate
process control with subgroup totals equal to or less than tolerance,
but they do not cause CUSUM to fall to the start line or below, reset
CUSUM at the start number.
(ii) Inspector Actions. The inspector shall monitor product and
process actions by making spot-check observations to ensure that all
program requirements are met.
(e) Postchill testing. Postchill subgroups shall be collected after
the product leaves the chiller but before the product is divided into
separate processes. Each bird sampled shall be observed and its
conformance measured against the postchill criteria. The subgroup
nonconformance weights shall be totaled and the CUSUM calculated by
subtracting the tolerance from the sum of the subgroup total and the
starting CUSUM.
(1) Actions to be taken when the process is in control. If the CUSUM
is less than the action number and the subgroup absolute limit is not
exceeded, the process is judged to be in control.
(i) Establishment Actions. The establishment shall conduct a 10-bird
subgroup test for each chiller system at a randomly selected time of
production. In no case shall the time between tests exceed 2 hours of
production time.
(ii) Inspector Actions. The inspector shall:
(A) Select random times for postchill monitoring.
(B) Monitor each chill system twice per shift.
(C) Conduct subgroup tests at preselected random times.
(2) Actions to be taken when the subgroup absolute limit is
exceeded. If either an inspector or establishment subgroup test exceeds
the subgroup absolute limit of tolerance plus 5(T+5), the establishment
shall determine if any of
[[Page 452]]
the last 5 postchill monitoring subgroups resulted in a CUSUM above the
start number.
(i) If all of the past 5 postchill monitoring subgroups resulted in
a CUSUM at or below the start number, the establishment shall
immediately retest a subgroup to determine sample validity. If this
retest subgroup total exceeds tolerance, the establishment shall proceed
as if CUSUM reaches the action number and shall begin process actions as
set forth in paragraph (b)(3)(iv)(e)(3) of this section.
(ii) If any of the past 5 postchill monitoring subgroups resulted in
a CUSUM above the start number, the establishment shall proceed as if
CUSUM reaches the action number and shall begin process actions as set
forth in paragraph (b)(3)(iv)(e)(3) of this section.
(3) Actions to be taken when the CUSUM reaches the action number.
Once CUSUM reaches the action number, the process is judged to be not in
control.
(i) Establishment Actions. The establishment shall:
(A) Notify the inspector in charge and the production supervisor
responsible for product in the chiller.
(B) Suspend random time postchill subgroup testing.
(C) Immediately conduct an additional postchill subgroup test. If
the retest subgroup total exceeds tolerance, the establishment shall
identify subsequent product for rework. Product will continue
accumulating for rework until a subsequent subgroup test results in a
subgroup total equal to or less than tolerance.
(D) After two consecutive additional postchill subgroup tests
results in subgroup totals equal to or less than tolerance:
-- Resume random time postchill subgroup testing as set forth in
actions to be taken when the process is in control at paragraph
(b)(3)(iv)(e)(1) of this section.
-- If the two consecutive additional postchill subgroup totals equal
to or less than tolerance do not cause CUSUM to fall to the start number
or below, reset CUSUM at the start number.
(ii) Inspector Actions. The inspector shall monitor product and
process actions to ensure that program requirements are met.
(v) When the prechill or postchill product has been identified as
having been produced when the process was not in control, additional
online subgroup testing by the establishment is required to determine
its conformance to the standard. If any of the additional plant subgroup
testing results in a subgroup total exceeding tolerance, offline product
corrective actions must take place. The responsibilities of the
establishment and the inspector change depending on the CUSUM.
All corrective actions such as identifying affected product,
segregating product, and maintaining control through rework actions are
the establishment's responsibility. Corrective actions by the inspector
depends upon the establishment's ability to control rework of affected
product. If the establishment fails in its responsibilities, the
inspector will identify, segregate, and retain affected product to
prevent adulterated product from reaching consumers.
(a) Offline product. The establishment shall identify the affected
product so that it may be segregated and accumulated offline for rework.
The inspector shall spot check the establishment's identification,
segregation, and control of reworked product to ensure that program
requirements are met.
(b) Reworked product. Reworked product must be tested by the
establishment with a randomly selected subgroup test of the accumulated
reworked lot. Before product is released, the random subgroup test must
result in a subgroup total equal to or less than tolerance. If the
subgroup test of a reworked lot results in a subgroup total exceeding
tolerance, the lot must be reworked again before another subgroup is
selected. The following actions are required.
(1) Establishment Actions. The establishment shall:
(i) Select the random subgroup from throughout the lot only after
the total lot has been reworked.
(ii) Conduct the subgroup test using the same criteria (prechill or
postchill) that resulted in the rework action.
[[Page 453]]
(iii) Release the lot if the reworked subgroup test resulted in a
subgroup total equal to or less than tolerance.
(iv) Identify and control the lot to be reworked if the reworked
subgroup total again exceeds tolerance.
(2) Inspector Actions: The inspector shall spot check the rework
procedure to ensure that plant monitoring and production meet the
requirements of the program.
(vi) After the 10 bird subgroup tests are completed, the prechill
and postchill processing nonconformances shall be corrected on all bird
samples prior to returning the samples to the product flow. Samples with
trim nonconformances shall be returned to the trim station for
correction prior to their return to the product flow.
Table 1--Definitions of Nonconformances
A Processing Nonconformances
1 Extraneous material [le]\1/16\
--Include any specks, tiny smears, or stains of material that
measure \1/16\ or less in the greatest dimension.
Examples: Ingesta, unattached feathers, grease, bile remnants, and/
or whole gall bladder or spleen, embryonic yolk, etc.
--Factor is one.
--1 to 5=1 defect: 6 to 10=2 defects; 11 or more=3 defects. A
maximum of three incidents per carcass.
2 Extraneous material \1/16\ to 1
--The same material as line 1, but measuring \1/16\ to 1 in the longest dimension.
--Factor is one.
--A maximum of three incidents per carcass.
3 Extraneous material 1
--The same material as lines 1 to 2, but measuring greater than one
inch.
--Factor is two.
--A maximum of two incidents per carcass.
4 Oil glands remnant--less than two whole glands
--Recognizable fragment(s) of one or both oil glands equals one
incident.
--Factor is one.
--Maximum of one incident per carcass.
5 Oil glands--two whole glands
--Both whole oil glands with no missing fragments equals one
incident. If the oil glands are cut, but no fragment is removed,
consider them to be whole. But if even a small fragment is removed,
use line 4.
--Factor is two.
--A maximum of one incident per carcass.
6 Lung [ge]\1/4\ whole
--Any portion less than a whole lung, and equal to or greater than
\1/4\ at the greatest dimension, equals one incident.
--Factor is one.
--A maximum of two incidents per carcass.
7 Lung--whole
--Each whole lung equals one incident.
--Factor is two.
--A maximum of two incidents per carcass.
8 Intestine
--Any identifiable portion of the terminal portion of the intestinal
tract with a lumen (closed circle) present, or split piece of
intestine large enough to be closed to form a lumen.
--Factor is five.
--A maximum of one incident per carcass.
9 Cloaca
--Any identifiable portion of the terminal portion of the intestinal
tract with mucosal lining.
--Factor is five.
--A maximum of one incident per carcass.
10 Bursa of Fabricius
--A whole rosebud, or identifiable portion with two or more mucosal
folds.
--Factor is two.
--A maximum of one incident per carcass.
11 Esophagus
--Any portion of the esophagus with identifiable mocosal lining.
--Factor is two.
--A maximum of one incident per carcass.
12 Crop--partial--with mucosa
--Any portion of the crop that includes the mucosal lining.
--Factor is two.
--A maximum of one incident per carcass.
13 Crop--whole
--Any complete crop.
--Factor is five.
--A maximum of one incident per carcass.
14 Trachea [le]1
--Identifiable portion of trachea less than or equal to one inch
long.
--Factor is one.
--A maximum of one incident per carcass.
15 Trachea 1
--Identifiable portion of trachea greater than one inch.
--Factor is two.
--A maximum of one incident per carcass.
[[Page 454]]
16 Hair [ge]\1/4\ 26 or more.
--Hair which is one-fourth inch long or longer measured from the top
of the follicle to the end of the hair. 26 or more hairs equal one
incident.
--Factor is one.
--A maximum of one incident per carcass.
17 Feather and/or Pinfeathers [le]1
--Attached feathers or protruding pinfeathers less than or equal to
one inch long. Scored 5 to 10 per carcass as one incident, 11 to 15
per carcass as two incidents, and 16 or more as three incidents.
--Factor is one.
--A maximum of three incidents per carcass.
18 Feathers 1
--Attached feathers longer than one inch. Scored 1 to 3 per carcass
as one incident 4 to 6 per carcass as two incidents, and 7 or more
as three incidents.
--Factor is one.
--A maximum of three incidents per carcass.
19 Long Shank--both condyles covered
--If the complete tibiotarsal joint is covered, it equals one
incident.
--Factor is two.
--A maximum of two incidents per carcass.
B Trim nonconformances
1 Breast blister
--Inflammatory tissue, fluid, or pus between the skin and keel must
be trimmed if membrane "slips" or if firm nodule is greater than
\1/2\ in diameter (dime size).
--Factor is two.
--A maximum of one incident per carcass.
2 Breast blister--partially trimmed
--All inflammatory tissue, including that which adheres tightly to
the keel bone, must be removed.
--Factor is two.
--A maximum of one incident per carcass.
3 Bruise \1/2\ to 1
--Blood clumps or clots in the superficial layers of tissue, skin,
muscle or loose subcutaneous tissue may be slit and the blood
completely washed out. When the bruise extends into the deeper
layers of muscle, the affected tissue must be removed. Very small
bruises less than \1/2\ (dime size) and areas showing
only slight reddening need not be counted as defects.
--Factor is one.
--A maximum of five incidents per carcass.
4 Bruise 1
--Same criteria as in line three, but greater than one inch in
greatest dimension.
--Factor is two.
--A maximum of three incidents per carcass.
5 Bruise black/green \1/4\ to 1
--Bruises \1/4\ to 1 that have changed from
red to a black/blue or green color due to age.
--Factor is two.
--A maximum of three incidents per carcass.
6 Bruise Black/green 1
--Same as line 5, but measuring greater that 1 in
greatest dimension.
--Factor is five.
--A maximum of two incidents per carcass.
7 Trimmable lesions/Condition
--A trimmable tumor or identifiable portion of a tumor on any part
of the carcass.
--Trimmable Synovitis/airsacculitis (saddle/frog) lesions that have
not been removed.
--Lesion/condition subject to removal following an approved cleanout
process. Examples: airsacculitis, salpingitis, nephritis, spleen,
or liver conditions requiring removal of the kidneys.
Note: All establishments shall develop and maintain a permanent marking
system that identifies carcasses with removable lesions/conditions on
the inside surfaces. When removable lesions/conditions are identified
inside the carcass by the inspector, the helper will be notified to
apply the permanent mark. When removable inside lesions/conditions are
found on a subgroup sample without the permanent mark, the error is not
recorded in line 7. The affected carcass(s) will be hungback for IIC
disposition and corrective action.
--Factor is five.
--A maximum of one incident per carcass.
8 Failure to complete task as indicated by marking system.
Example: Synovitis, airsacculitis, inflammatory process,
contamination, etc.
--The helper, under the inspector's direction, will apply a mark to
the carcass, indicating to the trimmer(s) that specific action must
be taken on that carcass. When airsac and kidney cleanout, or
synovitis part removal, or carcass removal from the line is not
completed, or only partially completed, this occurrence is recorded
as one defect.
[[Page 455]]
--Factor is five. It will also be recorded as a line 7 defect for a
total factor of 10.
--A maximum of one incident per carcass.
9 Compound fracture
--Any bone fracture (i.e., leg or wing) that has caused an opening
through the skin. May be accompanied with a bruise, but not always.
Do not count the bruise in line 3 or 4 if it is associated with the
compound fracture.
--Factor is two.
--A maximum of three incidents per carcass.
10 Wingtip compound fracture
--Same criteria as line 9, but only for wingtips.
Note: Bruises not associated with the fracture should be recorded
in the appropriate lines.
--Factor is one.
--A maximum of two incidents per carcass.
11 Untrimmed short hock
--When no cartilage of the hock surface is present and no tendons
are attached to the bone.
--Factor is two.
--A maximum of two incidents per carcass.
12 Sores, scabs, inflammatory process, etc. [le]\1/2\
--Any defects such as sores, abscesses, scabs, wounds, dermatitis,
inflammatory process, that measure less than or equal to \1/2\ in the greatest dimension.
--Factor is two.
--A maximum of two incidents per carcass.
13 Sores, scabs, inflammatory process, etc. \1/2\
--Same as line 12, but greatest dimension is greater than \1/2\, or a cluster of smaller lesions in close proximity \1/2\, this category also includes turkey leg edema.
--Factor is five.
--A maximum of one incident per carcass.
14 External mutilation
--Mutilation to the skin and/or muscle that is caused by the
slaughter, dressing or eviscerating processes. Skinned elbows
(bucked wings) do not trim require unless affected wing joint
capsule is also opened.
--Factor is one.
--A maximum of three incidents per carcass.
C Postchill nonconformances--(Designed to monitor those nonconformances
added to product during the chilling process)
1 Extraneous material [le]\1/16\
--Include specks, grease, or unidentifiable foreign material that
measure \1/16\ or less in the greatest dimension.
--Example: Ingesta, grease, or unidentifiable foreign material.
--Factor is one.
--3 to 7=1 defect; 8 to 12=2 defects; 13 or more=3 defects. A
maximum of three incidents per carcass.
2 Extraneous material \1/16\ to 1
--This includes ingesta, grease, or unidentifiable foreign material
measureing \1/16\ to 1 longest
dimension.
--Factor is one.
--A maximum of three incidents per carcass.
3 Extraneous material 1
--The same material as line 2, but measuring greater than one inch.
--Factor is two.
--A maximum of two incidents per carcass.
Table 2--Finished Product Standards
SIS
Prechill Processing Nonconformance
Tolerance number (T)......................................... 25
Subgroup Absolute Limit (T+5)................................ 30
Action number................................................ 22
Start number................................................. 11
Prechill Trim Nonconformance
Tolerance number (T)......................................... 12
Subgroup Absolute Limit (T+5)................................ 17
Action number................................................ 15
Start number................................................. 8
Postchill Nonconformance
Tolerance number (T)......................................... 5
Subgroup Absolute Limit (T+5)................................ 10
Action number................................................ 10
Start number................................................. 5
(4) The following requirements are also applicable to NELS
inspection:
(i) Inspection under NELS is conducted in two phases, as post-mortem
inspection phase and a reinspection phase.
(a) Post-mortem inspection. The establishment shall provide three
inspection stations on each eviscerating line in compliance with the
facility requirements Sec. 381.36(d)(1). The three inspectors shall
inspect the inside, viscera, and outside of all birds presented. Each
[[Page 456]]
inspector shall be flanked by two establishment employees--the presenter
and the helper. The presenter shall ensure that the bird is properly
eviscerated and presented for inspection and the viscera uniformly
trailing or leading. The inspector shall determine which birds shall be
salvaged, reprocessed, condemned, retained for disposition by the
veterinarian, or allowed to proceed down the line as a passed bird
subject to reinspection. Poultry carcasses with certain defects not
requiring condemnation of the entire carcass shall be passed by the
inspector, but shall be subject to reinspection to ensure the physical
removal of the specified defects. The helper, under the supervision of
the inspector, shall mark such carcasses for trim when the defects are
not readily observable. Trimming or birds passed subject to reinspection
shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after giblet harvest and
prior to reinspection.
(b) A reinspection station shall be located at the end of each line.
This station shall comply with the facility requirements in
Sec. 381.36(d)(2). The inspector shall ensure that the establishment has
performed the indicated trimming of carcasses passed subject to
reinspection by visually monitoring, checking data, or gathering samples
at the station or at other critical points on the line.
(ii)-(iii) [Reserved]
(iv) The maximum inspection rate for NELS shall be 91 birds per
minute per eviscerating line.
(5) The following requirements are also applicable to the NTI
System:
(i) Inspection under the NTI System is conducted in two phases, a
post-mortem inspection phase and a reinspection phase. The NTI-1
Inspection System requires that the establishment provide one inspection
station for each line and adequate reinspection facilitiates so
carcasses can be removed from each line for evaluation. The NTI-2
Inspection System requires that the establishment provide two inspection
stations for each line and adequate reinspection facilities so carcasses
can be removed from each line for evaluation.
(a) Post-mortem inspection. Each inspection station must comply with
the facility requirements in Sec. 381.36(e)(1). Each inspector shall be
flanked by and establishment employee assigned to be the inspector's
helper. The one inspector on an NTI-1 Inspection System shall be
presented every bird. Each inspector on an NTI-2 Inspection System line
shall be presented every other bird on the line. An establishment
employee shall present each bird to the inspector properly eviscerated
with the back side toward the inspector and the viscera uniformly
trailing or leading. Each inspector shall inspect the inside, viscera,
and outside of all birds presented. The inspector shall determine which
bird shall be salvaged, reprocessed, condemned, retained for disposition
by a veterinarian, or allowed to proceed down the line as a passed bird
subject to reinspection. Turkey carcasses with certain defects not
requiring condemnation of the entire carcass shall be passed by the
inspector, but shall be subject to reinspection to ensure the physical
removal of the specified defects. The helper, under the supervision of
the inspector, shall mark such carcasses for trim when the defects of
birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after the giblet harvest
and prior to reinspection.
(b) Reinspection. A reinspection station shall be located at the end
of the lines. This station shall comply with the facility requirements
in Sec. 381.36(e)(2). The inspector shall ensure that establishments
have performed the indicated trimming of each carcass passed subject to
reinspection by visually monitoring, checking data, and/or sampling
product at the reinspection station and, if necessary, at other points,
critical to the wholesomeness of product, on the eviscerating line.
[[Page 457]]
(ii)-(iii) [Reserved]
(Recordkeeping requirements approved by the Office of Management and
Budget under control number 0583-0008)
[47 FR 23435, May 28, 1982, as amended at 49 FR 42555, Oct. 23, 1984; 50
FR 37513, Sept. 16, 1985; 50 FR 38097, Sept. 20, 1985; 51 FR 3574, Jan.
29, 1986; 53 FR 46861, Nov. 21, 1988; 62 FR 5143, Feb. 4, 1997; 65 FR
34390, May 30, 2000; 66 FR 22906, May 7, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.77]
[Page 457]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.77 Carcasses held for further examination.
Each carcass, including all parts thereof, in which there is any
lesion of disease, or other condition which might render such carcass or
any part thereof adulterated and with respect to which a final decision
cannot be made on first examination by the inspector, shall be held for
further examination. The identity of each such carcass, including all
parts thereof, shall be maintained until a final examination has been
completed.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.78]
[Page 457]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.78 Condemnation of carcasses and parts: separation of poultry suspected of containing biological residues.
(a) At the time of any inspection under this subpart each carcass,
or any part thereof, which is found to be adulterated shall be
condemned, except that any such articles which may be made not
adulterated by reprocessing, need not be so condemned if so reprocessed
under the supervision of an inspector and thereafter found to be not
adulterated.
(b) When a lot of poultry suspected of containing biological
residues is inspected in an official establishment, all carcasses and
any parts of carcasses in such lot which are condemned shall be kept
separate from all other condemned carcasses or parts.
[37 FR 9706, May 16, 1972, as amended at 48 FR 22899, May 23, 1983; 48
FR 23807, May 27, 1983]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.79]
[Page 457]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.79 Passing of carcasses and parts.
Each carcass and all organs and other parts of carcasses which are
found to be not adulterated shall be passed for human food.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.80]
[Page 457]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.80 General; biological residues.
(a) The carcasses or parts of carcasses of all poultry inspected at
an official establishment and found at the time of post mortem
inspection, or at any subsequent inspection, to be affected with any of
the diseases or conditions named in other sections in this subpart,
shall be disposed of in accordance with the section pertaining to the
disease or condition. Owing to the fact that it is impracticable to
formulate rules for each specific disease or conditions and to designate
at just what stage a disease process results in an adulterated article,
the decision as to the disposal of all carcasses, organs or other parts
not specifically covered by the regulations, or by instructions of the
Administrator issued pursuant thereto, shall be left to the inspector in
charge, and if the inspector in charge is in doubt concerning the
disposition to be made, specimens from such carcasses shall be forwarded
to the Inspection Service laboratory for diagnosis.
(b) All carcasses, organs, or other parts of carcasses of poultry
shall be condemned if it is determined on the basis of a sound
statistical sample that they are adulterated because of the presence of
any biological residues.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.81]
[Page 457]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.81 Tuberculosis.
Carcasses of poultry affected with tuberculosis shall be condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.82]
[Page 457]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.82 Diseases of the leukosis complex.
Carcasses of poultry affected with any one or more of the several
forms of the avian leukosis complex shall be condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.83]
[Page 457]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.83 Septicemia or toxemia.
Carcasses of poultry showing evidence of any septicemic or toxemic
disease, or showing evidence of an abnormal physiologic state, shall be
condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.84]
[Page 457-458]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.84 Airsacculitis.
Carcasses of poultry with evidence of extensive involvement of the
air sacs with airsacculitis or those showing airsacculitis along with
systemic changes shall be condemned. Less affected carcasses may be
passed for food
[[Page 458]]
after complete removal and condemnation of all affected tissues
including the exudate.
[40 FR 14297, Mar. 31, 1975]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.85]
[Page 458]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.85 Special diseases.
Carcasses of poultry showing evidence of any disease which is
characterized by the presence, in the meat or other edible parts of the
carcass, or organisms or toxins dangerous to the consumer, shall be
condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.86]
[Page 458]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.86 Inflammatory processes.
Any organ or other part of a carcass which is affected by an
inflammatory process shall be condemned and, if there is evidence of
general systemic disturbance, the whole carcass shall be condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.87]
[Page 458]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.87 Tumors.
Any organ or other part of a carcass which is affected by a tumor
shall be condemned and when there is evidence of metastasis or that the
general condition of the bird has been affected by the size, position,
or nature of the tumor, the whole carcass shall be condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.88]
[Page 458]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.88 Parasites.
Organs or other parts of carcasses which are found to be infested
with parasites, or which show lesions of such infestation shall be
condemned and, if the whole carcass is affected, the whole carcass shall
be condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.89]
[Page 458]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.89 Bruises.
Any part of a carcass which is badly bruised shall be condemned and,
if the whole carcass is affected as a result of the bruise, the whole
carcass shall be condemned. Parts of a carcass which show only slight
reddening from a bruise may be passed for food.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.90]
[Page 458]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.90 Cadavers.
Carcasses of poultry showing evidence of having died from causes
other than slaughter shall be condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.91]
[Page 458-459]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.91 Contamination.
(a) Carcasses of poultry contaminated by volatile oils, paints,
poisons, gases, scald vat water in the air sac system, or other
substances which render the carcasses adulterated shall be condemned.
Any organ or other part of a carcass which has been accidentally
multilated in the course of processing shall be condemned, and if the
whole carcass is affected, the whole carcass shall be condemned.
(b)(1) Any carcass of poultry accidentally contaminated during
slaughter with digestive tract contents shall not be condemned if
promptly reprocessed under the supervision of an inspector and
thereafter found not to be adulterated. Contaminated surfaces that are
cut shall be removed only by trimming. Contaminated inner surfaces that
are not cut may be cleaned by trimming alone, or at an approved
reprocessing station away from the main processing line, by any method
that will remove the contamination, such as vacuuming, washing, and
trimming, singly or in combination. All visible specks of contamination
must be removed, and if the inner surfaces are reprocessed other than
soley by trimming, all surfaces of the carcass shall be treated with
chlorinated water containing 20 ppm available chlorine.
(2) An area will be designated as an approved reprocessing station
only if the Administrator determines that reprocessing operations can be
conducted in that area in accordance with all of the requirements of
this part, and that the reprocessing methods to be utilized are capable
of removing all visible specks of contamination on the inner surface of
a carcass. Requests for such approval shall be submitted to the
inspector in charge and shall describe the proposed area, proposed
methods of reprocessing, and proposed equipment to be utilized. Whenever
the Administrator finds that reprocessing operations cannot be conducted
in such area in accordance with all of the requirements of this part or
that the reprocessing methods utilized are not capable of removing all
visible specks of contamination on the inner surface of a carcass, he
may withdraw approval of such area, effective upon oral or written
notification, whichever is earlier, to the operator of the
establishment. In the event of oral notification, a written confirmation
thereof shall be given to the operator as promptly as circumstances
permit. The notification
[[Page 459]]
shall specify the reasons for such withdrawal and shall afford the
operator of the establishment an opportunity to present his views. In
any instance where there is a conflict as to the facts, a hearing shall
be held to resolve such conflict.
[37 FR 9706, May 16, 1972, as amended at 43 FR 12847, Mar. 28, 1978]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.92]
[Page 459]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.92 Overscald.
Carcasses of poultry which have been overscalded, resulting in a
cooked appearance of the flesh, shall be condemned.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.93]
[Page 459]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.93 Decomposition.
Carcasses of poultry deleteriously affected by post mortem changes
shall be disposed of as follows:
(a) Carcasses which have reached a state of putrefaction or stinking
fermentation shall be condemned.
(b) Any part of a carcass which is green struck shall be condemned
and, if the carcass is so extensively affected that removal of affected
parts is impracticable, the whole carcass shall be condemned.
(c) Carcasses affected by types of post mortem change which are
superficial in nature may be passed for human food after removal and
condemnation of the affected parts.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.94]
[Page 459-462]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart K--Post Mortem Inspection; Disposition of Carcasses and Parts
Sec. 381.94 Contamination with Microorganisms; process control verification criteria and testing; pathogen reduction standards.
(a) Criteria for verifying process control; E. coli testing.
(1) Each official establishment that slaughters poultry shall test
for Escherichia coli Biotype I (E. coli). Establishments that slaughter
more than one type of poultry and/or poultry and livestock, shall test
the type of poultry or livestock slaughtered in the greatest number. The
establishment shall:
(i) Collect samples in accordance with the sampling techniques,
methodology, and frequency requirements in paragraph (a)(2) of this
section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of
this section; and
(iii) Maintain records of such analytic results in accordance with
paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written
specimen collection procedures which shall identify employees designated
to collect samples, and shall address location(s) of sampling, how
sampling randomness is achieved, and handling of the sample to ensure
sample integrity. The written procedure shall be made available to FSIS
upon request.
(ii) Sample collection. A whole bird must be taken from the end of
the chilling process. If this is impracticable, the whole bird can be
taken from the end of the slaughter line. Samples must be collected by
rinsing the whole carcass in an amount of buffer appropriate for that
type of bird. Samples from turkeys or ratites also may be collected by
sponging the carcass on the back and thigh.\1\
---------------------------------------------------------------------------
\1\ A copy of FSIS's "Guidelines for Escherichia coli Testing for
Process Control Verification in Poultry Slaughter Establishments," and
"FSIS Turkey Microbiological Procedures for Sponge Sample Collection
and Methods of Analysis" are available for inspection in the FSIS
Docket Room.
---------------------------------------------------------------------------
(iii) Sampling frequency. Slaughter establishments, except very low
volume establishments as defined in paragraph (a)(2)(v) of this section,
must take samples at a frequency proportional to the establishment's
volume of production at the following rates:
(A) Chickens: 1 sample per 22,000 carcasses, but a minimum of one
sample during each week of operation.
(B) Turkeys, Ducks, Geese, Guineas, Squabs, and Ratites: 1 sample
per 3,000 carcasses, but at a minimum one sample each week of operation.
(iv) Sampling frequency alternatives. An establishment operating
under a validated HACCP plan in accordance with Sec. 417.2(b) of this
chapter may substitute an alternative frequency for the frequency of
sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in
writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's processing controls.
[[Page 460]]
(v) Sampling in very low volume establishments.
(A) Very low volume establishments annually slaughter no more than
440,000 chickens, 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000
guineas, 60,000 squabs, 6,000 ratites, or a combination of all types of
poultry not exceeding 60,000 turkeys and 440,000 birds total. Very low
volume establishments that slaughter turkeys, ducks, geese, guineas,
squabs, or ratites in the largest number must collect at least one
sample during each week of operation after June 1 of each year, and
continue sampling at a minimum of once each week the establishment
operates until June of the following year or until 13 samples have been
collected, whichever comes first.
(B) Upon the establishment's meeting the requirements of paragraph
(a)(2)(v)(A) of this section, weekly sampling and testing is optional,
unless changes are made in establishment facilities, equipment,
personnel or procedures that may affect the adequacy of existing process
control measures, as determined by the establishment or by FSIS. FSIS
determinations that changes have been made requiring resumption of
weekly testing shall be provided to the establishment in writing.
(3) Analysis of samples. Laboratories may use any quantitative
method for analysis of E. coli that is approved as an AOAC Official
Method of the AOAC International (formerly the Association of Official
Analytical Chemists) \2\ or approved and published by a scientific body
and based on the results of a collaborative trial conducted in
accordance with an internationally recognized protocol on collaborative
trials and compared against the three tube Most Probable Number (MPN)
method and agreeing with the 95 percent upper and lower confidence limit
of the appropriate MPN index.
---------------------------------------------------------------------------
\2\ A copy of the current edition/revision of the "Official Methods
of AOAC International," 16th edition, 3rd revision, 1997, is on file
with the Director, Office of the Federal Register, and may be purchased
from the Association of Official Analytical Chemists International,
Inc., 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------
(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of CFU/ml of rinse fluid.
Results shall be recorded onto a process control chart or table showing
at least the most recent 13 test results, by type of poultry
slaughtered. Records shall be retained at the establishment for a period
of 12 months and shall be made available to FSIS upon request.
(5)(i) Criteria for Evaluation of test results. An establishment is
operating within the criteria when the most recent E. coli test result
does not exceed the upper limit (M), and the number of samples, if any,
testing positive at levels above (m) is three or fewer out of the most
recent 13 samples (n) taken, as follows:
Table 1.--Evaluation of E. Coli Test Results
----------------------------------------------------------------------------------------------------------------
Maximum number
Lower limit of Upper limit of Number of permitted in
Types of poultry marginal range marginal range samples marginal range
(m) (M) tested (n) (c)
----------------------------------------------------------------------------------------------------------------
Chickens........................................ \1\ 100 \1\ 1,000 13 3
Turkeys......................................... *NA *NA *NA *NA
Ducks........................................... *NA *NA *NA *NA
Geese........................................... *NA *NA *NA *NA
Guineas......................................... *NA *NA *NA *NA
Squabs.......................................... *NA *NA *NA *NA
Ratites......................................... *NA *NA *NA *NA
----------------------------------------------------------------------------------------------------------------
\1\ CFU/ml.
* Values will be added upon completion of data collection programs.
(ii) For types of poultry appearing in paragraph (a)(5)(1) Table 1
of this section that do not have m/N criteria, establishments shall
evaluate E. coli test results using statistical process control
techniques.
[[Page 461]]
(6) Failure to meet criteria. Test results that do not meet the
criteria described in paragraph (a)(5) of this section are an indication
that the establishment may not be maintaining process controls
sufficient to prevent fecal contamination. FSIS shall take further
action as appropriate to ensure that all applicable provisions of the
law are being met.
(7) Failure to test and record. Inspection will be suspended in
accordance with rules of practice that will be adopted for such
proceeding, upon a finding by FSIS that one or more provisions of
paragraphs (a) (1)-(4) of this section have not been complied with and
written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standards; Salmonella.
(1) Raw poultry product performance standards for Salmonella. (i) An
establishment's raw poultry products, when sampled and tested by FSIS
for Salmonella as set forth in this section, may not test positive for
Salmonella at a rate exceeding the applicable national pathogen
reduction performance standard, as provided in Table 2:
Table 2.--Salmonella Performance Standards
----------------------------------------------------------------------------------------------------------------
Performance
Standard Number of Maximum number
Class of product (percent samples tested of positives to
positive for (n) achieve
salmonella) \a\ standard (c)
----------------------------------------------------------------------------------------------------------------
Broilers.................................................. 20.0% 51 12
Ground chicken............................................ 44.6 53 26
Ground turkey............................................. 49.9 53 29
Turkeys................................................... b NA NA NA
Squabs.................................................... b NA NA NA
Ratites................................................... b NA NA NA
----------------------------------------------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw
products based on data developed by FSIS in its nationwide microbiological baseline data collection programs
and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide
Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the
FSIS Docket Room.)
b Not available; baseline targets for turkeys, squabs, or ratites will be added upon completion of the data
collection programs for that product.
(2) Enforcement. FSIS will sample and test raw poultry products in
an individual establishment on an unannounced basis to determine
prevalence of Salmonella in such products to determine compliance with
the standard. The frequency and timing of such testing will be based on
the establishment's previous test results and other information
concerning the establishment's performance. In an establishment
producing more than one class of product subject to the pathogen
reduction standard, FSIS may sample any or all such classes of
products.\3\
---------------------------------------------------------------------------
\3\ A copy of FSIS's "Sample Collection Guidelines and Procedure
for Isolation and Identification of Salmonella from Raw Meat and Poultry
Products" is available for inspection in the FSIS Docket Room.
---------------------------------------------------------------------------
(3) Noncompliance and establishment response. When FSIS determines
that an establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the
standard.
(ii) If the establishment fails to meet the standard on the next
series of compliance tests for that product, the establishment shall
reassess its HACCP plan for that product.
(iii) Failure by the establishment to act in accordance with
paragraph (b)(3)(ii) of this section, or failure to meet the standard on
the third consecutive series of FSIS-conducted tests for that product,
constitutes failure to maintain sanitary conditions and failure to
maintain an adequate HACCP plan, in accordance with part 417 of this
chapter, for that product, and will cause FSIS to suspend inspection
services. Such suspension will remain in effect until the establishment
submits to the FSIS Administrator or his/her designee satisfactory
written assurances detailing the action taken to correct the HACCP
system and, as appropriate,
[[Page 462]]
other measures taken by the establishment to reduce the prevalence of
pathogens.
[61 FR 38866, July 25, 1996, as amended at 62 FR 26218, May 13, 1997; 62
FR 61009, Nov. 14, 1997; 64 FR 66553, Nov. 29, 1999; 67 FR 13258, Mar.
22, 2002]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.95]
[Page 462]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart L--Handling and Disposal of Condemned or Other Inedible Products
at Official Establishments
Sec. 381.95 Disposal of condemned poultry products.
All condemned carcasses, or condemned parts of carcasses, or other
condemned poultry products, except those condemned for biological
residues shall be disposed of by one of the following methods, under the
supervision of an inspector of the Inspection Service. (Facilities and
materials for carrying out the requirements in this section shall be
furnished by the official establishment.)
(a) Steam treatment (which shall be accomplished by processing the
condemned product in a pressure tank under at least 40 pounds of steam
pressure) or thorough cooking in a kettle or vat, for a sufficient time
to effectively destroy the product for human food purposes and preclude
dissemination of disease through consumption by animals. (Tanks and
equipment used for this purpose or for rendering or preparing inedible
products shall be in rooms or compartments separate from those used for
the preparation of edible products. There shall be no direct connection
by means of pipes, or otherwise, between tanks containing inedible
products and those containing edible products.)
(b) Incineration or complete destruction by burning.
(c) Chemical denaturing, which shall be accomplished by the liberal
application to all carcasses and parts thereof, of:
(1) Crude carbolic acid,
(2) Kerosene, fuel oil, or used crankcase oil, or
(3) Any phenolic disinfectant conforming to commercial standards CS
70-41 or CS 71-41 which shall be used in at least 2 percent emulsion or
solution.
(d) Any other substance or method that the Administrator approves in
specific cases, which will denature the poultry product to the extent
necessary to accomplish the purposes of this section.
(e) Carcasses and parts of carcasses condemned for biological
residue shall be disposed of in accordance with paragraph (b) of this
section or by burying under the supervision of an inspector.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.96]
[Page 462-463]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.96 Wording and form of the official inspection legend.
Except as otherwise provided in this subpart, the official
inspection legend required to be used with respect to inspected and
passed poultry products shall include wording as follows: "Inspected
for wholesomeness by U.S. Department of Agriculture." This wording
shall be contained within a circle. The form and arrangement of such
wording shall be exactly as indicated in the example in Figure 1, except
that the appropriate official establishment number shall be shown, and
if the establishment number appears elsewhere on the labeling material
in the manner prescribed in Sec. 381.123(b), it may be omitted from the
inspection mark. The administrator may approve the use of abbreviations
of such inspection mark; and such approved abbreviations shall have the
same force and effect as the inspection mark. The official inspection
legend, or the approved abbreviation thereof, shall be printed on
consumer packages and other immediate containers of inspected and passed
poultry products, or on labels to be securely affixed to such containers
of such products and may be printed or stenciled thereon, but shall not
be applied by rubber stamping. When applied by a stencil, the legend
shall not be less than 4 inches in diameter. An official brand must be
applied to inspected and passed carcasses and parts of ratites that are
shipped unpacked.
[[Page 463]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.037
[66 FR 22906, May 7, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.98]
[Page 463]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.98 Official seal.
The official mark for use in sealing means of conveyance used in
transporting poultry products under any requirement in this part shall
be the inscription and a serial number as shown below, and any seals
approved by the Administrator for applying such mark shall be an
official device.
[GRAPHIC] [TIFF OMITTED] TC11SE91.038
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.99]
[Page 463]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.99 Official retention and rejection tags.
The official marks for use in post-mortem inspection and
identification of adulterated products, insanitary equipment and
facilities are:
(a) A paper tag (a portion of Form MP-35) bearing the legend "U.S.
Retained" for use on poultry or poultry products under this section.
(b) A paper tag (another portion of Form C&MS 510) bearing the
legend "U.S. Rejected" for use on equipment, utensils, rooms and
compartments under this section.
[64 FR 56417, Oct. 20, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.100]
[Page 463]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.100 Official detention tag.
The detention tag prescribed in Sec. 381.211 is an official device.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.101]
[Page 463]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.101 Official U.S. Condemned mark.
The term "U.S. Condemned" as shown below is an official mark and
the devices used by the Department for applying such mark are official
devices.
[GRAPHIC] [TIFF OMITTED] TC11SE91.039
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.103]
[Page 463-464]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.103 Official poultry condemnation certificates; issuance and form.
Upon request by the operator of the establishment, the inspector in
charge shall issue a poultry condemnation certificate (Form MP-514-1),
showing the total number of poultry in the lot and the numbers condemned
and the reasons for such condemnations.
The official poultry condemnation certificate authorized by this
subpart is a paper certificate (Form MP-514-1), for signature by an
inspector, bearing the legend
[[Page 464]]
U.S. Department of Agriculture Animal and Plant Health Inspection
Service
poultry condemnation certificate
and the seal of the United States Department of Agriculture, with a
certification that the poultry enumerated on the form were inspected and
condemned for the listed causes in compliance with the regulations of
the Department. A statement to the effect that certain figures on the
certificate were derived from information supplied by plant management,
and a signature line for an authorized plant official is also shown.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.104]
[Page 464]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.104 Official export certificates, marks and devices.
The form of certificate described in Sec. 381.106 is an official
export certificate, and the mark shown below is the official mark used
on outside containers to identify inspected and passed poultry products
for export. Devices used by the Department to apply such a mark are
official devices.
[GRAPHIC] [TIFF OMITTED] TC11SE91.040
[47 FR 29823, July 9, 1982]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.105]
[Page 464-465]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.105 Export certification; marking of containers.
(a) Upon request or application by any person intending to export
any poultry product, any inspector is authorized to issue an official
export certificate as prescribed in Sec. 381.107 with respect to the
shipment to any foreign country of any inspected and passed poultry
product, after adequate inspection of the product has been made by the
inspector to determine its identity as inspected and passed and eligible
for export: Provided, that the product is offered for inspection at an
official establishment. Each shipping container covered by the export
certificate, except ship stores, small quantities exclusively for the
personal use of the consignee and not for sale or distribution, and
shipments by and for the U.S. Armed Forces, shall be marked with an
official export stamp as shown in Sec. 381.104 bearing the number of the
export certificate. Official export certificates will be issued only
upon condition that the products covered thereby shall be subject to
reinspection at any place and at any time prior to exportation to
determine the identity of the products and their eligibility for
certification, and such certificates shall become invalid if such
reinspection is refused or discloses that the products are not eligible
for certification. If reinspection discloses that any poultry products
covered by an export certificate are not eligible for such
certification, a superseding certificate setting forth such findings
shall be issued and copies shall be furnished to interested persons.
(b) The original and a duplicate of each official export certificate
shall be delivered to the person who requested such certificate or his
agent. Such person may duplicate such numbers of exact copies of the
original as he requires in connection with the exportation of the
poultry products. Additional official file copies of the export
certificates shall be prepared and distributed by the inspector in
accordance with the instructions of the Administrator.
(c) Only one certificate shall be issued for each consignment,
except in case of error in the certificate or loss of the certificate
originally issued. A request for a new certificate, except in the case
of a lost certificate, shall be accompanied by the original and all
copies of the first certificate. The new certificate shall carry the
following statement: "This certificate supersedes certificate No. -----
- Dated ----------. The outside container of the poultry product covered
by this certificate is
[[Page 465]]
stamped with United States Department of Agriculture Certificate No. ---
---."
[37 FR 9706, May 16, 1972, as amended at 50 FR 25204, June 18, 1985]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.106]
[Page 465]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.106 Form of official export certificate.
The official export certificate authorized by this subpart is a
paper certificate form for signature by an inspector, bearing a
letterhead and the seal of the U.S. Department of Agriculture, with a
certification that the slaughtered poultry and other poultry products
described on the form came from birds that were officially given an
ante-mortem and post-mortem inspection and passed in accordance with the
regulations of the Department and that such products are wholesome and
fit for human consumption. The certificate also bears a serial number,
such as "MPA 002805", and shows the respective names of the exporter
and consignee, the destination, the shipping marks, the names of such
products, the total net weight thereof, and such other information as
the Administrator may prescribe or approve in specific cases.
[47 FR 29823, July 9, 1982]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.107]
[Page 465]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.107 Special procedures as to certification of poultry products for export to certain countries.
When export certificates are required by any foreign country for
poultry products exported to such country, the Administrator shall in
specific cases prescribe or approve the form of export certificate to be
used and the methods and procedures he deems appropriate with respect to
the processing of such products, in order to comply with requirements
specified by the foreign country regarding the export products.
Inspectors shall satisfy themselves that all such requirements are met
before issuing such an export certificate. It shall be the
responsibility of the exporter to provide any unofficial documentation
needed to meet the foreign requirements, before the export certificate
will be issued. Such certificates may also cover articles exempted from
definition as a poultry product under Sec. 381.15 if they have been
inspected and are certified under the regulations in part 362 of this
chapter.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 41 FR
23702, June 11, 1976]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.108]
[Page 465]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.108 Official poultry inspection certificates; issuance and disposition.
(a) Upon the request of an interested party, any veterinary
inspector is authorized to issue an official poultry inspection
certificate with respect to any lot of slaughtered poultry inspected by
him. At any official establishment each such certificate shall be signed
by the inspector who made the inspection covered by the certificate, and
if more than one inspector participated in the inspection of the lot of
poultry, each such inspector shall sign the certificate with respect to
such lot. If the inspection of a lot covered by a certificate was made
by a food inspector, such certificate shall also be signed by the
inspector in charge when such inspection was made. Any inspector is
authorized to issue a poultry inspection certificate with respect to any
other poultry product inspected by him.
(b) The original and one copy of each poultry inspection certificate
shall be issued to the applicant who requested such certificate, and one
copy shall be retained by the inspector for filing. The inspector who
issues any inspection certificate is authorized to furnish an additional
copy of such certificate upon the request of an interested party. The
person who sold the live poultry involved to the official establishment
is an interested party for purposes of this section.
[37 FR 9706, May 16, 1972, as amended at 39 FR 36000, Oct. 7, 1974]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.109]
[Page 465-466]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.109 Form of official poultry inspection certificate.
(a) The official poultry inspection certificate authorized by this
subpart is a paper certificate (Form MP-505) for signature by an
inspector, bearing the legend
[[Page 466]]
U.S. Department of Agriculture Animal and Plant Health Inspection
Service Meat and Poultry Inspection Program
poultry inspection certificate
and the seal of the U.S. Department of Agriculture, with a certification
that the poultry described therein had been inspected in compliance with
the Regulations of the Secretary of Agriculture Governing the Inspection
of Poultry and Poultry Products.
(b) The certificate also bears a serial number such as "B 3208"
and shows the respective name and address of the applicant, the shipper
or seller and the receiver or buyer and the net weight in pounds of
amount passed, amount rejected or condemned, type of poultry, lot number
and class, and such other information as the Administrator may prescribe
or approve in specific cases.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.110]
[Page 466]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.110 Erasures or alterations made on certificates.
Erasures or alterations not initialed by the issuing inspector shall
not be permitted on any official certificate or any copy thereof. All
certificates rendered useless through clerical error or otherwise and
all certificates canceled for whatever cause shall be voided and
initialed, and one copy shall be retained in the inspector's file; and
the original and all other copies shall be forwarded to the appropriate
program supervisor.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.111]
[Page 466]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.111 Data to be entered in proper spaces.
All certificates shall be so executed that the data entered thereon
will appear in the proper spaces on each copy of the certificate.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.112]
[Page 466]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart M--Official Marks, Devices, and Certificates; Export
Certificates; Certification Procedures
Sec. 381.112 Official mark for maintaining the identity and integrity of samples.
The official mark for use in sealing containers of samples submitted
under any requirements in this part and section 11(b) of the Poultry
Products Inspection Act shall bear the designation "Sample Seal"
accompanied by the official USDA logo as shown below. Any seal approved
by the Administrator for applying such mark shall be deemed an official
device for purposes of the Act. Such device shall be supplied to
inspectors, compliance officers, and other designated Agency officials
by the United States Department of Agriculture.
[GRAPHIC] [TIFF OMITTED] TC11SE91.041
[52 FR 41958, Nov. 2, 1987]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.115]
[Page 466]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.115 Containers of inspected and passed poultry products required to be labeled.
Except as may be authorized in specific cases by the Administrator
with respect to shipment of poultry products between official
establishments, each shipping container and each immediate container of
any inspected and passed poultry product shall at the time it leaves the
official establishment bear a label which contains information, and has
been approved, in accordance with this subpart.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.116]
[Page 466-467]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.116 Wording on labels of immediate containers.
(a) Each label for use on immediate containers for inspected and
passed poultry products shall bear on the principal display panel
(except as otherwise permitted in the regulations), the items of
information required by this subpart. Such items of information shall be
in distinctly legible form. Except as provided in Sec. 381.128, all
words, statements and other information required by or under authority
of the Act to appear on the label or labeling shall appear thereon in
the English language: Provided, however, That in the case of products
distributed solely in Puerto Rico, Spanish may be substituted for
English for all printed matter except the USDA inspection legend.
[[Page 467]]
(b) The principal display panel shall be the part of a label that is
most likely to be displayed, presented, shown, or examined under
customary conditions of display for sale. The principal display panel
shall be large enough to accommodate all the mandatory label information
required to be placed thereon by the regulations with clarity and
conspicuousness and without being obscured by design or vignettes, or
crowding. Where packages bear alternate principal display panels,
information required to be placed on the principal display panel shall
be duplicated on each principal display panel. The area that is to bear
the principal display panel shall be:
(1) In the case of a rectangular package, one entire side, the area
of which is the product of the height times the width of that side.
(2) In the case of a cylindrical or nearly cylindrical container:
(i) An area on the side of the container that is 40 percent of the
product of the height of the container times the circumference, or
(ii) A panel, the width of which is one-third of the circumference
and the height of which is as high as the container: Provided, however,
That there is, immediately to the right or left of such principal
display panel, a panel which has a width not greater than 20 percent of
the circumference and a height as high as the container, and which is
reserved for information prescribed in Secs. 381.118, 381.122, and
381.123. Such panel shall be known as the "20 percent panel" and such
information may be shown on that panel in lieu of showing it on the
principal display panel as provided in this Sec. 381.116.
(3) In the case of a container of any other shape, 40 percent of the
total surface of the container.
In determining the area of the principal display panel, exclude tops,
bottoms, flanges at tops and bottoms of cans, and shoulders and necks of
bottles or jars.
(c) (1) The information panel is that part of a label that is the
first surface to the right of the principal display panel as observed by
an individual facing the principal display panel, with the following
exceptions:
(i) If the first surface to the right of the principal display panel
is too small to accommodate the required information or is otherwise
unusable label space, e.g., folded flaps, tear strips, opening flaps,
heat-sealed flaps, the next panel to the right of this part of the label
may be used.
(ii) If the package has one or more alternate principal display
panels, the information panel is to the right of any principal display
panel.
(iii) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(2) (i) Except as otherwise permitted in this part, all information
required to appear on the principal display panel or permitted to appear
on the information panel shall appear on the same panel unless there is
insufficient space. In determining the sufficiency of the available
space, except as otherwise prescribed in this part, any vignettes,
designs, and any other nonmandatory information shall not be considered.
If there is insufficient space for all required information to appear on
a single panel, it may be divided between the principal display panel
and the information panel, provided that the information required by any
given provision of this part, such as the ingredients statement, is not
divided and appears on the same panel.
(ii) All information appearing on the information panel pursuant to
this section shall appear in one place without intervening material,
such as designs or vignettes.
[37 FR 9706, May 16, 1972, as amended at 40 FR 11347, Mar. 11, 1975; 59
FR 40214, Aug. 8, 1994]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.117]
[Page 467-469]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.117 Name of product and other labeling.
(a) The label shall show the name of the product, which, in the case
of a poultry product which purports to be or is represented as a product
for which a definition and standard of identity or composition is
prescribed in subpart P, shall be the name of the food specified in the
standard, and in the case of any other poultry product shall be the
common or usual name of the food, if any
[[Page 468]]
there be, and if there is none, a truthful descriptive designation.
(b) The name of the product required to be shown on labels for fresh
or frozen raw whole carcasses of poultry shall be in either of the
following forms: The name of the kind (such as chicken, turkey, or duck)
preceded by the qualifying term "young" or "mature" or "old",
whichever is appropriate; or the appropriate class name as described in
Sec. 381.170(a). The name of the kind may be used in addition to the
class name, but the name of the kind alone without the qualifying age or
class term is not acceptable as the name of the product, except that the
name "chicken" may be used without such qualification with respect to
a ready-to-cook pack of fresh or frozen cut-up young chickens, or a half
of a young chicken, and the name "duckling" may be used without such
qualification with respect to a ready-to-cook pack of fresh or frozen
young ducks. The class name may be appropriately modified by changing
the word form, such as using the term "roasting chicken", rather than
"roaster." The appropriate names for cut-up parts are set forth in
Sec. 381.170(b). When naming parts cut from young poultry, the identity
of both the kind of poultry and the name of the part shall be included
in the product name. The product name for parts or portions cut from
mature poultry shall include, along with the part or portion name, the
class name or the qualifying term "mature." The name of the product
for cooked or heat processed poultry products shall include the kind
name of the poultry from which the product was prepared but need not
include the class name or the qualifying term "mature."
(c) Poultry products containing light and dark chicken or turkey
meat in quantities other than the natural proportions, as indicated in
Table 1 in this paragraph, must have a qualifying statement in
conjunction with the name of the product indicating, as shown in Table
1, the types of meat actually used, except that when the product
contains less than 10 percent cooked deboned poultry meat or is
processed in such a manner that the character of the light and dark meat
is not distinguishable, the qualifying statement will not be required,
unless the product bears a label referring to the light or dark meat
content. In the latter case, the qualifying statement is required if the
light and dark meat are not present in natural proportions. The
qualifying statement must be in type at least one-half the size and of
equal boldness as the name of the product; e.g., Boned Turkey (Dark
Meat).
Table 1
------------------------------------------------------------------------
Percent Percent
Label terminology light meat dark meat
------------------------------------------------------------------------
Natural proportions........................... 50-65 50-35
Light or white meat........................... 100 0
Dark meat..................................... 0 100
Light and dark meat........................... 51-65 49-35
Dark and light meat........................... 35-49 65-51
Mostly white meat............................. 66 or more 34 or less
Mostly dark meat.............................. 34 or less 66 or more
------------------------------------------------------------------------
(d) Boneless poultry products shall be labeled in a manner that
accurately describes their actual form and composition. The product name
shall specify the form of the product (e.g., emulsified, finely chopped,
etc.), and the kind name of the poultry, and if the product does not
consist of natural proportions of skin and fat, as they occur in the
whole carcass, shall also include terminology that describes the actual
composition. If the product is cooked, it shall be so labeled. For the
purpose of this paragraph, natural proportions of skin, as found on a
whole chicken or turkey carcass, will be considered to be as follows:
------------------------------------------------------------------------
Percent
-----------------
Raw Cooked
------------------------------------------------------------------------
Chicken............................................... 20 25
Turkey................................................ 15 20
------------------------------------------------------------------------
Boneless poultry product shall not have a bone solids content of more
than 1 percent, calculated on a weight basis.
(e) On the label of any "Mechanically Separated (Kind of Poultry)
" described in Sec. 381.173, the name of such product shall be followed
immediately by the phrase: "with excess skin" unless such product is
made from poultry product that does not include skin in excess of the
natural proportion of skin present on the whole carcass, as specified in
paragraph (d) of this section. Appropriate terminology on the label
shall
[[Page 469]]
indicate if heat treatment has been used in the preparation of the
product. The labeling information described in this paragraph shall be
identified on the label before the product leaves the establishment at
which it is manufactured.
(f) The labels of sausages encased in natural casings made from meat
or poultry viscera shall identify the type of meat or poultry from which
the casings were derived, if the casings are from a different type of
meat or poultry than the encased meat or poultry. The identity of the
casing, if required, may be placed on the principal display panel or in
the ingredient statement. Establishments producing, manufacturing, or
using natural sausage casings are to maintain records documenting the
meat or poultry source in accordance with subpart Q of this part.
(g) The labels of sausages encased in regenerated collagen casings
shall disclose this fact on the product label. The fact that the sausage
is encased in collagen may be placed on the principal display panel or
in the ingredient statement.
[37 FR 9706, May 16, 1972, as amended at 60 FR 55983, Nov. 3, 1995; 66
FR 40845, Aug. 6, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.118]
[Page 469-470]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.118 Ingredients statement.
(a)(1) The label shall show a statement of the ingredients in the
poultry product if the product is fabricated from two or more
ingredients. Such ingredients shall be listed by their common or usual
names in the order of their descending proportions, except as prescribed
in paragraph (a)(2) of this section.
(2)(i) Product ingredients which are present in individual amounts
of 2 percent or less by weight may be listed in the ingredients
statement in other than descending order of predominance: Provided, That
such ingredients are listed by their common or usual names at the end of
the ingredients statement and preceded by a quantifying statement, such
as "Contains ---------- percent or less of ---------- ," or "Less
than ---------- percent of ---------- ." The percentage of the
ingredient(s) shall be filled in with a threshold level of 2 percent,
1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient
to which the quantifying statement applies may be present in an amount
greater than the stated threshold. Such a quantifying statement may also
be utilized when an ingredients statement contains a listing of
ingredients by individual components. Each component listing may utilize
the required quantifying statement at the end of each component
ingredients listing.
(ii) Such ingredients may be adjusted in the product formulation
without a change being made in the ingredients statement on the
labeling, provided that the adjusted amount complies with
Sec. 381.147(f)(4) and subpart P of this part, and does not exceed the
amount shown in the quantifying statement. Any such adjustments to the
formulation shall be provided to the inspector-in-charge.
(b) For the purpose of this paragraph, the term "chicken meat,"
unless modified by an appropriate adjective, is construed to mean
deboned white and dark meat; whereas the term "chicken" may include
other edible parts such as skin and fat not in excess of their natural
proportions, in addition to the chicken meat. If the term "chicken
meat" is listed and the product also contains skin, giblets, or fat, it
is necessary to list each such ingredient. Similar principles shall be
followed in listing ingredients of poultry products processed from other
kinds of poultry.
(c) The terms spice, natural flavor, natural flavoring, flavor or
flavoring may be used in the following manner:
(1) The term "spice" means any aromatic vegetable substance in the
whole, broken, or ground form, with the exceptions of onions, garlic and
celery, whose primary function in food is seasoning rather than
nutritional and from which no portion of any volatile oil or other
flavoring principle has been removed. Spices include the spices listed
in 21 CFR 182.10, and 184.
(2) The term "natural flavor," "nat- ural flavoring," "flavor"
or "fla- voring" means the essential oil, oleoresin, essence or
extractive, protein hy- drolysate, distillate, or any product of
roasting, heating or enzymolysis, which contains the flavoring
constituents derived from a spice, fruit or fruit
[[Page 470]]
juice, vegetable or vegetable juice, edible yeast, herb, bark, bud,
root, leaf or any other edible portions of a plant, meat, seafood,
poultry, eggs, dairy products, or fermentation products thereof, whose
primary function in food is flavoring rather than nutritional. Natural
flavors include the natural essence or extractives obtained from plants
listed in 21 CFR 182.10, 182.20, 182.40, 182.50 and 184, and the
substances listed in 21 CFR 172.510. The term natural flavor, natural
flavoring, flavor or flavoring may also be used to designate spices,
powdered onion, powdered garlic, and powdered celery.
(i) Natural flavor, natural flavoring, flavor or flavoring as
described in paragraph (c)(1) and (2) of this section, which are also
colors shall be designated as "natural flavor and coloring," "natural
flavoring and coloring," "flavor and coloring" or "flavoring and
coloring" unless designated by their common or usual name.
(ii) Any ingredient not designated in paragraphs (c) (1) and (2) of
this section whose function is flavoring, either in whole or in part,
must be designated by its common or usual name. Those ingredients which
are of livestock or poultry origin must be designated by names that
include the species and livestock and poultry tissues from which the
ingredients are derived.
(d) On containers of frozen dinners, entrees, and pizzas, and
similarly packaged products in cartons, the ingredient statement may be
placed on the front riser panel: Provided, That the words "see
ingredients," followed immediately by an arrow pointing to the front
riser panel, are placed on the principal display panel immediately above
the location of such statement, without intervening printing or designs.
(e) The ingredients statement may be placed on the information
panel, except as otherwise permitted in this subchapter.
(f) Establishments may interchange the identity of two kinds of
poultry (e.g., chicken and turkey, chicken meat and turkey meat) used in
a product formulation without changing the product's ingredient
statement or product name under the following conditions:
(1)(i) The two kinds of poultry used must comprise at least 70
percent by weight of the poultry and the poultry ingredients [e.g.
giblets, skin or fat in excess of natural proportions, or mechanically
separated (kind)] used; and,
(ii) Neither of the two kinds of poultry used can be less than 30
percent by weight of the total poultry and poultry ingredients used;
(2) The word "and" in lieu of a comma must be shown between the
declaration of the two kinds of poultry in the ingredients statement and
in the product name.
[37 FR 9706, May 16, 1972, as amended at 55 FR 7294, Mar. 1, 1990; 55 FR
26422, June 28, 1990; 58 FR 38049, July 15, 1993; 59 FR 40215, Aug. 8,
1994; 63 FR 11360, Mar. 9, 1998]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.119]
[Page 470]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.119 Declaration of artificial flavoring or coloring.
(a) When an artificial smoke flavoring or a smoke flavoring is added
as an ingredient in the formula of any poultry product, there shall
appear on the label, in prominent letters and contiguous to the name of
the product, a statement such as "Artificial Smoke Flavoring Added" or
"Smoke Flavoring Added," as applicable, and the ingredient statement
shall identify any artificial smoke flavoring or smoke flavoring added
as an ingredient in the formula of the poultry product.
(b) Any poultry product which bears or contains any artificial
flavoring other than an artificial smoke flavoring or a smoke flavoring,
or bears or contains any artificial coloring shall bear a statement
stating that fact on the immediate container or, if there is none, on
the product.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.120]
[Page 470-471]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.120 Antioxidants; chemical preservatives; and other additives.
When an antioxidant is added to a poultry product, there shall
appear on the label in prominent letters and contiguous to the name of
the product, a statement showing the name of the antioxidant and the
purpose for which it is added, such as "BHA added to help protect the
flavor." Immediate containers of poultry products packed in, bearing,
or containing any chemical preservative shall bear a label stating that
fact and naming the additive and
[[Page 471]]
the purpose of its use. Immediate containers of poultry products packed
in, bearing or containing any other chemical additive shall bear a label
naming the additive and the purpose of its use when required by the
Administrator in specific cases. When approved proteolytic enzymes as
permitted in a regulation permitting that use in this subchapter or 9
CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or
Subchapter B of this subchapter are used in mature poultry muscle
tissue, there shall appear on the label, in a prominent manner,
contiguous to the product name, the statement "Tenderized with
[approved enzyme]," to indicate the use of such enzymes. Any other
approved substance which may be used in the solution shall also be
included in the statement. When approved inorganic chlorides as
permitted in a regulation permitting that use in this subchapter or 9
CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or
Subchapter B of this subchapter are used in mature poultry muscle
tissue, there shall appear on the label, in a prominent manner,
contiguous to the product name, the statement, "Tenderized with (name
of approved inorganic chloride(s))" to indicate the use of such
inorganic chlorides. Any other approved substance which may be used in
the solution shall also be included in the statement.
[37 FR 9706, May 16, 1972, as amended at 45 FR 58820, Sept. 5, 1980; 49
FR 18999, May 4, 1984; 64 FR 72175, Dec. 23, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.121]
[Page 471-473]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.121 Quantity of contents.
(a) The label shall bear a statement of the quantity of contents in
terms of weight or measures as provided in paragraph (c)(5) of this
section. However, the Administrator may approve the use of labels for
certain types of consumer packages which do not bear a statement of the
net weight that would otherwise be required under this subparagraph:
Provided, That the shipping container bears a statement "Net weight to
be marked on consumer packages prior to display and sale": And provided
further, That the total net weight of the contents of the shipping
container is marked on such container: And provided further, That the
shipping container bears a statement "Tare weight of consumer package"
and in close proximity thereto, the actual tare weight (weight of
packaging material), weighed to the nearest one-eighth ounce or less, of
the individual consumer package in the shipping container. The above-
specified statements may be added to approved shipping container labels
upon approval by the inspector in charge.
(b) When a poultry product and a nonpoultry product are separately
wrapped and are placed in a single immediate container bearing the same
name of both products, the net weight on such immediate container may be
the total net weight of the products, or such immediate container may
show the net weights of the poultry product and the nonpoultry product
separately. Notwithstanding the other provisions of this paragraph, the
label on consumer size retail packages of stuffed poultry and other
stuffed poultry products must show the total net weight of the poultry
product, and in close proximity thereto, a statement specifying the
minimum weight of the poultry in the product.
(c)(1) The statement of net quantity of contents shall appear
(except as otherwise permitted under this paragraph (c)), on the
principal display panel of all containers to be sold at retail intact,
in conspicuous and easily legible boldface print or type, in distinct
contrast to other matter on the container, and shall be declared in
accordance with the provisions of this paragraph (c). An unused tare
weight, as defined in section 381.121b of this subchapter, may be
printed adjacent to the statement of net quantity of contents when the
product is packaged totally with impervious packaging material and is
packed with a usable medium.
(2) The statement shall be placed on the principal display panel
within the bottom 30 percent of the area of the panel, in lines
generally parallel to the base: Provided, That on packages having a
principal display panel of 5 square inches or less, the requirement for
placement within the bottom 30 percent of the area of the label panel
shall not apply when the statement meets
[[Page 472]]
the other requirements of this paragraph. The declaration may appear in
more than one line.
(3) The statement shall be in letters and numerals in type size
established in relationship to the area of the principal display panel
of the package and shall be uniform for all packages of substantially
the same size by complying with the following type specifications:
(i) Not less than one-sixteenth inch in height on containers, the
principal display panel of which has an area of 5 square inches or less;
(ii) Not less than one-eighth inch in height on containers, the
principal display panel of which has an area of more than 5 but not more
than 25 square inches;
(iii) Not less than three-sixteenth inch in height on containers,
the principal display panel of which has an area of more than 25 but not
more than 100 square inches;
(iv) Not less than one-quarter inch in height on containers, the
principal display panel of which has an area of more than 100 but not
more than 400 square inches;
(v) Not less than one-half inch in height on containers, the
principal display panel of which has an area of more than 400 square
inches.
(vi) The ratio of height to width of letters and numerals shall not
exceed a differential of 3 units to 1 unit (no more than 3 times as high
as it is wide). This height standard pertains to upper case or capital
letters. When upper and lower case or all lower case letters are used,
it is the lower case letter "o" or its equivalent that shall meet the
minimum standards. When fractions are used, each component numeral shall
meet one-half the height standards.
(4) The statement shall appear as a distinct item on the principal
display panel and shall be separated, from other label information
appearing to the left or right of the statement, by a space at least
equal in width to twice the width of the letter "N" of the style of
type used in the quantity of contents statement and shall be separated
from other label information appearing above or below the statement by a
space at least equal in height to the height of the lettering used in
the statement.
(5) The terms "net weight" or "net wt." shall be used when
stating the net quantity of contents in terms of weight, and the term
"net contents" or "contents" when stating the net quantity of
contents in terms of fluid measure. Except as provided in Sec. 381.128,
the statement shall be expressed in terms of avoirdupois weight or
liquid measure. Where no general consumer usage to the contrary exists,
the statement shall be in terms of liquid measure, if the product is
liquid, or in terms of weight if the product is solid, semisolid,
viscous or a mixture of solid and liquid. On packages containing less
than 1 pound or 1 pint, the statement shall be expressed in ounces or
fractions of a pint, respectively. On packages containing 1 pound or 1
pint or more, and less than 4 pounds or 1 gallon, the statement shall be
expressed as a dual declaration both in ounces and (immediately
thereafter in parenthesis) in pounds, with any remainder in terms of
ounces or common or decimal fraction of the pound, or in the case of
liquid measure, in the largest whole units with any remainder in terms
of fluid ounces or common or decimal fraction of the pint or quart. For
example, a declaration of three-fourths pound avoirdupois weight shall
be expressed as "Net Wt. 12 oz."; a declaration of 1\1/2\ pounds
avoirdupois weight shall be expressed as "Net Wt. 24 oz. (1 lb. 8
oz.)," "Net Wt. 24 oz. (1\1/2\ lb.)," or "Net Wt. 24 oz. (1.5
lbs.)." However, on random weight packages the statement shall be
expressed in terms of pounds and decimal fractions of the pound, for
packages over 1 pound, and for packages which do not exceed 1 pound the
statement may be in decimal fractions of the pound in lieu of ounces.
The numbers may be written in provided the unit designation is printed.
Paragraphs (c) (8) and (9) of this section permit certain exceptions to
this paragraph for multi-unit packages, and random weight consumer size
and small packages (less than \1/2\ ounce), respectively.
(6) The statement as it is shown on a label shall not be false or
misleading and shall express an accurate statement of the quantity of
contents of the
[[Page 473]]
container. Reasonable variations caused by loss or gain of moisture
during the course of good distribution practices or by unavoidable
deviations in good manufacturing practices will be recognized.
Variations from stated quantity of contents shall be as provided in
section 381.121b of this subchapter. The statement shall not include any
term qualifying a unit of weight, measure, or count such as "jumbo
quart," "full gallon," "giant quart," "when packed," "minimum,"
or words of similar importance except as provided in paragraph (b) of
this section.
(7) Labels for containers which bear any representation as to the
number of servings contained therein shall bear, contiguous to such
representation, and in the same size type as is used for such
representation, a statement of the net quantity of each such serving.
(8) On a multiunit retail package, a statement of the quantity of
contents shall appear on the outside of the package and shall include
the number of individual units, the quantity of each individual unit,
and, in parentheses, the total quantity of contents of the multiunit
package in terms of avoirdupois or fluid ounces, except that such
declaration of total quantity need not be followed by an additional
parenthetical declaration in terms of the largest whole units and
subdivisions thereof, as otherwise required by this paragraph (c). "A
multiunit retail package" is a package containing two or more
individually packaged units of the identical commodity and in the same
quantity, with the individual packages intended to be sold as part of
the multiunit retail package but capable of being sold individually.
Open multiunit retail packages that do not obscure the number of units
and the labeling thereon are not subject to this paragraph (c) (8) if
the labeling of each individual unit complies with the requirements of
this paragraph (c).
(9) The following exemptions from the requirements contained in this
section are hereby established:
(i) Individually wrapped, random weight consumer size packages of
poultry products (as specified in paragraph (c)(10) of this section) and
poultry products that are subject to shrinkage through moisture loss
during good distribution practices and are designated as gray area type
of products as defined in NBS handbook 133, section 3.18.2, need not
bear a net weight statement when shipped from an official establishment
provided a net weight shipping statement which meets the requirements of
paragraph (c)(6) of this section is applied to the shipping container
prior to shipping it from the official establishment. Net weight
statements so applied to the shipping container are exempt from the type
size, dual declaration, and placement requirements of this paragraph if
an accurate statement of net weight is shown conspicuously on the
principal display panel of the shipping container. The net weight also
shall be applied directly to random weight consumer size packages prior
to retail display and sale. The net weight statement of random weight
consumer size packages for retail sale shall be exempt from the type
size, dual declaration, and placement requirements of this paragraph if
an accurate statement of net weight is shown conspicuously on the
principal display panel of the package.
(ii) Individually wrapped and labeled packages of less than \1/2\
ounce net weight and random weight consumer size packages shall be
exempt from the requirements of this paragraph if they are in a shipping
container and the statement of net quantity of contents on the shipping
container meets the requirements of paragraph (c)(6) of this section;
(iii) Individually wrapped and labeled packages of less than \1/2\
ounce net weight bearing labels declaring net weight, price per pound,
and total price, shall be exempt from the type size, dual declaration,
and placement requirements of this paragraph if an accurate statement of
net weight is shown conspicuously on the principal display panel of the
package.
(10) As used in this section a "random weight consumer size
package" is one of a lot, shipment or delivery of packages of the same
product, with varying weights and with no fixed weight pattern.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 53 FR
28635, July 29, 1988; 55 FR 49835, Nov. 30, 1990]
[[Page 474]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.121a]
[Page 474]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.121a Quantity of contents labeling.
Sections 381.121a through 381.121e of this part prescribe the
procedures to be followed for determining net weight compliance and
prescribe the reasonable variations from the declared net weight on the
labels of immediate containers of products in accordance with
Sec. 381.121 of this part.
[55 FR 49835, Nov. 30, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.121b]
[Page 474-475]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.121b Definitions and procedures for determining net weight compliance.
(a) For the purpose of Sec. 381.121b of this part, the reasonable
variations allowed, definitions, and procedures to be used in
determining net weight and net weight compliance are described in the
National Institute of Standards and Technology (NIST) Handbook 133,
"Checking the Net Contents of Packaged Goods," Third Edition,
September 1988, and Supplements 1, 2, 3, and 4 dated September 1990,
October 1991, October 1992, and October 1994, respectively, which are
incorporated by reference, with the exception of the NIST Handbook 133
and Supplements 1 and 3 requirements listed in paragraphs (b) and (c) of
this section. Those provisions, incorporated by reference herein, are
considered mandatory requirements. This incorporation was approved by
the Director of the Federal Register in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. (These materials are incorporated as they exist on
the date of approval.) Copies may be purchased from the Superintendent
of Documents, U.S. Government Printing Office, Washington, DC 20402. It
is also available for inspection at the Office of the Federal Register
Information Center, 800 North Capitol Street NW., suite 700, Washington,
DC 20408.
(b) The following NBS Handbook 133 requirements are not incorporated
by reference.
Chapter 2--General Considerations
2.13.1 Polyethylene Sheeting and Film
2.13.2 Textiles
2.13.3 Mulch
Chapter 3--Methods of Test for Packages Labeled by Weight
3.11. Aerosol Packages
3.14. Glazed Raw Seafood and Fish
3.15. Canned Coffee
3.16. Borax
3.17. Flour
Chapter 4--Methods of Test for Packages Labeled by Volume
4.7. Milk
4.8. Mayonnaise and Salad Dressing
4.9. Paint, Varnish, and Lacquers--Nonaerosol
4.11. Peat Moss
4.12. Bark Mulch
4.15. Ice Cream Novelties
Chapter 5--Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combinations of Quantities
5.4. Polyethlene Sheeting
5.5. Paper Plates
5.6. Sanitary Paper Products
5.7. Pressed and Blown Glass Tumblers and Stemware
Appendix D: Package Net Contents Regulations
D.1.1 U.S. Department of Health and Human Servcies, Food and Drug
Administration
D.1.2 U.S. Department of Agriculture, Food Safety and Inspection
Servcie
D.1.3 Federal Trade Commission
D.1.4 Environmental Protection Agency
D.1.5 U.S. Department of the Treasury, Bureau of Alcohol, Tobacco, and
Firearms
(c) The following requirements of Supplement 1 dated September 1990,
Supplement 3 dated October 1992, and Supplement 4 dated October 1994, of
NIST Handbook 133 are not incorporated by reference.
Supplement 1
Chapter 2 General Considerations
2.13.1. Polyethylene Sheeting and Film
2.13.2. Textiles
2.13.3. Mulch
Chapter 3 Methods of Test for Packages Labeled by Weight
3.11.4. Exhausting the Aerosol Container
Chapter 4 Methods of Test for Packages Labeled by Volume
4.6.4. Method D: Determining the Net Contents of Compressed Gas in
Cylinders
4.7. Milk
4.16. Fresh Oysters Labeled by Volume
Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combinations of Quantities
5.4. Polyethylene Sheeting
[[Page 475]]
Supplement 3
Chapter 3 Methods of Test for Packages Labeled by Weight
3.17. Flour and Dry Pet Food
Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combinations of Quantities
5.4. Polyethylene Sheeting
5.5. Paper Plates
65.8. Baler Twine
Appendix A. Forms and Worksheets
Supplement 4
3.11 Aerosol Packages
3.11.1 Equipment
3.11.2 Preparation for Test
3.11.3 The Determination of Net Contents: Part 1
3.11.4 Exhausting the Aerosol Container
3.11.5 The Determination of Net Contents: Part 2
[55 FR 49835, Nov. 30, 1990, as amended at 60 FR 12885, Mar. 9, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.121c]
[Page 475]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.121c Scale requirements for accurate weights, repairs, adjustments, and replacement after inspection.
(a) All scales used to weight poultry products sold or otherwise
distributed in commerce in federally inspected poultry plants shall be
installed, maintained, and operated to insure accurate weights. Such
scales shall meet the applicable requirements contained in National
Institute of Standards and Technology (NIST) Handbook 44,
"Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices", 1999 Edition, November 1998, which is
incorporated by reference. This incorporation was approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. (These materials are incorporated as they exist on the
date of approval.) A notice of any change in the Handbook cited herein
will be published in the Federal Register. Copies may be purchased from
the Superintendent of Documents, U.S. Government Printing Office,
Washington, DC 20402. It is also available for inspection at the Office
of the Federal Register Information Center, 800 North Capitol Street
NW., suite 700, Washington, DC 20408.
(b) All scales used to weigh poultry products sold or otherwise
distributed in commerce or in State designated under section 5(c) of the
Poultry Products Inspection Act, shall be of sufficient capacity to
weigh the entire unit and/or package.
(c) No scale shall be used at a federally inspected establishment to
weigh poultry products unless it has been found upon test and inspection
as specified in NIST Handbook 44 to provide accurate weight. If a scale
is inspected or tested and found to be inaccurate, or if any repairs,
adjustments or replacements are made to a scale, it shall not be used
until it has been reinspected and retested by a USDA official, or a
State or local government weights and measures official, or a State
registered or licensed scale repair firm or person, and it must meet all
accuracy requirements as specified in NIST Handbook 44. If a USDA
inspector has put a "Retain" tag on a scale it can only be removed by
a USDA inspector. As long as the tag is on the scale, it shall not be
used.
[55 FR 49836, Nov. 30, 1990, as amended at 60 FR 12885, Mar. 9, 1995; 64
FR 53188, Oct. 1, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.121d]
[Page 475]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.121d Scales; testing of.
(a) The operator of each official establishment that weighs poultry
food products shall cause such scales to be tested for accuracy in
accordance with the technical requirements of NIST Handbook 44, at least
once during the calendar year. In cases where the scales are found not
to maintain accuracy between tests, more fequent tests may be required
and monitored by an authorized USDA program official.
(b) The operator of each official establishment shall display on or
near each scale a valid certification of the scale's accuracy from a
State or local government's weights and measures authority or from a
State registered or licensed scale repair firm or person, or shall have
alternative documented procedures showing that the scale has been tested
for accuracy in accordance with the requirements of NIST Handbook 44.
[55 FR 49836, Nov. 30, 1990, as amended at 62 FR 45026, Aug. 25, 1997;
65 FR 34390, May 30, 2000; 66 FR 52486, Oct. 16, 2001]
[[Page 476]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.121e]
[Page 476]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.121e Handling of failed product.
Any lot of product which is found to be out of compliance with net
weight requirements upon testing in accordance with Sec. 381.121b of
this subchapter shall be handled as follows:
(a) A lot tested in an official establishment and found not to
comply with net weight requirements may be reprocessed and must be
reweighed and remarked to satisfy the net weight requirements of this
section, and be reinspected in accordance with the requirements of this
part.
(b) A lot tested outside of an official establishment and found not
to comply with net weight requirements must be reweighed and remarked
with a proper net weight statement, provided that such reweighing and
remarking shall not deface, cover, or destroy any other marking or
labeling required under this subchapter and the net quantity of contents
is shown with the same prominence as the most conspicuous feature of a
label.
[55 FR 49836, Nov. 30, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.122]
[Page 476]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.122 Identification of manufacturer, packer or distributor.
The name and address, including zip code, of the manufacturer,
packer, or distributor shall be shown on the label and if only the name
and address of the distributor is shown, it shall be qualified by such
term as "packed for," "distributed by," or "distributors." The
name and place of business of the manufacturer, packer, or distributor
may be shown on the principal display panel, on the 20-percent panel of
the principal display panel reserved for required information, on the
front riser panel of frozen food cartons, or on the information panel.
[37 FR 9706, May 16, 1972, as amended at 59 FR 40215, Aug. 8, 1994]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.123]
[Page 476]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.123 Official inspection mark; official establishment number.
The immediate container of every inspected and passed poultry
product shall bear:
(a) The official inspection legend; and
(b) The official establishment number of the official establishment
in which the product was processed under inspection and placed as
follows:
(1) Within the official inspection legend in the form required by
subpart M of this part; or
(2) Outside the official inspection legend elsewhere on the exterior
of the container or its labeling, e.g., the lid of a can, if shown in a
prominent and legible manner in a size sufficient to insure easy
visibility and recognition and accompanied by the prefix "P"; or
(3) Off the exterior of the container, e.g., on a metal clip used to
close casings or bags, or on the back of a paper label of a canned
product, or on other packaging or labeling in the container, e.g., on
aluminum pans and trays placed within containers, when a statement of
its location is printed contiguous to the official inspection legend,
such as "Plant No. on Package Closure" or "Plant No. on Pan", if
shown in a prominent and legible manner in a size sufficient to ensure
easy visibility and recognition; or
(4) On an insert label placed under a transparent covering if
clearly visible and legible and accompanied by the prefix "P".
[47 FR 29515, July 7, 1982]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.124]
[Page 476]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.124 Dietary food claims.
If a product purports to be or is represented for any special
dietary use by man, its label shall bear a statement concerning its
vitamin, mineral, and other dietary properties upon which the claim for
such use is based in whole or in part and shall be in conformity with
regulations (21 CFR part 125) established pursuant to sections 403 and
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.125]
[Page 476-477]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.125 Special handling label requirements.
(a) Packaged products which require special handling to maintain
their wholesome condition shall have prominently displayed on the
principal display panel of the label the statement: "Keep
Refrigerated," "Keep Frozen," "Keep Refrigerated or Frozen,"
"Perishable--Keep Under Refrigeration," or such similar statement as
the Administrator may approve in specific cases. The immediate
containers for products that are frozen during distribution and intended
to be thawed prior to or during display for sale shall
[[Page 477]]
bear the statement "Shipped/Stored and Handled Frozen for Your
Protection, Keep Refrigerated or Freeze." For all canned perishable
products, the statement shall be shown in upper case letters one-fourth
inch in height for containers having a net weight of 3 pounds or less,
and for containers having a net weight over 3 pounds, the statement
shall be shown in letters one-half inch in height.
(b) Safe handling instructions shall be provided for all poultry
products not processed in accordance with the provisions of
Sec. 381.150(a) or that have not undergone other processing that would
render them ready-to-eat, except as exempted under paragraph (b)(4) of
this section.
(1) (i) Safe handling instructions shall accompany the poultry
products, specified in this paragraph (b), destined for household
consumers, hotels, restaurants, or similar institutions and shall appear
on the label. The information shall be in lettering no smaller than one-
sixteenth of an inch in size and shall be prominently placed with such
conspicuousness (as compared with other words, statements, designs or
devices in the labeling) as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.
(ii) The safe handling information shall be presented on the label
under the heading "Safe Handling Instructions" which shall be set in
type size larger than the print size of the rationale statement and
handling statements as discussed in paragraphs (b)(2) and (b)(3) of this
section. The safe handling information shall be set off by a border and
shall be one color type printed on a single color contrasting background
whenever practical.
(2) (i) The labels of the poultry products, specified in this
paragraph (b) and prepared from inspected and passed poultry, shall
include the following rationale statement as part of the safe handling
instructions, "This product was prepared from inspected and passed meat
and/or poultry. Some food products may contain bacteria that could cause
illness if the product is mishandled or cooked improperly. For your
protection, follow these safe handling instructions." This statement
shall be placed immediately after the heading and before the safe
handling statements.
(ii) The labels of the poultry products, specified in this paragraph
(b) and prepared pursuant to Sec. 381.10(a) (2), (5), (6), and (7),
shall include the following rationale statement as part of the safe
handling instructions, "Some food products may contain bacteria that
could cause illness if the product is mishandled or cooked improperly.
For your protection, follow these safe handling instructions." This
statement shall be placed immediately after the heading and before the
safe handling statements.
(3) Poultry products, specified in this paragraph (b), shall bear
the labeling statements.
(i) Keep refrigerated or frozen. Thaw in refrigerator or microwave.
(Any portion of this statement that is in conflict with the product's
specific handling instructions may be omitted, e.g., instructions to
cook without thawing.) (A graphic illustration of a refrigerator shall
be displayed next to the statement.);
(ii) Keep raw meat and poultry separate from other foods. Wash
working surfaces (including cutting boards), utensils, and hands after
touching raw meat or poultry. (A graphic illustration of soapy hands
under a faucet shall be displayed next to the statement.);
(iii) Cook thoroughly. (A graphic illustration of a skillet shall be
displayed next to the statement.); and
(iv) Keep hot foods hot. Refrigerate leftovers immediately or
discard. (A graphic illustration of a thermometer shall be displayed
next to the statement.)
(4) Poultry products intended for further processing at another
official establishment are exempt from the requirements prescribed in
paragraphs (b)(1) through (b)(3) of this section.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR
14540, Mar. 28, 1994; 64 FR 746, Jan. 6, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.126]
[Page 477-478]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.126 Date of packing and date of processing; contents of cans.
(a) Either the immediate container or the shipping container of all
poultry
[[Page 478]]
food products shall be plainly and permanently marked by code or
otherwise with the date of packing. If calendar dating is used, it must
be accompanied by an explanatory statement, as provided in
Sec. 381.129(c)(2).
(b) The immediate container for dressed poultry shall be marked with
a lot number which shall be the number of the day of the year on which
the poultry was slaughtered or a coded number.
(c) All canned products shall be plainly and permanently marked, by
code or otherwise, on the containers, with the identity of the contents
and date of canning, except that canned products packed in glass
containers are not required to be marked with the date of canning if
such information appears on the shipping container. If calendar dating
is used, it must be accompanied by an explanatory statement, as provided
in Sec. 381.129(c)(2).
(d) If any marking is by code, the inspector in charge shall be
informed as to its meaning.
[37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39
FR 35784, Oct. 4, 1974]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.127]
[Page 478]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.127 Wording on labels of shipping containers.
(a) Each label for use on a shipping container for inspected and
passed poultry products shall bear, in distinctly legible form, the
following information:
(1) The official inspection legend.
(2) The official establishment number of the official establishment
in which the poultry product was inspected, either within the official
inspection mark, or elsewhere on the container clearly visible and in
proximity to the official inspection mark.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.128]
[Page 478]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.128 Labels in foreign languages.
Any label to be affixed to a container of any dressed poultry or
other poultry product for foreign commerce may be printed in a foreign
language. However, the official inspection legend and establishment
number shall appear on the label in English, but in addition, may be
literally translated into such foreign language. Each such label shall
be subject to the applicable provisions of Secs. 381.115 to 381.141,
inclusive. Deviations from the form of labeling required under the
regulations may be approved by the Administrator in specific cases and
such modified labeling may be used for poultry products to be exported:
Provided, (a) That the proposed labeling accords to the specifications
of the foreign purchaser, (b) that it is not in conflict with the Act or
the laws of the country to which it is intended for export, and (c) that
the outside of the shipping container is labeled to show that it is
intended for export; but if such product is sold or offered for sale in
domestic commerce, all the requirements of the regulations shall apply.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.129]
[Page 478-480]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.129 False or misleading labeling or containers.
(a) No poultry product subject to the Act shall have any false or
misleading labeling or any container that is so made, formed, or filled
as to be misleading. However, established trade names and other labeling
and containers which are not false or misleading and which are approved
by the Administrator in the regulations or in specific cases are
permitted.
(b) No statement, word, picture, design, or device which is false or
misleading in any particular or conveys any false impression or gives
any false indication of origin, identity, or quality, shall appear on
any label. For example:
(1) Official grade designations such as the letter grades A, B, and
C may be used in labeling individual carcasses of poultry or containers
of poultry products only if such articles have been graded by a licensed
grader of the Federal or Federal-State poultry grading service and found
to qualify for the indicated grade.
(2) Terms having geographical significance with reference to a
particular locality may be used only when the product was produced in
that locality.
(3) "Fresh frozen", "quick frozen", "frozen fresh", and terms
of similar import apply only to ready-to-cook poultry processed in
accordance with Sec. 381.66(f)(1). Ready-to-cook poultry handled in any
other manner and dressed poultry may be labeled "fro- zen" only if it
is frozen in accordance
[[Page 479]]
with Sec. 381.66(f)(2) under Department supervision and is in fact in a
frozen state. "Individually quick frozen (Kind)" and terms of similar
import are applicable only to poultry products that are frozen as stated
on the label and whose component parts can be easily separated at time
of packing.
(4) Poultry products labeled with a term quoted in any paragraph of
Sec. 381.170(b) shall comply with the specifications in the applicable
paragraph. However, parts of poultry may be cut in any manner the
processor desires as long as the labeling appropriately reflects the
contents of the container of such poultry.
(5) The terms "All," "Pure," "100%," and terms of similar
connotation shall not be used on labels for products to identify
ingredient content, unless the product is prepared solely from a single
ingredient.
(6)(i) Raw poultry product whose internal temperature has ever been
below 26 deg.F may not bear a label declaration of "fresh." Raw
poultry product bearing a label declaration of "fresh" but whose
internal temperature has ever been below 26 deg.F is mislabeled. The
"fresh" designation may be deleted from such product in accordance
with Sec. 381.133(b)(9)(xxiv). The temperature of individual packages of
raw poultry product within an official establishment may deviate below
the 26 deg.F standard by 1 deg. (i.e., have a temperature of 25 deg.F)
and still be labeled "fresh." The temperature of individual packages
of raw poultry product outside an official establishment may deviate
below the 26 deg.F standard by 2 deg. (i.e., have a temperature of
24 deg.F) and still be labeled "fresh." The average temperature of
poultry product lots of each specific product type must be 26 deg.F.
Product described in this paragraph is not subject to the freezing
procedures required in Sec. 381.66(f)(2) of this subchapter.
(ii) Raw poultry product whose internal temperature has ever been at
or below 0 deg.F must be labeled with the descriptive term "frozen,"
except when such labeling duplicates or conflicts with the labeling
requirements in Sec. 381.125 of this subchapter. The word "previously"
may be placed next to the term "frozen" on an optional basis. The
descriptive term must be prominently displayed on the principal display
panel of the label. If additional labeling containing the descriptive
term is affixed to the label, it must be prominently affixed to the
label. The additional labeling must be so conspicuous (as compared with
other words, statements, designs, or devices in the labeling) that it is
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use. Product described in this
paragraph is subject to the freezing procedures required in
Sec. 381.66(f)(2) of this subchapter.
(iii) Raw poultry product whose internal temperature has ever been
below 26 deg.F, but is above 0 deg.F, is not required to bear any
specific descriptive term. Raw poultry product whose internal
temperature has ever been below 26 deg.F, but is above 0 deg.F, may bear
labeling with an optional, descriptive term, provided the optional,
descriptive term does not cause the raw poultry product to become
misbranded. If used, an optional, descriptive term must be prominently
displayed on the principal display panel of the label. If additional
labeling containing the optional, descriptive term is affixed to the
label, it must be prominently affixed on the label. The additional
labeling must be so conspicuous (as compared with other words,
statements, designs, or devices in the labeling) that it is likely to be
read and understood by the ordinary individual under customary
conditions of purchase and use.
(iv) Handling and relabeling of products. (A) Except as provided
under paragraph (b)(6)(iii)(C) of this section, when any inspected and
passed product has become misbranded under this subpart after it has
been transported from an official establishment, such product may be
transported in commerce to an official establishment after oral
permission is obtained from the Area Supervisor of the area in which
that official establishment is located. The transportation of the
product may be to the official establishment from which it had been
transported or to another official establishment designated by the
person desiring to handle the product. The transportation shall be
authorized only for the purpose of the
[[Page 480]]
relabeling of the product. The Area Supervisor shall record the
authorization and other information necessary to identify the product
and shall provide a copy of the record to the inspector at the
establishment receiving the product. The shipper shall be furnished a
copy of the authorization record upon request.
(B) Upon the arrival of the shipment at the official establishment,
a careful inspection shall be made of the product by the inspector, and
if it is found that the product is not adulterated, it may be received
into the establishment; but if the product is found to be adulterated,
it shall at once be condemned and disposed of in accordance with
Sec. 381.95 of this subchapter. Wholesome product will be relabeled in
accordance with paragraph (b)(6) (i) or (ii) of this section, as
appropriate.
(C) When any inspected and passed product has become misbranded
under this subpart after it has been transported from an official
establishment, the owner may transport the product in commerce to a
retail entity for relabeling in accordance with paragraph (b)(6) (i) or
(ii) of this section, as appropriate, or to other end users, such as
hotels, restaurants or similar institutions; or, relabel the product in
accordance with paragraph (b)(6) (i) or (ii) of this section, as
appropriate if the product is already at a retail entity. A hotel,
restaurant or similar institution is not required to relabel product
misbranded under this subpart; Provided, That the product is prepared in
meals or as entrees only for sale or service directly to individual
consumers at such institutions, and that the mark of inspection is
removed or obliterated. Oral permission shall be obtained from the Area
Officer-in-Charge of the Compliance Program for the area in which the
product is located prior to such transportation or relabeling. The Area
Officer-in-Charge shall record the authorization and other information
necessary to identify the product, and shall furnish a copy of the
authorization record upon request. Before being offered for sale at a
retail entity, such product shall be relabeled.
(c) A calendar date may be shown on labeling when declared in
accordance with the provisions of this paragraph:
(1) The calendar date shall express the month of the year and the
day of the month for all products and also the year in the case of
products hermetically sealed in metal or glass containers, dried or
frozen products, or any other products that the Administrator finds
should be labeled with the year because the distribution and marketing
practices with respect to such products may cause a label without a year
identification to be misleading.
(2) Immediately adjacent to the calendar date shall be a phrase
explaining the meaning of such date in terms of "packing" date, "sell
by" date, or "use before" date, with or without a further qualifying
phrase, e.g., "For Maximum Freshness" or "For Best Quality", and
such phrases shall be approved by the Administrator as prescribed in
Sec. 381.132.
(d) When sodium alginate, calcium carbonate, lactic acid, and
calcium lactate are used together in a dry binding matrix in ground and
formed poultry products, as permitted in Sec. 381.147 of this
subchapter, there shall appear on the label contiguous to the product
name, a statement to indicate the use of sodium alginate, calcium
carbonate, lactic acid, and calcium lactate.
(e) When transglutaminase enzyme is used to bind pieces of poultry
to form a cut of poultry, or to reform a piece of poultry from a
multiple cuts of poultry, there shall appear on the label, as part of
the product name, a statement that indicates that the product has been
"formed" or "reformed," in addition to other preparation steps,
e.g., "Formed Turkey Thigh Roast" or "Reformed and Shaped Chicken
Breast."
[37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39
FR 42339, Dec. 5, 1974; 55 FR 5977, Feb. 21, 1990; 60 FR 44412, Aug. 25,
1995; 61 FR 66200, Dec. 17, 1996; 61 FR 68821, Dec. 30, 1996; 66 FR
54916, Oct. 31, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.130]
[Page 480-481]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.130 False or misleading labeling or containers; orders to withhold from use.
If the Administrator has reason to believe that any marking or other
labeling or the size or form of any container in use or proposed for use
with respect to any article subject to the Act is false or misleading in
any particular, he may direct that the use of
[[Page 481]]
the article be withheld unless it is modified in such manner as the
Administrator may prescribe so that it will not be false or misleading.
If the person using or proposing to use the labeling or container does
not accept the determination of the Administrator, he may request a
hearing, but the use of the labeling or container shall, if the
Administrator so directs, be withheld pending hearing and final
determination by the Secretary in accordance with applicable rules of
practice. Any such determination with respect to the matter by the
Secretary shall be conclusive unless, within 30 days after the receipt
of notice of such final determination, the person adversely affected
thereby appeals to the U.S. Court of Appeals for the Circuit in which he
has his principal place of business, or to the U.S. Court of Appeals for
the District of Columbia Circuit. The provisions of section 204 of the
Packers and Stockyards Act of 1921, as amended, shall be applicable to
appeals taken under this section.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.131]
[Page 481]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.131 Preparation of labeling or other devices bearing official inspection marks without advance approval prohibited; exceptions.
(a) Except for the purposes of preparing and submitting a sample or
samples of the same to the Administrator for approval, no brand
manufacturer, printer, or other person shall cast, print, lithograph, or
otherwise make any marking device containing any official mark or
simulation thereof, or any label bearing any such mark or simulation,
without the written authority therefor of the Administrator. However,
when any such sample label, or other marking device, is approved by the
Administrator, additional supplies of the approved label, or marking
device, may be made for use in accordance with the regulations in this
subchapter, without further approval by the Administrator. The
provisions of this paragraph do not apply to marking devices containing
the official inspection legend shown in Figure 5 of Sec. 381.102.
(b) No brand manufacturer or other person shall cast or otherwise
make, without an official certificate issued in quadruplicate by a
Program employee, a marking device containing the official inspection
legend shown in Figure 5 of Sec. 381.102 or any simulation of that
legend.
(1) The certificate is a Food Safety and Inspection Service form for
signature by a Program employee and the official establishment ordering
the marking device, bearing a certificate serial number and a letterhead
and the seal of the United States Department of Agriculture. The
certificate authorizes the making of only the devices of the type and
quantity listed on the certificate.
(2) After signing the certificate, the Program employee and the
establishment shall each keep a copy, and the remaining two copies shall
be given to the marking device manufacturer.
(3) The manufacturer of the marking devices shall engrave or
otherwise mark each marking device with a permanent identifying serial
number unique to it. The manufacturer shall list on each of the two
copies of the certificate given to the manufacturer the number of each
marking device authorized by the certificate. The manufacturer shall
retain one copy of the certificate for the manufacturer's records and
return the remaining copy with the marking devices to the Program
employee whose name and address are given on the certificate as the
recipient.
(4) In order that all such marking devices bear identifying numbers,
within one year after June 24, 1985, an establishment shall either
replace each such marking device that does not bear an identifying
number, or, under the direction of the inspector-in-charge, mark such
marking device with a permanent identifying number.
(Recordkeeping requirements approved by the Office of Management and
Budget under control number 0583-0015)
[50 FR 21423, May 24, 1985]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.132]
[Page 481-482]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.132 Labeling approval.
(a) No final labeling shall be used on any product unless the sketch
labeling of such final labeling has been submitted for approval to the
Food Labeling Division, Regulatory Programs, Food Safety and Inspection
Service, and approved by such division, accompanied by FSIS Form,
Application for
[[Page 482]]
Approval of Labels, Marking, and Devices, except for generically
approved labeling authorized for use in Sec. 381.133(b) (2)-(9). The
management of the official establishment or establishment certified
under a foreign inspection system, in accordance with subpart T of this
part, must maintain a copy of all labeling used, along with the product
formulation and processing procedure, in accordance with subpart Q of
this part. Such records shall be made available to any duly authorized
representative of the Secretary upon request.
(b) The Food Labeling Division shall permit submission for approval
of only sketch labeling, as defined in Sec. 381.132(d), for all
products, except as provided in Sec. 381.133(b) (2)-(9) and except for
temporary use of final labeling as prescribed in paragraph (f) of this
section.
(c) All labeling required to be submitted for approval as set forth
in Sec. 381.132(b) shall be submitted in duplicate to the Food Labeling
Division, Regulatory Programs, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250. A parent company for a
corporation may submit only one labeling application (in duplicate) for
a product produced in other establishments that are owned by the
corporation.
(d) "Sketch" labeling is a printer's proof or equivalent which
clearly shows all labeling features, size, location, and indication of
final color, as specified in subpart N of this part. FSIS will accept
sketches that are hand drawn, computer generated or other reasonable
facsimiles that clearly reflect and project the final version of the
labeling. Indication of final color may be met by: submission of a color
sketch, submission of a sketch which indicates by descriptive language
the final colors, or submission with the sketch of previously approved
final labeling that indicates the final colors.
(e) Inserts, tags, liners, pasters, and like devices containing
printed or graphic matter and for use on, or to be placed within,
containers and coverings of product shall be submitted for approval in
the same manner as provided for labeling in Sec. 381.132(a), except that
such devices which contain no reference to product and bear no
misleading feature shall be used without submission for approval as
prescribed in Sec. 381.133(b)(9).
(f)(1) Consistent with the requirements of this section, temporary
approval for the use of a final label or other final labeling that may
otherwise be deemed deficient in some particular may be granted by the
Food Labeling Division. Temporary approvals may be granted for a period
not to exceed 180 calendar days under the following conditions:
(i) The proposed labeling would not misrepresent the product;
(ii) The use of the labeling would not present any potential health,
safety, or dietary problems to the consumer;
(iii) Denial of the request would create undue economic hardship;
and
(iv) An unfair competitive advantage would not result from the
granting of the temporary approval.
(2) Extensions of temporary approvals may also be granted by the
Food Labeling Division, provided that the applicant demonstrates that
new circumstances, meeting the above criteria, have developed since the
original temporary approval was granted.
[60 FR 67456, Dec. 29, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.133]
[Page 482-484]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.133 Generically approved labeling.
(a)(1) An official establishment or an establishment certified under
a foreign inspection system, in accordance with subpart T of this part,
is authorized to use generically approved labeling, as defined in
paragraph (b) of this section, without such labeling being submitted for
approval to the Food Safety and Inspection Service in Washington or the
field, provided the labeling is in accord with this section and shows
all mandatory features in a prominent manner as required in subpart N of
this part, and is not otherwise false or misleading in any particular.
(2) The Food Safety and Inspection Service shall select samples of
generically approved labeling from the records maintained by official
establishments and establishments certified under foreign inspection
systems, in accordance with subpart T of this part, as required in
Sec. 381.132, to determine
[[Page 483]]
compliance with labeling requirements. Any finding of false or
misleading labeling shall institute the proceedings prescribed in
Sec. 381.233.
(b) Generically approved labeling is labeling which complies with
the following:
(1) Labeling for a product which has a product standard as specified
in subpart 381 of this subchapter or the Standards and Labeling Policy
Book and which does not contain any special claims, such as quality
claims, nutrient content claims, health claims, negative claims,
geographical origin claims, or guarantees, or which is not a domestic
product labeled in a foreign language;
(2) Labeling for single-ingredient products (such as chicken legs or
turkey breasts) which does not contain any special claims, such as
quality claims, nutrient content claims, health claims, negative claims,
geographical origin claims, or guarantees, or which is not a domestic
product labeled with a foreign language;
(3) Labeling for containers of products sold under contract
specifications to Federal Government agencies, when such product is not
offered for sale to the general public, provided that the contract
specifications include specific requirements with respect to labeling,
and are made available to the inspector-in-charge;
(4) Labeling for shipping containers which contain fully labeled
immediate containers, provided such labeling complies with Sec. 381.127;
(5) Labeling for products not intended for human food, provided they
comply with Secs. 381.152(c) and 381.193, and labeling for poultry heads
and feet for export for processing as human food if they comply with
Sec. 381.190(b);
(6) Poultry inspection legends, which comply with subpart M of this
part;
(7) Inserts, tags, liners, pasters, and like devices containing
printed or graphic matter and for use on, or to be placed within
containers, and coverings of products, provided such devices contain no
reference to product and bear no misleading feature;
(8) Labeling for consumer test products not intended for sale; and
(9) Labeling which was previously approved by the Food Labeling
Division as sketch labeling, and the final labeling was prepared without
modification or with the following modifications:
(i) All features of the labeling are proportionately enlarged or
reduced, provided that all minimum size requirements specified in
applicable regulations are met and the labeling is legible;
(ii) The substitution of any unit of measurement with its
abbreviation or the substitution of any abbreviation with its unit of
measurement, e.g., "lb." for "pound," or "oz." for "ounce," or
of the word "pound" for "lb." or "ounce" for "oz.";
(iii) A master or stock label has been approved from which the name
and address of the distributor are omitted and such name and address are
applied before being used (in such case, the words "prepared for" or
similar statement must be shown together with the blank space reserved
for the insertion of the name and address when such labels are offered
for approval);
(iv) Wrappers or other covers bearing pictorial designs, emblematic
designs or illustrations, e.g., floral arrangements, illustrations of
animals, fireworks, etc. are used with approved labeling (the use of
such designs will not make necessary the application of labeling not
otherwise required);
(v) A change in the language or the arrangement of directions
pertaining to the opening of containers or the serving of the product;
(vi) The addition, deletion, or amendment of a dated or undated
coupon, a cents-off statement, cooking instructions, packer product code
information, or UPC product code information;
(vii) Any change in the name or address of the packer, manufacturer
or distributor that appears in the signature line;
(viii) Any change in the net weight, provided that the size of the
net weight statement complies with Sec. 381.121;
(ix) The addition, deletion, or amendment of recipe suggestions for
the product;
(x) Any change in punctuation;
(xi) Newly assigned or revised establishment numbers for a
particular establishment for which use of the labeling has been approved
by the Food Labeling Division, Regulatory Programs;
[[Page 484]]
(xii) The addition or deletion of open dating information;
(xiii) A change in the type of packaging material on which the label
is printed;
(xiv) Brand name changes, provided that there are no design changes,
the brand name does not use a term that connotes quality or other
product characteristics, the brand name has no geographic significance,
and the brand name does not affect the name of the product;
(xv) The deletion of the word "new" on new product labeling;
(xvi) The addition, deletion, or amendment of special handling
statements, provided that the change is consistent with Sec. 381.125(a);
(xvii) The addition of safe handling instructions as required by
Sec. 381.125(b);
(xviii) Changes reflecting a change in the quantity of an ingredient
shown in the formula without a change in the order of predominance shown
on the label, provided that the change in quantity of ingredients
complies with any minimum or maximum limits for the use of such
ingredients prescribed in Sec. 381.147 and subpart P of this part;
(xix) Changes in the color of the labeling, provided that sufficient
contrast and legibility remain;
(xx) A change in the product vignette, provided that the change does
not affect mandatory labeling information or misrepresent the content of
the package;
(xxi) The addition, deletion, or substitution of the official USDA
poultry grade shield; (xxii) A change in the establishment number by a
corporation or parent company for an establishment under its ownership;
(xxiii) Changes in nutrition labeling that only involve quantitative
adjustments to the nutrition labeling information, except for services
sizes, provided the nutrition labeling information maintains its
accuracy and consistency;
(xxiv) Deletion of any claim, and the deletion of non-mandatory
features or non-mandatory information;
(xxv) The addition or deletion of a direct translation of the
English language into a foreign language for products marked "for
export only"; and
(xxvi) The use of the descriptive term "fresh" in accordance with
Sec. 381.129(b)(6)(i) of this subchapter.
(xxvii) The use of the descriptive Term frozen as required by
Sec. 381.129(b)(6)(ii) of this subchapter.
[60 FR 67457, Dec. 29, 1995, as amended at 61 FR 66201, Dec. 17, 1996]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.134]
[Page 484]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.134 Requirement of formulas.
Copies of each label submitted for approval, shall when the
Administrator requires in any specific case, be accompanied by a
statement showing, by their common or usual names, the kinds and
percentages of the ingredients comprising the poultry product and by a
statement indicating the method or preparation of the product with
respect to which the label is to be used. Approximate percentages may be
given in cases where the percentages of ingredients may vary from time
to time, if the limits of variation are stated.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR
45196, Sept. 1, 1994. Redesignated at 60 FR 67457, Dec. 29, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.136]
[Page 484]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.136 Affixing of official identification.
(a) No official inspection legend or any abbreviation or other
simulation thereof may be affixed to or placed on or caused to be
affixed to or placed on any poultry product or container thereof, except
by an inspector or under the supervision of an inspector or other person
authorized by the Administrator, and no container bearing any such
legend shall be filled except under such supervision.
(b) No official inspection legend shall be used on any poultry
product or other article which does not qualify for such mark under the
regulations.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.137]
[Page 484]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.137 Evidence of labeling and devices approval.
No inspector shall authorize the use of any device bearing any
official inspection legend unless he or she has on file evidence that
such device has been approved in accordance with the provisions of this
subpart.
[60 FR 67458, Dec. 29, 1995]
[[Page 485]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.138]
[Page 485]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.138 Unauthorized use or disposition of approved labeling or devices.
(a) Labeling and devices approved for use pursuant to Sec. 381.115
shall be used only for the purpose for which approved, and shall not be
disposed of from the official establishment for which approved except
with written approval of the Administrator. Any unauthorized use or
disposition of approved labeling or devices bearing official inspection
marks is prohibited and may result in cancellation of the approval.
(b) Labeling and containers bearing any official inspection marks,
with or without the official establishment number, may be transported
from one official establishment to any other official establishment,
only if such shipments are made with the prior authorization of the
inspector in charge at point of origin, who will notify the inspector in
charge at destination concerning the date of shipment, quantity, and
type of labeling material involved. Approved labeling and containers may
be moved without restriction under this part between official
establishments operated by the same person if such labeling and
containers are approved for use at all such establishments. No such
material shall be used at the establishment to which it is shipped
unless such use conforms with the requirements of this subpart.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.139]
[Page 485]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.139 Removal of official identifications.
(a) Every person who receives any poultry product in containers
which bear any official inspection legend shall remove or deface such
legend or destroy the containers upon removal of such articles from the
containers.
(b) No person shall alter, detach, deface, or destroy any official
identifications prescribed in subpart M that were applied pursuant to
the regulations, unless he is authorized to do so by an inspector or
this section; and no person shall fail to use any such official
identification when required by this part.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.140]
[Page 485]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.140 Relabeling poultry products.
When it is claimed by the operator of an official establishment that
some of its labeled poultry product, which has been transported to a
location other than an official establishment, is in need of relabeling
because the labeling has become mutilated or damaged, or for some other
reason needs relabeling, the requests for relabeling the poultry product
shall be sent to the Administrator and accompanied with a statement of
the reasons therefor and the quantity of labeling required. Labeling
material intended for relabeling inspected and passed product shall not
be transported from an official establishment until permission has been
received from the Administrator. The relabeling of inspected and passed
product with official labels shall be done under the supervision of an
inspector pursuant to the regulations in part 362 of this chapter. The
establishment shall reimburse the Inspection Service for any cost
involved in supervising the relabeling of such product as provided in
said regulations.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.144]
[Page 485-486]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart N--Labeling and Containers
Sec. 381.144 Packaging materials.
(a) Edible products may not be packaged in a container which is
composed in whole or in part of any poisonous or deleterious substances
which may render the contents adulterated or injurious to health. All
packaging materials must be safe for the intended use within the meaning
of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended
(FFDCA).
(b) Packaging materials entering the official establishment must be
accompanied or covered by a guaranty, or statement of assurance, from
the packaging supplier under whose brand name and firm name the material
is marketed to the official establishment. The guaranty shall state that
the material's intended use complies with the FFDCA and all applicable
food additive regulations. The guaranty must identify the material,
e.g., by the distinguishing brand name or code designation appearing on
the packaging material shipping container; must specify the applicable
conditions of use, including temperature limits and other pertinent
limits specified under the FFDCA and food additive regulations; and must
be signed by an authorized official of the supplying firm. The guaranty
may be limited to a specific
[[Page 486]]
shipment of an article, in which case it may be part of or attached to
the invoice covering such shipment, or it may be general and continuing,
in which case, in its application to any article or other shipment of an
article, it shall be considered to have been given at the date such
article was shipped by the person who gives the guaranty. Guaranties
consistent with the Food and Drug Administration's regulations regarding
such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The
management of the establishment must maintain a file containing
guaranties for all food contact packaging materials in the
establishment. The file shall be made available to Program inspectors or
other Department officials upon request. While in the official
establishment, the identity of all packaging materials must be traceable
to the applicable guaranty.
(c) The guaranty by the packaging supplier will be accepted by
Program inspectors to establish that the use of material complies with
the FFDCA and all applicable food additive regulations.
(d) The Department will monitor the use of packaging materials in
official establishments to assure that the requirements of paragraph (a)
of this section are met, and may question the basis for any guaranty
described under paragraph (b) of this section. Official establishments
and packaging suppliers providing written guaranties to those official
establishments will be permitted an opportunity to provide information
to designated Department officials as needed to verify the basis for any
such guaranty. The required information will include, but is not limited
to, manufacturing firm's name, trade name or code designation for the
material, complete chemical composition, and use. Selection of a
material for review does not in itself affect a material's
acceptability. Materials may continue to be used during the review
period. However, if information requested from the supplier is not
provided within the time indicated in the request--a minimum of 30 days-
-any applicable guaranty shall cease to be effective and approval to
continue using the specified packaging material in official
establishments may be denied. The Administrator may extend this time
where reasonable grounds for extension are shown, as, for example, where
data must be obtained from suppliers.
(e) The Administrator may disapprove for use in official
establishments packaging materials whose use cannot be confirmed as
complying with the FFDCA and applicable food additive regulations.
Before approval to use a packaging material is finally denied by the
Administrator, the affected official establishment and the supplier of
the material shall be given notice and the opportunity to present their
views to the Administrator. If the official establishment and the
supplier do not accept the Administrator's determination, a hearing in
accordance with applicable rules of practice will be held to resolve
such dispute. Approval to use the materials pending the outcome of the
presentation of views or hearing shall be denied if the Administrator
determines that such use may present an imminent hazard to public
health.
(f) Periodically, the Administrator will issue to inspectors a
listing, by distinguishing brand name or code designation, of packaging
materials that have been reviewed and that fail to meet the requirements
of paragraph (a) of this section. Listed materials will not be permitted
for use in official establishments. If a subsequent review of any
material indicates that it meets the requirements of paragraph (a), the
material will be deleted from the listing.
(g) Nothing in this section shall affect the authority of Program
inspectors to refuse a specific material if he/she determines the
material may render products adulterated or injurious to health.
[49 FR 2236, Jan. 19, 1984]
[[Page 487]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.145]
[Page 487-490]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart O--Entry of Articles Into Official Establishments; Processing
Inspection and Other Reinspections; Processing Requirements
Sec. 381.145 Poultry products and other articles entering or at official establishments; examination and other requirements.
(a) No poultry product (including poultry broth for use in any
poultry product in any official establishment) may be brought into any
official establishment unless it has been processed in the United States
only in an official establishment or imported from a foreign country
listed in Sec. 381.196(b), and inspected and passed, in accordance with
the regulations; and unless the container of such product is marked so
as to identify the product as so inspected and passed, in accordance
with Sec. 381.115 or Sec. 381.205, except that poultry products
inspected and passed and identified as such under the laws of an "at
least equal" State or territory listed in Sec. 381.187 may be brought
into any official establishment solely for storage and distribution
therefrom without repackaging, relabeling, or processing in such
establishment. No carcass, part thereof, meat or meat food product of
cattle, sheep, swine, goats, or equines may be brought into an official
establishment unless it has been prepared in the United States only in
an official meat packing establishment, or imported, and inspected and
passed, in accordance with the Federal Meat Inspection Act, and the
regulations under such Act (Subchapter A of this chapter) and is
properly marked as so inspected and passed; or has been inspected and
passed and is identified as such in accordance with the requirements of
the law and regulations of a State not designated in Sec. 331.2 of this
chapter; or is present in the official establishment by reason of an
exemption allowed in the Federal Meat Inspection Act and the regulations
under such Act (Subchapter A of this chapter) or the law and regulations
of a State not so designated. However, such exempted articles may enter
only under conditions approved by the Administrator in specific cases,
including but not limited to, complete separation of inspected poultry
products and processing and other operations with respect thereto from
the exempted articles and operations with respect thereto, complete
cleanup of facilities and equipment between processing of inspected
poultry products and the exempted articles and no commingling of
inspected and exempted articles in receiving, holding or storage areas.
(b) All poultry products and all carcasses, parts thereof, meat and
meat food products of cattle, sheep, swine, goats, or equines which
enter any official establishment shall be identified by the operator of
the official establishment at the time of receipt at the official
establishment. All poultry products, and all carcasses, parts thereof,
meat and meat food products of such animals, which are processed or
otherwise handled at any official establishment shall be subject to
examination by an inspector at the official establishment in such manner
and at such times as may be deemed necessary by the inspector in charge
to assure compliance with the regulations. Upon such examination, if any
such article or portion thereof is found to be adulterated, such article
or portion shall, in the case of poultry products, be condemned and
disposed of as prescribed in Sec. 381.95, unless by reprocessing they
may be made not adulterated, and shall, in the case of such other
articles be disposed of according to applicable law.
Such examination may be accomplished through use of statistically sound
sampling plans that assure a high level of confidence. The inspector in
charge shall designate the type of plan and the program employee shall
select the specific plan to be used in accordance with instructions
issued by the Administrator. \1\
---------------------------------------------------------------------------
\1\ Further information concerning sampling plans which have been
adopted for specific products may be obtained from the Circuit
Supervisor. These sampling plans are developed for individual products
by the Washington staff and will be distributed for field use as they
are developed. The type of plan applicable depends on factors such as
whether the product is in containers, stage of preparation, and
procedures followed by the establishment operator. The specific plan
applicable depends on the kind of product involved.
---------------------------------------------------------------------------
[[Page 488]]
(c) Applying for Total Plant Quality Control. Any owner or operator
of an official establishment preparing poultry product who has a total
plant quality control system or plan for controlling such products,
after ante-mortem and post-mortem inspection, through all stages of
preparation, may request the Administrator to evaluate it to determine
whether or not that system is adequate to result in product being in
compliance with the requirements of the Act and therefore qualify as a
U.S. Department of Agriculture (USDA) Total Plant Quality Control
Establishment. Such a request shall, as a minimum, include:
(1) A letter to the Administrator from the establishment owner or
operator stating the company's basis and purpose for seeking an approved
quality control system and willingness to adhere to the requirements of
the system as approved by the Department; that all the establishment's
data, analyses, and information generated by its quality control system
will be maintained to enable the Department to monitor compliance and
available to Department personnel; that plant quality control personnel
will have authority to halt production or shipping of product in cases
where the submitted quality control systems require it; and that the
owner or operator (or his/her designee) will be available for
consultation at any time Department personnel consider it necessary.
(2) In the case of an establishment having one or more full-time
persons whose primary duties are related to the quality control system,
an organizational chart showing that such people ultimately report to an
establishment official whose quality control responsibilities are
independent of or not predominantly production responsibilities. In the
case of a small establishment which does not have full-time quality
control personnel, information indicating the nature of the duties and
responsibilities of the person who will also be responsible for the
quality control system.
(3) A list identifying those subparts and sections of the poultry
products inspection regulations which are applicable to the operations
of the establishment applying for approval of a quality control system.
This list shall also identify which part of the system will serve to
maintain compliance with the applicable regulations.
(4) Detailed information concerning the manner in which the system
will function. Such information should include, but not necessarily be
limited to, questions of raw material control, the critical check or
control points, the nature and frequency of tests to be made, the nature
of charts and other records that will be used, the length of time such
charts and records will be maintained in the custody of the official
establishment, the nature of deficiencies the quality control system is
designed to identify and control, the parameters of limits which will be
used and the points at which corrective action will occur, and the
nature of such corrective action--ranging from the least to most severe:
Provided, That subsequent to approval of the total plant quality control
system by the Administrator, the official establishment may produce a
new product for test marketing provided labeling for the product has
been approved by the Administrator, the inspector in charge has
determined that the procedures for preparing the product will assure
that all Federal requirements are met, and the production for test
marketing does not exceed 6 months. Such new product shall not be
produced at that establishment after the 6-month period unless approval
of the quality control system for that product has been received from
the Administrator.
(d)-(e) [Reserved]
(f) Labeling Logo. Owners and operators of official establishments
having a total plant quality control system approved under the
provisions of paragraph (c) of this section, may only use, as a part of
any labeling, the following logo. Any labeling bearing the logo and any
wording of explanation with respect to this logo shall be approved as
required by subparts M and N of this part.
[[Page 489]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.043
(g) Termination of Quality Control Systems. (1) The approval of a
total plant quality control system may be terminated at any time by the
owner or operator of the official establishment upon written notice to
the Administrator.
(2) The approval of a total plant quality control system or a
quality control system for irradiation facilities may be terminated upon
the establishment's receipt of a written notice from the Administrator
under the following conditions:
(i) If adulterated or misbranded poultry product is found by the
Adminstrator to have been prepared for or distributed in commerce by the
subject establishment. In such case, opportunity will be provided to the
establishment owner or operator to present views to the Administrator
within 30 days of the date of terminating the approval. In those
instances where there is a conflict of facts, a hearing, under
applicable Rules of Practice, will be afforded to the establishment
owner or operator, if requested, to resolve the conflict, The
Administrator's termination of approval shall remain in effect pending
the final determination of the proceeding.
(ii) If the establishment fails to comply with the quality control
system to which it has agreed after being notified by letter from the
Administrator or his designee. Prior to such termination, opportunity
will be provided to the establishment owner or operator to present views
to the Adminstrator within 30 days of the date of the letter. In those
instances where there is a conflict of facts, a hearing, under
applicable Rules of Practice, will be afforded to the establishment
owner or operator, if requested, to resolve the conflict. The
Administrator's termination of quality control approval shall remain in
effect pending the final determination of the proceeding.
(3) If approval of the total establishment quality control system
has been terminated in accordance with the provisions of this section,
an application and request for approval of the same or modified total
establishment quality control system will not be evaluated by the
Administrator for at least 6 months from the termination date.
(4) If approval of a quality control system for irradiation
facilities, as specified in section 381.149 of this subpart, has been
terminated in accordance with the provisions of this section, a request
for approval of the same or a modified quality control system will be
evaluated by the Administrator upon receipt.
(h)(1) Operating Schedule Under Total Plant Quality Control. An
official establishment with an approved total plant quality control
system may request approval for an operating schedule of up to 12
consecutive hours per shift. Permissions will be granted provided that:
(i) The official establishment has satisfactorily operated under a
total plant quality control system for at least 1 year.
(ii) All products prepared and packaged, or processed after the end
of 8 hours of inspection shall only be a continuation of the processing
monitored by the inspector and being conducted during the last hour of
inspection.
(iii) All immediate containers of products prepared and packaged
shall bear code marks that are unique to any period of production beyond
the 8 hours of inspection. The form of such code marks will remain
constant from day to day, and a facsimile of the code marks and their
meaning shall be provided to the inspector.
(2) Application. Applications shall be submitted to the Regional
Director and shall specify how the conditions in Sec. 381.145(h)(1) have
been or will be met.
[[Page 490]]
(3) Monitoring by Inspectors. In order to verify that an
establishment is preparing and shipping product in accordance with the
approved total plant quality control system and the Act and regulations
after the 8 hours of inspection, the official establishment may be
provided overtime inspectiom services at the discretion of the circuit
supervisor and charged for such services.
(i) To ensure the safe use of preparations used in poultry scald
water, the label or labeling on containers of such preparations shall
bear adequate directions to ensure use in compliance with any
limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B
or 9 CFR Chapter III, Subchapter A or Subchapter E.
(Recordkeeping requirements approved by the Office of Management and
Budget under control number 0583-0015)
[37 FR 9706, May 16, 1972, as amended at 45 FR 54323, Aug. 15, 1980; 46
FR 48904, Oct. 5, 1981; 50 FR 6, Jan. 2, 1985; 51 FR 32304, Sept. 11,
1986; 57 FR 43598, Sept. 21, 1992; 62 FR 45026, Aug. 25, 1997; 62 FR
54759, Oct. 22, 1997; 64 FR 72175, Dec. 23, 1999; 65 FR 34390, May 30,
2000]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.146]
[Page 490]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart O--Entry of Articles Into Official Establishments; Processing
Inspection and Other Reinspections; Processing Requirements
Sec. 381.146 Sampling at official establishments.
Inspectors may take, without cost to the Department, such samples as
are necessary of any poultry product, or other article for use as an
ingredient of any poultry product, at any official establishment to
determine whether it complies with the requirements of the regulations.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.148]
[Page 490]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart O--Entry of Articles Into Official Establishments; Processing
Inspection and Other Reinspections; Processing Requirements
Sec. 381.148 Processing and handling requirements for frozen poultry products.
Procedures with respect to processing of frozen ready-to-heat-and-
eat poultry products or stuffed ready-to-roast poultry shall be in
accordance with sound operating practices and carried out in a manner
which will assure freedom from adulteration of the products. Products to
be frozen shall be moved into the freezer promptly under such
supervision by an inspector as is necessary to assure preservation of
the products by prompt and efficient freezing. Adequate freezing
facilities shall be provided within the official establishment where
products to be frozen are prepared, except that, upon written request,
and under such conditions as may be prescribed by the Administrator in
specific cases, such products may be moved from the official
establishment prior to freezing: Provided, That the official
establishment and freezer are so located and the necessary arrangements
are made so that the Inspection Service will have access to the freezing
room and adequate opportunity to determine that the products are being
properly handled and frozen.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.150]
[Page 490-491]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart O--Entry of Articles Into Official Establishments; Processing
Inspection and Other Reinspections; Processing Requirements
Sec. 381.150 Requirements for the production of fully cooked poultry products and partially cooked poultry breakfast strips.
(a) Fully cooked poultry products must be produced using processes
ensuring that the products meet the following performance standards:
(1) Lethality. A 7-log10 reduction of Salmonella or an
alternative lethality that achieves an equivalent probability that no
viable Salmonella organisms remain in the finished product, as well as
the reduction of other pathogens and their toxins or toxic metabolites
necessary to prevent adulteration, must be demonstrated to be achieved
throughout the product. The lethality process must include a cooking
step. Controlled intermediate step(s) applied to raw product may form
part of the basis for the equivalency.
(2) Stabilization. There can be no multiplication of toxigenic
microorganisms such as Clostridium botulinum, and no more than a 1
log10 multiplication of Clostridium perfringens within the
product.
(b) Partially cooked poultry breakfast strips must be produced using
processes ensuring that the products meet the performance standard
listed in paragraph (a)(2) of this section. Labeling for these products
must comply with Sec. 381.125. In addition, the statement "Partially
Cooked: For Safety, Cook Until Well Done" must appear on the principal
display panel in letters no smaller than \1/2\ the size of the largest
letter in the product name. Detailed cooking instructions shall be
provided on the immediate container of the products.
[[Page 491]]
(c) For each product produced using a process other than one
conducted in accordance with the Hazard Analysis and Critical Control
Point (HACCP) system requirements in part 417 of this chapter, an
establishment must develop and have on file, available to FSIS, a
process schedule, as defined in Sec. 381.1(b). Each process schedule
must be approved in writing by a process authority for safety and
efficacy in meeting the performance standards established for the
product in question. A process authority must have access to an
establishment in order to evaluate and approve the safety and efficacy
of each process schedule.
(d) Under the auspices of a processing authority, an establishment
must validate new or altered process schedules by scientifically
supportable means, such as information gleaned from the literature or by
challenge studies conducted outside the plant.
[64 FR 746, Jan. 6, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.151]
[Page 491]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart O--Entry of Articles Into Official Establishments; Processing
Inspection and Other Reinspections; Processing Requirements
Sec. 381.151 Adulteration of product by polluted water; procedure for handling.
(a) In the event there is polluted water (including but not limited
to flood water) in an official establishment, all poultry products and
ingredients for use in the preparation of such products that have been
rendered adulterated by the water shall be condemned.
(b) After the polluted water has receded from an official
establishment, all walls, ceilings, posts, and floors of the rooms and
compartments involved, including the equipment therein, shall, under the
supervision of an inspector, be cleaned thoroughly by the official
establishment personnel. An adequate supply of hot water under pressure
is essential to make such cleaning effective. After cleaning a solution
of sodium hypochlorite containing approximately one-half of 1 percent
available chlorine (5,000 p/m) or other equivalent disinfectant approved
by the Administrator \1\ shall be applied to the surface of the rooms
and equipment and rinsed with potable water before use.
---------------------------------------------------------------------------
\1\ A list of approved disinfectants is available upon request to
Scientific Services, Meat and Poultry Inspection Program, Food Safety
and Inspection Service, U.S. Department of Agriculture, Washington, DC
20250.
---------------------------------------------------------------------------
(c) Hermetically sealed containers of poultry product which have
been contaminated by polluted water shall be examined promptly by the
official establishment under supervision of an inspector and rehandled
as follows:
(1) Separate and condemn all poultry products in damaged or
extensively rusted containers.
(2) Remove paper labels and wash the remaining containers in warm
soapy water, using a brush where necessary to remove rust or other
foreign material. Disinfect these containers by either of the following
methods:
(i) Immerse in a solution of sodium hypochlorite containing not less
than 100 p/m of available chlorine or other equivalent disinfectant
approved by the Administrator, \1\ rinse in potable water, and dry
thoroughly; or
(ii) Immerse in 212 deg.F. water, bring temperature of the water
back to 212 deg.F. and maintain the temperature at 212 deg.F. for 5
minutes, then remove containers from water and cool them to 95 deg.F.
and dry thoroughly.
(3) After handling as described in paragraph (c)(2) of this section,
the containers may be relacquered, if necessary, and then relabeled with
approved labels applicable to the product therein.
(4) The identity of the canned poultry product shall be maintained
throughout all stages of the rehandling operations, to insure correct
labeling of containers.
[38 FR 34456, Dec. 14, 1973]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.152]
[Page 491-492]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart O--Entry of Articles Into Official Establishments; Processing
Inspection and Other Reinspections; Processing Requirements
Sec. 381.152 Preparation in an official establishment of articles not for human food.
(a) Requirements applicable when prepared in an edible products
department. When an article (including, but not being limited to, animal
food) that is not for use as human food is prepared in any room or
compartment, in an official establishment where poultry products are
prepared or handled (such room or compartment being herein referred to
as an "edible products department"), sufficient space and equipment
shall be provided to assure that the preparation of the article in no
way interferes with the preparation or
[[Page 492]]
other handling of the poultry products. Where necessary, separate
equipment shall be provided for the preparation of the article. To
assure the maintenance of the requisite sanitary conditions in the
edible products department, the operations incident to the preparation
of the article shall be subject to the same sanitary requirements as
apply to the handling of poultry products in the edible products
department. Preparation of the article shall be limited to those hours
during which the official establishment operates under the supervision
of an inspector. The ingredients used in the preparation of the article
shall, unless otherwise approved by the Administrator in specific cases,
be such as may be used in the preparation of a poultry product. The
article may be stored in, and distributed from, the edible products
department if the article is properly identified.
(b) Requirements applicable when prepared in an inedible products
department. When an article (including, but not being limited to, animal
food) that is not for use as human food, is prepared in any part of an
official establishment other than an edible products department (such
part of the establishment being herein referred to as the "inedible
products department"), the area in which such article is prepared shall
be distinctly separated from all edible products departments. Poultry
products and inedible products may be brought from any edible products
department into any inedible products department, but no poultry product
or inedible product may be brought from an inedible products department
into an edible products department except that any such articles as are
in sealed containers or are handled under conditions prescribed or
approved by the Administrator in specific cases may be brought into an
edible products department. Diseased carcasses or diseased parts of any
carcass shall not be used in the preparation of any animal food unless
they have been treated in the manner prescribed in Sec. 381.95(a).
Trucks or containers used for the transportation of poultry products or
inedible products into an inedible products department shall be cleaned
before being returned to or brought into an edible products department.
Sufficient space shall be allotted and adequate equipment and facilities
provided so that the preparation of the article does not interfere with
the preparation of poultry products or the maintenance of the requisite
sanitary conditions in the official establishment. The preparation of
any such article shall be subject to supervision by an inspector.
(c) Containers to be labeled. The immediate container of any such
article that is prepared in an official establishment shall be
conspicuously labeled so as to distinguish it from human food. Such
articles are also subject to the requirements under the Federal Food,
Drug, and Cosmetic Act.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.153]
[Page 492-506]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart O--Entry of Articles Into Official Establishments; Processing
Inspection and Other Reinspections; Processing Requirements
Sec. 381.153 Accreditation of chemistry laboratories.
(a) Definitions:
Accreditation--Determination by FSIS that a laboratory is qualified
to analyze official samples of product subject to regulations in this
subchapter and subchapter A of this chapter for the presence and amount
of all four food chemistry analytes (protein, moisture, fat, and salt);
or a determination by FSIS that a laboratory is qualified to analyze
official samples of product subject to regulations in this subchapter
and subchapter A of this chapter for the presence and amount of one of
several classes of chemical residue, in accordance with the requirements
of the Accredited Laboratory Program. Accreditations are granted
separately for the food chemistry analysis of official samples and for
the analysis of such samples for any one of the several classes of
chemical residue. A laboratory may hold more than one accreditation.
Accredited laboratory-- A non-Federal analytical laboratory that has
met the requirements for accreditation specified in this section and
hence, at an establishment's discretion, may be used in lieu of an FSIS
laboratory for analyzing official regulatory samples. Payment for the
analysis of official samples is to be made by the establishment using
the accredited laboratory.
AOAC methods--Methods of chemical analysis, Chapter 39, Association
of Official Analytical Chemists published in the "Official Methods of
Analysis of the Association of Official Analytical
[[Page 493]]
Chemists", 15th edition 1990.\1\ The "Official Methods of Analysis of
the Association of Official Analytical Chemists," 15th edition, 1990,
is incorporated by reference with the approval of the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
---------------------------------------------------------------------------
\1\ A copy of the "Official Methods of Analysis of the Association
of Analytical Chemists," 15th edition, 1990, is on file with the
Director, Office of the Federal Register, and may be purchased from the
Association of Official Analytical Chemists, 2200 Wilson Boulevard,
Suite 400, Arlington, Virginia 22201. 15th edition, 1990, is
incorporated by reference with the approval of the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
---------------------------------------------------------------------------
Chemical residue misidentification-- see "Correct Chemical Residue
Identification" definition.
Coefficient of variation (CV)-- The standard deviation of a
distribution of analytical values multipled by 100, and divided by the
mean of those values.
Comparison Mean--The average, for a sample, of all accredited and
FSIS laboratories' average results, each of which has a large deviation
measure of zero, except when only two laboratories perform the analysis,
as in the case of split sample analysis by both an accredited laboratory
and an FSIS laboratory. In the latter case, the comparison mean is the
average of the two laboratories' results. For food chemistry, a result
for a laboratory is the obtained analytical value; for chemical
residues, a result is the logarithmic transformation of the obtained
analytical value.
Correct chemical residue identification--Correct identification by a
laboratory of a chemical residue whose concentration, in a sample, is
equal to or greater than the minimum reporting level for that residue,
as determined by the median of all positive analytical values obtained
by laboratories analyzing the sample. Failure of a laboratory to report
the presence of such a chemical residue is considered a
misidentification. In addition, reporting the presence of a residue at a
level equal to or above the minimum reporting level that is not reported
by 90 percent or more of all other laboratories analyzing the sample, is
considered a misidentification.
CUSUM--A class of statistical procedures for assessing whether or
not a process is "in control". Each CUSUM value is constructed by
accumulating incremental values obtained from observed results of the
process, and then determined to either exceed or fall within acceptable
limits for that process. The initial CUSUM values for each laboratory
whose application for accreditation is accepted are set at zero. The
four CUSUM procedures are:
(1) Positive systematic laboratory difference CUSUM (CUSUM-P)--
monitors how consistently an accredited laboratory gets numerically
greater results than the comparison mean;
(2) Negative systematic laboratory difference CUSUM (CUSUM-N)--
monitors how consistently an accredited laboratory gets numerically
smaller results than the comparison mean;
(3) Variability CUSUM (CUSUM-V)--monitors the average "total
discrepancy" (i.e., the combination of the random fluctuations and
systematic differences) between an accredited laboratory's results and
the comparison mean;
(4) Individual large discrepancy CUSUM (CUSUM-D)--monitors the
magnitude and frequency of large differences between the results of an
accredited laboratory and the comparison mean.
Individual large deviation-- An analytical result from a non-Federal
laboratory that differs from the sample comparison mean by more than
would be expected assuming normal laboratory variability.
Initial accreditation check sample-- A sample prepared and sent by
an FSIS laboratory to a non-Federal laboratory to ascertain if the non-
Federal laboratory's analytical capability meets the standards for
granting accreditation.
Interlaboratory accreditation maintenance check sample--A sample
prepared and sent by FSIS to a non-Federal laboratory to assist in
determining if acceptable levels of analytical capability are being
maintained by the accredited laboratory.
Large deviation measure-- A measure that quantifies an unacceptably
large
[[Page 494]]
difference between a non-Federal laboratory's analytical result and the
sample comparison mean.
Minimum proficiency level--The minimum concentration of a residue at
which an analytical result will be used to assess a laboratory's
quantification capability. This concentration is an estimate of the
smallest concentration for which the average coefficient of variation
(CV) for reproducibility (i.e., combined within and between laboratory
variability) does not exceed 20 percent. (See Table 2)
Minimum reporting level-- The number such that if any obtained
analytical value equals or exceeds this number, then the residue is
reported together with the obtained analytical value.
Official Sample--A sample selected by an inspector or inspection
service employee in accordance with FSIS procedures for regulatory use.
Probation-- The period commencing with official notification to an
accredited laboratory that its check or split sample results no longer
satisfy the performance requirements specified in this rule, and ending
with official notification that accreditation is either fully restored,
suspended, or revoked.
QA (quality assurance) recovery-- The ratio of a laboratory's
unadjusted analytical value of a check sample residue to the residue
level fortified by the FSIS laboratory that prepared the sample,
multiplied by 100. (See Table 2.)
QC (quality control) recovery-- The ratio of a laboratory's
unadjusted analytical value of a quality control standard to the
fortification level of the standard, multiplied by 100. (See Table 2.)
Refusal of Accreditation--An action taken when a laboratory which is
applying for accreditation is denied the accreditation.
Responsibly connected.-- Any individual who or entity which is a
partner, officer, director, manager, or owner of 10 per centum or more
of the voting stock of the applicant or recipient of accreditation or an
employee in a managerial or executive capacity or any employee who
conducts or supervises the chemical analysis of FSIS official samples.
Revocation of Accreditation--An action taken against a laboratory
which removes its right to analyze official samples.
Split sample--An official sample divided into duplicate portions,
one portion to be analyzed by an accredited laboratory (for official
regulatory purposes) and the other portion by an FSIS laboratory (for
comparison purposes).
Standardizing Constant--The number which is the result of a
mathematical adjustment to the "standardized value." Specifically, the
number equals the square root of the expected variance of the difference
between the accredited or applying laboratory's result and the
comparison mean on a sample, taking into consideration the standardizing
value, the correlation and number of repeated results by a laboratory on
a sample, and the number of laboratories that analyzed the sample.
Standardized Difference--The quotient of the difference between a
laboratory's result on a sample and the comparison mean of the sample
divided by the standardizing constant.
Standardizing Value--A number representing the performance standard
deviation of an individual result (see Tables 1 and 2 and footnotes to
the Tables for determining exact procedures for calculation).
Suspension of Accreditation--Action taken against a laboratory which
temporarily removes its right to analyze official samples. Suspension of
accreditation ends when accreditation is either fully restored or
revoked.
Systematic laboratory difference--A comparison of one laboratory's
results with the comparison means on samples that shows, on average, a
consistent relationship. A laboratory that is reporting, on average,
numerically greater results than the comparison mean has a positive
systematic laboratory difference and, conversely, numerically smaller
results indicate a negative systematic laboratory difference.
Variability-- Random fluctuations in a laboratory's processes that
cause its analytical results to deviate from a true value.
Variance-- The expected average of the squared differences of sample
results from an expected sample mean.
[[Page 495]]
Table 1--Standardizing Values for Food Chemistry
(By analyte)
------------------------------------------------------------------------
Moisture Protein \1\ Fat \2\ Salt \3\
------------------------------------------------------------------------
0.57 0.060 0.26 0.127
(0.30)
------------------------------------------------------------------------
\1\ To obtain the standardizing value for a sample the appropriate entry
in this column is multiplied by X0.65 where X is the comparison mean
of the sample.
\2\ To obtain the standardizing value for a sample, the appropriate
entry in this column is multiplied by X0.25, where X is the comparison
mean of the sample. The appropriate entry is equal to the value in
parentheses when X is equal to or greater than 12.5 percent, otherwise
it is equal to 0.26.
\3\ To obtain the standardizing value for a sample, when the comparison
mean of the sample, X, is less than 1.0 percent, the standardizing
value equals 0.127, otherwise the appropriate entry is multiplied by
X0.25. When X is equal to or greater than 4.0 percent for dry salami
and pepperoni products, the standardizing value equals 0.22.
Table 2--Minimum Proficiency Levels, Percent Expected recoveries (QC and QA), and Standardizing Values for
Chemical Residues
----------------------------------------------------------------------------------------------------------------
Percent
expected Standardizing
Class of residues Minimum proficiency level recovery (QC value \3\
and QA)
----------------------------------------------------------------------------------------------------------------
Chlorinated Hydrocarbons: \1\
Aldrin................................ 0.10 ppm 80-110 0.20
Benzene Hexachloride.................. 0.10. ppm 80-110 0.20
Chlordane............................. 0.30 ppm 80-110 0.20
Dieldrin.............................. 0.10 ppm 80-110 0.20
DDT................................... 0.15 ppm 80-110 0.20
DDE................................... 0.10 ppm 80-110 0.20
TDE................................... 0.15 ppm 80-110 0.20
Endrin................................ 0.10 ppm 80-110 0.20
Heptachlor............................ 0.10 ppm 80-110 0.20
Heptachlor Epoxide.................... 0.10 ppm 80-110 0.20
Lindane............................... 0.10 ppm 80-110 0.20
Methoxychlor.......................... 0.50 ppm 80-110 0.20
Toxaphene............................. 1.00 ppm 80-110 0.20
Hexachlorobenzene..................... 0.10 ppm 80-110 0.20
Mirex................................. 0.10 ppm 80-110 0.20
Nonachlor............................. 0.15 ppm 80-110 0.20
Polychlorinated Biphenyls................. 0.50 ppm 80-110 0.20
Arsenic \2\............................... 0.20 ppm 90-105 0.25
Sulfonamides \2\.......................... 0.08 ppm 70-120 0.25
Volatile Nitrosamine \2\.................. 5 ppb 70-110 0.25
----------------------------------------------------------------------------------------------------------------
\1\ Laboratory statistics are computed over all results (excluding PCB results), and for specific chemical
residues.
\2\ Laboratory statistics are only computed for specific chemical residues.
\3\ The standardizing value of all initial accreditation and probationary check samples computations is 0.15.
(b) Laboratories accredited for analysis of protein, moisture, fat,
and salt content of poultry and poultry products--
(1) Applying for accreditation. Application for accreditation shall
be made on designated forms provided by FSIS, or otherwise in writing,
by the owner or manager of a non-Federal analytical laboratory and sent
to the Accredited Laboratory Program, room 516-A, Annex Building, Food
Safety and Inspection Service, U.S. Department of Agriculture, 300 12th
Street SW., Washington DC, 20250-3700, and shall specify the kinds of
accreditation that are wanted by the owner or manager of the laboratory.
A laboratory whose accreditation has been refused or revoked may reapply
for accreditation after 60 days from the effective date of that action,
and must provide written documentation specifying what corrections were
made.
(i) At the time that an Application for Accreditation is filed with
the Accredited Laboratory Program, FSIS, and annually thereafter upon
receipt of the bill issued by FSIS on the anniversary date of each
accreditation, the management of a laboratory shall reimburse the
program at the rate specified in 9 CFR 391.5 for the cost of each
accreditation that is sought by the laboratory or that the laboratory
holds.
(ii) Simultaneously with the initial application for accreditation,
the management of a laboratory shall forward a check, bank draft, or
money order in the amount specified in 9 CFR 391.5 made payable to the
U.S. Department
[[Page 496]]
of Agriculture along with the completed application for the
accreditation(s) sought for the laboratory. Accreditation will not be
granted or continued, without further procedure, for failure to pay the
accreditation fee(s). The fee(s) paid shall be nonrefundable and shall
be credited to the account from which the expenses of the laboratory
accreditation program are paid.
(iii) Annually on the anniversary date of each accreditation, FSIS
will issue a bill in the amount specified in 9 CFR 391.5.
(iv) Bills are payable upon receipt by check, bank draft, or money
order made payable to the U.S. Department of Agriculture and become
delinquent 30 days from the date of the bill. Accreditation will be
terminated without further procedure for having a delinquent account.
The fee(s) paid shall be nonrefundable and shall be credited to the
account from which the expenses of the Accredited Laboratory Program are
paid.
(v) The accreditation of a laboratory that was accredited by FSIS on
or before December 13, 1993 and was not on probation and whose
accreditation on that date was not in suspension or revocation shall be
continued, provided that such laboratory reapply for accreditation in
accordance with the provisions of this paragraph (b)(1) by January 13,
1994 (30 days of the effective date of this section), and that the
reapplication be accepted by the Agency. The CUSUM values for such
laboratory will be reset at zero upon acceptance of its reapplication.
The accreditation of a laboratory that is on probation shall be
continued, provided that the laboratory reapply for accreditation by
February 11, 1994 (60 days of the effective date of this section), that
the reapplication be accepted by the Agency, and that the laboratory
satisfy the terms of the probation.
(2) Criteria for obtaining accreditation. Non-Federal analytical
laboratories may be accredited for the analyses of moisture, protein,
fat, and salt content of poultry and poultry products. Accreditation
will be given only if the applying laboratory successfully satisfies the
requirements presented below, for all four analytes. This accreditation
authorizes official FSIS acceptance of the analytical test results
provided by these laboratories on official samples. To obtain FSIS
accreditation for moisture, protein, fat, and salt analyses, a non-
Federal analytical laboratory must:
(i) Be supervised by a person holding, as a minimum, a bachelor's
degree in either chemistry, food science, food technology, or a related
field and having 1 year's experience in food chemistry, or equivalent
qualifications, as determined by the Administrator.
(ii) Demonstrate acceptable levels of systematic laboratory
difference, variability, and individual large deviations in the analyses
of moisture, protein, fat, and salt content using AOAC methods. An
applying laboratory will successfully demonstrate these capabilities if
its moisture, protein, fat, and salt results from a 36 check sample
accreditation study each satisfy the criteria presented below.\2\ If the
laboratory's analysis of an analyte (or analytes) from the first set of
36 check samples does not meet the criteria for obtaining accreditation,
a second set of 36 check samples will be provided within 30 days
following the date of receipt by FSIS of a request from the applying
laboratory. The second set of samples shall be analyzed for only the
analyte(s) for which unacceptable initial results had been obtained by
the laboratory. If the results of the second set of samples do not meet
the accreditation criteria, the laboratory may reapply after a 60-day
waiting period, commencing from the date of refusal of accreditation by
FSIS. At that time, a new application, all fees, and all documentation
of corrective action required for accreditation must be submitted.
---------------------------------------------------------------------------
\2\ All statistical computations are rounded to the nearest tenth,
except where otherwise noted.
---------------------------------------------------------------------------
(A) Systematic laboratory difference: The absolute value of the
average standardized difference must not exceed 0.73 minus the product
of 0.17 and the standard deviation of the standardized differences.
(B) Variability: The estimated standard deviation of the
standardized differences must not exceed 1.15.
[[Page 497]]
(C) Individual large deviations: One hundred times the average of
the large deviation measures of the individual samples must be less than
5.0.\3\
---------------------------------------------------------------------------
\3\ A result will have a large deviation measure equal to zero when
the absolute value of the result's standardized difference, (d), is less
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------
(iii) Allow inspection of the laboratory by FSIS officials prior to
the determination of granting accredited status.
(iv) Pay the accreditation fee by the date required.
(3) Criteria for maintaining accreditation. To maintain
accreditation for moisture, protein, fat, and salt analyses, a non-
Federal analytical laboratory must:
(i) Report analytical results of the moisture, protein, fat, and
salt content of official samples, weekly, on designated forms to the
FSIS Eastern Laboratory, College Station Road, P.O. Box 6085, Athens, GA
30604, or to the address designated by the Quality Systems Branch, FSIS
Chemistry Division.
(ii) Maintain laboratory quality control records for the most recent
3 years that samples have been analyzed under this Program.
(iii) Maintain complete records of the receipt, analysis, and
disposition of official samples for the most recent 3 years that samples
have been analyzed under this Program.
(iv) Maintain a standards book, which is a permanently bound book
with sequentially numbered pages, containing all readings and
calculations for standardization of solutions, determination of
recoveries, and calibration of instruments. All entries are to be dated
and signed by the analyst immediately upon completion of the entry and
by his/her supervisor within 2 working days. The standards book is to be
retained for a period of 3 years after the last entry is made.
(v) Analyze interlaboratory accreditation maintenance check samples
and return the results to FSIS within 3 weeks of sample receipt. This
must be done whenever requested by FSIS and at no cost to FSIS.
(vi) Inform the Accredited Laboratory Program, Room 516-A, Annex
Building, Food Safety and Inspection Service, U.S. Department of
Agriculture, 300 12th Street, SW., Washington, DC 20250-3700, by
certified or registered mail, within 30 days of any change in the
laboratory's ownership, officers, directors, supervisory personnel, or
other responsibly connected individual or entity.
(vii) Permit any duly authorized representative of the Secretary to
perform both announced and unannounced on-site laboratory reviews of
facilities and records during normal business hours, and to copy any
records pertaining to the laboratory's participation in the Accredited
Laboratory Program.
(viii) Use official AOAC methods \4\ on official and check samples.
The "Official Methods of Analysis of the Association of Official
Analytical Chemists," 15th edition, 1990, is incorporated by reference
with the approval of the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51.
---------------------------------------------------------------------------
\4\ A copy of the "Official Methods of Analysis of the Association
of Analytical Chemists," 15th edition, 1990, is on file with the
Director, Office of the Federal Register, and may be purchased from the
Association of Analytical Chemists, Inc., 2200 Wilson Boulevard, Suite
400, Arlington, Virginia 22201.
---------------------------------------------------------------------------
(ix) Demonstrate that acceptable limits of systematic laboratory
difference, variability, and individual large deviations are being
maintained in the analyses of moisture, protein, fat, and salt content.
An accredited laboratory will successfully demonstrate the maintenance
of these capabilities if its moisture, protein, fat, and salt results
from interlaboratory accreditation maintenance check samples and/or
split samples satisfy the criteria presented in this paragraph
(b)(3)(ix).\5\
---------------------------------------------------------------------------
\5\ All statistical computations are rounded to the nearest tenth,
except where otherwise noted.
---------------------------------------------------------------------------
(A) Systematic laboratory difference-- (1) Positive systematic
laboratory difference: The standardized difference between the
accredited laboratory's result and that of the FSIS laboratory for each
split or interlaboratory accreditation maintenance check sample is used
to determine a CUSUM value, designated as CUSUM-P. This value is
computed and evaluated as follows:
[[Page 498]]
(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:
2.0, if the standardized difference is greater than 2.4,
-2.0, if the standardized difference is less than -1.6,
or
the standardized difference minus 0.4, if the standardized difference
lies between -1.6 and 2.4, inclusive.
(ii) Compute the new CUSUM-P value. The new CUSUM-P value is
obtained by adding, algebraically, the CUSUM increment to the last
previously computed CUSUM-P value. If this computation yields a value
smaller than 0, the new CUSUM-P value is set equal to 0. [CUSUM-P values
are initialized at zero; that is, the CUSUM-P value associated with the
first sample is set equal to the CUSUM increment for that sample.]
(iii) Evaluate the new CUSUM-P value. The new CUSUM-P value must not
exceed 5.2.
(2) Negative systematic laboratory difference: The standardized
difference between the accredited laboratory's result and that of the
FSIS laboratory for each split or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-N. This value is computed and evaluated as follows:
(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:
2.0, if the standardized difference is greater than 1.6,
-2.0, if the standardized difference is less than -2.4,
or
the standardized difference plus 0.4, if the standardized difference
lies between -2.4 and 1.6, inclusive.
(ii) Compute the new CUSUM-N value. The new CUSUM-N value is
obtained by subtracting, algebraically, the CUSUM increment to the last
previously computed CUSUM-N value. If this computation yields a value
smaller than 0, the new CUSUM-N value is set equal to 0. [CUSUM-N values
are initialized at zero; that is, the CUSUM-N value associated with the
first sample is set equal to the CUSUM increment for that sample.]
(iii) Evaluate the new CUSUM-N value. The new CUSUM-N value must not
exceed 5.2.
(B) Variability: The absolute value of the standardized difference
between the accredited laboratory's result and that of the FSIS
laboratory for each split sample or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-V. This value is computed and evaluated as follows:
(1) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to the larger of -0.4 and the absolute value of
the standardized difference minus 0.9. If this computation yields a
value larger than 1.6, the increment is set equal to 1.6.
(2) Compute the new CUSUM-V value. The new CUSUM-V value is obtained
by adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-V value. If this computation yields a value less than 0,
the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized
at zero; that is, the CUSUM-V value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not
exceed 4.3.
(C) Large deviations: The large deviation measure of the accredited
laboratory's result for each split sample or interlaboratory
accreditation maintenance check sample is used to determine a CUSUM
value, designated as CUSUM-D.\6\ This value is computed and evaluated as
follows:
---------------------------------------------------------------------------
\6\ See footnote 3.
---------------------------------------------------------------------------
(1) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to the value of the large deviation measure minus
0.025.
(2) Compute the new CUSUM-D value. The new CUSUM-D value is obtained
by adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-D value. If this computation yields a value less than 0,
the new CUSUM-D value is set equal to 0. [CUSUM-D values are initialized
at zero; that is, the CUSUM-
[[Page 499]]
D value associated with the first sample is set equal to the CUSUM
increment for that sample.]
(3) Evaluate the new CUSUM-D value. The new CUSUM-D value must not
exceed 1.0.
(x) Meet the following requirements if placed on probation pursuant
to paragraph (e) of this section:
(A) Send all official samples that have not been analyzed as of the
date of written notification of probation to a specified FSIS laboratory
by certified mail or private carrier or, as an alternative, to an
accredited laboratory approved for food chemistry. Mailing expenses will
be paid by FSIS.
(B) Analyze a set of check samples similar to those used for initial
accreditation, and submit the analytical results to FSIS within 3 weeks
of receipt of the samples.
(C) Satisfy criteria for check samples specified in paragraphs
(b)(2)(ii) (A), (B), and (C) of this section.
(xi) Expeditiously report analytical results of official samples to
the FSIS Eastern Laboratory, College Station Road, P.O. Box 6085,
Athens, GA 30604, or to the address designated by the Quality Systems
Branch, FSIS Chemistry Division. The Federal inspector at any
establishment may assign the analysis of official samples of an FSIS
laboratory if, in the inspector's judgment, there are delays in
receiving test results on official samples from an accredited
laboratory.
(xii) Pay the required accreditation fee when it is due.
(c) Laboratories accredited for analysis of a class of chemical
residues in poultry and poultry products--(1) Applying for
accreditation. Application for accreditation shall be made on designated
forms provided by FSIS, or otherwise in writing, by the owner or manager
of the non-Federal analytical laboratory and sent to the Accredited
Laboratory Program, room 516-A, Annex Building, Food Safety and
Inspection Service, U.S. Department of Agriculture, 300 12th Street,
SW., Washington, DC 20250-3700, and shall specify the kinds of
accreditation that are wanted by the owner or manager of the laboratory.
A laboratory whose accreditation has been refused or revoked may reapply
for accreditation after 60 days from the effective date of that action,
and must provide written documentation specifying what corrections were
made.
(i) At the time that an Application for Accreditation is filed with
the Accredited Laboratory Program, FSIS, and annually thereafter upon
receipt of the bill issued by FSIS on the anniversary date of each
accreditation, the management of a laboratory shall reimburse the
program at the rate specified in 9 CFR 391.5 for the cost of each
accreditation that is sought by the laboratory or that the laboratory
holds.
(ii) Simultaneously with the initial application for accreditation,
the management of a laboratory shall forward a check, bank draft, or
money order in the amount specified in 9 CFR 391.5 made payable to the
U.S. Department of Agriculture along with the completed application for
the accreditation(s) sought by the laboratory. Accreditation will not be
granted or continued, without further procedure, for failure to pay the
accreditation fee(s). The fee(s) paid shall be nonrefundable and shall
be credited to the account from which the expenses of the laboratory
accreditation program are paid.
(iii) Annually on the anniversary date of each accreditation, FSIS
will issue a bill in the amount specified in 9 CFR 391.5.
(iv) Bills are payable upon receipt by check, bank draft, or money
order made payable to the U.S. Department of Agriculture and become
delinquent 30 days from the date of the bill. Accreditation will be
terminated without further procedure for having a delinquent account.
The fee(s) paid shall be nonrefundable and shall be credited to the
account from which the expenses of the Accredited Laboratory Program are
paid.
(v) The accreditation of a laboratory that was accredited by FSIS on
or before December 13, 1993 and was not on probation and whose
accreditation on that date was not in suspension or revocation shall be
continued, provided that such laboratory reapply for accreditation in
accordance with the provisions of this paragraph (c)(1) by January 12,
1994 (30 days of the effective date of this section), and that the
reapplication be accepted by the Agency. The CUSUM values for such
laboratory
[[Page 500]]
will be reset at zero upon acceptance of its reapplication. The
accreditation of a laboratory that is on probation shall be continued,
provided that the laboratory reapply for accreditation by February 11,
1994 (60 days of the effective date of this section), that the
reapplication be accepted by the Agency, and that the laboratory satisfy
the terms of the probation.
(2) Criteria for obtaining accreditation. Non-Federal analytical
laboratories may be accredited for the analysis of a class of chemical
residues in poultry and poultry products. Accreditation will be given
only if the applying laboratory successfully satisfies the requirements
presented below. This accreditation authorizes official FSIS acceptance
of the analytical test results provided by these laboratories on
official samples. To obtain FSIS accreditation for the analysis of a
class of chemical residues, a non-Federal analytical laboratory must:
(i) Be supervised by a person holding, as a minimum, a bachelor's
degree in either chemistry, food science, food technology, or a related
field and either the supervisor or the analyst assigned to analyze the
sample has 3 years' experience determining analytes at or below part per
million levels, or equivalent qualifications, as determined by the
Administrator.
(ii) Demonstrate acceptable limits of systematic laboratory
difference, variability, individual large deviations, recoveries, and
proper identification in the analysis of the class of chemical residues
for which application was made, using FSIS approved procedures. An
applying laboratory will successfully demonstrate these capabilities if
its analytical results for each specific chemical residue provided in a
check sample accreditation study containing a minimum of 14 samples
satisfy the criteria presented in this paragraph (c)(2)(ii).\7\ In
addition, if the laboratory is requesting accreditation for the analysis
of chlorinated hydrocarbons, all analytical results for the residue
class must collectively satisfy the criteria. [Conformance to criteria
(c)(2)(ii) (A), (B), (C), (D), (E), and (F) of this section will only be
determined when six or more analytical results with associated
comparison means at or above the logarithm of the minimum proficiency
level are available.] If the results of the first set of check samples
do not meet these criteria for obtaining accreditation, a second set of
at least 14 samples will be provided within 30 days following the date
of receipt by FSIS of a request from the applying laboratory. If the
results of the second set of samples do not meet accreditation criteria,
the laboratory may reapply after a 60-day waiting period, commencing
from the date of refusal of accreditation by FSIS. At that time, a new
application, all fees, and all documentation of corrective action
required for accreditation must be submitted.
---------------------------------------------------------------------------
\7\ All statistical computations are rounded to the nearest tenth,
unless otherwise noted.
---------------------------------------------------------------------------
(A) Systematic laboratory difference: The absolute value of the
average standardized difference must not exceed 1.67 (2.00 if there are
less than 12 analytical results) minus the product of 0.29 and the
standard deviation of the standardized differences.
(B) Variability: The standard deviation of the standardized
differences must not exceed a computed limit. This limit is a function
of the number of analytical results used in the computation of the
standard deviation, and of the amount of variability associated with the
results from the participating FSIS laboratories.
(C) Individual large deviations: One hundred times the average of
the large deviation measures of the individual analytical results must
be less than 5.0.\8\
---------------------------------------------------------------------------
\8\ A result will have a large deviation measure equal to zero when
the absolute value of the result's standardized difference, (d), is less
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------
(D) QA recovery: The average of the QA recoveries of the individual
analytical results must lie within the range given in Table 2 under the
column entitled "Percent Expected Recovery."
(E) QC recovery: All QC recoveries must lie within the range given
in Table 2 under "Percent Expected Recovery." Supporting documentation
must be made available to FSIS upon request.
[[Page 501]]
(F) Correct identification: There must be correct identification of
all chemical residues in all samples.
(iii) Allow inspection of the laboratory by FSIS officials prior to
the determination of granting accredited status.
(iv) Pay the accreditation fee by the date required.
(3) Criteria for maintaining accreditation. To maintain
accreditation for analysis of a class of chemical residues, a non-
Federal analytical laboratory must:
(i) [Reserved]
(ii) Maintain laboratory quality control records for the most recent
3 years that samples have been analyzed under this Program.
(iii) Maintain complete records of the receipt, analysis, and
disposition of official samples for the most recent 3 years that samples
have been analyzed under the Program.
(iv) Maintain a standards book, which is a permanently bound book
with sequentially numbered pages, containing all readings and
calculations for standardization of solutions, determination of
recoveries, and calibration of instruments. All entries are to be dated
and signed by the analyst immediately upon completion of the entry and
by his/her supervisor within 2 working days. The standards book is to be
retained for a period of 3 years after the last entry is made.
(v) Analyze interlaboratory accreditation maintenance check samples
and return the results to FSIS within 3 weeks of sample receipt. This
must be done whenever requested by FSIS and at no cost to FSIS.
(vi) Inform the Accredited Laboratory Program, Room 516-A, Annex
Building, Food Safety and Inspection Service, U.S. Department of
Agriculture, 300 12th Street, SW., Washington, DC 20250-3700, by
certified or registered mail, within 30 days when there is any change in
the laboratory's ownership, officers, directors, supervisory personnel,
or any other responsibly connected individual or entity.
(vii) Permit any duly authorized representative of the Secretary to
perform both announced and unannounced on-site laboratory reviews of
facilities and records during normal business hours, and to copy any
records pertaining to the laboratory's participation in the Accredited
Laboratory Program.
(viii) Use analytical procedures designated and approved by FSIS.
(ix) Demonstrate that acceptable limits of systematic laboratory
difference, variability, and individual large deviations are being
maintained in the analysis of samples, in the chemical residue class for
which accreditation was granted. A laboratory will successfully
demonstrate the maintenance of these capabilities if its analytical
results for each specific chemical residue found in interlaboratory
accreditation maintenance check samples and/or split samples satisfy the
criteria presented below.\9\ \10\ In addition, if the laboratory is
accredited for the analysis of chlorinated hydrocarbons, all analytical
results for the residue class must collectively satisfy the criteria.
---------------------------------------------------------------------------
\9\ All statistical computations are rounded to the nearest tenth,
except where otherwise noted.
\10\ An analytical result will only be used in the statistical
evaluation of the laboratory if the associated comparison mean is equal
to or greater than the logarithm of the minimum proficiency level for
the residue.
---------------------------------------------------------------------------
(A) Systematic laboratory difference:
(1) Positive systematic laboratory difference: The standardized
difference between the accredited laboratory's result and that of the
FSIS laboratory for each split and/or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-P.\11\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------
\11\ When determining compliance with this criterion for all
chlorinated hydrocarbon results in a sample collectively, the following
statistical procedure must be followed to account for the correlation of
analytical results within a sample: the average of the standardized
differences of the analytical results within the sample, divided by a
constant, is used in place of a single standardized difference to
determine the CUSUM-P (or CUSUM-N) value for the sample. The constant is
a function of the number of analytical results used to compute the
average standardized difference.
---------------------------------------------------------------------------
(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:
[[Page 502]]
2.0, if the standardized difference is greater than 2.5,
-2.0, if the standardized difference is less than -1.5,
or
the standardized difference minus 0.5, if the standardized difference
lies between -1.5 and 2.5, inclusive.
(ii) Compute the new CUSUM-P value. The new CUSUM-P value is
obtained by adding, algebraically, the CUSUM increment to the last
previously computed CUSUM-P value. If this computation yields a value
smaller than 0, the new CUSUM-P value is set equal to 0. [CUSUM-P values
are initialized at zero; that is, the CUSUM-P value associated with the
first sample is set equal to the CUSUM increment for that sample.]
(iii) Evaluate the new CUSUM-P value. The new CUSUM-P value must not
exceed 4.8.
(2) Negative systematic laboratory difference: The standardized
difference between the accredited laboratory's result and that of the
FSIS laboratory for each split and/or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-N.\12\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------
\12\ See footnote 11.
---------------------------------------------------------------------------
(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:
2.0, if the standardized difference is greater than 1.5,
-2.0, if the standardized difference is less than -2.5,
or
the standardized difference plus 0.5, if the standardized difference
lies between -2.5 and 1.5, inclusive.
(ii) Compute the new CUSUM-N value. The new CUSUM-N value is
obtained by subtracting, algebraically, the CUSUM increment to the last
previously computed CUSUM-N value. If this computation yields a value
smaller than 0, the new CUSUM-N value is set equal to 0. [CUSUM-N values
are initialized at zero; that is, the CUSUM-N value associated with the
first sample is set equal to the CUSUM increment for that sample.]
(iii) Evaluate the new CUSUM-N value. The new CUSUM-N value must not
exceed 4.8.
(B) Variability: The absolute value of the standardized difference
between the accredited laboratory's result and that of the FSIS
laboratory for each split and/or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-V.\13\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------
\13\ When determining compliance with this criterion for all
chlorinated hydrocarbon results in a sample collectively, the following
statistical procedure must be followed to account for the correlation of
analytical results within a sample: the square root of the sum of the
within sample variance and the average standardized difference of the
sample, divided by a constant, is used in place of the absolute value of
the standardized difference to determine the CUSUM-V value for the
sample. The constant is a function of the number of analytical results
used to compute the average standardized difference.
---------------------------------------------------------------------------
(1) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to the larger of -0.4 and the absolute value of
the standardized difference minus 0.9. If this computation yields a
value larger than 1.6, the increment is set equal to 1.6.
(2) Compute the new CUSUM-V value. The new CUSUM-V value is obtained
by adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-V value. If this computation yields a value less than 0,
the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized
at zero; that is, the CUSUM-V value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not
exceed 4.3.
(C) Large Deviations: The large deviation measure of the accredited
laboratory's result for each split and/or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-D.\14\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------
\14\ A result will have a large deviation measure equal to zero when
the absolute value of the result's standardized difference, (d), is less
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------
[[Page 503]]
(1) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to the large deviation measure minus 0.025.
(2) Compute the new CUSUM-D value. The new CUSUM-D is obtained by
adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-D value. If this computation yields a value less than 0,
the new CUSUM-D value is set equal to 0. [CUSUM-D values are initialized
at zero; that is, the CUSUM-D value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-D value. The new CUSUM-D value must not
exceed 1.0.
(x) Meet the following requirements if placed on probation pursuant
to paragraph (e) of this section:
(A) Send all official samples that have not been analyzed as of the
date of written notification of probation to a specified FSIS Science
Laboratory by certified mail or private carrier or, as an alternative,
to an accredited laboratory accredited for this specific chemical
residue. Mailing expenses will be paid by FSIS.
(B) Analyze a set of check samples similar to those used for initial
accreditation, and submit analytical results to FSIS within 3 weeks of
receipt of the samples.
(C) Satisfy criteria for check samples as specified in paragraphs
(c)(2)(ii) (A), (B), (C), (D), (E), and (F) of this section
(xi) Expeditiously report analytical results of official samples to
the FSIS Eastern Laboratory, College Station Road, P.O. Box 6085,
Athens, GA 30604, or to the address designated by the Quality Systems
Branch, FSIS Chemistry Division. The Federal inspector at any
establishment may assign the analysis of official samples to an FSIS
laboratory if, in the judgment of the inspector, there are delays in
receiving test results on official samples from an accredited
laboratory.
(xii) Every QC recovery associated with reporting of official
samples must be within the appropriate range given in Table 2 under
"Percent Expected Recovery." Supporting documentation must be made
available to FSIS upon request.
(xiii) Demonstrate that acceptable levels of systematic laboratory
difference, variability, individual large deviations, recoveries, and
proper identification are being maintained in the analysis of
interlaboratory accreditation maintenance check samples, in the chemical
residue class for which accreditation was granted. A laboratory will
successfully demonstrate the maintenance of these capabilities if its
analytical results for each specific chemical residue found in
interlaboratory accreditation maintenance check samples satisfy the
criteria presented below. In addition, if the laboratory is accredited
for the analysis of chlorinated hydrocarbons, all analytical results for
the residue class must collectively satisfy the criteria.
(A) Systematic laboratory difference--(1) Positive systematic
laboratory difference: The standardized difference between the
accredited laboratory's result and the comparison mean for each
interlaboratory accreditation maintenance check sample is used to
determine a CUSUM value, designated as CUSUM-P.\15\ This value is
computed and evaluated as follows:
---------------------------------------------------------------------------
\15\ See footnote 11.
---------------------------------------------------------------------------
(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:
2.0, if the standardized difference is greater than 2.5,
-2.0, if the standardized difference is less than -1.5,
or
the standardized difference minus 0.5, if the standardized difference
lies between -1.5 and 2.5, inclusive.
(ii) Compute the new CUSUM-P value. The new CUSUM-P value is
obtained by adding, algebraically, the CUSUM increment to the last
previously computed CUSUM-P value. If this computation yields a value
smaller than 0, the new CUSUM-P value is set equal to 0. [CUSUM-P values
are initialized at zero; that is, the CUSUM-P value associated with the
first sample is set equal to the CUSUM increment for that sample.]
[[Page 504]]
(iii) Evaluate the new CUSUM-P value. The new CUSUM-P value must not
exceed 4.8.
(2) Negative systematic laboratory difference: The standardized
difference between the accredited laboratory's result and the comparison
mean for each interlaboratory accreditation maintenance check sample is
used to determine a CUSUM value, designated as CUSUM-N.\16\ This value
is computed and evaluated as follows:
---------------------------------------------------------------------------
\16\ See footnote 11.
---------------------------------------------------------------------------
(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:
2.0, if the standardized difference is greater than 1.5,
-2.0, if the standardized difference is less than -2.5,
or
the standardized difference plus 0.5, if the standardized difference
lies between -2.5 and 1.5, inclusive.
(ii) Compute the new CUSUM-N value. The new CUSUM-N value is
obtained by subtracting, algebraically, the CUSUM increment to the last
previously computed CUSUM-N value. If this computation yields a value
smaller than 0, the new CUSUM-N value is set equal to 0. [CUSUM-N values
are initialized at zero; that is, the CUSUM-N value associated with the
first sample is set equal to the CUSUM increment for that sample.]
(iii) Evaluate the new CUSUM-N value. The new CUSUM-N value must not
exceed 4.8.
(B) Variability: The absolute value of the standardized difference
between the accredited laboratory's result and the comparison mean for
each interlaboratory accreditation maintenance check sample is used to
determine a CUSUM value, designated as CUSUM-V.\17\ This value is
computed and evaluated as follows:
---------------------------------------------------------------------------
\17\ See footnote 13.
---------------------------------------------------------------------------
(1) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to the larger of -0.4 or the absolute value of
the standardized difference minus 0.9. If this computation yields a
value larger than 1.6, the increment is set equal to 1.6.
(2) Compute the new CUSUM-V value. The new CUSUM-V value is obtained
by adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-V value. If this computation yields a value less than 0,
the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized
at zero; that is, the CUSUM-V value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not
exceed 4.3.
(C) Large deviations: The large deviation measure of the accredited
laboratory's result for each interlaboratory accreditation maintenance
check sample is used to determine a CUSUM value, designated as CUSUM-
D.\18\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------
\18\ A result will have a large deviation measure equal to zero when
the absolute value of the result's standardized difference, (d), is less
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------
(1) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to the value of the large deviation measure minus
0.025.
(2) Compute the new CUSUM-D value The new CUSUM-D is obtained by
adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-D value. If this computation yields a value less than 0,
the new CUSUM-D value is set equal to 0. [CUSUM-D values are initialized
at zero; that is, the CUSUM-D value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-D value. The new CUSUM-D value must not
exceed 1.0.
(D) Each QC Recovery is within the range given in Table 2 under
"Percent Expected Recovery". Supporting documentation must be made
available to FSIS upon request.
(E) Not more than 1 residue misidentification in any 2 consecutive
check samples.
(F) Not more than 2 residue misidentifications in any 8 consecutive
check samples.
(xiv) Pay the accreditation fee when it is due.
[[Page 505]]
(d) Refusal of accreditation. Upon a determination by the
Administrator, a laboratory will be refused accreditation for the
following reasons:
(1) A laboratory shall be refused accreditation for moisture,
protein, fat, and salt analysis for failure to meet the requirements of
paragraph (b)(1) or (b)(2) of this section.
(2) A laboratory shall be refused accreditation for chemical residue
analysis for failure to meet the requirements of paragraph (c)(1) or
(c)(2) of this section.
(3) A laboratory shall be refused subsequent accreditation for
failure to return to an FSIS laboratory, by certified mail or private
carrier, all official samples which have not been analyzed as of the
notification of a loss of accreditation.
(4) A laboratory shall be refused accreditation if the applicant or
any individual or entity responsibly connected with the applicant has
been convicted of or is under indictment or if charges on an information
have been brought against the applicant or responsibly connected
individual or entity in any Federal or State court concerning the
following violations of law:
(i) Any felony.
(ii) Any misdemeanor based upon acquiring, handling, or distributing
of unwholesome, misbranded, or deceptively packaged food or upon fraud
in connection with transactions in food.
(iii) Any misdemeanor based upon a false statement to any
governmental agency.
(iv) Any misdemeanor based upon the offering, giving or receiving of
a bribe or unlawful gratuity.
(e) Probation of accreditation. Upon a determination by the
Administrator, a laboratory shall be placed on probation for the
following reasons:
(1) If the laboratory fails to complete more than one
interlaboratory accreditation maintenance check sample analysis within
12 consecutive months as required by paragraphs (b)(3)(v) and (c)(3)(v)
of this section, unless written permission is granted by the
Administrator to exceed the time limit.
(2) If the laboratory fails to meet any of the criteria set forth in
paragraphs (b)(3)(v) and (b)(3)(ix) and (c)(3)(v) and (c)(3)(ix) of this
section.
(f) Suspension of accreditation. The accreditation of a laboratory
shall be suspended if the laboratory or any individual or entity
responsibly connected with the laboratory is indicted or if charges on
an information have been brought against the laboratory or responsibly
connected individual or entity in any Federal or State court concerning
any of the following violations of law:
(1) Any felony.
(2) Any misdemeanor based upon acquiring, handling or distributing
of unwholesome, misbranded, or deceptively packaged food or upon fraud
in connection with transactions in food.
(3) Any misdemeanor based upon a false statement to any governmental
agency.
(4) Any misdemeanor based upon the offering, giving or receiving of
a bribe or unlawful gratuity.
(g) Revocation of accreditation. The accreditation of a laboratory
shall be revoked for the following reasons:
(1) An accredited laboratory which is accredited to perform analysis
under paragraph (b) of this section shall have its accreditation revoked
for failure to meet any of the requirements of paragraph (b)(3) except
for the following circumstances. If the accredited laboratory fails to
meet the criteria for reporting the analytical results on
interlaboratory accreditation maintenance check samples as set forth in
paragraph (b)(3)(v) of this section or if, at any time, the CUSUM
results from the analysis of such interlaboratory accreditation
maintenance check samples and/or split samples have not satisfied the
criteria specified in paragraph (b)(3)(ix) of this section and there
have been, during the previous 12 months, no other occasions on which
such CUSUM results have not satisfied such criteria, the laboratory
shall be placed on probation; but if there have been such other
occasions during those 12 months, the laboratory's accreditation will be
revoked.
(2) An accredited laboratory which is accredited to perform analysis
for a class of chemical residues under paragraph (c) of this section
shall have the accreditation to perform this analysis revoked if it
fails to meet any of the requirements in paragraph (c)(3) of this
[[Page 506]]
section except for the following circumstances. If the accredited
laboratory fails to meet any of the criteria set forth in paragraphs
(c)(3)(v), (c)(3)(ix), and (c)(3)(xiii) of this section and it has not
so failed during the 12 months preceding its failure to meet the
criteria, it shall be placed on probation, but if it has so failed at
any time during those 12 months, its accreditation will be revoked.
(3) An accredited laboratory shall have its accreditation revoked if
the Administrator determines that the laboratory or any responsibly
connected individual or any agent or employee has:
(i) Altered any official sample or analytical finding, or,
(ii) Substituted any analytical result from any other laboratory for
its own.
(4) An accredited laboratory shall have its accreditation revoked if
the laboratory or any individual or entity responsibly connected with
the laboratory is convicted in a Federal or State court of any of the
following violations of law:
(i) Any felony.
(ii) Any misdemeanor based upon acquiring, handling, or distributing
of unwholesome, misbranded, or deceptively packaged food or upon fraud
in connection with transactions in food.
(iii) Any misdemeanor based upon a false statement to any
governmental agency.
(iv) Any misdemeanor based upon the offering, giving or receiving of
a bribe or unlawful gratuity.
(h) Notification and hearings. Accreditation of any laboratory shall
be refused, suspended, or revoked under the conditions previously
described herein. The owner or operator of the laboratory shall be sent
written notice of the refusal, suspension, or revocation of
accreditation by the Administrator. In such cases, the laboratory owner
or operator will be provided an opportunity to present, within 30 days
of the date of the notification, a statement challenging the merits or
validity of such action and to request an oral hearing with respect to
the denial, suspension, or revocation decision. An oral hearing shall be
granted if there is any dispute of material fact joined in such
responsive statement. The proceeding shall thereafter be conducted in
accordance with the applicable rules of practice which shall be adopted
for the proceeding. Any such refusal, suspension, or revocation shall be
effective upon the receipt by the laboratory of the notification and
shall continue in effect until final determination of the matter by the
Administrator.
(Reporting and recordkeeping requirements approved by the Office of
Management and Budget under control number 0583-0015)
[52 FR 2192, Jan. 20, 1987, as amended at 58 FR 65264, 65266-65268, Dec.
13, 1993; 59 FR 33642, 33643, June 30, 1994; 59 FR 66448, Dec. 27, 1994;
60 FR 10305, Feb. 24, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.155]
[Page 506-507]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.155 General.
(a) Authorization to establish specifications. (1) The Administrator
is authorized to establish specifications or definitions and standards
of identity or composition, covering the principal constituents of any
poultry product with respect to which a specified name of the product or
other labeling terminology may be used, whenever he determines such
action is necessary to prevent sale of the product under false or
misleading labeling. Further, the Administrator is authorized to
prescribe definitions and standards of identity or composition for
poultry products whenever he determines such action is otherwise
necessary for the protection of the public. The requirements of this
subpart are hereby found to be necessary for these purposes and
standards are hereby established as set forth in this subpart.
(2) Where cooked poultry meat is specified in this subpart as an
ingredient of poultry products, this means poultry meat derived from
poultry processed, cooked, and cooled in a manner approved by the
Administrator in specific cases without use of liquid or moisture in
direct contact with the poultry meat following the cooking and cooling
of the poultry.
(3) If, following cooking and cooling of poultry meat to be used in
poultry products, liquid or moisture is used in direct contact with such
poultry meat
[[Page 507]]
and the percentage of solids, excluding salt, in the poultry meat is
found to be below 34 percent when such poultry meat is tested by
acceptable methods, the percentage of poultry meat required by this
section for any poultry product shall be increased in proportion to the
deficiency, or the meat shall be so processed as to raise the solids
content, excluding salt, to 34 percent. The official establishment shall
furnish adequate facilities for such testing.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.156]
[Page 507]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.156 Poultry meat content standards for certain poultry products.
Poultry products with labeling terminology as set forth in Table I
shall comply with the specifications for percent light meat and percent
dark meat set forth in said table.
Table I
------------------------------------------------------------------------
Label terminology Percent light meat Percent dark meat
------------------------------------------------------------------------
Natural proportions............. 50-65............. 50-35.
Light or white meat............. 100............... 0.
Dark meat....................... 0................. 100.
Light and dark meat............. 51-65............. 49-35.
Dark and light meat............. 35-49............. 65-51.
Mostly white meat............... 66 or more........ 34 or less.
Mostly dark meat................ 34 or less........ 66 or more.
------------------------------------------------------------------------
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.157]
[Page 507-508]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.157 Canned boned poultry and baby or geriatric food.
(a) Canned boned poultry shall, unless otherwise specified in this
section, be prepared from cooked deboned poultry meat and may contain
skin and fat not in excess of natural whole carcass proportions.
Gelatin, stabilizers, or similar solidifying or emulsifying agents shall
not be added to product labeled "Boned (Kind)--Solid Pack," but may be
added in quantities not in excess of a total of 0.5 percent of the total
ingredients in the preparation of other canned boned poultry products
and in such cases the common name of the substance shall be included in
the name of the product, e.g., "Boned Chicken with Broth--Gelatin
Added."
(b) Canned boned poultry, except poultry within paragraph (c) of
this section, shall meet the requirements set forth in Table II. The
percentages in Table II shall be calculated on the basis of the total
ingredients used in the preparation of the product.
(c) Canned boned poultry with natural juices (Boned (Kind) with
natural juices) shall be prepared from either raw boned poultry or a
mixture of raw boned poultry and cooked boned poultry and shall have no
liquid added during the preparation of the product.
(d) Canned shredded poultry (Shredded Kind), consists of poultry
meat reduced to a shredded appearance, from the kind of poultry
indicated, with meat, skin, and fat not in excess of the natural whole
carcass proportions. Canned shredded poultry from specific parts may
include skin or fat in excess of the proportions normally found on a
whole carcass, but not in excess of the proportions of skin and fat
normal to the particular part or parts; and such product shall be
labeled in accordance with Sec. 381.117(d).
(e) Canned boned poultry shall be prepared as set forth in Table II,
items 1, 2, 3, or 4, whichever is applicable.
Table II
------------------------------------------------------------------------
Minimum
percent
cooked,
deboned Maximum
poultry percent
Product name meat of liquid
kind that may
indicated, be added
with skin, \1\
fat, and
seasoning
------------------------------------------------------------------------
1. Boned (Kind)--solid pack.................... 95 5
2. Boned (Kind)................................ 90 10
3. Boned (Kind) with broth \2\................. 80 20
4. Boned (Kind) (----) percent broth \2, 3\.... 50 50
------------------------------------------------------------------------
\1\ Liquid may be in the form of, but is not limited to, broth or
extractives.
\2\ Alternatively, product may be prepared from raw boned poultry in
combination with cooked boned poultry so long as the product complies
with the specified standard.
\3\ Total amount of liquid added shall be included in the name of the
product; e.g., "Boned Chicken with 25 percent broth."
(f) Poultry products intended for infant or geriatric use and
represented as having a "high meat" content shall contain not less
than 18.75 percent cooked, deboned poultry meat of the kind indicated,
with seasoning.
[[Page 508]]
Table IIa
------------------------------------------------------------------------
Minimum
percent
cooked, Maximum
deboned, percent
poultry liquid
Product name meat of that may
kind be added
indicated, \1\
with
seasoning
------------------------------------------------------------------------
1. Strained or chopped (Kind) with broth \2, 3\ 43 57
2. High meat dinner \3\........................ 18.75
------------------------------------------------------------------------
\1\ Liquid may be in the form of, but not limited to, broth or
extractives.
\2\ Alternatively, product may be prepared from raw boned poultry meat
in combination with cooked bone poultry meat so long as the product
complies with the specified standard.
\3\ Label must indicate in some manner that product is for infant or
geriatric servings.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.158]
[Page 508]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.158 Poultry dinners (frozen) and pies.
Poultry dinners (frozen) and pies shall meet the requirements set
forth in Table III of this section and the percentage or weight
specified therein shall be calculated on the basis of total ingredients
used in the preparation of the poultry product.
Table III
------------------------------------------------------------------------
Minimum cooked Minimum raw deboned
deboned poultry poultry meat of
meat of kind kind indicated
indicated --------------------
---------------------
Percent Weight Percent Weight
------------------------------------------------------------------------
(Kind) Pies................... 14 or 1\1/8\ 25 or 2 oz.
oz. per 8- per 8-oz.
oz. pie pie.\1\
\1\
(Kind) Dinners................ 18 or 2 oz.2,
3
------------------------------------------------------------------------
\1\ 14 percent or 1\1/8\ oz., whichever is greater; or 25 percent or 2
oz., whichever is greater.
\2\ Excluding weight of appetizers, desserts, etc.
\3\ 18 percent or 2 oz., whichever is greater. A minimum of 45 percent,
or 5 ounces per dinner, whichever is greater, of cooked poultry
including bone and breading may be used in lieu of minimum 18 percent
or 2 ounces of cooked deboned poultry meat and the cooked poultry
including bone and breading shall not contain more than 30 percent
breading.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.159]
[Page 508]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.159 Poultry rolls.
(a) Binders or extenders may be added in accordance with a
regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or in
21 CFR Chapter I, Subchapter A or Subchapter B. In addition to the
binders referred to in the preceding sentence, the following substances
are permitted for use as binders in poultry rolls: transglutaminase
enzyme at up to 65 ppm. When binding agents are added in excess of 3
percent for cooked rolls and 2 percent for raw rolls, the common name of
the agent or the term "Binders Added" shall be included in the name of
the product; e.g., "Turkey Roll-Gelatin Added."
(b) With respect to heat processed rolls, 2 percent or less liquid
based on the weight of the finished product without liquid may remain
with or be returned to product labeled as "(Kind) Roll."
(c) Heat processed rolls which have more than 2 percent liquid
remaining with or returned to the product shall be labeled as "(Kind)
Roll with Natural Juices." If more than 2 percent of any liquid other
than natural cookout juices is added, the product must be labeled to
indicate that fact; e.g., "Turkey Roll with Broth." Liquid shall not
be returned or added to product within this paragraph graph in excess of
the amount normally cooked out during preparation.
[37 FR 9706, May 16, 1972, as amended at 55 FR 34684, Aug. 24, 1990; 66
FR 54916, Oct. 31, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.160]
[Page 508]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.160 (Kind) burgers; (Kind) patties.
Such product consists of 100 percent poultry of the kind indicated,
with skin and fat not in excess of natural proportions. Product
containing fillers or binders shall be named "(Kind) Patties."
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.161]
[Page 508]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.161 "(Kind) A La Kiev."
Such product consists of poultry meat of the kind indicated, stuffed
with butter which may be seasoned and the product may be wrapped in
sufficient skin to cover the meat. It may be dipped in batter, fried,
and frozen.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.162]
[Page 508]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.162 "(Kind) steak or fillet."
Such product consists of a boneless slice or strip of poultry meat
of the kind indicated.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.163]
[Page 508]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.163 "(Kind) baked" or "(Kind) roasted."
Such product consists of ready-to-cook poultry of the kind
indicated, that has been cooked in dry source heat, e.g., oven roasted
or oven baked.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.164]
[Page 508-509]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.164 "(Kind) barbecued."
Such product consists of ready-to-cook poultry of the kind
indicated,
[[Page 509]]
that has been cooked in dry heat and basted with a seasoned sauce.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.165]
[Page 509]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.165 "(Kind) barbecued prepared with moist heat."
Such product consists of ready-to-cook poultry of the kind indicated
that has been cooked by the action of moist heat in a barbecue sauce.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.166]
[Page 509]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.166 Breaded products.
"Breaded" is a term applicable to any poultry product which is
coated with breading or a batter and breading in an amount not to exceed
30 percent of the weight of the finished breaded product.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.167]
[Page 509]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.167 Other poultry dishes and specialty items.
Poultry dishes and specialty items listed in Table IV of this
paragraph shall meet the requirements set forth in said table,
irrespective of the type of packaging, and the percentages in Table IV
shall be calculated on a ready-to-serve basis, except that soup bases in
institutional packs which are prepared for sale to institutional users
shall have a minimum of 15 percent cooked deboned poultry meat based on
the weight of the soup base product.
Table IV
------------------------------------------------------------------------
Minimum Minimum
percent percent
cooked cooked
deboned poultry of
Product name \1\ poultry kind
meat of indicated,
kind indicating
indicated bone
------------------------------------------------------------------------
(Kind) Ravioli................................ 2 ...........
(Kind) Soup................................... 2 ...........
Chop Suey with (Kind)......................... 2 ...........
(Kind) Chop Suey.............................. 4 ...........
(Kind) Chow Mein without noodles.............. 4 ...........
(Kind) Tamales................................ 6 ...........
Noodles or Dumplings with (Kind) \2\.......... 6 ...........
(Kind) Stew................................... 12 ...........
(Kind) Fricassee of Wings..................... ........... 40
(Kind) Noodles or Dumplings \2\............... 15 30
(Kind) with Vegetables........................ 15 ...........
Gravy with sliced (Kind)...................... 15 ...........
(Kind) Tetrazzini............................. 15 ...........
(Kind) chili with beans....................... 17 ...........
Creamed (Kind)................................ 20 ...........
(Kind) Cacciatore............................. 20 40
(Kind) Fricassee.............................. 20 40
(Kind) A-La-King.............................. 20 ...........
(Kind) croquettes............................. 25 ...........
Slice (Kind) with Gravy and Dressing.......... 25 ...........
(Kind) Salad \3\.............................. 25 ...........
(Kind) chili.................................. 28 ...........
(Kind) Hash................................... 30 ...........
Sliced (Kind) with Gravy...................... 35 ...........
Minced (Kind) Barbecue........................ 40 ...........
------------------------------------------------------------------------
\1\ The product name may contain other appropriate descriptive terms
such as "noodle"; e.g., "Chicken Noodle Soup."
\2\ This standard also applies to products named (Kind) with rice or
similar starches.
\3\ The 25 percent-standard listed includes poultry meat plus
proportions of skin and fat natural to the poultry used.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.168]
[Page 509]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.168 Maximum percent of skin in certain poultry products.
The poultry products listed in Table V shall have not more than the
percent of skin specified in the table, when raw and when cooked.
Table V
------------------------------------------------------------------------
Percent skin
Product name -----------------
Raw Cooked
------------------------------------------------------------------------
Boneless Turkey Breast
or
Boneless Turkey Breast Roll........................... 14
Boneless Turkey Thigh
or
Boneless Turkey Thigh Roll............................ 8
Boneless Turkey
or
Turkey Roll........................................... 15
Boneless Chicken Breast
or
Boneless Chicken Breast Roll.......................... 18 20
Boneless Chicken
or
Chicken Roll.......................................... 20 25
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.169]
[Page 509-510]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.169 Ready-to-cook poultry products to which solutions are added.
(a) Butter alone, or solutions of poultry broth, poultry stock,
water, or edible fats, or mixtures thereof, in which are included
functional substances such as spices, flavor enhancers, emulsifiers,
phosphates, coloring materials, or other substances, approved by the
Administrator in specific cases, may be introduced by injection into the
thick muscles (breast and legs) of ready-to-cook poultry carcasses and
may be introduced by injection or marinating into any separate bone-in
part therefrom, for the purpose of providing a basting medium or similar
function.
[[Page 510]]
The ingredients of the added materials and the manner of addition to the
products must be found acceptable by the Administrator, in all cases.
The introduction of the added materials shall increase the weight of the
processed product by approximately 3 percent over the weight of the raw
product after washing and chilling in compliance with Sec. 381.66. The
weight of the added materials introduced into the poultry products as
provided in this paragraph shall be included as part of the weight of
the poultry for purposes of the net weight labeling provisions in
Sec. 381.121(b).
(b) A raw poultry product, into which added materials are introduced
as provided in paragraph (a) of this section must be labeled with a
conspicuous, legible, and descriptive name, including terms that
concisely describe the method of addition and function of the added
material. All major terms in the product name must be printed with the
same prominence, except that the words which describe the function of
the added materials (such as "Injected for Flavored Basting") may be
more prominent, provided this does not detract from the conspicuousness
of the other terms in the product name (such as "Young Turkey"). The
label must also bear a statement, in bold type, immediately below and
adjacent to the product name, listing the common or usual names of the
added materials in descending order of predominance. The first part of
this statement must consist of terms adequate to inform consumers about
the amount and manner of introduction of the solution (such as
"Injected with approximately 3 percent of a solution of ----------"),
and must be printed at least one-fourth the size of the most prominent
letter in the product name, with a minimum size of one-fourth inch for a
ready-to-cook turkey and proportionately smaller for other poultry
products. The remainder of the solution ingredients shall be declared in
type at least one-eighth inch in height. The entire statement must be
printed in a color that contrasts with the background and be displayed
on the principal display panel.
(c) Approval for use of a label for product under this section
depends upon the ability of the processor to control the finished
product, within a range of three-tenths of 1 percent accuracy, so that
the average percent of basting material in each outgoing lot is not
greater than 3.3 percent or less than 2.7 percent of basting material
when tested by an approved plant control procedure would be in
compliance. As used in this section, "a lot" may be any reasonable
portion of production designated by the operator of the official
establishment, with a maximum of an entire shift's production from one
production line. The control procedures to be eligible for approval by
the Administrator must:
(1) Assure compliance with all labeling requirements.
(2) Control the variability of the amount of added approved solution
within the limits defined above.
(3) Provide for the disposition in accordance with the regulations
of all products not in compliance with this section.
(4) Incorporate a system of raw weight identification of a
sufficient number of poultry and/or poultry parts to allow effective
monitoring of the system by Federal inspectors and official
establishment employees.
[37 FR 9706, May 16, 1972, as amended at 39 FR 36000, Oct. 7, 1974]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.170]
[Page 510-512]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.170 Standards for kinds and classes, and for cuts of raw poultry.
(a) The following standards specify the various classes of the
specified kinds of poultry, and the requirements for each class:
(1) Chickens--(i) Rock Cornish game hen or Cornish game hen. A Rock
Cornish game hen or Cornish game hen is a young immature chicken
(usually 5 to 6 weeks of age) weighing not more than 2 pounds ready-to-
cook weight, which was prepared from a Cornish chicken or the progeny of
a Cornish chicken crossed with another breed of chicken.
(ii) Rock Cornish fryer, roaster, or hen. A Rock Cornish fryer,
roaster, or hen is the progeny of a cross between a purebred Cornish and
a purebred Rock chicken, without regard to the weight of the carcass
involved; however, the term "fryer," "roaster," or "hen" shall
apply only if the carcasses are from birds with ages and characteristics
[[Page 511]]
that qualify them for such designation under paragraph (a)(1) (iii) or
(iv) of this section.
(iii) Broiler or fryer. A broiler or fryer is a young chicken
(usually under 13 weeks of age), of either sex, that is tender-meated
with soft, pliable, smooth-textured skin and flexible breastbone
cartilage.
(iv) Roaster or roasting chicken. A bird of this class is a young
chicken (usually 3 to 5 months of age), of either sex, that is tender-
meated with soft, pliable, smooth-textured skin and breastbone cartilage
that may be somewhat less flexible than that of a broiler or fryer.
(v) Capon. A capon is a surgically unsexed male chicken (usually
under 8 months of age) that is tender-meated with soft, pliable, smooth-
textured skin.
(vi) Hen, fowl, or baking or stewing. A bird of this class is a
mature female chicken (usually more than 10 months of age) with meat
less tender than that of a roaster, or roasting chicken and nonflexible
breastbone tip.
(vii) Cock or rooster. A cock or rooster is a mature male chicken
with coarse skin, toughened and darkened meat, and hardened breastbone
tip.
(2) Turkeys--(i) Fryer-roaster turkey. A fryer-roaster turkey is a
young immature turkey (usually under 16 weeks of age), of either sex,
that is tender-meated with soft, pliable, smooth-textured skin, and
flexible breastbone cartilage.
(ii) Young turkey. A young turkey is a turkey (usually under 8
months of age) that is tender-meated with soft, pliable, smooth-textured
skin, and breastbone cartilage that is somewhat less flexible than in a
fryer-roaster turkey. Sex designation is optional.
(iii) Yearling turkey. A yearling turkey is a fully matured turkey
(usually under 15 months of age) that is reasonably tender-meated and
with reasonably smooth-textured skin. Sex designation is optional.
(iv) Mature turkey or old turkey (hen or tom). A mature or old
turkey is an old turkey of either sex (usually in excess of 15 months of
age) with coarse skin and toughened flesh.
(3) Ducks--(i) Broiler duckling or fryer duckling. A broiler
duckling or fryer duckling is a young duck (usually under 8 weeks of
age), of either sex, that is tender-meated and has a soft bill and soft
windpipe.
(ii) Roaster duckling. A roaster duckling is a young duck (usually
under 16 weeks of age), of either sex, that is tender-meated and has a
bill that is not completely hardened and a windpipe that is easily
dented.
(iii) Mature duck or old duck. A mature duck or an old duck is a
duck (usually over 6 months of age), of either sex, with toughened
flesh, hardened bill, and hardened windpipe.
(4) Geese--(i) Young goose. A young goose may be of either sex, is
tender-meated, and has a windpipe that is easily dented.
(ii) Mature goose or old goose. A mature goose or old goose may be
of either sex and has toughened flesh and hardened windpipe.
(5) Guineas--(i) Young guinea. A young guinea may be of either sex,
is tender-meated, and has a flexible breastbone cartilage.
(ii) Mature guinea or old guinea. A mature guinea or an old guinea
may be of either sex, has toughened flesh, and a hardened breastbone.
(b) The following standards specify the requirements for the
specified cuts of poultry:
(1) "Breasts" shall be separated from the back at the shoulder
joint and by a cut running backward and downward from that point along
the junction of the vertebral and sternal ribs. The ribs may be removed
from the breasts, and the breasts may be cut along the breastbone to
make two approximately equal halves; or the wishbone portion, as
described in paragraph (b)(3) of this section, may be removed before
cutting the remainder along the breastbone to make three parts. Pieces
cut in this manner may be substituted for lighter or heavier pieces for
exact weight-making purposes and the package may contain two or more of
such parts without affecting the appropriateness of the labeling as
e.g., "chicken breasts." Neck skin shall not be included with the
breasts, except that "turkey breasts" may include neck skin up to the
whisker.
(2) "Breasts with ribs" shall be separated from the back at the
junction of
[[Page 512]]
the vertebral ribs and back. Breasts with ribs may be cut along the
breastbone to make two approximately equal halves; or the wishbone
portion, as described in paragraph (b)(3) of this section, may be
removed before cutting the remainder along the breastbone to make three
parts. Pieces cut in this manner may be substituted for lighter or
heavier pieces for exact weight-making purposes and the package may
contain two or more of such parts without affecting the appropriateness
of the labeling as "breasts with ribs." Neck skin shall not be
included, except that "turkey breasts with ribs" may include neck skin
up to the whisker.
(3) "Wishbones" (Pulley Bones), with covering muscle and skin
tissue, shall be severed from the breast approximately halfway between
the end of the wishbone (hypocledium) and front point of the breastbone
(cranial process of the sternal crest) to a point where the wishbone
joins the shoulder. Neck skin shall not be included with the wishbone.
(4) "Drumsticks" shall be separated from the thigh by a cut
through the knee joint (femorotibial and patellar joint) and from the
hock joint (tarsal joint).
(5) "Thighs" shall be disjointed at the hip joint and may include
the pelvic meat, but shall not include the pelvic bones. Back skin shall
not be included.
(6) "(Kind) legs" shall be the poultry product which includes the
thigh and the drumstick, i.e., the whole leg, and may include the pelvic
meat, but shall not include the pelvic bones. Back skin shall not be
included.
(7) "Wings" shall include the entire wing with all muscle and skin
tissue intact, except that the wingtip may be removed.
(8) "Backs" shall include the pelvic bones and all the vertebrae
posterior to the shoulder joint. The meat shall not be peeled from the
pelvic bones. The vertebral ribs and/or scapula may be removed or
included without affecting the appropriateness of the name. Skin shall
be substantially intact.
(9) "Stripped backs" shall include the vertebrae from the shoulder
joint to the tail, and include the pelvic bones. The meat may be
stripped off of the pelvic bones.
(10) "Necks", with or without neck skin, shall be separated from
the carcass at the shoulder joint.
(11) "Halves" are prepared by making a full-length back and breast
split of an eviscerated poultry carcass so as to produce approximately
equal right and left sides.
(12) "Quarters" consist of the entire eviscerated poultry carcass,
which has been cut into four equal parts, but excluding the neck.
(13) "Breast quarter" consists of half a breast with the wing and
a portion of the back attached.
(14) "Breast quarter without wing" consists of a front quarter of
a poultry carcass, from which the wing has been removed.
(15) "Leg quarter" consists of a poultry thigh and drumstick, with
a portion of the back attached.
(16) "Thigh with back portion" consists of a poultry thigh with
back portion attached.
(17) "Legs with pelvic bone" consists of a poultry leg with
adhering meat and skin and pelvic bone.
(18) "Wing drummette" consists of the humerus of a poultry wing
with adhering skin and meat attached.
(19) "Wing portion" consists of a poultry wing except that the
drummette has been removed.
(20) "Cut-up Poultry" is any cut-up or disjointed portion of
poultry or any edible part thereof, as described in this section.
(21) "Giblets" consist of approximately equal numbers of hearts,
gizzards, and livers, as determined on a count basis.
(22) "Major portions" of eviscerated poultry carcasses are either
carcasses from which parts may be missing, or the front or rear portions
of transversely-split carcasses.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 63 FR
48960, Sept. 11, 1998]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.171]
[Page 512-513]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.171 Definition and standard for "Turkey Ham."
(a) "Turkey Ham" shall be fabricated from boneless, turkey thigh
meat with skin and the surface fat attached to the skin removed. The
thighs shall be
[[Page 513]]
that cut of poultry described in Sec. 381.170(b)(5) of this part.
(b) The product may or may not be smoked, and shall be cured using
one or more of the approved curing agents as provided in a regulation
permitting that use in this subchapter or 9 CFR Chapter III, Subchapter
E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. The product may
also contain cure accelerators, phosphates, and flavoring agents as
provided in a regulation permitting that use in this subchapter or 9 CFR
Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or
Subchapter B; common salt, sugars, spices, spice extractives, dehydrated
garlic, and dehydrated onions; and water for purpose of dissolving and
dispersing the substances specified above.
(c) The cooked finished product weight shall be no more than the
original weight of the turkey thigh meat used prior to curing.
(d) The product name on the label shall show the word "Turkey" in
the same size, style, color, and with the same background as the word
"Ham" and shall precede and be adjacent to it.
(e) The product name shall be qualified with the statement "Cured
Turkey Thigh Meat." The qualifying statement shall be contiguous to the
product name, without intervening type or designs, shall be not less
than one-half the size of the product name but not less than one-eighth
inch in height, and shall be in the same style and color and with the
same background as the product name.
(f) If the product is fabricated from pieces of turkey thigh meat
that result from the cutting through the muscle (as opposed the whole
thighs intact or whole thighs with some incidental separation of muscle
tissue during removal of the bone), the product name shall be further
qualified by a descriptive statement. The product name of product
fabricated from such pieces of turkey thigh meat equivalent in size to a
one-half inch cube or greater shall be further qualified to specify that
the product is "Chunked and Formed." The product name of product
fabricated from such pieces of turkey thigh meat smaller than the
equivalent of a one-half inch cube shall be further qualified to specify
that the product is "Ground and Formed" or "Chopped and Formed" as
appropriate. The qualifying statement shall immediately follow and be
contiguous to the statement required in paragraph (e) of this section,
and shall be not less than one-half the size of the product name but not
less than one-eighth inch in height, and shall be in the same style and
color and with the same background as the product name.
[44 FR 51190, Aug. 31, 1979; 64 FR 72175, Dec. 23, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.173]
[Page 513-514]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.173 Mechanically Separated (Kind of Poultry).
(a) "Mechanically Separated (Kind of Poultry)" is any product
resulting from the mechanical separation and removal of most of the bone
from attached skeletal muscle and other tissue of poultry carcasses and
parts of carcasses that has a paste-like form and consistency, that may
or may not contain skin with attached fat and meeting the other
provisions of this section. Examples of such product are "Mechanically
Separated Chicken" and "Mechanically Separated Turkey."
(b) "Mechanically Separated (Kind of Poultry)" shall not have a
bone solids content of more than 1 percent. At least 98 percent of the
bone particles present in "Mechanically Separated (Kind of Poultry) "
shall have a maximum size no greater than 1.5 mm (millimeter) in their
greatest dimension and there shall be no bone particles larger than 2.0
mm in their greatest dimension.
(c) "Mechanically Separated (Kind of Poultry)" shall not have a
calcium content exceeding 0.235 percent when made from mature chickens
or from turkeys as defined in Sec. 381.170(a)(l)(vi) and (vii) and
(a)(2), respectively, or 0.175 percent when made from other poultry,
based on the weight of product that has not been heat treated, as a
measure of a bone solids content of not more than 1 percent.
(d) "Mechanically Separated (Kind of Poultry)" may be used in the
formulation of poultry products in accordance with Sec. 381.174 and meat
food products in accordance with subchapter A of this chapter.
(e) Product resulting from the mechanical separation process that
fails
[[Page 514]]
to meet the bone particle size or calcium content requirements for
"Mechanically Separated (Kind of Poultry)" shall be used only in
producing poultry extractives, including fats, stocks, and broths and
labeled as "Mechanically Separated (Kind of Poultry) for Further
Processing."
[60 FR 55983, Nov. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.174]
[Page 514]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart P--Definitions and Standards of Identity or Composition
Sec. 381.174 Limitations with respect to use of Mechanically Separated (Kind of Poultry).
(a) A poultry product required to be prepared from a particular kind
of poultry (e.g., chicken) shall not contain "Mechanically Separated
(Kind of Poultry)" described in Sec. 381.173, that is made from any
other kind of poultry (e.g., Mechanically Separated Turkey).
(b) "Mechanically Separated (Kind of Poultry)" described in
Sec. 381.173 may be used in the formulation of any poultry or meat food
product, provided such use conforms with any applicable requirements of
the definitions and standards of identity or composition in this
subchapter or part 319 of this chapter, and provided that it is
identified as "Mechanically Separated (Kind of Poultry)."
[60 FR 55983, Nov. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.175]
[Page 514]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Q--Records, Registration, and Reports
Sec. 381.175 Records required to be kept.
(a) Every person within any of the classes specified in paragraph
(a) (1), (2), or (3) of this section is required by the Act to keep such
records as are properly necessary for the effective enforcement of the
Act:
(1) Any person that engages in the business of slaughtering any
poultry or processing, freezing, packaging, or labeling any carcasses,
or parts or products of carcasses, of any poultry, for commerce, for use
as human food or animal food;
(2) Any person that engages in the business of buying or selling (as
a poultry products broker, wholesaler, or otherwise) or transporting, in
commerce, or storing in or for commerce, or importing, any carcasses, or
parts or products of carcasses, of any poultry;
(3) Any person that engages in business, in or for commerce, as a
renderer, or engages in the business of buying, selling, or transporting
in commerce, or importing, any dead, dying, disabled, or diseased
poultry or parts of the carcasses of any poultry that died otherwise
than by slaughter.
(b) The required records are:
(1) Records, such as bills of sale, invoices, bills of lading, and
receiving and shipping papers, giving the following information with
respect to each transaction in which any poultry or poultry carcass, or
part or product of a poultry carcass, is purchased, sold, shipped,
received, transported, or otherwise handled by said person in connection
with any business subject to the Act.
(i) The name or description of the poultry or other articles;
(ii) The net weight of the poultry or other articles;
(iii) The number of outside containers;
(iv) The name and address of the buyer of the poultry or other
articles sold by such person, and the name and address of the seller of
the poultry or other articles purchased by such person;
(v) The name and address of the consignee or receiver (if other than
the buyer);
(vi) The method of shipment;
(vii) The date of shipment; and
(viii) The name and address of the carrier.
(2) Guaranties provided by suppliers of packaging materials under
Sec. 381.144.
(3) Records of canning as required by subpart X of this part 381, of
subchapter C, 9 CFR chapter III.
(4) Records of irradiation as required by sections 381.149 of this
part.
(5) Records of nutrition labeling as required by subpart Y of this
part.
(6) Records of all labeling, along with the product formulation and
processing procedures, as prescribed in Secs. 381.132 and 381.133.
(Approved by the Office of Management and Budget under control number
0583-0015)
[37 FR 9706, May 16, 1972, as amended at 47 FR 746, Jan. 7, 1982; 49 FR
2236, Jan. 19, 1984; 51 FR 45633, Dec. 19, 1986; 57 FR 43600, Sept. 21,
1992; 58 FR 675, Jan. 6, 1993; 60 FR 67458, Dec. 29, 1995]
[[Page 515]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.176]
[Page 515]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Q--Records, Registration, and Reports
Sec. 381.176 Place of maintenance of records.
Every person engaged in any business described in Sec. 381.175(a)
shall maintain the records required by Sec. 381.175 at the place of
business where such business is conducted, except that, if such person
conducts such business at multiple locations, he may maintain such
records at his headquarters' office. When not in actual use, all such
records shall be kept in a safe place at the prescribed location in
accordance with good commercial practices.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.177]
[Page 515]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Q--Records, Registration, and Reports
Sec. 381.177 Record retention period.
(a) Every record required to be maintained under this subpart shall
be retained for a period not to exceed 2 years after December 31 of the
year in which the transaction to which the record relates has occurred,
and for such further period as the Administrator may require for
purposes of any investigation or litigation under the Act, by written
notice to the person required to keep such record under this subpart.
(b) Records of canning as required by subpart X of this part 381,
subchapter C, 9 CFR chapter III, shall be retained as required in
Sec. 381.307; except that records required by Sec. 381.302 (b) and (c)
shall be retained as required by those sections.
[37 FR 9706, May 16, 1972, as amended at 51 FR 45633, Dec. 19, 1986]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.178]
[Page 515]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Q--Records, Registration, and Reports
Sec. 381.178 Access to and inspection of records, facilities and inventory; copying and sampling.
Every person within any of the classes specified in Sec. 381.175(a)
shall, upon the presentation of official credentials by any authorized
representative of the Secretary, during ordinary business hours, permit
such representative to enter his or its place of business and examine
the records required to be kept by Sec. 381.175(b) and the facilities
and inventory pertaining to the business of such person subject to the
Act, and to copy all such records, and to take reasonable samples of the
inventory upon payment of the fair market value therefor. Any necessary
facilities (other than reproduction equipment) for such examination and
copying of records and for such examination and sampling of inventory
shall be afforded to such authorized representative of the Secretary.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.179]
[Page 515-516]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Q--Records, Registration, and Reports
Sec. 381.179 Registration.
(a) Except as provided in paragraph (c) of this section, every
person that engages in business, in or for commerce, as a poultry
products broker, renderer, or animal food manufacturer, or engages in
business in commerce as a wholesaler of any carcasses, or parts or
products of the carcasses, of any poultry, whether intended for human
food or other purposes, or engages in the business as a public
warehouseman storing any such articles in or for commerce, or engages in
the business of buying, selling, or transporting in commerce, or
importing, any dead, dying, disabled, or diseased poultry, or parts of
the carcasses of any poultry that died otherwise than by slaughter,
shall register with the Administrator, giving such information as is
required, including his name, and the address of each place of business
at which, and all trade names under which he conducts such business.
Such persons shall register under this section by filing with the
Administrator, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250, a form containing such information,
within 90 days after the effective date hereof or after such later date
as he begins to engage in such business if not engaged therein upon said
effective date. All information submitted shall be current and correct.
The registration form shall be obtained from the Compliance Program,
Regulatory Programs, Food Safety and Inspection Service, U.S. Department
of Agriculture, Washington, DC 20250.
(b) Whenever any change is made in the name of, or address of any
place of business at which, or any trade name under which a registrant
conducts his business, he shall report such change in writing to the
Administrator within 15 days after making the change.
(c) The registration requirements prescribed in this section shall
not apply to persons conducting any of the
[[Page 516]]
businesses specified in this section only at an official establishment.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 57 FR
53982, Nov. 16, 1992]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.180]
[Page 516]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Q--Records, Registration, and Reports
Sec. 381.180 Information and reports required from official establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, mandatory
microbiological testing, and other aspects of the operations of the
establishment and the conduct of inspection thereat, as may be required
by the Administrator in special cases.
(b) The operator of each official establishment shall also make such
other reports as the Administrator may from time to time require under
the Act.
[37 FR 9706, May 16, 1972, as amended at 61 FR 38868, July 25, 1996]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.181]
[Page 516]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Q--Records, Registration, and Reports
Sec. 381.181 Reports by consignees of allegedly adulterated or misbranded products; sale or transportation as violations.
Whenever the consignee of any poultry product which bears an
official inspection legend refuses to accept delivery of such product on
the grounds that it is adulterated or misbranded, the consignee shall
notify the appropriate program supervisor, Meat and Poultry Inspection
Program, Food Safety and Inspection Service, U.S. Department of
Agriculture, of the kind, quantity, source and present location of the
product and the respects in which it is alleged to be adulterated or
misbranded, and it will be a violation of the Act for any person to sell
or transport, or offer for sale or transportation or receive for
transportation, in commerce, any such product which is capable of use as
human food and is in fact adulterated or misbranded at the time of such
sale, transportation, offer, or receipt: Provided, That any such
allegedly adulterated or misbranded product may be transported to any
official establishment for reinspection.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.182]
[Page 516]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Q--Records, Registration, and Reports
Sec. 381.182 Reports of inspection work.
Reports of the inspection work carried on within official
establishments shall be forwarded to the Administrator by the inspector
in charge in such a manner as may be specified by the Administrator.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.185]
[Page 516-517]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart R--Cooperation With States and Territories; Certification of
State and Territorial Programs as at Least Equal to Federal Program
Sec. 381.185 Assistance to State and Territorial programs.
(a) The Administrator is authorized, under paragraph (a) of section
5 of the Act, when he determines it would effectuate the purposes of the
Act, to cooperate with any State (including Puerto Rico) or any
organized territory in developing and administering the poultry product
inspection program of such jurisdiction, with a view to assuring that it
imposes and enforces requirements at least equal to those under sections
2 through 4, 6 through 10, and 12 through 22 of the Act, with respect to
establishments at which poultry are slaughtered or poultry products are
processed for use as human food, solely for distribution within such
jurisdiction, and with respect to the poultry products of such
establishments. Such cooperation is authorized if the jurisdiction has
enacted a mandatory law imposing ante mortem and post mortem inspection,
reinspection, and sanitation requirements (at least equal to those under
the Federal Act), with respect to all or certain classes of persons
engaged in slaughtering poultry or otherwise processing poultry products
for use as human food solely for distribution within such jurisdiction.
(b) The Administrator is also authorized under paragraph (a) of
section 5 of the Act, to cooperate with any State (including Puerto
Rico) or any organized territory in developing and administering
programs under the laws of such jurisdiction containing authorities at
least equal to those provided in section 11 of the Act (relating to
records; registration of specified classes of operators; dead, dying,
disabled,
[[Page 517]]
or diseased poultry; and products not intended for human food) when he
determines that such cooperation would effectuate the purposes of the
Act.
(c) Such cooperation may include advisory assistance, technical and
laboratory assistance and training, and financial aid. The Federal
contribution to any State (or territory) for any year shall not exceed
50 percent of the estimated total cost of the cooperative State (or
territorial) program. A cooperative program under this section is called
a State-Federal program.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.186]
[Page 517]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart R--Cooperation With States and Territories; Certification of
State and Territorial Programs as at Least Equal to Federal Program
Sec. 381.186 Cooperation of States and other jurisdictions in Federal programs.
Under the "Talmadge-Aiken Act" of September 28, 1962 (7 U.S.C.
450), the Administrator is authorized under stated conditions to utilize
employees and facilities of any State in carrying out Federal functions
under the Poultry Products Inspection Act. A cooperative program for
this purpose is called a Federal-State program. Under paragraph (a) of
section 5 of the Poultry Products Inspection Act, the Administrator is
also authorized to conduct examinations, investigations, and inspections
under the Act through any officer or employee of any State or territory
or the District of Columbia commissioned by him for such purpose.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.189]
[Page 517]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart S--Transportation; Exportation; or Sale of Poultry or Poultry
Products
Sec. 381.189 Provisions inapplicable to specimens for laboratory examination, etc., or to naturally inedible articles.
The provisions of this subpart do not apply:
(a) To dead, dying, disabled or diseased poultry and specimens of
undenatured, uninspected or adulterated carcasses, parts, or products of
poultry sent to or by the Department of Agriculture or divisions thereof
in Washington, DC, or elsewhere, for laboratory examination, exhibition
purposes, or other official use;
(b) To dead, dying, disabled or diseased poultry and specimens of
undenatured, uninspected or adulterated carcasses, parts, or products of
poultry thereof for educational, research, or other nonfood purposes
shipped under permit issued by the inspector in charge upon his
determination that collection and movement thereof will not interfere
with inspection or sanitary conditions at the establishment, and the
specimens are for nonfood purposes. The person desiring such specimens
shall make a written application to the inspector in charge for such
permit on Form MP-112 and shall obtain permission from the operator of
the official establishment to obtain the specimens. Permits shall be
issued for a period not longer than one year. The permit may be revoked
by the inspector in charge if he determines after notice and opportunity
to present views is afforded to the permittee that any such specimens
were not used as stated in the application, or if the collection or
handling of the specimens interferes with inspection or the maintenance
of sanitary conditions in the establishment. The specimens referred to
in this paragraph shall be collected and handled only at such time and
place and in such manner as not to interfere with the inspection or to
cause any objectionable condition and shall be identified as inedible
when they leave the establishment.
(c) To parts of poultry carcasses that are naturally inedible by
humans, such as entrails and feathers in their natural state.
[40 FR 55310, Nov. 28, 1975]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.190]
[Page 517-518]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart S--Transportation; Exportation; or Sale of Poultry or Poultry
Products
Sec. 381.190 Transactions in slaughtered poultry and other poultry products restricted; vehicle sanitation requirements.
(a) No person shall sell, transport, offer for sale or
transportation, or receive for transportation, in commerce or from any
official establishment, any slaughtered poultry from which the blood,
feathers, feet, head, or viscera have not been removed in accordance
with the regulations.
(b)(1) No person shall sell, transport, offer for sale or
transportation, or receive for transportation, in commerce, any
slaughtered poultry or other poultry product which is capable of use as
human food and is adulterated or fails to bear an official inspection
legend or is otherwise misbranded at the time of
[[Page 518]]
such sale, transportation, offer or receipt, except as otherwise
provided in this paragraph (b) and subpart C or T.
(2)(i) Poultry heads and feet that are collected and handled at an
official establishment in an acceptable manner may be shipped from the
official establishment directly for export as human food, if they have
been examined and found to be suitable for such purpose, by an inspector
and are labeled as prescribed in this paragraph.
(ii) The containers of all such products shall bear a label showing:
(A) The name of the products; (B) the name and address of the packer or
distributor, and, when the name of the distributor is shown, it shall be
qualified by such terms as "packed for," "distributed by," or
"distributors"; and (C) the official establishment number of the
establishment where packed.
(iii) Such products shall not bear the official inspection legend.
(3)(i) Poultry heads and feet that are collected and handled at an
official establishment in an acceptable manner may be shipped from the
official establishment and in commerce directly to another official
establishment for processing before export, provided the receiving
establishment maintains records that:
(A) Identify the source of the incoming undenatured poultry product;
(B) Identify the location of the product at all times during
processing and preparation for export; and
(C) Contain a written certification from an official of the
receiving establishment that the undenatured poultry product intended
for export has not been, and will not be, commingled with any product
intended for consumption in the United States.
(ii) The receiving establishment may only ship the undenatured
poultry product intended for export in accordance with the inspection
and labeling requirements of paragraph (b)(2) of this section.
(c) No person, engaged in the business of buying, selling, freezing,
storing, or transporting, in or for commerce, poultry products capable
of use as human food, or importing such articles, shall transport, offer
for transportation, or receive for transportation, in commerce or in any
State designated under Sec. 381.221, any poultry product which is
capable of use as human food and is not wrapped, packaged, or otherwise
enclosed to prevent adulteration by airborne contaminants, unless the
railroad car, truck, or other means of conveyance in which the product
is contained or transported is completely enclosed with tight fitting
doors or other covers for all openings. In all cases, the means of
conveyance shall be reasonably free of foreign matter (such as dust,
dirt, rust, or other articles or residues), and free of chemical
residues, so that product placed therein will not become adulterated.
Any cleaning compound, lye, soda solution, or other chemical used in
cleaning the means of conveyance must be thoroughly removed from the
means of conveyance prior to its use. Such means of conveyance onto
which product is loaded, being loaded, or intended to be loaded, shall
be subject to inspection by an inspector at any official establishment.
The decision whether or not to inspect a means of conveyance in a
specific case, and the type and extent of such inspection shall be at
the Inspection Service's discretion and shall be adequate to determine
if poultry product in such conveyance is, or when moved could become,
adulterated.
Circumstances of transport that can be reasonably anticipated shall be
considered in making said determination. These include, but are not
limited to, weather conditions, duration and distance of trip, nature of
product covering, and effect of restowage at stops en route. Any means
of conveyance found upon such inspection to be in such condition that
poultry product placed therein could become adulterated shall not be
used until such condition which could cause adulteration is corrected.
Poultry product placed in any means of conveyance that is found by the
inspector to be in such condition that the poultry product may have
become adulterated shall be removed from the means of conveyance and
handled in accordance with Sec. 381.145(b).
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 40 FR
42338, Sept. 12, 1975; 41 FR 23700, June 11, 1976; 60 FR 43358, Aug. 21,
1995]
[[Page 519]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.191]
[Page 519]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart S--Transportation; Exportation; or Sale of Poultry or Poultry
Products
Sec. 381.191 Distribution of inspected products to small lot buyers.
For the purpose of facilitating the distribution in commerce of
inspected poultry products to small lot buyers (such as small
restaurants), distributors or jobbers may remove inspected and passed
non-consumer-packaged poultry carcasses or consumer-packaged poultry
products from shipping containers or immediate containers, other than
consumer packages, and place them into other containers which do not
bear an official inspection mark: Provided, That the individual non-
consumer-packaged carcasses bear the official inspection legend and the
official establishment number of the establishment that processed the
articles; and the consumer-packaged articles are fully labeled in
accordance with subpart N: And provided further, That the other
container is marked with the name and address of the distributor or
jobber and bears the statement "The poultry product contained herein
was inspected by the U.S.D.A." in the case of poultry products
processed in the United States, or the statement "The poultry products
contained herein have been approved for importation under P.P.I.A." in
the case of imported poultry products.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.192]
[Page 519]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart S--Transportation; Exportation; or Sale of Poultry or Poultry
Products
Sec. 381.192 Penalties inapplicable to carriers.
No carrier shall be subject to the penalties of the Act, other than
the penalties for violation of section 11, by reason of his receipt,
carriage, holding, or delivery, in the usual course of business, as a
carrier, of poultry or poultry products, owned by another person, unless
the carrier has knowledge, or is in possession of facts which would
cause a reasonable person to believe that such poultry or poultry
products were not inspected or marked in accordance with the provisions
of the Act or where otherwise not eligible for transportation under the
Act, or unless the carrier refuses to furnish on request of a
representative of the Secretary, the name and address of the person from
whom he received such poultry or poultry products, and copies of all
documents, if any there be, pertaining to the delivery of the poultry or
poultry products to such carrier.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.193]
[Page 519-520]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart S--Transportation; Exportation; or Sale of Poultry or Poultry
Products
Sec. 381.193 Poultry carcasses, etc., not intended for human food.
(a) Except as provided in paragraph (b) of this section, poultry
carcasses, and parts and products thereof, that are not intended for use
as human food may, after they have been denatured as prescribed in
Sec. 381.95, be bought, sold, transported, offered for sale or
transportation, or received for transportation, in commerce, or
imported, even though they do not comply with all the provisions of the
regulations, provided they are marked "Not fit for human food." These
requirements do not apply to parts of poultry carcasses that are
naturally inedible by humans, such as entrails.
(b)(1) Except as provided in paragraphs (b) (2), (3), and (4) of
this section, no animal food processed, in whole or in part, from
materials derived from the carcasses of poultry in an official
establishment or elsewhere, shall be bought, sold, transported, offered
for sale or transportation, or received for transportation in commerce,
or imported, unless:
(i) It is properly identified as animal food;
(ii) It is not represented as being a human food; and
(iii) It has been denatured as prescribed in Sec. 381.95 so as to be
readily distinguishable from an article of human food.
(2) Notwithstanding the provisions of paragraph (b)(1) of this
section, an animal food that consists of less than 5 percent of parts or
products of the carcasses of poultry and that is not represented by
labeling or appearance or otherwise as being a human food or as a
product of the poultry industry need not be denatured in accordance with
Sec. 381.95.
(3) Notwithstanding the provisions of paragraph (b)(1) of this
section, animal food packed in hermetically sealed, retort processed,
conventional retail-size containers, and retail-size packages of semi-
moist animal food need not be denatured in accordance with Sec. 381.95
if the name of the article clearly conveys the article's intended use
for animal food and appears on the label in a conspicuous manner.
(i) Except as provided in paragraph (ii) of paragraph (b)(3) of this
section,
[[Page 520]]
the name of the article must be stated on the label as "Animal Food,"
"Pet Food," or "(name of species) Food" (e.g., "Dog Food" or "Cat
Food"). To be considered conspicuous, the name of the article, wherever
it appears on the label, must be stated in letters at least twice as
high, wide, and thick as the letters indicating the presence in the
article of any ingredients derived from carcasses of poultry.
(ii) Notwithstanding the provisions of paragraph (i) of paragraph
(b)(3) of this section, the article's name may be stated on the label to
show that it is or contains poultry carcass-source material and that the
article is for animals; e.g., "Chicken for Pets" or "Turkey Dinner
for Cats": Provided, That the entire name of the article is stated,
wherever it appears on the label, as an individual, contiguous unit,
whether stated on a single line or more than one line, and the letters
denoting the article's intended use for animal food are at least as
high, wide, and thick as the letters indicating the presence of material
derived from any poultry carcass. However, when the label bears on its
principal display panel a vignette which pictures, in clearly
recognizable form and size, one or more animals of the species for which
the article's name indicates the article is intended, the letters used
to state the article's intended use shall be at least one-half as high,
wide, and thick as the letters used in the article's name or other
letters indicating the presence of material derived from any poultry
carcass, but shall not be less than \1/8\ inch high. The letters used to
state the article's intended use may be separated from the article's
name by the vignette.
(iii) Letters used to denote the intended use of the article must
contrast as markedly with their background as the letters indicating the
presence in the article of poultry carcass-source material contrast with
their background.
(4) The requirements of this part do not apply to livestock or
poultry feed manufactured from processed poultry byproducts (such as
poultry byproduct meal, hydrolyzed poultry feathers, and hydrolyzed
poultry byproducts aggregate), or to processed dry animal food.
[49 FR 47479, Dec. 5, 1984]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.194]
[Page 520-521]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart S--Transportation; Exportation; or Sale of Poultry or Poultry
Products
Sec. 381.194 Transportation and other transactions concerning dead, dying, disabled, or diseased poultry, and parts of carcasses of poultry that died otherwise
than by slaughter.
No person engaged in the business of buying, selling, or
transporting in commerce, or importing any dead, dying, disabled, or
diseased poultry or parts of the carcasses of any poultry that died
otherwise than by slaughter shall:
(a) Sell, transport, offer for sale or transportation or receive for
transportation, in commerce, any dead, dying, disabled, or diseased
poultry, or parts of the carcasses of any poultry that died otherwise
than by slaughter, unless such poultry and parts are consigned and
delivered, without avoidable delay, to establishments of animal food
manufacturers, renderers, or collection stations that are registered as
required by Sec. 381.179, or to official establishments that operate
under Federal inspection, or to establishments that operate under a
State or Territorial inspection system approved by the Secretary as one
that imposes requirements at least equal to the Federal requirements for
purposes of section 5(c) of the Act.
(b) Buy in commerce or import any dead, dying, disabled, or diseased
poultry or parts of the carcasses of any poultry that died otherwise
than by slaughter, unless he is an animal food manufacturer or renderer
and is registered as required by Sec. 381.179, or is the operator of an
establishment inspected as required by paragraph (a) of this section and
such poultry or parts of carcasses are to be delivered to establishments
eligible to receive them under paragraph (a) of this section.
(c) Unload en route to any establishment eligible to receive them
under paragraph (a) of this section, any dead, dying, disabled, or
diseased poultry or parts of the carcasses of any poultry that died
otherwise than by slaughter, which are transported in commerce or
imported by any such person: Provided, That any such dead, dying,
disabled, or diseased poultry, or parts of carcasses may be unloaded
from a means of conveyance en route where necessary in case of a wreck
or otherwise extraordinary emergency, and may be reloaded
[[Page 521]]
into another means of conveyance; but in all such cases, the carrier
shall immediately report the facts by telegraph or telephone to the
Director, Compliance Staff, Meat and Poultry Inspection Program, Food
Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250.
[40 FR 55310, Nov. 28, 1975]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.195]
[Page 521]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.195 Definitions; requirements for importation into the United States.
(a) When used in this part, the following terms shall be construed
to mean:
(1) Import (Imported). To bring within the territorial limits of the
United States whether that arrival is accomplished by land, air, or
water.
(2) For product from eligible countries other than Canada:
(i) Offer(ed) for entry. The point at which the importer presents
the imported product to the Program for reinspection.
(ii) Entry (entered). The point at which imported product offered
for entry receives reinspection and is marked with the official mark of
inspection in accordance with Sec. 327.26 of this part.
(3) For product from Canada:
(i) Offer(ed) for entry from establishments participating in the
"streamlined" inspection procedures. The point at which an official of
the Canadian inspection system contacts the Import Field Office for an
inspection assignment.
(ii) Offer(ed) for entry from nonparticipating establishments. The
point at which the importer presents the imported product to the Program
for reinspection.
(iii) Entry (entered) for product not subject to reinspection. When
the containers or the products themselves if not in containers are
marked with the Canadian export stamp and upon the filing of Customs
Form 7533 at the port of entry or at the nearest customshouse in
accordance with 19 CFR part 123.
(iv) Entry (entered) for product subject to reinspection. When the
containers or the products themselves if not in containers are marked
with the Canadian export stamp and the foreign inspection certificate
accompanying the product is stamped as "Inspected and Passed" by the
import inspector.
(b) No slaughtered poultry, or parts or products thereof, shall be
imported into the United States unless they are healthful, wholesome,
fit for human food, not adulterated, and contain no dye, chemical,
preservative, or ingredient which renders them unhealthful, unwholesome,
adulterated, or unfit for human food and they also comply with the
regulations prescribed in this subpart to assure that they comply with
the standards provided for in the Act: Provided, That the provisions of
this subpart apply to such articles only if they are capable of use as
human food.
(c) Except as provided in Sec. 381.207, slaughtered poultry and
other poultry products may be imported only if they were processed
solely in countries listed in Sec. 381.196(b). Slaughtered poultry may
be imported only if it qualifies as ready-to-cook poultry.
[37 FR 9706, May 16, 1972, as amended at 40 FR 42338, Sept. 12, 1975; 54
FR 41049, Oct. 5, 1989]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.196]
[Page 521-524]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.196 Eligibility of foreign countries for importation of poultry products into the United States.
(a)(1) Whenever it shall be determined by the Administrator that the
system of poultry inspection maintained by any foreign country, with
respect to establishments preparing products in such country for export
to the United States, insures compliance of such establishments and
their poultry products, with requirements equivalent to all the
provisions of the Act and the regulations in this part which are applied
to official establishments in the United States, and their poultry
products, and that reliance can be placed upon certificates required
under this subpart from authorities of such foreign country, notice of
that fact will be given by including the name of such foreign country in
paragraph (b) of this section. Thereafter, poultry products processed in
such establishments which
[[Page 522]]
are certified and approved in accordance with paragraph (a)(3) of this
section shall be eligible, so far as the regulations in this part are
concerned, for importation into the United States from such foreign
country after applicable requirements of this part have been met.
(2) The determination of acceptability of a foreign poultry
inspection system for purposes of this section shall be based on an
evaluation of the foreign program in accordance with the following
requirements and procedures:
(i) The system shall have a program organized and administered by
the national government of the foreign country. The system as
implemented must provide standards equivalent to those of the Federal
system of poultry inspection in the United States with respect to:
(A) Organizational structure and staffing, so as to insure uniform
enforcement of the requisite laws and regulations in all establishments
throughout the system at which poultry products are processed for export
to the United States;
(B) Ultimate control and supervision by the national government over
the official activities of all employees or licensees of the system;
(C) The assignment of competent, qualified inspectors;
(D) Authority and responsibility of national inspection officials to
enforce the requisite laws and regulations governing poultry inspection
and to certify or refuse to certify poultry products intended for
export;
(E) Adequate administrative and technical support;
(F) The inspection, sanitation, quality, species verification, and
residue standards applied to products produced in the United States.
(G) Other requirements of adequate inspection service as required by
the regulations.
(ii) The legal authority for the system and the regulations
thereunder shall impose requirements equivalent to those governing the
system of poultry inspection organized and maintained in the United
States with respect to:
(A) Ante mortem inspection of poultry for slaughter, which shall be
performed by veterinarians or by other employees or licensees of the
system under the direct supervision of veterinarians;
(B) Post mortem inspection of carcasses and parts thereof at time of
slaughter, performed by veterinarians or other employees or licensees of
the system under the direct supervision of veterinarians;
(C) Official controls by the national government over establishment
construction, facilities, and equipment;
(D) Direct and continuous official supervision of slaughtering of
poultry and processing of poultry products, by the assignment of
inspectors to establishments certified under paragraph (a)(3) of this
section to assure that adulterated or misbranded poultry products are
not processed for export to the United States;
(E) Complete separation of establishments certified under
subparagraph (3) of this paragraph from establishments not certified,
and the maintenance of a single standard of inspection and sanitation
throughout all certified establishments;
(F) Requirements for sanitation at certified establishments and for
sanitary handling of poultry products;
(G) Official controls over condemned material until destroyed or
removed and thereafter excluded from the establishment;
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as
set forth in part 417 of this chapter.
(I) Other matters for which requirements are contained in the Act or
the regulations in this part.
(iii) Countries desiring to establish eligibility for importation of
poultry products into the United States may request a determination of
eligibility by presenting copies of the laws and regulations on which
the foreign poultry inspection system is based and such other
information as the Administrator may require with respect to matters
enumerated in paragraphs (a)(2) (i) and (ii). Determination of
eligibility is based on a study of the documents and other information
presented and an initial review of the system in operation by a
representative of the Department using the criteria listed in
[[Page 523]]
paragraphs (a)(2) (i) and (ii) of this section. Maintenance of
eligibility of a country for importation of poultry products into the
United States depends on the results of periodic reviews of the foreign
poultry inspection system in operation by a representative of the
Department, and the timely submission of such documents and other
information related to the conduct of the foreign inspection system as
the Administrator may find pertinent to and necessary for the
determinations required by this section.
(iv) The foreign inspection system must maintain a program to assure
that the requirements referred to in this section, equivalent to those
applicable to the Federal system in the United States, are being met.
The program as implemented must provide for the following:
(A) Periodic supervisory visits by a representative of the foreign
inspection system not less frequently than one such visit per month to
each establishment certified in accordance with paragraph (a)(3) of this
section to assure that requirements referred to in paragraphs
(a)(2)(ii)(A) through (a)(2)(ii)(H) of this section are being met:
Provided, that such visits are not required with respect to any
establishment during a period when the establishment is not operating or
is not engaged in producing products for exportation to the United
States;
(B) Written reports prepared by the representative of the foreign
inspection system who has conducted a supervisory visit, documenting his
or her findings with respect to the requirements referred to in
paragraphs (a)(2)(ii)(A) through (a)(2)(ii)(H) of this section, copies
of which shall be made available to the representative of the Department
at the time of the representative's review upon request by that
representative to a responsible foreign inspection official: Provided,
that such reports are not required during a period when the
establishment is not operating or not engaged in producing products for
exportation to the United States.
(C) Random sampling and testing at the point of slaughter of
carcasses, including internal organs and fat, for residues identified by
the exporting country's inspection authorities or by this Agency as
potential contaminants, in accordance with sampling and analytical
techniques approved by the Administrator: Provided, that such testing is
required only on samples taken of carcasses from which poultry or
poultry products intended for importation into the United States are
produced.
(3) Only those establishments that are determined and certified to
the Department by a responsible official of the foreign poultry
inspection system as fully meeting the requirements of paragraphs (a)(2)
(i) and (ii) of this section are eligible to have their products
imported into the United States. Eligibility of certified establishments
is subject to review by the Department (including observations of the
establishments by Program representatives at times prearranged with the
officials of the foreign inspection system). Certifications of
establishments must be renewed annually. Notwithstanding certification
by a foreign official, the Administrator may, at his discretion,
terminate the eligibility of any foreign establishment for importation
of its poultry products into the United States if he has information
that such establishment does not comply with the requirements listed in
paragraphs (a)(2) (i) and (ii) of this section or if he cannot obtain
current information concerning such establishment. The Administrator
will provide reasonable notice to the foreign government of the proposed
termination of eligibility of any foreign establishment for importation
of its poultry products into the United States unless, in his judgment,
delay in terminating its eligibility could result in the importation of
any adulterated or misbranded poultry products. Certifications of
official establishments by the responsible official of the foreign
poultry inspection system shall be in the following form:
Foreign Official Poultry Establishment Certificate
I hereby certify that the establishment(s) listed below fully
complies (comply) with requirements of (specify foreign country)
equivalent to all the provisions of the Poultry Products Inspection Act
and regulations issued thereunder, which apply to official
establishments in the United States, and their poultry products, as
provided in
[[Page 524]]
Sec. 381.196(a)(2)(i) and (ii) of the poultry products inspection
regulations of the United States.
Control numbers Name Address
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Date------------.
----------------------------
(Signature)
----------------------------
(Official title)
(4) Poultry products from foreign countries not listed in paragraph
(b) of this section are not eligible for importation into the United
States, except as provided by Secs. 381.207 and 381.209. The listing of
any foreign country under this section may be withdrawn whenever it
shall be determined by the Administrator that the system of poultry
inspection maintained by such foreign country does not assure compliance
with requirements equivalent to all the requirements of the Act and the
regulations as applied to official establishments in the United States;
or that reliance cannot be placed upon certificates required under this
subpart from authorities of such foreign country; or that, for lack of
current information concerning the system of poultry inspection being
maintained by such foreign country, such foreign country should be
required to reestablish its eligibility for listing.
(b) It has been determined that poultry products from the following
countries, covered by foreign poultry inspection certificates of the
country of origin as required by Sec. 381.197, are eligible under the
regulations in this subpart for entry into the United States, after
inspection and marking as required by the applicable provisions of this
subpart: \1\
---------------------------------------------------------------------------
\1\ Listing of any country in this section does not relieve the
poultry products of such country from applicable requirements under
other Federal laws.
Canada.
France.
Great Britain.
Hong Kong.
Israel.
Mexico.\2\
---------------------------------------------------------------------------
\2\ May export to the United States only processed poultry products
slaughtered under Federal inspection in the United States or in a
country eligible to export slaughtered poultry products to the United
States.
[37 FR 9706, May 16, 1972, as amended at 43 FR 8117, Feb. 28, 1978; 52
FR 23021, June 17, 1987; 54 FR 41049, Oct. 5, 1989; 54 FR 43951, Oct.
30, 1989; 60 FR 38668, July 28, 1995; 61 FR 38868, July 25, 1996; 64 FR
49645, Sept. 14, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.197]
[Page 524-525]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.197 Imported products; foreign inspection certificates required.
(a) Except as provided in Secs. 381.207 and 381.209, each
consignment containing any slaughtered poultry or other poultry product
consigned to the United States from a foreign country shall be
accompanied with a foreign inspection certificate substantially in the
form illustrated in paragraph (b) of this section.
(b) The form of foreign poultry product inspection certificate shall
be as follows:
Foreign Poultry Product Inspection Certificate
Place___________________________________________________________________
(City)
----------------------------
(Country)
Date____________________________________________________________________
I hereby certify that the poultry products herein described were
derived from poultry which received ante mortem and post mortem
inspections at the time of slaughter; and that such poultry products are
sound, healthful, wholesome, clean and otherwise fit for human food, and
are not adulterated and have not been treated with and do not contain
any dye, chemical, preservative, or ingredient not permitted by the
regulations governing the inspection of poultry and poultry products of
the U.S. Department of Agriculture, filed with me, and that said poultry
products have been handled only in a sanitary manner in this country;
and are otherwise in compliance with requirements at least equal to
those in the Poultry Products Inspection Act and said regulations.
Kind of Product
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Number of pieces or packages Weight
________________________________________________________________________
________________________________________________________________________
[[Page 525]]
________________________________________________________________________
Identification marks on containers______________________________________
Consignor_______________________________________________________________
Address_________________________________________________________________
Consignee_______________________________________________________________
Destination_____________________________________________________________
Shipping marks__________________________________________________________
(Signature)_______________________________________________________
(Name of official of national foreign government authorized to issue
inspection certificates for poultry products exported to the United
States)
(Official title)__________________________________________________
[37 FR 9706, May 16, 1972, as amended at 40 FR 42338, Sept. 12, 1975]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.198]
[Page 525]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.198 Importer to make application for inspection of poultry products offered for entry.
(a) Each person who wishes to offer for entry any slaughtered
poultry or other poultry product shall make application for inspection
to the import supervisor of the import field office at the port where
the poultry product is to be offered for entry, or to the Administrator,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250, as long as possible in advance of the anticipated
arrival of each consignment of such product, except in the case of
poultry product exempted from inspection by Secs. 381.207 or 381.209.
Each application shall state the approximate date on which the
consignment is due to arrive in the United States, the name of the ship
or other carrier transporting it, the name of the country where the
product was processed, the name of the country from which the product
was shipped, the place of destination, the quantity and kind of product,
whether fresh, frozen, cured, or canned, and the point of first arrival
in the United States.
(b) For participating Canadian establishments, an official of the
Canadian meat inspection system shall contact the Import Field Office
for an inspection assignment (see Sec. 301.2(yyy)).
(1) If the Automated Import Information System (AIIS) does not
designate the consignment for reinspection, the consignment may be
transported to its consignee for further distribution.
(2) If the AIIS designates the consignment for reinspection, the
official shall:
(i) Select samples in accordance with USDA sampling tables.
(ii) Identify and place samples in the vehicle for easy removal and
reinspection by a Program import inspector.
(3) In the event that any one of the requirements provided in
paragraph (d)(2) of this section is not met, inspection of the
consignment shall be conduced by a Program import inspector in
accordance with established procedures provided for in the regulations
for other imported products.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 51 FR
37710, Oct. 24, 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. 5,
1989]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.199]
[Page 525-526]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.199 Inspection of poultry products offered for entry.
(a)(1) Except as provided in Secs. 381.198(b)(1) and 381.209 of this
part, and paragraph (c) of this section, all slaughtered poultry and
poultry products offered for entry from any foreign country shall be
reinspected by a Program import inspector before they shall be allowed
entry into the United States.
(2) Every lot of product shall routinely be given visual inspection
for appearance and condition, and checked for certification and label
compliance, except as provided in Sec. 381.198(b)(1).
(3) The computerized Automated Import Information System (AIIS)
shall be consulted for reinspection instructions. The AIIS will assign
inspection levels and procedures based on established sampling plans or
established product and plant history and established sampling plans.
(b) Inspectors may take, without cost to the United States, from
each consignment of poultry products offered for entry, such samples of
the products as are deemed necessary to determine the eligibility of the
products for entry into the commerce of the United States.
(c) Poultry products imported under Sec. 381.207 shall not be
sampled and inspected under this section unless there is reason for
suspecting the presence therein of a substance in violation of that
section, and in such case they shall be sampled and inspected in
accordance with paragraph (a) of this section.
[[Page 526]]
(d) In addition to the provisions specified in paragraphs (a), (b),
and (c) of this section, the following requirements apply to imported
canned product.
(1) Imported canned products are required to be sound, healthful,
properly labeled, wholesome, and otherwise not adulterated at the time
the products are offered for importation into the United States.
Provided other requirements of this part are met, the determination of
the acceptability of the product and the condition of the containers
shall be based on the results of an examination of a statistical sample
drawn from the consignment as provided in paragraph (a) of this section.
If the inspector determines, on the basis of the sample examination,
that the product does not meet the requirements of the Act and
regulations thereunder, the consignment shall be refused entry. However,
a consignment rejected for container defects but otherwise acceptable
may be reoffered for inspection under the following conditions:
(i) If the defective containers are not indicative of an unsafe or
unstable product as determined by the Administrator;
(ii) If the number and kinds of container defects found in the
original sample do not exceed the limits specified for this purpose in
FSIS guidelines; and
(iii) If the defective containers in the consignment have been
sorted out and exported or destroyed under the supervision of an
inspector.
(2) Representative samples of canned product designated by the
Administrator in instructions to inspectors shall be incubated under the
supervision of such inspectors in accordance with Sec. 381.309
(d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii), and
(d)(1)(viii) of this subchapter. The importer or his/her agent shall
provide the necessary incubation facilities in accordance with
Sec. 381.309(d)(1)(i) of this subchapter.
(3) Sampling plans and acceptance levels as prescribed in paragraphs
(d)(1) and (d)(2) of this section may be obtained, upon request, from
International Programs, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250.
[37 FR 9706, May 16, 1972, as amended at 49 FR 36819, Sept. 20, 1984; 51
FR 45633, Dec. 19, 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. 5,
1989]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.200]
[Page 526]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.200 Poultry products offered for entry, retention in customs custody; delivery under bond; movement prior to inspection; handling; facilities and
assistance.
(a) No slaughtered poultry or other poultry product required by this
subpart to be inspected shall be released from customs custody prior to
inspection, but such product may be delivered to the consignee, or his
agent, prior to inspection, if the consignee shall furnish a bond, in
form prescribed by the Secretary of the Treasury, conditioned that the
product shall be returned, if demanded, to the collector of the port
where the same is offered for clearance through the customs.
(b) Except as provided in paragraph (a) of this section, no product
required by this subpart to be inspected shall be moved, prior to
inspection, from the port of arrival where first unloaded, and if
arriving by water, from the wharf where first unloaded at such port, to
any place other than the place designated in accordance with this
subpart as the place where the same shall be inspected; and no product
shall be conveyed in any manner other than in compliance with this
subpart.
(c) The consignee, or his agent, shall furnish such facilities and
shall provide such assistance for handling and marking poultry products
offered for entry as the inspector may require.
[37 FR 9706, May 16, 1972, as amended at 51 FR 37710, Oct. 24, 1986; 54
FR 41050, Oct. 5, 1989; 56 FR 65180, Dec. 16, 1991]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.201]
[Page 526-527]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.201 Means of conveyance and equipment used in handling poultry products offered for entry to be maintained in sanitary condition.
Compartments of steamships, railroad cars, and other means of
conveyance transporting any poultry product to the United States, and
all chutes, platforms, racks, tables, tools, utensils, and all other
devices used in moving and handling any poultry product offered for
entry into the United
[[Page 527]]
States, shall be maintained in a sanitary condition.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.202]
[Page 527-528]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.202 Poultry products offered for entry; reporting of findings to customs; handling of articles refused entry; appeals, how made; denaturing
procedures.
(a)(1) Program inspectors shall report their findings as to any
product which has been inspected in accordance with this part, to the
Director of Customs at the original port of entry.
(2) When product has been identified as "U.S. refused entry," the
inspector shall request the Director of Customs to refuse admission to
such product and to direct that it be exported by the owner or consignee
within the time specified in this section, unless the owner or
consignee, within the specified time, causes it to be destroyed by
disposing of it under the supervision of a Program employee so that the
product can no longer be used as human food, or by converting it to
animal food uses, if permitted by the Food and Drug Administration. The
owner or consignee of the refused entry product shall not transfer legal
title to such product, except to a foreign consignee for direct and
immediate exportation, or an end user, e.g., an animal food manufacturer
or a renderer, for destruction for human food purposes. "Refused
entry" product must be delivered to and used by the manufacturer or
renderer within the 45-day time limit. Even if such title is illegally
transferred, the subsequent purchaser will still be required to export
the product or have it destroyed as specified in the notice under
paragraph (a)(4) of this section.
(3) No lot of product which has been refused entry may be subdivided
during disposition pursuant to paragraph (a)(2) of this section, except
that removal and destruction of any damaged or otherwise unsound product
from a lot destined for reexportation is permitted under supervision of
USDA prior to exportation. Additionally, such refused entry lot may not
be shipped for export from any port other than that through which the
product came into the United States without the expressed consent of the
Administrator, based on full information concerning the product's
disposition, including the name of the vessel and the date of export.
For the purposes of this paragraph, the term "lot" shall refer to that
product identified on MP Form 410 in the original request for inspection
for importation pursuant to Sec. 381.198.
(4) The owner or consignee shall have 45 days after notice is given
by FSIS to the Director of Customs at the original port of entry to take
the action required in paragraph (a)(2) of this section for "refused
entry" product. Extension beyond the 45-day period may be granted by
the Administrator when extreme circumstances warrant it; e.g., a dock
workers' strike or an unforeseeable vessel delay.
(5) If the owner or consignee fails to take the required action
within the time specified under paragraph (a)(4) of this section, the
Department will take such actions as may be necessary to effectuate its
order to have the product destroyed for human food purposes. The
Department shall seek court costs and fees, storage, and proper expenses
in the appropriate forum.
(6) No product which has been refused entry and exported to another
country pursuant to paragraph (a)(2) of this section may be returned to
the United States under any circumstance. Any such product so returned
to the United States shall be subject to administrative detention in
accordance with section 19 of the Act, and seizure and condemnation in
accordance with section 20 of the Act.
(b) Upon the request of the Director of Customs at the port where a
product is offered for clearance through the customs, the consignee of
the product shall, at the consignee's own expense, immediately return to
the Director any product which has been delivered to consignee under
this subpart and subsequently designated "U.S. Refused Entry" or found
in any request not to comply with the requirements in this subpart.
(c) Except as provided in Sec. 381.200(a) or (b), no person shall
remove or cause to be removed from any place designated as the place of
inspection, any poultry product which the regulations in this subpart
require to be marked in any way, unless the same has been
[[Page 528]]
clearly and legibly marked in compliance with this subpart.
(d) Any person receiving inspection service may, if dissatisfied
with any decision of an inspector relating to any inspection, file an
appeal from such decision: Provided, That such appeal is filed within 48
hours from the time the decision was made. Any such appeal from a
decision of an inspector shall be made to his/her immediate supervisor
having jurisdiction over the subject matter of the appeal, and such
supervisor shall determine whether the inspector's decision was correct.
Review of such appeal determination, when requested, shall be made by
the immediate supervisor of the employee of the Department making the
appeal determination. The cost of any such appeal shall be borne by the
appellant if the Administrator determines that the appeal is frivolous.
The charges for such frivolous appeal shall be at the rate of $9.28 per
hour for the time required to make the appeal inspection. The poultry or
poultry products involved in any appeal shall be identified by U.S.
retained tags and segregated in a manner approved by the inspector
pending completion of an appeal inspection.
(e) All condemned carcasses, or condemned parts of carcasses, or
other condemned poultry products, except those condemned for biological
residues, shall be disposed of by one of the following methods, under
the supervision of an inspector of the Inspection Service. (Facilities
and materials for carrying out the requirements in this section shall be
furnished by the official establishments.)
(1) Steam treatment (which shall be accomplished by processing the
condemned product in a pressure tank under at least 40 pounds of steam
pressure) or thorough cooking in a kettle or vat, a sufficient time to
effectively destroy the product for human food purposes and preclude
dissemination of disease through consumption by animals. (Tanks and
equipment used for this purpose or for rendering or preparing inedible
products shall be in rooms or compartments separate from those used for
the preparation of edible products. There shall be no direct connection
by means of pipes, or otherwise, between tanks containing inedible
products and those containing edible products.)
(2) Incineration or complete destruction by burning.
(3) Chemical denaturing, which shall be accomplished by the liberal
application to all carcasses and parts thereof, of:
(i) Crude carbolic acid,
(ii) Kerosene, fuel oil, or used crankcase oil, or
(iii) Any phenolic disinfectant conforming to commercial standards
CS 70-41 or CS 71-41 which shall be used in at least 2 percent emulsion
or solution.
(4) Any other substances or method that the Administrator approves
in specific cases, which will denature the poultry product to the extent
necessary to accomplish the purposes of this section.
(5) Carcasses and parts of carcasses condemned for biological
residue shall be disposed of in accordance with paragraph (e)(2) of this
section or by burying under the supervision of an inspector.
[37 FR 9706, May 16, 1972, as amended at 48 FR 15890, Apr. 13, 1983; 50
FR 19908, May 13, 1985; 51 FR 37709, Oct. 24, 1986; 53 FR 17015, May 13,
1988; 54 FR 50735, Dec. 11, 1989; 60 FR 67458, Dec. 29, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.203]
[Page 528]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.203 Products offered for entry; charges for storage, cartage, and labor with respect to products which are refused entry.
All charges for storage, cartage, and labor with respect to any
product offered for entry which is refused entry pursuant to the
regulations shall be paid by the owner or consignee and, in default of
such payment, shall constitute a lien against any other products offered
for entry thereafter by or for such owner or consignee.
[54 FR 41050, Oct. 5, 1989]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.204]
[Page 528-530]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.204 Marking of poultry products offered for entry; official import inspection marks and devices.
(a) Except for products offered for entry from Canada, poultry
products which upon reinspection are found to be acceptable for entry
into the United States shall be marked with the official inspection
legend shown in paragraph (b) of this section. Such inspection legend
shall be placed upon such
[[Page 529]]
products only after completion of official import inspection and product
acceptance.
(b) The official mark for marking poultry products offered for entry
as "U.S. inspected and passed" shall be in the following form, and any
device approved by the Administrator for applying such mark shall be an
official device.\2\
---------------------------------------------------------------------------
\2\ The number "I-42" is given as an example only. The
establishment number of the official establishment or official import
inspection establishment where the product was inspected shall be shown
on each stamp impression.
[GRAPHIC] [TIFF OMITTED] TC11SE91.044
Figure 1
(c) When products are refused entry into the United States, the
official mark to be applied to the products refused entry shall be in
the following form:
[GRAPHIC] [TIFF OMITTED] TC11SE91.045
Figure 2
(d) The import warning notice prescribed in Sec. 381.200(c) is an
official mark.
(e) The ordering and manufacture of brands shall be in accordance
with the provisions contained in Sec. 317.3(c) of the Federal meat
inspection regulations.
(f) The inspection legend may be placed on containers of product
before completion of official import inspection if the containers are
being inspected by an import inspector who reports to an Import Field
Office Supervisor, the product is not required to be held at the
establishment pending the receipt of laboratory test results; and a
written procedure for controlled stamping, submitted by the import
establishment and approved by the Director, Import Inspection Division,
is on file at the import inspection facility where the inspection is to
be performed.
(1) The written procedure for controlled pre-stamping should be in
the form of a letter and shall include the following:
(i) That stamping under this subpart will be limited to those lots
of product which can be inspected on the day that certificates for the
product are examined;
(ii) That all products which have been pre-stamped will be stored in
the facility where the import inspection will occur;
(iii) That inspection marks applied under this part will be removed
from any lot of product subsequently refused entry on the day the
product is rejected; and
(iv) That the establishment will maintain a daily stamping log
containing the following information for each lot of product: the date
of inspection, the country of origin, the foreign establishment number,
the product name, the number of units, the shipping container marks, and
the MP-410 number covering the product to be inspected. The daily
stamping log must be retained by the establishment in accordance with
the requirements of Sec. 381.177.
(2) An establishment's controlled pre-stamping privilege may be
cancelled orally or in writing by the inspector who is supervising its
enforcement whenever the inspector finds that the establishment has
failed to comply with the provisions of this subpart or any conditions
imposed pursuant thereto. If the cancellation is oral, the decision and
the reasons therefor shall
[[Page 530]]
be confirmed in writing, as promptly as circumstances allow. Any person
whose controlled pre-stamping privilege has been cancelled may appeal
the decision to the Administrator, in writing, within ten (10) days
after receiving written notification of the cancellation. The appeal
shall state all of the facts and reasons upon which the person relies to
show that the controlled pre-stamping was wrongfully cancelled. The
Administrator shall grant or deny the appeal, in writing, stating the
reasons for such decision, as promptly as circumstances allow. If there
is a conflict as to any material fact, a hearing shall be held to
resolve such conflict. Rules of practice concerning such a hearing will
be adopted by the Administrator. The cancellation of the controlled pre-
stamping privilege will be in effect until there is a final
determination in the proceeding.
(Approved by the Office of Management and Budget under control number
0583-0015)
[51 FR 37710, Oct. 24, 1986, as amended at 53 FR 17015, May 13, 1988; 54
FR 41050, Oct. 5, 1989]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.205]
[Page 530]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.205 Labeling of immediate containers of poultry products offered for entry.
(a) Immediate containers of poultry products imported into the
United States shall bear a label printed in English showing in
accordance with subpart N of this part all information required by that
section (except that the inspection mark and establishment number
assigned by the foreign poultry inspection system and certified to the
Inspection Service shall be shown instead of the official dressed
poultry identification mark or other official inspection legend, and
official establishment number); and in addition the label shall show the
name of the country of origin preceded by the words "Product of,"
which statement shall appear immediately under the name of the product.
(b) The labels shall not be false or misleading in any respect.
(c) All marks and other labeling for use on or with immediate
containers shall be approved for use by the Food Safety and Inspection
Service in accordance with Secs. 381.132 and 381.133 before products
bearing such marks and other labeling will be permitted for entry into
the United States.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 54 FR
41050, Oct. 5, 1989; 60 FR 67458, Dec. 29, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.206]
[Page 530]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.206 Labeling of shipping containers of poultry products offered for entry.
Shipping containers of imported poultry products are required to
bear in a prominent and legible manner the name of the product, the name
of the country of origin, the foreign inspection system establishment
number of the establishment in which the product was processed, and the
inspection mark of the country of origin. Labeling on shipping
containers shall be examined at the time of inspection in the United
States and if found to be false or misleading, the product shall be
refused entry. All labeling used with a shipping container of imported
poultry products must be approved in accordance with subpart N of this
part.
[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989; 60
FR 67458, Dec. 29, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.207]
[Page 530-531]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.207 Small importations for consignee's personal use, display, or laboratory analysis.
Any poultry product (other than one which is forbidden entry by
other Federal law or regulation) from any country in quantities of less
than 50 pounds net weight, exclusively for the personal use of the
consignee, or for display or laboratory analysis by the consignee, and
not for sale or distribution; which is sound, healthful, wholesome, and
fit for human food, and which is not adulterated and contains no
substance not permitted by the Act or regulations, may be imported into
the United States without a foreign inspection certificate, and such
product is not required to be inspected upon arrival in the United
States and may be shipped to the consignee without further restriction
under this part, except as provided in Sec. 381.199(c): And provided,
That the Department may with respect to any specific importation,
require that the consignee certify that such product is exclusively for
the personal use of
[[Page 531]]
said consignee, or for display or laboratory analysis by said consignee,
and not for sale or distribution.
[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.208]
[Page 531]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.208 Poultry products offered for entry and entered to be handled and transported as domestic; entry into official establishments; transportation.
(a) All poultry products, after entry into the United States in
compliance with this subpart, shall be deemed and treated and, except as
provided in Sec. 381.207, shall be handled and transported as domestic
products, and shall be subject to the applicable provisions of this part
and to the provisions of the Poultry Products Inspection Act and the
Federal Food, Drug, and Cosmetic Act.
(b) Poultry products entered in accordance with this subpart may,
subject to the provisions of the regulations, be taken into official
establishments and be mixed with or added to poultry products that are
inspected and passed or exempted from inspection in such establishments.
(c) Imported poultry products which have been inspected, passed, and
marked under this subpart may be transported in commerce, only upon
compliance with the applicable regulations.
[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.209]
[Page 531]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart T--Imported Poultry Products
Sec. 381.209 Returned United States inspected and marked poultry products; exemption.
Poultry products which have been inspected and passed by the U.S.
Department of Agriculture and are so marked, and are returned from
foreign countries, may be imported if they are not adulterated or
misbranded at the time of such return. Such products are exempted from
further requirements under this part. Such returned shipments shall be
reported to the Administrator by letter prior to arrival at the United
States port of entry.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.210]
[Page 531]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.210 Poultry and other articles subject to administrative detention.
Any poultry carcass, or part thereof; or any product made wholly or
in part from any poultry carcass or part thereof; or any dead, dying,
disabled, or diseased poultry is subject to detention for a period not
to exceed 20 days when found by any authorized representative of the
Secretary upon any premises where it is held for purposes of, or during
or after distribution in commerce or otherwise subject to the Act, and
there is reason to believe that any such poultry or other article is
adulterated or misbranded and is capable of use as human food or has not
been inspected, in violation of the provisions of the Act, any other
Federal law, or the laws of any State or territory, or the District of
Columbia; or that it has been or is intended to be distributed in
violation of the provisions of the Act, any other Federal law, or the
laws of any State or territory, or the District of Columbia.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.211]
[Page 531]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.211 Method of detention; form of detention tag.
An authorized representative of the Secretary shall detain any
poultry or other article to be detained under this subpart, by affixing
an official "U.S. Detained" tag (FSIS Form 8400-2) to such article.
[55 FR 47843, Nov. 16, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.212]
[Page 531-532]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.212 Notification of detention to the owner of the poultry or other article, or the owner's agent, and person having custody.
(a) When any poultry or other article is detained under this
subpart, an authorized representative of the Secretary shall:
(1) Orally notify the immediate custodian of the poultry or other
article detained, and
(2) Promptly furnish a copy of a completed "Notice of Detention"
(FSIS Form 8080-1) to the immediate custodian of the detained poultry or
other article.
[[Page 532]]
(b) If the owner of the detained poultry or other article, or the
owner's agent, is not the immediate custodian at the time of detention
and if the owner, or owner's agent, can be ascertained and notified, an
authorized representative of the Secretary shall furnish a copy of the
completed "Notice of Detention" to the owner, or the owner's agent.
Such copy shall be served, as soon as possible, by delivering the
notification to the owner, or the owner's agent, or by certifying and
mailing the notification to the owner, or the owner's agent, at his or
her last known residence or principal office or place of business.
[55 FR 47843, Nov. 16, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.213]
[Page 532]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.213 Notification of governmental authorities having jurisdiction over article detained; form of written notification.
Within 48 hours after the detention of any poultry or other article
pursuant to Sec. 381.211, an authorized representative of the Secretary
shall give oral or written notification of such detention to any Federal
authorities not connected with the Inspection Service, and any State or
other governmental authorities, having jurisdiction over such article.
In the event notification is given orally, it shall be confirmed in
writing, as promptly as circumstances permit.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.214]
[Page 532]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.214 Movement of poultry or other article detained; removal of official marks.
(a) No poultry or other article detained in accordance with the
provisions in this subpart shall be moved by any person from the place
at which it is located when so detained, until released by an authorized
representative of the Secretary: Provided, That any such article may be
moved from the place at which it is located when so detained, for
refrigeration or freezing, or storage purposes if such movement has been
approved by an authorized representative of the Secretary and the
article so moved will be further detained by an authorized
representative of the Secretary after such movement.
(b) Upon terminating the detention of such article, an authorized
representative of the Secretary shall:
(1) Orally notify the immediate custodian of the released article,
and
(2) Furnish copies of a completed "Notice of Termination of
Detention" (FSIS Form 8400-1) to the persons notified when the article
was detained. The notice shall be served by either delivering the notice
to such persons or by certifying and mailing the notice to such persons
at their last known residences or principal offices or places of
business.
(c) All official marks may be required by such representative to be
removed from such article before it is released unless it appears to the
satisfaction of the representative that the article is eligible to
retain such marks.
[37 FR 9706, May 16, 1972, as amended at 55 FR 47843, Nov. 16, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.215]
[Page 532]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.215 Poultry or other articles subject to judicial seizure and condemnation.
Any poultry carcass, or part thereof, or any product made wholly or
in part from any poultry carcass or part thereof; except those exempted
from the definition of a poultry product in Sec. 381.15, or any dead,
dying, disabled, or diseased poultry, that is being transported in
commerce or is otherwise subject to the Act, or is held for sale in the
United States after such transportation, is subject to seizure and
condemnation, in a judicial proceeding pursuant to section 20 of the Act
if such poultry or other article:
(a) Is or has been processed, sold, transported, or otherwise
distributed or offered or received for distribution in violation of the
Act; or
(b) Is capable of use as human food and is adulterated or
misbranded; or
(c) In any other way is in violation of the Act.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.216]
[Page 532]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.216 Procedure for judicial seizure, condemnation, and disposition.
Any poultry or other article subject to seizure and condemnation
under this subpart is liable to be proceeded against and seized and
condemned, and disposed of, at any time, on an appropriate pleading in
any U.S. district court, or other proper court specified in section 21
of the Act, within the jurisdiction of which the article is found.
[[Page 533]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.217]
[Page 533]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.217 Authority for condemnation or seizure under other provisions of law.
The provisions of this subpart relating to detention, seizure,
condemnation and disposition of poultry or other articles do not
derogate from authority for retention, condemnation, or seizure
conferred by other provisions of the Act, or other laws.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.218]
[Page 533]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart U--Detention; Seizure and Condemnation; Criminal Offenses
Sec. 381.218 Criminal offenses.
The Act contains criminal provisions with respect to numerous
offenses specified in the Act, including but not limited to forcible
assaults on, or other interference with, any person while engaged in, or
on account of the performance of, his official duties under the Act.
Criminal provisions with respect to gifts or offers of bribes to such
persons and related offenses are contained in the general criminal code
(18 U.S.C. 201).
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.220]
[Page 533]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart V--Special Provisions for Designated States and Territories;
Sec. 381.220 Definition of "State".
Criteria and Procedure for Designating Establishments With Operations
Which Would Clearly Endanger the Public Health; Disposition of Poultry
Products Therein
For purposes of this subpart, the term "State" means any State
(including the Commonwealth of Puerto Rico) or organized territory.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.221]
[Page 533]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart V--Special Provisions for Designated States and Territories;
Sec. 381.221 Designation of States under paragraph 5(c) of the Act.
Each of the following States has been designated, under paragraph
5(c) of the Act, as a State in which the provisions of sections 1
through 4, 6 through 10, and 12 through 22 of the Act shall apply to
operations and transactions wholly within the State. The Federal
provisions apply, effective on the dates shown below:
------------------------------------------------------------------------
Effective date of
States application of Federal
provisions
------------------------------------------------------------------------
Alaska.................................... July 31, 1999.
Arkansas.................................. Jan. 2, 1971.
California................................ Apr. 1, 1976.
Colorado.................................. Jan. 2, 1971.
Connecticut............................... Oct. 1, 1975.
Florida................................... Dec. 2, 1997.
Georgia................................... Jan. 2, 1971.
Guam...................................... Jan. 21, 1972.
Hawaii.................................... Nov. 1, 1995.
Idaho..................................... Jan. 2, 1971.
Kentucky.................................. July 28, 1971.
Maryland.................................. Mar. 31, 1991.
Massachusetts............................. Jan. 12, 1976.
Michigan.................................. Jan. 2, 1971.
Nebraska.................................. July 28, 1971.
Nevada.................................... July 1, 1973.
New Hampshire............................. Aug. 6, 1978
New Jersey................................ Do.
New York.................................. Apr. 10, 1977.
North Dakota.............................. Jan. 2, 1971.
Northern Mariana Islands.................. Oct. 29, 1979.
Oregon.................................... Jan. 2, 1971.
Pennsylvania.............................. Oct. 31, 1971.
Puerto Rico............................... Jan. 17, 1972.
Rhode Island.............................. Oct. 1, 1981.
South Dakota.............................. Jan. 2, 1971.
Tennessee................................. Oct. 1, 1975.
Virgin Islands............................ Nov. 27, 1971.
Washington................................ June 1, 1973.
------------------------------------------------------------------------
[42 FR 2949, Jan. 14, 1977, as amended at 42 FR 13270, Mar. 10, 1977; 43
FR 29269, July 7, 1978; 44 FR 55809, Sept. 28, 1979; 46 FR 43829, Sept.
1, 1981; 53 FR 20101, June 2, 1988; 55 FR 36609, Sept. 6, 1990; 56 FR
8909, Mar. 4, 1991; 60 FR 49495, Sept. 26, 1995; 60 FR 54414, Oct. 24,
1995; 62 FR 61010, Nov. 14, 1997; 64 FR 37667, July 13, 1999; 65 FR
6887, Feb. 11, 2000; 66 FR 2207, Jan. 11, 2001; 67 FR 61768, Oct. 2,
2002]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.222]
[Page 533-535]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart V--Special Provisions for Designated States and Territories;
Sec. 381.222 States designated under paragraph 5(c) of the Act; application of regulations.
The provisions of the regulations in this part apply to operations
and transactions wholly within each State designated in Sec. 381.221
under paragraph 5(c) of the Act, except as otherwise provided in this
section. (The provisions of the regulations apply in all respects to
operations and transactions in or for commerce.)
(a) Each establishment located in such a designated State, shall be
granted inspection required under Sec. 381.6(b) only if it is found,
upon a combined evaluation of its premises, facilities, and operating
procedures, to be capable of producing products that are not adulterated
or misbranded.
(b) Section 381.26 will apply to establishments required to have
inspection under Sec. 381.6(b), except that existing interconnections
between official and unofficial establishments or between
[[Page 534]]
official establishments will be permitted if it is determined in
specific cases that the interconnections are such that transfer of
inedible poultry product into the official establishment would be
difficult or unusual, and any such transfers are strictly prohibited,
except as permitted under other provisions of the regulations. It is
essential that separation of facilities be maintained to the extent
necessary to assure that inedible poultry product does not enter the
official establishment contrary to the regulations.
(c) Sections 381.49 and 381.51 shall apply to such establishments,
except that separate facilities for men and women workers will not be
required when the majority of the workers in the establishment are
related by blood or marriage, provided that this will not conflict with
municipal or State requirements; and except that separation of toilet
soil lines from house drainage lines to a point outside the buildings
will not be required in existing construction when positive acting
backflow devices are installed.
(d) Subpart N of this part shall apply to such establishments except
as provided in this paragraph (d).
(1) The operator of each such establishment shall, prior to the
inauguration of inspection, identify all labeling and marking devices in
use, or proposed for use (upon the date of inauguration of inspection)
to the Circuit Supervisor in which the establishment is located.
Temporary approval, pending formal approval under Sec. 381.132, will be
granted by the Circuit Supervisor for labeling and marking devices that
he determines are neither false nor misleading, provided the official
inspection legend bearing the official establishment number is applied
to the principal display panel of each label, either by a mechanical
printing device or a self-destructive pressure sensitive sticker, and
provided the label shows the true product name, an accurate ingredient
statement, the name and address of the manufacturer, packer, or
distributor, and any other features required by paragraph 4(h) of the
Act.
(2) The Circuit Supervisor will forward one copy of each item of
labeling and a description of each marking device for which he has
granted temporary approval to the Washington, DC; office of the Labels
and Packaging Staff and will retain one copy in a temporary approval
file for the establishment.
(3) The operator of the official establishment shall promptly
forward a copy of each item of labeling and a description of each
marking device for which temporary approval has been granted by the
Circuit Supervisor (showing any modifications required by the Circuit
Supervisor) to the Labels and Packaging Staff, Meat and Poultry
Inspection Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250, accompanied by the formula and
details of preparation and packaging for each product. Within 90 days
after inauguration of inspection, all labeling material and marking
devices temporarily approved by the Circuit Supervisor must receive
approval as required by Sec. 381.132 or their use must be discontinued.
(4) The Circuit Supervisor will also review all shipping containers
to insure that they do not have any false or misleading labeling and are
otherwise not misbranded. Modifications of unacceptable information on
labeling material by the use of pressure sensitive tape of a type that
cannot be removed without visible evidence of such removal, or by
blocking out with an ink stamp will be authorized on a temporary basis
to permit the maximum allowable use of all labeling materials on hand.
All unacceptable labeling material which is not modified to comply with
the requirements of the regulations must be destroyed or removed from
the official establishment.
(e) Sections 381.175 through 381.179 apply to operations and
transactions not in or for commerce in a State designated under
paragraph 5(c) only if the State is also designated under section 11 of
the Act and if such provisions are applicable as shown in Sec. 381.224.
(f) Section 381.185(a) will not apply to States designated under
paragraph 5(c) of the Act.
[[Page 535]]
(g) Provisions of this part relating to exports and imports do not
apply to operations and transactions solely in or for intrastate
commerce.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 62 FR
45027, Aug. 25, 1997]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.223]
[Page 535]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart V--Special Provisions for Designated States and Territories;
Sec. 381.223 Control and disposition of nonfederally inspected poultry products in States designated under paragraph 5(c) of the Act.
Upon the effective date of designation of a State under paragraph
5(c) of the Act, no poultry products can be processed within the State
unless they are prepared under inspection pursuant to the regulations or
are exempted from the requirement of inspection under Sec. 381.10, and
no unexempted poultry products which were processed without any
inspection can lawfully be distributed within the State. For a period of
90 days from the effective date of such designation, poultry products
which were processed in any State listed in Sec. 381.187 and inspected
and passed under the supervision of a responsible State or local
inspection agency or exempted from State inspection can be distributed
solely within the State, provided they are not adulterated or
misbranded, except that the official inspection legend shall not be
used. Such products may not enter official establishments. After said
90-day period, only federally inspected and passed products may be
distributed within the designated State, except as provided in
Sec. 381.10.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.224]
[Page 535-536]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart V--Special Provisions for Designated States and Territories;
Sec. 381.224 Designation of States under section 11 of the Act; application of sections of the Act and the regulations.
Each of the following States has been designated, effective on the
date shown below, under section 11 of the Act, as a State in which the
provisions of the sections of the Act and regulations specified below
shall apply to operators engaged, other than in or for commerce, in the
kinds of business indicated below:
----------------------------------------------------------------------------------------------------------------
Paragraphs of act and regulations Classes of operators State Effective date
----------------------------------------------------------------------------------------------------------------
Act, 11(b): Secs. 381.175- Persons engaged (not in or for Alaska............... July 31, 1999.
381.178. commerce) in (1) the business of Arkansas............. Apr. 1, 1976.
slaughtering any poultry or California........... July 1, 1975.
processing, freezing, packaging, Colorado............. Oct. 1, 1975.
or labeling any poultry Connecticut.......... Nov. 12, 1976.
carcasses, or parts or products Georgia.............. Nov. 19, 1976.
thereof, for use as human food Guam................. Nov. 12, 1976.
or animal food; (2) the business Idaho................ Apr. 18, 1973.
of buying or selling (as a Kentucky............. Nov. 12, 1976.
poultry products broker, Maryland............. Jan. 12, 1976.
wholesaler, or otherwise), Massachusetts........ Nov. 12, 1976.
transporting or storing any Michigan............. Jan. 31, 1975.
poultry carcasses, or parts or Nebraska............. Jan. 31, 1975.
products thereof; or (3) Nevada............... Oct. 29, 1979.
business as a renderer or in the New Hampshire........ July 1, 1975.
business of buying, selling, or New Jersey........... July 16, 1975.
transporting any dead, dying, New York............. July 23, 1973.
disabled, or diseased poultry or North Dakota......... Oct. 29, 1979.
parts of carcasses of any Northern Mariana Jan. 31, 1975.
poultry that died otherwise than Islands.
by slaughter. Oregon............... May 2, 1974.
Pennsylvania......... Nov. 19, 1976.
Puerto Rico.......... Mar. 29, 1982.
Rhode Island......... Nov. 12, 1976.
South Dakota......... Oct. 1, 1975.
Tennessee............ Nov. 19, 1976.
Virgin Islands....... Jan. 31, 1975.
Washington........... Nov. 12, 1976.
[[Page 536]]
Act, 11(c); Sec. 381.179........ Persons engaged (not in or for Alaska............... July 31, 1999.
commerce) in business as a Arkansas............. Apr. 1, 1976.
poultry products broker; California........... July 1, 1975.
renderer; animal food Colorado............. Oct. 1, 1975.
manufacturer; wholesaler or Connecticut.......... Nov. 12, 1976.
public warehouseman of poultry Georgia.............. Nov. 19, 1976.
carcasses, or parts or products Guam................. Nov. 12, 1976.
thereof; or buying, selling, or Idaho................ Apr. 18, 1973.
transporting dead, dying, Kentucky............. Nov. 12, 1976.
disabled, or diseased poultry or Maryland............. Jan. 12, 1976.
parts of carcasses of any Massachusetts........ Nov. 12, 1976.
poultry that died otherwise than Michigan............. Jan. 31, 1975.
by slaughter. Nebraska............. Jan. 31, 1975.
Nevada............... Oct. 29, 1979.
New Hampshire........ July 1, 1975.
New Jersey........... July 16, 1975.
New York............. July 23, 1973.
North Dakota......... Oct. 29, 1979.
Northern Mariana Jan. 31, 1975.
Islands.
Oregon............... May 2, 1974.
Pennsylvania......... Nov. 19, 1976.
Puerto Rico.......... Mar. 29, 1982.
Rhode Island......... Nov. 12, 1976.
South Dakota......... Oct. 1, 1975.
Tennessee............ Nov. 19, 1976.
Virgin Islands....... Jan. 31, 1975.
Washington........... Nov. 12, 1976.
Act, 11(d); 381.194.............. Persons engaged (not in or for Alaska............... July 31, 1999.
commerce) in the business of Arkansas............. Nov. 12, 1976.
buying, selling or transporting Georgia.............. Nov. 19, 1976.
any dead, dying, disabled or Guam................. Nov. 12, 1976.
diseased poultry, or parts or Idaho................ Nov. 12, 1976.
carcasses of any poultry that Maryland............. Nov. 12, 1976.
died otherwise than by slaughter. Michigan............. Oct. 29, 1979.
New Hampshire........ Oct. 29, 1979.
Northern Mariana Nov. 19, 1976.
Islands.
Puerto Rico.......... Mar. 29, 1982.
Rhode Island......... Nov. 12, 1976.
South Dakota......... Nov. 19, 1976.
Virgin Islands....... Nov. 12, 1976.
----------------------------------------------------------------------------------------------------------------
[37 FR 9706, May 16, 1972; 65 FR 6888, Feb. 11, 2000]
Editorial Note: For Federal Register citations affecting
Sec. 381.224, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.225]
[Page 536-538]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart V--Special Provisions for Designated States and Territories;
Sec. 381.225 Criteria and procedure for designating establishments with operations which would clearly endanger the public health; disposition of poultry
products therein.
(a) An establishment in any State not listed in Sec. 381.221 that is
preparing poultry products solely for distribution within such State
shall be designated as one producing adulterated products which would
clearly endanger the public health, if:
(1) Any poultry product processed at the establishment is
adulterated in any of the following respects:
(i) It bears or contains a pesticide chemical, food additive, or
color additive, that is "unsafe" within the meaning of section 408,
409, or 706 of the Federal Food, Drug, and Cosmetic Act or was
intentionally subjected to radiation in a manner not permitted under
section 409 of said Act; or if it bears or contains any other added
poisonous or
[[Page 537]]
added deleterious substance which may render it injurious to health or
make it unfit for human food; or
(ii) It consists in whole or in part of any filthy, putrid or
decomposed substance or is for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food (for example, it was
prepared from a poultry carcass or other ingredients exhibiting spoilage
characteristics); or it is, or was prepared from, a poultry carcass
which would be required to be condemned under subpart K at official
establishments; or
(iii) It has been prepared, packed or held under insanitary
conditions whereby it may have become contaminated with filth or may
have been rendered injurious to health (for example, if insects or
vermin are not effectively controlled at the establishment, or
insanitary water is used in preparing poultry products for human food);
or
(iv) It is, in whole or in part, the product of poultry that died
otherwise than by slaughter; or
(v) Its container is composed, in whole or in part, of any poisonous
or deleterious substance which may render the contents injurious to
health; and
(2) Such adulterated articles are intended to be or are distributed
from the establishment while capable of use as human food.
(b) When any such establishment is identified by an inspector as one
producing adulterated poultry products which would clearly endanger
public health under the criteria in paragraph (a) of this section, the
following procedure will be followed:
(1) The inspector will informally advise the operator of the
establishment concerning the deficiencies found by him and report his
findings to the appropriate Regional Director for the Inspection
Service. When it is determined by the Regional Director that any
establishment preparing poultry products solely for distribution within
any State is producing adulterated poultry products for distribution
within such State which would clearly endanger the public health,
written notification thereof will be issued to the appropriate State
officials, including the Governor of the State and the appropriate
Advisory Committee, for effective action under State or local law to
prevent such endangering of the public health. Such written notification
shall clearly specify the deficiencies deemed to result in the
production of adulterated poultry products and shall specify a
reasonable time for such action under State or local law.
(2) If effective action is not taken under State or local law within
the specified time, written notification shall be issued by the Regional
Director to the operator of the establishment, specifying the
deficiencies involved and allowing him 10 days to present his views or
make the necessary corrections, and notifying him that failure to
correct such deficiencies may result in designation of the establishment
and operator thereof as subject to the provisions of sections 1 through
4, 6 through 10, and 12 through 22 of the Act as though engaged in
commerce.
(3) Thereafter the inspector shall survey the establishment and
designate it if he determines, in consultation with the Regional
Director, that it is producing adulterated poultry products, which would
clearly endanger the public health, and formal notice of such
designation will be issued to the operator of the establishment by the
Regional Director.
(c) Poultry products on hand at the time of designation of an
establishment under this section are subject to retention or detention,
and seizure and condemnation in accordance with Sec. 381.145 or subpart
U of this part: Provided, That poultry products that have been federally
inspected and so identified and that have not been further prepared at
any nonfederally inspected establishment may be released for
distribution if the products appear to be not adulterated or misbranded
at the time of such release.
(d) No establishment designated under this section can lawfully
prepare any poultry products unless it first obtains inspection or
qualifies for exemption under Sec. 381.10 of this subpart. All other
provisions of the regulations shall apply to establishments designated
under this section to the same extent and in the same manner as if
[[Page 538]]
they were engaged in commerce, except that the exceptions provided for
in Sec. 381.222 shall apply to such establishments.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.300]
[Page 538-539]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.300 Definitions.
Source: 51 FR 45634, Dec. 19, 1986, unless otherwise noted.
(a) Abnormal container. A container with any sign of swelling or
product leakage or any evidence that the contents of the unopened
container may be spoiled.
(b) Acidified low acid product. A canned product which has been
formulated or treated so that every component of the finished product
has a pH of 4.6 or lower within 24 hours after the completion of the
thermal process unless data are available from the establishment's
processing authority demonstrating that a longer time period is safe.
(c) Bleeders. Small orifices on a retort through which steam, other
gasses, and condensate are emitted from the retort throughout the entire
thermal process.
(d) Canned product. A poultry food product with a water activity
above 0.85 which receives a thermal process either before or after being
packed in a hermetically sealed container. Unless otherwise specified,
the term "product" as used in this subpart G shall mean "canned
product."
(e) Closure technician. The individual(s) identified by the
establishment as being trained to perform specific container integrity
examinations as required by this subpart and designated by the
establishment to perform such examinations.
(f) Code lot. All production of a particular product in a specific
size container marked with a specific container code.
(g) Come-up time. The elapsed time, including venting time (if
applicable), between the introduction of the heating medium into a
closed retort and the start of process timing.
(h) Critical factor. Any characteristic, condition or aspect of a
product, container, or procedure that affects the adequacy of the
process schedule. Critical factors are established by processing
authorities.
(i) Headspace. That portion of a container not occupied by the
product.
(1) Gross headspace. The vertical distance between the level of the
product (generally the liquid surface) in an upright rigid container and
the top edge of the container (i.e., the flange of an unsealed can, the
top of the double seam on a sealed can, or the top edge of an unsealed
jar).
(2) Net headspace. The vertical distance between the level of the
product (generally the liquid surface) in an upright rigid container and
the inside surface of the lid.
(j) Hermetically sealed containers. Air-tight containers which are
designed and intended to protect the contents against the entry of
microorganisms during and after thermal processing.
(1) Rigid container. A container, the shape or contour of which,
when filled and sealed, is neither affected by the enclosed product nor
deformed by external mechanical pressure of up to 10 pounds per square
inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
(2) Semirigid container. A container, the shape or contour of which,
when filled and sealed, is not significantly affected by the enclosed
product under normal atmospheric temperature and pressure, but can be
deformed by external mechanical pressure of less than 10 pounds per
square inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
(3) Flexible container. A container, the shape or contour of which,
when filled and sealed, is significantly affected by the enclosed
product.
(k) Incubation tests. Tests in which the thermally processed product
is kept at a specific temperature for a specified period of time in
order to determine if outgrowth of microorganisms occurs.
(l) Initial temperature. The temperature, determined at the
initiation of a thermal process cycle, of the contents of the coldest
container to be processed.
(m) Low acid product. A canned product in which any component has a
pH value above 4.6.
[[Page 539]]
(n) Process schedule. The thermal process and any specified critical
factors for a given canned product required to achieve shelf stability.
(o) Process temperature. The minimum temperature(s) of the heating
medium to be maintained as specified in the process schedule.
(p) Process time. The intended time(s) a container is to be exposed
to the heating medium while the heating medium is at or above the
process temperature(s).
(q) Processing authority. The person(s) or organization(s) having
expert knowledge of thermal processing requirements for foods in
hermetically sealed containers, having access to facilities for making
such determinations, and designated by the establishment to perform
certain functions as indicated in this subpart.
(r) Program employee. Any inspector or other individual employed by
the Department or any cooperating agency who is authorized by the
Secretary to do any work or perform any duty in connection with the
Program (see Sec. 301.2(f)).
(s) Retort. A pressure vessel designed for thermal processing of
product packed in hermetically sealed containers.
(t) Seals. Those parts of a semirigid container and lid or of a
flexible container that are fused together in order to hermetically
close the container.
(u) Shelf stability. The condition achieved by application of heat,
sufficient, alone or in combination with other ingredients and/or
treatments, to render the product free of microorganisms capable of
growing in the product at nonrefrigerated conditions (over 50 deg.F or
10 deg.C) at which the product is intended to be held during
distribution and storage. Shelf stability and shelf stable are
synonymous with commercial sterility and commercially sterile,
respectively.
(v) Thermal process. The heat treatment necessary to achieve shelf
stability as determined by the establishment's processing authority. It
is quantified in terms of:
(1) Time(s) and temperature(s); or
(2) Minimum product temperature.
(w) Venting. The removal of air from a retort before the start of
process timing.
(x) Water activity. The ratio of the water vapor pressure of the
product to the vapor pressure of pure water at the same temperature.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.301]
[Page 539-542]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.301 Containers and closures.
(a) Examination and cleaning of empty containers. (1) Empty
containers, closures, and flexible pouch roll stock shall be evaluated
by the establishment to ensure that they are clean and free of
structural defects and damage that may affect product or container
integrity. Such an examination should be based upon a statistical
sampling plan.
(2) All empty containers, closures, and flexible pouch roll stock
shall be stored, handled, and conveyed in such a manner that will
prevent soiling and damage that could affect the hermetic condition of
the sealed container.
(3) Just before filling, rigid containers shall be cleaned to
prevent incorporation of foreign matter into the finished product.
Closures, semirigid containers, preformed flexible pouches, and flexible
pouch roll stock contained in original wrappings do not need to be
cleaned before use.
(b) Closure examinations for rigid containers (cans). (1) Visual
examinations. A closure technician shall visually examine the double
seams formed by each closing machine head. When seam defects (e.g.,
cutovers, sharpness, knocked down flanges, false seams, droops) are
observed, necessary corrective actions, such as adjusting or repairing
the closing machine, shall be taken. In addition to the double seams,
the entire container shall be examined for product leakage or obvious
defects. A visual examination shall be performed on at least one
container from each closing machine head, and the observations, along
with any corrective actions, shall be recorded. Visual examinations
shall be recorded. Visual examinations shall be conducted with
sufficient frequency to ensure proper closure and should be conducted at
least every 30 minutes of continuous closing machine operation.
Additional visual examinations shall be made by the closure technician
at the beginning
[[Page 540]]
of production, immediately following every jam in the closing machine
and after closing machine adjustment (including adjustment for changes
in container size).
(2) Teardown examinations. Teardown examinations of double seams
formed by each closing machine head shall be performed by a closure
technician at a frequency sufficient to ensure proper closure. These
examinations should be made at intervals of not more than 4 hours of
continuous closing machine operation. At least one container from each
closing head shall be examined on the packer's end during each regular
examination period. Examination results along with any necessary
corrective actions, such as adjusting or repairing the closing machine,
shall be promptly recorded by the closure technician. The establishment
shall have container specification guidelines for double seam integrity
on file and available for review by Program employees. A teardown
examination of the can maker's end shall be performed on at least one
container selected from each closing machine during each examination
period except when teardown examinations are made on incoming empty
containers or when, in the case of self-manufactured containers, the
containers are made in the vicinity of the establishment and the
container plant records are made available to Program employees.
Additional teardown examinations on the packer's end should be made at
the beginning of production, immediately following every jam in a
closing machine and after closing machine adjustment (including
adjustment for a change in container size). The following procedures
shall be used in teardown examinations of double seams:
(i) One of the following two methods shall be employed for
dimensional measurements of the double seam.
(a) Micrometer measurement. For cylindrical containers, measure the
following dimensions (Figure 1) at three points approximately 120
degrees apart on the double seam excluding and at least one-half inch
from the side seam juncture:
(1) Double seam length--W;
(2) Double seam thickness--S;
(3) Body hook length--BH; and
(4) Cover hook length--CH.
Maximum and minimum values for each dimensional measurement shall be
recorded by the closure technician.
[GRAPHIC] [TIFF OMITTED] TC11SE91.046
(b) Seamscope or seam projector. Required measurements of the seam
include thickness, body hook, and overlap. Seam thickness shall be
obtained by micrometer. For cylindrical containers, at least two
locations, excluding the side seam juncture, shall be used to obtain the
required measurements.
(ii) Seam tightness. Regardless of the dimensional measurement
method used to measure seam dimensions, at a minimum, the seam(s)
examined shall be stripped to assess the degree of wrinkling.
(iii) Side seam juncture rating. Regardless of the dimensional
measurement method used to measure seam dimensions, the cover hook shall
be stripped to examine the cover hook droop at the juncture for
containers having side seams.
(iv) Examination of noncylindrical containers. Examination of
noncylindrical containers (e.g., square, rectangular, "D"-shaped, and
irregularly-shaped) shall be conducted as described in paragraphs (b)(2)
(i), (ii), and (iii) of this section except that the required
dimensional measurements shall be made on the double seam at the points
listed in
[[Page 541]]
the establishment's container specification guidelines.
(c) Closure examinations for glass containers. (1) Visual
examinations. A closure technician shall visually assess the adequacy of
the closures formed by each closing machine. When closure defects, such
as loose or cocked caps, fractured or cracked containers and low vacuum
jars, are observed, necessary corrective actions, such as adjusting or
repairing the closing machine, shall be taken and recorded. In addition
to the closures, the entire container shall be examined for defects.
Visual examinations shall be made with sufficient frequency to ensure
proper closure and should be conducted at least every 30 minutes of
continuous closing machine operation. Additional visual examinations
shall be made by the closure technician and the observations recorded at
the beginning of production, immediately following every jam in the
closing machine, and after closing machine adjustment (including
adjustment for a change in container size).
(2) Closure examinations and tests. Depending upon the container and
closure, tests shall be performed by a closure technician at a frequency
sufficient to ensure proper closure. These examinations should be made
either before or after thermal processing and at intervals of not more
than 4 hours of continuous closing machine operation. At least one
container from each closing machine shall be examined during each
regular examination period. Examination results along with any necessary
corrective actions, such as adjusting or repairing the closing machine,
shall be promptly recorded by the closure technician. The establishment
shall have specification guidelines for closure integrity on file and
available for review by Program employees. Additional closure
examinations should be made at the beginning of production, immediately
following every jam in the closing machine and after closing machine
adjustment (including adjustment for a change in container size).
(d) Closure examinations for semirigid and flexible containers--(1)
Heat seals--(i) Visual examinations. A closure technician shall visually
examine the seals formed by each sealing machine. When sealing defects
are observed, necessary corrective actions, such as adjusting or
repairing the sealing machine, shall be taken and recorded. In addition
to examining the heat seals, the entire container shall be examined for
product leakage or obvious defects. Visual examinations shall be
performed before and after the thermal processing operation with
sufficient frequency to ensure proper closure. These examinations should
be conducted at least in accordance with a statistical sampling plan.
All defects noted and corrective actions taken shall be promptly
recorded.
(ii) Physical tests. Tests determined by the establishment as
necessary to assess container integrity shall be conducted by the
closure technician at a frequency sufficient to ensure proper closure.
These tests shall be performed after the thermal processing operation
and should be made at least every 2 hours of continuous production. The
establishment's acceptance guidelines for each test procedure shall be
on file and available for review by Program employees. Test results
along with any necessary corrective actions, such as adjusting or
repairing the sealing machine, shall be recorded.
(2) Double seams on semirigid or flexible containers shall be
examined and the results recorded as provided in paragraph (b) of this
section. Any additional measurements specified by the container
manufacturer shall also be made and recorded.
(e) Container coding. Each container shall be marked with a
permanent, legible, identifying code mark. The mark shall, at a minimum,
identify in code the product (unless the product name is lithographed or
printed elsewhere on the container) and the day and year the product was
packed.
(f) Handling of containers after closure. (1) Containers and
closures shall be protected from damage which may cause defects that are
likely to affect the hermetic condition of the containers. The
accumulation of stationary containers on moving conveyors should be
minimized to avoid damage to the containers.
[[Page 542]]
(2) The maximum time lapse between closing and initiation of thermal
processing shall be 2 hours. However, the Administrator may specify a
shorter period of time when considered necessary to ensure product
safety and stability. A longer period of time between closing and the
initiation of thermal processing may be permitted by the Administrator.
(Approved by the Office of Management and Budget under control number
0583-0015)
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.302]
[Page 542]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.302 Thermal processing.
(a) Process schedules. Prior to the processing of canned product for
distribution in commerce, an establishment shall have a process schedule
(as defined in Sec. 381.300(n) of this subpart) for each canned poultry
product to be packed by the establishment.
(b) Source of process schedules. (1) Process schedules used by an
establishment shall be developed or determined by a processing
authority.
(2) Any change in product formulation, ingredients, or treatments
that are not already incorporated in a process schedule and that may
adversely affect either the product heat penetration profile or
sterilization value requirements shall be evaluated by the
establishment's processing authority. If it is determined that any such
change adversely affects the adequacy of the process schedule, the
processing authority shall amend the process schedule accordingly.
(3) Complete records concerning all aspects of the development or
determination of a process schedule, including any associated incubation
tests, shall be made available by the establishment to the Program
employee upon request.
(c) Submittal of process information. (1) Prior to the processing of
canned product for distribution in commerce, the establishment shall
provide the inspector at the establishment with a list of the process
schedules (including alternate schedules) along with any additional
applicable information, such as the retort come-up operating procedures
and critical factors.
(2) Letters or other written communications from a processing
authority recommending all process schedules shall be maintained on file
by the establishment. Upon request by Program employees, the
establishment shall make available such letters or written
communications (or copies thereof). If critical factors are identified
in the process schedule, the establishment shall provide the inspector
with a copy of the procedures for measuring, controlling, and recording
these factors, along with the frequency of such measurements, to ensure
that the critical factors remain within the limits used to establish the
process schedule. Once submitted, the process schedules and associated
critical factors and the procedures for measuring (including the
frequency), controlling, and recording of critical factors shall not be
changed without the prior written submittal of the revised procedures
(including supporting documentation) to the inspector at the
establishment.
(Approved by the Office of Management and Budget under control number
0583-0015)
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.303]
[Page 542-543]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.303 Critical factors and the application of the process schedule.
Critical factors specified in the process schedule shall be
measured, controlled and recorded by the establishment to ensure that
these factors remain within the limits used to establish the process
schedule. Examples of factors that are often critical to process
schedule adequacy may include:
(a) General. (1) Maximum fill-in weight or drained weight;
(2) Arrangement of pieces in the container;
(3) Container orientation during thermal processing;
(4) Product formulation;
(5) Particle size;
(6) Maximum thickness for flexible, and to some extent semirigid
containers during thermal processing;
(7) Maximum pH;
(8) Percent salt;
(9) Ingoing (or formulated) nitrite level (ppm);
(10) Maximum water activity; and
(11) Product consistency or viscosity.
(b) Continuous rotary and batch agitating retorts. (1) Minimum
headspace; and
(2) Retort reel speed.
(c) Hydrostatic retorts. (1) Chain or conveyor speed.
[[Page 543]]
(d) Steam/air retorts. (1) Steam/air ratio; and
(2) Heating medium flow rate.
(Approved by the Office of Management and Budget under control number
0583-0015)
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.304]
[Page 543]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.304 Operations in the thermal processing area.
(a) Posting of processes. Process schedules (or operating process
schedules) for daily production, including minimum initial temperatures
and operating procedures for thermal processing equipment, shall be
posted in a conspicuous place near the thermal processing equipment.
Alternatively, such information shall be available to the thermal
processing system operator and the inspector.
(b) Process indicators and retort traffic control. A system for
product traffic control shall be established to prevent product from
bypassing the thermal processing operation. Each basket, crate or
similar vehicle containing unprocessed product, or at least one visible
container in each vehicle, shall be plainly and conspicuously marked
with a heat sensitive indicator that will visually indicate whether such
unit has been thermally processed. Exposed heat sensitive indicators
attached to container vehicles shall be removed before such vehicles are
refilled with unprocessed product. Container loading systems for
crateless retorts shall be designed to prevent unprocessed product from
bypassing the thermal processing operation.
(c) Initial temperature. The initial temperature of the contents of
the coldest container to be processed shall be determined and recorded
by the establishment at the time the processing cycle begins to assure
that the temperature of the contents of every container to be processed
is not lower than the minimum initial temperature specified in the
process schedule. Thermal processing systems which subject the filled
and sealed containers to water at any time before process timing begins
shall be operated to assure that such water will not lower the
temperature of the product below the minimum initial temperature
specified in the process schedule.
(d) Timing devices. Devices used to time applicable thermal
processing operation functions or events, such as process schedule time,
come-up time and retort venting, shall be accurate to assure that all
such functions or events are achieved. Pocket watches and wrist watches
are not considered acceptable timing devices. Analog and digital clocks
are considered acceptable. If such clocks do not display seconds, all
required timed functions or events shall have at least a 1-minute safety
factor over the specified thermal processing operation times.
Temperature/time recording devices shall correspond within 15 minutes to
the time of the day recorded on written records required by
Sec. 381.306.
(e) Measurement of pH. Unless other methods are approved by the
Administrator, potentiometric methods using electronic instruments (pH
meters) shall be used for making pH determinations when a maximum pH
value is specified as a critical factor in a process schedule.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.305]
[Page 543-555]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.305 Equipment and procedures for heat processing systems.
(a) Instruments and controls common to different thermal processing
systems--(1) Indicating temperature devices. Each retort shall be
equipped with at least one indicating temperature device that measures
the actual temperature within the retort. The indicating temperature
device, not the temperature/time recording device, shall be used as the
reference instrument for indicating the process temperature.
(i) Mercury-in-glass thermometers. A mercury-in-glass thermometer
shall have divisions that are readable to 1 deg.F (or 0.5 deg.C) and
whose scale contains not more than 17 deg.F/inch (or 4.0 deg.C/cm) of
graduated scale. Each mercury-in-glass thermometer shall be tested for
accuracy against a known accurate standard upon installation and at
least once a year to ensure its accuracy. Records that specify the date,
standard used, test method, and the person or testing authority
performing the test shall be maintained on file by the establishment and
made available to Program employees. A mercury-in-glass thermometer that
has a divided mercury column or that cannot be adjusted to
[[Page 544]]
the standard shall be repaired and tested for accuracy before further
use, or replaced.
(ii) Other devices. Temperature-indicating devices used in lieu of
mercury-in-glass thermometers, such as resistance temperature detectors,
shall meet known, accurate standards for such devices when tested for
accuracy. The records of such testing shall be available to FSIS program
employees.
(2) Temperature/time recording devices. Each thermal processing
system shall be equipped with at least one temperature/time recording
device to provide a permanent record of temperatures within the thermal
processing system. This recording device may be combined with the steam
controller and may be a recording/controlling instrument. When compared
to the known accurate indicating temperature device, the recording
accuracy shall be equal to or better than 1 deg.F (or 0.5 deg.C) at
the process temperature. The temperature recording chart should be
adjusted to agree with, but shall never be higher than, the known
accurate indicating temperature device. A means of preventing
unauthorized changes in the adjustment shall be provided. For example, a
lock or a notice from management posted at or near the recording device
warning that only authorized persons are permitted to make adjustments,
are satisfactory means for preventing unauthorized changes. Air-operated
temperature controllers shall have adequate filter systems to ensure a
supply of clean, dry air. The recorder timing mechanism shall be
accurate.
(i) Chart-type devices. Devices using charts shall be used only with
the correct chart. Each chart shall have a working scale of not more
than 55 deg.F/inch (or 12 deg.C/cm) within a range of 20 deg.F (or 11
deg.C) of the process temperature. Chart graduations shall not exceed 2
deg.F (or 1 deg.C) within a range of 10 deg.F (or 5 deg.C) of the
process temperature. Multipoint plotting chart-type devices shall print
temperature readings at intervals that will assure that the parameters
of the process time and process temperature have been met. The frequency
of recording should not exceed 1-minute intervals.
(ii) Other devices. Temperature/time recording devices or procedures
used in lieu of chart-type devices must meet known accurate standards
for such devices or procedures when tested for accuracy. Such a device
must be accurate enough for ensuring that process time and temperature
parameters have been met.
(3) Steam controllers. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording/controlling instrument when combined with a temperature/
time recording device.
(4) Air valves. All air lines connected to the retorts designed for
pressure processing in steam shall be equipped with a globe valve or
other equivalent-type valve or piping arrangement that will prevent
leakage of air into the retort during the process cycle.
(5) Water valves. All retort water lines that are intended to be
closed during a process cycle shall be equipped with a globe valve or
other equivalent-type valve or piping arrangement that will prevent
leakage of water into the retort during the process cycle.
(b) Pressure processing in steam--(1) Batch still retorts. (i) The
basic requirements and recommendations for indicating temperature
devices and temperature/time recording devices are described in
paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths
or probes of indicating temperature devices and probes of temperature/
time recording devices shall be installed either within the retort shell
or in external wells attached to the retort. External wells shall be
connected to the retort through at least a \3/4\ inch (1.9 cm) diameter
opening and equipped with a \1/16\ inch (1.6 mm) or larger bleeder
opening so located as to provide a constant flow of steam past the
length of the bulb or probe. The bleeder for external wells shall emit
steam continuously during the entire thermal processing period.
(ii) Steam controllers are required as described in paragraph (a)(3)
of this section.
(iii) Steam inlet. The steam inlet to each retort shall be large
enough to provide steam for proper operation of the retort, and shall
enter at a point to facilitate air removal during venting.
[[Page 545]]
(iv) Crate supports. Vertical still retorts with bottom steam entry
shall employ bottom retort crate supports. Baffle plates shall not be
used in the bottom of retorts.
(v) Steam spreader. Perforated steam spreaders, if used, shall be
maintained to ensure they are not blocked or otherwise inoperative.
Horizontal still retorts shall be equipped with perforated steam
spreaders that extend the full length of the retort unless the adequacy
of another arrangement is documented by heat distribution data or other
documentation from a processing authority. Such information shall be
maintained on file by the establishment and made available to Program
employees for review.
(vi) Bleeders and condensate removal. Bleeders, except those for
external wells of temperature devices, shall have \1/8\ inch (or 3 mm)
or larger openings and shall be wide open during the entire process
including the come-up time. For horizontal still retorts, bleeders shall
be located within approximately 1 foot (or 30 cm) of the outermost
locations of containers at each end along the top of the retort.
Additional bleeders shall be located not more than 8 feet (2.4 m) apart
along the top. Bleeders may be installed at positions other than those
specified above, as long as the establishment has heat distribution data
or other documentation from the manufacturer or from a processing
authority demonstrating that the bleeders accomplish removal of air and
circulate the steam within the retort. This information shall be
maintained on file by the establishment and made available to Program
employees for review. All bleeders shall be arranged in a way that
enables the retort operator to observe that they are functioning
properly. Vertical retorts shall have at least one bleeder opening
located in the portion of the retort opposite the steam inlet. All
bleeders shall be arranged so that the retort operator can observe that
they are functioning properly. In retorts having a steam inlet above the
level of the lowest container, a bleeder shall be installed in the
bottom of the retort to remove condensate. The condensate bleeder shall
be so arranged that the retort operator can observe that it is
functioning properly. The condensate bleeder shall be checked with
sufficient frequency to ensure adequate removal of condensate. Visual
checks should be performed at intervals of not more than 15 minutes and
the results recorded. Intermittent condensate removal systems shall be
equipped with an automatic alarm system that will serve as a continuous
monitor of condensate bleeder functioning. The automatic alarm system
shall be tested at the beginning of each shift for proper functioning
and the results recorded. If the alarm system is not functioning
properly, it must be repaired before the retort is used.
(vii) Stacking equipment. (a) Equipment for holding or stacking
containers in retorts. Crates, trays, gondolas, carts, and other
vehicles for holding or stacking product containers in the retort shall
be so constructed to ensure steam circulation during the venting, come-
up, and process times. The bottom of each vehicle shall have
perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm)
centers or the equivalent unless the adequacy of another arrangement is
documented by heat distribution data or other documentation from a
processing authority and such information is maintained on file by the
establishment and made available to Program employees for review.
(b) Divider plates. Whenever one or more divider plates are used
between any two layers of containers or placed on the bottom of a retort
vehicle, the establishment shall have on file documentation that the
venting procedure allows the air to be removed from the retort before
timing of the thermal process is started. Such documentation shall be in
the form of heat distribution data or documentation from a processing
authority. This information shall be made available to Program employees
for review.
(viii) Bleeder and vent mufflers. If mufflers are used on bleeders
or vent systems, the establishment shall have on file documentation that
the mufflers do not impede the removal of air from the retort. Such
documentation shall consist of either heat distribution data or
documentation from the muffler
[[Page 546]]
manufacturer or from a processing authority. This information shall be
made available to Program employees for review.
(ix) Vents. (a) Vents shall be located in that portion of the retort
opposite the steam inlet and shall be designed, installed, and operated
in such a way that air is removed from the retort before timing of the
thermal process is started. Vents shall be controlled by a gate, plug
cock, or other full-flow valve which shall be fully opened to permit
rapid removal of air from retorts during the venting period.
(b) Vents shall not be connected to a closed drain system without an
atmospheric break in the line. Where a retort manifold connects several
pipes from a single retort, the manifold shall be controlled by a gate,
plug cock, or other full-flow valve and the manifold shall be of a size
such that the cross-sectional area of the manifold is larger than the
total cross-sectional area of all connecting vents. The discharge shall
not be connected to a closed drain without an atmospheric break in the
line. A manifold header connecting vents or manifolds from several still
retorts shall lead to the atmosphere. The manifold header shall not be
controlled by a valve and shall be of a size such that the cross-
sectional area is at least equal to the total cross-sectional area of
all connecting retort manifold pipes from the maximum number of retorts
to be vented simultaneously.
(c) Some typical installations and operating procedures are
described below. Other retort installations, vent piping arrangements,
operating procedures or auxiliary equipment such as divider plates may
be used provided there is documentation that the air is removed from the
retort before the process is started. Such documentation shall be in the
form of heat distribution data or other documentation from the equipment
manufacturer or processing authority. This information shall be
maintained on file by the establishment and made available to Program
employees for review.
(d) For crateless retort installations, the establishment shall have
heat distribution data or other documentation from the equipment
manufacturer or from a processing authority that demonstrates that the
venting procedure used accomplishes the removal of air and condensate.
This information shall be maintained on file by the establishment and
made available to Program employees for review.
(e) Examples of typical installations and operating procedures that
comply with the requirements of this section are as follows:
(1) Venting horizontal retorts.
(i) Venting through multiple 1 inch (2.5 cm) vents discharging
directly to the atmosphere.
[GRAPHIC] [TIFF OMITTED] TC11SE91.047
Specifications (Figure 1): One, 1-inch (2.5 cm) vent for every 5
feet (1.5 m) of retort length, equipped with a gate, plug cock, or other
full-flow valve and discharging to atmosphere. The end vents shall not
be more than 2\1/2\ feet (or 75 cm) from ends of retort.
Venting method (Figure 1): Vent valves shall be wide open for at
least 5 minutes and to at least 225 deg.F (or 107 deg.C), or at least
7 minutes and to at least 220 deg.F (or 104.5 deg.C).
(ii) Venting through multiple 1 inch (2.5 cm) vents discharging
through a manifold to the atmosphere.
[GRAPHIC] [TIFF OMITTED] TC11SE91.048
Specifications (Figure 2): One, 1-inch (2.5 cm) vent for every 5
feet (1.5 m) of retort length; vents not over 2\1/2\ feet (or 75 cm)
from ends of retort; size of manifold for retorts less than 15 feet (4.6
m) in length, 2\1/2\ inches (6.4 cm), and for retorts 15 feet (4.6 m)
and over in length, 3 inches (7.6 cm).
Venting method (Figure 2): The manifold vent gate, plug cock, or
other full-flow valve shall be wide open for at least 6 minutes and
[[Page 547]]
to at least 225 deg.F (or 107 deg.C) or for at least 8 minutes and to
at least 220 deg.F (or 104.5 deg.C).
(iii) Venting through water spreaders.
[GRAPHIC] [TIFF OMITTED] TC11SE91.049
Specifications (Figure 3): Size of vent and vent valve. For retorts
less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15
feet (4.6 m) and over in length, 2\1/2\ inches (6.4 cm).
Size of water spreader (Figure 3): For retorts less than 15 feet
(4.6 m) in length, 1\1/2\ inches (3.8 cm); for retorts 15 feet (4.6 m)
and over in length 2 inches (or 5 cm). The number of holes shall be such
that their total cross-sectional area is equal to the cross-sectional
area of the vent pipe inlet.
Venting method (Figure 3): The gate, plug cock, or other full-flow
valve on the water spreader vent shall be wide open for at least 5
minutes and to at least 225 deg.F (or 107 deg.C), or for at least 7
minutes and to at least 220 deg.F (or 104.5 deg.C).
(iv) Venting through a single 2\1/2\ inch (6.4 cm) top vent for
retorts not exceeding 15 feet (4.6 m) in length.
[GRAPHIC] [TIFF OMITTED] TC11SE91.050
Specifications (Figure 4): A 2\1/2\ inch (6.4 cm) vent equipped with
a 2\1/2\ inch (6.4 cm) gate, plug cock, or other full-flow valve and
located within 2 feet (61 cm) of the center of the retort.
Venting method (Figure 4): The vent valve shall be wide open for at
least 4 minutes and to at least 220 deg.F (or 104.5 deg.C).
(2) Venting vertical retorts.
(i) Venting through a 1\1/2\ inch (3.8 cm) overflow.
[GRAPHIC] [TIFF OMITTED] TC11SE91.051
Specifications (Figure 5): A 1\1/2\ inch (3.8 cm) overflow pipe
equipped with a 1\1/2\ inch (3.8 cm) gate, plug cock, or other full-flow
valve and with not more than 6 feet (1.8 m) of 1\1/2\ inch (3.8 cm) pipe
beyond the valve before a break to the atmosphere or to a manifold
header.
Venting method (Figure 5): The vent valve shall be wide open for at
least 4 minutes and to at least 218 deg.F (or 103.5 deg.C), or for at
least 5 minutes and to at least 215 deg.F (or 101.5 deg.C).
(ii) Venting through a single 1 inch (2.5 cm) side or top vent.
[[Page 548]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.052
Specifications (Figure 6 or 7): A 1 inch (2.5 cm) vent in lid or top
side, equipped with a gate, plug cock, or other full-flow valve and
discharging directly into the atmosphere or to a manifold header.
Venting method (Figure 6 or 7): The vent valve shall be wide open
for at least 5 minutes and to at least 230 deg.F (110 deg.C), or for
at least 7 minutes and to at least 220 deg.F (or 104.5 deg.C).
(2) Batch agitating retorts. (i) The basic requirements for
indicating temperature devices and temperature/time recording devices
are described in paragraphs (a) (1) and (2) of this section.
Additionally, bulb sheaths or probes of indicating temperature devices
and probes of temperature/time recording devices shall be installed
either within the retort shell or in external wells attached to the
retort. External wells shall be connected to the retort through at least
a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ (1.6
mm) or larger bleeder opening so located as to provide a constant flow
of steam past the length of the bulbs or probes. The bleeder for
external wells shall emit steam continuously during the entire thermal
processing period.
(ii) Steam controllers are required as described in paragraph (a)(3)
of this section.
(iii) Steam inlet. The steam inlet to each retort shall be large
enough to provide steam for proper operation of the retort and shall
enter at a point(s) to facilitate air removal during venting.
(iv) Bleeders. Bleeders, except those for external wells of
temperature devices, shall be \1/8\ inch (or 3 mm) or larger and shall
be wide open during the entire process including the come-up time.
Bleeders shall be located within approximately 1 foot (or 30 cm) of the
outermost location of containers, at each end along the top of the
retort. Additional bleeders shall be located not more than 8 feet (2.4
m) apart along the top. Bleeders may be installed at positions other
than those specified above, as long as the establishment has heat
distribution data or other documentation from the manufacturer or from a
processing authority that the
[[Page 549]]
bleeders accomplish removal of air and circulate the steam within the
retort. This information shall be maintained on file by the
establishment and made available to Program employees for review. All
bleeders shall be arranged in a way that enables the retort operator to
observe that they are functioning properly.
(v) Venting and condensate removal. The air in the retort shall be
removed before processing is started. Heat distribution data or other
documentation from the manufacturer or from the processing authority who
developed the venting procedure shall be kept on file by the
establishment and made available to Program employees for review. At the
time the steam is turned on, the drain shall be opened to remove steam
condensate from the retort. A bleeder shall be installed in the bottom
of the retort to remove condensate during retort operation. The
condensate bleeder shall be so arranged that the retort operator can
observe that it is functioning properly. The condensate bleeder shall be
checked with sufficient frequency to ensure adequate removal of
condensate. Visual checks should be performed at intervals of not more
than 15 minutes and the results recorded. Intermittent condensate
removal systems shall be equipped with an automatic alarm system that
will serve as a continuous monitor of condensate bleeder functioning.
The automatic alarm system shall be tested at the beginning of each
shift for proper functioning and the results recorded. If the alarm
system is not functioning properly, it must be repaired before the
retort is used.
(vi) Retort or reel speed timing. The retort or reel speed shall be
checked before process timing begins and, if needed, adjusted as
specified in the process schedule. In addition, the rotational speed
shall be determined and recorded at least once during process timing of
each retort load processed. Alternatively, a recording tachometer can be
used to provide a continuous record of the speed. The accuracy of the
recording tachometer shall be determined and recorded at least once per
shift by checking the retort or reel speed using an accurate stopwatch.
A means of preventing unauthorized speed changes on retorts shall be
provided. For example, a lock or a notice from management posted at or
near the speed adjustment device warning that only authorized persons
are permitted to make adjustments are satisfactory means of preventing
unauthorized changes.
(vii) Bleeder and vent mufflers. If mufflers are used on bleeders or
vent systems, the establishment shall have documentation that the
mufflers do not impede the removal of air from the retort. Such
documentation shall consist of either heat distribution data or
documentation from the muffler manufacturer or from a processing
authority. This information shall be maintained on file by the
establishment and made available to Program employees for review.
(3) Continuous rotary retorts. (i) The basic requirements for
indicating temperature devices and temperature/time recording devices
are described in paragraphs (a) (1) and (2) of this section.
Additionally, bulb sheaths or probes of indicating temperature devices
and probes of temperature/time recording devices shall be installed
either within the retort shell or in external wells attached to the
retort. External wells shall be connected to the retort through at least
a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ inch
(1.6 mm) or larger bleeder opening so located as to provide a constant
flow of steam past the length of the bulbs or probes. The bleeder for
external wells shall emit steam continuously during the entire thermal
processing period.
(ii) Steam controllers are required as described in paragraph (a)(3)
of this section.
(iii) Steam inlet. The steam inlet to each retort shall be large
enough to provide steam for proper operation of the retort, and shall
enter at a point(s) to facilitate air removal during venting.
(iv) Bleeders. Bleeders, except those for external wells of
temperature devices, shall be \1/8\ inch (3.2 mm) or larger and shall be
wide open during the entire process, including the come-up time.
Bleeders shall be located within approximately 1 foot (or 30 cm) of the
outermost location of containers at each end along the top of the
retort.
[[Page 550]]
Additional bleeders shall be located not more than 8 feet (2.4 m) apart
along the top of the retort. Bleeders may be installed at positions
other than those specified above, as long as the establishment has heat
distribution data or other documentation from the manufacturer or a
processing authority that the bleeders accomplish removal of air and
circulate the steam within the retort. This information shall be
maintained on file by the establishment and made available to Program
employees for review. All bleeders shall be arranged so that the retort
operator can observe that they are functioning properly.
(v) Venting and condensate removal. The air in the retort shall be
removed before processing is started. Heat distribution data or other
documentation from the manufacturer or from the processing authority who
developed the venting procedure shall be kept on file by the
establishment and made available to Program employees for review. At the
time the steam is turned on, the drain shall be opened to remove steam
condensate from the retort. A bleeder shall be installed in the bottom
of the shell to remove condensate during the retort operation. The
condensate bleeder shall be so arranged that the retort operator can
observe that it is functioning properly. The condensate bleeder shall be
checked with sufficient frequency to ensure adequate removal of
condensate. Visual checks should be performed at intervals of not more
than 15 minutes and the results recorded. Intermittent condensate
removal systems shall be equipped with an automatic alarm system that
will serve as a continuous monitor of condensate bleeder functioning.
The automatic alarm system shall be tested at the beginning of each
shift for proper functioning and the results recorded. If the alarm
system is not functioning properly, it must be repaired before the
retort is used.
(vi) Retort speed timing. The rotational speed of the retort shall
be specified in the process schedule. The speed shall be adjusted as
specified, and recorded by the establishment when the retort is started,
and checked and recorded at intervals not to exceed 4 hours to ensure
that the correct retort speed is maintained. Alternatively, a recording
tachometer may be used to provide a continuous record of the speed. If a
recording tachometer is used, the speed shall be manually checked
against an accurate stopwatch at least once per shift and the results
recorded. A means of preventing unauthorized speed changes on retorts
shall be provided. For example, a lock or a notice from management
posted at or near the speed adjustment device warning that only
authorized persons are permitted to make adjustments are satisfactory
means of preventing unauthorized changes.
(vii) Bleeders and vent mufflers. If mufflers are used on bleeders
or vent systems, the establishment shall have documentation that the
mufflers do not impede the removal of air from the retort. Such
documentation shall consist of either heat distribution data or other
documentation from the muffler manufacturer or from a processing
authority. This information shall be maintained on file by the
establishment and made available to Program employees for review.
(4) Hydrostatic retorts. (i) The basic requirements for indicating
temperature devices and temperature/time recording devices are described
in paragraphs (a) (1) and (2) of this section. Additionally, indicating
temperature devices shall be located in the steam dome near the steam/
water interface. Where the process schedule specifies maintenance of
particular water temperatures in the hydrostatic water legs, at least
one indicating temperature device shall be located in each hydrostatic
water leg so that it can accurately measure water temperature and be
easily read. The temperature/time recorder probe shall be installed
either within the steam dome or in a well attached to the dome. Each
probe shall have a \1/16\ inch (1.6 mm) or larger bleeder opening which
emits steam continuously during the processing period. Additional
temperature/time recorder probes shall be installed in the hydrostatic
water legs if the process schedule specifies maintenance of particular
temperatures in these water legs.
(ii) Steam controllers are required as described in paragraph (a)(3)
of this section.
[[Page 551]]
(iii) Steam inlet. The steam inlets shall be large enough to provide
steam for proper operation of the retort.
(iv) Bleeders. Bleeder openings \1/4\ inch (or 6 mm) or larger shall
be located in the steam chamber(s) opposite the point of steam entry.
Bleeders shall be wide open and shall emit steam continuously during the
entire process, including the come-up time. All bleeders shall be
arranged in such a way that the operator can observe that they are
functioning properly.
(v) Venting. Before the start of processing operations, the retort
steam chamber(s) shall be vented to ensure removal of air. Heat
distribution data or other documentation from the manufacturer or from a
processing authority demonstrating that the air is removed from the
retort prior to processing shall be kept on file at the establishment
and made available to Program employees for review.
(vi) Conveyor speed. The conveyor speed shall be calculated to
obtain the required process time and recorded by the establishment when
the retort is started. The speed shall be checked and recorded at
intervals not to exceed 4 hours to ensure that the correct conveyor
speed is maintained. A recording device may be used to provide a
continuous record of the conveyor speed. When a recording device is
used, the speed shall be manually checked against an accurate stopwatch
at least once per shift by the establishment. A means of preventing
unauthorized speed changes of the conveyor shall be provided. For
example, a lock or a notice from management posted at or near the speed
adjustment device warning that only authorized persons are permitted to
make adjustments are satisfactory means of preventing unauthorized
changes.
(vii) Bleeders and vent mufflers. If mufflers are used on bleeders
or vent systems, the establishment shall have documentation that the
mufflers do not impede the removal of air from the retort. Such
documentation shall consist of either heat distribution data or other
documentation from the muffler manufacturer or from a processing
authority. This information shall be maintained on file by the
establishment and made available to Program employees for review.
(c) Pressure processing in water--(1) Batch still retorts. (i) The
basic requirements for indicating temperature devices and temperature/
time recording devices are described in paragraphs (a)(1) and (2) of
this section. Additionally, bulbs or probes of indicating temperature
devices shall be located in such a position that they are beneath the
surface of the water throughout the process. On horizontal retorts, the
indicating temperature device bulb or probe shall be inserted directly
into the retort shell. In both vertical and horizontal retorts, the
indicating temperature device bulb or probe shall extend directly into
the water a minimum of 2 inches (or 5 cm) without a separable well or
sleeve. In vertical retorts equipped with a recorder/controller, the
controller probe shall be located at the bottom of the retort below the
lowest crate rest in such a position that the steam does not strike it
directly. In horizontal retorts so equipped, the controller probe shall
be located between the water surface and the horizontal plane passing
through the center of the retort so that there is no opportunity for
direct steam impingement on the controller probe. Air-operated
temperature controllers shall have filter systems to ensure a supply of
clean, dry air.
(ii) Pressure recording device. Each retort shall be equipped with a
pressure recording device which may be combined with a pressure
controller.
(iii) Steam controllers are required as described in paragraph
(a)(3) of this section.
(iv) Heat distribution. Heat distribution data or other
documentation from the equipment manufacturer or a processing authority
demonstrating uniform heat distribution within the retort shall be kept
on file at the establishment and made available to Program employees for
review.
(v) Crate supports. A bottom crate support shall be used in vertical
retorts. Baffle plates shall not be used in the bottom of the retort.
(vi) Stacking equipment. For filled flexible containers and, where
applicable, semirigid containers, stacking equipment shall be designed
to ensure
[[Page 552]]
that the thickness of the filled containers does not exceed that
specified in the process schedule and that the containers do not become
displaced and overlap or rest on one another during the thermal process.
(vii) Drain valve. A nonclogging, water-tight drain valve shall be
used. Screens shall be installed over all drain openings.
(viii) Water level. There shall be a means of determining the water
level in the retort during operation (i.e., by using a gauge, electronic
sensor, or sight glass indicator). For retorts requiring complete
immersion of containers, water shall cover the top layer of containers
during the entire come-up time and thermal processing periods and should
cover the top layer of containers during cooling. For retorts using
cascading water or water sprays, the water level shall be maintained
within the range specified by the retort manufacturer or processing
authority during the entire come-up, thermal processing, and cooling
periods. A means to ensure that water circulation continues as specified
throughout the come-up, thermal processing, and cooling periods shall be
provided. The retort operator shall check and record the water level at
intervals to ensure it meets the specified processing parameters.
(ix) Air supply and controls. In both horizontal and vertical still
retorts, a means shall be provided for introducing compressed air or
steam at the pressure required to maintain container integrity.
Compressed air and steam entry shall be controlled by an automatic
pressure control unit. A nonreturn valve shall be provided in the air
supply line to prevent water from entering the system. Overriding air or
steam pressure shall be maintained continuously during the come-up,
thermal processing, and cooling periods. If air is used to promote
circulation, it shall be introduced into the steam line at a point
between the retort and the steam control valve at the bottom of the
retort. The adequacy of the air circulation for maintaining uniform heat
distribution within the retort shall be documented by heat distribution
data or other documentation from a processing authority, and such data
shall be maintained on file by the establishment and made available to
Program employees for review.
(x) Water recirculation. When a water recirculation system is used
for heat distribution, the water shall be drawn from the bottom of the
retort through a suction manifold and discharged through a spreader that
extends the length or circumference of the top of the retort. The holes
in the water spreader shall be uniformly distributed. The suction
outlets shall be protected with screens to keep debris from entering the
recirculation system. The pump shall be equipped with a pilot light or a
similar device to warn the operator when it is not running, and with a
bleeder to remove air when starting operations. Alternatively, a flow-
meter alarm system can be used to ensure proper water circulation. The
adequacy of water circulation for maintaining uniform heat distribution
within the retort shall be documented by heat distribution data or other
documentation from a processing authority and such data shall be
maintained on file by the establishment and made available to Program
employees for review. Alternative methods for recirculation of water in
the retort may be used, provided there is documentation in the form of
heat distribution data or other documentation from a processing
authority maintained on file by the establishment and made available to
Program employees for review.
(xi) Cooling water entry. In retorts for processing product packed
in glass jars, the incoming cooling water should not directly strike the
jars, in order to minimize glass breakage by thermal shock.
(2) Batch agitating retorts. (i) The basic requirements and
recommendations for indicating temperature devices and temperture/time
recording devices are described in paragraphs (a) (1) and (2) of this
section. Additionally, the indicating temperature device bulb or probe
shall extend directly into the water without a separable well or sleeve.
The recorder/controller probe shall be located between the water surface
and the horizontal plane passing through the center of the retort so
that
[[Page 553]]
there is no opportunity for steam to directly strike the controller bulb
or probe.
(ii) Pressure recording device. Each retort shall be equipped with a
pressure recording device which may be combined with a pressure
controller.
(iii) Steam controllers are required as described in paragraph
(a)(3) of this section.
(iv) Heat distribution. Heat distribution data or other
documentation from the equipment manufacturer or a processing authority
shall be kept on file by the establishment and made available to Program
employees for review.
(v) Stacking equipment. All devices used for holding product
containers (e.g., crates, trays, divider plates) shall be so constructed
to allow the water to circulate around the containers during the come-up
and thermal process periods.
(vi) Drain valve. A nonclogging, water-tight drain valve shall be
used. Screens shall be installed over all drain openings.
(vii) Water level. There shall be a means of determining the water
level in the retort during operation (i.e., by using a gauge, electronic
sensor, or sight glass indicator). Water shall completely cover all
containers during the entire come-up, thermal processing, and cooling
periods. A means to ensure that water circulation continues as specified
throughout the come-up, thermal processing, and cooling periods shall be
provided. The retort operator shall check and record the adequacy of the
water level with sufficient frequency to ensure it meets the specified
processing parameters.
(viii) Air supply and controls. Retorts shall be provided with a
means for introducing compressed air or steam at the pressure required
to maintain container integrity. Compressed air and steam entry shall be
controlled by an automatic pressure control unit. A nonreturn valve
shall be provided in the air supply line to prevent water from entering
the system. Overriding air or steam pressure shall be maintained
continuously during the come-up, thermal processing, and cooling
periods. If air is used to promote circulation, it shall be introduced
into the steam line at a point between the retort and the steam control
valve at the bottom of the retort. The adequacy of the air circulation
for maintaining uniform heat distribution within the retort shall be
documented by heat distribution data or other documentation from a
processing authority, and such data shall be maintained on file by the
establishment and made available to Program employees for review.
(ix) Retort or reel speed timing. The retort or reel speed timing
shall be checked before process timing begins and, if needed, adjusted
as specified in the process schedule. In addition, the rotational speed
shall be determined and recorded at least once during process timing of
each retort load processed. Alternatively, a recording tachometer can be
used to provide a continuous record of the speed. The accuracy of the
recording tachometer shall be determined and recorded at least once per
shift by the establishment by checking the retort or reel speed using an
accurate stopwatch. A means of preventing unauthorized speed changes on
retorts shall be provided. For example, a lock or a notice from
management posted at or near the speed adjustment device warning that
only authorized persons are permitted to make adjustments are
satisfactory means of preventing unauthorized changes.
(x) Water recirculation. If a water recirculation system is used for
heat distribution, it shall be installed in such a manner that water
will be drawn from the bottom of the retort through a suction manifold
and discharged through a spreader which extends the length of the top of
the retort. The holes in the water spreader shall be uniformly
distributed. The suction outlets shall be protected with screens to keep
debris from entering the recirculation system. The pump shall be
equipped with a pilot light or a similar device to warn the operator
when it is not running and with a bleeder to remove air when starting
operations. Alternatively, a flow-meter alarm system can be used to
ensure proper water circulation. The adequacy of water circulation for
maintaining uniform heat distribution within the retort shall be
documented by heat distribution data or other documentation from a
processing authority and such data shall be maintained
[[Page 554]]
on file by the establishment and made available to Program employees for
review. Alternative methods for recirculation of water in the retort may
be used provided there is documentation in the form of heat distribution
data or other documentation from a processing authority maintained on
file by the establishment and made available to Program employees for
review.
(xi) Cooling water entry. In retorts for processing product packed
in glass jars, the incoming cooling water should not directly strike the
jars, in order to minimize glass breakage by thermal shock.
(d) Pressure processing with steam/air mixtures in batch retorts.
(1) The basic requirements for indicating temperature devices and
temperature/time recording devices are described in paragraphs (a) (1)
and (2) of this section. Additionally, bulb sheaths or probes for
indicating temperature devices and temperature/time recording devices or
controller probes shall be inserted directly into the retort shell in
such a position that steam does not strike them directly.
(2) Steam controllers are required as described in paragraph (a)(3)
of this section.
(3) Recording pressure controller. A recording pressure controller
shall be used to control the air inlet and the steam/air mixture outlet.
(4) Circulation of steam/air mixture. A means shall be provided for
the circulation of the steam/air mixture to prevent formation of low-
temperature pockets. The efficiency of the circulation system shall be
documented by heat distribution data or other documentation from a
processing authority, and such data shall be maintained on file by the
establishment and made available to Program employees for review. The
circulation system shall be checked to ensure its proper functioning and
shall be equipped with a pilot light or a similar device to warn the
operator when it is not functioning. Because of the variety of existing
designs, reference shall be made to the equipment manufacturer for
details of installation, operation and control.
(e) Atmospheric cookers--(1) Temperature/time recording device. Each
atmospheric cooker (e.g., hot water bath) shall be equipped with at
least one temperature/time recording device in accordance with the basic
requirements described in paragraph (a)(2) of this section.
(2) Heat distribution. Each atmospheric cooker shall be equipped and
operated to ensure uniform heat distribution throughout the processing
system during the thermal process. Heat distribution data or other
documentation from the manufacturer or a processing authority
demonstrating uniform heat distribution within the cooker shall be kept
on file by the establishment and made available to Program employees for
review.
(f) Other systems. All other systems not specifically delineated in
this section and used for the thermal processing of canned product shall
be adequate to produce shelf-stable products consistently and uniformly.
(g) Equipment maintenance. (1) Upon installation, all
instrumentation and controls shall be checked by the establishment for
proper functioning and accuracy and, thereafter, at any time their
functioning or accuracy is suspect.
(2) At least once a year each thermal processing system shall be
examined by an individual not directly involved in daily operations to
ensure the proper functioning of the system as well as all auxiliary
equipment and instrumentation. In addition, each thermal processing
system should be examined before the resumption of operation following
an extended shutdown.
(3) Air and water valves that are intended to be closed during
thermal processing shall be checked by the establishment for leaks.
Defective valves shall be repaired or replaced as needed.
(4) Vent and bleeder mufflers shall be checked and maintained or
replaced by the establishment to prevent any reduction in vent or
bleeder efficiency.
(5) When water spreaders are used for venting, a maintenance
schedule shall be developed and implemented to assure that the holes are
maintained at their original size.
(6) Records shall be kept on all maintenance items that could affect
the adequacy of the thermal process. Records shall include the date and
type
[[Page 555]]
of maintenance performed and the person conducting the maintenance.
(h) Container cooling and cooling water. (1) Potable water shall be
used for cooling except as provided for in paragraphs (h) (2) and (3) of
this section.
(2) Cooling canal water shall be chlorinated or treated with a
chemical approved by the Administrator as having a bactericidal effect
equivalent to chlorination. There shall be a measurable residual of the
sanitizer in the water at the discharge point of the canal. Cooling
canals shall be cleaned and replenished with potable water to prevent
the buildup of organic matter and other materials.
(3) Container cooling waters that are recycled or reused shall be
handled in systems that are so designed, operated, and maintained so
there is no buildup of microorganisms, organic matter, and other
materials in the systems and in the waters. System equipment, such as
pipelines, holding tanks and cooling towers, shall be constructed and
installed so that they can be cleaned and inspected. In addition, the
establishment shall maintain, and make available to Program employees
for review, information on at least the following:
(i) System design and construction;
(ii) System operation including the rates of renewal with fresh,
potable water and the means for treating the water so that there is a
measurable residual of an acceptable sanitizer, per paragraph (h)(2) of
this section, in the water at the point where the water exits the
container cooling vessel;
(iii) System maintenance including procedures for the periodic
cleaning and sanitizing of the entire system; and
(iv) Water quality standards, such as microbiological, chemical and
physical, monitoring procedures including the frequency and site(s) of
sampling, and the corrective actions taken when water quality standards
are not met.
(i) Post-process handling of containers. Containers shall be handled
in a manner that will prevent damage to the hermetic seal area. All worn
and frayed belting, can retarders, cushions, and the like shall be
replaced with nonporous materials. To minimize container abrasions,
particularly in the seal area, containers should not remain stationary
on moving conveyors. All post-process container handling equipment
should be kept clean so there is no buildup of microorganisms on
surfaces in contact with the containers.
(Approved by the Office of Management and Budget under control number
0583-0015)
[51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.306]
[Page 555-556]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.306 Processing and production records.
At least the following processing and production information shall
be recorded by the establishment: Date of production; product name and
style; container code; container size and type; and the process
schedule, including the minimum initial temperature. Measurements made
to satisfy the requirements of Sec. 381.303 regarding the control of
critical factors shall be recorded. In addition, where applicable, the
following information and data shall also be recorded:
(a) Processing in steam--(1) Batch still retorts. For each retort
batch, record the retort number or other designation, the approximate
number of containers or the number of retort crates per retort load,
product initial temperature, time steam on, the time and temperature
vent closed, the start of process timing, time steam off, and the actual
processing time. The indicating temperature device and the temperature
recorder shall be read at the same time at least once during process
timing and the observed temperatures recorded.
(2) Batch agitating retorts. In addition to recording the
information required for batch, still steam retorts in paragraph (a)(1)
of this section, record the functioning of the condensate bleeder(s) and
the retort or reel speed.
(3) Continuous rotary retorts. Record the retort system number, the
approximate total number of containers retorted, product initial
temperature, time steam on, the time and temperature vent closed, time
process temperature reached, the time the first can enters and the time
the last can exits the retort. The retort or reel speed shall be
determined and recorded at intervals not to exceed 4 hours. Readings of
the indicating temperature device(s) and
[[Page 556]]
temperature recorder(s) shall be made and recorded at the time the first
container enters the retort and thereafter with sufficient frequency to
ensure compliance with the process schedule. These observations should
be made and recorded at intervals not exceeding 30 minutes of continuous
retort operation. Functioning of the condensate bleeder(s) shall be
observed and recorded at the time the first container enters the retort
and thereafter as specified in Sec. 381.305(b)(3)(v).
(4) Hydrostatic retorts. Record the retort system number, the
approximate total number of containers retorted, product initial
temperature, time steam on, the time and temperature vent(s) closed,
time process temperature reached, time first containers enter the
retort, time last containers exit the retort, and, if specified in the
process schedule, measurements of temperatures in the hydrostatic water
legs. Readings of the temperature indicating device, which is located in
the steam/water interface, and the temperature recording device shall be
observed and the temperatures recorded at the time the first containers
enter the steam dome. Thereafter, these instruments shall be read and
the temperatures recorded with sufficient frequency to ensure compliance
with the temperature specified in the process schedule and should be
made at least every hour of continuous retort operation. Container
conveyor speed, and for agitating hydrostatic retorts, the rotative
chain speed, shall be determined and recorded at intervals of sufficient
frequency to ensure compliance with the process schedule and should be
performed at least every 4 hours.
(b) Processing in water--(1) Batch still retorts. For each retort
batch, record the retort number or other designation, the approximate
number of containers or number of retort crates per retort load, product
initial temperature, time steam on, the start of process timing, water
level, water recirculation rate (if critical), overriding pressure
maintained, time steam off, and actual processing time. The indicating
temperature device and the temperature recorder shall be read at the
same time at least once during process timing and the observed
temperatures recorded.
(2) Batch agitating retorts. In addition to recording the
information required in paragraph (b)(1) of this section, record the
retort or reel speed.
(c) Processing in steam/air mixtures. For each retort batch, record
the retort number or other designation, the approximate number of
containers or number of retort crates per retort load, product initial
temperature, time steam on, venting procedure, if applicable, the start
of process timing, maintenance of circulation of the steam/air mixture,
air flow rate or forced recirculation flow rate (if critical),
overriding pressure maintained, time steam off, and actual processing
time. The indicating temperature device and the temperature recorder
shall be read at the same time at least once during process timing and
the observed temperatures recorded.
(d) Atmospheric cookers--(1) Batch-type systems. For each cooker
batch, record the cooker number or other designation and the approximate
number of containers. In addition, record all critical factors of the
process schedule such as cooker temperature, initial temperature, the
time the thermal process cycle begins and ends, hold time, and the final
internal product temperature.
(2) Continuous-type systems. Record the cooker number or other
designation, the time the first containers enter and the last containers
exit a cooker, and the approximate total number of containers processed.
In addition, record all critical factors of the process schedule such as
the initial temperature, cooker speed, and final internal product
temperature.
(Approved by the Office of Management and Budget under control number
0583-0015)
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.307]
[Page 556-557]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.307 Record review and maintenance.
(a) Process records. Charts from temperature/time recording devices
shall be identified by production date, container code, processing
vessel number or other designation and other data as necessary to enable
correlation with the records required in Sec. 381.306. Each entry on a
record shall be made at the time the specific event occurs, and the
[[Page 557]]
recording individual shall sign or initial each record form. No later
than 1 working day after the actual process, the establishment shall
review all processing and production records to ensure completeness and
to determine if all product received the process schedule. All records,
including the temperature/time recorder charts and critical factor
control records, shall be signed or initialed and dated by the person
conducting the review. All processing and production records required in
this subpart shall be made available to Program employees for review.
(b) Automated process monitoring and recordkeeping. Automated
process monitoring and recordkeeping systems shall be designed and
operated in a manner which will ensure compliance with the applicable
requirements of Sec. 381.306.
(c) Container closure records. Written records of all container
closure examinations shall specify the container code, the date and time
of container closure examination, the measurement(s) obtained, and any
corrective actions taken. Records shall be signed or initialed by the
container closure technician and shall be reviewed and signed by the
establishment within 1 working day after the actual production to ensure
that the records are complete and that the closing operations have been
properly controlled. All container closure examination records required
in this subpart shall be made available to Program employees for review.
(d) Distribution of product. Records shall be maintained by the
establishment identifying initial distribution of the finished product
to facilitate, if necessary, the segregation of specific production lots
that may have been contaminated or are otherwise unsound for their
intended use.
(e) Retention of records. Copies of all processing and production
records required in Sec. 381.306 shall be retained for no less than 1
year at the establishment, and for an additional 2 years at the
establishment or other location from which the records can be made
available to Program employees within 3 working days.
(Approved by the Office of Management and Budget under control number
0583-0015)
[51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.308]
[Page 557-559]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.308 Deviations in processing.
(a) Whenever the actual process is less than the process schedule or
when any critical factor does not comply with the requirements for that
factor as specified in the process schedule, it shall be considered a
deviation in processing.
(b) Deviations in processing (or process deviations) must be handled
according to:
(1)(i) A HACCP plan for canned product that addresses hazards
associated with microbial contamination, or,
(ii) Alternative documented procedures that will ensure that only
safe and stable product is shipped in commerce; or
(iii) Paragraph (d) of this section.
(2) Paragraph (d) of this section.
(c) [Reserved]
(d) Procedures for handling process deviations where the HACCP plan
for thermally processed/commercially sterile product does not address
food safety hazards associated with microbial contamination, where there
is no approved total quality control system, or where the establishment
has no alternative documented procedures for handling process
deviations.
(1) Deviations identified in-process. If a deviation is noted at any
time before the completion of the intended process schedule, the
establishment shall:
(i) Immediately reprocess the product using the full process
schedule; or,
(ii) Use an appropriate alternate process schedule provided such a
process schedule has been established in accordance with Sec. 381.302
(a) and (b) and is filed with the inspector in accordance with
Sec. 381.302(c); or,
(iii) Hold the product involved and have the deviation evaluated by
a processing authority to assess the safety and stability of the
product. Upon completion of the evaluation, the establishment shall
provide the inspector the following:
[[Page 558]]
(a) A complete description of the deviation along with all necessary
supporting documentation;
(b) A copy of the evaluation report; and,
(c) A description of any product disposition actions, either taken
or proposed.
(iv) Product handled in accordance with paragraph (d)(1)(iii) of
this section shall not be shipped from the establishment until the
Program has reviewed all of the information submitted and approved the
product disposition actions.
(v) If an alternate process schedule is used that is not on file
with the inspector or if an alternate process schedule is immediately
calculated and used, the product shall be set aside for further
evaluation in accordance with paragraphs (d)(1) (iii) and (iv) of this
section.
(vi) When a deviation occurs in a continuous rotary retort, the
product shall be handled in accordance with paragraphs (d)(1) (iii) and
(iv) of this section or in accordance with the following procedures:
(a) Emergency stops.
(1) When retort jams or breakdowns occur during the processing
operations, all containers shall be given an emergency still process
(developed per Sec. 381.302(b)) before the retort is cooled or the
retort shall be cooled promptly and all containers removed and either
reprocessed, repacked and reprocessed, or destroyed. Regardless of the
procedure used, containers in the retort intake valve and in transfer
valves between retort shells at the time of a jam or breakdown shall be
removed and either reprocessed, repacked and reprocessed, or destroyed.
Product to be destroyed shall be handled as "U.S. Inspected and
Condemned", as defined in Sec. 301.2(ee) of this chapter, and disposed
of in accordance with part 314 of this chapter.
(2) The time the retort reel stopped and the time the retort is used
for an emergency still retort process shall be noted on the temperature/
time recording device and entered on the other production records
required in Sec. 381.306.
(b) Temperature drops. When the retort temperature drops below the
temperature specified in the process schedule, the reel shall be stopped
and the following actions shall be taken:
(1) For temperature drops of less than 10 deg.F (or 5.5 deg.C)
either (i) all containers in the retort shall be given an emergency
still process (developed per Sec. 381.302(b)) before the reel is
restarted; (ii) container entry to the retort shall be prevented and an
emergency agitating process (developed per Sec. 381.302(b)) shall be
used before container entry to the retort is restarted; or (iii)
container entry to the retort shall be prevented and the reel restarted
to empty the retort. The discharged containers shall be reprocessed,
repacked and reprocessed, or destroyed. Product to be destroyed shall be
handled as "U.S. Inspected and Condemned", as defined in
Sec. 301.2(ee) of this chapter, and disposed of in accordance with part
314 of this chapter.
(2) For temperature drops of 10 deg.F (or 5.5 deg.C) or more, all
containers in the retort shall be given an emergency still process
(developed per Sec. 381.302(b)). The time the reel was stopped and the
time the retort was used for a still retort process shall be marked on
the temperature/time recording device by the establishment and entered
on the other production records required in Sec. 381.306. Alternatively,
container entry to the retort shall be prevented and the reel restarted
to empty the retort. The discharged containers shall be either
reprocessed, repacked and reprocessed, or destroyed. Product to be
destroyed shall be handled as "U.S. Inspected and Condemned" as
defined in Sec. 301.2(ee) of this chapter, and disposed of in accordance
with part 314 of this chapter.
(2) Deviations identified through record review. Whenever a
deviation is noted during review of the processing and production
records required by Sec. 381.307 (a) and (b), the establishment shall
hold the product involved and the deviation shall be handled in
accordance with paragraphs (d)(1) (iii) and (iv) of this section.
(e) Process deviation file. The establishment shall maintain full
records regarding the handling of each deviation. Such records shall
include, at a minimum, the appropriate processing and production
records, a full description of the corrective actions taken, the
evaluation procedures and results, and the
[[Page 559]]
disposition of the affected product. Such records shall be maintained in
a separate file or in a log that contains the appropriate information.
The file or log shall be retained in accordance with Sec. 381.307(e) and
shall be made available to Program employees upon request.
(Approved by the Office of Management and Budget under control number
0583-0015)
[51 FR 45634, Dec. 19, 1986, as amended at 62 FR 45027, Aug. 25, 1997;
65 FR 34390, May 30, 2000; 65 FR 53533, Sept. 5, 2000]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.309]
[Page 559-560]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.309 Finished product inspection.
(a) Finished product inspections must be handled according to:
(1) A HACCP plan for canned product that addresses hazards
associated with microbiological contamination; or
(2) An FSIS-approved total quality control system; or
(3) Alternative documented procedures that will ensure that only
product that is safe and stable is shipped in commerce; or
(4) Paragraph (d) of this section.
(b)-(c) [Reserved]
(d) Procedures for finished product inspections where the HACCP plan
for thermally processed/commercially sterile product does not address
food safety hazards associated with microbial contamination, where there
is no approved total quality control system, or where the establishment
has no alternative documented procedures for handling process
deviations.
(1) Incubation of shelf stable canned product--(i) Incubator. The
establishment shall provide incubation facilities which include an
accurate temperature/time recording device, an indicating temperature
device, a means for the circulation of the air inside the incubator to
prevent temperature variations, and a means to prevent unauthorized
entry into the facility. The Program is responsible for the security of
the incubator.
(ii) Incubation temperature. The incubation temperature shall be
maintained at 955 deg.F (352.8 deg.C). If the
incubation temperature falls below 90 deg.F (or 32 deg.C) or exceeds
100 deg.F (or 38 deg.C) but does not reach 103 deg.F (or 39.5
deg.C), the incubation temperature shall be adjusted within the required
range and the incubation time extended for the time the sample
containers were held at the deviant temperature. If the incubation
temperature is at or above 103 deg.F (or 39.5 deg.C) for more than 2
hours, the incubation test(s) shall be terminated, the temperature
lowered to within the required range, and new sample containers
incubated for the required time.
(iii) Product requiring incubation. Shelf stable product requiring
incubation includes:
(a) Low acid products as defined in Sec. 381.300(m); and
(b) Acidified low acid products as defined in Sec. 381.300(b).
(iv) Incubation samples. (a) From each load of product processed in
a batch-type thermal processing system (still or agitation), the
establishment shall select at least one container for incubation.
(b) For continuous rotary retorts, hydrostatic retorts, or other
continuous-type thermal processing systems, the establishment shall
select at least one container per 1,000 for incubation.
(c) Only normal-appearing containers shall be selected for
incubation.
(v) Incubation time. Canned product requiring incubation shall be
incubated for not less than 10 days (240 hours) under the conditions
specified in paragraph (d)(1)(ii) of this section.
(vi) Incubation checks and record maintenance. Designated
establishment employees shall visually check all containers under
incubation each working day and the inspector shall be notified when
abnormal containers are detected. All abnormal containers should be
allowed to cool before a final decision on their condition is made. For
each incubation test the establishment shall record at least the product
name, container size, container code, number of containers incubated, in
and out dates, and incubation results. The establishment shall retain
such records, along with copies of the temperature/time recording
charts, in accordance with Sec. 381.307(e).
(vii) Abnormal containers. The finding of abnormal containers (as
defined in Sec. 381.300(a)) among incubation samples is cause to
officially retain at least the code lot involved.
(viii) Shipping. No product shall be shipped from the establishment
before
[[Page 560]]
the end of the required incubation period except as provided in this
paragraph or paragraph (b) or (c) of this section. An establishment
wishing to ship product prior to the completion of the required
incubation period shall submit a written proposal to the area
supervisor. Such a proposal shall include provisions that will assure
that shipped product will not reach the retail level of distribution
before sample incubation is completed and that product can be returned
promptly to the establishment should such action be deemed necessary by
the incubation test results. Upon receipt of written approval from the
area supervisor, product may be routinely shipped provided the
establishment continues to comply with all requirements of this subpart.
(2) Container condition. (i) Normal containers. Only normal-
appearing containers shall be shipped from an establishment as
determined by an appropriate sampling plan or other means acceptable to
Program employees.
(ii) Abnormal containers. When abnormal containers are detected by
any means other than incubation, the establishment shall inform the
inspector and the affected code lot(s) shall not be shipped until the
Program has determined that the product is safe and stable. Such a
determination will take into account the cause and level of abnormals in
the affected lot(s) as well as any product disposition actions either
taken or proposed by the establishment.
(Approved by the Office of Management and Budget under control number
0583-0015)
[51 FR 45634, Dec. 19, 1986, as amended at 57 FR 37872, Aug. 21, 1992;
57 FR 55443, Nov. 25, 1992; 62 FR 45027, Aug. 25, 1997; 65 FR 34391, May
30, 2000; 65 FR 53533, Sept. 5, 2000]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.310]
[Page 560]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.310 Personnel and training.
All operators of thermal processing systems specified in
Sec. 381.305 and container closure technicians shall be under the direct
supervision of a person who has successfully completed a school of
instruction that is generally recognized as adequate for properly
training supervisors of canning operations.
[51 FR 45634, Dec. 19, 1986]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.311]
[Page 560]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart X--Canning and Canned Products
Sec. 381.311 Recall procedure.
Establishments shall prepare and maintain a current procedure for
the recall of all canned product covered by this subpart. Upon request,
the recall procedure shall be made available to Program employees for
review.
(Approved by the Office of Management and Budget under control number
0583-0015)
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.400]
[Page 560]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.400 Nutrition labeling of poultry products.
Source: 58 FR 675, Jan. 6, 1993, unless otherwise noted.
(a) Nutrition labeling shall be provided for all poultry products
intended for human consumption and offered for sale, except single-
ingredient, raw products, in accordance with the requirements of
Sec. 381.409, except as exempted under Sec. 381.500 of this subpart.
(b) Nutrition labeling may be provided for single-ingredient, raw
poultry products in accordance with the requirements of Secs. 381.409
and 381.445. Significant participation in voluntary nutrition labeling
shall be measured by the Agency in accordance with Secs. 381.443 and
381.444 of this subpart.
[58 FR 675, Jan. 6, 1993, as amended at 60 FR 197, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.402]
[Page 560-561]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.402 Location of nutrition information.
(a) Nutrition information on a label of a packaged poultry product
shall appear on the label's principal display panel or on the
information panel, except as provided in paragraphs (b) and (c) of this
section.
(b) Nutrition information for gift packs may be shown at a location
other than on the product label, provided that the labels for these
products bear no nutrition claim. In lieu of on the product label,
nutrition information may be provided by alternate means such as product
label inserts.
(c) Poultry products in packages that have a total surface area
available to bear labeling greater than 40 square inches but whose
principal display panel and information panel do not
[[Page 561]]
provide sufficient space to accommodate all required information may use
any alternate panel that can be readily seen by consumers for the
nutrition information. In determining the sufficiency of available space
for the nutrition information, the space needed for vignettes, designs,
and other nonmandatory label information on the principal display panel
may be considered.
[58 FR 675, Jan. 6, 1993, as amended at 59 FR 40215, Aug. 8, 1994]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.408]
[Page 561]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.408 Labeling of poultry products with number of servings.
The label of any package of a poultry product that bears a
representation as to the number of servings contained in such package
shall meet the requirements of Sec. 381.121(c)(7).
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.409]
[Page 561-580]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.409 Nutrition label content.
(a) All nutrient and food component quantities shall be declared in
relation to a serving as defined in this section.
(b)(1) The term "serving" or "serving size" means an amount of
food customarily consumed per eating occasion by persons 4 years of age
or older, which is expressed in a common household measure that is
appropriate to the product. When the product is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of
this section and for products that are intended for weight control and
are available only through a weight-control or weight-maintenance
program, the serving size declared on a product label shall be
determined from the "Reference Amounts Customarily Consumed Per Eating
Occasion--General Food Supply" (Reference Amount(s)) that appear in
Sec. 381.412(b) using the procedures described in this paragraph (b).
For products that are both intended for weight control and available
only through a weight-control program, a manufacturer may determine the
serving size that is consistent with the meal plan of the program. Such
products must bear a statement, "for sale only through the ------
program" (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal display
panel. However, the Reference Amounts in Sec. 381.412(b) shall be used
for purposes of evaluating whether weight-control products that are
available only through a weight-control program qualify for nutrition
claims.
(3) The declaration of nutrient and food component content shall be
on the basis of the product "as packaged" for all products, except
that single-ingredient, raw products may be declared on the basis of the
product "as consumed" as set forth in Sec. 381.445(a)(1). In addition
to the required declaration on the basis of "as packaged" for products
other than single ingredient, raw products, the declaration may also be
made on the basis of "as consumed," provided that preparation and
cooking instructions are clearly stated.
(4) For products in discrete units (e.g., chicken wings, and
individually packaged products within a multi-serving package), and for
products which consist of two or more foods packaged and presented to be
consumed together where the ingredient represented as the main
ingredient is in discrete units (e.g., chicken wings and barbecue
sauce), the serving size shall be declared as follows:
(i) If a unit weighs 50 percent or less of the Reference Amount, the
serving size shall be the number of whole units that most closely
approximates the Reference Amount for the product category.
(ii) If a unit weighs more than 50 percent but less than 67 percent
of the Reference Amount, the manufacturer may declare one unit or two
units as the serving size.
(iii) If a unit weighs 67 percent or more but less than 200 percent
of the Reference Amount, the serving size shall be one unit.
(iv) If a unit weighs 200 percent or more of the Reference Amount,
the manufacturer may declare one unit as the serving size if the whole
unit can
[[Page 562]]
reasonably be consumed at a single eating occasion.
(v) For products that have Reference Amounts of 100 grams (or
milliliter) or larger and are individual units within a multi-serving
package, if a unit contains more than 150 percent but less than 200
percent of the Reference Amount, the manufacturer may decide whether to
declare the individual unit as 1 or 2 servings.
(vi) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., chicken wings and
barbecue sauce), the serving size may be the number of discrete units
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product as determined
in Sec. 381.412(c).
(vii) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving containers),
the serving size shall be 1 unit.
(5) For products in large discrete units that are usually divided
for consumption (e.g., pizza, pan of poultry lasagna), for unprepared
products where the entire contents of the package is used to prepare
large discrete units that are usually divided for consumption (e.g.,
pizza kit), and for products which consist of two or more foods packaged
and presented to be consumed together where the ingredient represented
as the main ingredient is a large discrete unit usually divided for
consumption, the serving size shall be the fractional slice of the
ready-to-eat product (e.g., \1/8\ quiche, \1/4\ pizza) that most closely
approximates the Reference Amount for the product category. The serving
size may be the fraction of the package used to make the Reference
Amount for the unprepared product determined in Sec. 381.412(d) or the
fraction of the large discrete unit represented as the main ingredient
plus proportioned minor ingredients used to make the Reference Amount of
the combined product determined in Sec. 381.412(c). In expressing the
fractional slice, manufacturers shall use \1/2\, \1/3\, \1/4\, \1/5\,
\1/6\, or smaller fractions that can be generated by further division by
2 or 3.
(6) For nondiscrete bulk products (e.g., whole turkey, turkey
breast, ground poultry), and for products which consist of two or more
foods packaged and presented to be consumed together where the
ingredient represented as the main ingredient is a bulk product (e.g.,
turkey breast and gravy), the serving size shall be the amount in
household measure that most closely approximates the Reference Amount
for the product category and may be the amount of the bulk product
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product determined in
Sec. 381.412(c).
(7) For labeling purposes, the term "common household measure" or
"common household unit" means cup, tablespoon, teaspoon, piece, slice,
fraction (e.g., \1/4\ pizza), ounce (oz), or other common household
equipment used to package food products (e.g., jar or tray). In
expressing serving size in household measures, except as specified in
paragraphs (b)(7)(iv), (v), and (vi) of this section, the following
rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup
increments, tablespoons in whole number of tablespoons for quantities
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp),
1, 1\1/3\, 1\1/2\, or 1\2/3\ tbsp for quantities less than 2 tbsp but
greater than or equal to 1 tbsp, and teaspoons in whole number of
teaspoons for quantities less than 1 tbsp but greater than or equal to 1
teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 1
tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If cups, tablespoons and teaspoons, or units such as piece,
slice, tray, jar, or fraction are not applicable, ounces may be used.
Ounce measurements shall be expressed in 0.5-ounce
[[Page 563]]
increments most closely approximating the Reference Amount with rounding
indicated by the use of the term "about" (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be
used for single-serving containers and meal-type products and for
individually packaged products within multi-serving containers (e.g.,
can, box, package, meal, or dinner). A description of the individual
unit shall be used for other products in discrete units (e.g., wing,
slice, link, or patty).
(v) For unprepared products where the entire contents of the package
is used to prepare large discrete units that are usually divided for
consumption (e.g., pizza kit), the fraction or portion of the package
may be used.
(vi) For products that consist of two or more distinct ingredients
or components packaged and presented to be consumed together (e.g.,
chicken wings with a glaze packet), the nutrition information may be
declared for each component or as a composite. The serving size may be
provided in accordance with the provisions of paragraphs (b)(4), (b)(5),
and (b)(6) of this section.
(vii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz
in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in
Sec. 381.412(b) and the procedures described in this section, falls
exactly half way between two serving sizes (e.g., 2.5 tbsp),
manufacturers shall round the serving size up to the next incremental
size.
(8) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable Reference Amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving, except for products that
have Reference Amounts of 100 g (or mL) or larger, manufacturers may
decide whether a package that contains more than 150 percent but less
than 200 percent of the Reference Amount is 1 or 2 servings. Packages
sold individually that contain 200 percent or more of the applicable
Reference Amount may be labeled as a single-serving if the entire
content of the package can reasonably be consumed at a single-eating
occasion.
(9) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs (b)(2)
through (b)(8) of this section and shall be followed by the equivalent
metric quantity in parenthesis (fluids in milliliters and all other
foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement on
the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to paragraph
(b)(11) of this section. However, if a manufacturer voluntarily provides
the metric quantity on products that can be sold as single servings,
then the numerical value provided as part of the serving size
declaration must be identical to the metric quantity declaration
provided as part of the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household
measure should be rounded to the nearest whole number except for
quantities that are less than 5 g (mL). The gram (mL) quantity between 2
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL)
quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(iii) In addition, serving size may be declared in ounce, in
parenthesis, following the metric measure separated by a slash where
other common household measures are used as the primary unit for serving
size, e.g., 1 slice (28 g/1 oz) for sliced chicken roll. The ounce
quantity equivalent to the metric quantity should be expressed in 0.1-oz
increments.
(iv) If a manufacturer elects to use abbreviations for units, the
following abbreviations shall be used: tbsp for tablespoon, tsp for
teaspoon, g for gram, mL for milliliter, and oz for ounce.
(10) Determination of the number of servings per container shall be
based on the serving size of the product determined by following the
procedures described in this section.
[[Page 564]]
(i) The number of servings shall be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term "about" (e.g., about 2 servings;
about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained
solids basis and the number of servings varies because of a natural
variation in unit size, the manufacturer may state the typical number of
servings per container (e.g., usually 5 servings).
(iii) For random weight products, a manufacturer may declare
"varied" for the number of servings per container provided the
nutrition information is based on the Reference Amount expressed in
ounces. The manufacturer may provide the typical number of servings in
parenthesis following the "varied" statement (e.g., varied
(approximately 8 servings per pound)).
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving containers),
the number of servings shall be the number of individual packages within
the total package.
(v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by multiplying
the number of individual multi-serving units in the total package by the
number of servings in each individual unit.
(11) The declaration of nutrient and food component content shall be
on the basis of product as packaged or purchased with the exception of
products that are packed or canned in water, brine, or oil but whose
liquid packing medium is not customarily consumed. Declaration of the
nutrient and food component content of products that are packed in
liquid which is not customarily consumed shall be based on the drained
solids.
(12) Serving size for meal-type products as defined in
Sec. 381.413(l) shall be the entire content (edible portion only) of the
package.
(13) Another column of figures may be used to declare the nutrient
and food component information in the same format as required by
Sec. 381.409(e),
(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as
packaged or purchased.
(ii) Per one unit if the serving size of a product in discrete units
in a multi-serving container is more than one unit.
(14) If a product consists of assortments of poultry products (e.g.,
variety packs) in the same package, nutrient content shall be expressed
on the entire package contents or on each individual product.
(15) If a product is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare the nutrient contents on the basis of the product as
consumed for the product alone (e.g., a cream soup mix may be labeled
with one set of Daily Values for the dry mix (per serving), and another
set for the serving of the final soup when prepared (e.g., per serving
of cream soup mix and 1 cup of vitamin D fortified whole milk)):
Provided, that the type and quantity of the other ingredients to be
added to the product by the user and the specific method of cooking and
other preparation shall be specified prominently on the label.
(c) The declaration of nutrition information on the label or in
labeling of a poultry product shall contain information about the level
of the following nutrients, except for those nutrients whose inclusion,
and the declaration of amounts, is voluntary as set forth in this
paragraph. No nutrients or food components other than those listed in
this paragraph as either mandatory or voluntary may be included within
the nutrition label. Except as provided for in paragraph (f) or (g) of
this section, nutrient information shall be presented using the nutrient
names specified and in the following order in the formats specified in
paragraph (d) or (e) of this section.
[[Page 565]]
(1) "Calories, total," "Total calories," or "Calories": A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero. Energy content per serving may also be
expressed in kilojoule units, added in parenthesis immediately following
the statement of the caloric content.
(i) Caloric content may be calculated by the following methods.
Where either specific or general food factors are used, the factors
shall be applied to the actual amount (i.e., before rounding) of food
components (e.g., fat, carbohydrate, protein, or ingredients with
specific food factors) present per serving.
(A) Using specific Atwater factors (i.e., the Atwater method) given
in Table 13, page 25, "Energy Value of Foods--Basis and Derivation,"
by A. L. Merrill and B. K. Watt, United States Department of Agriculture
(USDA), Agriculture Handbook No. 74 (Slightly revised February 1973),
which is incorporated by reference. Table 13 of the "Energy Value of
Foods--Basis and Derivation," Agriculture Handbook No. 74 is
incorporated as it exists on the date of approval. This incorporation by
reference was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for
inspection at the Office of the Federal Register, suite 700, 800 North
Capitol Street, NW., Washington, DC, or at the office of the FSIS Docket
Clerk, Room 3171, South Building, 14th and Independence Avenue, SW.,
Washington, DC. Copies of the incorporation by reference are available
from the Product Assessment Division, Regulatory Programs, Food Safety
and Inspection Service, U.S. Department of Agriculture, Room 329, West
End Court Building, Washington, DC 20250-3700;
(B) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate, and total fat, respectively, as described
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973),
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture
Handbook No. 74 is incorporated as it exists on the date of approval.
This incorporation by reference was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
(The availability of this incorporation by reference is given in
paragraph (c)(1)(i)(A) of this section.);
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate less the amount of insoluble dietary fiber,
and total fat, respectively, as described in USDA's Agriculture Handbook
No. 74 (Slightly revised February 1973), pages 9-11, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. (The availability of this incorporation by reference is given
in paragraph (c)(1)(i)(A) of this section.); or
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of 21 CFR, or by other means, as
appropriate.
(ii) "Calories from fat": A statement of the caloric content
derived from total fat as defined in paragraph (c)(2) of this section
per serving, expressed to the nearest 5-calorie increment, up to and
including 50 calories, and the nearest 10-calorie increment above 50
calories, except that label declaration of "calories from fat" is not
required on products that contain less than 0.5 gram of fat per serving
and amounts less than 5 calories may be expressed as zero. This
statement shall be declared as provided in paragraph (d)(5) of this
section.
(iii) "Calories from saturated fat" or "Calories from saturated"
(VOLUNTARY): A statement of the caloric content derived from saturated
fat as defined in paragraph (c)(2)(i) of this section per serving may be
declared voluntarily, expressed to the nearest 5-calorie increment, up
to and including 50 calories, and the nearest 10-calorie increment above
50 calories, except that amounts less than 5 calories may be expressed
as zero. This statement shall be indented under the statement of
calories from fat as provided in paragraph (d)(5) of this section.
(2) "Fat, total" or "Total fat": A statement of the number of
grams of total fat per serving defined as total
[[Page 566]]
lipid fatty acids and expressed as triglycerides. Amounts shall be
expressed to the nearest 0.5 (\1/2\)-gram increment below 5 grams and to
the nearest gram increment above 5 grams. If the serving contains less
than 0.5 gram, the content shall be expressed as zero.
(i) "Saturated fat" or "Saturated": A statement of the number of
grams of saturated fat per serving defined as the sum of all fatty acids
containing no double bonds, except that label declaration of saturated
fat content information is not required for products that contain less
than 0.5 gram of total fat per serving if no claims are made about fat
or cholesterol content, and if "calories from saturated fat" is not
declared. Saturated fat content shall be indented and expressed as grams
per serving to the nearest 0.5 (\1/2\)-gram increment below 5 grams and
to the nearest gram increment above 5 grams. If the serving contains
less than 0.5 gram, the content shall be expressed as zero.
(A) "Stearic Acid" (VOLUNTARY): A statement of the number of grams
of stearic acid per serving may be declared voluntarily, except that
when a claim is made about stearic acid, label declaration shall be
required. Stearic acid content shall be indented under saturated fat and
expressed to the nearest 0.5 (\1/2\)-gram increment below 5 grams and
the nearest gram increment above 5 grams. If the serving contains less
than 0.5 gram, the content shall be expressed as zero.
(B) [Reserved]
(ii) "Polyunsaturated fat" or "Polyunsaturated" (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat per serving
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may
be declared voluntarily, except that when monounsaturated fat is
declared, or when a claim about fatty acids or cholesterol is made on
the label or in labeling of a product other than one that meets the
criteria in Sec. 381.462(b)(1) for a claim for "fat free," label
declaration of polyunsaturated fat is required. Polyunsaturated fat
content shall be indented and expressed as grams per serving to the
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram
increment above 5 grams. If the serving contains less than 0.5 gram, the
content shall be expressed as zero.
(iii) "Monounsaturated fat" or "Monounsaturated" (VOLUNTARY): A
statement of the number of grams of monounsaturated fat per serving
defined as cis-monounsaturated fatty acids may be declared voluntarily,
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a
product other than one that meets the criteria in Sec. 381.462(b)(1) for
a claim for "fat free," label declaration of monounsaturated fat is
required. Monounsaturated fat content shall be indented and expressed as
grams per serving to the nearest 0.5 (\1/2\)-gram increment below 5
grams and to the nearest gram increment above 5 grams. If the serving
contains less than 0.5 gram, the content shall be expressed as zero.
(3) "Cholesterol": A statement of the cholesterol content per
serving expressed in milligrams to the nearest 5-milligram increment,
except that label declaration of cholesterol information is not required
for products that contain less than 2 milligrams of cholesterol per
serving and make no claim about fat, fatty acids, or cholesterol
content, or such products may state the cholesterol content as zero. If
the product contains 2 to 5 milligrams of cholesterol per serving, the
content may be stated as "less than 5 milligrams."
(4) "Sodium": A statement of the number of milligrams of sodium
per serving expressed as zero when the serving contains less than 5
milligrams of sodium, to the nearest 5-milligram increment when the
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140
milligrams.
(5) "Potassium" (VOLUNTARY): A statement of the number of
milligrams of potassium per serving may be declared voluntarily, except
that when a claim is made about potassium content, label declaration
shall be required. Potassium content shall be expressed as zero when the
serving contains less than 5 milligrams of potassium, to the nearest 5-
milligram increment when the serving contains 5 to
[[Page 567]]
140 milligrams of potassium, and to the nearest 10-milligram increment
when the serving contains greater than 140 milligrams.
(6) "Carbohydrate, total" or "Total carbohydrate": A statement
of the number of grams of total carbohydrate per serving expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement "Contains less than 1 gram" or "less than 1 gram" may
be used as an alternative, or, if the serving contains less than 0.5
gram, the content may be expressed as zero. Total carbohydrate content
shall be calculated by subtraction of the sum of the crude protein,
total fat, moisture, and ash from the total weight of the product. This
calculation method is described in USDA's Agriculture Handbook No. 74
(Slightly revised February 1973), pages 2 and 3, which is incorporated
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated
as it exists on the date of approval. This incorporation by reference
was approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this
incorporation by reference is given in paragraph (c)(1)(i)(A) of this
section.).
(i) "Dietary fiber": A statement of the number of grams of total
dietary fiber per serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required, or, alternatively, the statement
"Contains less than 1 gram" or "less than 1 gram" may be used, and
if the serving contains less than 0.5 gram, the content may be expressed
as zero.
(A) "Soluble fiber" (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber per serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
"Contains less than 1 gram" or "less than 1 gram" may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(B) "Insoluble fiber" (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber per serving may be declared voluntarily
except when a claim is made on the label or in labeling about insoluble
fiber, label declaration shall be required. Insoluble fiber content
shall be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
"Contains less than 1 gram" or "less than 1 gram" may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(ii) "Sugars": A statement of the number of grams of sugars per
serving, except that label declaration of sugars content is not required
for products that contain less than 1 gram of sugars per serving if no
claims are made about sweeteners, sugars, or sugar alcohol content.
Sugars shall be defined as the sum of all free mono- and disaccharides
(such as glucose, fructose, lactose, and sucrose). Sugars content shall
be indented and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement "Contains less than 1 gram"
or "less than 1 gram" may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.
(iii) "Sugar alcohol" (VOLUNTARY): A statement of the number of
grams of sugar alcohols per serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
product, sugar alcohol content shall be declared. For nutrition labeling
purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of
the term "sugar alcohol," the name of the specific sugar alcohol
(e.g., "xylitol") present in the product may be used in the nutrition
label, provided that only one sugar alcohol is present in the product.
Sugar alcohol content
[[Page 568]]
shall be indented and expressed to the nearest gram, except that if a
serving contains less than 1 gram, the statement "Contains less than 1
gram" or "less than 1 gram" may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.
(iv) "Other carbohydrate" (VOLUNTARY): A statement of the number
of grams of other carbohydrate per serving may be declared voluntarily.
Other carbohydrate shall be defined as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared (even if present), it shall
be defined as the difference between total carbohydrate and the sum of
dietary fiber and sugars. Other carbohydrate content shall be indented
and expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement "Contains less than 1 gram" or "less
than 1 gram" may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero.
(7) "Protein": A statement of the number of grams of protein per
serving expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement "Contains less than 1 gram" or "less
than 1 gram" may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero. When the
protein in products represented or purported to be for adults and
children 4 or more years of age has a protein quality value that is a
protein digestibility-corrected amino acid score of less than 20
expressed as a percent, or when the protein in a product represented or
purported to be for children greater than 1 but less than 4 years of age
has a protein quality value that is a protein digestibility-corrected
amino acid score of less than 40 expressed as a percent, either of the
following shall be placed adjacent to the declaration of protein content
by weight: The statement "not a significant source of protein," or a
listing aligned under the column headed "Percent Daily Value" of the
corrected amount of protein per serving, as determined in paragraph
(c)(7)(ii) of this section, calculated as a percentage of the Daily
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate,
for protein and expressed as percent of Daily Value. When the protein
quality in a product as measured by the Protein Efficiency Ratio (PER)
is less than 40 percent of the reference standard (casein) for a product
represented or purported to be for infants, the statement "not a
significant source of protein" shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on the
basis of the factor of 6.25 times the nitrogen content of the food as
determined by appropriate methods of analysis in accordance with
Sec. 381.409(h), except when the procedure for a specific food requires
another factor.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be for infants or
children under 4 years of age. When such a declaration is provided, it
shall be placed on the label adjacent to the statement of grams of
protein and aligned under the column headed "Percent Daily Value," and
expressed to the nearest whole percent. However, the percentage of the
RDI for protein shall not be declared if the product is represented or
purported to be for infants and the protein quality value is less than
40 percent of the reference standard.
(ii) The corrected amount of protein (grams) per serving for
products represented or purported to be for adults and children 1 or
more years of age is equal to the actual amount of protein (grams) per
serving multiplied by the amino acid score corrected for protein
digestibility. If the corrected score is above 1.00, then it shall be
set at 1.00. The protein digestibility-corrected amino acid score shall
be determined by methods given in sections 5.4.1, 7.2.1, and 8 in
"Protein Quality Evaluation, Report of the Joint FAO/WHO Expert
[[Page 569]]
Consultation on Protein Quality Evaluation," Rome, 1990, which is
incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the "Report
of the Joint FAO/WHO Expert Consultation on Protein Quality
Evaluation," as published by the Food and Agriculture Organization of
the United Nations/World Health Organization, is incorporated as it
exists on the date of approval. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the
Office of the Federal Register, suite 700, 800 North Capitol Street,
NW., Washington, DC, or at the office of the FSIS Docket Clerk, Room
3171, South Building, 14th and Independence Avenue, SW., Washington, DC.
Copies of the incorporation by reference are available from the Product
Assessment Division, Regulatory Programs, Food Safety and Inspection
Service, U.S. Department of Agriculture, Room 329, West End Court
Building, Washington, DC 20250-3700. For products represented or
purported to be for infants, the corrected amount of protein (grams) per
serving is equal to the actual amount of protein (grams) per serving
multiplied by the relative protein quality value. The relative protein
quality value shall be determined by dividing the subject product's
protein PER value by the PER value for casein. If the relative protein
value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the DRV or RDI,
a value of 50 grams of protein shall be the DRV for adults and children
4 or more years of age, and the RDI for protein for children less than 4
years of age, infants, pregnant women, and lactating women shall be 16
grams, 14 grams, 60 grams, and 65 grams, respectively.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, calculated as
a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d) through (g) of this section, products
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women shall use the RDI's
that are specified for the intended group. For products represented or
purported to be for use by both infants and children under 4 years of
age, the percent of Daily Value shall be presented by separate
declarations according to paragraph (e) of this section based on the RDI
values for infants from birth to 12 months of age and for children under
4 years of age. Similarly, the percent of Daily Value based on both the
RDI values for pregnant women and for lactating women shall be declared
separately on products represented or purported to be for use by both
pregnant and lactating women. When such dual declaration is used on any
label, it shall be included in all labeling, and equal prominence shall
be given to both values in all such labeling. All other products shall
use the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a percent of the
RDI shall include vitamin A, vitamin C, calcium, and iron, in that
order, and shall include any of the other vitamins and minerals listed
in paragraph (c)(8)(iv) of this section when they are added, or when a
claim is made about them. Other vitamins and minerals need not be
declared if neither the nutrient nor the component is otherwise referred
to on the label or in labeling or advertising and the vitamins and
minerals are:
(A) Required or permitted in a standardized food (e.g., thiamin,
riboflavin, and niacin in enriched flour) and that standardized food is
included as an ingredient (i.e., component) in another product; or
(B) Included in a product solely for technological purposes and
declared only in the ingredients statement. The declaration may also
include any of the other vitamins and minerals listed in paragraph
(c)(8)(iv) of this section when they are naturally occurring in the
food. The additional vitamins and minerals shall be listed in the order
established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment up to and
[[Page 570]]
including the 10-percent level, the nearest 5-percent increment above 10
percent and up to and including the 50-percent level, and the nearest
10-percent increment above the 50-percent level. Amounts of vitamins and
minerals present at less than 2 percent of the RDI are not required to
be declared in nutrition labeling but may be declared by a zero or by
the use of an asterisk (or other symbol) that refers to another asterisk
(or symbol) that is placed at the bottom of the table and that is
followed by the statement "Contains less than 2 percent of the Daily
Value of this (these) nutrient (nutrients)." Alternatively, if vitamin
A, vitamin C, calcium, or iron is present in amounts less than 2 percent
of the RDI, label declaration of the nutrient(s) is not required if the
statement "Not a significant source of -------- (listing the vitamins
or minerals omitted)" is placed at the bottom of the table of nutrient
values.
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams
(v) The following synonyms may be added in parenthesis immediately
following the name of the nutrient or dietary component:
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folacin
Calories--Energy
(vi) A statement of the percent of vitamin A that is present as
beta-carotene may be declared voluntarily. When the vitamins and
minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are
arrayed horizontally, the statement of percent shall be presented in
parenthesis following the declaration of vitamin A and the percent of
Daily Value of vitamin A in the product (e.g., "Percent Daily Value:
Vitamin A 50 (90 percent as beta-carotene)"). When declared, the
percentages shall be expressed in the same increments as are provided
for vitamins and minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the
following DRV's are established for the following food components based
on the reference caloric intake of 2,000 calories:
------------------------------------------------------------------------
Food component Unit of measurement DRV
------------------------------------------------------------------------
Fat................................... grams (g)............... 65
Saturated fatty acids................. ......do................ 20
Cholesterol........................... milligrams (mg)......... 300
Total carbohydrate.................... grams (g)............... 300
Fiber................................. ......do................ 25
Sodium................................ milligrams (mg)......... 2400
Potassium............................. ......do................ 3500
Protein............................... grams (g)............... 50
------------------------------------------------------------------------
(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on products in the following format, except
on products on which dual columns of nutrition information are declared
as provided for in paragraph (e) of this section, on those products on
which the simplified format is permitted to be used as provided for in
paragraph (f) of this section, on products for infants and children less
than 4 years of age as provided for in Sec. 381.500(c), and on products
in packages that have a total surface area available to bear labeling of
40 or less square inches as provided for in paragraph (g) of this
section.
(i) The nutrition information shall be set off in a box by use of
hairlines and shall be all black or one color type, printed on a white
or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
[[Page 571]]
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of
text) except that at least four points leading shall be utilized for the
information required by paragraphs (d)(7) and (d)(8) of this section,
and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and
(d)(8) of this section shall be in type size no smaller than 8 point.
Except for the heading "Nutrition Facts," the information required in
paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other
information contained within the nutrition label shall be in type size
no smaller than 6 point. When provided, the information described in
paragraph (d)(10) of this section shall also be in type no smaller than
6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6)
of this section (i.e., "Nutrition Facts," "Amount Per Serving," and
"% Daily Value*"), the names of all nutrients that are not indented
according to requirements of paragraph (c) of this section (i.e.,
Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate,
and Protein), and the percentage amounts required by paragraph
(d)(7)(ii) of this section shall be highlighted by bold or extra bold
type or other highlighting (reverse printing is not permitted as a form
of highlighting) that prominently distinguishes it from other
information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text shall
separate "Amount Per Serving" from the calorie statements required in
paragraph (d)(5) of this section and shall separate each nutrient and
its corresponding percent of Daily Value required in paragraphs
(d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent
of Daily Value above and below it.
(2) The information shall be presented under the identifying heading
of "Nutrition Facts" which shall be set in a type size larger than all
other print size in the nutrition label and, except for labels presented
according to the format provided for in paragraph (d)(11) of this
section, unless impractical, shall be set the full width of the
information provided under paragraph (d)(7) of this section.
(3) Information on serving size shall immediately follow the
heading. Such information shall include:
(i) "Serving Size": A statement of the serving size as specified
in paragraph (b)(9) of this section.
(ii) "Servings Per Container": The number of servings per
container, except that this statement is not required on single-serving
containers as defined in paragraph (b)(8) of this section.
(4) A subheading "Amount Per Serving" shall be separated from
serving size information by a bar.
(5) Information on calories shall immediately follow the heading
"Amount Per Serving" and shall be declared in one line, leaving
sufficient space between the declaration of "Calories" and "Calories
from fat" to allow clear differentiation, or, if "Calories from
saturated fat" is declared, in a column with total "Calories" at the
top, followed by "Calories from fat" (indented), and "Calories from
saturated fat" (indented).
(6) The column heading "% Daily Value," followed by an asterisk
(e.g., "% Daily Value*"), shall be separated from information on
calories by a bar. The position of this column heading shall allow for a
list of nutrient names and amounts as described in paragraph (d)(7) of
this section to be to the left of, and below, this column heading. The
column heading "Percent Daily Value," "Percent DV," or "% DV" may
be substituted for "% Daily Value."
(7) Except as provided for in paragraph (g) of this section, and
except as permitted by Sec. 381.500(d)(2), nutrient information for both
mandatory and any voluntary nutrients listed in paragraph (c) of this
section that are to be declared in the nutrition label, except vitamins
and minerals, shall be declared as follows:
(i) The name of each nutrient, as specified in paragraph (c) of this
section, shall be given in a column and followed immediately by the
quantitative amount by weight for that nutrient appended with a "g"
for grams or "mg" for milligrams.
(ii) A listing of the percent of the DRV as established in
paragraphs
[[Page 572]]
(c)(7)(iii) and (c)(9) of this section shall be given in a column
aligned under the heading "% Daily Value" established in paragraph
(d)(6) of this section with the percent expressed to the nearest whole
percent for each nutrient declared in the column described in paragraph
(d)(7)(i) of this section for which a DRV has been established, except
that the percent for protein may be omitted as provided in paragraph
(c)(7) of this section. The percent shall be calculated by dividing
either the amount declared on the label for each nutrient or the actual
amount of each nutrient (i.e., before rounding) by the DRV for the
nutrient, except that the percent for protein shall be calculated as
specified in paragraph (c)(7)(ii) of this section. The numerical value
shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns, except that when more than
four vitamins and minerals are declared, they may be declared vertically
with percentages listed under the column headed "% Daily Value."
(9) A footnote, preceded by an asterisk, shall be placed beneath the
list of vitamins and minerals and shall be separated from that list by a
hairline.
(i) The footnote shall state: Percent Daily Values are based on a
2,000 calorie diet. Your daily values may be higher or lower depending
on your calorie needs.
------------------------------------------------------------------------
Calories 2,000 2,500
------------------------------------------------------------------------
Total fat..................... Less than..... 65 g 80 g
Saturated fat................. Less than..... 20 g 25 g
Cholesterol................... Less than..... 300 mg 300 mg
Sodium........................ Less than..... 2400 mg 2400 mg
Total carbohydrate............ .............. 300 g 375 g
Dietary fiber................. .............. 25 g 30 g
------------------------------------------------------------------------
(ii) If the percent of Daily Value is given for protein in the
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of
this section, protein shall be listed under dietary fiber, and a value
of 50 g shall be inserted on the same line in the column headed
"2,000" and value of 65 g in the column headed "2,500."
(iii) If potassium is declared in the column described in paragraph
(d)(7)(i) of this section, potassium shall be listed under sodium and
the DRV established in paragraph (c)(9) of this section shall be
inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (g)(2) of this
section may be used within the footnote.
(10) Caloric conversion information on a per-gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in paragraph (d)(9), separated from that information by a
hairline. This information may be presented horizontally (i.e.,
"Calories per gram: Fat 9, Carbohydrate 4, Protein 4") or vertically
in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in
paragraph (d)(9) of this section, the information required in paragraph
(d)(9) may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent of Daily Value information. The
caloric conversion information provided for in paragraph (d)(10) of this
section may be presented beneath either side or along the full length of
the nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not
adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in paragraph (d)(9) of this
section, the remaining information may be moved to the right and set off
by a line that distinguishes it and sets it apart from the percent of
Daily Value information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately 3 inches) to accommodate the required components of the
nutrition label up to and including the mandatory declaration of iron,
the nutrition label may be presented in a tabular display in which
[[Page 573]]
the footnote required by paragraph (d)(9) of the section is given to the
far right of the label, and additional vitamins and minerals beyond the
four that are required (i.e., vitamin A, vitamin C, calcium, and iron)
are arrayed horizontally following declarations of the required vitamins
and minerals.
(12) The following sample label illustrates the provisions of
paragraph (d) of this section:
[[Page 574]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.053
(13)(i) Nutrition labeling on the outer label of packages of poultry
products that contain two or more products in the same packages (e.g.,
variety packs) or of packages that are used interchangeably for the same
type of food (e.g., poultry salad containers) may use an aggregate
display.
(ii) Aggregate displays shall comply with format requirements of
paragraph
[[Page 575]]
(d) of this section to the maximum extent possible, except that the
identity of each food shall be specified to the right of the "Nutrition
Facts" title, and both the quantitative amount by weight (i.e., g/mg
amounts) and the percent Daily Value for each nutrient shall be listed
in separate columns under the name of each food.
(14) When nutrition labeling appears in a second language, the
nutrition information may be presented in a separate nutrition label for
each language or in one nutrition label with the information in the
second language following that in English. Numeric characters that are
identical in both languages need not be repeated (e.g., "Protein/
Proteinas 2 g"). All required information must be included in both
languages.
(e) Nutrition information may be presented for two or more forms of
the same product (e.g., both "raw" and "cooked") or for common
combinations of foods as provided for in paragraph (b) of this section,
or for different units (e.g., per 100 grams) as provided for in
paragraph (b) of this section, or for two or more groups for which RDI's
are established (e.g., both infants and children less than 4 years of
age) as provided for in paragraph (c)(8)(i) of this section. When such
dual labeling is provided, equal prominence shall be given to both sets
of values. Information shall be presented in a format consistent with
paragraph (d) of this section, except that:
(1) Following the subheading of "Amount Per Serving," there shall
be two or more column headings accurately describing the forms of the
same product (e.g., "raw" and "roasted"), the combinations of foods,
the units, or the RDI groups that are being declared. The column
representing the product as packaged and according to the label serving
size based on the Reference Amount in Sec. 381.412(b) shall be to the
left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of the
same product, for combinations of foods, or for different units, total
calories and calories from fat (and calories from saturated fat, when
declared) shall be listed in a column and indented as specified in
paragraph (d)(5) of this section with quantitative amounts declared in
columns aligned under the column headings set forth in paragraph (e)(1)
of this section.
(3) Quantitative information by weight required in paragraph
(d)(7)(i) of this section shall be specified for the form of the product
as packaged and according to the label serving size based on the
Reference Amount in Sec. 381.412(b).
(i) Quantitative information by weight may be included for other
forms of the product represented by the additional column(s) either
immediately adjacent to the required quantitative information by weight
for the product as packaged and according to the label serving size
based on the Reference Amount in Sec. 381.412(b) or as a footnote.
(A) If such additional quantitative information is given immediately
adjacent to the required quantitative information, it shall be declared
for all nutrients listed and placed immediately following and
differentiated from the required quantitative information (e.g.,
separated by a comma). Such information shall not be put in a separate
column.
(B) If such additional quantitative information is given in a
footnote, it shall be declared in the same order as the nutrients are
listed in the nutrition label. The additional quantitative information
may state the total nutrient content of the product identified in the
second column or the nutrient amounts added to the product as packaged
for only those nutrients that are present in different amounts than the
amounts declared in the required quantitative information. The footnote
shall clearly identify which amounts are declared. Any subcomponents
declared shall be listed parenthetically after principal components
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
(ii) Total fat and its quantitative amount by weight shall be
followed by an asterisk (or other symbol) (e.g., "Total fat (2 g)*")
referring to another asterisk (or symbol) at the bottom of the nutrition
label identifying the form(s) of the product for which quantitative
information is presented.
[[Page 576]]
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this
section shall be presented under the subheading "% DAILY VALUE" and in
columns directly under the column headings set forth in paragraph (e)(1)
of this section.
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
[[Page 577]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.054
(f)(1) Nutrition information may be presented in a simplified format
as set forth herein when any required nutrients, other than the core
nutrients (i.e., calories, total fat, sodium, total carbohydrate, and
protein), are present in insignificant amounts. An insignificant amount
shall be defined as that
[[Page 578]]
amount that may be rounded to zero in nutrition labeling, except that
for total carbohydrate, dietary fiber, sugars and protein, it shall be
an amount less than 1 gram.
(2) The simplified format shall include information on the following
nutrients:
(i) Total calories, total fat, total carbohydrate, sodium, and
protein;
(ii) Any of the following that are present in more than
insignificant amounts: Calories from fat, saturated fat, cholesterol,
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are added in fortified or fabricated foods.
(3) Other nutrients that are naturally present in the product in
more than insignificant amounts may be voluntarily declared as part of
the simplified format.
(4) Any required nutrient, other than a core nutrient, that is
present in an insignificant amount may be omitted from the tabular
listing, provided that the following statement is included at the bottom
of the nutrition label, "Not a significant source of --------." The
blank shall be filled in with the appropriate nutrient or food
component. Alternatively, amounts of vitamins and minerals present in
insignificant amounts may be declared by the use of an asterisk (or
symbol) that is placed at the bottom of the table of nutrient values and
that is followed by the statement "Contains less than 2 percent of the
Daily Value of this (these) nutrient (nutrients)."
(5) Except as provided for in paragraph (g) of this section and in
Sec. 381.500(c) and (d), nutrient information declared in the simplified
format shall be presented in the same manner as specified in paragraphs
(d) or (e) of this section, except that the footnote required in
paragraph (d)(9) of this section is not required. When the footnote is
omitted, an asterisk shall be placed at the bottom of the label followed
by the statement "Percent Daily Values are based on a 2,000 calorie
diet" and, if the term "Daily Value" is not spelled out in the
heading, a statement that "DV" represents "Daily Value."
(g) Foods in packages that have a total surface area available to
bear labeling of 40 or less square inches may modify the requirements of
paragraphs (c) through (f) of this section and Sec. 381.402(a) by one or
more of the following means:
(1)(i) Presenting the required nutrition information in a tabular or
linear (i.e., string) fashion, rather than in vertical columns if the
product has a total surface area available to bear labeling of less than
12 square inches, or if the product has a total surface area available
to bear labeling of 40 or less square inches and the package shape or
size cannot accommodate a standard vertical column or tabular display on
any label panel. Nutrition information may be given in a linear fashion
only if the package shape or size will not accommodate a tabular
display.
(ii) When nutrition information is given in a linear display, the
nutrition information shall be set off in a box by the use of a
hairline. The percent Daily Value is separated from the quantitative
amount declaration by the use of parenthesis, and all nutrients, both
principal components and subcomponents, are treated similarly. Bolding
is required only on the title "Nutrition Facts" and is allowed for
nutrient names for "Calories," "Total fat," "Cholesterol,"
"Sodium," "Total carbohydrate," and "Protein."
(2) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
(3) Omitting the footnote required in paragraph (d)(9) of this
section and placing another asterisk at the bottom of the label followed
by the statement "Percent Daily Values are based on a 2,000 calorie
diet" and, if the term "Daily Value" is not spelled out in the
[[Page 579]]
heading, a statement that "DV" represents "Daily Value."
(4) Presenting the required information on any other label panel.
(h) Compliance with this section shall be determined as follows:
(1) A production lot is a set of food production consumer units that
are from one production shift. Alternatively, a collection of consumer
units of the same size, type, and style produced under conditions as
nearly uniform as possible, designated by a common container code or
marking, constitutes a production lot.
(2) The sample for nutrient analysis shall consist of a composite of
a minimum of six consumer units, each from a production lot.
Alternatively, the sample for nutrient analysis shall consist of a
composite of a minimum of six consumer units, each randomly chosen to be
representative of a production lot. In each case, the units may be
individually analyzed and the results of the analyses averaged, or the
units would be composited and the composite analyzed. In both cases, the
results, whether an average or a single result from a composite, will be
considered by the Agency to be the nutrient content of a composite. All
analyses shall be performed by appropriate methods and procedures used
by the Department for each nutrient in accordance with the "Chemistry
Laboratory Guidebook," or, if no USDA method is available and
appropriate for the nutrient, by appropriate methods for the nutrient in
accordance with the 1990 edition of the "Official Methods of Analysis"
of the AOAC International, formerly Association of Official Analytical
Chemists, 15th ed., which is incorporated by reference, unless a
particular method of analysis is specified in Sec. 381.409(c), or, if no
USDA, AOAC, or specified method is available and appropriate, by other
reliable and appropriate analytical procedures as so determined by the
Agency. The "Official Methods of Analysis" is incorporated as it
exists on the date of approval. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC
International, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201. It is
also available for inspection at the Office of the Federal Register
Information Center, suite 700, 800 North Capitol Street, NW.,
Washington, DC.
(3) Two classes of nutrients are defined for purposes of compliance:
(i) Class I. Added nutrients in fortified or fabricated foods; and
(ii) Class II. Naturally occurring (indigenous) nutrients. If any
ingredient which contains a naturally occurring (indigenous) nutrient is
added to a food, the total amount of such nutrient in the final food
product is subject to Class II requirements unless the same nutrient is
also added, which would make the total amount of such nutrient subject
to Class I requirements.
(4) A product with a label declaration of a vitamin, mineral,
protein, total carbohydrate, dietary fiber, other carbohydrate,
polyunsaturated or monounsaturated fat, or potassium shall be deemed to
be misbranded under section 4(h) of the Poultry Products Inspection Act
(21 U.S.C. 453(h)(4)) unless it meets the following requirements:
(i) Class I vitamin, mineral, protein, dietary fiber, or potassium.
The nutrient content of the composite is at least equal to the value for
that nutrient declared on the label.
(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or
potassium. The nutrient content of the composite is at least equal to 80
percent of the value for that nutrient declared on the label; Provided,
That no regulatory action will be based on a determination of a nutrient
value which falls below this level by an amount less than the
variability generally recognized for the analytical method used in that
product at the level involved, and inherent nutrient variation in a
product.
(5) A product with a label declaration of calories, sugars, total
fat, saturated fat, cholesterol, or sodium shall be deemed to be
misbranded under section 4(h) of the Poultry Products Inspection Act (21
U.S.C. 453(h)(4)) if the nutrient content of the composite is greater
than 20 percent in excess of the value for that nutrient declared on the
label; Provided, That no regulatory action will be based on a
determination of a
[[Page 580]]
nutrient value which falls above this level by an amount less than the
variability generally recognized for the analytical method used in that
product at the level involved, and inherent nutrient variation in a
product.
(6) The amount of a vitamin, mineral, protein, total carbohydrate,
dietary fiber, other carbohydrate, polyunsaturated or monounsaturated
fat, or potassium may vary over labeled amounts within good
manufacturing practice. The amount of calories, sugars, total fat,
saturated fat, cholesterol, or sodium may vary under labeled amounts
within good manufacturing practice.
(7) Compliance will be based on the metric measure specified in the
label statement of serving size.
(8) The management of the establishment must maintain records to
support the validity of nutrient declarations contained on product
labels. Such records shall be made available to the inspector or any
duly authorized representative of the Agency upon request.
(9) The compliance provisions set forth in paragraph (h)(1) through
(8) of this section shall not apply to single-ingredient, raw poultry
products, including those that have been previously frozen, when
nutrition labeling is based on the most current representative data base
values contained in USDA's National Nutrient Data Bank or its published
form, the Agriculture Handbook No. 8 series.
(Paperwork requirements were approved by the Office of Management and
Budget under control number 0583-0088.)
[58 FR 675, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58
FR 47628, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 197, Jan. 3,
1995; 60 FR 10304, Feb. 24, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.412]
[Page 580-585]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.412 Reference amounts customarily consumed per eating occasion.
(a) The general principles followed in arriving at the reference
amounts customarily consumed per eating occasion (Reference Amount(s)),
as set forth in paragraph (b) of this section, are:
(1) The Reference Amounts are calculated for persons 4 years of age
or older to reflect the amount of food customarily consumed per eating
occasion by persons in this population group. These Reference Amounts
are based on data set forth in appropriate national food consumption
surveys.
(2) The Reference Amounts are calculated for an infant or child
under 4 years of age to reflect the amount of food customarily consumed
per eating occasion by infants up to 12 months of age or by children 1
through 3 years of age, respectively. These Reference Amounts are based
on data set forth in appropriate national food consumption surveys. Such
Reference Amounts are to be used only when the product is specially
formulated or processed for use by an infant or by a child under 4 years
of age.
(3) An appropriate national food consumption survey includes a large
sample size representative of the demographic and socioeconomic
characteristics of the relevant population group and must be based on
consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating
occasion, the mean, median, and mode of the consumed amount per eating
occasion were considered.
(5) When survey data were insufficient, FSIS took various other
sources of information on serving sizes of food into consideration.
These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or
recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the
Reference Amount and, in turn, the serving size declared on the product
label are based on only the edible portion of food, and not bone, seed,
shell, or other inedible components.
(7) The Reference Amount is based on the major intended use of the
product (e.g., a mixed dish measurable with a cup as a main dish and not
as a side dish).
[[Page 581]]
(8) The Reference Amounts for products that are consumed as an
ingredient of other products, but that may also be consumed in the form
in which they are purchased (e.g., ground poultry), are based on use in
the form purchased.
(9) FSIS sought to ensure that foods that have similar dietary
usage, product characteristics, and customarily consumed amounts have a
uniform Reference Amount.
(b) The following Product Categories and Reference Amounts shall be
used as the basis for determining serving sizes for specific products:
Table 1--Reference Amounts Customarily Consumed per Eating Occasion--
Infant and Toddler Foods 1,2,3
------------------------------------------------------------------------
Reference
Product category amount
------------------------------------------------------------------------
Infant & Toddler Foods:
Dinner Dry Mix............................................ 15 g
Dinner, ready-to-serve, strained type..................... 60 g
Dinner, soups, ready-to-serve junior type................. 110 g
Dinner, stew or soup ready-to-serve toddlers.............. 170 g
Plain poultry and poultry sticks, ready-to-serve.......... 55 g
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-1978 and the
1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the Reference
Amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve). If not listed separately, the
Reference Amount for the unprepared form (e.g., dehydrated cereal) is
the amount required to make one Reference Amount of the prepared form.
\3\ Manufacturers are required to convert the Reference Amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures established by the regulation.
Table 2--Reference Amounts Customarily Consumed per Eating Occasion--General Food Supply 1,2,3,4,5
----------------------------------------------------------------------------------------------------------------
Reference Amount Reference Amount
Product category -----------------------------------------------------------------------
Ready-to-serve Ready-to-cook
----------------------------------------------------------------------------------------------------------------
Egg mixtures, (western style omelet, 110 g n/a
souffle, egg foo young with poultry).
Salad and potato toppers; e.g., poultry 7 g n/a
bacon bits.
Bacon; e.g., poultry breakfast strips... 15 g 26 g = bacon.
18 g = breakfast strips
Dried; e.g., poultry jerky, dried 30 g n/a
poultry, poultry sausage products with
a moisture/protein ratio of less than
2:1.
Snacks; e.g., poultry snack food sticks. 30 g n/a
Luncheon products, poultry bologna, 55 g n/a
poultry Canadian style bacon, poultry
crumbles, poultry luncheon loaf, potted
poultry products, poultry taco filings.
Linked poultry sausage products, poultry 55 g n/a
franks, poultry Polish sausage, smoked 69 g = uncooked sausage.
or pickled poultry meat, poultry smoked
sausage.
Entrees without sauce, poultry cuts, 85 g 114g
ready to cook poultry cuts, including
marinated, tenderized, injected cuts of
poultry, poultry corn dogs, poultry
croquettes, poultry fritters, cured
poultry ham products, adult pureed
poultry.
Canned poultry, canned chicken, canned 55 g n/a
\4\ turkey.
Entrees with sauce, turkey and gravy.... 140 g n/a
Mixed dishes NOT measurable with a cup; 140 g (plus 55 g for products n/a
\5\ e.g., poultry burrito, poultry toppings)
enchiladas, poultry pizza, poultry
quiche, all types of poultry
sandwiches, cracker and poultry lunch-
type packages, poultry gyro, poultry
stromboli, poultry frank on a bun,
poultry burger on a bun, poultry taco,
chicken cordon bleu, poultry calzone,
stuffed vegetables with poultry,
poultry kabobs.
Mixed dishes, measurables with a cup; 1 cup n/a
e.g., poultry casserole, macaroni and
cheese with poultry, poultry pot pie,
poultry spaghetti with sauce, poultry
chili, poultry chili with beans,
poultry hash, creamed dried poultry,
poultry ravioli in sauce, poultry a la
king, poultry stew, poultry goulash,
poultry lasagna, poultry-filled pasta.
Salads--pasta or potato, potato salad 140 g n/a
with poultry, macaroni and poultry
salad.
Salads--all other, poultry salads, 100 g n/a
chicken salad, turkey salad.
Soups--all varieties.................... 245 g n/a
Major main entree type sauce; e.g., 125 g n/a
spaghetti sauce with poultry.
Minor main entree sauce; e.g., pizza \1/4\ cup n/a
sauce with poultry, gravy.
Seasoning mixes dry, freeze dry,
dehydrated, concentrated soup mixes,
bases, extracts, dried broths and stock/
juice, freeze dry trail mix products
with poultry.
[[Page 582]]
As reconstituted: Amount to make one
Reference Amount of the final dish;
e.g.--
Gravy............................... \1/4\ cup n/a
Major main entree type sauce........ 125 g n/a
Soup................................ 245 g n/a
Entree measurable with a cup........ 1 cup n/a
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per eating occasion and were primarily
derived from the 1977-78 and the 1987-88 Nationwide Food Consumption Surveys conducted by the U.S. Department
of Agriculture.
\2\ Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure
most appropriate to their specific product using the procedures established by regulation.
\3\ Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist
manufacturers in identifying appropriate product Reference Amount.
\4\ If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which
both the solids and liquids are customarily consumed.
\5\ Pizza sauce is part of the pizza and is not considered to be a sauce topping.
(c) For products that have no Reference Amount listed in paragraph
(b) of this section for the unprepared or the prepared form of the
product and that consist of two or more foods packaged and presented to
be consumed together (e.g., poultry lunch meat with cheese and
crackers), the Reference Amount for the combined product shall be
determined using the following rules:
(1) For bulk products, the Reference Amount for the combined product
shall be the Reference Amount, as established in paragraph (b) of this
section, for the ingredient that is represented as the main ingredient
plus proportioned amounts of all minor ingredients.
(2) For products where the ingredient represented as the main
ingredient is one or more discrete units, the Reference Amount for the
combined product shall be either the number of small discrete units or
the fraction of the large discrete unit that is represented as the main
ingredient that is closest to the Reference Amount for that ingredient
as established in paragraph (b) of this section plus proportioned
amounts of all minor ingredients.
(3) If the Reference Amounts are in compatible units, they shall be
summed (e.g., ingredients in equal volumes such as tablespoons). If the
Reference Amounts are in incompatible units, the weights of the
appropriate volumes should be used (e.g., grams of one ingredient plus
gram weight of tablespoons of a second ingredient).
(d) If a product requires further preparation, e.g., cooking or the
addition of water or other ingredients, and if paragraph (b) of this
section provides a Reference Amount for the product in the prepared
form, then the Reference Amount for the unprepared product shall be
determined using the following rules:
(1) Except as provided for in paragraph (d)(2) of this section, the
Reference Amount for the unprepared product shall be the amount of the
unprepared product required to make the Reference Amount for the
prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used to
prepare one large discrete unit usually divided for consumption, the
Reference Amount for the unprepared product shall be the amount of the
unprepared product required to make the fraction of the large discrete
unit closest to the Reference Amount for the prepared product as
established in paragraph (b) of this section.
(e) The Reference Amount for an imitation or substitute product or
altered product as defined in Sec. 381.413(d), such as a "low calorie"
version, shall be the same as for the product for which it is offered as
a substitute.
(f) The Reference Amounts set forth in paragraphs (b) through (e) of
this section shall be used in determining whether a product meets the
criteria for nutritional claims. If the serving
[[Page 583]]
size declared on the product label differs from the Reference Amount,
and the product meets the criteria for the claim only on the basis of
the Reference Amount, the claim shall be followed by a statement that
sets forth the basis on which the claim is made. That statement shall
include the Reference Amount as it appears in paragraph (b) of this
section followed, in parenthesis, by the amount in common household
measure if the Reference Amount is expressed in measures other than
common household measures.
(g) The Administrator, on his or her own initiative or on behalf of
any interested person who has submitted a labeling application, may
issue a proposal to establish or amend a Product Category or Reference
Amount identified in paragraph (b) of this section.
(1) Labeling applications and supporting documentation to be filed
under this section shall be submitted in quadruplicate, except that the
supporting documentation may be submitted on a computer disc copy. If
any part of the material submitted is in a foreign language, it shall be
accompanied by an accurate and complete English translation. The
labeling application shall state the applicant's post office address.
(2) Pertinent information will be considered as part of an
application on the basis of specific reference to such information
submitted to and retained in the files of the Food Safety and Inspection
Service. However, any reference to unpublished information furnished by
a person other than the applicant will not be considered unless use of
such information is authorized (with the understanding that such
information may in whole or part be subject to release to the public) in
a written statement signed by the person who submitted it. Any reference
to published information should be accompanied by reprints or
photostatic copies of such references.
(3) The availability for public disclosure of labeling applications,
along with supporting documentation, submitted to the Agency under this
section will be governed by the rules specified in subchapter D, title
9.
(4) Data accompanying the labeling application, such as food
consumption data, shall be submitted on separate sheets, suitably
identified. If such data has already been submitted with an earlier
labeling application from the applicant, the present labeling
application must provide the data.
(5) The labeling application must be signed by the applicant or by
his or her attorney or agent, or (if a corporation) by an authorized
official.
(6) The labeling application shall include a statement signed by the
person responsible for the labeling application, that to the best of his
or her knowledge, it is a representative and balanced submission that
includes unfavorable information, as well as favorable information,
known to him or her pertinent to the evaluation of the labeling
application.
(7) Labeling applications for a new Reference Amount and/or Product
Category shall be accompanied by the following data which shall be
submitted in the following form to the Director, Food Labeling Division,
Regulatory Programs, Food Safety and Inspection Service, Washington, DC
20250:
________________________________________________________________________
(Date)
The undersigned, ------------ submits this labeling application
pursuant to 9 CFR 381.412 with respect to Reference Amount and/or
Product Category.
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement of the objective of the labeling application;
(ii) A description of the product;
(iii) A complete sample product label including nutrition label,
using the format established by regulation;
(iv) A description of the form in which the product will be
marketed;
(v) The intended dietary uses of the product with the major use
identified (e.g., turkey as a luncheon meat);
(vi) If the intended use is primarily as an ingredient in other
foods, list of foods or food categories in which the product will be
used as an ingredient with information on the prioritization of the use;
(vii) The population group for which the product will be offered for
use (e.g., infants, children under 4 years of age);
(viii) The names of the most closely-related products (or in the
case of foods for special dietary use and imitation or substitute foods,
the names of the products for which they are offered as substitutes);
[[Page 584]]
(ix) The suggested Reference Amount (the amount of edible portion of
food as consumed, excluding bone, skin or other inedible components) for
the population group for which the product is intended with full
description of the methodology and procedures that were used to
determine the suggested Reference Amount. In determining the Reference
Amount, general principles and factors in paragraph (a) of this section
should be followed.
(x) The suggested Reference Amount shall be expressed in metric
units. Reference Amounts for foods shall be expressed in grams except
when common household units such as cups, tablespoons, and teaspoons are
more appropriate or are more likely to promote uniformity in serving
sizes declared on product labels. For example, common household measures
would be more appropriate if products within the same category differ
substantially in density such as mixed dishes measurable with a cup.
(A) In expressing the Reference Amount in grams, the following
general rules shall be followed:
(1) For quantities greater than 10 grams, the quantity shall be
expressed in nearest 5 grams increment.
(2) For quantities less than 10 grams, exact gram weights shall be
used.
(B) [Reserved]
(xi) A labeling application for a new subcategory of food with its
own Reference Amount shall include the following additional information:
(A) Data that demonstrate that the new subcategory of food will be
consumed in amounts that differ enough from the Reference Amount for the
parent category to warrant a separate Reference Amount. Data must
include sample size, and the mean, standard deviation, median, and modal
consumed amount per eating occasion for the product identified in the
labeling application and for other products in the category. All data
must be derived from the same survey data.
(B) Documentation supporting the difference in dietary usage and
product characteristics that affect the consumption size that
distinguishes the product identified in the labeling application from
the rest of the products in the category.
(xii) In conducting research to collect or process food consumption
data in support of the labeling application, the following general
guidelines should be followed.
(A) Sampled population selected should be representative of the
demographic and socioeconomic characteristics of the target population
group for which the food is intended.
(B) Sample size (i.e., number of eaters) should be large enough to
give reliable estimates for customarily consumed amounts.
(C) The study protocol should identify potential biases and describe
how potential biases are controlled for or, if not possible to control,
how they affect interpretation of results.
(D) The methodology used to collect or process data including study
design, sampling procedures, materials used (e.g., questionnaire,
interviewer's manual), procedures used to collect or process data,
methods or procedures used to control for unbiased estimates, and
procedures used to correct for nonresponse, should be fully documented.
(xiii) A statement concerning the feasibility of convening
associations, corporations, consumers, and other interested parties to
engage in negotiated rulemaking to develop a proposed rule.
Yours very truly,
Applicant_________________________________________________________
By________________________________________________________________
(Indicate authority)
(8) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall inform
the applicant that the labeling application is undergoing Agency review
and that the applicant shall subsequently be notified of the Agency's
decision to consider for further review or deny the labeling
application.
(9) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(10) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
Reference Amount and/or Product Category is false or misleading. The
notification letter shall inform the applicant that the applicant may
submit a written statement by way of answer to the notification, and
that the applicant shall have the right to request a hearing with
respect to the merits or validity of the Administrator's decision to
deny the use of the proposed Reference Amount and/or Product Category.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the
[[Page 585]]
initial determination to be correct, the Administrator shall file with
the Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(11) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish in the Federal Register a
proposed rule to amend the regulations to authorize the use of the
Reference Amount and/or Product Category. The proposal shall also
summarize the labeling application, including where the supporting
documentation can be reviewed. The Administrator's proposed rule shall
seek comment from consumers, the industry, consumer and industry groups,
and other interested persons on the labeling application and the use of
the proposed Reference Amount and/or Product Category. After public
comment has been received and reviewed by the Agency, the Administrator
shall make a determination on whether the proposed Reference Amount and/
or Product Category shall be approved for use on the labeling of poultry
products.
(i) If the Reference Amount and/or Product Category is denied by the
Administrator, the Agency shall notify the applicant, in writing, of the
basis for the denial, including the reason why the Reference Amount and/
or Product Category on the labeling was determined by the Agency to be
false or misleading. The notification letter shall also inform the
applicant that the applicant may submit a written statement by way of
answer to the notification, and that the applicant shall have the right
to request a hearing with respect to the merits or validity of the
Administrator's decision to deny the use of the proposed Reference
Amount and/or Product Category.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia.
(ii) If the Reference Amount and/or Product Category is approved,
the Agency shall notify the applicant, in writing, and shall also
publish in the Federal Register a final rule amending the regulations to
authorize the use of the Reference Amount and/or Product Category.
(Paperwork requirements were approved by the Office of Management and
Budget under control number 0583-0088.)
[58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58
FR 47628, Sept. 10, 1993; 59 FR 45198, Sept. 1, 1994; 60 FR 207, Jan. 3,
1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.413]
[Page 585-589]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.413 Nutrient content claims; general principles.
(a) This section applies to poultry products that are intended for
human consumption and that are offered for sale.
[[Page 586]]
(b) A claim which, expressly or by implication, characterizes the
level of a nutrient (nutrient content claim) of the type required in
nutrition labeling pursuant to Sec. 381.409, may not be made on a label
or in labeling of that product unless the claim is made in accordance
with the applicable provisions in this subpart.
(1) An expressed nutrient content claim is any direct statement
about the level (or range) of a nutrient in the product, e.g., "low
sodium" or "contains 100 calories."
(2) An implied nutrient content claim is any claim that:
(i) Describes the product or an ingredient therein in a manner that
suggests that a nutrient is absent or present in a certain amount (e.g.,
"high in oat bran"); or
(ii) Suggests that the product, because of its nutrient content, may
be useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient (e.g.,
"healthy, contains 3 grams (g) of fat").
(3) Except for claims regarding vitamins and minerals described in
paragraph (q)(3) of this section, no nutrient content claims may be made
on products intended specifically for use by infants and children less
than 2 years of age unless the claim is specifically provided for in
subpart Y of this part.
(4) Reasonable variations in the spelling of the terms defined in
applicable provisions in this subpart and their synonyms are permitted
provided these variations are not misleading (e.g., "hi" or "lo").
(c) Information that is required or permitted by Sec. 381.409 to be
declared in nutrition labeling, and that appears as part of the
nutrition label, is not a nutrient content claim and is not subject to
the requirements of this section. If such information is declared
elsewhere on the label or in labeling, it is a nutrient content claim
and is subject to the requirements for nutrient content claims.
(d) A "substitute" product is one that may be used interchangeably
with another product that it resembles, i.e., that it is
organoleptically, physically, and functionally (including shelf life)
similar to, and that it is not nutritionally inferior to unless it is
labeled as an "imitation."
(1) If there is a difference in performance characteristics that
materially limits the use of the product, the product may still be
considered a substitute if the label includes a disclaimer adjacent to
the most prominent claim as defined in paragraph (j)(2)(iii) of this
section, informing the consumer of such difference (e.g., "not
recommended for frying").
(2) This disclaimer shall be in easily legible print or type and in
a size no less than that required by Sec. 381.121(c) for the net
quantity of contents statement, except where the size of the claim is
less than two times the required size of the net quantity of contents
statement, in which case the disclaimer statement shall be no less than
one-half the size of the claim but no smaller than \1/16\-inch minimum
height, except as permitted by Sec. 381.500(d)(2).
(e)(1) Because the use of a "free" or "low" claim before the
name of a product implies that the product differs from other products
of the same type by virtue of its having a lower amount of the nutrient,
only products that have been specially processed, altered, formulated,
or reformulated so as to lower the amount of the nutrient in the
product, remove the nutrient from the product, or not include the
nutrient in the product, may bear such a claim (e.g., "low sodium
chicken noodle soup").
(2) Any claim for the absence of a nutrient in a product, or that a
product is low in a nutrient when the product has not been specially
processed, altered, formulated, or reformulated to qualify for that
claim shall indicate that the product inherently meets the criteria and
shall clearly refer to all products of that type and not merely to the
particular brand to which the labeling attaches (e.g., "chicken breast
meat, a low sodium food").
(f) A nutrient content claim shall be in type size and style no
larger than two times that of the statement of identity and shall not be
unduly prominent in type style compared to the statement of identity.
(g) Labeling information required in Secs. 381.413, 381.454,
381.456, 381.460, 381.461, 381.462, and 381.480, whose type size is
[[Page 587]]
not otherwise specified, is required to be in letters and/or numbers no
less than \1/16\ inch in height, except as permitted by
Sec. 381.500(d)(2).
(h) [Reserved]
(i) Except as provided in Sec. 381.409 or in paragraph (q)(3) of
this section, the label or labeling of a product may contain a statement
about the amount or percentage of a nutrient if:
(1) The use of the statement on the product implicitly characterizes
the level of the nutrient in the product and is consistent with a
definition for a claim, as provided in subpart Y of this part, for the
nutrient that the label addresses. Such a claim might be, "less than 10
g of fat per serving;"
(2) The use of the statement on the product implicitly characterizes
the level of the nutrient in the product and is not consistent with such
a definition, but the label carries a disclaimer adjacent to the
statement that the product is not "low" in or a "good source" of the
nutrient, such as "only 200 milligrams (mg) sodium per serving, not a
low sodium product." The disclaimer must be in easily legible print or
type and in a size no less than required by Sec. 381.121(c) for the net
quantity of contents, except where the size of the claim is less than
two times the required size of the net quantity of contents statement,
in which case the disclaimer statement shall be no less than one-half
the size of the claim but no smaller than \1/16\-inch minimum height,
except as permitted by Sec. 381.500(d)(2);
(3) The statement does not in any way implicitly characterize the
level of the nutrient in the product and it is not false or misleading
in any respect (e.g., "100 calories" or "5 grams of fat"), in which
case no disclaimer is required.
(4) "Percent fat free" claims are not authorized by this
paragraph. Such claims shall comply with Sec. 381.462(b)(6).
(j) A product may bear a statement that compares the level of a
nutrient in the product with the level of a nutrient in a reference
product. These statements shall be known as "relative claims" and
include "light," "reduced," "less" (or "fewer"), and "more"
claims.
(1) To bear a relative claim about the level of a nutrient, the
amount of that nutrient in the product must be compared to an amount of
nutrient in an appropriate reference product as specified in this
paragraph (j).
(i)(A) For "less" (or "fewer") and "more" claims, the
reference product may be a dissimilar product within a product category
that can generally be substituted for one another in the diet or a
similar product.
(B) For "light," "reduced," and "added" claims, the reference
product shall be a similar product, and
(ii)(A) For "light" claims, the reference product shall be
representative of the type of product that includes the product that
bears the claim. The nutrient value for the reference product shall be
representative of a broad base of products of that type; e.g., a value
in a representative, valid data base; an average value determined from
the top three national (or regional) brands, a market basket norm; or,
where its nutrient value is representative of the product type, a market
leader. Firms using such a reference nutrient value as a basis for a
claim, are required to provide specific information upon which the
nutrient value was derived, on request, to consumers and appropriate
regulatory officials.
(B) For relative claims other than "light," including "less" and
"more" claims, the reference product may be the same as that provided
for "light" in paragraph (j)(1)(ii)(A) of this section or it may be
the manufacturer's regular product, or that of another manufacturer,
that has been offered for sale to the public on a regular basis for a
substantial period of time in the same geographic area by the same
business entity or by one entitled to use its trade name, provided the
name of the competitor is not used on the labeling of the product. The
nutrient values used to determine the claim when comparing a single
manufacturer's product to the labeled product shall be either
[[Page 588]]
the values declared in nutrition labeling or the actual nutrient values,
provided that the resulting labeling is internally consistent (i.e.,
that the values stated in the nutrition information, the nutrient values
in the accompanying information, and the declaration of the percentage
of nutrient by which the product has been modified are consistent and
will not cause consumer confusion when compared), and that the actual
modification is at least equal to the percentage specified in the
definition of the claim.
(2) For products bearing relative claims:
(i) The label or labeling must state the identity of the reference
product and the percent (or fraction) of the amount of the nutrient in
the reference product by which the nutrient has been modified, (e.g.,
"50 percent less fat than `reference product' " or "\1/3\ fewer
calories than `reference product' "); and
(ii) This information shall be immediately adjacent to the most
prominent claim in easily legible boldface print or type, in distinct
contrast to other printed or graphic matter, that is no less than that
required by Sec. 381.121(c) for net quantity of contents, except where
the size of the claim is less than two times the required size of the
net quantity of contents statement, in which case the referral statement
shall be no less than one-half the size of the claim, but no smaller
than \1/16\-inch minimum height, except as permitted by
Sec. 381.500(d)(2).
(iii) The determination of which use of the claim is in the most
prominent location on the label or labeling will be made based on the
following factors, considered in order:
(A) A claim on the principal display panel adjacent to the statement
of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount
of the subject nutrient in the product per labeled serving size with
that in the reference product; and
(B) This statement shall appear adjacent to the most prominent claim
or to the nutrition information.
(3) A relative claim for decreased levels of a nutrient may not be
made on the label or in labeling of a product if the nutrient content of
the reference product meets the requirement for a "low" claim for that
nutrient.
(k) The term "modified" may be used in the statement of identity
of a product that bears a relative claim that complies with the
requirements of this part, followed immediately by the name of the
nutrient whose content has been altered (e.g., "modified fat `product'
"). This statement of identity must be immediately followed by the
comparative statement such as "contains 35 percent less fat than
`reference product'." The label or labeling must also bear the
information required by paragraph (j)(2) of this section in the manner
prescribed.
(l) For purposes of making a claim, a "meal-type product" shall be
defined as a product that:
(1) Makes a significant contribution to the diet by weighing at
least 6 ounces, but no more than 12 ounces per serving (container), and
(2) Contains ingredients from two or more of the following four food
groups:
(i) Bread, cereal, rice and pasta group,
(ii) Fruits and vegetables group,
(iii) Milk, yogurt, and cheese group, and
(iv) Meat, poultry, fish, dry beans, eggs, and nuts group, and
(3) Is represented as, or is in a form commonly understood to be a
breakfast, lunch, dinner, meal, main dish, entree, or pizza. Such
representations may be made either by statements, photographs, or
vignettes.
(m) [Reserved]
(n) Nutrition labeling in accordance with Sec. 381.409 shall be
provided for any food for which a nutrient content claim is made.
(o) Compliance with requirements for nutrient content claims shall
be in accordance with Sec. 381.409(h).
(p)(1) Unless otherwise specified, the reference amount customarily
consumed set forth in Sec. 381.412(b) through
[[Page 589]]
(e) shall be used in determining whether a product meets the criteria
for a nutrient content claim. If the serving size declared on the
product label differs from the reference amount customarily consumed,
and the amount of the nutrient contained in the labeled serving does not
meet the maximum or minimum amount criterion in the definition for the
descriptor for that nutrient, the claim shall be followed by the
criteria for the claim as required by Sec. 381.412(f) (e.g., "very low
sodium, 35 mg or less per 55 grams").
(2) The criteria for the claim shall be immediately adjacent to the
most prominent claim in easily legible print or type and in a size that
is no less than that required by Sec. 381.121(c) for net quantity of
contents, except where the size of the claim is less than two times the
required size of the net quantity of contents statement, in which case
the criteria statement shall be no less than one-half the size of the
claim but no smaller than 1/16-inch minimum height, except as permitted
by Sec. 381.500(d)(2).
(q) The following exemptions apply:
(1) Nutrient content claims that have not been defined by regulation
and that appear as part of a brand name that was in use prior to
November 27, 1991, may continue to be used as part of that brand name,
provided they are not false or misleading under section 4(h) of the Act
(21 U.S.C. 453(h)(4)).
(2) [Reserved]
(3) A statement that describes the percentage of a vitamin or
mineral in the food, including foods intended specifically for use by
infants and children less than 2 years of age, in relation to a
Reference Daily Intake (RDI) as defined in Sec. 381.409 may be made on
the label or in the labeling of a food without a regulation authorizing
such a claim for a specific vitamin or mineral.
(4) The requirements of this section do not apply to infant formulas
and medical foods, as described in 21 CFR 101.13(q)(4).
(5) [Reserved]
(6) Nutrient content claims that were part of the name of a product
that was subject to a standard of identity as of November 27, 1991, are
not subject to the requirements of paragraph (b) of this section whether
or not they meet the definition of the descriptive term.
(7) Implied nutrient content claims may be used as part of a brand
name, provided that the use of the claim has been authorized by FSIS.
Labeling applications requesting approval of such a claim may be
submitted pursuant to Sec. 381.469.
[58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58
FR 47628, Sept. 10, 1993; 59 FR 40215, Aug. 8, 1994; 59 FR 45198, Sept.
1, 1994; 60 FR 208, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.443]
[Page 589]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.443 Significant participation for voluntary nutrition labeling.
(a) In evaluating significant participation for voluntary nutrition
labeling, FSIS will consider only the major cuts of single-ingredient,
raw poultry products, as identified in Sec. 381.444, including those
that have been previously frozen.
(b) FSIS will judge a food retailer to be participating at a
significant level if the retailer provides nutrition labeling
information for at least 90 percent of the major cuts of single-
ingredient, raw poultry products, listed in Sec. 381.444, that it sells,
and if the nutrition label is consistent in content and format with the
mandatory program, or nutrition information is displayed at point-of-
purchase in an appropriate manner.
(c) To determine whether there is significant participation by
retailers under the voluntary nutrition labeling guidelines, FSIS will
select a representative sample of companies allocated by type and size.
(d) FSIS will find that significant participation by food retailers
exists if at least 60 percent of all companies that are evaluated are
participating in accordance with the guidelines.
(e) FSIS will evaluate significant participation of the voluntary
program every 2 years beginning in May 1995.
(1) If significant participation is found, the voluntary nutrition
labeling guidelines shall remain in effect.
(2) If significant participation is not found, FSIS shall initiate
rulemaking to require nutrition labeling on those products under the
voluntary program.
[[Page 590]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.444]
[Page 590]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.444 Identification of major cuts of poultry products.
The major cuts of single-ingredient, raw poultry products are: Whole
chicken (without neck and giblets), chicken breast, chicken wing,
chicken drumstick, chicken thigh, whole turkey (without necks and
giblets; separate nutrient panels for white and dark meat permitted as
an option), turkey breast, turkey wing, turkey drumstick, and turkey
thigh.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.445]
[Page 590-591]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.445 Guidelines for voluntary nutrition labeling of single-ingredient, raw products.
(a) Nutrition information on the cuts of single-ingredient, raw
poultry products, including those that have been previously frozen,
shall be provided in the following manner:
(1) If a retailer or manufacturer chooses to provide nutrition
information on the label of these products, these products shall be
subject to all requirements of the mandatory nutrition labeling program,
except that nutrition labeling may be declared on the basis of either
"as consumed" or "as packaged." In addition, the declaration of the
number of servings per container need not be included in nutrition
labeling of single-ingredient, raw poultry products, including those
that have been previously frozen.
(2) A retailer may choose to provide nutrition information at the
point-of-purchase, such as by posting a sign, or by making the
information readily available in brochures, notebooks, or leaflet form
in close proximity to the food. The nutrition labeling information may
also be supplemented by a video, live demonstration, or other media. If
a nutrition claim is made on point-of-purchase materials all of the
requirements of the mandatory nutrition labeling program apply. However,
if only nutrition information--and not a nutrition claim--is supplied on
point-of-purchase materials:
(i) The requirements of the mandatory nutrition labeling program
apply, but the nutrition information may be supplied on an "as
packaged" or "as consumed," basis;
(ii) The listing of percent of Daily Value for the nutrients (except
vitamins and minerals specified in Sec. 381.409(c)(8)) and footnote
required by Sec. 381.409(d)(9) may be omitted; and
(iii) The point-of-purchase materials are not subject to any of the
format requirements.
(b) [Reserved]
(c) The declaration of nutrition information may be presented in a
simplified format as specified in Sec. 381.409(f) for the mandatory
nutrition labeling program.
(d) The nutrition label data should be based on either raw or cooked
edible portions of poultry cuts with skin. If data are based on cooked
portions, the methods used to cook the products must be specified and
should be those which do not add nutrients from other ingredients such
as flour, breading, and salt. Additional nutritional data may be
presented on an optional basis for the raw or cooked edible portions of
the skinless poultry meat.
(e) Nutrient data that are the most current representative data base
values contained in USDA's National Nutrient Data Bank or its published
form, the Agriculture Handbook No. 8 series, may be used for nutrition
labeling of single-ingredient, raw poultry products, including those
that have been previously frozen. These data may be composite data that
reflect different classes of turkey or other variables affecting
nutrient content. Alternatively, data that reflect specific classes or
other variables may be used, except that if data are used on labels
attached to a product which is labeled as to class of poultry or other
variables, the data must represent the product in the package when such
data are contained in the representative data base. When data are used
on labels attached to a product, the data must represent the edible
poultry tissues present in the package.
(f) If the nutrition information is in accordance with paragraph (e)
of this section, a nutrition label or labeling will not be subject to
the Agency compliance review under Sec. 381.409(h), unless a nutrition
claim is made on the basis of the representative data base values.
(g) Retailers may use data bases that they believe reflect the
nutrient content of single-ingredient, raw poultry products, including
those that have been previously frozen; however, such
[[Page 591]]
labeling shall be subject to the compliance procedures of paragraph (e)
of this section and the requirements specified in this subpart for the
mandatory nutrition labeling program.
[58 FR 675, Jan. 6, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 60
FR 209, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.454]
[Page 591-592]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.454 Nutrient content claims for "good source," "high," and "more."
(a) General requirements. Except as provided in paragraph (e) of
this section, a claim about the level of a nutrient in a product in
relation to the Reference Daily Intake (RDI) or Daily Reference Value
(DRV), established for that nutrient (excluding total carbohydrate) in
Sec. 381.409(c), may only be made on the label or in labeling of the
product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 381.409.
(b) "High" claims. (1) The terms "high," "rich in," or
"excellent source of" may be used on the label or in labeling of
products, except meal-type products as defined in Sec. 381.413(l),
provided that the product contains 20 percent or more of the RDI or the
DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (b)(1) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains a food that meets the definition of
"high" in paragraph (b)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., "the serving of broccoli in this meal is
high in vitamin C").
(c) "Good Source" claims. (1) The terms "good source,"
"contains," or "provides" may be used on the label or in labeling of
products, except meal-type products as described in Sec. 381.413(l),
provided that the product contains 10 to 19 percent of the RDI or the
DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (c)(1) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains a food that meets the definition of "good
source" in paragraph (c)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., "the serving of sweet potatoes in this meal
is a good source of fiber").
(d) Fiber claims. (1) If a nutrient content claim is made with
respect to the level of dietary fiber, i.e., that the product is high in
fiber, a good source of fiber, or that the product contains "more"
fiber, and the product is not "low" in total fat as defined in
Sec. 381.462(b)(2) or, in the case of a meal-type product, is not
"low" in total fat as defined in Sec. 381.462(b)(3), then the labeling
shall disclose the level of total fat per labeled serving size (e.g.,
"contains 12 grams (g) of fat per serving"); and
(2) The disclosure shall appear in immediate proximity to such claim
and be in a type size no less than one-half the size of the claim.
(e) "More" claims. (1) A relative claim using the terms "more"
and "added" may be used on the label or in labeling to describe the
level of protein, vitamins, minerals, dietary fiber, or potassium in a
product, except meal-type products as defined in Sec. 381.413(l),
provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per reference amount
customarily consumed than an appropriate reference product as described
in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
"contains 10 percent more of the Daily Value for fiber than `reference
product' "); and
[[Page 592]]
(B) Quantitative information comparing the level of the nutrient in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "fiber content of `reference product'
is 1 g per serving; `this product' contains 4 g per serving").
(2) A relative claim using the terms "more" and "added" may be
used on the label or in labeling to describe the level of protein,
vitamins, minerals, dietary fiber, or potassium in meal-type products as
defined in Sec. 381.413(l), provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per 100 g of product than an
appropriate reference product as described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
"contains 10 percent more of the Daily Value for fiber per 3 ounces
(oz) than does `reference product' "), and
(B) Quantitative information comparing the level of the nutrient in
the meal-type product per specified weight with that of the reference
product that it replaces is declared adjacent to the most prominent
claim or to the nutrition information (e.g., "fiber content of
`reference product' is 2 g per 3 oz; `this product' contains 5 g per 3
oz").
[60 FR 210, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.456]
[Page 592-594]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.456 Nutrient content claims for "light" or "lite."
(a) General requirements. A claim using the terms "light" or
"lite" to describe a product may only be made on the label or in
labeling of the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 381.409.
(b) "Light" claims. The terms "light" or "lite" may be used on
the label or in labeling of products, except meal-type products as
defined in Sec. 381.413(l), without further qualification, provided
that:
(1) If the product derives 50 percent or more of its calories from
fat, its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to an appropriate reference product
as described in Sec. 381.413(j)(1); or
(2) If the product derives less than 50 percent of its calories from
fat:
(i) The number of calories is reduced by at least one-third (33\1/3\
percent) per reference amount customarily consumed compared to an
appropriate reference product as described in Sec. 381.413(j)(1); or
(ii) Its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to the appropriate reference
product as described in Sec. 381.413(j)(1); and
(3) As required in Sec. 381.413(j)(2) for relative claims:
(i) The identity of the reference product and the percent (or
fraction) that the calories and the fat were reduced are declared in
immediate proximity to the most prominent such claim (e.g., "\1/3\
fewer calories and 50 percent less fat than the market leader"); and
(ii) Quantitative information comparing the level of calories and
fat content in the product per labeled serving size with that of the
reference product that it replaces is declared adjacent to the most
prominent claim or to the nutrition information (e.g., "lite `this
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving"); and
(iii) If the labeled product contains less than 40 calories or less
than 3 g fat per reference amount customarily consumed, the percentage
reduction for that nutrient need not be declared.
(4) A "light" claim may not be made on a product for which the
reference
[[Page 593]]
product meets the definition of "low fat" and "low calorie."
(c)(1)(i) A product for which the reference product contains 40
calories or less and 3 g fat or less per reference amount customarily
consumed may use the terms "light" or "lite" without further
qualification if it is reduced by 50 percent or more in sodium content
compared to the reference product; and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., "50 percent less
sodium than the market leader"); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., "lite `this product'--500 milligrams (mg) sodium per
serving; regular `reference product'--1,000 mg sodium per serving").
(2)(i) A product for which the reference product contains more than
40 calories or more than 3 g fat per reference amount customarily
consumed may use the terms "light in sodium" or "lite in sodium" if
it is reduced by 50 percent or more in sodium content compared to the
reference product, provided that "light" or "lite" is presented in
immediate proximity with "in sodium" and the entire term is presented
in uniform type size, style, color, and prominence; and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., "50 percent less
sodium than the market leader"); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., or "lite `this product'--170 mg sodium per serving;
regular `reference product'--350 mg per serving").
(3) Except for meal-type products as defined in Sec. 381.413(l), a
"light in sodium" claim may not be made on a product for which the
reference product meets the definition of "low in sodium."
(d)(1) The terms "light" or "lite" may be used on the label or
in labeling of a meal-type product as defined in Sec. 381.413(l),
provided that:
(i) The product meets the definition of:
(A) "Low in calories" as defined in Sec. 381.460(b)(3); or
(B) "Low in fat" as defined in Sec. 381.462(b)(3); and
(ii)(A) A statement appears on the principal display panel that
explains whether "light" is used to mean "low fat," "low
calories," or both (e.g., "Light Delight, a low fat meal"); and
(B) The accompanying statement is no less than one-half the type
size of the "light" or "lite" claim.
(2)(i) The terms "light in sodium" or "lite in sodium" may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that the product meets the definition of "low
in sodium" as defined in Sec. 381.461(b)(5)(i); and
(ii) "Light" or "lite" and "in sodium" are presented in
uniform type size, style, color, and prominence.
(3) The terms "light" or "lite" may be used in the brand name of
a product to describe the sodium content, provided that:
(i) The product is reduced by 50 percent or more in sodium content
compared to the reference product;
(ii) A statement specifically stating that the product is "light in
sodium" or "lite in sodium" appears:
(A) Contiguous to the brand name; and
(B) In uniform type size, style, color, and prominence as the
product name; and
(iii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim; and
[[Page 594]]
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information.
(e) Except as provided in paragraphs (b) through (d) of this
section, the terms "light" or "lite" may not be used to refer to a
product that is not reduced in fat by 50 percent, or, if applicable, in
calories by \1/3\ or, when properly qualified, in sodium by 50 percent
unless:
(1) It describes some physical or organoleptic attribute of the
product such as texture or color and the information (e.g., "light in
color" or "light in texture") so stated, clearly conveys the nature
of the product; and
(2) The attribute (e.g., "color" or "texture") is in the same
style, color, and at least one-half the type size as the word "light"
and in immediate proximity thereto.
(f) If a manufacturer can demonstrate that the word "light" has
been associated, through common use, with a particular product to
reflect a physical or organoleptic attribute to the point where it has
become part of the statement of identity, such use of the term "light"
shall not be considered a nutrient content claim subject to the
requirements in this part.
(g) The term "lightly salted" may be used on a product to which
has been added 50 percent less sodium than is normally added to the
reference product as described in Sec. 381.413(j)(1)(i)(B) and
(j)(1)(ii)(B), provided that if the product is not "low in sodium" as
defined in Sec. 381.461(b)(4), the statement "not a low sodium food,"
shall appear adjacent to the nutrition information and the information
required to accompany a relative claim shall appear on the label or
labeling as specified in Sec. 381.413(j)(2).
[60 FR 210, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.460]
[Page 594-596]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.460 Nutrient content claims for calorie content.
(a) General requirements. A claim about the calorie or sugar content
of a product may only be made on the label or in labeling of the product
if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 381.409.
(b) Calorie content claims. (1) The terms "calorie free," "free
of calories," "no calories," "zero calories," "without calories,"
"trivial source of calories," "negligible source of calories," or
"dietarily insignificant source of calories" may be used on the label
or in labeling of products, provided that:
(i) The product contains less than 5 calories per reference amount
customarily consumed and per labeled serving size; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms "low calorie," "few calories," "contains a small
amount of calories," "low source of calories," or "low in calories"
may be used on the label or in labeling of products, except meal-type
products as defined in Sec. 381.413(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does
not provide more than 40 calories per reference amount customarily
consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and does not provide more than 40 calories per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 381.409(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the "as prepared" form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or
[[Page 595]]
reformulation to lower the caloric content, it is labeled to clearly
refer to all products of its type and not merely to the particular brand
to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 120 calories or less per 100 g of product;
and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the calorie content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which it attaches.
(4) The terms "reduced calorie," "reduced in calories,"
"calorie reduced," "fewer calories," "lower calorie," or "lower
in calories" may be used on the label or in labeling of products,
except meal-type products as defined in Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent fewer calories per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., lower
calorie `product'--"33 \1/3\ percent fewer calories than our regular
`product' "); and
(B) Quantitative information comparing the level of calories in the
product per labeled serving size with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "calorie content has been reduced from 150
to 100 calories per serving").
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of products if the reference product
meets the definition for "low calorie."
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent fewer calories per 100
g of product than an appropriate reference product as described in
Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "calorie
reduced `product', 25% less calories per ounce (oz) (or 3 oz) than our
regular `product' "); and
(B) Quantitative information comparing the level of calories in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "calorie content has been reduced from 110
calories per 3 oz to 80 calories per 3 oz").
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of products if the reference product
meets the definition for "low calorie."
(c) Sugar content claims. (1) Terms such as "sugar free," "free
of sugar," "no sugar," "zero sugar," "without sugar,"
"sugarless," "trivial source of sugar," "negligible source of
sugar," or "dietarily insignificant source of sugar" may reasonably
be expected to be regarded by consumers as terms that represent that the
product contains no sugars or sweeteners, e.g., "sugar free," or "no
sugar," as indicating a product which is low in calories or
significantly reduced in calories. Consequently, except as provided in
paragraph (c)(2) of this section, a product may not be labeled with such
terms unless:
(i) The product contains less than 0.5 g of sugars, as defined in
Sec. 381.409(c)(6)(ii), per reference amount customarily consumed and
per labeled serving size or, in the case of a meal-type product, less
than 0.5 g of sugars per labeled serving size;
(ii) The product contains no ingredient that is a sugar or that is
generally understood by consumers to contain sugars unless the listing
of the ingredient in the ingredients statement
[[Page 596]]
is followed by an asterisk that refers to the statement below the list
of ingredients, which states: "Adds a trivial amount of sugar," "adds
a negligible amount of sugar," or "adds a dietarily insignificant
amount of sugar;" and
(iii)(A) It is labeled "low calorie" or "reduced calorie" or
bears a relative claim of special dietary usefulness labeled in
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this
section; or
(B) Such term is immediately accompanied, each time it is used, by
either the statement "not a reduced calorie product," "not a low
calorie product," or "not for weight control."
(2) The terms "no added sugar," "without added sugar," or "no
sugar added" may be used only if:
(i) No amount of sugars, as defined in Sec. 381.409(c)(6)(ii), or
any other ingredient that contains sugars that functionally substitute
for added sugars is added during processing or packaging;
(ii) The product does not contain an ingredient containing added
sugars such as jam, jelly, or concentrated fruit juice;
(iii) The sugars content has not been increased above the amount
present in the ingredients by some means such as the use of enzymes,
except where the intended functional effect of the process is not to
increase the sugars content of a product, and a functionally
insignificant increase in sugars results;
(iv) The product that it resembles and for which it substitutes
normally contains added sugars; and
(v) The product bears a statement that the product is not "low
calorie" or "calorie reduced" (unless the product meets the
requirements for a "low" or "reduced calorie" product) and that
directs consumers' attention to the nutrition panel for further
information on sugar and calorie content.
(3) Paragraph (c)(1) of this section shall not apply to a factual
statement that a product, including products intended specifically for
infants and children less than 2 years of age, is unsweetened or
contains no added sweeteners in the case of a product that contains
apparent substantial inherent sugar content, e.g., juices.
(4) The terms "reduced sugar," "reduced in sugar," "sugar
reduced," "less sugar," "lower sugar," or "lower in sugar" may be
used on the label or in labeling of products, except meal-type products
as defined in Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less sugars per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "this
product contains 25 percent less sugar than our regular product"); and
(B) Quantitative information comparing the level of the sugar in the
product per labeled serving size with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "sugar content has been lowered from 8 g
to 6 g per serving").
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less sugars per 100 g
of product than an appropriate reference product as described in
Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "reduced
sugar `product'--
25% less sugar than our regular `product' "); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "sugar content has been reduced from 17 g
per 3 oz to 13 g per 3 oz").
[60 FR 211, Jan. 3, 1995]
[[Page 597]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.461]
[Page 597-599]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.461 Nutrient content claims for the sodium content.
(a) General requirements. A claim about the level of sodium in a
product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 381.409.
(b) Sodium content claims. (1) The terms "sodium free," "free of
sodium," "no sodium," "zero sodium," "without sodium," "trivial
source of sodium," "negligible source of sodium," or "dietarily
insignificant source of sodium" may be used on the label or in labeling
of products, provided that:
(i) The product contains less than 5 milligrams (mg) of sodium per
reference amount customarily consumed and per labeled serving size or,
in the case of a meal-type product, less than 5 mg of sodium per labeled
serving size;
(ii) The product contains no ingredient that is sodium chloride or
is generally understood by consumers to contain sodium unless the
listing of the ingredient in the ingredients statement is followed by an
asterisk that refers to the statement below the list of ingredients,
which states: "Adds a trivial amount of sodium," "adds a negligible
amount of sodium" or "adds a dietarily insignificant amount of
sodium;" and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms "very low sodium" or "very low in sodium" may be
used on the label or in labeling of products, except meal-type products
as defined in Sec. 381.413(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and
contains 35 mg or less sodium per reference amount customarily consumed;
or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 35 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 381.409(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the "as prepared" form);
and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 35 mg or less of sodium per 100 g of
product; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms "low sodium," "low in sodium," "little sodium,"
"contains a small amount of sodium," or "low source of sodium" may
be used on the label and in labeling of products, except meal-type
products as defined in Sec. 381.413(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp and contains 140 mg or less
sodium per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 140 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 381.409(f)(1), of all nutrients
[[Page 598]]
per reference amount customarily consumed, the per-50-g criterion refers
to the "as prepared" form); and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 140 mg or less sodium per 100 g of product;
and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(6) The terms "reduced sodium," "reduced in sodium," "sodium
reduced," "less sodium," "lower sodium," or "lower in sodium" may
be used on the label or in labeling of products, except meal-type
products as defined in Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less sodium per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 381.413(j)(l); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "reduced
sodium `product', 50 percent less sodium than regular `product' "); and
(B) Quantitative information comparing the level of sodium in the
product per labeled serving size with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "sodium content has been lowered from 300
to 150 mg per serving").
(iii) Claims described in paragraph (b)(6) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low sodium."
(7) The terms defined in paragraph (b)(6) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less sodium per 100 g
of product than an appropriate reference product as described in
Sec. 381.413(j)(l); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "reduced
sodium `product'--30% less sodium per 3 oz than our `regular product'
"); and
(B) Quantitative information comparing the level of sodium in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "sodium content has been reduced from 220
mg per 3 oz to 150 mg per 3 oz").
(iii) Claims described in paragraph (b)(7) of this section may not
be made on the label or in labeling of products if the nutrient content
of the reference product meets the definition for "low sodium."
(c) The term "salt" is not synonymous with "sodium." Salt refers
to sodium chloride. However, references to salt content such as
"unsalted," "no salt," "no salt added" are potentially misleading.
(1) The term "salt free" may be used on the label or in labeling
of products only if the product is "sodium free" as defined in
paragraph (b)(1) of this section.
(2) The terms "unsalted," "without added salt," and "no salt
added" may be used on the label or in labeling of products only if:
(i) No salt is added during processing;
(ii) The product that it resembles and for which it substitutes is
normally processed with salt; and
[[Page 599]]
(iii) If the product is not sodium free, the statement "not a
sodium free product" or "not for control of sodium in the diet"
appears adjacent to the nutrition information of the product bearing the
claim.
(3) Paragraph (c)(2) of this section shall not apply to a factual
statement that a product intended specifically for infants and children
less than 2 years of age is unsalted, provided such statement refers to
the taste of the product and is not false or otherwise misleading.
[60 FR 213, Jan. 3, 1995; 60 FR 5762, Jan. 30, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.462]
[Page 599-604]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content.
(a) General requirements. A claim about the level of fat, fatty
acid, and cholesterol in a product may only be made on the label or in
labeling of products if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 381.409.
(b) Fat content claims. (1) The terms "fat free," "free of fat,"
"no fat," "zero fat," "without fat," "nonfat," "trivial source
of fat," "negligible source of fat," or "dietarily insignificant
source of fat" may be used on the label or in labeling of products,
provided that:
(i) The product contains less than 0.5 gram (g) of fat per reference
amount customarily consumed and per labeled serving size or, in the case
of a meal-type product, less than 0.5 g of fat per labeled serving size;
(ii) The product contains no added ingredient that is a fat or is
generally understood by consumers to contain fat unless the listing of
the ingredient in the ingredients statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: "Adds a trivial amount of fat," "adds a negligible amount of
fat," or "adds a dietarily insignificant amount of fat"; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label attaches.
(2) The terms "low fat," "low in fat," "contains a small amount
of fat," "low source of fat," or "little fat" may be used on the
label and in labeling of products, except meal-type products as defined
in Sec. 381.413(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g
or less of fat per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 3 g or less of fat per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 381.409(f)(1), of
all nutrients per reference amount customarily consumed, the per-50-g
criterion refers to the "as prepared" form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 3 g or less of total fat per 100 g of
product and not more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label attaches.
[[Page 600]]
(4) The terms "reduced fat," "reduced in fat," "fat reduced,"
"less fat," "lower fat," or "lower in fat" may be used on the
label or in labeling of products, except meal-type products as defined
in Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less fat per reference
amount customarily consumed than an appropriate reference product as
described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., "reduced
fat--50 percent less fat than our regular `product' "); and
(B) Quantitative information comparing the level of fat in the
product per labeled serving size with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "fat content has been reduced from 8 g to
4 g per serving").
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low fat."
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less fat per 100 g of
product than an appropriate reference product as described in
Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., "reduced
fat `product', 33 percent less fat per 3 oz than our regular `product'
"); and
(B) Quantitative information comparing the level of fat in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent such claim or to the
nutrition information (e.g., "fat content has been reduced from 8 g per
3 oz to 5 g per 3 oz").
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low fat."
(6) The term "------------ percent fat free" may be used on the
label or in labeling of products, provided that:
(i) The product meets the criteria for "low fat" in paragraph
(b)(2) or (b)(3) of this section;
(ii) The percent declared and the words "fat free" are in uniform
type size; and
(iii) A "100 percent fat free" claim may be made only on products
that meet the criteria for "fat free" in paragraph (b)(1) of this
section, that contain less than 0.5 g of fat per 100 g, and that contain
no added fat.
(iv) A synonym for "------ percent fat free" is "------ percent
lean."
(c) Fatty acid content claims. (1) The terms "saturated fat free,"
"free of saturated fat," "no saturated fat," "zero saturated fat,"
"without saturated fat," "trivial source of saturated fat,"
"negligible source of saturated fat," or "dietarily insignificant
source of saturated fat" may be used on the label or in labeling of
products, provided that:
(i) The product contains less than 0.5 g of saturated fat and less
than 0.5 g trans fatty acids per reference amount customarily consumed
and per labeled serving size or, in the case of a meal-type product,
less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids
per labeled serving size;
(ii) The product contains no ingredient that is generally understood
by consumers to contain saturated fat unless the listing of the
ingredient in the ingredients statement is followed by an asterisk that
refers to the statement below the list of ingredients, which states:
"Adds a trivial amount of saturated fat," "adds a negligible amount
of saturated fat," or "adds a dietarily insignificant amount of
saturated fat;" and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or
[[Page 601]]
reformulation to lower saturated fat content, it is labeled to clearly
refer to all products of its type and not merely to the particular brand
to which the label attaches.
(2) The terms "low in saturated fat," "low saturated fat,"
"contains a small amount of saturated fat," "low source of saturated
fat," or "a little saturated fat" may be used on the label or in
labeling of products, except meal-type products as defined in
Sec. 381.413(l), provided that:
(i) The product contains 1 g or less of saturated fat per reference
amount customarily consumed and not more than 15 percent of calories
from saturated fat; and
(ii) If the product meets these conditions without benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (c)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 1 g or less of saturated fat per 100 g and
less than 10 percent calories from saturated fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms "reduced saturated fat," "reduced in saturated
fat," "saturated fat reduced," "less saturated fat," "lower
saturated fat," or "lower in saturated fat" may be used on the label
or in labeling of products, except meal-type products as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less saturated fat per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
"reduced saturated fat `product', contains 50 percent less saturated
fat than the national average for `product' "); and
(B) Quantitative information comparing the level of saturated fat in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "saturated fat reduced from 3 g to 1.5
g per serving").
(iii) Claims described in paragraph (c)(4) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low saturated fat."
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less saturated fat per
100 g of product than an appropriate reference product as described in
Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
"reduced saturated fat `product', 50 percent less saturated fat than
our regular `product' "); and
(B) Quantitative information comparing the level of saturated fat in
the product per specified weight with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "saturated fat content has been reduced
from 2.5 g per 3 oz to 1.5 g per 3 oz").
(iii) Claims described in paragraph (c)(5) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low saturated fat."
[[Page 602]]
(d) Cholesterol content claims. (1) The terms "cholesterol free,"
"free of cholesterol," "zero cholesterol," "without cholesterol,"
"no cholesterol," "trivial source of cholesterol," "negligible
source of cholesterol," or "dietarily insignificant source of
cholesterol" may be used on the label or in labeling of products,
provided that:
(i) The product contains less than 2 milligrams (mg) of cholesterol
per reference amount customarily consumed and per labeled serving size
or, in the case of a meal-type product as defined in Sec. 381.413(l),
less than 2 mg of cholesterol per labeled serving size;
(ii) The product contains no ingredient that is generally understood
by consumers to contain cholesterol, unless the listing of the
ingredient in the ingredients statement is followed by an asterisk that
refers to the statement below the list of ingredients, which states:
"Adds a trivial amount of cholesterol," "adds a negligible amount of
cholesterol," or "adds a dietarily insignificant amount of
cholesterol";
(iii) The product contains 2 g or less of saturated fat per
reference amount customarily consumed or, in the case of a meal-type
product as defined in Sec. 381.413(l), 2 g or less of saturated fat per
labeled serving size; and
(iv) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which it attaches; or
(v) If the product meets these conditions only as a result of
special processing, alteration, formulation, or reformulation, the
amount of cholesterol is reduced by 25 percent or more from the
reference product it replaces as described in Sec. 381.413(j)(1) and for
which it substitutes as described in Sec. 381.413(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol was reduced are declared in immediate
proximity to the most prominent such claim (e.g., "cholesterol free
`product', contains 100 percent less cholesterol than `reference
product' "); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "contains no cholesterol compared with
30 mg in one serving of `reference product' ").
(2) The terms "low in cholesterol," "low cholesterol,"
"contains a small amount of cholesterol," "low source of
cholesterol," or "little cholesterol" may be used on the label or in
labeling of products, except meal-type products as defined in
Sec. 381.413(l), provided that:
(i)(A) If the product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed; and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed; or
(B) If the product has a reference amount customarily consumed of 30
g or less or 2 tbsp or less:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 381.409(f)(1), of
all nutrients per reference amount customarily consumed, the per-50-g
criterion refers to the "as prepared" form); and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed.
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches; or
(iii) If the product contains 20 mg or less of cholesterol only as a
result of special processing, alteration, formulation, or reformulation,
the amount of cholesterol is reduced by 25 percent or more from the
reference product it replaces as described in Sec. 381.413(j)(1) and
[[Page 603]]
for which it substitutes as described in Sec. 381.413(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., "low
cholesterol `product', contains 85 percent less cholesterol than our
regular `product"'); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "cholesterol lowered from 30 mg to 5
mg per serving").
(3) The terms defined in paragraph (d)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 20 mg or less of cholesterol per 100 g of
product;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms "reduced cholesterol," "reduced in cholesterol,"
"cholesterol reduced," "less cholesterol," "lower cholesterol," or
"lower in cholesterol" may be used on the label or in labeling of
products or products that substitute for those products as specified in
Sec. 381.413(d), excluding meal-type products as defined in
Sec. 381.413(l), provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 381.413(j)(1) and for
which it substitutes as described in Sec. 381.413(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per reference
amount customarily consumed; and
(iii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., "25 percent
less cholesterol than `reference product' "); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "cholesterol lowered from 55 mg to 30
mg per serving").
(iv) Claims described in paragraph (d)(4) of this section may not be
made on the label or in labeling of a product if the nutrient content of
the reference product meets the definition for "low cholesterol."
(5) The terms defined in paragraph (d)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 381.413(j)(1) and for
which it substitutes as described in Sec. 381.413(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., "25% less
cholesterol than `reference product' "); and
(B) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "cholesterol content
[[Page 604]]
has been reduced from 35 mg per 3 oz to 25 mg per 3 oz).
(iv) Claims described in paragraph (d)(5) of this section may not be
made on the label or in labeling of a product if the nutrient content of
the reference product meets the definition for "low cholesterol."
(e) "Lean" and "Extra Lean" claims. (1) The term "lean" may be
used on the label or in labeling of a product, provided that the product
contains less than 10 g of fat, 4.5 g or less of saturated fat, and less
than 95 mg of cholesterol per 100 g of product and per reference amount
customarily consumed for individual foods, and per 100 g of product and
per labeled serving size for meal-type products as defined in
Sec. 381.413(l).
(2) The term "extra lean" may be used on the label or in labeling
of a product, provided that the product contains less than 5 g of fat,
less than 2 g of saturated fat, and less than 95 mg of cholesterol per
100 g of product and per reference amount customarily consumed for
individual foods, and per 100 g of product and per labeled serving size
for meal-type products as defined in Sec. 381.413(l).
[60 FR 214, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.463]
[Page 604-605]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.463 Nutrient content claims for "healthy."
(a) The term "healthy," or any other derivative of the term
"health," may be used on the labeling of any poultry product, provided
that the product is labeled in accordance with Sec. 381.409 and
Sec. 381.413.
(b)(1) The product shall meet the requirements for "low fat" and
"low saturated fat," as defined in Sec. 381.462, except that single-
ingredient, raw products may meet the total fat and saturated fat
criteria for "extra lean" in Sec. 381.462.
(2) The product shall not contain more than 60 milligrams (mg) of
cholesterol per reference amount customarily consumed, per labeled
serving size, and, only for foods with reference amounts customarily
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50
g, and, for dehydrated products that must be reconstituted with water or
a diluent containing an insignificant amount, as defined in
Sec. 381.409(f)(1), of all nutrients, the per-50-g criterion refers to
the prepared form, except that:
(i) A meal-type product, as defined in Sec. 381.413(l), and
including meal-type products that weigh more than 12 ounces (oz) per
serving (container), shall not contain more than 90 mg of cholesterol
per labeled serving size; and
(ii) Single-ingredient, raw products may meet the cholesterol
criterion for "extra lean" in Sec. 381.462.
(3) The product shall not contain more than 360 mg of sodium, except
that it shall not contain more than 480 mg of sodium effective through
January 1, 2003, per reference amount customarily consumed, per labeled
serving size, and, only for foods with reference amounts customarily
consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for
dehydrated products that must be reconstituted with water or a diluent
containing an insignificant amount, as defined in Sec. 381.409(f)(1), of
all nutrients, the per-50-g criterion refers to the prepared form,
except that:
(i) A meal-type product, as defined in Sec. 381.413(l), and
including meal-type products that weigh more than 12 oz per serving
(container), shall not contain more than 480 mg of sodium, except that
it shall not contain more than 600 mg of sodium effective through
January 1, 2003, per labeled serving size; and
(ii) The requirements of this paragraph (b)(3) do not apply to
single-ingredient, raw products.
(4) The product shall contain 10 percent or more of the Reference
Daily Intake or Daily Reference Value as defined in Sec. 381.409 for
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference
amount customarily consumed prior to any nutrient addition, except that:
(i) A meal-type product, as defined in Sec. 381.413(l), and
including meal-type products that weigh at least 6 oz but less than 10
oz per serving (container), shall meet the level for two of the
nutrients per labeled serving size; and
(ii) A meal-type product, as defined in Sec. 381.413(l), and
including meal-type products that weigh 10 oz or more per serving
(container), shall meet the
[[Page 605]]
level for three of the nutrients per labeled serving size.
[59 FR 24228, May 10, 1994, as amended at 60 FR 217, Jan. 3, 1995; 63 FR
7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.469]
[Page 605-610]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.469 Labeling applications for nutrient content claims.
(a) This section pertains to labeling applications for claims,
express or implied, that characterize the level of any nutrient required
to be on the label or in labeling of product by this subpart.
(b) Labeling applications included in this section are:
(1) Labeling applications for a new (heretofore unauthorized)
nutrient content claim,
(2) Labeling applications for a synonymous term (i.e., one that is
consistent with a term defined by regulation) for characterizing the
level of a nutrient, and
(3) Labeling applications for the use of an implied claim in a brand
name.
(c) Labeling applications and supporting documentation to be filed
under this section shall be submitted in quadruplicate, except that the
supporting documentation may be submitted on a computer disc copy. If
any part of the material submitted is in a foreign language, it shall be
accompanied by an accurate and complete English translation. The
labeling application shall state the applicant's post office address.
(d) Pertinent information will be considered as part of an
application on the basis of specific reference to such information
submitted to and retained in the files of the Food Safety and Inspection
Service. However, any reference to unpublished information furnished by
a person other than the applicant will not be considered unless use of
such information is authorized (with the understanding that such
information may in whole or part be subject to release to the public) in
a written statement signed by the person who submitted it. Any reference
to published information should be accompanied by reprints or
photostatic copies of such references.
(e) If nonclinical laboratory studies accompany a labeling
application, the applicant shall include, with respect to each
nonclinical study included with the application, either a statement that
the study has been, or will be, conducted in compliance with the good
laboratory practice regulations as set forth in part 58 of chapter 1,
title 21, or, if any such study was not conducted in compliance with
such regulations, a brief statement of the reason for the noncompliance.
(f) If clinical investigations accompany a labeling application, the
applicant shall include, with respect to each clinical investigation
included with the application, either a statement that the investigation
was conducted in compliance with the requirements for institutional
review set forth in part 56 of chapter 1, title 21, or was not subject
to such requirements in accordance with Sec. 56.194 or Sec. 56.105, and
that it was conducted in compliance with the requirements for informed
consents set forth in part 50 of chapter 1, title 21.
(g) The availability for public disclosure of labeling applications,
along with supporting documentation, submitted to the Agency under this
section will be governed by the rules specified in subchapter D, title
9.
(h) The data specified under this section to accompany a labeling
application shall be submitted on separate sheets, suitably identified.
If such data has already been submitted with an earlier labeling
application from the applicant, the present labeling application must
provide the data.
(i) The labeling application must be signed by the applicant or by
his or her attorney or agent, or (if a corporation) by an authorized
official.
(j) The labeling application shall include a statement signed by the
person responsible for the labeling application, that to the best of his
or her knowledge, it is a representative and balanced submission that
includes unfavorable information, as well as favorable information,
known to him or her pertinent to the evaluation of the labeling
application.
(k)(1) Labeling applications for a new nutrient content claim shall
be accompanied by the following data which shall be submitted in the
following form to the Director, Food Labeling Division, Regulatory
Programs, Food
[[Page 606]]
Safety and Inspection Service, Washington, DC 20250:
________________________________________________________________________
(Date)
The undersigned, ------------ submits this labeling application
pursuant to 9 CFR 381.469 with respect to (statement of the claim and
its proposed use).
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement identifying the nutrient content claim and the
nutrient that the term is intended to characterize with respect to the
level of such nutrient. The statement shall address why the use of the
term as proposed will not be misleading. The statement shall provide
examples of the nutrient content claim as it will be used on labels or
labeling, as well as the types of products on which the claim will be
used. The statement shall also specify the level at which the nutrient
must be present or what other conditions concerning the product must be
met for the appropriate use of the term in labels or labeling, as well
as any factors that would make the use of the term inappropriate.
(ii) A detailed explanation supported by any necessary data of why
use of the food component characterized by the claim is of importance in
human nutrition by virtue of its presence or absence at the levels that
such claim would describe. This explanation shall also state what
nutritional benefit to the public will derive from use of the claim as
proposed and why such benefit is not available through the use of
existing terms defined by regulation. If the claim is intended for a
specific group within the population, the analysis shall specifically
address nutritional needs of such group, and scientific data sufficient
for such purpose, and data and information to the extent necessary to
demonstrate that consumers can be expected to understand the meaning of
the term under the proposed conditions of use.
(iii) Analytical data that demonstrates the amount of the nutrient
that is present in the products for which the claim is intended. The
assays should be performed on representative samples in accordance with
381.409(h). If no USDA or AOAC methods are available, the applicant
shall submit the assay method used, and data establishing the validity
of the method for assaying the nutrient in the particular food. The
validation data shall include a statistical analysis of the analytical
and product variability.
(iv) A detailed analysis of the potential effect of the use of the
proposed claim on food consumption, and any corresponding changes in
nutrient intake. The analysis shall specifically address the intake of
nutrients that have beneficial and negative consequences in the total
diet. If the claim is intended for a specific group within the
population, the above analysis shall specifically address the dietary
practices of such group, and shall include data sufficient to
demonstrate that the dietary analysis is representative of such group.
Yours very truly,
Applicant_________________________________________________________
By________________________________________________________________
(Indicate authority)
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall inform
the applicant that the labeling application is undergoing Agency review
and that the applicant shall subsequently be notified of the Agency's
decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
nutrient content claim is false or misleading. The notification letter
shall inform the applicant that the applicant may submit a written
statement by way of answer to the notification, and that the applicant
shall have the right to request a hearing with respect to the merits or
validity of the Administrator's decision to deny the use of the proposed
nutrient content claim.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
[[Page 607]]
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish in the Federal Register a
proposed rule to amend the regulations to authorize the use of the
nutrient content claim. The proposal shall also summarize the labeling
application, including where the supporting documentation can be
reviewed. The Administrator's proposed rule shall seek comment from
consumers, the industry, consumer and industry groups, and other
interested persons on the labeling application and the use of the
proposed nutrient content claim. After public comment has been received
and reviewed by the Agency, the Administrator shall make a determination
on whether the proposed nutrient content claim shall be approved for use
on the labeling of poultry products.
(i) If the claim is denied by the Administrator, the Agency shall
notify the applicant, in writing, of the basis for the denial, including
the reason why the claim on the labeling was determined by the Agency to
be false or misleading. The notification letter shall also inform the
applicant that the applicant may submit a written statement by way of
answer to the notification, and that the applicant shall have the right
to request a hearing with respect to the merits or validity of the
Administrator's decision to deny the use of the proposed nutrient
content claim.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the
applicant, in writing, and shall also publish in the Federal Register a
final rule amending the regulations to authorize the use of the claim.
(l)(1) Labeling applications for a synonymous term shall be
accompanied by the following data which shall be submitted in the
following form to the Director, Food Labeling Division, Regulatory
Programs, Food Safety and Inspection Service, Washington, DC 20250:
________________________________________________________________________
(Date)
The undersigned, ------------ submits this labeling application
pursuant to 9 CFR 381.469 with respect to (statement of the synonymous
term and its proposed use in a nutrient content claim that is consistent
with an existing term that has been defined under subpart Y of part
381).
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement identifying the synonymous term, the existing term
defined by a regulation with which the synonymous term is claimed to be
consistent, and the nutrient that the term is intended to characterize
the level of. The statement shall address why the use of the synonymous
term as proposed will not be misleading. The statement shall provide
examples of the nutrient content claim as it will be used on labels or
labeling, as well as the types of products on which the claim will be
used. The statement shall also
[[Page 608]]
specify whether any limitations not applicable to the use of the defined
term are intended to apply to the use of the synonymous term.
(ii) A detailed explanation supported by any necessary data of why
use of the proposed term is requested, including whether the existing
defined term is inadequate for the purpose of effectively characterizing
the level of a nutrient. This explanation shall also state what
nutritional benefit to the public will derive from use of the claim as
proposed, and why such benefit is not available through use of existing
terms defined by regulation. If the claim is intended for a specific
group within the population, the analysis shall specifically address
nutritional needs of such group, scientific data sufficient for such
purpose, and data and information to the extent necessary to demonstrate
that consumers can be expected to understand the meaning of the term
under the proposed conditions of use.
Yours very truly,
Applicant_________________________________________________________
By________________________________________________________________
(Indicate authority)
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall inform
the applicant that the labeling application is undergoing Agency review
and that the applicant shall subsequently be notified of the Agency's
decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
synonymous term is false or misleading. The notification letter shall
inform the applicant that the applicant may submit a written statement
by way of answer to the notification, and that the applicant shall have
the right to request a hearing with respect to the merits or validity of
the Administrator's decision to deny the use of the proposed synonymous
term.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(5) If the claim is approved, the Agency shall notify the applicant,
in writing, and shall publish in the Federal Register a notice informing
the public that the synonymous term has been approved for use.
(m)(1) Labeling applications for the use of an implied nutrient
content claim in a brand name shall be accompanied by the following data
which shall be submitted in the following form to the Director, Food
Labeling Division, Regulatory Programs, Food Safety and Inspection
Service, Washington, DC 20250:
________________________________________________________________________
(Date)
The undersigned, ------------ submits this labeling application
pursuant to 9 CFR 381.469 with respect to (statement of the implied
nutrient content claim and its proposed use in a brand name).
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement identifying the implied nutrient content claim, the
nutrient the claim is intended to characterize, the corresponding term
for characterizing the level of such nutrient as defined by a
regulation,
[[Page 609]]
and the brand name of which the implied claim is intended to be a part.
The statement shall address why the use of the brand-name as proposed
will not be misleading. The statement shall provide examples of the
types of products on which the brand name will appear. It shall also
include data showing that the actual level of the nutrient in the food
would qualify the label of the product to bear the corresponding term
defined by regulation. Assay methods used to determine the level of a
nutrient shall meet the requirements stated under labeling application
format in paragraph (k)(1)(iii) of this section.
(ii) A detailed explanation supported by any necessary data of why
use of the proposed brand name is requested. This explanation shall also
state what nutritional benefit to the public will derive from use of the
brand name as proposed. If the branded product is intended for a
specific group within the population, the analysis shall specifically
address nutritional needs of such group and scientific data sufficient
for such purpose.
Yours very truly,
Applicant_________________________________________________________
By________________________________________________________________
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall inform
the applicant that the labeling application is undergoing Agency review
and that the applicant shall subsequently be notified of the Agency's
decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
implied nutrient content claim is false or misleading. The notification
letter shall inform the applicant that the applicant may submit a
written statement by way of answer to the notification, and that the
applicant shall have the right to request a hearing with respect to the
merits or validity of the Administrator's decision to deny the use of
the proposed implied nutrient content claim.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish a notice of the labeling
application in the Federal Register seeking a comment on the use of the
implied nutrient content claim. The notice shall also summarize the
labeling application, including where the supporting documentation can
be reviewed. The Administrator's notice shall seek comment from
consumers, the industry, consumer and industry groups, and other
interested persons on the labeling application and the use of the
implied nutrient content claim. After public comment has been received
and reviewed by the Agency, the Administrator shall make a determination
on whether the implied nutrient content claim shall be approved for use
on the labeling of poultry products.
(i) If the claim is denied by the Administrator, the Agency shall
notify the applicant, in writing, of the basis for the denial, including
the reason why the claim on the labeling was determined by the Agency to
be false or
[[Page 610]]
misleading. The notification letter shall also inform the applicant that
the applicant may submit a written statement by way of answer to the
notification, and that the applicant shall have the right to request a
hearing with respect to the merits or validity of the Administrator's
decision to deny the use of the proposed implied nutrient content claim.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the
applicant, in writing, and shall also publish in the Federal Register a
notice informing the public that the implied nutrient content claim has
been approved for use.
(Paperwork requirements were approved by the Office of Management and
Budget under control number 0583-0088.)
[58 FR 675, Jan. 6, 1993, as amended at 59 FR 45198, Sept. 1, 1994; 60
FR 217, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.480]
[Page 610-611]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.480 Label statements relating to usefulness in reducing or maintaining body weight.
(a) General requirements. Any product that purports to be or is
represented for special dietary use because of usefulness in reducing
body weight shall bear:
(1) Nutrition labeling in conformity with Sec. 381.409 of this
subpart, unless exempt under that section, and
(2) A conspicuous statement of the basis upon which the product
claims to be of special dietary usefulness.
(b) Nonnutritive ingredients. (1) Any product subject to paragraph
(a) of this section that achieves its special dietary usefulness by use
of a nonnutritive ingredient (i.e., one not utilized in normal
metabolism) shall bear on its label a statement that it contains a
nonnutritive ingredient and the percentage by weight of the nonnutritive
ingredient.
(2) A special dietary product may contain a nonnutritive sweetener
or other ingredient only if the ingredient is safe for use in the
product under the applicable law and regulations of this chapter. Any
product that achieves its special dietary usefulness in reducing or
maintaining body weight through the use of a nonnutritive sweetener
shall bear on its label the statement required by paragraph (b)(1) of
this section, but need not state the percentage by weight of the
nonnutritive sweetener. If a nutritive sweetener(s) as well as
nonnutritive sweetener(s) is added, the statement shall indicate the
presence of both types of sweetener; e.g., "Sweetened with nutritive
sweetener(s) and nonnutritive sweetener(s)."
(c)"Low calorie" foods. A product purporting to be "low calorie"
must comply with the criteria set forth for such foods in Sec. 381.460.
(d) "Reduced calorie" foods and other comparative claims. A
product purporting to be "reduced calorie" or otherwise containing
fewer calories than a reference food must comply with the criteria set
forth for such foods in Sec. 387.460(b) (4) and (5).
(e) "Label terms suggesting usefulness as low calorie or reduced
calorie foods". (1) Except as provided in paragraphs (e)(2) and (e)(3)
of this section, a product may be labeled with terms such as "diet,"
"dietetic," "artificially sweetened," or "sweetened with
nonnutritive sweetener" only if the claim is not false or misleading,
and the product is
[[Page 611]]
labeled "low calorie" or "reduced calorie" or bears another
comparative calorie claim in compliance with the applicable provisions
in this subpart.
(2) Paragraph (e)(1) of this section shall not apply to any use of
such terms that is specifically authorized by regulation governing a
particular food, or, unless otherwise restricted by regulation, to any
use of the term "diet" that clearly shows that the product is offered
solely for a dietary use other than regulating body weight, e.g., "for
low sodium diets."
(3) Paragraph (e)(1) of this section shall not apply to any use of
such terms on a formulated meal replacement or other product that is
represented to be of special dietary use as a whole meal, pending the
issuance of a regulation governing the use of such terms on foods.
(f) "Sugar free" and "no added sugar". Criteria for the use of
the terms "sugar free" and "no added sugar" are provided for in
Sec. 381.460(c).
[58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58
FR 47628, Sept. 10, 1993; 60 FR 217, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.500]
[Page 611-612]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart Y--Nutrition Labeling
Sec. 381.500 Exemption from nutrition labeling.
(a) The following poultry products are exempt from nutrition
labeling:
(1) Food products produced by small businesses, provided that the
labels for these products bear no nutrition claims or nutrition
information,
(i) A food product, for purposes of the small business exemption, is
defined as a formulation, not including distinct flavors which do not
significantly alter the nutritional profile, sold in any size package in
commerce.
(ii) For purposes of this paragraph, a small business is any single-
plant facility or multi-plant company/firm that employs 500 or fewer
people and produces no more than the following amounts of pounds of the
product qualifying the firm for exemption from this subpart:
(A) During the first year of implementation of nutrition labeling,
from July 1994 to July 1995, 250,000 pounds or less,
(B) During the second year of implementation of nutrition labeling,
from July 1995 to July 1996, 175,000 pounds or less, and
(C) During the third year of implementation and subsequent years
thereafter, 100,000 pounds or less.
(iii) For purposes of this paragraph, calculation of the amount of
pounds shall be based on the most recent 2-year average of business
activity. Where firms have been in business less than 2 years or where
products have been produced for less than 2 years, reasonable estimates
must indicate that the annual pounds produced will not exceed the
amounts specified.
(2) Products intended for further processing, provided that the
labels for these products bear no nutrition claims or nutrition
information,
(3) Products that are not for sale to consumers, provided that the
labels for these products bear no nutrition claims or nutrition
information,
(4) Products in small packages that are individually wrapped
packages of less than \1/2\ ounce net weight, provided that the labels
for these products bear no nutrition claims or nutrition information,
(5) Products custom slaughtered or prepared,
(6) Products intended for export, and
(7) The following products prepared and served or sold at retail
provided that the labels or the labeling of these products bear no
nutrition claims or nutrition information:
(i) Ready-to-eat products that are packaged or portioned at a retail
store or similar retail-type establishment; and
(ii) Multi-ingredient products (e.g. sausage) processed at a retail
store or similar retail-type establishment.
(b) Restaurant menus generally do not constitute labeling or fall
within the scope of these regulations.
(c)(1) Foods represented to be specifically for infants and children
less than 2 years of age shall bear nutrition labeling as provided in
paragraph (c)(2) of this section, except such labeling shall not include
calories from fat, calories from saturated fat, saturated fat, stearic
acid, polyunsaturated fat, monounsaturated fat, and cholesterol.
[[Page 612]]
(2) Foods represented or purported to be specifically for infants
and children less than 4 years of age shall bear nutrition labeling
except that:
(i) Such labeling shall not include declarations of percent of Daily
Value for total fat, saturated fat, cholesterol, sodium, potassium,
total carbohydrate, and dietary fiber;
(ii) Nutrient names and quantitative amounts by weight shall be
presented in two separate columns;
(iii) The heading "Percent Daily Value" required in
Sec. 381.409(d)(6) shall be placed immediately below the quantitative
information by weight for protein;
(iv) The percent of the Daily Value for protein, vitamins, and
minerals shall be listed immediately below the heading "Percent Daily
Value"; and
(v) Such labeling shall not include the footnote specified in
Sec. 381.409(d)(9).
(d)(1) Products in packages that have a total surface area available
to bear labeling of less than 12 square inches are exempt from nutrition
labeling, provided that the labeling for these products bear no
nutrition claims or other nutrition information. The manufacturer,
packer, or distributor shall provide, on the label of packages that
qualify for and use this exemption, an address or telephone number that
a consumer can use to obtain the required nutrition information (e.g.,
"For nutrition information call 1-800-123-4567").
(2) When such products bear nutrition labeling, either voluntarily
or because nutrition claims or other nutrition information is provided,
all required information shall be in a type size no smaller than 6 point
or all upper case type of \1\/16-inch minimum height, except
that individual serving-size packages of poultry products that have a
total area available to bear labeling of 3 square inches or less may
provide all required information in a type size no smaller than \1\/
32-inch minimum height.
[58 FR 675, Jan. 6, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 59
FR 45198, Sept. 1, 1994; 60 FR 217, Jan. 3, 1995]
