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: 9CFR318]
[Page 229-230]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec.
318.1 Products and other articles entering official establishments.
318.2 Reinspection, retention, and disposal of meat and poultry
products at official establishments.
318.3 Designation of places of receipt of products and other articles
for reinspection.
318.4 Preparation of products to be officially supervised;
responsibilities of official establishments; plant operated
quality control.
318.5 Requirements concerning procedures.
318.6 Requirements concerning ingredients and other articles used in
preparation of products.
318.8 Preservatives and other substances permitted in product for
export only; handling; such product not to be used for
domestic food purposes.
318.9 Samples of products, water, dyes, chemicals, etc., to be taken
for examination.
318.10 Prescribed treatment of pork and products containing pork to
destroy trichinae.
318.11 [Reserved]
[[Page 230]]
318.12 Manufacture of dog food or similar uninspected article at
official establishments.
318.13 Mixtures containing product but not amendable to the Act.
318.14 Adulteration of product by polluted water; procedure for
handling.
318.15 Tagging chemicals, preservatives, cereals, spices, etc., "U.S.
retained."
318.16 Pesticide chemicals and other residues in products.
318.17 Requirements for the production of cooked beef, roast beef, and
cooked corned beef products.
318.18 Handling of certain material for mechanical processing.
318.19 Compliance procedure for cured pork products.
318.20 Use of animal drugs.
318.21 Accreditation of chemistry laboratories.
318.22 Determination of added water in cooked sausages.
318.23 Heat-processing and stabilization requirements for uncured meat
patties.
318.24 Compliance procedures for meat derived from advanced meat/bone
separation machinery and recovery systems.
Subparts B-F [Reserved]
Subpart G--Canning and Canned Products
318.300 Definitions.
318.301 Containers and closures.
318.302 Thermal processing.
318.303 Critical factors and the application of the process schedule.
318.304 Operations in the thermal processing area.
318.305 Equipment and procedures for heat processing systems.
318.306 Processing and production records.
318.307 Record review and maintenance.
318.308 Deviations in processing.
318.309 Finished product inspection.
318.310 Personnel and training.
318.311 Recall procedure.
Authority: 7 U.S.C. 38f, 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
[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: 9CFR318.1]
[Page 230-231]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.1 Products and other articles entering official establishments.
Source: 35 FR 15586, Oct. 3, 1970, unless otherwise noted.
(a) Except as otherwise provided in paragraphs (g) and (h) of this
section or Sec. 318.12, no product shall be brought into an official
establishment unless it has been prepared only in an official
establishment and previously inspected and passed by a Program employee,
and is identified by an official inspection legend as so inspected and
passed. Notwithstanding the foregoing provisions of this subparagraph,
product imported in accordance with part 327 of this subchapter and not
prepared in the United States outside an official establishment, may
enter any official establishment subject in other respects to the same
restrictions as apply to domestic product. Products received in an
official establishment during the Program employees absence shall be
identified and maintained in a manner acceptable to such employee.
Product entering any official establishment shall not be used or
prepared thereat until it has been reinspected in accordance with
Sec. 318.2. Any product originally prepared at any official
establishment may not be returned into any part of such establishment,
except the receiving area approved under Sec. 318.3, until it has been
reinspected by the inspector.
(b) No slaughtered poultry or poultry product shall be brought into
an official establishment unless it has been (1) previously inspected
and passed and is identified as such in accordance with the requirements
of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the
regulations thereunder, and has not been prepared other than in an
establishment inspected under said Act, or (2) has been inspected and
passed and is identified as such in accordance with the requirements of
a State law.
(c) Every article for use as an ingredient in the preparation of
meat food products, when entering any official establishment and at all
times while it is in such establishment, shall bear a label showing the
name of the article, the amount or percentage therein of any substances
restricted by this part or part 317 of this subchapter, and a list of
ingredients in the article if composed of two or more ingredients:
Provided, That in the case of articles received in tank car lots, only
one such label shall be used to identify each lot. In addition, the
label must show the name and address of the shipper.
(d) To ensure the safe use of preparations used in hog scalding
water or in
[[Page 231]]
the denuding of tripe, 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.
(e) Dyes, chemicals, or other substances the use of which is
restricted to certain products may be brought into or kept in an
official establishment only if such products are prepared thereat. No
prohibited dye, chemical, preservative, or other substance shall be
brought into or kept in an official establishment.
(f) [Reserved]
(g) Glands and organs, such as cotyledons, ovaries, prostate glands,
tonsils, spinal cords, and detached lymphatic, pineal, pituitary,
parathyroid, suprarenal, pancreatic and thyroid glands, used in
preparing pharmaceutical, organotherapeutic, or technical products and
which are not used as human food (whether or not prepared at official
establishments) may be brought into and stored in edible product
departments of inspected establishments if packaged in suitable
containers so that the presence of such glands and organ will in no way
interfere with the maintenance of sanitary conditions or constitute an
interference with inspection. Glands or organs which are regarded as
human food products, such as livers, testicles, and thymus glands, may
be brought into official establishments for pharmaceutical,
organotherapeutic or technical purposes, only if U.S. inspected and
passed and so identified. Lungs and lung lobes derived from livestock
slaughtered in any establishment may not be brought into any official
establishment except as provided in Sec. 318.12(a).
(h)(1) Carcasses of game animals, and carcasses derived from the
slaughter by any person of livestock of his own raising in accordance
with the exemption provisions of paragraph 23(a) of the Act, and parts
of such carcasses, may be brought into an official establishment for
preparation, packaging, and storing in accordance with the provisions of
Sec. 303.1(a)(2) of this subchapter.
(2) Meat, meat byproducts, and meat food products bearing official
marks showing that they were inspected and passed under State inspection
in any State not designated in Sec. 331.2 of this subchapter may be
received by official establishments for storage and distribution solely
in intrastate commerce. The presence of such State inspected products
must not create any unsanitary condition or otherwise result in
adulteration of any products at the official establishment or interfere
with the conduct of inspection under this subchapter. In addition, such
State inspected products must be stored separately and apart from the
federally inspected products in the official establishment.
(i) The operator of the official establishment shall furnish such
information as is necessary to determine the origin of any product or
other article entering the official establishment. Such information
shall include, but is not limited to, the name and address of the seller
or supplier, transportation company, agent, or broker involved in the
sale or delivery of the product or article in question.
(j) Any product or any poultry or poultry product or other article
that is brought into an official establishment contrary to any provision
of this section may be required by the Administrator to be removed
immediately from such establishment by the operator thereof, and failure
to comply with such requirement shall be deemed a violation of this
regulation. If any slaughtered poultry or poultry products or other
articles are received at an official establishment and are suspected of
being adulterated or misbranded under the Poultry Products Inspection
Act or the Federal Food, Drug, and Cosmetic Act, or applicable State
laws, the appropriate governmental authorities will be notified.
[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 38
FR 5152, Feb. 26, 1973; 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10,
1984; 64 FR 72174, 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: 9CFR318.2]
[Page 231-232]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments.
(a) All products and all slaughtered poultry and poultry products
brought
[[Page 232]]
into any official establishment shall be identified by the operator of
the official establishment at the time of receipt at the official
establishment and shall be subject to reinspection by a Program employee
at the official establishment in such manner and at such times as may be
deemed necessary to assure compliance with the regulations in this
subchapter.
(b) All products, whether fresh, cured, or otherwise prepared, even
though previously inspected and passed, shall be reinspected by Program
employees as often as they may deem necessary in order to ascertain that
they are not adulterated or misbranded at the time they enter or leave
official establishments and that the requirements of the regulations in
this subchapter are complied with.
(c) Reinspection may be accomplished through use of statistically
sound sampling plans that assure a high level of confidence. The circuit
supervisor 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
Supervisors of Program circuits. 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, such
as liver, oxtails, etc.
---------------------------------------------------------------------------
(d) A U.S. retained tag shall be placed by a Program employee at the
time of reinspection at any official establishment on all products which
are suspected on such reinspection of being adulterated or misbranded,
and such products shall be held for further inspection. Such tags shall
be removed only by authorized Program employees. When further inspection
is made, if the product is found to be adulterated, all official
inspection legends or other official marks for which the product is
found to be ineligible under the regulations in this subchapter, shall
be removed or defaced and the product will be subject to condemnation
and disposal in accordance with part 314 of this subchapter, except that
a determination regarding adulteration may be deferred if a product has
become soiled or unclean by falling on the floor or in any other
accidental way or if the product is affected with any other condition
which the inspector deems capable of correction, in which case the
product shall be cleaned (including trimming if necessary) or otherwise
handled in a manner approved by the inspector to assure that it will not
be adulterated or misbranded and shall then be presented for
reinspection and disposal in accordance with this section. If upon final
inspection, the product is found to be neither adulterated nor
misbranded, the inspector shall remove the U.S. retained tag. If a
product is found upon reinspection to be misbranded, it shall be held
under a U.S. retained tag, or a U.S. detention tag as provided in part
329 of this subchapter, pending correction of the misbranding or
issuance of an order under section 7 of the Act to withhold from use the
labeling or container of the product, or the institution of a judicial
seizure action under section 403 of Act or other appropriate action. The
inspector shall make a complete record of each transaction under this
paragraph and shall report his action to the area supervisor.
[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]
[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: 9CFR318.3]
[Page 232]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.3 Designation of places of receipt of products and other articles for reinspection.
Every official establishment shall designate, with the approval of
the circuit supervisor, a dock or place at which products and other
articles subject to reinspection under Sec. 318.2 shall be received, and
such products and articles shall be received only at such dock or place.
[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: 9CFR318.4]
[Page 232-235]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.
(a) All processes used in curing, pickling, rendering, canning, or
otherwise
[[Page 233]]
preparing any product in official establishments shall be supervised by
Program employees unless such preparation is conducted as a custom
operation exempted from inspection under Sec. 303.1(a)(2) of this
subchapter in any official establishment or consists of operations that
are exempted from inspection under Sec. 303.1(d) of this subchapter and
are conducted in a retail store in an establishment subject to
inspection only because the State or Territory in which the
establishment is located is designated under paragraph 301(c) of the
Act. No fixtures or appliances, such as tables, trucks, trays, tanks,
vats, machines, implements, cans, or containers of any kind, shall be
used unless they are of such materials and construction as will not
contaminate or otherwise adulterate the product and are clean and
sanitary. All steps in the preparation of edible products shall be
conducted carefully and with strict cleanliness in rooms or compartments
separate from those used for inedible products.
(b) It shall be the responsibility of the operator of every official
establishment to comply with the Act and the regulations in this
subchapter. In order to carry out this responsibility effectively, the
operator of the establishment shall institute appropriate measures to
assure the maintenance of the establishment and the preparation,
marking, labeling, packaging and other handling of its products strictly
in accordance with the sanitary and other requirements of this
subchapter. The effectiveness of such measures will be subject to review
by the Department.
(c) Applying for Total Plant Quality Control. Any owner or operator
of an official establishment preparing meat food product who has a total
plant quality control system or plan for controlling such product, 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 of
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 system requires 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 an establishment which does not have full-time quality control
personnel, information indicating the nature of the duties and
responsibilities of the person who will be responsible for the quality
control system.
(3) A list identifying those parts and sections of the Federal meat
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 quality control 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
[[Page 234]]
designed to identify and control, the parameters or limits which will be
used, and the points at which corrective action will occur and the
nature of such corrective action--ranging from 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) [Reserved]
(e) Evaluation and Approval of Total Plant Quality Control. (1) The
Administrator shall evaluate the material presented in accordance with
the provisions of paragraph (c) of this section. If it is determined by
the Administrator, on the basis of the evaluation, that the total
quality control system will result in finished products controlled in
this manner being in full compliance with the requirements of the Act
and regulations thereunder, the total quality control system will be
approved and plans will be made for implementation under departmental
supervision.
(2) In any situation where the system is found by the Administrator
to be unacceptable, formal notification shall be given to the applicant
of the basis for the denial. The applicant will be afforded an
opportunity to modify the system in accordance with the notification.
The applicant shall also be afforded an opportunity to submit a written
statement in response to this notification of denial and a right to
request a hearing with respect to the merits or validity of the denial.
If the applicant requests a hearing and the Administrator, after review
of the answer, determines the initial determination to be correct, he
shall file with the Hearing Clerk of the Department the notification,
answer and the request for hearing, which shall constitute the complaint
and answer in the proceeding, which shall thereafter be conducted in
accordance with Rules of Practice which shall be adopted for this
proceeding.
(3) The establishment owner or operator shall be responsible for the
effective operation of the approved total plant quality control system
to assure compliance with the requirements of the Act and regulations
thereunder. The Secretary shall continue to provide the Federal
inspection necessary to carry out his responsibilities under the Act.
(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 parts 316 and 317 of this subchapter.
[GRAPHIC] [TIFF OMITTED] TC11SE91.015
(g) Termination of Total Plant Quality Control. (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 may be
terminated upon the establishment's receipt of a written notice from the
Administrator under the following conditions:
[[Page 235]]
(i) If adulterated or misbranded meat food product is found by the
Administrator 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 conflict of facts, a hearing, under
applicable Rules of Practice, will be provided to the establishment
owner or operator 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 or program 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 Administrator 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 provided to the
establishment owner or operator 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 a modified total
establishment quality control system will not be evaluated by the
Administrator for at least 6 months from the termination date.
(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. Permission 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. 318.4(h)(1) have
been or will be met.
(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 inspection services at the discretion of the circuit
supervisor and charged for such services.
(Reporting requirements were approved by the Office of Management and
Budget under control number 0583-0015)
[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45
FR 54322, Aug. 15, 1980; 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug.
25, 1997; 62 FR 54759, Oct. 22, 1997; 65 FR 34389, 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: 9CFR318.5]
[Page 235-236]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.5 Requirements concerning procedures.
(a)(1) Care shall be taken to assure that product is not adulterated
when placed in freezers. If there is doubt as to the soundness of any
frozen product, the inspector will require the defrosting and
reinspection of a sufficient quantity thereof to determine its actual
condition.
(2) Frozen product may be defrosted in water or pickle in a manner
and with the use of facilities which are acceptable to the inspector.
Before such product is defrosted, a careful examination shall be made to
determine its condition. If necessary, this examination shall include
defrosting of representative samples by means other than in water or
pickle.
(b) Product, such as pork tenderloins, brains, sweetbreads, stew, or
chop suey, shall not be packed in hermetically sealed metal or glass
containers,
[[Page 236]]
unless subsequently heat processed or otherwise treated to preserve the
product in a manner approved by the Administrator in specific cases.
(c) Care shall be taken to remove bones and parts of bones from
product which is intended for chopping.
(d) Heads for use in the preparation of meat food products shall be
split and the bodies of the teeth, the turbinated and ethmoid bones, ear
tubes, and horn butts removed, and the heads then thoroughly cleaned.
(e) Kidneys for use in the preparation of meat food products shall
first be freely sectioned and then thoroughly soaked and washed. All
detached kidneys, including beef kidneys with detached kidney fat, shall
be inspected before being used in or shipped from the official
establishment.
(f) Cattle paunches and hog stomachs for use in the preparation of
meat food products shall be thoroughly cleaned on all surfaces and parts
immediately after being emptied of their contents, which shall follow
promptly their removal from the carcasses.
(g) Clotted blood shall be removed from hog hearts before they are
shipped from the official establishment or used in the preparation of
meat food products.
(h) Beef rounds, beef bungs, beef middles, beef bladders, calf
rounds, hog bungs, hog middles, and hog stomachs which are to be used as
containers of any meat food product shall be presented for inspection,
turned with the fat surface exposed.
(i) Portions of casings which show infection with Oesophagostomum or
other nodule-producing parasite, and weasands infected with the larvae
of Hypoderma lineatum, shall be rejected, except that when the
infestation is slight and the nodules and larvae are removed, the casing
or weasand may be passed.
[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]
[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: 9CFR318.6]
[Page 236-237]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.6 Requirements concerning ingredients and other articles used in preparation of products.
(a) All ingredients and other articles used in the preparation of
any product shall be clean, sound, healthful, wholesome, and otherwise
such as will not result in the product being adulterated. Official
establishments shall furnish inspectors accurate information on all
procedures involved in product preparation including product composition
and any changes in such procedures essential for inspectional control of
the product.
(b)(1) The only animal casings that may be used as containers of
product are those from cattle, sheep, swine, or goats.
(2) Casings for products shall be carefully inspected by Program
employees. Only those casings which have been carefully washed and
thoroughly flushed with clean water immediately before stuffing and are
suitable for containers, are clean, and are passed on such inspection
shall be used, except that preflushed animal casings packed in salt or
salt and glycerine solution or other approved medium may be used without
additional flushing provided they are found to be clean and otherwise
acceptable and are thoroughly rinsed before use.
(3) Hog and sheep casings intended for use as containers of product
may be treated by soaking in or applying thereto sound, fresh pineapple
juice or papain or bromelin or pancreatic extract to permit the enzymes
contained in these substances to act on the casings to make them less
resistant. The casings shall be handled in a clean and sanitary manner
throughout and the treatment shall be followed by washing and flushing
the casings with water sufficiently to effectively remove the substance
used and terminate the enzymatic action.
(4) On account of the invariable presence of bone splinters,
detached spinal cords shall not be used in the preparation of edible
product other than for rendering where they constitute a suitable raw
material.
(5) Testicles if handled as an edible product may be shipped from
the official establishment as such, but they shall not be used as an
ingredient of a meat food product.
(6) Tonsils shall be removed and shall not be used as ingredients of
meat food products.
(7) Blood from livestock prepared in accordance with Sec. 310.20 of
this subchapter may be used as an ingredient
[[Page 237]]
of a meat food product for which a standard is prescribed in part 319 of
this subchapter, if permitted by such standard, and may be used in any
meat food product for which no such standard is prescribed in part 319
of this subchapter if it is a common and usual ingredient of such
product.
(8) Intestines shall not be used as ingredients in any meat food
product for which a standard is prescribed in part 319 of this
subchapter and shall not be used in other products unless the products
are labeled in accordance with Sec. 317.8(b)(3) of this subchapter.
(9) Poultry products and egg products (other than shell eggs) which
are intended for use as ingredients of meat food products shall be
considered acceptable for such use only when identified as having been
inspected and passed for wholesomeness by the Department under the
regulations in 7 CFR part 59 or 9 CFR part 362 or 381 and when found to
be sound and otherwise acceptable when presented for use. Poultry
products and egg products (other than shell eggs) which have not been so
inspected and passed for wholesomeness shall not be used in the
preparation of such meat food products.
(10) Dry milk products which are intended for use as ingredients of
meat food products shall be considered acceptable for such use only when
produced in a plant approved by the Department under the regulations in
7 CFR part 58, and when found to be sound and otherwise acceptable when
presented for use. Dry milk products prepared in a plant not so approved
shall not be used in the preparation of such meat food products.
(11) [Reserved]
(12) Ingredients for use in any product may not bear or contain any
pesticide chemical or other residues in excess of level permitted in
Sec. 318.16.
(13) Use of "Mechanically Separated (Kind of Poultry)," as defined
in Sec. 381.173 of this chapter, in the preparation of meat food
products shall accord with Sec. 381.174 and all other applicable
provisions of this subchapter.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 14368, June 1, 1973; 38
FR 29214, Oct. 23, 1973; 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June
11, 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 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: 9CFR318.8]
[Page 237-238]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.8 Preservatives and other substances permitted in product for export only; handling; such product not to be used for domestic food purposes.
(a) Preservatives and other substances not permitted in domestic
product under the regulations in this subchapter may be used in the
preparation and packing of product intended for export provided the
product (1) accords to the specifications or directions of the foreign
purchaser; (2) is not in conflict with the laws of the country to which
it is intended for export; and (3) is labeled on the outside container
to show that it is intended for export, and is otherwise labeled as
required by this subchapter for such export product.
(b) The preparation and packing of export product as provided for in
paragraph (a) of this section shall be done in a manner acceptable to
the inspector in charge so that the identity of the export product is
maintained conclusively and the preparation of domestic product is
adequately protected. The preservatives and other substances not
permitted in domestic product shall be stored in a room or compartment
separate from areas used to store other supplies and shall be held under
Program lock. Use of the preservatives or other substances shall be
under the direct supervision of a Program employee.
(c) The packing of all articles under paragraph (a) of this section
shall be conducted under the direct supervision of a Program employee.
(d) No article prepared or packed for export under paragraph (a) of
this section shall be sold or offered for sale for domestic use or
consumption, but unless exported shall be destroyed for food purposes
under the direct supervision of a Program employee.
(e) The contents of the container of any article prepared or packed
for export under paragraph (a) of this section shall not be removed, in
whole or in part, from such container prior to exportation, except under
the supervision of a Program employee. If such contents are removed
prior to exportation, then the article shall be either repacked, in
accordance with the provisions of paragraphs (b) and (c) of this
[[Page 238]]
section, or destroyed for food purposes under the direct supervision of
a Program employee.
(f) Permission must be obtained from the Administrator before meats
packed in borax are shipped from one official establishment to another
or to an unofficial establishment for storage, except such meat prepared
for the account of Federal agencies.
(g) At all times, the identity of meat to which borax has been added
shall be effectively maintained. In no case shall such meat, nor any
trimmings or fat derived from such meat, whether unwashed or washed, or
otherwise treated, be diverted to domestic use.
(h) Salt used for bulking meat previously packed in borax may not
again be used in an edible products department other than in connection
with the packing of meat in borax. Only metal equipment should be used
for handling such meat. Particularly effective cleansing will be
required if wooden equipment such as trucks, washing vats, etc., is
used. Boxes from which boraxed meat has been removed may be used for
repacking meat in borax, but their use as containers for other meat will
be dependent upon the effective removal of all traces of borax.
(i) The following instructions pertain to export cured pork packed
in borax for the account of Federal agencies. The meat may be packed in
borax in a room in which there is borax-free meat, provided proper care
is taken to see that the borax-free meat is not affected by the borax.
Under the same condition, meat packed in borax may be received,
unpacked, defrosted, soaked, washed, smoked, and repacked in a room
where there is other meat. However, meat originally packed in borax
shall at all times be subject to the restrictions of meat so packed,
even though repacked without borax. After packing or repacking, borax
packed meat may be stored in a room with meat not packed in borax,
provided a reasonable degree of separation is maintained between the two
classes of product.
[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 38
FR 29214, Oct. 23, 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: 9CFR318.9]
[Page 238]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.9 Samples of products, water, dyes, chemicals, etc., to be taken for examination.
Samples of products, water, dyes, chemicals, preservatives, spices,
or other articles in any official establishment shall be taken, without
cost to the Program, for examination, as often as may be deemed
necessary for the efficient conduct of the inspection.
[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: 9CFR318.10]
[Page 238-248]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.10 Prescribed treatment of pork and products containing pork to destroy trichinae.
(a)(1) All forms of fresh pork, including fresh unsmoked sausage
containing pork muscle tissue, and pork such as bacon and jowls, other
than those covered by paragraph (b) of this section, are classed as
products that are customarily well cooked in the home or elsewhere
before being served to the consumer. Therefore, the treatment of such
products for the destruction of trichinae is not required.
(2) Pork from carcasses or carcass parts that have been found free
of trichinae as described under paragraph (e) or (f) of this section is
not required to be treated for the destruction of trichinae.
(b) Products named in this paragraph, and products of the character
hereof, containing pork muscle tissue (not including pork hearts, pork
stomachs, and pork livers), or the pork muscle tissue which forms an
ingredient of such products, shall be effectively heated, refrigerated,
or cured to destroy any possible live trichinae, as prescribed in this
section at the official establishment where such products are prepared:
Bologna, frankfurter, vienna, and other cooked sausage; smoked sausage;
knoblauch sausage; mortadella; all forms of summer or dried sausage,
including mettwurst; flavored pork sausages such as those containing
wine or similar flavoring materials; cured pork sausage; sausage
containing cured and/or smoked pork; cooked loaves; roasted, baked,
boiled, or cooked hams, pork shoulders, or pork shoulder picnics;
Italian-style hams; Westphalia-style hams; smoked boneless pork shoulder
butts; cured meat rolls; capocollo (capicola, capacola); coppa; fresh or
cured boneless pork shoulder butts, hams, loins, shoulders, shoulder
[[Page 239]]
picnics, and similar pork cuts, in casings or other containers in which
ready-to-eat delicatessen articles are customarily enclosed (excepting
Scotch-style hams); breaded pork products; cured boneless pork loins;
boneless back bacon; bacon used for wrapping around patties, steaks and
similar products; and smoked pork cuts such as hams, shoulders, loins,
and pork shoulder picnics (excepting smoked hams, and smoked pork
shoulder picnics which are specially prepared for distribution in
tropical climates or smoked hams delivered to the Armed Services);
ground meat mixtures containing pork and beef, veal, lamb, mutton, or
goat meat and other product consisting of mixtures of pork and other
ingredients, which the Administrator determines at the time the labeling
for the product is submitted for approval in accordance with part 317 of
the regulations in this subchapter or upon subsequent reevaluation of
the product, would be prepared in such a manner that the product might
be eaten rare or without thorough cooking because of the appearance of
the finished product or otherwise. Cured boneless pork loins shall be
subjected to prescribed treatment for destruction of trichinae prior to
being shipped from the establishment where cured.
(c) The treatment shall consist of heating, refrigerating, or
curing, as follows:
(1) Heating. (i) All parts of the pork muscle tissue shall be heated
according to one of the time and temperature combinations in the
following table:
------------------------------------------------------------------------
Minimum internal temperature
--------------------------------------------------
Degrees Minimum time
Degrees fahrenheit centigrade
------------------------------------------------------------------------
120.................................. 49.0 21 hours.
122.................................. 50.0 9.5 hours.
124.................................. 51.1 4.5 hours.
126.................................. 52.2 2 hours.
128.................................. 53.4 1 hour.
130.................................. 54.5 30 minutes.
132.................................. 55.6 15 minutes.
134.................................. 56.7 6 minutes.
136.................................. 57.8 3 minutes.
138.................................. 58.9 2 minutes.
140.................................. 60.0 1 minute.
142.................................. 61.1 1 minute.
144.................................. 62.2 Instant.
------------------------------------------------------------------------
(ii) Time and temperature shall be monitored by a calibrated
recording instrument that meets the requirements of paragraph (d) of
this section, except for paragraph (c)(1)(iv).
(iii) The time to raise product temperature from 60 deg.F. to 120
deg.F shall not exceed 2 hours unless the product is cured or fermented.
(iv) Time, in combination with temperatures of 138 deg.F to 143
deg.F, need not be monitored if the product's minimum thickness exceeds
2 inches (5.1 cm) and refrigeration of the product does not begin within
5 minutes of attaining 138 deg.F (58.9 deg.C).
(v) The establishment shall use procedures which insure the proper
heating of all parts of the product. It is important that each piece of
sausage, each ham, and other product treated by heating in water be kept
entirely submerged throughout the heating period; and that the largest
pieces in a lot, the innermost links of bunched sausage or other massed
articles, and pieces placed in the coolest part of a heating cabinet or
compartment or vat be included in the temperature tests.
(2) Refrigerating. At any stage of preparation and after preparatory
chilling to a temperature of not above 40 deg.F. or preparatory
freezing, all parts of the muscle tissue of pork or product containing
such tissue shall be subjected continuously to a temperature not higher
than one of those specified in table 1, the duration of such
refrigeration at the specified temperature being dependent on the
thickness of the meat or inside dimensions of the container.
Table 1--Required Period of Freezing at Temperature Indicated
------------------------------------------------------------------------
Temperature deg.F. Group 1 (Days) Group 2 (Days)
------------------------------------------------------------------------
5 20 30
-10 10 20
-20 6 12
------------------------------------------------------------------------
(i) Group 1 comprises product in separate pieces not exceeding 6
inches in thickness, or arranged on separate racks with the layers not
exceeding 6 inches in depth, or stored in crates or boxes not exceeding
6 inches in depth, or stored as solidly frozen blocks not exceeding 6
inches in thickness.
(ii) Group 2 comprises product in pieces, layers, or within
containers, the thickness of which exceeds 6 inches but
[[Page 240]]
not 27 inches, and product in containers including tierces, barrels,
kegs, and cartons having a thickness not exceeding 27 inches.
(iii) The product undergoing such refrigeration or the containers
thereof shall be so spaced while in the freezer as will insure a free
circulation of air between the pieces of meat, layers, blocks, boxes,
barrels, and tierces in order that the temperature of the meat
throughout will be promptly reduced to not higher than 5 deg.F., -10
deg.F., or -20 deg.F., as the case may be.
(iv) In lieu of the methods prescribed in Table 1, the treatment may
consist of commercial freeze drying or controlled freezing, at the
center of the meat pieces, in accordance with the times and temperatures
specified in Table 2.
Table 2--Alternate Periods of Freezing at Temperatures Indicated
------------------------------------------------------------------------
Maximum internal temperature
--------------------------------------------------
Degrees Minimum Time
Degrees Fahrenheit centigrade
------------------------------------------------------------------------
0.................................. -17.8 106 hours.
-5................................... -20.6 82 hours.
-10.................................. -23.3 63 hours.
-15.................................. -26.1 48 hours.
-20.................................. -28.9 35 hours.
-25.................................. -31.7 22 hours.
-30.................................. -34.5 8 hours.
-35.................................. -37.2 \1/2\ hour.
------------------------------------------------------------------------
(v) During the period of refrigeration the product shall be kept
separate from other products and in the custody of the Program in rooms
or compartments equipped and made secure with an official Program lock
or seal. The rooms or compartments containing product undergoing
freezing shall be equipped with accurate thermometers placed at or above
the highest level at which the product undergoing treatment is stored
and away from refrigerating coils. After completion of the prescribed
freezing of pork to be used in the preparation of product covered by
paragraph (b) of this section the pork shall be kept under close
supervision of an inspector until it is prepared in finished form as one
of the products enumerated in paragraph (b) of this section or until it
is transferred under Program control to another official establishment
for preparation in such finished form.
(vi) Pork which has been refrigerated as specified in this
subparagraph may be transferred in sealed railroad cars, sealed
motortrucks, sealed trailers, or sealed closed containers to another
official establishment at the same or another location, for use in the
preparation of product covered by paragraph (b) of this section. Such
vehicles and containers shall be sealed and transported between official
establishments in accordance with Sec. 325.7 of this subchapter.
(3) Curing--(i) Sausage. The sausage may be stuffed in animal
casings, hydrocellulose casings, or cloth bags. During any stage of
treating the sausage for the destruction of live trichinae, except as
provided in Method 5, these coverings shall not be coated with paraffin
or like substance, nor shall any sausage be washed during any prescribed
period of drying. In the preparation of sausage, one of the following
methods may be used:
Method No. 1. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After being stuffed, sausage having a diameter not
exceeding 3\1/2\ inches, measured at the time of stuffing, shall be held
in a drying room not less than 20 days at a temperature not lower than
45 deg.F., except that in sausage of the variety known as pepperoni, if
in casings not exceeding 1\3/8\ inches in diameter measured at the time
of stuffing, the period of drying may be reduced to 15 days. In no case,
however, shall the sausage be released from the drying room in less than
25 days from the time the curing materials are added, except that
sausage of the variety known as pepperoni, if in casings not exceeding
the size specified, may be released at the expiration of 20 days from
the time the curing materials are added. Sausage in casings exceeding
3\1/2\ inches, but not exceeding 4 inches, in diameter at the time of
stuffing, shall be held in a drying room not less than 35 days at a
temperature not lower than 45 deg.F., and in no case shall the sausage
be released from the drying room in less than 40 days from the time the
curing materials are added to the meat.
Method No. 2. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed
[[Page 241]]
with the ground or chopped meat. After being stuffed, sausage having a
diameter not exceeding 3\1/2\ inches, measured at the time of stuffing,
shall be smoked not less than 40 hours at a temperature not lower than
80 deg.F., and finally held in a drying room not less than 10 days at a
temperature not lower than 45 deg.F. In no case, however, shall the
sausage be released from the drying room in less than 18 days from the
time the curing materials are added to the meat. Sausage exceeding 3\1/
2\ inches, but not exceeding 4 inches, in diameter at the time of
stuffing, shall be held in a drying room, following smoking as above
indicated, not less than 25 days at a temperature not lower than 45
deg.F., but in no case shall the sausage be released from the drying
room in less than 33 days from the time the curing materials are added
to the meat.
Method No. 3. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After admixture with the salt and other curing materials
and before stuffing, the ground or chopped meat shall be held at a
temperature not lower than 34 deg.F. for not less than 36 hours. After
being stuffed, the sausage shall be held at a temperature not lower than
34 deg.F. for an additional period of time sufficient to make a total
of not less than 144 hours from the time the curing materials are added
to the meat, or the sausage shall be held for the time specified in a
pickle-curing medium of not less than 50 deg. strength (salometer
reading) at a temperature not lower than 44 deg.F. Finally, sausage
having a diameter not exceeding 3\1/2\ inches, measured at the time of
stuffing, shall be smoked for not less than 12 hours. The temperature of
the smokehouse during this period at no time shall be lower than 90
deg.F.; and for 4 consecutive hours of this period the smokehouse shall
be maintained at a temperature not lower than 128 deg.F. Sausage
exceeding 3\1/2\ inches, but not exceeding 4 inches, in diameter at the
time of stuffing shall be smoked, following the prescribed curing, for
not less than 15 hours. The temperature of the smokehouse during the 15-
hour period shall at no time be lower than 90 deg.F., and for 7
consecutive hours of this period the smokehouse shall be maintained at a
temperature not lower than 128 deg.F. In regulating the temperature of
the smokehouse for the treatment of sausage under this method, the
temperature of 128 deg.F. shall be attained gradually during a period
of not less than 4 hours.
Method No. 4. The meat shall be ground or chopped into pieces not
exceeding one-fourth of an inch in diameter. A dry-curing mixture
containing not less than 2\1/2\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After admixture with the salt and other curing materials
and before stuffing, the ground or chopped sausage shall be held as a
compact mass, not more than 6 inches in depth, at a temperature not
lower than 36 deg.F. for not less than 10 days. At the termination of
the holding period, the sausage shall be stuffed in casings or cloth
bags not exceeding 3\1/3\ inches in diameter, measured at the time of
stuffing. After being stuffed, the sausage shall be held in a drying
room at a temperature not lower than 45 deg.F. for the remainder of a
35-day period, measured from the time the curing materials are added to
the meat. At any time after stuffing, if the establishment operator
deems it desirable, the product may be heated in a water bath for a
period not to exceed 3 hours at a temperature not lower than 85 deg.F.,
or subjected to smoking at a temperature not lower than 80 deg.F., or
the product may be both heated and smoked as specified. The time
consumed in heating and smoking, however, shall be in addition to the
35-day holding period specified.
Method No. 5. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After being stuffed, the sausage shall be held for not
less than 65 days at a temperature not lower than 45 deg.F. The
coverings for sausage prepared according to this method may be coated at
any stage of the preparation before or during the holding period with
paraffin or other substance approved by the Administrator.
Method No. 6. (A) Basic requirements. The meat shall be ground or
chopped into pieces not exceeding three-fourths of an inch in diameter.
A dry-curing mixture containing not less than 3.33 pounds of salt to
each hundredweight of the unstuffed sausage, excluding the weight of dry
ingredients, shall be thoroughly mixed with the ground or chopped meat.
After the curing mixture has been added, the sausage shall be held for
two time periods, a holding period and a drying period. The holding
period will be for a minimum of 48 hours at a room temperature not lower
than 35 deg.F. This holding period requirement may be fulfilled totally
or in part before the drying period and then the remainder, if any,
after the drying period or as an extension of the drying period. During
the drying period, the sausage shall be held in a drying room at a
temperature not lower than 50 (10.0 deg.F. (10.0 deg.C) for a period
of time determined by Tables 3A, 3B, and 4. The length of the drying
period, established in (c)(3)(i)(A), may be modified as provided in
paragraphs (c)(3)(i)(B) and (c)(3)(i)(C) of this section.
[[Page 242]]
Table 3A--Sausage Drying Room Times by Method No. 6
------------------------------------------------------------------------
Days in
Diameter of casing at time of stuffing\1\ drying
room\2\
------------------------------------------------------------------------
Up to:
1 inches................................................... 14
1\1/2\ inches.............................................. 15
2 inches................................................... 16
2\1/2\ inches.............................................. 18
3 inches................................................... 20
3\1/2\ inches.............................................. 23
4 inches................................................... 25
4\1/2\ inches.............................................. 30
5 inches................................................... 35
5\1/2\ inches.............................................. 43
6 inches................................................... 50
------------------------------------------------------------------------
\1\ The drying room times for flattened or oval sausages shall use a
diameter derived by measuring the circumference and dividing by 3.14
(pi).
\2\ Drying room time may be modified as set forth in Tables 3B and 4.
(B) Reduction in Drying Room Time. During the holding period, the
sausage may be smoked or fermented. If the temperature is increased to
70 deg.F. (21.1 deg.C) or higher, while the sausage is being held
after adding curing materials but before the drying period, the
subsequent drying room times prescribed for this method may be reduced
according to the schedule in Table 3B. No interpolation of values is
permissible.
Table 3B--Percentage Reduction in Drying Room Time (Table 3A) Permitted by Holding Times and Temperatures Prior to Drying \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Minimum Temperature \2\
---------------------------------------------------------------------------------------------------
70 75 80 85 90 95 100 105 110 120
Minimum Time deg.F deg.F deg.F deg.F deg.F deg.F deg.F deg.F deg.F deg.F
---------------------------------------------------------------------------------------------------
21.1 23.9 26.7 29.5 32.2 35.0 37.9 40.6 43.3 48.9
deg.C deg.C deg.C deg.C deg.C deg.C deg.C deg.C deg.C deg.C
--------------------------------------------------------------------------------------------------------------------------------------------------------
24 hours............................................ 4 5 8 10 15 23 37 57 90 \3\ 100
48 hours............................................ 9 12 18 25 35 49 88 \3\ 100 \3\ 100 100
72 hours............................................ 14 19 28 39 55 74 \3\ 100 100 100 100
96 hours............................................ 19 26 38 53 75 98 100 100 100 100
120 hours........................................... 24 33 48 67 95 \3\ 100 100 100 100 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ In computing the days to be deducted, the number with any fraction shall be rounded to the next lower whole number and shall be deducted from the
required total drying time. Example: Sausage stuffed in 3 diameter casing requires 20 days in the drying room (from Drying Room Times,
Table 3A). If allowed to ferment, after addition of curing materials, at 80 deg.F. for 48 hours, the 20 day drying time may be reduced 18% (from
Table 3B). Eighteen percent of 20 day equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the drying room,
therefore, will be 17 days.
\2\ Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a moisture-protein ratio of
2.3:1 or less. Internal product temperature shall be used for all other sausages.
\3\ Trichinae will be destroyed during fermentation or smoking at the temperature and length of time indicated. Therefore, no drying room period is
required for products so treated.
(C) Reduced Salt Content--Drying Room Times. Salt content of less
than 3.33 pounds for each hundredweight of sausage formulation,
excluding dry ingredients, (such as salts, sugars, and spices), may be
permitted provided the drying time is increased according to the
schedule contained in Table 4.
Trichina Treatment of Sausage by Method No. 6;
Table 4--Reduced Salt Content--Drying Room Times
[Required percentage increase in drying room time (table 3A) for added
salt of less than 3.33 pounds per hundredweight of sausage]
------------------------------------------------------------------------
Increase
in drying
Minimum pounds of salt added to sausage \1\ room time
\2\
------------------------------------------------------------------------
3.3.......................................................... 1
3.2.......................................................... 4
3.1.......................................................... 7
3.0.......................................................... 10
2.9.......................................................... 13
2.8.......................................................... 16
2.7.......................................................... 19
2.6.......................................................... 22
2.5.......................................................... 25
2.4.......................................................... 28
2.3.......................................................... 31
2.2.......................................................... 34
2.1.......................................................... 37
2.0.......................................................... 40
------------------------------------------------------------------------
\1\ Calculate the salt content for column 1 as follows: Multiply the
pounds of salt in the sausage formulation by 100. Then divide this
number by the total weight of sausage formulation minus the weight of
dry ingredients and round down to the next lowest 0.1%. Percents may
be substituted for pounds.
Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. wine, 1
lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. sodium
nitrite total weight is 127.872 lbs.
[[Page 243]]
(3.56x100)/(127.872-3.56-2-.8-.012)=356/121.5=2.93
Therefore, the sausage drying time must be increased by 13 percent.
\2\ In computing the days to be added to the required total drying time,
fractions shall be rounded to the next higher whole number and added
to the required total drying time. Example: Sausage stuffed in 3\1/2\
inch diameter casing requires 23 days in the drying room (from Drying
Room Times). If the quantity of salt added per hundredweight of
sausage is 2 pounds instead of 3.33 pounds, the drying room time must
be increased by 40 percent (from Reduced Salt Content-Drying Room
Times), or 9.2 days. The 9.2 is rounded up to 10 days and is added to
the 23 days to equal 33 days. The total drying time required in the
drying room, therefore, will be 33 days.
Method No. 7, Dry Sausages. (A) General Requirements. The
establishment shall use meat particles reduced in size to no more than
1/4 inch in diameter. The establishment shall add a curing mixture
containing no less than 2.7 pounds of salt per hundred pounds of meat
and mix it uniformly throughout the product. The establishment shall
hold, heat, and dry the product according to paragraph (B) or (C) below.
(B) Holding, Heating, and Drying Treatment, Large Sausages. Except
as permitted in (C) below, the establishment shall subject sausages in
casings not exceeding 105 mm in diameter, at the time of stuffing, to
all of the following minimum chamber temperatures and time periods.
Treatment Schedule for Sausages 105 Millimeters (4\1/8\ Inches) or Less
in Diameter
------------------------------------------------------------------------
Minimum chamber temperature
------------------------------------------------- Minimum time (hours)
( deg.F) ( deg.C)
------------------------------------------------------------------------
50 10 12
90 32.2 1
100 37.8 1
110 43.3 1
120 48.9 1
125 51.7 7
------------------------------------------------------------------------
Following the preceding treatment, the establishment shall dry the
sausages at a temperature not lower than 50 deg.F (10 deg.C) for not
less than 7 days.
(C) Heating and Drying Treatment, Small Sausages. Alternatively, the
establishment may subject sausages in casings not exceeding 55 mm in
diameter, at the time of stuffing, to all of the following minimum
chamber temperatures and time periods.
Treatment Schedule for Sausages 55 Millimeters (2\1/8\ Inches) or Less
in Diameter
------------------------------------------------------------------------
Minimum chamber temperature
------------------------------------------------- Minimum time (hours)
( deg.F) ( deg.C)
------------------------------------------------------------------------
50 10 12
100 37.8 1
125 51.7 6
------------------------------------------------------------------------
Following the preceding heat treatment, the establishment shall dry the
sausages at a temperature not lower than 50 deg.F (10 deg.C) for not
less than 4 days.
(ii) Capocollo (capicola, capacola). Boneless pork butts for
capocollo shall be cured in a dry-curing mixture containing not less
than 4\1/2\ pounds of salt per hundredweight of meat for a period of not
less than 25 days at a temperature not lower than 36 deg.F. If the
curing materials are applied to the butts by the process known as
churning, a small quantity of pickle may be added. During the curing
period the butts may be overhauled according to any of the usual
processes of overhauling, including the addition of pickle or dry salt
if desired. The butts shall not be subjected during or after curing to
any treatment designed to remove salt from the meat, except that
superficial washing may be allowed. After being stuffed, the product
shall be smoked for a period of not less than 30 hours at a temperature
not lower than 80 deg.F., and shall finally be held in a drying room
not less than 20 days at a temperature not lower than 45 deg.F.
(iii) Coppa. Boneless pork butts for coppa shall be cured in a dry-
curing mixture containing not less than 4\1/2\ pounds of salt per
hundredweight of meat for a period of not less than 18 days at a
temperature not lower than 36 deg.F. If the curing mixture is applied
to the butts by the process known as churning, a small quantity of
pickle may be added. During the curing period the butts may be
overhauled according to any of the usual processes of overhauling,
including the addition of pickle or dry salt if desired. The butts shall
not be subjected during or after curing to any treatment designed to
remove salt from the meat, except that superficial washing may be
allowed. After being stuffed, the product shall be held in a drying room
not less than 35 days at a temperature not lower than 45 deg.F.
(iv) Hams and pork shoulder picnics. In the curing of hams and pork
shoulder picnics, one of the methods below shall be used. For
calculating days per pound, the establishment shall use the weight of
the heaviest ham or picnic in the lot.
Method No. 1. The hams and pork shoulder picnics shall be cured by a
dry-salt curing process not less than 40 days at a temperature no lower
than 36 deg.F. The products shall
[[Page 244]]
be laid down in salt, not less than 4 pounds to each hundredweight of
product, the salt being applied in a thorough manner to the lean meat of
each item. When placed in cure, the products may be pumped with pickle
if desired. At least once during the curing process, the products shall
be overhauled (turned over for the application of additional cure) and
additional salt applied, if necessary, so that the lean meat of each
item is thoroughly covered. After removal from cure, the products may be
soaked in water at a temperature not higher than 70 deg.F for not more
than 15 hours, during which time the water may be changed once, but they
shall not be subjected to any other treatment designed to remove salt
from the meat except that superficial washing may be allowed. The
products shall finally be dried or smoked at a time and temperature not
less than a combination prescribed in Table 5 of Method No. 3.
Method No. 2. [Reserved]
Method No. 3. (A) Curing. (Other than bag curing): Establishments
shall cure hams and shoulders by using a cure mixture containing not
less than 70 percent salt by weight to cover all exposed muscle tissue
and to pack the hock region. Total curing time consists of a mandatory
cure contact time and an optional equalization time.
(B) Cure Contact Time. This is the cure contact period, during which
the establishment shall keep exposed muscle tissue coated with the cure
mixture at least 28 days but for no less than 1.5 days per pound of ham
or shoulder. Overhaul is optional so long as the exposed muscle tissue
remains coated with curing mixture.
(C) Equalization. The establishment may provide an equalization
period after the minimum cure contact period in (B) above to permit the
absorbed salt to permeate the product's inner tissues. Equalization is
the time after the excess cure has been removed from the product at the
end of the cure contact period until the product is placed in the drying
room and the drying period begins. The total curing time (equalization
plus cure contact) shall be at least 40 days and in no case less than 2
days per pound of an uncured ham or shoulder.
(D) Removing Excess Cure. After the required cure contact period,
the establishment may remove excess cure mixture from the product's
surface mechanically or by rinsing up to 1 minute with water, but not by
soaking.
(E) Bag Curing. Bag curing is a traditional ham curing technique in
which the manufacturer wraps the ham and all of the cure mixture
together in kraft paper then hangs them individually. The paper keeps
the extra cure mixture in close contact with the product making
reapplication of salt unnecessary, and it protects the product from
mites and insects. Establishments may employ the bag curing method as an
alternative to (A) through (D) above. An establishment which elects to
use the bag curing method shall apply a cure mixture containing at least
6 pounds of salt per 100 pounds of uncured product. The establishment
shall rub the curing mixture into the exposed muscle tissue, pack the
hock region with the curing mixture, and use uncoated wrapping paper to
wrap the product together with any remaining curing mixture. The bag
cured product shall remain wrapped throughout the curing period and may
or may not remain wrapped during the drying period. In any case, the
curing period shall be at least 40 days but not less than 2 days per
pound of an uncured ham or shoulder. After curing, the cured product
shall be exposed to a drying time and temperature prescribed in Table 5.
(F) Curing Temperature. During the curing period the establishment
shall use one of the following procedures:
(1) The establishment shall control the room temperature at not less
than 35 deg.F (1.7 deg.C) nor greater than 45 deg.F (7.2 deg.C) for
the first 1.5 days per pound of an uncured ham or shoulder, and not less
than 35 deg.F (1.7 deg.C) nor greater than 60 deg.F (15.6 deg.C) for
the remainder of the curing period.
(2) The establishment shall monitor and record daily product
temperature. The room temperature need not be controlled but days on
which the product temperature drops below 35 deg.F (1.7 deg.C) shall
not be counted as curing time. If the product temperature exceeds 45
deg.F (7.2 deg.C) within the first period of 1.5 days per pound of an
uncured ham or shoulder or if it exceeds 60 deg.F (15.6 deg.C) for the
remainder of the curing period, the establishment shall cool the product
back to the 45 deg.F (7.2 deg.C) maximum during the first period or 55
deg.F (12.8 deg.C) maximum during the remainder of the period.
(3) The establishment shall begin curing product only between the
dates of December 1 and February 13. The room temperature need not be
controlled, but the establishment shall monitor and record daily room
temperatures, and days in which the room temperature drops below 35
deg.F (1.7 deg.C) shall not be counted as curing time.
(G) Drying. After the curing period, establishments shall use one of
three procedures for drying:
(1) The establishment shall subject the product to a controlled room
temperature for a minimum time and minimum temperature combination
prescribed in Table 5 or for a set of such combinations in which the
total of the fractional periods (in column 4 of Table 5) exceeds 1.5.
(2) Establishments using uncontrolled room temperatures shall
monitor and record the internal product temperature. The drying period
shall be complete when, from the days which can be counted as curing
time, one of the time/temperature combinations of
[[Page 245]]
Table 5 is satisfied or when the total of the fractional values for the
combinations exceeds 1.5.
(3) Establishments using uncontrolled room temperatures shall dry
the product for a minimum of 160 days including the entire months of
June, July, and August. This procedure is obviously dependent on local
climatic conditions and no problem exists with respect to current
producers who use this procedure. Future applicants shall demonstrate
that their local monthly average temperatures and the local monthly
minimum temperatures are equal to or warmer than the normal average
temperatures and normal minimum temperatures compiled by the National
Oceanic and Atmospheric Administration for Boone, North Carolina,
station 31-0977, 1951 through 1980.
Monthly Temperatures ( deg.F) for Boone NC, 1951-1980
----------------------------------------------------------------------------------------------------------------
Jan. Feb. Mar. Apr. May June July Aug. Sep.
----------------------------------------------------------------------------------------------------------------
Normal average temperatures
----------------------------------------------------------------------------------------------------------------
32.2 34.1 41.3 51.2 59.1 65.1 68.3 67.5 61.6
----------------------------------------------------------------------------------------------------------------
Normal minimum temperatures
----------------------------------------------------------------------------------------------------------------
22.8 24.2 30.8 39.6 48.1 54.7 58.5 57.6 51.6
----------------------------------------------------------------------------------------------------------------
Drying Times and Temperatures for Trichina Inactivation in Hams and
Shoulders
Table 5--Minimum Drying Days at a Minimum Temperature*
------------------------------------------------------------------------
Minimum Drying Temperature Fractional
-------------------------------------------- Minimum days period for
Degrees at drying one day of
Degrees fahrenheit centigrade temperature drying
------------------------------------------------------------------------
130........................... 54.4 1.5 .67
125........................... 51.7 2 .50
120........................... 48.9 3 .33
115........................... 46.1 4 .25
110........................... 43.3 5 .20
105........................... 40.6 6 .17
100........................... 37.8 7 .14
95............................ 35.0 9 .11
90............................ 32.2 11 .091
85............................ 29.4 18 .056
80............................ 26.7 25 .040
75............................ 23.9 35 .029
------------------------------------------------------------------------
* Interpolation of these times or temperatures is not acceptable;
establishments wishing to use temperatures or times not in this Table
shall first validate their efficacy as provided by 318.10(c)(4) of
this section.
Method No. 4. (A) Cure: Establishments shall cure hams and shoulders
by using a cure mixture containing not less than 71.5 percent salt by
weight to cover all exposed muscle tissue and to pack the hock region.
Establishments may substitute potassium chloride (KCl) for up to half of
the required salt on an equal weight basis.
(B) Curing. Establishments shall apply the cure at a rate not less
than 5.72 pounds of salt and KCl per hundred pounds of fresh meat. The
cure shall be applied in either three or four approximately equal
amounts (two or three overhauls) at separate times during the first 14
days of curing.
(C) Cure Contact Time. Establishments shall keep the product in
contact with the cure mixture for no less than 2 days per pound of an
uncured ham or shoulder but for at least 30 days. Establishments shall
maintain the curing temperature at no less than 35 deg.F (1.7 deg.C)
during the cure contact time.
(D) Equalization. After the cure contact period, establishments
shall provide an added equalization period of no less than 1 day per
pound of an uncured ham or shoulder but at least 14 days. Equalization
is the time after the excess cure has been removed from the product, the
end of the cure contact period, and before the drying period begins.
Establishments may substitute additional cure contact days for an equal
number of equalization days.
(E) Removing Excess Cure. After the required cure contact period,
the establishment may remove excess cure mixture from the product's
surface mechanically or by rinsing up to 1 minute with water, but not by
soaking.
(F) Drying. After the curing period, establishments shall use one of
the controlled temperature methods for drying listed in Method No. 3 of
this subparagraph.
Method No. 5 (A) Curing. The establishment shall cure the ham to a
minimum brine concentration of 6 percent by the end of the drying
period. Brine concentration is calculated as 100 times the salt
concentration divided by the sum of the salt and water concentrations.
Percent brine = 100 x [salt] / ([salt] + [water])
The Agency will accept the brine concentration in the biceps femoris
as a reasonable estimate of the minimum brine concentration in the ham.
(B) Drying and Total Process Times. The establishment shall dry the
cured ham at a minimum temperature of 55 deg.F (13 deg.C) for at least
150 days. The total time of drying plus curing shall be at least 206
days.
[[Page 246]]
(C) Ensuring an Acceptable Internal Brine Concentration. (1) To
establish compliance, the establishment shall take product samples from
the first 12 lots of production as follows: From each lot,
(i) One sample shall be taken from each of 5 or more hams;
(ii) Each sample shall be taken from the biceps femoris. As an
alternative to the use of the biceps femoris, the Agency shall consider
other method(s) of sampling the dry-cured hams to determine the minimum
internal brine concentration, as long as the establishment proposes it
and submits data and other information to establish its sufficiency to
the Director of the Processed Products Inspection Division;
(iii) Each sample shall weigh no less than 100 grams;
(iv) The samples shall be combined as one composite sample and
sealed in a water vapor proof container;
(v) The composite sample shall be submitted to a laboratory
accredited under the provisions of Sec. 318.21 to be analyzed for salt
and water content using methods from the "Official Methods of Analysis
of the Association of Official Analytical Chemists (AOAC)," 15th
Edition, 1990, Section 983.18 (page 931) and Section 971.19 (page 933)
which are incorporated by reference. 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 obtained from the
Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson
Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the
Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250 or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC 20408. If the time
between sampling and submittal of the composite sample to the accredited
laboratory will exceed 8 hours, then the establishment shall freeze the
composite sample immediately after the samples are combined;
(vi) Once the laboratory results for the composite sample are
received, the manufacturer shall calculate the internal brine
concentration by multiplying the salt concentration by 100 and then
dividing that figure by the sum of the salt and water concentrations;
(vii) Compliance is established when the samples from the first 12
lots of production have a minimum internal brine concentration of 6
percent. Lots being tested to establish compliance shall be held until
the internal brine concentration has been determined and found to be at
least 6 percent. If the minimum internal brine concentration is less
than 6 percent, the lot being tested shall be held until the
establishment brings the lot into compliance by further processing.
(2) To maintain compliance, the establishment shall take samples,
have the samples analyzed, and perform the brine calculations as set
forth above from one lot every 13 weeks. Lots being tested to maintain
compliance shall not be held. If the minimum internal brine
concentration is less than 6 percent in a lot being tested to maintain
compliance, the establishment shall develop and propose steps acceptable
to FSIS to ensure that the process is corrected.
(3) Accredited laboratory results and the brine calculations shall
be placed on file at the establishment and available to Program
employees for review.
Method No. 6 (A) Curing. The establishment shall cure the ham to a
minimum brine concentration of 6 percent by the end of the drying
period. Brine concentration is calculated as 100 times the salt
concentration divided by the sum of the salt and water concentrations.
Percent brine = 100 x [salt] / ([salt] + [water])
The Agency will accept the brine concentration in the biceps femoris
as a reasonable estimate of the minimum brine concentration.
(B) Drying and Total Process Times. The establishment shall dry the
cured ham at a minimum temperature of 110 deg.F (43 deg.C) for at
least 4 days. The total time of drying plus curing shall be at least 34
days.
(c) Ensuring an Acceptable Internal Brine Concentration.
(1) To establish compliance the establishment shall take product
samples from the first 12 lots of production as follows: From each lot,
(i) One sample shall be taken from each of 5 or more hams;
(ii) Each sample shall be taken from the biceps femoris. As an
alternative to the use of the biceps femoris, the Agency will consider
other methods of sampling the dry-cured hams to determine internal brine
concentration, as long as the establishment proposes it and submits data
and other information to establish its sufficiency to the Director of
the Processed Products Inspection Division;
(iii) Each sample shall weigh no less than 100 grams;
(iv) The samples shall be combined as one composite sample and
sealed in a water vapor proof container;
(v) The composite sample shall be submitted to a laboratory
accredited under the provisions of Sec. 318.21 to be analyzed for salt
and water content using methods from the "Official Methods of Analysis
of the Association of Official Analytical Chemists (AOAC)," 15th
Edition, 1990, section 983.18 (page 931) and section 971.19 (page 933)
which are incorporated by reference. This incorporation by reference was
approved by the Director of the Federal Register in accordance
[[Page 247]]
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the
Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson
Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the
Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250 or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC. If the time between
sampling and submittal of the composite sample to the accredited
laboratory will exceed 8 hours, then the establishment shall freeze the
composite sample immediately after the samples are combined;
(vi) Compliance is established when the samples from the first 12
lots of production have a minimum internal brine concentration of 6
percent. Lots being tested to establish compliance shall be held until
the internal brine concentration has been determined and found to be at
least 6 percent. If the minimum internal brine concentration is less
than 6 percent, the lot being tested shall be held until the
establishment brings the lot into compliance by further processing.
(2) To maintain compliance, the establishment shall take samples,
have the samples analyzed, and perform the brine calculations as set
forth above from one lot every 13 weeks. Lots being tested to maintain
compliance shall not be held. If the minimum internal brine
concentration is less than 6 percent in a lot being tested to maintain
compliance, the establishment shall develop and propose steps acceptable
to FSIS to ensure that the process is corrected.
(3) Accredited laboratory results and the brine calculations shall
be placed on file in the establishment and available to Program
employees for review.
(v) Boneless pork loins and loin ends. In lieu of heating or
refrigerating to destroy possible live trichinae in boneless loins, the
loins may be cured for a period of not less than 25 days at a
temperature not lower than 36 deg.F. by the use of one of the following
methods:
Method No. 1. Application of a dry-salt curing mixture containing
not less than 5 pounds of salt to each hundredweight of meats.
Method No. 2. Application of a pickle solution of not less than
80 deg. strength (salometer) on the basis of not less than 60 pounds of
pickle to each hundredweight of meat.
Method No. 3. Application of a pickle solution added to the dry-salt
cure prescribed as Method No. 1 in this subdivision (v) provided the
pickle solution is not less than 80 deg. strength (salometer).
After removal from cure, the loins may be soaked in water for not
more than 1 hour at a temperature not higher than 70 deg.F. or washed
under a spray but shall not be subjected, during or after the curing
process, to any other treatment designed to remove salt.
Following curing, the loins shall be smoked for not less than 12
hours. The minimum temperature of the smokehouse during this period at
no time shall be lower than 100 deg.F., and for 4 consecutive hours of
this period the smokehouse shall be maintained at a temperature not
lower than 125 deg.F.
Finally, the product shall be held in a drying room for a period of
not less than 12 days at a temperature not lower than 45 deg.F.
(4) The Administrator shall consider additional processing methods
upon petition by manufacturers, and shall approve any such method upon
his/her determination that it can be properly monitored by an inspector
and that the safety of such methods is adequately documented by data
which has been developed by following an experimental protocol
previously reviewed and accepted by the Department.
(d) General instructions: When necessary to comply with the
requirements of this section, the smokehouses, drying rooms, and other
compartments used in the treatment of pork to destroy possible live
trichinae shall be suitably equipped, by the operator of the official
establishment, with accurate automatic recording thermometers. Circuit
supervisors are authorized to approve for use in sausage smokehouses,
drying rooms, and other compartments, such automatic recording
thermometers as are found to give satisfactory service and to disapprove
and require discontinuance of use, for purposes of the regulations in
this subchapter, any thermometers (including any automatic recording
thermometers) of the establishment that are found to be inaccurate or
unreliable.
(e) The requirements for using the pooled sample digestion technique
to analyze pork for the presence of trichina cysts are:
(1) The establishment shall submit for the approval of the Regional
Director its proposed procedure for identifying and pooling carcasses,
collecting and pooling samples, testing samples (including the name and
address of the laboratory), communicating test results, retesting
individual carcasses, and maintaining positive identification
[[Page 248]]
and clear separation of pork found to be trichina-free from untested
pork or trichina-positive pork.
(2) The establishment shall use the services of a laboratory
approved by the Administrator for all required testing. Such approval
shall be based on adequacy of facilities, reagents, and equipment, and
on demonstration of continuing competency and reliability in performing
the pooled sample digestion technique for trichinae.
(3) The establishment shall sample no less than 5 grams of diaphragm
muscle or tongue tissue from each carcass or no less than 10 grams of
other muscle tissue. Samples may be pooled but a pool shall not consist
of more than 100 grams of sample. Sampling and sample preparation are
subject to inspection supervision.
(4) Pork or products made from tested pork shall not be released as
trichina free from the official establishment without treatment until
the inspector in charge receives a laboratory report that the tested
pork is free of trichina cysts.
(f) Approval of other tests for trichinosis in pork. The
Administrator shall consider any additional analytical method for
trichinosis upon petition by a manufacturer, and may approve that method
upon the determination that it will detect at least 98 percent of swine
bearing cysts present at a tissue density equal to or less than one cyst
per gram of muscle from the diaphragm pillars at a 95 percent confidence
level. Any such petitions shall be supported by any data and other
information that the Administrator finds necessary. Notice of any
approval shall be given in the Federal Register, and the approved method
will be incorporated into this section.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 31517; Nov. 15, 1973; 39
FR 40580, Nov. 19, 1974; 50 FR 5229, Feb. 7, l985; 50 FR 48075, Nov. 21,
1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, June 22, 1992; 57 FR
33633, July 30, 1992; 57 FR 56440, Nov. 30, 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: 9CFR318.12]
[Page 248-249]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.12 Manufacture of dog food or similar uninspected article at official establishments.
(a) When dog food, or similar uninspected article is manufactured in
an edible product department, there shall be sufficient space allotted
and adequate equipment provided so that the manufacture of the
uninspected article in no way interferes with the handling or
preparation of edible products. Where necessary to avoid adulteration of
edible products, separate equipment shall be provided for the
uninspected article. To assure the maintenance of sanitary conditions in
the edible product departments, the operations incident to the
manufacture of the uninspected article will be subject to the same
sanitary requirements that apply to all operations in edible product
departments. The manufacture of the uninspected article shall be limited
to those hours during which the establishment operates under
inspectional supervision; and there shall be no handling, other than
receiving at the official establishment, of any of the product
ingredient of the uninspected article, other than during the regular
hours of inspection. The materials used in the manufacture of the
uninspected article shall not be used so as to interfere with the
inspection of edible product or the maintenance of sanitary conditions
in the department or render any edible product adulterated. The meat,
meat byproducts, and meat food product ingredients of the uninspected
article may be admitted into any edible products department of an
official establishment only if they are U.S. Inspected and Passed.
Products within Sec. 314.11 of this subchapter or parts of carcasses of
kinds not permitted under the regulations in this subchapter to be
prepared for human food (e.g., lungs or intestines), which are produced
at any official establishment, may be brought into the inedible products
department of any official establishment for use in uninspected articles
under this section. The uninspected article may be stored in, and
distributed from, edible product departments: Provided, That adequate
facilities are furnished, there is no interference with the maintenance
of sanitary conditions, and such article is properly identified.
(b) When dog food or similar uninspected article is manufactured in
a part of an official establishment other than an edible product
department, the area in which the article is
[[Page 249]]
manufactured shall be separated from edible product departments in the
manner required for separation between edible product departments and
inedible product departments. Sufficient space must be allotted and
adequate equipment provided so that the manufacture of the uninspected
article does not interfere with the proper functioning of the other
operations at the establishment. Except as provided in Sec. 314.11 of
this subchapter, nothing in this paragraph shall be construed as
permitting any deviation from the requirement that dead animals,
condemned products, and similar materials of whatever origin, must be
placed in the inedible product rendering equipment, and without undue
delay. The manufacture of the uninspected article must be such as not to
interfere with the maintenance of general sanitary conditions on the
premises, and it shall be subject to inspectional supervision similar to
that exercised over other inedible product departments. There shall be
no movement of any product from an inedible product department to any
edible product department. Trucks, barrels, and other equipment shall be
cleaned before being returned to edible product departments from
inedible product departments. Unoffensive material prepared outside
edible product departments may be stored in, and distributed from,
edible product departments only if packaged in clean, properly
identified, sealed containers.
(c) Animal food shall be distinguished from articles of human food,
so as to avoid distribution of such animal food as human food. To
accomplish this, such animal food shall be labeled or otherwise
identified in accordance with Sec. 325.11(d) of this subchapter.
[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 53
FR 24679, June 30, 1988]
[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: 9CFR318.13]
[Page 249]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.13 Mixtures containing product but not amendable to the Act.
Mixtures containing product but not classed as a meat food product
under the Act shall not bear the inspection legend or any abbreviation
or representation thereof unless manufactured under the food inspection
service provided for in part 350 of subchapter B of this chapter. When
such mixtures are manufactured in any part of an official establishment,
the sanitation of that part of the establishment shall be supervised by
Program employees, and the manufacture of such mixtures shall not cause
any deviation from the requirement of Sec. 318.1.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 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: 9CFR318.14]
[Page 249-250]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.14 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 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.
(c) Hermetically sealed containers of 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 product 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
[[Page 250]]
the Administrator, \1\ rinse in potable water, and dry thoroughly; or
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
(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 product shall be maintained
throughout all stages of the rehandling operations to insure correct
labeling of the containers.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 34455, 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: 9CFR318.15]
[Page 250]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.15 Tagging chemicals, preservatives, cereals, spices, etc., "U.S. retained."
When any chemical, preservative, cereal, spice, or other substance
is intended for use in an official establishment, it shall be examined
by a Program employee and if found to be unfit or otherwise unacceptable
for the use intended, or if final decision regarding acceptance is
deferred pending laboratory or other examination, the employee shall
attach a "U.S. retained" tag to the substance or container thereof.
The substance so tagged shall be kept separate from other substances as
the circuit supervisor may require and shall not be used until the tag
is removed, and such removal shall be made only by a Program employee
after a finding that the substance can be accepted, or, in the case of
an unacceptable substance, when it is removed from the 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: 9CFR318.16]
[Page 250]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.16 Pesticide chemicals and other residues in products.
(a) Nonmeat ingredients. Residues of pesticide chemicals, food
additives and color additives or other substances in or on ingredients
(other than meat, meat byproducts, and meat food products) used in the
formulation of products shall not exceed the levels permitted under the
Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must
otherwise be in compliance with the requirements under that Act.
(b) Products, and meat, meat byproduct, or other meat food product
ingredients. Products, and products used as ingredients of products,
shall not bear or contain any pesticide chemical, food additives, or
color additive residue in excess of the level permitted under the
Federal Food, Drug, and Cosmetic Act and the regulations in this
subchapter, or any other substance that is prohibited by such
regulations or that otherwise makes the products adulterated.
(c) Standards and procedures. Instructions specifying the standards
and procedures for determining when ingredients of finished products are
in compliance with this section shall be issued to the inspectors by the
Administrator. Copies of such instructions will be made available to
interested persons upon request made to 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: 9CFR318.17]
[Page 250-251]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.17 Requirements for the production of cooked beef, roast beef, and cooked corned beef products.
(a) Cooked beef, roast beef, and cooked corned beef products must be
produced using processes ensuring that the products meet the following
performance standards:
(1) Lethality. A 6.5-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 1-
log10 multiplication of Clostridium perfringens within the
product.
[[Page 251]]
(b) 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 and available to FSIS, a
process schedule, as defined in Sec. 301.2 of this chapter. 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 the
establishment in order to evaluate and approve the safety and efficacy
of each process schedule.
(c) 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 744, 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: 9CFR318.18]
[Page 251]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.18 Handling of certain material for mechanical processing.
Material to be processed into "Mechanically Separated (Species)"
shall be so processed within 1 hour from the time it is cut or separated
from carcasses or parts of carcasses, except that such product may be
held for no more than 72 hours at 40 deg.F. (4 deg.C.) or less, or
held indefinitely at 0 deg.F. (-18 deg.C.) or less. "Mechanically
Separated (Species)" shall, directly after being processed, be used as
an ingredient in a meat food product except that it may be held prior to
such use for no more than 72 hours at 40 deg.F. (4 deg.C.) or less or
indefinitely at 0 deg.F. (-18 deg.C.) or less.
[43 FR 26423, June 20, 1978, as amended at 47 FR 28256, June 29, 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: 9CFR318.19]
[Page 251-255]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.19 Compliance procedure for cured pork products.
(a) Definitions. For the purposes of this section:
(1) A product is that cured pork article which is contained within
one Group as defined in paragraph (a)(2) of this section and which
purports to meet the criteria for a single product designated under the
heading "Product Name and Qualifying Statements" in the chart in
Sec. 319.104 or the chart in Sec. 319.105.
(2) A Product Group or a Group means one of the following:
Group I, consisting of cured pork products which have been cooked
while imperviously encased. Any product which fits into the Group will
be placed in this Group regardless of any other considerations.
Group II, consisting of cured pork products which have been water
cooked. Any product which does not fit into Group I but does fit into
Group II will be placed into Group II regardless of any other
considerations.
Group III, consisting of boneless smokehouse heated cured pork
products. Any boneless product that does not fit into Group I or Group
II shall be placed in Group III.
Group IV, consisting of bone-in or semi-boneless smokehouse heated
cured pork products. Any product that is not completely boneless or
still contains all the bone which is traditional for bone-in product,
and does not fit into Group I, Group II, or Group III shall be placed in
this Group.
(3) A lot is that product from one production shift.
(4) A production rate is frequency of production, expressed in days
per week.
(5) Protein fat free percentage, protein fat free content, PFF
percentage, PFF content or PFF of a product means the meat protein
(indigenous to the raw, unprocessed pork cut) content expressed as a
percent of the non-fat portion of the finished product.
(b) Normal Compliance Procedures. The Department shall collect
samples of cured pork products and analyze them for their PFF content.
Analyses shall be conducted in accordance with the "Official Methods of
Analysis of the Association of Official Analytical Chemists
Secs. 950.46, and 928.08 (Chapter 39).\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.
[[Page 252]]
552(a) and 1 CFR part 51. Each analytical result shall be recorded and
evaluated to determine whether future sampling of product Groups within
an official establishment shall be periodic or daily under the
provisions of paragraph (b)(1) of this section, and if the affected lot
and subsequent production of like product shall be U.S. retained, or
administratively detained, as appropriate, as provided in paragraph
(b)(2) of this section.\2\
---------------------------------------------------------------------------
\1\ A copy of the "Official Methods of Analysis of the Association
of Official 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, Inc., 2200 Wilson
Boulevard, Suite 400, Arlington, Virginia 22201.
\2\ Rules for Rounding:
1. Laboratory results for percent meat protein and fat will be
reported to the second decimal place (hundredths).
2. PFF and Sample Values for charting purposes will be calculated
from the reported laboratory results to the second decimal place.
Rounding of calculations to reach two decimal places will be done by the
following rule:
All values of five-thousandths (0.005) or more will be rounded up to
the next highest hundredth. All values of less than five-thousandths
(0.005) will be dropped.
3. For compliance with the Absolute Minimum PFF requirements, the
PFF will be rounded to the first decimal place (tenths). Rounding of
calculations to reach one decimal place will be done by the following
rule:
All PFF values of five-hundredths (0.05) or more will be rounded up
to the next highest tenth. All PFF values of less than five-hundredths
(0.05) will be dropped.
4. For product disposition (pass-fail of a minimum PFF standard for
retained product) the average PFF calculation will be rounded to the
first decimal place. Individual PFF Values will be calculated to the
nearest hundredth as in (2) above. The average, however, will be rounded
to the nearest tenth as in (3) above.
---------------------------------------------------------------------------
(1) Criteria to determine sampling frequency of Product Groups. For
each official plant preparing cured pork products, Product Groups shall
be sampled periodically or daily. Analytical results shall be evaluated
and the sampling frequency determined as follows:
(i) Determine the difference between the individual PFF analysis and
the applicable minimum PFF percentage requirement of Sec. 319.104 or
Sec. 319.105. The resulting figure shall be negative when the individual
sample result is less than the applicable minimum PFF percentage
requirement and shall be positive when the individual sample result is
greater than the applicable minimum PFF percentage requirement.
(ii) Divide the resulting number by the standard deviation assigned
to the Product Group represented by the sample to find the Standardized
Difference. The standard deviation assigned to Groups I and II is 0.75
and to Groups III and IV is 0.91.
(iii) Add 0.25 to the Standardized Difference to find the Adjusted
Standardized Difference.
(iv) Use the lesser of 1.90 and the Adjusted Standardized Difference
as the Sample Value.
(v) Cumulatively total Sample Values to determine the Group Value.
The first Sample Value in a Group shall be the Group Value, and each
succeeding Group Value shall be determined by adding the most recent
Sample Value to the existing Group Value; provided, however, that in no
event shall the Group Value exceed 1.00. When calculation of a Group
Value results in a figure greater than 1.00, the Group Value shall be
1.00 and all previous Sample Values shall be ignored in determining
future Group Values.
(vi) The frequency of sampling of a Group shall be periodic when the
Group Value is greater than -1.40 (e.g., -1.39, -1.14, 0, 0.50, etc.)
and shall be daily when the Group Value is -1.40 or less (e.g., -1.40, -
1.45, -1.50, etc.); provided, however, that once daily sampling has been
initiated, it shall continue until the Group Value is 0.00 or greater,
and each of the last seven Sample Values is -1.65 or greater (e.g., -
1.63, -1.50, etc.), and there is no other product within the affected
Group being U.S. retained as produced, under provisions of paragraph
(b)(2) or (c).
(2) Criteria for U.S. retention or administrative detention of cured
pork products for further analysis. Cured prok products shall be U.S.
retained, or administratively detained, as appropriate, when prescribed
by paragraphs (b)(2) (i) or (ii) of this section as follows:
(i) Absolute Minimum PFF Requirement. In the event that an analysis
of an individual sample indicates a PFF content below the applicable
minimum requirement of Sec. 319.104 or Sec. 319.105 by 2.3 or more
percentage points for a Group I or II product, or 2.7 or more percentage
points for a Group III or IV product, the lot from which the sample
[[Page 253]]
was collected shall be U.S. retained if in an official establishment and
shall be subject to administrative detention if not in an official
establishment unless returned to an official establishment and there
U.S. retained. Any subsequently produced lots of like product and any
lots of like product for which production dates cannot be established
shall be U.S. retained or subject to administrative detention. Such
administratively detained product shall be handled in accordance with
part 329 of this subchapter, or shall be returned to an official
establishment and subjected to the provisions of paragraph (c)(1) (i) or
(ii) of this section, or shall be relabeled in compliance with the
applicable standard, under the supervision of a program employee, at the
expense of the product owner. Disposition of such U.S. retained product
shall be in accordance with paragraph (c) of this section.
(ii) Product Value requirement. The Department shall maintain, for
each product prepared in an official establishment, a Product Value.
Except as provided in paragraph (c)(2) of this section, calculation of
the Product Value and its use to determine if a product shall be U.S.
retained shall be as follows:
(A) Determine the difference between the individual PFF analysis and
applicable minimum PFF percentage requirement of Sec. 319.104 and
Sec. 319.105. The resulting figure shall be negative when the individual
sample result is less than the applicable minimum PFF percentage
requirement and shall be positive when the individual sample result is
greater than the applicable minimum PFF percentage requirement.
(B) Divide the difference determined in paragraph (b)(2)(ii)(A) of
this section by the standard deviation assigned to the product's Group
in paragraph (b)(1)(ii) of this section to find the standardized
difference.
(C) Use the lesser of 1.65 and the standardized difference as the
Sample Value.
(D) Cumulatively total Sample Values to determine the Product Value.
The first Sample Value of a product shall be the Product Value, and each
succeeding Product Value shall be determined by adding the most recent
Sample Value to the existing Product Value; provided, however, that in
no event shall the Product Value exceed 1.15. When calculation of a
Product Value results in a figure greater than 1.15, the Product Value
shall be 1.15, and all previous Sample Values shall be ignored in
determining future Product Values.
(E) Provided daily group sampling is in effect pursuant to the
provisions of paragraph (b)(1) of this section, and provided further the
Product Value is -1.65 or less (e.g., -1.66), the affected lot (if
within the official establishment) and all subsequent lots of like
product prepared by and still within the official establishment shall be
U.S. retained and further evaluated under paragraph (c) of this section.
Except for release of individual lot pursuant to paragraph (c)(1),
subsequently produced lots of like product shall continue to be U.S.
retained until discontinued pursuant to paragraph (c)(2) of this
section.
(c) Compliance procedure during product retention. When a product
lot is U.S. retained under the provisions of paragraph (b)(2) of this
section, the Department shall collect three randomly selected samples
from each such lot and analyze them individually for PFF content. The
PFF content of the three samples shall be evaluated to determine
disposition of the lot as provided in paragraph (c)(1) of this section
and the action to be taken on subsequently produced lots of like product
as provided in paragraph (c)(2) of this section.\3\
---------------------------------------------------------------------------
\3\ If the processor does not wish to have the product evaluated in
this manner, alternate sampling plans may be used provided such plans
have been formulated by the processor and approved by the Administrator
prior to evaluation by the three-sample criteria, and provided the
analyses specified in such plans are performed at the expense of the
processor.
---------------------------------------------------------------------------
(1) A product lot which is U.S. retained under the provisions of
paragraph (b)(2) of this section may be released for entry into commerce
provided one of the following conditions is met:
(i) The average PFF content of the three samples randomly selected
from the lot is equal to or greater than the applicable minimum PFF
percentage
[[Page 254]]
required by Sec. 319.104 or Sec. 319.105. Further processing to remove
moisture for the purpose of meeting this provision is permissible. In
lieu of further analysis to determine the effects of such processing,
each 0.37 percent weight reduction due to moisture loss resulting from
the processing may be considered the equivalent of a 0.1 percent PFF
gain.
(ii) The lot of the product is relabeled to conform to the
provisions of Sec. 319.104 or Sec. 319.105, under the supervision of a
program employee.
(iii) The lot is one that has been prepared subsequent to
preparation of the lot which, under the provisions of paragraph (c)(2)
of this section, resulted in discontinuance of U.S. retention of new
lots of like product. Such lot may be released for entry into commerce
prior to receipt of analytical results for which sampling has been
conducted. Upon receipt of such results, they shall be subjected to the
provisions of paragraphs (b)(2)(i) and (c)(2) of this section.
(2) The PFF content of three randomly selected samples from each
U.S. retained lot shall be used to maintain the Product Value described
in paragraph (c)(2)(ii). The manner and effect of such maintenance shall
be as follows: (i) Find the average PFF content of the three samples.
(ii) Determine the difference between that average and the
applicable minimum PFF percentage requirement of Sec. 319.104 or
Sec. 319.105. The resulting figure shall be negative when the average of
the sample results is less than the applicable minimum PFF percentage
requirement and shall be positive when the average of the sample results
is greater than the applicable minimum PFF requirements.
(iii) Divide the resulting figure by the standard deviation assigned
to the product's Group in paragraph (b)(1)(ii) of this section, to find
the standardized difference.
(iv) Use the lesser of 1.30 and the standardized difference as the
Sample Value.
(v) Add the first Sample Value thus calculated to the latest Product
Value calculated under the provisions of paragraph (c)(2)(ii) of this
section to find the new Product Value. To find each succeeding Product
Value, add the most recent Sample Value to the existing Product Value;
provided, however, that in no event shall the Product Value exceed 1.15.
When the addition of a Sample Value to an existing Product Value results
in a figure greater than 1.15, the Product Value shall be 1.15 and all
previous Sample Values shall be ignored in determining future Product
Values.
(vi) New lots of like product shall continue to be retained pending
disposition in accordance with paragraph (c)(1) of this section until,
after 5 days of production, the Product Value is 0.00 or greater, and
the PFF content of no individual sample from a U.S. retained lot is less
than the Absolute Minimum PFF requirement specified in paragraph
(b)(2)(i) of this section. Should an individual sample fail to meet its
Absolute Minimum PFF requirement, the 5-day count shall begin anew.
(vii) When U.S. retention of new lots is discontinued under the
above provisions, maintenance of the Product Value shall revert to the
provisions of paragraph (b)(2)(ii) of this section.
(3) For purposes of this section, the plant owner or operator shall
have the option of temporarily removing a product from its Product
Group, provided product lots are being U.S. retained, as produced, and
provided further that the average production rate of the product, over
the 8-week period preceding the week in which the first U.S. retained
lot was prepared, is not greater than 20 percent of the production rate
of its Group. When a product is thus removed from its Group, analytical
results of product samples shall not cause daily sampling of the Group.
When pursuant to paragraph (c)(2)(vi) of this section, new lots of the
product are no longer being U.S. retained, the product shall again be
considered with its Group.
(d) Adulterated and misbranded products. Products not meeting
specified PFF requirements, determined according to procedures set forth
in this section, may be deemed adulterated under section 1(m)(8) of the
Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act
(21 U.S.C. 601(n)).
(e) Quality control. Cured pork products bearing on their labeling
the
[[Page 255]]
statement "X% of Weight is Added Ingredients" shall be prepared only
under a quality control system or program in accordance with Sec. 318.4
of this subchapter. With respect to any other cured pork product,
official establishments may institute quality control procedures under
Sec. 318.4 of this subchapter. Cured pork products produced in such
establishments may be exempt from the requirements of this section,
provided inplant quality control procedures are shown to attain the same
or higher degree of compliance as the procedures set forth in this
section; provided, however, that all cured pork products produced shall
be subject to the applicable Absolute Minimum PFF content requirement,
regardless of any quality control procedures in effect.
[49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. 23, 1984, as amended at
59 FR 33642, June 30, 1994; 60 FR 10304, Feb. 24, 1995; 62 FR 45025,
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: 9CFR318.20]
[Page 255]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.20 Use of animal drugs.
Animal drug residues are permitted in meat and meat food products if
such residues are from drugs which have been approved by the Food and
Drug Administration and any such drug residues are within tolerance
levels approved by the Food and Drug Administration, unless otherwise
determined by the Administrator and listed herein.
[50 FR 32165, Aug. 9, 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: 9CFR318.21]
[Page 255-269]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.21 Accreditation of chemistry laboratories.
(a) Definitions--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.
Accreditation--Determination by FSIS that a laboratory is qualified
to analyze official samples of product subject to regulations in this
subchapter and part 381 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 part 381 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.
AOAC methods--Methods of chemical analysis, Chapter 39, Association
of Official Analytical Chemists (AOAC), published in the "Official
Methods of Analysis of the Association of Official Analytical
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 Official 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, Inc., 2200 Wilson
Boulevard, Suite 400, Arlington, Virginia 22201.
---------------------------------------------------------------------------
Chemical residue misidentification-- see "correct chemical residue
identification" definition.
Coefficient of variation (CV)-- The standard deviation of a
distribution of analytical values multiplied 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
[[Page 256]]
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 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 systemic 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 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 a Program 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.)
[[Page 257]]
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.
Table 1--Standardizing Values for Food Chemistry
[By product class and analyte]
----------------------------------------------------------------------------------------------------------------
Product/Class Moisture Protein \1\ Fat \2\ Salt \3\
----------------------------------------------------------------------------------------------------------------
Cured Pork/Canned Ham.......................................... 0.50 0.060 0.26 (0.30) 0.127
Ground Beef.................................................... 0.71 0.060 (0.35) 0.127
Other.......................................................... 0.57 0.060 0.26 (0.30) 0.127
----------------------------------------------------------------------------------------------------------------
\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
Class of residues Minimum recovery (QC and Standardizing
proficiency level QA) value \3\
----------------------------------------------------------------------------------------------------------------
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
[[Page 258]]
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 ppm 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 meat and meat 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 for 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
[[Page 259]]
that such laboratory reapply for accreditation in accordance with the
provisions of this paragraph (b)(1) by January 12, 1994 (30 days after
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 after
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 meat and meat food 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 AOC 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.
(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.
[[Page 260]]
(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, when there is 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 Official 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 below.\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:
(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 -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
[[Page 261]]
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 that 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 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
[[Page 262]]
analysis of official samples to 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 meat and meat food 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 for 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 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 (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 will be reset at zero upon acceptance of its reapplication.
The accreditation of a laboratory that is on probation shall be
continued, provided that such 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 meat and meat food 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. Further,
[[Page 263]]
either the supervisor or the analyst assigned to analyze the sample must
have 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) 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,
except where 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 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.
(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
[[Page 264]]
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
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 in this paragraph (c)(3)(ix).\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:
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
[[Page 265]]
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\.
---------------------------------------------------------------------------
(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 laboratory
by certified
[[Page 266]]
mail or private carrier or, as an alternative, to an accredited
laboratory accredited for this specific chemical residue. Mailing
expense 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 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.]
(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
[[Page 267]]
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.
(d) Refusal of accreditation. Upon a determination by the
Administrator, a laboratory shall 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:
[[Page 268]]
(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.
(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) of this
section 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
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
[[Page 269]]
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 2185, Jan. 20, 1987, as amended at 58 FR 65260, 65262-65264, Dec.
13, 1993; 59 FR 33642, 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: 9CFR318.22]
[Page 269]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.22 Determination of added water in cooked sausages.
(a) For purposes of this section, the following definitions apply.
(1) Cooked sausage. Cooked sausage is any product described in
Sec. 319.140 and Secs. 319.180-319.182 of this chapter.
(2) Group 1 Protein-Contributing Ingredients. Ingredients of
livestock or poultry origin from muscle tissue which is skeletal or
which is found in the edible organs, with or without the accompanying
and overlying fat, and the portions of bone, skin, sinew, nerve, and
blood vessels which normally accompany the muscle tissue and which are
not separated from it in the process of dressing; meat byproducts;
mechanically separated (species); and poultry products; except those
ingredients processed by hydrolysis, extraction, concentrating or
drying.
(3) Group 2 Protein-Contributing Ingredients. Ingredients from Gorup
1 protein-contributing ingredients processed by hydrolysis, extraction,
concentrating, or drying, or any other ingredient which contributes
protein.
(b) The amount of added water in cooked sausage is calculated by:
(1) Determining by laboratory analysis the total percentage of water
contained in the cooked sausage; and
(2) Determining by laboratory analysis the total percentage of
protein contained in the cooked sausage; and
(3) Calculating the percentage of protein in the cooked sausage
contributed by the Group 2 protein-contributing ingredients; and
(4) Subtracting one pecent from the total percentage of protein
calculated in (b)(3)); and
(5) Subtracting the remaining percentage of protein calculated in
(b)(3) from the total protein content determined in (b)(2); and
(6) Calculating the percentage of indigenous water in the cooked
sausage by multiplying the percentage of protein determined in (b)(5) by
4, (This amount is the percentage of water attributable to Group 1
protein-contributing ingredients and one percent of Group 2 protein-
contributing ingredients in a cooked sausage.); and
(7) Subtracting the percentage of water calculated in (b)(6) from
the total percentage of water determined in (b)(1). (This amount is the
percentage of added water in a cooked sausage.) \1\
---------------------------------------------------------------------------
\1\ The equation for the narrative description of the calculation
for added water is as follows: AW=TW-(TP-(P-1.0))4, Where AW=Added
Water, TW-Total Water Determined by Laboratory Analysis, TP=Total
Protein Determined by Laboratory Analysis, P=Protein Contributed by
Group 2 Protein-Contributing Ingredients, 1.0=Percent Allowance for
Group 2 Protein-Contributing Ingredients, 4=Moisture-Protein Ratio for
Cooked Sausage.
[55 FR 7299, Mar. 1, 1990]
[[Page 270]]
[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: 9CFR318.23]
[Page 270-271]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.23 Heat-processing and stabilization requirements for uncured meat patties.
(a) Definitions. For purposes of this section, the following
definitions shall apply:
(1) Patty. A shaped and formed, comminuted, flattened cake of meat
food product.
(2) Comminuted. A processing term describing the reduction in size
of pieces of meat, including chopping, flaking, grinding, or mincing,
but not including chunking or sectioning.
(3) Partially-cooked patties. Meat patties that have been heat
processed for less time or using lower internal temperatures than are
prescribed by paragraph (b)(1) of this section.
(4) Char-marked patties. Meat patties that have been marked by a
heat source and that have been heat processed for less time or using
lower internal temperatures than are prescribed by paragraph (b)(1) of
this section.
(b) Heat-processing procedures for fully-cooked patties. (1)
Official establishments which manufacture fully-cooked patties shall use
one of the following heat-processing procedures:
Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked
Patties
------------------------------------------------------------------------
Minimum internal temperature at the center of each Minimum holding time
patty (Degrees) after required
--------------------------------------------------- internal temperature
is reached (Time)
---------------------
Fahrenheit Or centigrade Or
Minutes seconds
------------------------------------------------------------------------
151............................ 66.1............. .68 41
152............................ 66.7............. .54 32
153............................ 67.2............. .43 26
154............................ 67.8............. .34 20
155............................ 68.3............. .27 16
156............................ 68.9............. .22 13
157 (and up)................... 69.4 (and up).... .17 10
------------------------------------------------------------------------
(2) The official establishment shall measure the holding time and
temperature of at least one fully-cooked patty from each production line
each hour of production to assure control of the heat process. The
temperature measuring device shall be accurate within 1 degree F.
(3) Requirements for handling heating deviations. (i) If for any
reason a heating deviation has occurred, the official establishment
shall investigate and identify the cause; take steps to assure that the
deviation will not recur; and place on file in the official
establishment, available to any duly authorized FSIS program employee, a
report of the investigation, the cause of the deviation, and the steps
taken to prevent recurrence.
(ii) In addition, in the case of a heating deviation, the official
establishment may reprocess the affected product, using one of the
methods in paragraph (b)(1) in this section; use the affected product as
an ingredient in another product processed to one of the temperature and
time combinations in paragraph (b)(1) in this section, provided this
does not violate the final product's standard of composition, upset the
order of predominance of ingredients, or perceptibly affect the normal
product characteristics; or relabel the affected product as a partially-
cooked patty product, if it meets the stabilization requirements in
paragraph (c) of this section.
(c) Stabilization. (1) Fully cooked, partially cooked, and char-
marked meat patties must be produced using processes ensuring no
multiplication of toxigenic microorganisms such as Clostridium
botulinum, and no more than a 1 log10 multiplication of
Clostridium perfringens, within the product.
(2) For each meat patty product produced using a stabilization
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. 301.2 of this chapter.
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.
[[Page 271]]
(3) 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.
(4) Partially cooked patties must bear the labeling statement
"Partially cooked: For Safety Cook Until Well Done (Internal Meat
Temperature 160 degrees F.)." The labeling statement must be adjacent
to the product name, and 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.
(5) Char-marked patties must bear the labeling statement "Uncooked,
Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature
160 degrees F.)." The labeling statement shall be adjacent to the
product name, at least one-half the size of the largest letter in the
product name, and 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.
[64 FR 744, 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: 9CFR318.24]
[Page 271-272]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.24 Compliance procedures for meat derived from advanced meat/bone separation machinery and recovery systems.
(a) The product resulting from the separating process shall not have
a calcium content exceeding 0.15 percent or 150 mg/100 gm of product
within a tolerance of 0.03 percent or 30 mg, as prescribed in
Sec. 301.2(rr)(2) of this subchapter.
(b) To verify the calcium content in meat derived from advanced
meat/bone separation machinery and recovery systems, a compliance
program consisting of the following parameters shall be followed by
manufacturers of meat defined in Sec. 301.2(rr)(2) of this subchapter.
(1) An analysis of a sample of at least 1 pound from each lot shall
be performed by the operator of the establishment or his or her agent.
For purposes of this paragraph, a lot shall consist of the meat derived
from advanced meat/bone separation machinery and recovery systems,
designated as such by the operator of the establishment or his or her
agent, from the product produced from a single species of livestock in
no more than one continuous shift of up to 12 hours. Individual results
from the chemical analyses shall be compared to the calcium limit,
prescribed in paragraph (a) of this section, in order to demonstrate
compliance. If compliance is not demonstrated, that is, if any single
analytical result is more than 0.18 percent,\1\ \2\ before product from
a production lot that is still at the establishment or one that is
subsequently produced can be considered to be in compliance, at least
three samples from that production lot shall be taken and analyzed for
calcium, either separately, or, at the option of the establishment, as a
composite (i.e., combining the three samples for analysis). The average
of the results or the composite result must be less than or equal to
0.15 percent. Taking three samples from each subsequently produced lot
and analyzing them in order to demonstrate compliance shall continue
until five consecutive lots have mean or composite results less than or
equal to 0.15 percent. If the statistical evidence indicates that a
production lot is not in compliance with the calcium limit, as
prescribed in Sec. 301.2(rr)(2) of this subchapter, the lot must be
labeled as MS(S) and meet all of the requirements for MS(S) in
Sec. 319.5 of this subchapter.
---------------------------------------------------------------------------
\1\ The value 0.18 percent was derived by multiplying by 3 the
expected analytical standard deviation obtained by FSIS laboratories on
the approved chemical procedure for measuring calcium which uses
Ethylenediaminetetraacetic acid (EDTA) as provided in the "Official
Methods of Analysis of the AOAC International" (formerly the
Association of Official Analytical Chemists), 15th Ed. (1990).
\2\ Individual or an average of results shall be rounded to the
nearest 0.01 percent calcium.
---------------------------------------------------------------------------
(2) The management of the establishment must maintain records to
support the validity of the calcium content (as a measure of bone
solids) to assure the
[[Page 272]]
process is in control. Such records shall be made available to the
inspector or any other duly authorized representative of the Agency upon
request. (Recordkeeping requirements were approved by the Office of
---------------------------------------------------------------------------
Management and Budget under control number 0583-0095.)
[59 FR 62561, Dec. 6, 1994]
Subparts B-F [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: 9CFR318.300]
[Page 272-273]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.300 Definitions.
Source: 51 FR 45619, 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 meat 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
[[Page 273]]
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.
(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: 9CFR318.301]
[Page 273-277]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.301 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 conducted with sufficient frequency to ensure proper closure
and should be conducted at least every 30 minutes of continuous
[[Page 274]]
closing machine operation. Additional visual examinations shall be made
by the closure technician at the beginning 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.
[[Page 275]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.016
(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
[[Page 276]]
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
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 and 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 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
[[Page 277]]
the hermetic condition of the containers. The accumulation of stationary
containers on moving conveyors should be minimized to avoid damage to
the containers.
(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: 9CFR318.302]
[Page 277]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.302 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. 318.300(n) of this subpart) for each canned meat
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: 9CFR318.303]
[Page 277-278]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.303 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.
[[Page 278]]
(b) Continuous rotary and batch agitating retorts. (1) Minimum
headspace; and
(2) Retort reel speed.
(c) Hydrostatic retorts. (1) Chain or conveyor speed.
(d) Steam/air retorts. (1) Steam/air ratio; and
(2) Heating medium flow rate.
[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: 9CFR318.304]
[Page 278]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.304 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. 318.306.
(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.
(Approved by 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: 9CFR318.305]
[Page 278-290]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.305 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 1F deg.(or 0.5C deg.) and
whose scale contains not more than 17F deg./inch (or 4.0C deg./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
[[Page 279]]
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 the standard shall be repaired and
tested for accuracy before further use, or replaced.
(ii) Other devices. Temperature-indicating devices, such as
resistance temperature detectors, used in lieu of mercury-in-glass
thermometers, 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 1F deg.(or 0.5C deg.) 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 55F deg./inch (or 12C deg./cm) within a range of 20F deg.(or
11C deg.) of the process temperature. Chart graduations shall not exceed
2F degrees (or 1C degree) within a range of 10F degrees (or 5C degrees)
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 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 under paragraph
(a)(3) of this section.
[[Page 280]]
(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.
(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
[[Page 281]]
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 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] TC11SE91.017
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] TC11SE91.018
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
[[Page 282]]
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 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] TC11SE91.019
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] TC11SE91.020
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] TC11SE91.021
Figure 5
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 283]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.022
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 bleeders accomplish removal of air and
circulate the steam within the retort. This information shall be
maintained on file by the establishment and made
[[Page 284]]
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.
B!eeders 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 of the retort. Bleeders may be installed at
positions other than those
[[Page 285]]
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
deve!oped 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.
(iii) Steam inlet. The steam inlets shall be large enough to provide
steam for proper operation of the retort.
[[Page 286]]
(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
muffler 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 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
[[Page 287]]
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 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 temperature/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 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
[[Page 288]]
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 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
[[Page 289]]
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 mixtures. 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 of maintenance performed and the person conducting the maintenance.
(h) Container cooling and cooling water. (1) Potable water shall be
used
[[Page 290]]
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 45619, Dec. 19, 1986, as amended at 65 FR 34389, 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: 9CFR318.306]
[Page 290-291]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.306 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. 318.303 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 temperature recorder(s) shall
be made and recorded at the time the first container enters the retort
and thereafter with sufficient frequency to ensure
[[Page 291]]
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. 318.305(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: 9CFR318.307]
[Page 291-292]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.307 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. 318.306. Each entry
on a record shall be made at the time the specific event occurs, and the
recording individual shall sign or initial each record form. No later
than 1 working day after the actual process, the establishment shall
review all
[[Page 292]]
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 that will ensure compliance with the applicable
requirements of Sec. 318.306.
(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. 318.306 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 45619, Dec. 19, 1986, as amended at 65 FR 34389, 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: 9CFR318.308]
[Page 292-294]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.308 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.
(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. 318.302
(a) and (b) and is filed with the inspector in accordance with
Sec. 318.302(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:
(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
[[Page 293]]
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. 318.302(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 and or
destroyed. Product to be destroyed shall be handled as "U.S. Inspected
and Condemned", as defined in Sec. 301.2(ttt) of this subchapter, and
disposed of in accordance with part 314 of this subchapter.
(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. 318.306.
(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. 318.302(b)) before the reel is
restarted; (ii) container entry to the retort shall be prevented and an
emergency agitating process (developed per Sec. 318.302(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. 318.2(ee) of this subchapter, and disposed of in accordance with
part 314 of this subchapter.
(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. 318.302(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. 318.306. 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 subchapter, and disposed of in
accordance with part 314 of this subchapter.
(2) Deviations identified through record review. Whenever a
deviation is noted during review of the processing and production
records required by Sec. 318.307 (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 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. 318.307(e) and shall be made
[[Page 294]]
available to Program employees upon request.
(Approved by the Office of Management and Budget under control number
0583-0015)
[51 FR 45619, Dec. 19, 1986, as amended at 53 FR 49848, Dec. 12, 1988;
62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 65 FR 53532,
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: 9CFR318.309]
[Page 294-295]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.309 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;
(2) An FSIS-approved total quality control system;
(3) Alternative documented procedures that will ensure that only
safe and stable product is shipped in commerce; or
(4) Paragraph (d) of this section.
(b)-(c) [Reserved]
(d) Procedures for handling 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. 318.300(m); and
(b) Acidified low acid products as defined in Sec. 318.300(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. 318.307(e).
(vii) Abnormal containers. The finding of abnormal containers (as
defined in Sec. 318.300(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 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
[[Page 295]]
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 45619, Dec. 19, 1986, as amended at 57 FR 37872, Aug. 21, 1992;
57 FR 55443, Nov. 25, 1992; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May
30, 2000; 65 FR 53532, 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: 9CFR318.310]
[Page 295]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.310 Personnel and training.
All operators of thermal processing systems specified in
Sec. 318.305 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 45619, 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: 9CFR318.311]
[Page 295]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart G--Canning and Canned Products
Sec. 318.311 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)
