[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: 9CFR301]
 
[Page 76]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 301--DEFINITIONS--Table of Contents
 
 
Sec.
301.1  Meaning of terms.
301.2  Definitions.
 
    Authority: 7 U.S.C. 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: 9CFR301.1]
 
[Page 76]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 301--DEFINITIONS--Table of Contents
 
Sec. 301.1  Meaning of terms.
 
    As used in this subchapter, unless otherwise required by the 
context, the singular form shall also import the plural and the 
masculine form shall also import the feminine, and vice versa.
 
[35 FR 15554, Oct. 3, 1970]
 
 
 
 
 
[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: 9CFR301.2]
 
[Page 76-83]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 301--DEFINITIONS--Table of Contents
 
Sec. 301.2  Definitions.
 
    As used in this subchapter, unless otherwise required by the 
context, the following terms shall be construed, respectively, to mean:
    The Act. The Federal Meat Inspection Act, as amended, (34 Stat. 
1260, as amended, 81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, 21 U.S.C., 
sec. 601 et seq.).
 
[[Page 77]]
 
    Administrator. The Administrator of the Food Safety and Inspection 
Service or any officer or employee of the Department to whom authority 
has heretofore been delegated or may hereafter be delegated to act in 
his/her stead.
    Adulterated. This term applies to any carcass, part thereof, meat or 
meat food product under one or more of the following circumstances:
    (1) If it bears or contains any such poisonous or deleterious 
substance which may render it injurious to health; but in case the 
substance is not an added substance, such article shall not be 
considered adulterated under this clause if the quantity of such 
substance in or on such article does not ordinarily render it injurious 
to health;
    (2)(i) If it bears or contains (by reason of administration of any 
substance to the live animal or otherwise) any added poisonous or added 
deleterious substance (other than one which is:
    (A) A pesticide chemical in or on a raw agricultural commodity;
    (B) A food additive; or
    (C) A color additive which may, in the judgment of the 
Administrator, make such article unfit for human food;
    (ii) If it is, in whole or in part, a raw agricultural commodity and 
such commodity bears or contains a pesticide chemical which is unsafe 
within the meaning of section 408 of the Federal Food, Drug, and 
Cosmetic Act;
    (iii) If it bears or contains any food additive which is unsafe 
within the meaning of section 409 of the Federal Food, Drug, and 
Cosmetic Act;
    (iv) If it bears or contains any color additive which is unsafe 
within the meaning of section 706 of the Federal Food, Drug, and 
Cosmetic Act: Provided, That an article which is not deemed adulterated 
under paragraphs (aa)(2) (ii), (iii), or (iv) of this section shall 
nevertheless be deemed adulterated if use of the pesticide chemical food 
additive, or color additive in or on such article is prohibited by the 
regulations in this subchapter in official establishments;
    (3) If it consists in whole or in part of any filthy, putrid, or 
decomposed substance or is for any other reason unsound, unhealthful, 
unwholesome, or otherwise unfit for human food;
    (4) If it has been prepared, packed, or held under unsanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health;
    (5) If it is, in whole or in part, the product of an animal which 
has died otherwise than by slaughter;
    (6) If its container is composed, in whole or in part, of any 
poisonous or deleterious substance which may render the contents 
injurious to health;
    (7) If it has been intentionally subjected to radiation, unless the 
use of the radiation was in conformity with a regulation or exemption in 
effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic 
Act;
    (8) If any valuable constituent has been in whole or in part omitted 
or abstracted therefrom; or if any substance has been substituted, 
wholly or in part therefor; or if damage or inferiority has been 
concealed in any manner; or if any substance has been added thereto or 
mixed or packed therewith so as to increase its bulk or weight, or 
reduce its quality or strength, or make it appear better or of greater 
value than it is; or,
    (9) If it is margarine containing animal fat and any of the raw 
material used therein consisted in whole or in part of any filthy, 
putrid, or decomposed substance, or is otherwise adulterated.
    Anesthesia. Loss of sensation or feeling.
    Animal food. Any article intended for use as food for dogs, cats, or 
other animals derived wholly, or in part, from the carcass or parts or 
products of the carcass of any livestock, except that the term animal 
food as used herein does not include:
    (1) Processed dry animal food or
    (2) Livestock or poultry feeds manufactured from processed livestock 
byproducts (such as meatmeal tankage, meat and bonemeal, bloodmeal, and 
feed grade animal fat).
    Animal food manufacturer. Any person engaged in the business of 
manufacturing or processing animal food.
    Area. One or more circuits under the supervision of an area 
supervisor.
    Area Supervisor. The official in charge of an area.
 
[[Page 78]]
 
    Artificial coloring. A coloring containing any dye or pigment, which 
dye or pigment was manufactured by a process of synthesis or other 
similar artifice, or a coloring which was manufactured by extracting a 
natural dye or natural pigment from a plant or other material in which 
such dye or pigment was naturally produced.
    Artificial flavoring. A flavoring containing any sapid or aromatic 
constituent, which constituent was manufactured by a process of 
synthesis or other similar artifice.
    Biological residue. Any substance, including metabolites, remaining 
in livestock at time of slaughter or in any of its tissues after 
slaughter as the result of treatment or exposure of the livestock to a 
pesticide, organic or inorganic compound, hormone, hormone-like 
substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or 
other therapeutic or prophylactic agent.
    Capable of use as human food. This term applies to any carcass, or 
part or product of a carcass, of any livestock, unless it is denatured 
or otherwise identified as required by the applicable provisions of 
Secs. 314.3, 314.10, 325.11, and 325.13 of this subchapter to deter its 
use as a human food, or it is naturally inedible by humans; e.g., hoofs 
or horns in their natural state.
    Captive bolt. A stunning instrument which when activated drives a 
bolt out of a barrel for a limited distance.
    Carbon dioxide. A gaseous form of the chemical formula 
CO2.
    Carbon dioxide concentration. Ratio of carbon dioxide gas and 
atmospheric air.
    Carcass. All parts, including viscera, of any slaughtered livestock.
    Chemical preservative. Any chemical that, when added to a meat or 
meat food product, tends to prevent or retard deterioration thereof, but 
does not include common salt, sugars, vinegars, spices, or oils 
extracted from spices or substances added to meat and meat food products 
by exposure to wood smoke.
    Other definitions, if any, that are applicable only for purposes of 
a specific part of the regulations in this subchapter, are set forth in 
such part.
    Circuit. One or more official establishments included under the 
supervision of a circuit supervisor.
    Circuit supervisor. The supervisor of a circuit.
    Commerce. Commerce between any State, any Territory, or the District 
of Columbia, and any place outside thereof; or within any Territory not 
organized with a legislative body, or the District of Columbia.
    Consciousness. Responsiveness of the brain to the impressions made 
by the senses.
    Cutting up. Any division of any carcass or part thereof, except that 
the trimming of carcasses or parts thereof to remove surface 
contaminants is not considered as cutting up.
    Dead livestock. The body (cadaver) of livestock which has died 
otherwise than by slaughter.
    The Department. The United States Department of Agriculture.
    Dying, diseased, or disabled livestock. Livestock which has or 
displays symptoms of having any of the following:
    (1) Central nervous system disorder;
    (2) Abnormal temperature (high or low);
    (3) Difficult breathing;
    (4) Abnormal swellings;
    (5) Lack of muscular coordination;
    (6) Inability to walk normally or stand;
    (7) Any of the conditions for which livestock is required to be 
condemned on ante-mortem inspection in accordance with the regulations 
in part 309 of this subchapter.
    Edible. Intended for use as human food.
    Experimental animal. Any animal used in any research investigation 
involving the feeding or other administration of, or subjection to, an 
experimental biological product, drug, or chemical or any 
nonexperimental biological product, drug, or chemical used in a manner 
for which it was not intended.
    Exposure time. The period of time an animal is exposed to an 
anesthesia-producing carbon dioxide concentration.
    Federal Food, Drug, and Cosmetic Act. The Act so entitled, approved 
June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or 
supplementary thereto.
 
[[Page 79]]
 
    Firm. Any partnership, association, or other unincorporated business 
organization.
    Food Safety and Inspection Service. The Food Safety and Inspection 
Service of the Department.
    Further processing. Smoking, cooking, canning, curing, refining, or 
rendering in an official establishment of product previously prepared in 
official establishments.
    Immediate container. The receptacle or other covering in which any 
product is directly contained or wholly or partially enclosed.
    Import Field Office (IFO). The office of the supervisor of import 
inspection activities for a particular importing field area. The areas 
are as follows:
 
IFO 1. Boston, MA--Covering the States of Massachusetts, New 
York (excluding New York City), Connecticut, Rhode Island, Vermont, New 
Hampshire and Maine.
IFO 2. New York, NY--Covering the areas of New York City and 
northern New Jersey.
IFO 3. Philadelphia, PA--Covering the State of Pennsylvania and 
the area of southern New Jersey.
IFO 4. Baltimore, MD--Covering the States of Maryland, 
Delaware, West Virginia, Virginia and Kentucky.
IFO 5. Charleston, SC--Covering the States of Tennessee, North 
Carolina, South Carolina, Georgia and Florida (excluding south Florida).
1IFO 6. Miami, FL--Covering the areas of southern Florida, 
Puerto Rico and the Virgin Islands.
1IFO 7. New Orleans, LA--Covering the States of Louisiana, 
Mississippi, Alabama, Arkansas, Texas, Oklahoma, Kansas, New Mexico and 
Colorado.
1IFO 8. San Pedro, CA--Covering the States of Hawaii, Arizona, 
Utah, Nevada, the area of southern California, American Samoa, Guam, and 
the Northern Marianas.
1IFO 9. Tacoma, WA--Covering the States of Washington, Oregon, 
Idaho, Montana, Wyoming, North Dakota, South Dakota, Alaska, and 
Nebraska, and the area of northern California.
1IFO 10. Detroit, MI--Covering the States of Michigan, 
Wisconsin, Minnesota, Iowa, Missouri, Illinois, Indiana and Ohio.
 
    Import Supervisor. The official in charge of import inspection 
activities within each of the import field offices.
    Inedible. Adulterated, uninspected, or not intended for use as human 
food.
    Inhumane slaughter or handling in connection with slaughter. 
Slaughter or handling in connection with slaughter not in accordance 
with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901 through 
1906, as amended by the Humane Methods of Slaughter Act of 1978, 92 
Stat. 1069) and part 313 of this subchapter.
    "Inspected and passed" or "U.S. Inspected and Passed" or "U.S. 
Inspected and Passed by Department of Agriculture" (or any authorized 
abbreviation thereof). This term means that the product so identified 
has been inspected and passed under the regulations in this subchapter, 
and at the time it was inspected, passed, and identified, it was found 
to be not adulterated.
    Inspector. An inspector of the Program.
    Inspector in charge. A designated program employee who is in charge 
of one or more official establishments within a circuit and is 
responsible to the circuit supervisor or his/her designee.
    Label. A display of written, printed, or graphic matter upon the 
immediate container (not including package liners) of any article.
    Labeling. All labels and other written, printed, or graphic matter:
    (1) Upon any article or any of its containers or wrappers, or
    (2) Accompanying such article.
    Livestock. Cattle, sheep, swine, goat, horse, mule, or other equine.
    Meat. (1) The part of the muscle of any cattle, sheep, swine, or 
goats, which is skeletal or which is found in the tongue, in the 
diaphragm, in the heart, or in the esophagus, 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. It does not 
include the muscle found in the lips, snout, or ears. This term, as 
applied to products of equines, shall have a meaning comparable to that 
provided in this paragraph with respect to cattle, sheep, swine, and 
goats.
    (2) The product derived from the mechanical separation of the 
skeletal muscle tissue from the bones of livestock using the advances in 
mechanical meat/bone separation machinery and meat recovery systems that 
do not crush, grind, or pulverize bones, and
 
[[Page 80]]
 
from which the bones emerge comparable to those resulting from hand-
deboning (i.e., essentially intact and in natural physical conformation 
such that they are recognizable, such as loin bones and rib bones, when 
they emerge from the machinery) which meets the criteria of no more than 
0.15 percent or 150 mg/100 gm of product for calcium (as a measure of 
bone solids content) within a tolerance of 0.03 percent or 30 mg.
    Meat broker. Any person engaged in the business of buying or selling 
carcasses, parts of carcasses, meat or meat food products of livestock 
on commission, or otherwise negotiating purchases or sales of such 
articles other than for his/her own account or as an employee of another 
person.
    Meat byproduct. Any part capable of use as human food, other than 
meat, which has been derived from one or more cattle, sheep, swine, or 
goats. This term, as applied to products of equines, shall have a 
meaning comparable to that provided in this paragraph with respect to 
cattle, sheep, swine, and goats.
    Meat food product. Any article capable of use as human food which is 
made wholly or in part from any meat or other portion of the carcass of 
any cattle, sheep, swine, or goats, except those exempted from 
definition as a meat food product by the Administrator in specific cases 
or by the regulations in part 317 of this subchapter, upon a 
determination that they contain meat or other portions of such carcasses 
only in a relatively small proportion or historically have not been 
considered by consumers as products of the meat food industry, and 
provided that they comply with any requirements that are imposed in such 
cases or regulations as conditions of such exemptions to assure that the 
meat or other portions of such carcasses contained in such articles are 
not adulterated and that such articles are not represented as meat food 
products. This term, as applied to food products of equines, shall have 
a meaning comparable to that provided in this paragraph with respect to 
cattle, sheep, swine, and goats.
    Misbranded. This term applies to any carcass, part thereof, meat or 
meat food product under one or more of the following circumstances:
    (1) If its labeling is false or misleading in any particular;
    (2) If it is offered for sale under the name of another food;
    (3) If it is an imitation of another food, unless its label bears, 
in type of uniform size and prominence, the word "imitation" and 
immediately thereafter, the name of the food imitated;
    (4) If its container is so made, formed, or filled as to be 
misleading;
    (5) If in a package or other container unless it bears a label 
showing:
    (i) The name and place of business of the manufacturer, packer, or 
distributor; and
    (ii) An accurate statement of the quantity of the contents in terms 
of weight, measure, or numerical count; except as otherwise provided in 
part 317 of this subchapter with respect to the quantity of contents;
    (6) If any word, statement, or other information required by or 
under authority of the Act to appear on the label or other labeling is 
not prominently placed thereon with such conspicuousness (as compared 
with other words, statements, designs, or devices, in the labeling) and 
in such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use;
    (7) If it purports to be or is represented as a food for which a 
definition and standard of identity or composition has been prescribed 
by the regulations in part 319 of this subchapter unless:
    (i) It conforms to such definition and standard, and
    (ii) Its label bears the name of the food specified in the 
definition and standard and, insofar as may be required by such 
regulations, the common names of optional ingredients (other than 
spices, flavoring, and coloring) present in such food;
    (8) If it purports to be or is represented as a food for which a 
standard or standards of fill of container have been prescribed by the 
regulations in part 319 of this subchapter, and it falls below the 
standard of fill of container applicable thereto, unless its label 
bears, in such manner and form as such
 
[[Page 81]]
 
regulations specify, a statement that it falls below such standard;
    (9) If it is not subject to the provisions of paragraph (vv)(7)(ii) 
of this section unless its label bears:
    (i) The common or usual name of the food, if any there be, and
    (ii) In case it is fabricated from two or more ingredients, the 
common or usual name of each such ingredient, except as otherwise 
provided in part 317 of this subchapter;
    (10) If it purports to be or is represented for special dietary 
uses, unless its label bears such information concerning its vitamin, 
mineral, and other dietary properties as is required by the regulations 
in part 317 of this subchapter.
    (11) If it bears or contains any artificial flavoring, artificial 
coloring, or chemical preservative, unless it bears a label stating that 
fact; except as otherwise provided by the regulations in part 317 of 
this subchapter; or
    (12) If it fails to bear, directly thereon or on its containers, 
when required by the regulations in part 316 or 317 of this subchapter, 
the inspection legend and, unrestricted by any of the foregoing, such 
other information as the Administrator may require in such regulations 
to assure that it will not have false or misleading labeling and that 
the public will be informed of the manner of handling required to 
maintain the article in a wholesome condition.
    Nonfood compound. Any substance proposed for use in official 
establishments, the intended use of which will not result, directly or 
indirectly, in the substance becoming a component or otherwise affecting 
the characteristics of meat food and meat products, excluding labeling 
and packaging materials as covered in part 317 of the subchapter.
    Official certificate. Any certificate prescribed by the regulations 
in this subchapter for issuance by an inspector or other person 
performing official functions under the Act.
    Official device. Any device prescribed by the regulations in part 
312 of this subchapter for use in applying any official mark.
    Official establishment. Any slaughtering, cutting, boning, meat 
canning, curing, smoking, salting, packing, rendering, or similar 
establishment at which inspection is maintained under the regulations in 
this subchapter.
    Official import inspection establishment. This term means any 
establishment, other than an official establishment as defined in 
paragraph (zz) of this section, where inspections are authorized to be 
conducted as prescribed in Sec. 327.6 of this subchapter.
    Official inspection legend. Any symbol prescribed by the regulations 
in this subchapter showing that an article was inspected and passed in 
accordance with the Act.
    Official mark. The official inspection legend or any other symbol 
prescribed by the regulations in this subchapter to identify the status 
of any article or animal under the Act.
    Packaging material. Any cloth, paper, plastic, metal, or other 
material used to form a container, wrapper, label, or cover for meat 
products.
    Person. Any individual, firm, or corporation.
    Pesticide chemical, food additive, color additive, raw agricultural 
commodity. These terms shall have the same meanings for purposes of the 
Act and the regulations in this subchapter as under the Federal Food, 
Drug, and Cosmetic Act.
    Prepared. Slaughtered, canned, salted, rendered, boned, cut up, or 
otherwise manufactured or processed.
    Process authority. A person or organization with expert knowledge in 
meat production process control and relevant regulations. This 
definition does not apply to subpart G of part 318.
    Process schedule. A written description of processing procedures, 
consisting of any number of specific, sequential operations directly 
under the control of the establishment employed in the manufacture of a 
specific product, including the control, monitoring, verification, 
validation, and corrective action activities associated with production. 
This definition does not apply to subpart G of part 318.
    Product. Any carcass, meat, meat byproduct, or meat food product, 
capable of use as human food.
    Program. The organizational unit within the Department having the 
responsibility for carrying out the provisions of the Act.
 
[[Page 82]]
 
    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.
    Regional Director. The official \1\ in charge of the program within 
each of the following regions:
---------------------------------------------------------------------------
 
    \1\ The addresses of the Regional Directors are as follows:
    Northeastern Region--Seventh Floor, 1421 Cherry Street, 
Philadelphia, PA 19102.
    Southeastern Region--Room 299 South, 1718 Peachtree Street, NW., 
Atlanta, GA 30309.
    North Central Region--607 East Second Street, Des Moines, IA 50309.
    Southwestern Region--Room 5-F41, 1100 Commerce Street, Dallas, TX 
75201.
    Western Region--Room 620 Central Avenue, Building 2C, Alameda, CA 
94501.
 
Northeastern Region--Connecticut, Delaware, District of Columbia, Maine, 
Maryland, Massachusetts, New Hampshire, New Jersey, New York, 
Pennsylvania, Rhode Island, Vermont, and Virginia (except for 
Northwestern part).
Southeastern Region-- Alabama, Florida, Georgia, Kentucky, Mississippi, 
North Carolina, South Carolina, Tennessee, Virginia (Northwestern), West 
Virginia, Puerto Rico, and the Virgin Islands.
North Central Region-- Illinois, Indiana, Iowa, Michigan, Minnesota, 
Ohio, and Wisconsin.
Southwestern Region-- Arkansas, Kansas, Louisiana, Missouri, Nebraska, 
New Mexico, Oklahoma, and Texas.
Western Region-- Alaska, Arizona, California, Colorado, Hawaii, Idaho, 
Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, 
and Wyoming, American Samoa, Guam, and the Northern Mariana Islands.
 
    Renderer. Any person engaged in the business of rendering carcasses 
or parts or products of the carcasses of any livestock except rendering 
conducted under inspection or exemption under Title I of the Act.
    Secretary. The Secretary of Agriculture of the United States or his/
her delegate.
    Shipping container. The outside container (box, bag, barrel, crate, 
or other receptacle or covering) containing or wholly or partly 
enclosing any product packed in one or more immediate containers.
    State. Any State of the United States or the Commonwealth of Puerto 
Rico.
    Supervision. The controls, as prescribed in instructions to Program 
employees, to be exercised by them over particular operations to insure 
that such operations are conducted in compliance with the Act and the 
regulations in this subchapter.
    Surgical anesthesia. A state of unconsciousness measured in 
conformity with accepted surgical practices.
    Territory. Guam, the Virgin Islands of the United States, American 
Samoa, and any other territory or possession of the United States, 
excluding the Canal Zone.
    U.S. Condemned. This term means that the livestock so identified has 
been inspected and found to be in a dying condition, or to be affected 
with any other condition or disease that would require condemnation of 
its carcass.
    U.S. Inspected and Condemned (or any authorized abbreviation 
thereof). This term means that the carcass, viscera, other part of 
carcass, or other product so identified has been inspected, found to be 
adulterated, and condemned under the regulations in this subchapter.
    U.S. Passed for Cooking. This term means that the meat or meat 
byproduct so identified has been inspected and passed on condition that 
it be cooked or rendered as prescribed by the regulations in part 315 of 
this chapter.
    U.S. Passed for Refrigeration. This term means that the meat or meat 
byproduct so identified has been inspected and passed on condition that 
it be refrigerated or otherwise handled as prescribed by the regulations 
in part 311 of this subchapter.
    U.S. Retained. This term means that the carcass, viscera, other part 
of carcass, or other product, or article so identified is held for 
further examination by an inspector to determine its disposal.
    U.S. Suspect. This term means that the livestock so identified is 
suspected of being affected with a disease or condition which may 
require its condemnation, in whole or in part, when slaughtered, and is 
subject to further examination by an inspector to determine its 
disposal.
 
[[Page 83]]
 
    United States. The States, the District of Columbia, and the 
Territories of the United States.
 
[35 FR 15554, Oct. 3, 1970]
 
    Editorial Note: For Federal Register citations affecting Sec. 301.2, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.