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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 deleterious substance which may renderit 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 jud ent 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 ad ve, 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

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.

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.

or

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, hormonelike substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other therapeutic 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 $$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 dioride 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.

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.

Erperimental 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.

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, Vir

ginia 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 Vir

gin Islands. IIFO #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 passedor U.S. Inspected and Passedor 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

or

from which the bones emerge comparable to those resulting from handdeboning (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 28 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, distributor; and

(ii) Ar 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 com

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

mon

names

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regulations specify, a statement that it dering, or similar establishment at falls below such standard;

which inspection is maintained under (9) If it is not subject to the provi- the regulations in this subchapter. sions of paragraph (vv)(7)(ii) of this Official import inspection establishment. section unless its label bears:

This term means any establishment, (i) The common or usual name of the other than an official establishment as food, if any there be, and

defined in paragraph (zz) of this sec(ii) In case it is fabricated from two tion, where inspections are authorized or more ingredients, the common or to be conducted as prescribed in $327.6 usual name of each such ingredient, ex- of this subchapter. cept as otherwise provided in part 317 Official inspection legend. Any symbol of this subchapter;

prescribed by the regulations in this (10) If it purports to be or is rep- subchapter showing that an article was resented for special dietary uses, unless inspected and passed in accordance its label bears such information con- with the Act. cerning its vitamin, mineral, and other Official mark. The official inspection dietary properties as is required by the legend or any other symbol prescribed regulations in part 317 of this sub-" by the regulations in this subchapter chapter.

to identify the status of any article or (11) If it bears or contains any artifi- animal under the Act. cial flavoring, artificial coloring, or Packaging material. Any cloth, paper, chemical preservative, unless it bears a plastic, metal, or other material used label stating that fact; except as other- to form a container, wrapper, label, or wise provided by the regulations in cover for meat products. part 317 of this subchapter; or

Person. Any individual, firm, or cor(12) If it fails to bear, directly there- poration. on or on its containers, when required Pesticide chemical, food additive, color by the regulations in part 316 or 317 of additive, agricultural commodity. this subchapter, the inspection legend These terms shall have the same meanand, unrestricted by any of the fore- ings for purposes of the Act and the going, such other information as the regulations in this subchapter as under Administrator may require in such reg- the Federal Food, Drug, and Cosmetic ulations to assure that it will not have Act. false or misleading labeling and that Prepared. Slaughtered, canned, saltthe public will be informed of the man- ed, rendered, boned, cut up, or otherner of handling required to maintain wise manufactured or processed. the article in a wholesome condition. Process authority. A person or organi

Nonfood compound. Any substance zation with expert knowledge in meat proposed for use in official establish- production process control and relments, the intended use of which will evant regulations. This definition does not result, directly or indirectly, in the not apply to subpart G of part 318. substance becoming a component or Process schedule. A written descripotherwise affecting the characteristics tion of processing procedures, conof meat food and meat products, ex- sisting of any number of specific, secluding labeling and packaging mate- quential operations directly under the rials as covered in part 317 of the sub- control of the establishment employed chapter.

in the manufacture of a specific prodOfficial certificate. Any certificate uct, including the control, monitoring, prescribed by the regulations in this verification, validation, and corrective subchapter for issuance by an inspector action activities associated with proor other person performing official duction. This definition does not apply functions under the Act.

to subpart G of part 318. Official device. Any device prescribed Product. Any carcass, meat, meat byby the regulations in part 312 of this product, or meat food product, capable subchapter for use in applying any offi- of use as human food. cial mark.

Program. The organizational

unit Official establishment. Any slaugh- within the Department having the retering, cutting, boning, meat 'canning, sponsibility for carrying out the provicuring, smoking, salting, packing, ren- sions of the Act.

203-028 D-4

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