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 official1 in charge of the program within each of the following regions:

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.

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.

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 car

cass.

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.

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 §301.2, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

PART 302-APPLICATION OF INSPECTION AND OTHER REQUIREMENTS

Sec.

302.1 Establishments requiring inspection. 302.2 Application of requirements in designated States or Territories; and to designated plants endangering public

health.

302.3 Livestock and products entering official establishments.

AUTHORITY: 21 U.S.C. 601-695; 7 CFR 2.17,

2.55.

§ 302.1 Establishments requiring inspection.

(a) Inspection under the regulations in this subchapter is required at:

(1) Every establishment, except as provided in § 303.1 (a) and (b), or (c) of this subchapter, in which any livestock are slaughtered for transportation or sale as articles of commerce, or in which any products of, or derived from, carcasses of livestock are, wholly or in part, prepared for transportation or sale as articles of commerce, which are intended for use as human food;

(2) Every establishment, except as provided in §303.1 (a) and (b), or (d) of this subchapter, within any State or organized Territory which is designated pursuant to paragraph 301(c) of the Act, at which any livestock are slaughtered or any products of any livestock are prepared, for use as human food solely for distribution within such jurisdiction; and

(3) Every establishment, except as provided in §303.1 (a) and (b) of this subchapter, that is designated by the Administrator pursuant to paragraph 301(c) of the Act as one producing adulterated products which would clearly endanger the public health.

[35 FR 15556, Oct. 3, 1970, as amended at 36 FR 12002, June 24, 1971]

§ 302.2 Application of requirements in designated States or Territories; and to designated plants endangering public health.

Special provisions with respect to establishments and their operations and transactions by any persons in designated States and Territories and with respect to establishments designated as producing adulterated products which clearly endanger public health, and the operators thereof, in any State or Territory appear in part 331 of this subchapter, and apply to such establishments, operations and transactions in lieu of the regulations elsewhere in this subchapter except insofar as such regulations are made applicable by the provisions in part 331 of this subchapter.

[35 FR 15556, Oct. 3, 1970, as amended at 51 FR 29909, Aug. 21, 1986]

(2) The custom slaughter by any person of cattle, sheep, swine, or goats delivered by the owner thereof for such slaughter, and the preparation by such slaughterer and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such livestock, exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees; nor to the custom preparation by any person of carcasses, parts thereof, meat or meat food products derived from the slaughter by any individual of cattle, sheep, swine, or goats of his own raising or from game animals, delivered by the owner thereof for such custom preparation, and transportation commerce of such custom prepared articles, exclusively for use in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That the following requirements are met by such custom operator;

in

(i) Establishments that conduct custom operations must be maintained and operated in accordance with the provisions of §§ 416.1 through 416.6, except for: §416.2(g)(2) through (6) of this chapter, regarding water reuse and any provisions of part 416 of this chapter relating to inspection or supervision of specified activities or other action by a Program employee. If custom operations are conducted in an official establishment, however, all of the provisions of Part 416 of this chapter of shall apply to those operations.

(ii) If the custom operator prepares or handles any products for sale, they are kept separate and apart from the custom prepared products at all times while the latter are in his custody;

(iii) The custom prepared products are plainly marked "Not for Sale" as provided in §316.16 of this subchapter, immediately after being prepared and are kept so identified until delivered to the owner; and

(iv) If exempted custom slaughtering or other preparation of products is conducted in an official establishment, all facilities and equipment in the official establishment used for such custom operations shall be thoroughly cleaned and sanitized before they are used for preparing any products for sale.

(b)(1) The exempted custom prepared products shall be prepared and handled in accordance with the provisions of §§ 318.5, 318.6, 318.7, 318.10, and 318.300 through 318.311 of this subchapter and shall not be adulterated as defined in paragraph 1(m) of the Act: Provided, That the provisions of §§ 318.5, 318.6, 318.10, and 318.300 through 318.311 relating to inspection or supervision of specified activities or other action by a Program inspector, and the provisions of §318.6(b)(9) and (10), shall not apply to the preparation and handling of such exempted products.

(2) The exempted custom prepared products shall comply with the requirements of §§ 316.16 and 317.16 of this subchapter.

(3) The custom operators claiming exemption under paragraph (a)(2) of this section shall keep records, in addition to records otherwise required by part 320 of this subchapter, showing the numbers and kinds of livestock slaughtered on a custom basis, the quantities and types of products prepared on a custom basis, and the names and addresses of the owners of the livestock and products.

(4) Articles capable of use as human food, resulting from the exempted custom slaughter or other preparation of products shall be promptly denatured or otherwise identified in accordance with § 325.13 of this subchapter and not removed from the establishment where the custom operations are conducted until so identified, unless they are delivered to the owner of the articles for use in accordance with paragraph (a)(2) of this section.

(c) It has been determined that it is impracticable to provide inspection of the preparation of products at establishments in any unorganized Territory at which livestock are slaughtered or their products are prepared for distribution solely within such jurisdiction and that exempting such establishments from requirements of the Act for such inspections under the conditions stated in this section will otherwise facilitate enforcement of the Act. Therefore, such inspection requirements of the Act and of the regulations in this subchapter shall not apply at such establishments if they are operated in accordance with the

regulations in part 416, §§ 416.1 through 416.5 of this chapter. However, the Administrator may refuse, withdraw, or modify any exemption under this paragraph when he determines in any specific case in accordance with the applicable rules of practice that such action is necessary to effectuate the purposes of this Act.

(d)(1) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments.

(2) For purposes of paragraph (d)(1) of this section:

(i) Operations of types traditionally and usually conducted at retail stores and restaurants are the following:

(a) Cutting up, slicing, and trimming carcasses, halves, quarters, or wholesale cuts into retail cuts such as steaks, chops, and roasts, and freezing such cuts;

(b) Grinding and freezing products made from meat;

(c) Curing, cooking, smoking, rendering or refining of livestock fat, or other preparation of products, except slaughtering or the retort processing of canned products;

(d) Breaking bulk shipments of products;

(e) Wrapping or rewrapping products. (ii) Any quantity or product purchased by a consumer from a particular retail supplier shall be deemed to be a normal retail quantity if the quantity so purchased does not in the aggregate exceed one-half carcass. The following amounts of product will be accepted as representing one-half carcass of the species identified:

(a) The sales of product are made to consumers only;

(b) At least 75 percent, in terms of dollar value, of total sales of product represents sales to household consumers and the total dollar value of sales of product to consumers other than household consumers does not exceed the dollar limitation per calendar year set by the Administrator. This dollar limitation is a figure which will automatically be adjusted during the first quarter of each calendar year, upward or downward, whenever the Consumer Price Index, published by the Bureau of Labor Statistics, Department of Labor, indicates a change in the price of this same volume of product which exceeds $500. Notice of the adjusted dollar limitation will be published in the FEDERAL REGISTER. 1

(c) Only federally or State inspected and passed product is handled or used in the preparation of any product, except that product resulting from the custom slaughter or custom preparation of product may be handled or used in accordance with paragraph (a)(2) and (b) of this section but not for sale;

(d) No sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section;

(e) The preparation of products for sale to household consumers is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section; and

The preparation of products for sale to other than household consumers is limited to traditional and usual operations as defined in paragraph (d)(2)(i) (a), (b), (d), and (e) of this section. (A retail store at which custom slaughtering or preparation of products is conducted is not thereby disqualified from exemption as a retail store under this paragraph (d).)

(iv) Restaurants. (a) A restaurant is any establishment where:

The dollar limitation currently in effect may be obtained by contacting Director, Slaughter Inspection Standards and Procedures Division, Technical Services, Food and Safety Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 (202) 447-3219.

(1) Product is prepared only for sale or service in meals or as entrees directly to individual consumers at such establishments;

(2) Only federally or State inspected and passed product or such product prepared at a retail store exempted under paragraph (d)(2)(iii) of this section is handled or used in the preparation of any product;

(3) No sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and

(4) The preparation of product is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.

(b) The definition of a restaurant includes a caterer which delivers or serves product in meals, or as entrees, only to individual consumers and otherwise meets the requirements of this paragraph.

(c) For purposes of this paragraph, operations conducted at a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares meat or meat food products that are ready to eat when they leave such facility (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to a receiving restaurant by its own employees, without intervening transfer or storage, maintained in a safe, unadulterated condition during transportation, and served in meals or as entrees only to customers at restaurants, or through vending machines, owned or operated by the same person that owns or operates such facility, and which otherwise meets the requirements of this paragraph: Provided, That the requirements of §§ 320.1 through 320.4 of this subchapter apply to such facility. Provided further, That the exempted facility may be subject to inspection requirements under the Act for as long as the Administrator deems necessary, if the Administrator determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its meat or meat food products are ren

dered adulterated. When the Administrator has made such determination and subjected a restaurant central kitchen facility to such inspection requirements, the operator of such facility shall be afforded an opportunity to dispute the Administrator's determination in a hearing pursuant to rules of practice which will be adopted for this proceeding.

(v) Similar retail-type establishment: Any establishment which is a combination retail store and restaurant; any delicatessen which meets the requirements for a retail store or restaurant as prescribed in paragraphs (d)(2) (iii) or (iv) of this section; or other establishment as determined by the Administrator in specific cases.

(vi) Consumer: Any household consumer, hotel, restaurant, or similar institution as determined by the Administrator in specific cases.

(3) Whenever any complaint is received by the Administrator from any person alleging that any retail store claiming exemption under this paragraph (d), in any designated State or organized Territory that is identified under section 205 of the Act (as one that does not have or is not exercising adequate authority with respect to recordkeeping requirements) has been operated in violation of the conditions prescribed in this section for exemption, and the Administrator, upon investigation of the complaint, has reason to believe that any such violation has occurred, he shall so notify the operator of the retail store and afford him reasonable opportunity to present his views informally with respect to the matter. Thereafter, if the Administrator still has reason to believe that such a violation has occurred, and that a requirement that the operator keep records concerning the operations of the retail store would effectuate the purposes of the Act, the Administrator shall order the operator to maintain complete, accurate, and legible records of total monthly purchases and of total monthly sales of meat, meat byproducts, and meat food products, in terms of dollar values of the products involved. Such records shall separately show total sales to household consumers and total sales to other consumers and shall be maintained for the