PART 302-APPLICATION OF INSPECTION AND OTHER REQUIREMENTS

Sec.

302.1 Establishments requiring inspection. 302.2 Application of requirements in the District of Columbia or in designated States or Territories; and to designated plants endangering public health. 302.3 Livestock and products entering official establishments.

AUTHORITY: 34 Stat. 1260, 79 Stat. 903, as amended, 81 Stat. 584, 84 Stat. 91, 438; 21 U.S.C. 71 et seq., 601 et seq., 33 U.S.C. 466466k.

§ 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]

ations in lieu of the regulations elsewhere in this subchapter, except insofar as such regulations are made applicable by the provisions in Part 330 of this subchapter.

(b) 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]

§ 302.3 Livestock and products entering official establishments.

All livestock and all products entering any official establishment and all products prepared, in whole or in part, therein, shall be inspected, handled, stored, prepared, packaged, marked, and labeled as required by the regulations in this subchapter.

[35 FR 15556, Oct. 3, 1970]

PART 303-EXEMPTIONS

§ 303.1 Exemptions.

(a) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to:

(1) The slaughtering by any individual of livestock of his own raising, and the preparation by him and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such livestock exclusively for use by him and members of his household and his nonpaying guests and employees;

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 in 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;

(i) The establishment in which the custom operations are conducted is maintained and operated in accordance with the provisions of §§ 308.4 through 308.11, 308.13, 308.14, and 308.3 (except § 308.3(d) (2) and (3), of this subchapter: Provided, That the provisions of said sections relating to inspection or supervision of specified activities or other action by a Program employee shall not apply to the preparation and handling of such exempted products: Provided, further, That the requirement of § 308.4 for separate facilities for men and women workers shall not apply to such establishments when the majority of the workers in the establishment are related by blood or marriage and this arrangement will not conflict with municipal or State requirements, and the requirement of § 308.4 for separation of toilet soil lines from house drainage lines to a point outside the buildings will not apply to such establishments when positive acting backflow devices are installed: And provided, further, That the requirements of § 308.13 for paved driveways, approaches, yards, pens, and alleys shall not apply to such establishments. However, if custom operations are conducted in an official establishment, all of the provisions of Part 308 shall apply to such establishment.

(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 318.11 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 318.11 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 accord

ance 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 308 of this sub1 chapter, except §§ 308.1, 308.2, and 308.15. 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

(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 in any State or organized Territory, for sale in normal retail quantities or service of such articles to consumers at such establishments, if such establishments would be subject to such inspection provisions only because the State or Territory is designated under paragraph 301(c) of the Act.

(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:

(iii) A retail store is any place of business where:

(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

The dollar limitation currently in effect may be obtained by contacting Dr. John Prucha, 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.

(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 (b)(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) A restaurant is any establishment where product is prepared only for sale or service, in meals, or as entrees, directly to individual consumers at such establishment; 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; no sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section and the preparation of product is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section. This definition 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.

(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 cperator 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 period prescribed in § 320.3 of this subchapter. If the operator maintains copies of bills of lading, receiving and shipping invoices, warehouse receipts, or similar documents which give the information required herein, additional records are not required by this subparagraph.

(e) The adulteration and misbranding provisions of the Act and the regulations in this subchapter, other than the requirement of the official inspection legend, apply to articles which are exempted from inspection or not required to be inspected under this section. This includes the requirement that any pork and any product containing pork be prepared only in com

pliance with any applicable requirement for the destruction of trichina as provided in § 318.10 of this subchapter.

(f) The Administrator may extend the requirements of titles I and IV of the Act to any establishment in any State or organized Territory at which products are prepared for distribution solely within such jurisdiction, if he determines in accordance with the provisions of paragraph 301(c)(1) of the Act that it is producing adulterated products which would clearly endanger the public health.

(g) The Administrator in specific cases may modify, by relieving, the inspection and related requirements of the regulations in this subchapter when he determines that application of the modified requirements will be adequate to effectuate the purposes of the Act.

OMB CONTROL No. 0583-0015. (47 FR 746, Jan. 7, 1982)

(34 Stat. 1260, 79 Stat. 903, as amended, 81 Stat. 584, 84 Stat. 91, 438; (21 U.S.C. 71 et seq., 601 et seq., 33 U.S.C. 466-466k; Pub. L. 96-511, 94 Stat. 2812 (44 U.S.C. 3501 et seq.)))

[35 FR 15558, Oct. 3, 1970, as amended at 36 FR 12002, 12004, June 24, 1971; as amended at 38 FR 29214, Oct. 23, 1973; 45 FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 18, 1981; 47 FR 746, Jan. 7, 1982]

PART 304-APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF INSPECTION

Sec.

304.1 Application for inspection. 304.2 Drawings, information to be furnished; grant or refusal of inspection.

§ 304.1 Application for inspection.

(a) Before the inspection is granted, each person conducting operations at an establishment subject to the Act, whether tenant, subsidiary, or landlord, shall make application therefor to the Administrator as provided for in this part.

(b) Every application under this section shall be made on an official form furnished by the Program, available from any Regional Director identified in § 301.2(iii) of this subchapter, and shall be completed to include all infor

mation requested. Trade names of the applicant for labeling purposes, shall be inserted in the appropriate blank in the application. Each applicant for inspection will be held responsible for compliance with the Act and the regulations in this subchapter if inspection is granted. Preparation of product and other operations at the establishment for which inspection is granted may be conducted only by the applicant named in the application.

(c) In cases of change of ownership or location, a new application shall be made.

(34 Stat. 1260, 79 Stat. 903, as amended, 81 Stat. 584, 84 Stat. 91, 438; 21 U.S.C. 71 et seq., 601 et seq., 33 U.S.C. 466-466k) [40 FR 2575, Jan. 14, 1975]

§ 304.2 Drawings, information to be furnished; grant or refusal of inspection. (a) Each applicant for inspection shall submit to the Program:

(1) Two sets of complete drawings containing: the floor plans of the establishment for which inspection is requested, showing the locations of principal pieces of equipment, floor drains, principal drainage lines, handwashing basins, and hose connections for cleanup purposes; a plot plan showing limits of the establishment's premises, locations in outline of buildings on the premises, cardinal points of the compass, and roadways and railways serving the establishment; and a room schedule showing the finish of walls, floors, and ceilings of all rooms in the establishment.

(2) Four sets of specifications, which shall include statements describing the water supply, plumbing, drainage, refrigeration, equipment, lighting, and operations of the establishment related to sanitation and proper performance of inspection. Applicants for inspection may request information from the Administrator concerning the requirements before submitting drawings and other documents required by this paragraph.

(b) Notice in writing shall be given to each applicant granted inspection, specifying the establishment to which the grant applies.

(c) The Administrator is authorized to grant inspection upon his determi