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.

$303.2 Experimentation: Intensity of inspection coverage.

(a) Pursuant to the Processed Products Inspection Improvement Act of 1986, Title IV of the Futures Trading Act of 1986 (Pub. L. 99-641), in establishments preparing products at which inspection under the Act and regulations is required, the frequency with which and the manner in which meat food products made from livestock previously slaughtered in official establishments are examined and inspected by Program employees is to be based on considerations relevant to effective regulation of meat food products and protection of the health and welfare of consumers. In order to test procedures for use in making such determinations and, in particular, for determining whether and, is so, to what extent the intensity of inspection coverage exceeds that which should be considered necessary pursuant to section 6 of the Act, as amended by section 403(a) of the Futures Trading Act of 1986, the Administrator is initiating experimentation of a new system of inspection for reviewing the performance of establishments and for designing the supervision and other conditions and methods of inspection coverage. For the period of such experimentation, the Administrator shall identify establishments for review, and the frequency and the manner of inspection by Program employees shall be determined on the basis of the results of those reviews and be otherwise in accordance with this section.

(b) The determinations referred to in paragraph (a) of this section shall be made by the program and shall reflect evaluations of the performance and the characteristics and such establish

ments.

(1) In assessing the performance of an establishment, the following factors are appropriate for consideration:

(i) The history of compliance with applicable regulatory requirements by the person conducting operations at such establishment or by anyone responsibly connected with the business conducting operations at such establishment, as "responsibly connected" is defined in section 401(g) of the Act,

(ii) The competence of the person conducting operations at such establishment, as indicated by:

(A) Knowledge of appropriate manufacturing practices and applicable regulatory requirements,

(B) Demonstrated ability to apply such knowlege in a timely and consistent manner, and

(C) Commitment to correcting deficiencies noted by Program employees and otherwise assuring compliance with applicable regulatory requirements, and

(iii) The procedures used in such establishment to control the production process, environment, and resulting product in order to assure and monitor compliance with the requirements of the Act and the rules and regulations promulgated thereunder.

(2) In assessing the characteristics of an establishment, the following factors are appropriate for consideration:

(i) The complexity of the processing operation(s) conducted at such establishment,

(ii) The frequency with which each such operation is conducted at such establishment,

(iii) The volume of product resulting from each such operation at such establishment,

(iv) Whether and to what extent slaughter operations also are conducted at such establishment,

(v) What, if any, food products not regulated under this Act or the Poultry Products Inspection Act also are prepared at such establishment, and

(vi) The size of such establishment. (c)(1) For the period of experimentation described in paragraph (a) of this section, the frequency of inspection by Program employees of operations other than slaughter may be reduced in an establishment in which the procedures referred therein are

to

being tested if and only if the evaluation of the performance of such establishment described in paragraph (b)(1) indicates that there are:

in

(i) No instances, documented records compiled no earlier than 10 years before, of substantial and recent noncompliance with applicable regulatory requirements (taking into account both the nature and frequency of any such noncompliance), and

(ii) The competence and control procedures needed to assure and monitor compliance with applicable regulatory requirements.

(2)(i) The frequency of Federal inspection and other conditions and methods of inspection coverage in any establishment in which the frequency of Federal inspection is reduced shall be based on:

(A) The evaluation of the characteristics of such establishment described in paragraph (b)(2) of this section,1

(B) The significance of potential public health consequences of noncompliance, and

(C) The availability of Program employees.

(ii) To the extent that such frequency of inspection or other conditions and methods of inspection coverage are identified as conflicting with provisions of the regulations in this subchapter, the Administrator will waive such provisions for the period of experimentation, in accordance with §303.1(g) of this subchapter.

[52 FR 10032, Mar. 30, 1987 and 52 FR 48091, Dec. 18, 1987]

PART 304-APPLICATION FOR INSPECTION; GRANT OF INSPECTION

Sec.

304.1 Application for inspection. 304.2 Information to be furnished; grant or refusal of inspection.

1 These evaluations will be based upon guidelines developed by FSIS and the complexity categorization in FSIS Directive 1030.2 (Documentation of Processing and Combination Assignments, 4/22/85). The guidelines and Directive will be available for public inspection and copying in the Policy Office, Room 3168, South Agriculture Building, 14th Street and Independence Avenue, SW., Washington, DC.

304.3 Conditions for receiving inspection. AUTHORITY: 21 U.S.C. 601-695; 7 CFR 2.18.

2.53.

§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(kkk) of this subchapter, and shall be completed to include all information 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.

[40 FR 2575, Jan. 14, 1975, as amended at 53 FR 49848, Dec. 12, 1988]

§304.2 Information to be furnished; grant or refusal of inspection.

(a) FSIS shall give notice in writing to each applicant granted inspection and shall specify in the notice the establishment, including the limits of the establishment's premises, to which the grant pertains.

(b) The Administrator is authorized to grant inspection upon his determination that the applicant and the establishment are eligible therefor and to refuse to grant inspection at any establishment if he determines that it does not meet the requirements of this part or the regulations in parts 305, 307, and part 416, §§ 416.1 through 416.6 of this chapter or that the applicant has not received approval of labeling and containers to be used at the establishment as required by the regulations in parts 316 and 317 of this subchapter. Any application for inspection may be

refused in accordance with the rules of practice in part 500 of this chapter.

(c)(1) Any applicant for inspection at an establishment where the operations thereof may result in any discharge into the navigable waters in the United States is required by subsection 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), to provide the Administrator with a certification as prescribed in said subsection that there is reasonable assurance that such activity will be conducted in a manner which will not violate the applicable water quality standards. No grant of inspection can be issued after April 3, 1970 (the date of enactment of the Water Quality Improvement Act), unless such certification has been obtained, or is waived because of failure or refusal of the State, interstate agency or the Secretary of the Interior to act on a request for certification within a reasonable period (which shall not exceed 1 year after receipt of such request).

(2) However, certification is not initially required in connection with an application for inspection granted after April 3, 1970, for facilities existing or under construction on April 3, 1970, although certification for such facilities is required to be obtained within the 3year period immediately following April 3, 1970. Failure to obtain such certification and meet the other requirements of subsection 21(b) prior to April 3, 1973, will result in the termination of inspection at such facilities on that date.

Further, any application for inspection pending on April 3, 1970, and granted within 1 year thereafter shall not require certification for 1 year following the grant of inspection but such grant of inspection shall terminate at the end of 1 year after its issuance unless prior thereto such certification has been obtained and the other requirements of subsection 21(b) are met.

[35 FR 15558, Oct. 3, 1970, as amended at 41 FR 4889, Feb. 3, 1976; 44 FR 68813, Nov. 30, 1979; 62 FR 45024, Aug. 25, 1997; 64 FR 56415, Oct. 20, 1999; 64 FR 66545, Nov. 29, 1999; 65 FR 2284, Jan. 14, 2000]

EFFECTIVE DATE NOTES: 1. At 64 FR 56415, Oct. 20, 1999, §304.2(b) was amended by removing the phrase "308" in the first sentence, and adding the phrase "Part 416,

(a) Before being granted Federal inspection, an establishment shall have developed written sanitation Standard Operating Procedures, as required by part 416 of this chapter.

(b) Before being granted Federal inspection, an establishment shall have conducted a hazard analysis and developed and validated a HACCP plan, as required by §§ 417.2 and 417.4 of this chapter. A conditional grant of inspection shall be issued for a period not to exceed 90 days, during which period the establishment must validate its HACCP plan.

(c) Before producing new product for distribution in commerce, an establishment shall have conducted a hazard analysis and developed a HACCP plan applicable to that product in accordance with § 417.2 of this chapter. During a period not to exceed 90 days after the date the new product is produced for distribution in commerce, the establishment shall validate its HACCP

plan, in accordance with §417.4 of this chapter.

[61 FR 38864, July 25, 1996]

PART 305-OFFICIAL NUMBERS; INAUGURATION OF INSPECTION; WITHDRAWAL OF INSPECTION; REPORTS OF VIOLATION

Sec.

305.1 Official numbers; subsidiaries and ten

ants.

305.2 Separation of official establishments. 305.3 Sanitation and adequate facilities.

305.4 Inauguration of inspection.

305.5 Withdrawal of inspection; statement of policy.

305.6 Reports of violations.

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

2.55.

SOURCE: 35 FR 15559, Oct. 3, 1970, unless otherwise noted.

§305.1 Official numbers; subsidiaries and tenants.

(a) An official number shall be assigned to each establishment granted inspection. Such number shall be used to identify all inspected and passed products prepared in the establishment. More than one number shall not be assigned to an establishment.

(b) Two or more official establishments under the same ownership or control may be granted the same official number, provided a serial letter is added in each case to identify each establishment and the products thereof.

(c) When inspection has been granted to any applicant at an establishment, it shall not be granted to any other person at the same establishment. However, persons operating as separate entities in the same building or structure may operate separate establishments therein only under their own grant of inspection. All such persons operating separate establishments in the same building or structure shall be responsible for compliance with the Act and regulations in their own establishments, which shall include common areas, e.g., hallways, stairways, and elevators.

[35 FR 15559, Oct. 3, 1970, as amended at 40 FR 2576, Jan. 14, 1975]

§305.2 Separation of official establishments.

(a) Each official establishment shall be separate and distinct from any unofficial establishment except a poultry products processing establishment operated under Federal inspection under the Poultry Products Inspection Act or under State inspection.

(b) The slaughter or other preparation of products of horses, mules, or other equines required to be conducted under inspection pursuant to the regulations in this subchapter shall be done in establishments separate from any establishment in which cattle, sheep. swine, or goats are slaughtered or their products are prepared.

(c) Inspection shall not be inaugurated in any building, any part of which is used as living quarters, unless the part for which inspection is requested is separated from such quarters by floors, walls, and ceilings of solid concrete, brick, wood, or similar material, and the floors, walls, and ceilings are without openings that directly or indirectly communicate with any part of the building used as living quarters.

§305.3 Sanitation and adequate facilities.

Inspection shall not be inaugurated if an establishment is not in a sanitary condition nor unless the establishment agrees to maintain a sanitary condition and provides adequate facilities for conducting such inspection.

§305.4 Inauguration of inspection.

When inspection is granted, the circuit supervisor shall, at or prior to the inauguration of inspection, inform the operator of the establishment of the requirements of the regulations in this subchapter. If the establishment, at the time inspection is inaugurated. contains any product which has not theretofore been inspected, passed, and marked in compliance with the regulations in this subchapter, the identity of the same shall be maintained, and it shall not be distributed in commerce, or otherwise subject to the requirements of such regulations, or dealt with as inspected and passed under the regulations. The establishment shall

adopt and enforce all necessary measures and shall comply with all such directions as the circuit supervisor may prescribe, for carrying out the purposes of this section.

$305.5 Withdrawal of inspection; statement of policy.

(a) The Administrator is authorized to withdraw inspection from an official establishment where the sanitary conditions are such that its products are rendered adulterated, or for failure of the operator to destroy condemned products as required by the Act and the regulations in this subchapter. Inspection may be withdrawn in accordance with section 401 of the Act and the applicable rules of practice.

(b) The assignment of inspectors may be temporarily suspended, in whole or in part, by the Administrator to the extent it is determined necessary to avoid impairment of the effective conduct of the program when the operator of any official establishment or any subsidiary therein, or any officer, employee, or agent of any such operator or any subsidiary therein, acting within the scope of his office, employment, or agency, threatens to forcibly assault or forcibly assaults, intimidates, or interferes with any program employee in or on account of the performance of his official duties under the act, unless promptly upon the incident being brought by an authorized supervisor of the program employee to the attention of the operator of the establishment the operator (1) satisfactorily justifies the incident, (2) takes effective steps to prevent a recurrence, or (3) provides acceptable assurance that there will not be any recurrences. Such suspension shall remain in effect until one of such actions is taken by the operator: Provided, That upon request of the operator he shall be afforded an opportunity for an expedited hearing to show cause why the suspension should be terminated.

(c) Inspection service may be temporarily suspended, in whole or in part, at an official establishment, by the Administrator, to the extent that it is determined necessary to prevent in-humane slaughtering or handling in connection with slaughter of livestock as defined in §301.2(kk) (9 CFR 301.2(kk)).

The Administrator shall notify the operator of an establishment orally or in writing, as promptly as circumstances permit, of such suspension and the reasons therefor. Such suspension shall remain in effect until the operator of the establishment takes effective steps to prevent a recurrence, or provides other satisfactory assurances that there will not be any recurrences. Upon request, the operator shall be afforded an opportunity for a hearing to show cause why the suspension should be terminated. [38 FR 9794, Apr. 20, 1973, as amended at 44 FR 68813, Nov. 30, 1979; 53 FR 49848, Dec. 12, 1988]

EFFECTIVE DATE NOTE: At 64 FR 66545, Nov. 29, 1999, §305.5 was removed, effective Jan. 25, 2000.

$305.6 Reports of violations.

Program employees shall report, in a manner prescribed by the Administrator, all violations of the Act or regulations in this subchapter of which they have information.

PART 306-ASSIGNMENT AND AUTHORITIES OF PROGRAM EMPLOYEES

Sec.

306.1 Designation of circuit supervisor and assistants.

306.2 Program employees to have access to establishments.

306.3 Badge as identification of inspectors. 306.4 Assignment of Program employees

where members of family employed; soliciting employment; procuring product from official establishments.

306.5 Appeals.

AUTHORITY: 21 U.S.C. 601-695; 7 CFR 2.18,

2.53.

SOURCE: 35 FR 15559, Oct. 3, 1970, unless otherwise noted.

§306.1 Designation of circuit supervisor and assistants.

The Administrator shall designate a circuit supervisor of the inspection in each circuit, and assign to said inspector such assistants as may be necessary.

$306.2 Program employees to have access to establishments.

For the purpose of any examination or inspection necessary to prevent the