[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 9CFR303.2]



[Page 97-98]

 

                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS

 

     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 

                               AGRICULTURE

 

PART 303_EXEMPTIONS--Table of Contents

 

Sec. 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 establishments.

    (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 knowledge 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 to therein are



[[Page 98]]



being tested if and only if the evaluation of the performance of such 

establishment described in paragraph (b)(1) indicates that there are:

    (i) No instances, documented in 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\

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    \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.

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    (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 Sec. 303.1(g) of this subchapter.



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