[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR303.2]

[Page 90-92]
 
                  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

[[Page 91]]

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 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 to therein are 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

[[Page 92]]

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]