[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: 9CFR381.3]

[Page 423-424]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
 
     Subpart B--Administration; Application of Inspection and Other 
                              Requirements
 
Sec. 381.3  Administration.


    (a) General authority to administer the Act has been delegated to 
the Administrator (29 FR 16210, as amended; 37 FR 6327, 6505).
    (b) The Administrator may in specific classes of cases waive for 
limited periods any provisions of the regulations in order to permit 
appropriate and necessary action in the event of a public health 
emergency or to permit experimentation so that new procedures, 
equipment, and processing techniques may be tested to facilitate 
definite improvements: Provided, That such waivers of the provisions of 
the regulations are not in conflict with the purposes or provisions of 
the Act.
    (c) Pursuant to section 6 of the Act, the Administrator believes 
that, in establishments processing poultry products at which inspection 
under the Act and regulations is required, the frequency with which and 
the manner in which poultry products made from poultry previously 
slaughtered and eviscerated in official establishments are reinspected 
by Inspection Service employees should be based on considerations 
relevant to effective regulation of poultry 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, if so, to what extent the intensity of inspection coverage 
exceeds that which should be deemed necessary pursuant to section 6 of 
the Act, 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 Inspection Service employees shall be determined 
on the basis of the results of those reviews and be otherwise in 
accordance with this section.
    (d) The determinations referred to in paragraph (c) of this section 
shall be made by the Inspection Service and shall reflect evaluations of 
the performance and the characteristics of 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 operating such establishment or by anyone 
responsibly connected with the business operating such establishment, as 
``responsibly connected'' is defined in section 18(a) of the Act,
    (ii) The competence of the person operating 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 Inspection 
Service 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 and evisceration 
operations also are conducted at such establishment,
    (v) What, if any, food products not regulated under this Act or the 
Federal Meat Inspection Act also are processed at such establishment, 
and
    (vi) The size of such establishment.
    (e)(1) For the period of experimentation described in paragraph (c) 
of

[[Page 424]]

this section, the frequency of inspection by Inspection Service 
employees of operations other than slaughter and evisceration 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 (d)(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 (d)(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 Inspection Service employees.
    (ii) To the extent that frequency of inspection or other conditions 
and methods of inspection coverage are identified as conflicting with 
provisions of the regulations in this part, the Administrator will waive 
such provisions for the period of experimentation, in accordance with 
paragraph (b) of this section.

[37 FR 9706, May 16, 1972, as amended at 52 FR 10033, Mar. 30, 1987]