[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2007]

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

[CITE: 9CFR381.3]



[Page 432-433]

 

                  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) [Reserved]

    (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



[[Page 433]]



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 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; 69 

FR 255, Jan. 5, 2004]