[Code of Federal Regulations]
[Title 9, Volume 2, Parts 200 to end]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.4]

[Page 231-234]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
 
                           Subpart A--General
 
Sec. 318.4  Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.

    (a) All processes used in curing, pickling, rendering, canning, or 
otherwise

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preparing any product in official establishments shall be supervised by 
Program employees unless such preparation is conducted as a custom 
operation exempted from inspection under Sec. 303.1(a)(2) of this 
subchapter in any official establishment or consists of operations that 
are exempted from inspection under Sec. 303.1(d) of this subchapter and 
are conducted in a retail store in an establishment subject to 
inspection only because the State or Territory in which the 
establishment is located is designated under paragraph 301(c) of the 
Act. No fixtures or appliances, such as tables, trucks, trays, tanks, 
vats, machines, implements, cans, or containers of any kind, shall be 
used unless they are of such materials and construction as will not 
contaminate or otherwise adulterate the product and are clean and 
sanitary. All steps in the preparation of edible products shall be 
conducted carefully and with strict cleanliness in rooms or compartments 
separate from those used for inedible products.
    (b) It shall be the responsibility of the operator of every official 
establishment to comply with the Act and the regulations in this 
subchapter. In order to carry out this responsibility effectively, the 
operator of the establishment shall institute appropriate measures to 
assure the maintenance of the establishment and the preparation, 
marking, labeling, packaging and other handling of its products strictly 
in accordance with the sanitary and other requirements of this 
subchapter. The effectiveness of such measures will be subject to review 
by the Department.
    (c) Applying for Total Plant Quality Control. Any owner or operator 
of an official establishment preparing meat food product who has a total 
plant quality control system or plan for controlling such product, after 
ante-mortem and post-mortem inspection, through all stages of 
preparation, may request the Administrator to evaluate it to determine 
whether or not that system is adequate to result in product being in 
compliance with the requirements of the Act and therefore qualify as a 
U.S. Department of Agriculture (USDA) Total Plant Quality Control 
Establishment. Such a request shall, as a minimum, include:
    (1) A letter to the Administrator from the establishment owner of 
operator stating the company's basis and purpose for seeking an approved 
quality control system and willingness to adhere to the requirements of 
the system as approved by the Department; that all the establishment's 
data, analyses, and information generated by its quality control system 
will be maintained to enable the Department to monitor compliance and 
available to Department personnel; that plant quality control personnel 
will have authority to halt production or shipping of product in cases 
where the submitted quality control system requires it; and that the 
owner or operator (or his/her designee) will be available for 
consultation at any time Department personnel consider it necessary.
    (2) In the case of an establishment having one or more full-time 
persons whose primary duties are related to the quality control system, 
an organizational chart showing that such people ultimately report to an 
establishment official whose quality control responsibilities are 
independent of or not predominantly production responsibilities. In the 
case of an establishment which does not have full-time quality control 
personnel, information indicating the nature of the duties and 
responsibilities of the person who will be responsible for the quality 
control system.
    (3) A list identifying those parts and sections of the Federal meat 
inspection regulations which are applicable to the operations of the 
establishment applying for approval of a quality control system. This 
list shall also identify which part of the quality control system will 
serve to maintain compliance with the applicable regulations.
    (4) Detailed information concerning the manner in which the system 
will function. Such information should include, but not necessarily be 
limited to, questions of raw material control, the critical check or 
control points, the nature and frequency of tests to be made, the nature 
of charts and other records that will be used, the length of time such 
charts and records will be maintained in the custody of the official 
establishment, the nature of deficiencies the quality control system is

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designed to identify and control, the parameters or limits which will be 
used, and the points at which corrective action will occur and the 
nature of such corrective action--ranging from least to most severe: 
Provided, That, subsequent to approval of the total plant quality 
control system by the Administrator, the official establishment may 
produce a new product for test marketing provided labeling for the 
product has been approved by the Administrator, the inspector in charge 
has determined that the procedures for preparing the product will assure 
that all Federal requirements are met, and the production for test 
marketing does not exceed 6 months. Such new product shall not be 
produced at that establishment after the 6-month period unless approval 
of the quality control system for that product has been received from 
the Administrator.
    (d) [Reserved]
    (e) Evaluation and Approval of Total Plant Quality Control. (1) The 
Administrator shall evaluate the material presented in accordance with 
the provisions of paragraph (c) of this section. If it is determined by 
the Administrator, on the basis of the evaluation, that the total 
quality control system will result in finished products controlled in 
this manner being in full compliance with the requirements of the Act 
and regulations thereunder, the total quality control system will be 
approved and plans will be made for implementation under departmental 
supervision.
    (2) In any situation where the system is found by the Administrator 
to be unacceptable, formal notification shall be given to the applicant 
of the basis for the denial. The applicant will be afforded an 
opportunity to modify the system in accordance with the notification. 
The applicant shall also be afforded an opportunity to submit a written 
statement in response to this notification of denial and a right to 
request a hearing with respect to the merits or validity of the denial. 
If the applicant requests a hearing and the Administrator, after review 
of the answer, determines the initial determination to be correct, he 
shall file with the Hearing Clerk of the Department the notification, 
answer and the request for hearing, which shall constitute the complaint 
and answer in the proceeding, which shall thereafter be conducted in 
accordance with Rules of Practice which shall be adopted for this 
proceeding.
    (3) The establishment owner or operator shall be responsible for the 
effective operation of the approved total plant quality control system 
to assure compliance with the requirements of the Act and regulations 
thereunder. The Secretary shall continue to provide the Federal 
inspection necessary to carry out his responsibilities under the Act.
    (f) Labeling Logo. Owners and operators of official establishments 
having a total plant quality control system approved under the 
provisions of paragraph (c) of this section, may only use, as a part of 
any labeling, the following logo. Any labeling bearing the logo and any 
wording of explanation with respect to this logo shall be approved as 
required by parts 316 and 317 of this subchapter.
[GRAPHIC] [TIFF OMITTED] TC11SE91.015

    (g) Termination of Total Plant Quality Control. (1) The approval of 
a total plant quality control system may be terminated at any time by 
the owner or operator of the official establishment upon written notice 
to the Administrator.
    (2) The approval of a total plant quality control system may be 
terminated upon the establishment's receipt of a written notice from the 
Administrator under the following conditions:

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    (i) If adulterated or misbranded meat food product is found by the 
Administrator to have been prepared for or distributed in commerce by 
the subject establishment. In such case, opportunity will be provided to 
the establishment owner or operator to present views to the 
Administrator within 30 days of the date of terminating the approval. In 
those instances where there is conflict of facts, a hearing, under 
applicable Rules of Practice, will be provided to the establishment 
owner or operator to resolve the conflict. The Administrator's 
termination of approval shall remain in effect pending the final 
determination of the proceeding.
    (ii) If the establishment fails to comply with the quality control 
system or program to which it has agreed after being notified by letter 
from the Administrator or his designee. Prior to such termination, 
opportunity will be provided to the establishment owner or operator to 
present views to the Administrator within 30 days of the date of the 
letter. In those instances where there is a conflict of facts, a 
hearing, under applicable Rules of Practice, will be provided to the 
establishment owner or operator to resolve the conflict. The 
Administrator's termination of quality control approval shall remain in 
effect pending the final determination of the proceeding.
    (3) If approval of the total establishment quality control system 
has been terminated in accordance with the provisions of this section, 
an application and request for approval of the same or a modified total 
establishment quality control system will not be evaluated by the 
Administrator for at least 6 months from the termination date.
    (h)(1) Operating Schedule Under Total Plant Quality Control. An 
official establishment with an approved total plant quality control 
system may request approval for an operating schedule of up to 12 
consecutive hours per shift. Permission will be granted provided that:
    (i) The official establishment has satisfactorily operated under a 
total plant quality control system for at least 1 year.
    (ii) All products prepared and packaged, or processed after the end 
of 8 hours of inspection shall only be a continuation of the processing 
monitored by the inspector and being conducted during the last hour of 
inspection.
    (iii) All immediate containers of products prepared and packaged 
shall bear code marks that are unique to any period of production beyond 
the 8 hours of inspection. The form of such code marks will remain 
constant from day to day, and a facsimile of the code marks and their 
meaning shall be provided to the inspector.
    (2) Application. Applications shall be submitted to the Regional 
Director and shall specify how the conditions in Sec. 318.4(h)(1) have 
been or will be met.
    (3) Monitoring by Inspectors. In order to verify that an 
establishment is preparing and shipping product in accordance with the 
approved total plant quality control system and the Act and regulations 
after the 8 hours of inspection, the official establishment may be 
provided overtime inspection services at the discretion of the circuit 
supervisor and charged for such services.

(Reporting requirements were approved by the Office of Management and 
Budget under control number 0583-0015)

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45 
FR 54322, Aug. 15, 1980; 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug. 
25, 1997; 62 FR 54759, Oct. 22, 1997; 65 FR 34389, May 30, 2000]