[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: 9CFR318.4]



[Page 240-243]

 

                  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 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



[[Page 241]]



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 

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



[[Page 242]]



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:

    (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



[[Page 243]]



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]