plan and the program employee shall select the specific plan to be used in accordance with instructions issued by the Administrator.1

(c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing poultry product who has a total plant quality control system or plan for controlling such products, 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 or operator stating the company's basis and purpose for seeking an approved qualarity 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 systems require 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

'Further information concerning sampling plans which have been adopted for specific products may be obtained from the Circuit Supervisor. These sampling plans are developed for individual products by the Washington staff and will be distributed for field use as they are developed. The type of plan applicable depends on factors such as whether the product is in containers, stage of preparation, and procedures followed by the establishment operator. The specific plan applicable depends on the kind of product involved.

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 a small establishment which does not have fulltime quality control personnel, information indicating the nature of the duties and responsibilities of the person who will also be responsible for the quality control system.

(3) A list identifying those Subparts and sections of the poultry products 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 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 of limits which will be used and the points at which corrective action will occur, and the nature of such corrective action-ranging from the 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) Applying for Partial Quality Control. Any owner or operator of an official establishment preparing poultry products who has a quality control program for a product, operation, or a part of an operation, may submit it to the Administrator and request a determination as to whether or not that program is adequate to result in product being in compliance with the requirements of the Act. Such a request shall, as a minimum, include:

(1) A letter from the establishment official responsible for quality control stating the objective of the program, and that all data and information generated by the program will be maintained to enable the Department to monitor compliance and available to Department personnel.

(2) Detailed information concerning raw material control, the critical check or control points, the nature and frequency of tests to be made, the charts and records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the limits which will be used and the points at which corrective action will occur; and the nature of the corrective actionranging from the least to the most

severe.

(e) Evaluation and Approval of Total Plant Quality Control or Partial Quality Control. (1) The Administrator shall evaluate the material presented in accordance with the provisions of paragraph (c) or (d) of this section. If it is determined by the Administrator, on the basis of the evaluation, that the total quality control system or partial quality control program will result in finished products controlled in this manner being in full compliance with the requirements of the Act and regulation thereunder, the total quality control system or partial quality control program will be approved and plans will be made for implementation under departmental supervision.

(2) In any situation where the system or program 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 or program in accordance with this 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 or partial quality control program 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 the responsibilities of 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 Subparts M and N of this part.

(g) Termination of Total Plant Quality Control or Partial Quality Control. (1) The approval of a total plant quality control system or a partial quality or control program may be terminated at any time by the owner or operator of the official establishment upon writthe ten notice to the Administrator.

(2) The approval of a total plant quality control system or partial quality control program may be terminated upon the establishment's receipt of a written notice from the Administrator under the following conditions:

(i) If adulterated or misbranded poultry product is found by the Adminstrator 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 a conflict of facts, a hearing, under applicable Rules of Practice, will be afforded to the establishment owner or operator, if requested, 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, oppor

tunity will be provided to the establishment owner or operator to present views to the Adminstrator 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 afforded to the establishment owner or operator, if requested, 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 plant quality control system or partial quality control program has been terminated in accordance with the provisions of this section, an application and request for approval of the same or a modified total plant quality control system will not be evaluated by the Administrator for at least 6 months from the termination date, or for at least 2 months from the termination date in the case of a partial quality control program.

(h) Containers with substances approved for use in the processing of products in § 381.147(f)(3) of this subchapter which enter any official establishment for use in poultry scald water shall, at all times, while they are in such establishment, bear labels showing the chemical names of the substances in such preparations. In the case of preparations containing substances which may be used under only § 381.147(f)(3) in limited amounts, the container labels shall also show the percentage of each such substance in the preparation and shall provide dilution directions which prescribe the maximum allowable use concentration of the preparation.

(Secs. 7, 11(b), 14, 16 and 22, 71 Stat. 441, as amended, 21 U.S.C. 456, 460(b), 463, 465, and 467d; 42 FR 35625, 35626, and 35631)

[37 FR 9706, May 16, 1972, as amended at 45 FR 54323, Aug. 15, 1980; 46 FR 48904, Oct. 5, 1981]

§ 381.146 Sampling at official establishments.

Inspectors may take, without cost to the Department, such samples as are necessary of any poultry product, or other article for use as an ingredient of any poultry product, at any official

establishment to determine whether it complies with the requirements of the regulations.

§ 381.147 Restrictions on the use of substances in poultry products.

(a) All ingredients and other substances used in the processing or handling of poultry products at official establishments shall be such as will not result in adulteration or misbranding of the poultry products.

(b) Poultry products and poultry broth used in the processing of poultry products shall have been processed in the United States only in an official establishment, or imported from a foreign country listed in § 381.196(b), and inspected and passed, in accordance with the regulations. Detached ova and offal shall not be used in the processing of any poultry products, except that poultry feet may be processed for use as human food when handled in a manner approved by the Administrator in specific cases, and detached ova may be used in the processing of poultry products if the processor demonstrates that such ova comply with the requirements under the Federal Food, Drug, and Cosmetic Act.

(c) Liquid, frozen, and dried egg products used in the processing of any poultry product shall have been prepared under inspection and be so marked in accordance with the Egg Products Inspection Act.

(d) Carcasses, parts thereof, meat and meat food products of cattle, sheep, swine, goats, or equines may be used in the processing of poultry products only if they were prepared in the United States only in an official meat packing establishment, or imported, and were inspected and passed, in accordance with the Federal Meat Inspection Act, and the regulations under such Act (Subchapter A of this chapter) and are so marked. Poultry products containing pork must be treated to destroy possible live trichinae by one of the methods prescribed in § 318.10(c) of the meat inspection regulations (9 CFR 318.10(c)), or in lieu of such treatment the pork ingredient may be so treated.

(e) All isolated soy protein used in poultry products processed in any official establishment shall contain not more and not less than 0.1 percent ti

tanium, incorporated as food grade titanium dioxide, and the presence of such substance must be shown on the label of the container of the isolated soy protein at all times that the article is in the official establishment.

(f)(1) No substance may be used as an ingredient or otherwise in the processing of any raw or cooked poultry product unless its use is approved as shown in Table 1 of paragraph (f)(4) of this section, or elsewhere in this part, or by the Administrator in specific cases.

(2) Approval of new substances or new uses or new levels of use of approved substances may be granted if:

(i) The substance has been previously approved by the Food and Drug Administration (FDA) for use in poultry or poultry products as a food additive, color additive or as a substance generally recognized as safe and is listed in Title 21 of the Code of Federal Regulations, Parts 73, 74, 81, 172, 173, 182, or 184.

(ii) Its use is in compliance with applicable FDA requirements; and

(iii) The Administrator has determined that:

(A) The use of the substance will not render he product in which it is used adulterated or misbranded or otherwise not in compliance with the Act; and

(B) Its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the desired technical effect as determined in specific cases.

(3) Whenever the Administrator determines that approval of a new substance or a new use or new level of use of an approved substance should be granted in accordance with pararaph (f)(1) of this section, the Administrator shall issue a final rule amending Table 1 of paragraph (f)(4) of this section to include the additional substance or new use of the substance, and any technical effect or change in the level of use of the substance.

(4) No poultry product shall bear or contain any substance which would render it adulterated or misbranded, or which is not approved in Part 381 or by the Administrator in specific

cases.