carry out his responsibilities under the Act.

(3) The approval of the partial quality control program under the NELS Inspection System or the NTI System may be terminated at any time by the owner or operator of the official establishment upon written notice to the Administrator. Establishments which operated under the NELS Inspection System will be provided inspection under either Traditional Inspection or Streamlined Inspection System, as appropriate. Establishments which operated under the NTI System will be provided inspection under the Traditional Inspection procedure.

(4) The approval of the partial quality control programs under the NELS Inspection System or the NTI System will terminate upon receipt by the establishment of written notice from the Administrator (or his designee). Such notice will specify the deficiency and will be issued:

(i) If unwholesome or otherwise adulterated poultry products are found by the Administrator to have been prepared for or distributed in commerce by the subject establishment, or

(ii) If the establishment fails to comply with the partial quality control program to which it has agreed.

(5) The establishment owner or operator receiving notice that approval has terminated may respond to the notice, in writing, to the Administrator within 30 days or receipt of such notice. In those instances where there are issues of fact, 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.

(6) If approval of the partial quality control program under the NELS Inspection System or the NTI System has been terminated in accordance with the provisions of this section, an application and request for approval of the same or modified quality control program will not be evaluated by the Administrator for at least 2 months from the termination date. In order for the Department to provide the Federal inspection required under the Act, an establishment whose partial quality

and parts: separation of poultry suspected of containing biological residues.

(a) At the time of any inspection under this subpart each carcass, or any part thereof, which is found to be adulterated shall be condemned, except that any such articles which may be made not adulterated by reprocessing, need not be so condemned if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated.

(b) When a lot of poultry suspected of containing biological residues is inspected in an official establishment, all carcasses and any parts of carcasses in such lot which are condemned shall be kept separate from all other condemned carcasses or parts.

[37 FR 9706, May 16, 1972, as amended at 48 FR 22899, May 23, 1983; 48 FR 23807, May 27, 1983]

§381.80 General; biological residues.

(a) The carcasses or parts of carcasses of all poultry inspected at an official establishment and found at the time of post mortem inspection, or at any subsequent inspection, to be affected with any of the diseases or conditions named in other sections in this subpart, shall be disposed of in accordance with the section pertaining to the disease or condition. Owing to the fact that it is impracticable to formulate rules for each specific disease or conditions and to designate at just what stage a disease process results in an adulterated article, the decision as to the disposal of all carcasses, organs or other parts not specifically covered by the regulations, or by instructions of the Administrator issued pursuant thereto, shall be left to the inspector in charge, and if the inspector in charge is in doubt concerning the disposition to be made, specimens from such carcasses shall be forwarded to the Inspection Service laboratory for diagnosis.

(b) All carcasses, organs, or other parts of carcasses of poultry shall be condemned if it is determined on the basis of a sound statistical sample that they are adulterated because of the presence of any biological residues.

§381.84 Airsacculitis.

Carcasses of poultry with evidence of extensive involvement of the air sacs with airsacculitis or those showing airsacculitis along with systemic changes shall be condemned. Less affected carcasses may be passed for food after complete removal and condemnation of all affected tissues including the exudate.

[40 FR 14297, Mar. 31, 1975]

§381.85 Special diseases.

Carcasses of poultry showing evidence of any disease which is characterized by the presence, in the meat or other edible parts of the carcass, or organisms or toxins dangerous to the consumer, shall be condemned.

§381.86 Inflammatory processes.

Any organ or other part of a carcass which is affected by an inflammatory process shall be condemned and, if there is evidence of general systemic disturbance, the whole carcass shall be condemned.

§381.87 Tumors.

Any organ or other part of a carcass which is affected by a tumor shall be condemned and when there is evidence of metastasis or that the general condition of the bird has been affected by the size, position, or nature of the tumor, the whole carcass shall be condemned.

§381.88 Parasites.

Organs or other parts of carcasses which are found to be infested with parasites, or which show lesions of such infestation shall be condemned and, if the whole carcass is affected, the whole carcass shall be condemned.

§381.89 Bruises.

Any part of a carcass which is badly bruised shall be condemned and, if the whole carcass is affected as a result of the bruise, the whole carcass shall be condemned. Parts of a carcass which show only slight reddening from a bruise may be passed for food.

§381.90 Cadavers.

Carcasses of poultry showing evidence of having died from causes other than slaughter shall be condemned.

§381.91 Contamination.

(a) Carcasses of poultry contaminated by volatile oils, paints, poisons, gases, scald vat water in the air sac system, or other substances which render the carcasses adulterated shall be condemned. Any organ or other part of a carcass which has been accidentally multilated in the course of processing shall be condemned, and if the whole carcass is affected, the whole carcass shall be condemned.

(b)(1) Any carcass of poultry accidentally contaminated during slaughter with digestive tract contents shall not be condemned if promptly reprocessed under the supervision of an inspector and thereafter found not to be adulterated. Contaminated surfaces that are cut shall be removed only by trimming. Contaminated inner surfaces that are not cut may be cleaned by trimming alone, or at an approved reprocessing station away from the main processing line, by any method that will remove the contamination, such as vacuuming, washing, and trimming, singly or in combination. All visible specks of contamination must be removed, and if the inner surfaces are reprocessed other than soley by trimming, all surfaces of the carcass shall be treated with chlorinated water containing 20 ppm available chlorine.

(2) An area will be designated as an approved reprocessing station only if the Administrator determines that reprocessing operations can be conducted in that area in accordance with all of the requirements of this part, and that the reprocessing methods to be utilized are capable of removing all visible specks of contamination on the inner surface of a carcass. Requests for such approval shall be submitted to the inspector in charge and shall describe the proposed area, proposed methods of reprocessing, and proposed equipment to be utilized. Whenever the Administrator finds that reprocessing operations cannot be conducted in such area in accordance with all of the requirements of this part or that the reprocessing methods utilized are not ca

pable of removing all visible specks of contamination on the inner surface of a carcass, he may withdraw approval of such area, effective upon oral or written notification, whichever is earlier. to the operator of the establishment. In the event of oral notification, a written confirmation thereof shall be given to the operator as promptly as circumstances permit. The notification shall specify the reasons for such withdrawal and shall afford the operator of the establishment an opportunity to present his views. In any instance where there is a conflict as to the facts, a hearing shall be held to resolve such conflict.

[37 FR 9706, May 16, 1972, as amended at 43 FR 12847, Mar. 28, 1978]

§381.92 Overscald.

Carcasses of poultry which have been overscalded, resulting in a cooked appearance of the flesh, shall be condemned.

§381.93 Decomposition.

Carcasses of poultry deleteriously affected by post mortem changes shall be disposed of as follows:

(a) Carcasses which have reached a state of putrefaction or stinking fermentation shall be condemned.

(b) Any part of a carcass which is green struck shall be condemned and, if the carcass is so extensively affected that removal of affected parts is impracticable, the whole carcass shall be condemned.

(c) Carcasses affected by types of post mortem change which are superficial in nature may be passed for human food after removal and condemnation of the affected parts.

8381.94 Contamination with Microorganisms; process control verification criteria and testing; pathogen reduction standards. (a) Criteria for verifying process control; E. coli testing.

(1) Each official establishment that slaughters poultry shall test for Escherichia coli Biotype I (E. coli). Establishments that slaughter more than one type of poultry and/or poultry and livestock, shall test the type of poultry or livestock slaughtered in the greatest number. The establishment shall:

(i) Collect samples in accordance with the sampling techniques, methodology, and frequency requirements in paragraph (a)(2) of this section;

(ii) Obtain analytic results in accordance with paragraph (a)(3) of this section; and

(iii) Maintain records of such analytic results in accordance with paragraph (a)(4) of this section.

(2) Sampling requirements.

(i) Written procedures. Each establishment shall prepare written specimen collection procedures which shall identify employees designated to collect samples, and shall address location(s) of sampling, how sampling randomness is achieved, and handling of the sample to ensure sample integrity. The written procedure shall be made available to FSIS upon request.

(ii) Sample collection. A whole bird must be taken from the end of the chilling process. If this is impracticable, the whole bird can be taken from the end of the slaughter line. Samples must be collected by rinsing the whole carcass in an amount of buffer appropriate for that type of bird. Samples from turkeys also may be collected by sponging the carcass on the back and thigh.1

(iii) Sampling frequency. Slaughter establishments, except very low volume establishments as defined in paragraph (a)(2)(v) of this section, must take samples at a frequency proportional to the establishment's volume of production at the following rates:

(A) Chickens: 1 sample per 22,000 carcasses, but a minimum of one sample during each week of operation.

(B) Turkeys, Ducks, Geese, and Guineas: 1 sample per 3,000 carcasses, but a minimum of one sample during each week of operation.

(iv) Sampling frequency alternatives. An establishment operating under a validated HACCP plan in accordance with §417.2(b) of this chapter may substitute an alternative frequency for the

1A copy of FSIS's "Guidelines for Escherichia coil Testing for Process Control Verification in Poultry Slaughter Establishments," and "FSIS Turkey Microbiological Procedures for Sponge Sample Collection and Methods of Analysis" are available for inspection in the FSIS Docket Room.

frequency of sampling required under paragraph (a)(2)(iii) of this section if,

(A) The alternative is an integral part of the establishment's verification procedures for its HACCP plan and,

(B) FSIS does not determine, and notify the establishment in writing, that the alternative frequency is inadequate to verify the effectiveness of the establishment's processing controls.

(v) Sampling in very low volume establishments.

(A) Very low volume establishments annually slaughter no more than 440,000 chickens or 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas or a combination of all types of poultry not exceeding 60,000 turkeys and 440,000 birds total. Very low volume establishments that slaughter turkeys, ducks, geese, or guineas in the largest number must collect at least one sample during each week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until June 1 of the following year or until 13 samples have been collected, whichever comes first. Very low volume establishments slaughtering chickens in the largest number shall collect one sample per week, starting the first full week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until one series of 13 tests meets the criteria set forth in paragraph (a)(5)(i) of this section.

(B) Upon the establishment's meeting the requirements of paragraph (a)(2)(v)(A) of this section, weekly sampling and testing is optional, unless changes are made in establishment facilities, equipment, personnel or procedures that may affect the adequacy of existing process control measures, as determined by the establishment or by FSIS. FSIS determinations changes have been made requiring resumption of weekly testing shall be provided to the establishment in writing.

that

(3) Analysis of samples. Laboratories may use any quantitative method for analysis of E. coli that is approved as an AOAC Official Method of the AOAC