bruises, either the bruised portion shall be removed immediately and disposed of in accordance with part 314 of this subchapter, or the carcass shall be promptly placed in a retaining room and kept until chilled and the bruised portion shall then be removed and disposed of as provided in part 314 of this subchapter.

$310.15 Disposition of thyroid glands and laryngeal muscle tissue.

(a) Livestock thyroid glands and laryngeal muscle tissue shall not be used for human food.

(b) Livestock thyroid glands and laryngeal muscle tissue may be distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with §314.9 or §325.19(c) of this subchapter, if they are labeled in accordance with §316.13(f) of this subchapter. Otherwise, they shall be disposed of at the official establishment in accordance with §314.1 or §314.3 of this subchapter.

[53 FR 45890, Nov. 15, 1988]

$310.16 Disposition of lungs.

(a) Livestock lungs shall not be saved for use as human food.

(b) Lungs found to be affected with disease or pathology and lungs found to be adulterated with chemical or biological residue shall be condemned and identified as "U.S. Inspected and Condemned." Condemned lungs may not be saved for pet food or other nonhuman food purposes. They shall be maintained under inspectional control and disposed of in accordance with §§314.1 and 314.3 of this subchapter.

(c) Lungs not condemned under paragraph (b) of this section may be used in the preparation of pet food or for other nonhuman food purposes at the official establishment, provided they are handled in the manner prescribed in §318.12 of this subchapter, or they may be distributed from the establishment in commerce, or otherwise, in accordance with the conditions prescribed in § 325.8 of this subchapter for nonhuman food purposes or they may be so distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with §§ 314.9 and 325.19(b) of this subchapter, if they are labeled as "Inedible [SPECIES] Lungs-for Pharmaceutical Use

(a) Lactating mammary glands and diseased mammary glands of cattle, sheep, swine, and goats shall be removed without opening the milk ducts or sinuses. If pus or other objectionable material is permitted to come in contact with the carcass, the parts of the carcass thus contaminated shall be removed and condemned.

(b) Nonlactating cow udders may be saved for food purposes provided suitable facilities for handling and inspecting them are provided. Examination of udders by palpation shall be done by a Program employee. When necessary, in the judgment of the Program employee for adequate inspection, the official establishment employees shall incise udders in sections no greater than 2 inches in thickness. All udders showing disease lesions shall be condemned by a Program employee. Each udder shall be properly identified with its respective carcass and kept separate and apart from other udders until its disposal has been accomplished in accordance with the provisions of part 311 of this subchapter.

(c) Lactating mammary glands of cattle, sheep, swine, and goats shall not be saved for edible purposes.

(d) The udders from cows officially designated as "Brucellosis reactors" or as "Mastitis elimination cows" shall be condemned.

$310.18 Contamination of carcasses, organs, or other parts.

(a) Carcasses, organs, and other parts shall be handled in a sanitary manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter; however, if contamination occurs, it shall be promptly removed in a manner satisfactory to the inspector.

(b) Brains, cheek meat, and head trimmings from animals stunned by lead, sponge iron, or frangible bullets shall not be saved for use as human food but shall be handled as described in §314.1 or § 314.3 of this subchapter.

$310.19 Inspection of kidneys.

An employee of the establishment shall open the kidney capsule and expose the kidneys of all livestock at the time of slaughter for the purpose of examination by a Program employee.

$310.20 Saving of blood from livestock

as an edible product.

Blood may be saved for edible purposes at official establishments provided it is derived from livestock, the carcasses of which are inspected and passed, and the blood is collected, defibrinated, and handled in a manner so as not to render it adulterated under the Federal Meat Inspection Act and regulations issued pursuant thereto. The defibrination of blood intended for human food purposes shall not be done with the hands. Anticoagulants may be used in accordance with 21 CFR Chapter I, Subchapter A and Subchapter B, or by regulation in 9 CFR Chapter III, Subchapter A or Subchapter E.

[64 FR 72174, Dec. 23, 1999]

EFFECTIVE DATE NOTE: At 64 FR 72174, Dec. 23, 1999, §310.20 was revised, effective Jan. 24, 2000. For the convenience of the user, the superseded text is set forth as follows:

$310.20 Saving of blood from livestock as an edible product.

Blood may be saved for edible purposes at official establishments provided it is derived from livestock, the carcasses of which are inspected and passed, and the blood is collected, defibrinated, and handled in a manner so as not to render it adulterated under the Federal Meat Inspection Act and regulations issued pursuant thereto. The defibrination of blood intended for human food purposes shall not be done with the hands. Anticoagulants specified in §318.7(c)(4) of this subchapter may be used in lieu of defibrination.

$310.21 Carcasses suspected of containing sulfa and antibiotic residues; sampling frequency; disposition of affected carcasses and parts. (a) Calf carcasses from animals suspected of containing biological residues under $309.16(d) of this subchapter shall, on post-mortem inspection, be handled in accordance with the provisions of this section.

(b) For purposes of this section, the following definitions shall apply:

(1) Calf. A calf up to 3 weeks of age or up to 150 pounds.

(2) Certified calf. A calf that the producer and all other subsequent custodians of the calf certify in writing has not been treated with any animal drug while in his or her custody or has been treated with one or more drugs in accordance with FDA approved label directions while in his or her custody and has been withheld from slaughter for the period(s) of time specified by those label directions.

(3) Healthy carcass. A carcass that an inspector determines shows no lesions of disease or signs of disease treatment at post-mortem inspection

(4) Producer. The owner of the calf at the time of its birth.

(5) Sick calf carcass. A calf carcass that an inspector on post-mortem inspection determines has either signs of disease treatment or lesions of disease or was from an animal identified as sick on ante-mortem.

or

(6) Sign of treatment. Sign of treatment of a disease is indicated by leakage around jugular veins, subcutaneous, intramuscular intraperitoneal injection lesions, or discoloration from particles or oral treatment in any part of the digestive tract.

(7) Veterinary medical officer. An inspector of the Program that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Program.

(c) Selection of carcasses for testing. The inspector shall perform a swab bioassay test1 on:

(1) Any carcass from a calf tagged as "U.S. Suspect" at the time of antemortem inspection, except that calves whose carcasses are condemned for pathology shall not be tested for drug residues.

(2) Any carcass which he/she finds has either lesions of disease which is not condemned because of these lesions

1The procedures for performing the swab bioassay test are set forth in one of two selfinstructional guides: "Performing the CAST" or "Fast Antimicrobial Screen Test." These guides are available for review in the office of the FSIS Docket Clerk. Room 4352 South, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.

(d) Testing of carcasses: (1) The inspector shall test all carcasses as prescribed in paragraph (c) of this section.

(2) Upon initiation of this program at an establishment, the inspector shall begin the testing rate for carcasses from healthy-appearing certified and noncertified calves at Level D as prescribed in paragraph (c)(4) of this section. The inspector shall increase the testing rate to the next higher level the following business day when three carcasses in 100 or less consecutively tested show a positive test result for a drug residue. The inspector shall decrease it to the next lower level when no more than two calves show a positive test result for a drug residue in either 500 calves consecutively tested or all calves tested over a 60 working day period.

(3) Test results shall be determined by the veterinary medical officer.

(4) The establishment may designate one or more of its employees to aid the inspector in performing the swab bioassay test under the supervision of the veterinary medical officer who shall interpret the results, maintain animal identification with the test unit, and ensure integrity of the testing program.

(5) All carcasses and parts thereof from calves selected for testing shall be retained until all test results are complete.

(6) The veterinary medical officer shall condemn all carcasses and parts thereof for which there are positive test results and release for human consumption all carcasses and parts thereof for which there are negative test results.

(7) If there is a positive test result, subsequent calves from the producer of the calf shall be tested in accordance with paragraph (e) of this section. These test results will not be included in computations to determine an establishment's compliance record.

(8) The veterinary medical officer may reduce inspection line rates when, in his/her judgment, the prescribed testing cannot be adequately performed within the time available because the establishment's compliance history dictates a need for extensive testing.

(e) Calves from producers with a previous residue condemnation. The inspector shall perform a swab bioassay test on all carcasses of all calves in the group. The veterinary medical officer shall determine the test results and shall condemn any carcass and parts thereof for which there is a positive test result and pass for human consumption any such carcass and parts thereof for which there is a negative test result. All subsequent calves from the same producer which has previously sold or delivered to official establishments any carcass that was condemned because of drug residues must be tested according to this paragraph until five consecutive animals test completely free of animal drug residues.

(f) If the owner or operator of an official establishment disagrees with the veterinary medical officer's disposition of carcasses and parts thereof, the owner or operator may appeal as provided in section 306.5 of this chapter.

[50 FR 32164, Aug. 9, 1985, as amended at 52 FR 2104, Jan. 20, 1987; 55 FR 7475, Mar. 2, 1990; 60 FR 66483, Dec. 22, 1995]

$310.22 [Reserved]

$310.23 Identification of carcasses and parts of swine.

(a) The identification of the carcasses and parts of swine identified in accordance with part 71 of this title shall be made available to the inspector upon the inspector's request throughout post-mortem inspection.

(b) If the establishment fails to provide required swine identification, the inspector shall order the retention of swine caracasses at the establishment until the completion of tests to confirm that the carcasses are not adulterated.

[53 FR 40387, Oct. 14, 1988]

$310.24 [Reserved]

process

$310.25 Contamination with microorganisms; control verification criteria and testing; pathogen reduction standards.

(a) Criteria for verifying process control; E. coli testing. (1) Each official establishment that slaughters livestock must test for Escherichia coli Biotype 1 (E.coli) Establishments that slaughter more than one type of livestock or both livestock and poultry, shall test the type of livestock or poultry 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. The establishment must collect samples from all chilled livestock carcasses, except

those boned before chilling (hot-boned), which must be sampled after the final wash. Samples must be collected in the following manner;

(A) For cattle, establishments must sponge or excise tissue from the flank, brisket and rump, except for hide-on calves, in which case establishments must take samples by sponging from inside the flank, inside the brisket, and inside the rump.

(B) For sheep, goat, horse, mule, or other equine carcasses, establishments must sponge from the flank, brisket and rump, except for hide-on carcasses, in which case establishments must take samples by sponging from inside the flank, inside the brisket, and inside the rump.

(C) For swine carcasses, establishments must sponge or excise tissue from the ham, belly and jowl areas.

(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 volume of production at the following rates:

(A) Cattle, sheep, goas, horses, mules, and other equines: 1 test per 300 carcasses, but, a minimum of one sample during each week of operation.

Swine: 1 test per 1,000 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 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 6,000 cattle, 6,000 sheep, 6,000 goats, 6,000 horses, mules or other equines, 20,000 swine, or a combination of livestock not exceeding 6,000 cattle and 20,000

total of all livestock. Very low volume establishments that collect samples by sponging shall collect at least 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 June 1 of the following year or until 13 samples have been collected, whichever comes first. Very low volume establishments collecting samples by excising tissue from carcasses 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 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 FSIS. FSIS determinations that changes have been made requiring resumption of weekly testing shall be provided to the establishment in writing.

an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists)2 or approved and published by a scientific body and based on the results of a collaborative trial conducted in accordance with an internationally recognized protocol on collaborative trials and compared against the three tube Most Probable Number (MPN) method and agreeing with the 95 percent upper and lower confidence limit of the appropriate MPN index.

(4) Recording of test results. The establishment shall maintain accurate records of all test results, in terms of CFU/cm2 of surface area sponged or excised. Results shall be recorded onto a process control chart or table showing at least the most recent 13 test results, by type of livestock slaughtered. Records shall be retained at the establishment for a period of 12 months and shall be made available to FSIS upon request.

(5) Criteria for evaluation of test results.

(ii) Establishments

sponging carcasses shall evaluate E. coli test results using statistical process control techniques.

(6) Failure to meet criteria. Test results that do not meet the criteria described in paragraph (a)(5) of this section are an indication that the establishment

2 A copy of the current edition/revision of the "Official Methods of AOAC International," 16th edition, 3rd revision, 1997, is on file with the Director, Office of the Fed

eral Register, and may be purchased from the Association of Official Analytical Chemists International, Inc., 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2417.