(2) Enforcement. FSIS will sample and test raw meat products in an individual establishment on an unannounced basis to determine prevalence of Salmonella in such products to determine compliance with the standard. The frequency and timing of such testing will be based on the establishment's previous test results and other information concerning the establishment's performance. In an establishment producing more than one class of product subject to the pathogen reduction standard, FSIS may sample any or all such classes of products.3

(3) Noncompliance and establishment response. When FSIS determines that an establishment has not met the performance standard:

(i) The establishment shall take immediate action to meet the standard.

(ii) If the establishment fails to meet the standard on the next series of com

3A copy of FSIS's "Sample Collection Guidelines and Procedure for Isolation and Identification of Salmonella from Meat and Poultry Products” is available for inspection in the FSIS Docket Room.

pliance tests for that product, the establishment shall reassess its HACCP plan for that product and take appropriate corrective actions.

(iii) Failure by the establishment to act in accordance with paragraph (b)(3)(ii) of this section, or failure to meet the standard on the third consecutive series of FSIS-conducted tests for that product, constitutes failure to maintain sanitary conditions and failure to maintain an adequate HACCP plan, in accordance with part 417 of this chapter, for that product, and will cause FSIS to suspend inspection services. Such suspension will remain in effect until the establishment submits to the FSIS Administrator or his/her designee satisfactory written assurances detailing the action taken to correct the HACCP system and, as appropriate, other measures taken by the establishment to reduce the prevalence of pathogens.

[61 FR 38864, July 25, 1996, as amended at 62 FR 26217, May 13, 1997; 63 FR 1735, Jan. 12, 1998;64 FR 66553, Nov. 29, 1999]

EFFECTIVE DATE NOTE: At 64 FR 66553, Nov. 29, 1999, §310.25 was amended by revising the

(ii) Sample collection. The establishment shall collect samples from all chilled swine or cattle carcasses, except those boned before chilling (hot-boned), which must be sampled after the final wash. Samples shall be collected by either sponging or excising tissue from three sites on the selected carcass. On cattle carcasses, establishments shall sponge or excise tissue from the flank, brisket and rump, except for hide-on calves, in which case establishments shall take samples by sponging from inside the flank, inside the brisket, and inside the rump; on swine carcasses, establishments shall sponge or excise tissue from the ham, belly and jowl areas. 1

A copy of FSIS's "Guidelines for E. coli Testing for Process Control verification in Cattle and Swine Slaughter Establishments" is available for inspection in the FSIS Docket Room.

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

Cattle: 1 test per 300 carcasses, but at a minimum one sample each week of operation.

Swine: 1 test per 1000 carcasses, but at a minimum one sample each week of operation.

(iii) Sampling frequency. Samples shall be taken at a frequency proportional to a slaughter establishment's volume of production, at the following rates: Bovines: 1 test per 300 carcasses Swine: 1 test per 1,000 carcasses

(V) * * *

(A) Very low volume establishments annually slaughter no more than 6,000 cattle, 20,000 swine, or a combination of cattle and

$311.1 Disposal of diseased or otherwise adulterated carcasses and parts; general.

(a) The carcasses or parts of carcasses of all animals slaughtered at an official establishment and found at the time of slaughter or at any subsequent inspection to be affected with any of the diseases or conditions named in this part shall be disposed of according to the section pertaining to the disease or condition: Provided, That no product shall be passed for human food under any such section unless it is found to be otherwise not adulterated. Products passed for cooking or refrigeration under this part must be so handled at the official establishment where they are initially prepared unless they are moved to another official establishment for such handling or in the case of products passed for refrigeration are moved for such refrigeration to a freezing facility approved by the Administrator in specific cases: Provided, That when SO moved the products are shipped in containers sealed in accordance with §318.10(c) of this subchapter or in a sealed means of conveyance as provided in §325.7 of this subchapter. Owning to the fact that it is impracticable to formulate rules covering every case and to designate at just what stage a disease process or a condition results in adulteration of a product, the decision as to the disposal of all carcasses, organs, or other parts not specifically covered in this part shall be left to the veterinary medical offi

cer. The veterinary medical officer shall exercise his judgment regarding the disposition of all carcasses or parts of carcasses under this part in a manner which will insure that only wholesome, unadulterated product is passed for human food.

(b) In cases of doubt as to a condition, a disease, or the cause of a condition, or to confirm a diagnosis, representative specimens of the affected tissues, properly prepared and packaged, shall be sent for examination to one of the laboratories of the Biological Control Section of the Program.

§311.2 Tuberculosis.

The following principles shall apply to the disposition of carcasses of livestock based on the difference in the pathogenesis of tuberculosis in swine, cattle, sheep, goats, and equines.

(a) Carcasses condemned. The entire carcass of swine, cattle, sheep, goats, and equines shall be condemned if any of the following conditions occur:

(1) When the lesions of tuberculosis are generalized (tuberculosis is considered to be generalized when the lesions are distributed in a manner made possible only by entry of the bacilli into the systemic circulation);

(2) When on ante mortem inspection the animal is observed to have a fever found to be associated with an active tuberculosis lesion on post mortem inspection;

(3) When there is an associated cachexia;

(4) When a tuberculosis lesion is found in any muscle or intermuscular tissue, or bone, or joint, or abdominal organ (excluding the gastrointestinal tract) or in any lymph node as a result of draining a muscle, bone, joint, or abdominal organ (excluding the gastrointestinal tract);

(5) When the lesions are extensive in tissues of either the thoracic or the abdominal cavity;

(6) When the lesions are multiple, acute, and actively progressive; or

(7) When the character or extent of the lesions otherwise is not indicative of a localized condition.

(b) Organs or other parts condemned. An organ or other part of a swine, cattle, sheep, goat, or equine carcass affected by localized tuberculosis shall

be condemned when it contains lesions of tuberculosis or when the corresponding lymph node contains lesions of tuberculosis.

(c) Carcasses of cattle passed without restriction for human food. Carcasses of cattle may be passed without restriction for human food only when the carcass of an animal not identified as a reactor to a tuberculin test administered by an Animal and Plant Health Inspection Service, State, or accredited veterinarian1 is found free of tuberculosis lesions during postmortem inspection.

(d) Portions of carcasses and carcasses of cattle passed for cooking. (1) When a cattle carcass reveals a tuberculosis lesion or lesions not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portion of the carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

(2) When the carcass of a cattle identified as a reactor to a tuberculin test administered by an Animal and Plant Health Inspection Service, State or accredited veterinarian is found free of lesions of tuberculosis, the carcass may be passed for cooking in accordance with part 315 of this chapter.

(e) Portions of carcasses and carcasses of swine passed without restriction for human food. Swine carcasses found free of tuberculosis lesions during post mortem inspection may be passed for human food without restriction. When tuberculosis lesions in any swine carcass are localized and confined to one primary seat of infection, such as the cervical lymph nodes, the mesenteric lymph nodes, or the mediastinal lymph nodes, the unaffected portion of the carcass may be passed for human food without restriction after the affected organ or other part is condemned.

(f) Portions of carcasses of swine passed for cooking. When the carcass of any swine reveals lesions more severe or

1 Such testing is conducted in the tuberculosis eradication program of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture.

more numerous than those described in paragraph (e) of this section, but not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portions of such carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

(g) Carcasses of sheep, goats, and equines passed without restriction for human food. Carcasses of sheep, goats. and equines may be passed without restriction for human food only if found free of tuberculosis lesions during post mortem inspection.

(h) Portions of carcasses of sheep, goats, and equines passed for cooking. If a carcass of any sheep, goat, or equine reveals a tuberculosis lesion or lesions that are not so severe or so numerous as the lesions described in paragraph (a) of this section, the unaffected portion of the carcass may be passed for cooking in accordance with part 315 of this chapter; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

[37 FR 2661, Feb. 4, 1972; 38 FR 29214, Oct. 23. 1973]

§311.3 Hog cholera.

(a) The carcasses of all hogs affected with hog cholera shall be condemned.

(b) Inconclusive but suspicious symptoms of hog cholera observed during the ante-mortem inspection of a U.S. suspect shall be duly considered in connection with post-mortem findings and when the carcass of such a suspect shows lesions in the kidneys and the lymph nodes which resemble lesions of hog cholera, they shall be regarded as those of hog cholera and the carcass shall be condemned.

(c) When lesions resembling those of hog cholera occur in kidneys and lymph nodes of carcasses of hogs which appeared normal on ante-mortem inspection, further inspection of such

carcasses shall be made for corroborative lesions. If on such further inspection, characteristic lesions of hog cholera are found in some organ or tissue in addition to those in the kidneys or in the lymph nodes or in both, then all lesions shall be regarded as those of hog cholera and the carcass shall be condemned. Immediate notification shall be given by the inspector to the official in the Veterinary Services unit of the Animal and Plant Health Inspection Service who has responsibility for control of swine diseases in the State where the swine are located.

[35 FR 15569, Oct. 3, 1970, as amended at 40 FR 27225, June 27, 1975]

$311.5 Swine erysipelas.

Carcasses affected with swine erysipelas which is acute or generalized, or which show systemic change, shall be condemned.

§311.6 Diamond-skin disease.

Carcasses of hogs affected with diamond-skin disease when localized and not associated with systemic change may be passed for human food after removal and condemnation of the affected parts, provided such carcasses are otherwise healthy.

§311.7 Arthritis.

(a) Carcasses affected with arthritis which is localized and not associated with systemic change may be passed for human food after removal and condemnation of all affected parts. Affected joints with corresponding lymph nodes shall be removed and condemned. In order to avoid contamination of the meat which is passed, a joint capsule shall not be opened until after the affected joint is removed.

(b) Carcasses affected with arthritis shall be condemned when there is evidence of systemic involvement.

$311.8 Cattle carcasses affected with anasarca or generalized edema.

(a) Carcasses of cattle found on postmortem inspection to be affected with

anasarca in advanced stages and characterized by an extensive or wellmarked generalized edema shall be condemned.

(b) Carcasses of cattle, including their detached organs and other parts, found on post-mortem inspection to be affected with anasarca to a lesser extent than as described in paragraph (a) of this section may be passed for human food after removal and condemnation of the affected tissues, provided the lesion is localized.

§311.9 Actinomycosis and actinobacillosis.

(a) The definition of generalization as outlined for tuberculosis in §311.2(a) shall apply for actinomycosis and actinobacillosis, and carcasses of livestock with generalized lesions of either such disease shall be condemned.

(b) Carcasses of livestock in a wellnourished condition showing uncomplicated localized lesions of actinomycosis or actinobacillosis may be passed for human food after the infected organs or other infected parts have been removed and condemned, except as provided in paragraphs (c) and (d) of this section.

(c) Heads affected with actinomycosis or actinobacillosis, including the tongue, shall be condemned, except that when the disease of the jaw is slight, strictly localized, and without suppuration, fistulous tracts, or lymph node involvement, the tongue, if free from disease, may be passed, or, when the disease is slight and confined to the lymph nodes, the head including the tongue, may be passed for human food after the affected nodes have been removed and condemned.

(d) When the disease is slight and confined to the tongue, with or without involvement of the corresponding lymph nodes, the head may be passed for human food after removal and condemnation of the tongue and corresponding lymph nodes.