9 CFR 381.94 - Contamination with Microorganisms; process control verification criteria and testing; pathogen reduction standards.

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§ 381.94 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 or ratites also may be collected by sponging the carcass on the back and thigh. 1

1 A copy of FSIS's “Guidelines for Escherichia coli 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.

(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, Guineas, Squabs, and Ratites: 1 sample per 3,000 carcasses, but at a minimum one sample 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 440,000 chickens, 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, 60,000 squabs, 6,000 ratites, 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, guineas, squabs, or ratites 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 of the following year or until 13 samples have been collected, whichever comes first.
(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 that changes have been made requiring resumption of weekly testing shall be provided to the establishment in writing.
(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 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.

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

(4) Recording of test results. The establishment shall maintain accurate records of all test results, in terms of CFU/ml of rinse fluid. Results shall be recorded onto a process control chart or table showing at least the most recent 13 test results, by type of poultry slaughtered. Records shall be retained at the establishment for a period of 12 months and shall be made available to FSIS upon request.
(i) Criteria for Evaluation of test results. An establishment is operating within the criteria when the most recent E. coli test result does not exceed the upper limit (M), and the number of samples, if any, testing positive at levels above (m) is three or fewer out of the most recent 13 samples (n) taken, as follows:
Table 1—Evaluation of E. Coli Test Results
Types of poultry Lower limit of marginal range (m) Upper limit of marginal range (M) Number of samplestested (n) Maximum number permitted in marginal range (c)
1 CFU/ml.
* Values will be added upon completion of data collection programs.
Chickens 1 100 1 1,000 13 3
Turkeys *NA *NA *NA *NA
Ducks *NA *NA *NA *NA
Geese *NA *NA *NA *NA
Guineas *NA *NA *NA *NA
Squabs *NA *NA *NA *NA
Ratites *NA *NA *NA *NA
(ii) For types of poultry appearing in paragraph (a)(5)(1) Table 1 of this section that do not have m/N criteria, establishments 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 may not be maintaining process controls sufficient to prevent fecal contamination. FSIS shall take further action as appropriate to ensure that all applicable provisions of the law are being met.
(7) Failure to test and record. Inspection will be suspended in accordance with rules of practice that will be adopted for such proceeding, upon a finding by FSIS that one or more provisions of paragraphs (a) (1)-(4) of this section have not been complied with and written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standards; Salmonella—(1) Raw poultry product performance standards for Salmonella. (i) An establishment's raw poultry products, when sampled and tested by FSIS for Salmonella as set forth in this section, may not test positive for Salmonella at a rate exceeding the applicable national pathogen reduction performance standard, as provided in Table 2:
Table 2—Salmonella Performance Standards
Class of product Performance Standard (percent positive for salmonella) a Number ofsamples tested (n) Maximumnumber of positives to achieve standard (c)
a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw products based on data developed by FSIS in its nationwide microbiological baseline data collection programs and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the FSIS Docket Room.)
b Not available; baseline targets for turkeys, squabs, or ratites will be added upon completion of the data collection programs for that product.
Broilers 20.0% 51 12
Ground chicken 44.6 53 26
Ground turkey 49.9 53 29
Turkeys b NA NA NA
Squabs b NA NA NA
Ratites b NA NA NA
(2) Enforcement. FSIS will sample and test raw poultry 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 A copy of FSIS's “Sample Collection Guidelines and Procedure for Isolation and Identification of Salmonella from Raw Meat and Poultry Products” is available for inspection in the FSIS Docket Room.

(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 compliance tests for that product, the establishment shall reassess its HACCP plan for that product.
(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 38866, July 25, 1996, as amended at 62 FR 26218, May 13, 1997; 62 FR 61009, Nov. 14, 1997; 64 FR 66553, Nov. 29, 1999; 67 FR 13258, Mar. 22, 2002]

Title 9 published on 2014-01-01

The following are only the Rules published in the Federal Register after the published date of Title 9.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-12-01; vol. 79 # 230 - Monday, December 1, 2014
    1. 79 FR 71007 - Uniform Compliance Date for Food Labeling Regulations
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Food Safety and Inspection Service
      Final rule.
      This rule is effective December 1, 2014. Comments on this final rule must be received on or before December 31, 2014.
      9 CFR Parts 317 and 381

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
U.S. Code: Title 7 - AGRICULTURE
U.S. Code: Title 21 - FOOD AND DRUGS

§ 451 - Congressional statement of findings

§ 452 - Congressional declaration of policy

§ 453 - Definitions

§ 454 - Federal and State cooperation in development and administration of State poultry product inspection programs

§ 455 - Inspection in official establishments

§ 456 - Operation of premises, facilities and equipment

§ 457 - Labeling and container standards

§ 458 - Prohibited acts

§ 459 - Compliance by all establishments

§ 460 - Miscellaneous activities subject to regulation

§ 461 - Offenses and punishment

§ 462 - Reporting of violations; notice; opportunity to present views

§ 463 - Rules and regulations

§ 464 - Exemptions

§ 465 - Limitations upon entry of poultry products and other materials into official establishments

§ 466 - Imports

§ 467 - Inspection services

§ 467a - Administrative detention; duration; pending judicial proceedings; notification of government authorities; release; removal of official marks

§ 467b - Seizure and condemnation

§ 467c - Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plaintiff; subpenas

§ 467d - Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts

§ 467e - Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments...purposes of adulterated or misbranded and imported articles; other matters

§ 467f - Federal Food, Drug, and Cosmetic Act applications

§ 468 - Cost of inspection; overtime

§ 469 - Authorization of appropriations

§ 470 - Omitted

Title 9 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR 381 after this date.

  • 2014-12-01; vol. 79 # 230 - Monday, December 1, 2014
    1. 79 FR 71007 - Uniform Compliance Date for Food Labeling Regulations
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Food Safety and Inspection Service
      Final rule.
      This rule is effective December 1, 2014. Comments on this final rule must be received on or before December 31, 2014.
      9 CFR Parts 317 and 381