[Code of Federal Regulations]
[Title 9, Volume 2, Parts 200 to end]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR310.25]
[Page 122-124]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 310--POST-MORTEM INSPECTION--Table of Contents
Sec. 310.25 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 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 paragaph (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 Sec. 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
[[Page 123]]
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.
(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.
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\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.
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(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of CFU/cm\2\ 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.
(i) An establishment excising samples from carcasses 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
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Maximum
Number of number
Type of livestock Lower limit of marginal Upper limit of marginal sample permitted
range range tested in marginal
range
(m).................... (M).................... (n) (c)
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Cattle.............................. Negative a............. 100 CFU/cm \2\......... 13 3
Swine............................... 10 CFU/cm \2\.......... 10,000 CFU/cm \2\...... 13 3
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a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of
at least 5 cfu/cm\2\ carcass surface area.
(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 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 shall be suspended in
accordance with rules of practice that will be adopted for such
proceedings 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 standard; Salmonella.
[[Page 124]]
(1) Raw meat product performance standards for Salmonella. An
establishment's raw meat 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
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Maximum
Performance number of
Standard Number of positives
Class of product (percent samples to achieve
positive for tested (n) Standard
Salmonella)a (c)
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Steers/heifers.................. 1.0% 82 1
Cows/bulls...................... 2.7% 58 2
Ground beef..................... 7.5% 53 5
Hogs............................ 8.7% 55 6
Fresh pork sausages............. b N.A. N.A. N.A.
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a Performance Standards are FSIS's calculation of the national
prevalence of Salmonella on the indicated raw product based on data
developed by FSIS in its nationwide microbiological 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; values for fresh pork sausage will be added upon
completion data collection programs for those products.
(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\
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\3\ A 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.
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(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 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]