[Federal Register Volume 63, Number 63 (Thursday, April 2, 1998)]
[Notices]
[Pages 16243-16245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8586]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 98-002N]
Pathogen Reduction Performance Standards: Salmonella Testing Data
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: At its December 16, 1997, Hazard Analysis and Critical Control
Points (HACCP) Implementation Meeting, FSIS discussed its strategy for
testing raw meat and poultry products to determine establishment
compliance with the pathogen reduction performance standards for
Salmonella. The Agency also presented its views on the public release
of Salmonella testing results. The issue papers on these subjects that
were made available at the meeting are published in this notice.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy
Administrator, Office of Policy, Program Development, and Evaluation,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250-3700; (202) 205-0699.
SUPPLEMENTARY INFORMATION: On December 16, 1997, in Washington, D.C.,
FSIS held the first of four one-day meetings to brief managers of large
(500+ employees) official meat and poultry establishments on how the
Agency will conduct inspection operations after January 26, 1998. This
is the date when, under the ``Pathogen Reduction (PR); Hazard Analysis
and Critical Control Point (HACCP) Systems'
[[Page 16244]]
final rule (61 FR 38806), those establishments are required to be
operating HACCP systems. At the meeting, FSIS officials discussed the
Agency's strategy for testing raw meat and poultry products to
determine establishment compliance with the pathogen reduction
performance standards for Salmonella that are set forth in the final
rule. The officials also presented Agency views on the release of
Salmonella testing results.
FSIS summarized its views on these subjects in two issue papers
that were distributed at the meeting. The Agency is aware that there is
considerable interest in the testing strategy and results and wishes to
make the information in the papers available to a wider public. The
issue papers are therefore published below:
Issue Paper: Strategy for Salmonella Testing
Background
The PR/HACCP final rule set pathogen reduction performance
standards for Salmonella that apply to establishments preparing
carcasses and raw ground products. The performance standards are
intended to ensure that each establishment is consistently achieving an
acceptable level of performance with regard to controlling and reducing
harmful bacteria on raw meat and poultry products. FSIS is carrying out
a microbiological testing program to ensure that the establishments are
meeting the performance standards. The standards complement the process
control performance criteria for fecal contamination on carcasses and
E. coli testing that slaughtering establishments are expected to meet.
FSIS has selected Salmonella as the target organism in its
microbiological testing for four reasons. First, it is the most common
bacterial cause of foodborne illness. Second, FSIS baseline data show
that Salmonella colonizes the intestinal tracts of a variety of mammals
and birds and occurs often enough to be detected and monitored. Third,
current methodologies can recover Salmonella from a variety of meat and
poultry products. And, finally, intervention strategies aimed at
reducing Salmonella on raw product should be effective against other
pathogens.
The purpose of the Salmonella performance standards is to provide
incentives for producers of raw meat and poultry products to reduce the
prevalence of Salmonella on their products and to provide an objective
basis for judging the effectiveness of establishments' HACCP plans by
both FSIS and establishments.
Testing Program
The testing program will be carried out in two phases, pre-
implementation testing and compliance testing.
FSIS began the pre-implementation phase in August 1996 with a trial
period to allow the laboratories, inspectors, and headquarters
employees to refine the process for scheduling, collecting and
analyzing samples. During this trial period, FSIS provided training for
Agency employees who were involved, determined what resources were
needed in Agency laboratories and in the field, and assessed the
processes used to collect samples and perform analyses. Official pre-
implementation sampling began on June 1, 1997 in large establishments.
Pre-implementation testing in small and very small establishments will
begin in 1998.
Establishments are subject to compliance-phase testing on the dates
when, according to the PR/HACCP final rule, the HACCP regulations
become applicable respectively to large, small, and very small
establishments. The HACCP regulations become applicable to large
establishments on January 26, 1998, to small establishments on January
25, 1999, and to very small establishments on January 25, 2000. After
the year 2000, all official establishments, regardless of size, will be
subject to the HACCP regulations.
The compliance-phase testing strategy consists of three elements:
Product-specific testing--Plants preparing products for
which the performance standards are in double digits--e.g., chicken
(20.0% positive), ground chicken (44.6%), ground turkey (49.9%)--will
be targeted. FSIS will schedule these plants for the collection and
analysis of sample sets.
Plant-specific targeting--A plant failing to meet a
performance standard when the first in a series of up to three
consecutive sample sets has been tested will be targeted for additional
testing. FSIS will schedule the plant for testing of a second sample
set.
On-going random testing--Plants not included in either of
the targeted-sampling frames will be subject to random testing.
Enforcement
The enforcement policy follows the framework established by the PR/
HACCP rule.
First Sample Set
If an establishment does not meet a performance standard, FSIS
Headquarters will notify the District Manager (DM) for the district in
which the establishment is located. The DM, in turn, will notify the
establishment that it is not in compliance with the performance
standard and must take immediate action to meet the standard. The fact
of the establishment's noncompliance will be documented in a
noncompliance report (NR). FSIS will schedule the establishment for a
second sample set, normally within 60 days, but the Agency may change
the sampling schedule if the DM recommends faster or slower action.
Second Sample Set
If an establishment does not meet the performance standard, FSIS
Headquarters will notify the DM. The DM, in turn, will notify the
establishment of its noncompliance, citing the regulatory requirement
for the establishment to reassess its HACCP plan for that product and
take corrective action. The fact of the establishment's noncompliance
will be documented in an NR.
FSIS will schedule the establishment for a third sample set, with
sampling to begin at a time recommended by the DM. Before recommending
that sampling resume, the DM will consider factors such as the
establishment's progress on reassessing its HACCP plan, its adherence
to process control performance criteria as measured by testing for E.
coli, or its pattern of failing checks for fecal contamination.
Third Sample Set
If the establishment fails to meet the performance standard, FSIS
Headquarters will notify the DM. The DM will inform the establishment
orally and by certified letter that it has failed to maintain an
adequate HACCP plan for the affected product in accordance with 9 CFR
Part 417. The fact of the establishment's noncompliance will be
documented in an NR. Inspection service for that product will be
suspended and will remain suspended until the establishment submits to
the FSIS Administrator, or designee, satisfactory written assurances
detailing actions it has taken to correct the HACCP system. (9 CFR
310.25(b)(3), 381.94(b)(3)).
During compliance-phase testing, any plant that is targeted for
sampling and achieves a ``pass'' result in sample-set testing will be
returned to the ``random pool.'' FSIS may select the establishment from
that pool for testing at some later time.
[[Page 16245]]
Issue Paper: Public Release of Salmonella Testing Results
Issue
The Food Safety and Inspection Service (FSIS) is providing its
views on the release of Salmonella testing data collected by FSIS in
connection with the HACCP/Pathogen Reduction final rule.
Background
With the publication of its HACCP/Pathogen Reduction final rule,
FSIS adopted pathogen reduction performance standards for raw meat and
poultry products using Salmonella as the target organism. To verify
that this requirement is being met, FSIS will conduct Salmonella
testing in establishments that produce raw meat and poultry products.
The goal of the Salmonella testing program is to verify that
pathogen reduction performance standards are being met by each
establishment, with an ultimate goal of reducing the incidence of that
organism and other enteric pathogens on raw meat and poultry products
nationwide. The pathogen reduction standard for Salmonella requires
testing of products not to determine product disposition but as a
measure of process effectiveness in limiting contamination with this
pathogen. Individual test results are not meaningful under this program
because the performance standards have been established to measure
performance over time; thus, multiple samples are required to make an
appropriate compliance determination.
FSIS is carrying out the Salmonella testing program in two phases:
a pre-implementation phase and a compliance phase. The principal
objective of the pre-implementation phase was to acquire test data to
enable both FSIS and establishments to see how they were performing
with respect to the performance standards. The pre-implementation phase
began on June 1, 1997. The compliance phase begins on January 26, 1998.
The effective dates for establishment compliance with the Salmonella
performance standards are the same as the effective dates for HACCP
implementation: January 26, 1998, for large plants; January 25, 1999,
for small plants; and January 25, 2000, for very small plants. After
the effective date(s), establishment failure to meet the performance
standards set forth in the HACCP/Pathogen Reduction final rule will
trigger enforcement action.
Availability of Salmonella Testing Data
Pre-implementation Salmonella testing data: This refers to
Salmonella testing data collected between June 1, 1997 and the date
when the HACCP regulations are applicable to an establishment. FSIS
does not intend to use the data collected between June 1, 1997, and
January 26, 1998, for any purpose because it did not collect as much
data as originally intended; there are many incomplete sets of data.
FSIS will collect pre-implementation testing data from small and very
small plants and will determine appropriate use and disclosure of this
data as data collection proceeds. Requests for pre-implementation data
under the Freedom of Information Act will be addressed on a case-by-
case basis.
Compliance-phase Salmonella testing data: This refers to
Salmonella testing data FSIS collects in plants subject to the HACCP
requirements. FSIS will send individual establishments the results of
testing on their own product upon completion of the full sample sets.
In addition, plant-specific testing data will be available in
accordance with the Freedom of Information Act. The Agency does not
consider testing to be complete until there is a full sample set. In
all cases, the Agency intends to provide an explanation of the purpose
of the testing and the meaning of the data (in general terms) with any
Salmonella testing data released. FSIS has no specific plans to post
the Salmonella data on its website.
FSIS believes that it should publish annually a report on
the Salmonella testing program. The contents and format of the report
have not yet been decided.
Done at Washington, DC, on: March 23, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-8586 Filed 4-1-98; 8:45 am]
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