[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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