[Federal Register: April 16, 2003 (Volume 68, Number 73)]
[Notices]               
[Page 18593-18596]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap03-26]                         

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 01-040N]

 
Announcement of and Request for Comment on FSIS' Tentative 
Determinations on the Availability of Salmonella Test Results

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
its intention to make publicly available the results of its testing for 
Salmonella on livestock and poultry carcasses and in raw ground meat 
and poultry products. The Agency also intends to post the results of 
all completed sampling sets on its Web site. FSIS conducts the 
Salmonella testing as part of its Hazard Analysis and Critical Control 
Point (HACCP) verification activities. FSIS is acting in response to a 
petition submitted by the Center for Science in the Public Interest, 
suggestions made by meat and poultry processors, and suggestions made 
by the National Advisory Committee on Microbiological Criteria for 
Foods (NACMCF).

DATES: Comments must be received on or before May 16, 2003.

ADDRESSES: Please submit one original and two copies of written 
comments to the FSIS Docket Room, Docket No. 01-040N, U.S. Department 
of Agriculture, Food Safety and Inspection Service, Room 112 Cotton 
Annex, 300 12th Street, SW., Washington, DC 20250-3700. Comments may 
also be submitted via facsimile at (202) 205-0381. All comments 
received in response to this notice will be considered part of the 
public record, and will be available for viewing in the FSIS Docket 
Room between 8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Ph.D, Acting 
Assistant Deputy Administrator for Policy Analysis and Formulation, 
Office of Policy and Program Development, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250-3700; 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Introduction

    On July 25, 1996, FSIS published a final rule in the Federal 
Register entitled, ``Pathogen Reduction; Hazard Analysis and Critical 
Control Point (PR/HACCP) Systems'' (61 FR 38806). This rule 
established, among other things, pathogen reduction performance 
standards for Salmonella that establishments slaughtering livestock and 
poultry and producing raw ground meat and poultry products must meet. 
FSIS conducts an ongoing testing program to determine compliance with 
these Salmonella performance standards for classes of livestock and 
poultry products.
    FSIS has received a petition from the Center for Science in the 
Public Interest (CSPI) requesting that FSIS post on its website all 
plant-specific test results for Salmonella in carcasses and raw ground 
meat and poultry products, and that FSIS post such test results in a 
timely and relevant manner as they become available. CSPI contends that 
consumers could use plant-specific Salmonella results posted on the 
FSIS website to determine whether individual establishments are meeting 
the Salmonella performance standard and could make informed purchasing 
decisions on the basis of that information.
    In addition, numerous establishments and industry associations have 
advised the Agency that it would be very valuable for them to receive 
the results of each sample as the Agency finishes its analysis during 
the course of a Salmonella set. Timely receipt of this information, the 
establishments say, will enable them to more readily associate the 
results with the conditions in their plants at the time the samples 
were taken and will facilitate corrections and improvements in their 
operations.
    FSIS has determined that, if it makes the results available to 
establishments on a sample-by-sample basis, the agency will not be able 
to protect the confidentiality of the results until the conclusion of 
the collection and testing of full sample sets, as is currently the 
case. The industry representatives have stated that the opportunities 
created by having the results available on a timely basis outweigh any 
disadvantages of the information being publicly available. The NACMCF 
has expressed similar views.
    Based on its consideration of the petition, the NACMCF's 
recommendation, and its contacts with industry, FSIS is announcing its 
intention to modify its handling of Salmonella testing results. The 
Agency requests comment on its plans.

Background

The Salmonella Performance Standards for Raw Meat and Poultry

    In 9 CFR 310.25(b) and 381.94(b), FSIS has set out performance 
standards for the prevalence of Salmonella in livestock and poultry 
carcasses and raw ground meat and poultry products. FSIS samples and 
tests raw meat and poultry products in individual establishments to 
determine the prevalence of Salmonella in the products and to determine 
compliance with the Salmonella performance standards.
    Prior to December 2001, FSIS used the sample results to directly 
enforce the performance standards in 9 CFR 310.25(b)(iii)(3) and 
381.94(b)(iii)(3). These regulations state that failure to meet the 
performance standard in three consecutives tests ``constitutes failure 
to maintain sanitary conditions and failure to maintain an adequate 
HACCP plan.'' The Agency stated that it would suspend inspection as a 
result of such a failure because it would not be able to find that the 
product of an establishment that had failed three sets in a row was not 
adulterated.
    A decision in early December 2001 by the U.S. Court of Appeals for 
the Fifth Circuit in Supreme Beef Processors, Inc. v. USDA, however, 
limited FSIS' ability to directly enforce the Salmonella performance 
standards in grinding operations. Based on the court's decision, a 
grinding operation's failure to meet a Salmonella performance standard 
is not in and of itself a noncompliance. However, the failure may be an 
indicator of noncompliances in aspects of the establishment's total 
food safety program, such as Sanitation Standard Operating Procedures 
(Sanitation SOPs) and HACCP plans. Thus, FSIS now uses sample set 
failures as an indication that there is something wrong in the 
establishment's HACCP system, and that the system needs to be carefully 
evaluated by the Agency. However, FSIS does not initiate enforcement 
actions based on individual Salmonella testing results. In addition to 
the Salmonella set failures, FSIS uses other pertinent information in 
its evaluation of an establishment's HACCP system. This information 
includes, but is not limited to, summary reports compiled from the 
evaluations of reviews of the establishment's SSOPs, prerequisite and 
good manufacturing programs, and HACCP plans by the consumer safety 
officer or food safety assessment team; documentation of observations 
and verification activities of in-plant inspection personnel; and 
generic E. coli and other microbial test results.

Public Release of Test Results and the Freedom of Information Act

    The Agency held public meetings on March 6 and December 16, 1997, 
to inform industry constituents and consumer advocates that FSIS would 
send individual establishments the results of testing on their own 
product upon completion of the full sample sets, and that plant-
specific results would be released to the public in accordance with the 
provisions of the Freedom of Information Act (FOIA) (5 U.S.C. Sec.  
552).\1\ At the December 16, 1997, public meeting, FSIS presented an 
issue paper entitled, ``Public Release of Salmonella Testing Results,'' 
which outlined the Agency's position.\2\ On April 2, 1998, FSIS 
published this issue paper in the Federal Register (63 FR 16245).\3\ In 
this paper, FSIS stated that it planned to ``publish annually a report 
on the Salmonella testing program.'' Since then, FSIS has made the 
Agency's Salmonella test results available on the Web site through a 
progress report: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/FOIA/popular.htm. In this 
report, FSIS provides Salmonella testing results on an aggregate basis 
for large, small, and very small plants; the percent of products that 
have tested positive for Salmonella; and the prevalence of Salmonella 
with each product category. Prevalence, for the purposes of the FSIS 
HACCP verification activity, is not a statistical representation of the 
true presence of Salmonella in product. FSIS conducts statistically-
based baseline studies to determine the true prevalence of microorganisms, including 
Salmonella.
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    \1\ Transcript of Proceedings, HACCP Implementation Meeting; 
Washington, DC, December 16, 1997, page 152-153. This document is 
available for review in the FSIS Docket Room Monday through Friday 
from 8:30 a.m. until 4:30 p.m. The document may also be accessed via 
the World Wide Web at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.fsis.usda.gov/FOIA/popular.htm as a 
related document under the Notices and Directives, and Federal 
Register Publications section. Transcript of Proceedings, 
Publication of Salmonella Testing Data; Washington, DC, March 6, 
1997, page 3. This document is also available for review in the FSIS 
Docket Room Monday through Friday from 8:30 a.m. until 4:30 p.m. 
This document may also be accessed via the World Wide Web at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.fsis.usda.gov/FOIA/popular.htm as a related document under the 
Notices and Directives, and Federal Register Publications section.
    \2\ Transcript of Proceedings, HACCP Implementation Meeting; 
December 16, 1997, Washington, DC, page 151-153.
    \3\ Notice, Pathogen Reduction Performance Standards: Salmonella 
Testing Data, 63 FR 16243-16245, April 2, 1998. This document is 
available for review in the FSIS Docket Room Monday through Friday 
from 8:30 a.m. until 4:30 p.m. This document may also be accessed 
via the World Wide Web at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.fsis.usda.gov/FOIA/popular.htm under 
the Notices and Directives, and Federal Register Publications 
section.
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    FSIS has considered the Salmonella test results as information for 
use by the Agency in its deliberative process on how best to proceed 
with respect to the establishment involved. Predecisional information 
can be exempted from disclosure under the FOIA (5 U.S.C. 552(b)(5)). 
Accordingly, FSIS has not disclosed plant-specific testing results 
until the set was complete.
    The FOIA requires that federal agencies make certain information 
that is released under the FOIA available to the public in electronic 
format and by computer telecommunications (5 U.S.C. 552(a)(2)). In 
response to legislative amendments to the FOIA (E-FOIA), on July 28, 
2000, the U.S. Department of Agriculture published a final rule, ``USDA 
Freedom of Information Act Regulations'' (65 FR 46335), in which the 
Department adopted regulations governing the electronic release of 
information requested under FOIA. Significant in consideration of the 
CSPI petition is that these regulations provide that one reason to 
release information requested under FOIA electronically is that ``it 
has become or is likely to become the subject of subsequent requests 
for substantially the same records.'' Salmonella testing results have 
been, and continue to be, requested in significant numbers.

Recommendations From the National Advisory Committee on Microbiological 
Criteria for Foods

    On October 8, 2002, the National Advisory Committee on 
Microbiological Criteria for Foods (NACMCF) made final a report that 
recommended that the data from the Salmonella performance standard 
program be made public, so as to provide guidance to industry in order 
that commercial operations may assess their process control.\4\ The 
Committee points out that, when HACCP systems and other prerequisite 
programs in ground beef operations are adequate and verified, the 
measurement of Salmonella reflects the total process control, 
particularly the microbial conditions of raw material. The report also 
states that the information would be helpful in meeting the Salmonella 
performance standards. In addition, the report recommends that the 
Salmonella test results be made available to each establishment as they 
become available to facilitate Continuous Improvement Programs. 
Finally, the report states that making Salmonella data that is suitably 
codified to protect proprietary information available to the public, to 
the extent possible, should lead to generation of additional data and 
increased knowledge of the many facets influencing control of enteric 
pathogens on raw meat and poultry.
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    \4\ Final Response, NACMCF Final Response to the Questions Posed 
by FSIS regarding Performance Standards with Particular Reference to 
Ground Beef Products, Washington, DC, October 8, 2002. This document 
is available for review in the FSIS Docket Room Monday through 
Friday from 8:30 a.m. until 4:30 p.m. This document may also be 
accessed via the World Wide Web at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.fsis.usda.gov/FOIA/popular.htm
.
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The CSPI Petition

    As mentioned above, FSIS received a petition dated October 1, 2001, 
from CSPI requesting that FSIS post on its website all plant-specific 
test results for Salmonella in carcasses and raw ground meat and 
poultry products, and that FSIS continue to post such test results in a 
timely and relevant manner as they become available. According to CSPI, 
consumers could use plant-specific Salmonella results posted on the 
FSIS website to determine whether individual establishments are meeting 
the Salmonella performance standard and could make informed purchasing 
decisions on the basis of that information.
    The petition states that the presence of Salmonella positives above 
the performance standard is an indication that the plant's system for 
controlling contamination is not working. Therefore, according to CSPI, 
posting the individual establishment test results on the web would 
encourage establishments to improve their sanitation procedures because 
consumers would be less likely to purchase products made by facilities 
that repeatedly exceed standards. Additionally, the petition states 
that posting test results on the FSIS Web site could benefit Federal 
and state health officials in their efforts to track the cause of food 
poisoning outbreaks and to identify contamination trends based on 
product type, plant geographical location, and seasonality. The 
petition also states that posting plant-specific Salmonella test 
results on the FSIS Web site would be consistent with the USDA's 
implementing regulations for FOIA. Quoting a House of Representatives 
report, the petitioner states that one of the purposes of the FOIA 
provisions requiring electronic release of information is to improve 
public access to agency records and information.

Industry and Consumer Advocate Comments and Concerns

    Before and during the March 6, 1997, public meeting referred to 
above, many industry representatives raised concerns regarding posting 
Salmonella testing results on the World Wide Web. Some of their 
concerns were based on the assumption that foreign countries who do not 
monitor their own products, nor have equivalent process controls 
established to determine whether Salmonella is present on meat and 
poultry products, could use the Salmonella data to discriminate against 
U.S. product. They argued that use of the data could lead to the 
following results: (1) A negative impact on U.S. companies' efforts to 
secure markets and fair prices internationally; (2) use of the data by 
foreign governments as a pretext for imposing non-tariff barriers 
against U.S. product and to protect their own domestic industry; and 
(3) discrimination against specific U.S. products and establishments by 
foreign buyers if an establishment received positive Salmonella test 
results. In addition, they stated that the context in which the 
Salmonella testing results would be presented would also have an impact 
on the aforementioned effects.
    At the same public meeting, consumer advocates favored publication 
of plant-specific Salmonella data along with the plant name, location, 
and product line.\5\ They stated that progressive companies would want 
the results of their Salmonella tests known, and that the public is 
sophisticated enough to accept the fact that there are going to be 
positive Salmonella test results on some raw product.\6\
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    \5\ Transcript of Proceedings, Publication of Salmonella Testing 
Data; Washington, DC, March 6, 1997, page 75.
    \6\ Transcript of Proceedings, Publication of Salmonella Testing 
Data; Washington, DC, March 6, 1997, pages 70-72.
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    On the other hand, during the December 16, 1997, meeting, an 
industry representative opined that, ``it would be beneficial for 
plants to have the Salmonella data as it was collected so if a trend 
was developing, the plant could take some corrective action before the 
whole series was out.''\7\
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    \7\ Transcript of Proceedings, HACCP Implementation Meeting; 
December 16, 1997, Washington, DC, page 153.
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    In the five years that have followed, the concerns expressed by 
industry about foreign reaction to specific Salmonella results have not 
materialized. However, through numerous informal communications and at 
scheduled meetings, the Agency has received industry input that 
correlates with the last comment cited and with the NACMCF's 
recommendations.

[[Page 18596]]

Availability of FSIS' Salmonella Testing Program's Results

    FSIS now agrees with CSPI and NACMCF that release of the Salmonella 
data as sample results are obtained, rather than at the completion of a 
full sample set, could lead to the generation of data and information 
that could be used to sort out which, if any, of the many factors that 
could influence control of enteric pathogens on raw meat and poultry is 
actually doing so. FSIS also agrees that providing Salmonella data to 
industry as test results are obtained will allow commercial operations 
to assess their process control more effectively.

Tentative Determinations

    In light of the foregoing, FSIS intends to release Salmonella 
testing results to individual establishments as they become available 
and before the conclusion of the collection and testing of full sample 
sets. Receiving this information in this way should allow 
establishments to more readily identify their process control 
deficiencies and assess the relative efficacy of their process 
controls.
    The Office of Public Health and Science (OPHS), Laboratory Sample 
Data Management Staff (LSDMS), has developed a double-folded mechanism 
to forward Salmonella testing results to individual establishments as 
they become available. First, all Salmonella testing results will be 
available via FSIS' Laboratory Electronic Application for Results 
Notification (LEARN) system. By maneuvering through the components of 
this electronic program, an inspector can copy the applicable page and 
forward it to an establishment's management official as 
``notification'' as instructed by the contents of the LEARN directive--
10,200.1. In addition, an establishment can elect to provide OPHS, 
LSDMS, with an e-mail address, and the establishment's Salmonella 
testing results will be e-mailed to them as they are entered into its 
internal database. If an individual requests Salmonella testing data 
for an establishment, FSIS intends to respond to the request in turn, 
generally providing the specific existent information requested. Once a 
sample set is concluded, FSIS will post the results on its Web site on 
an aggregate basis (e.g., results will be identifiable only by the 
establishments' state and district locations). As sample sets continue 
to be collected and tested, FSIS will regularly update the content of 
the postings (e.g., by season or quarter) throughout the year. FSIS 
will not make the establishments' sample-by-sample results available on 
its Web site because the Agency is not convinced of the value of 
posting this information. While the value of this information to the 
tested establishment is clear, the value to the general public is not. 
FSIS can see the value to the general public of more frequent posting 
of information about trends in Salmonella testing results than the 
current annual reports that the Agency issues.

Request for Comment

    FSIS is seeking comment on its plan to modify its handling of 
Salmonella testing results. The Agency's final decision regarding the 
availability of Salmonella testing results will be published in the 
Federal Register.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it and make copies of this Federal Register 
publication available through the FSIS Constituent Update. FSIS 
provides a weekly Constituent Update, which is communicated via 
Listserv, a free e-mail subscription service. In addition, the update 
is available on-line through the FSIS web page located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov.
 The update is used to provide information regarding 
FSIS policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, recalls, and any other types of information that could 
affect or would be of interest to our constituents/stakeholders. The 
constituent Listserv consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that have requested to be 
included. Through the Listserv and web page, FSIS is able to provide 
information to a much broader, more diverse audience.
    For more information contact the Congressional and Public Affairs 
Office, at (202) 720-9113. To be added to the free e-mail subscription 
service (Listserv) go to the ``Constituent Update'' page on the FSIS 
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/oa/update/update.htm. Click on the 
``Subscribe to the Constituent Update Listserv'' link, then fill out 
and submit the form.

    Done at Washington, DC, on April 7, 2003.
Dr. Garry L. McKee,
Administrator.
[FR Doc. 03-8971 Filed 4-15-03; 8:45 am]