[Federal Register: February 27, 2006 (Volume 71, Number 38)]
[Notices]
[Page 9772-9777]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe06-28]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[Page 9772]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 04-026N]
Salmonella Verification Sample Result Reporting: Agency Policy
and Use in Public Health Protection
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice and response to comments.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
changes in how it uses the results from its Salmonella verification
sampling program for meat and poultry establishments to enhance public
health protection. The Agency is also changing how it reports these
results. These actions follow an April 2003 FSIS Federal Register
Notice asking for public comment on whether and how Agency policy could
be improved. This Notice responds to the comments received and presents
the Agency's views on the issues raised in the 2003 Notice.
FSIS will begin adding results from individual Salmonella
verification sample tests to reports the Agency regularly makes to meat
and poultry establishments that have asked to be informed of various
test results. These Salmonella sample results will be sent to
establishments as soon as they become available. FSIS will begin
posting quarterly nationwide data for Salmonella, presented by product
class, on the Agency Web site.
Moreover, the Agency will assess each completed Salmonella sample
set in light of either existing regulatory standards or recently-
published baseline study results, as appropriate. FSIS expects to take
follow-up action, which may include scheduling of another sample set or
assessing the design and execution of the food safety system, based on
how a plant's performance compares to the existing regulatory standard
or nationwide baseline results and to the presence of serotypes of
Salmonella that are common causes of human illness.
To further encourage industry process control efforts, the Agency
is providing a new compliance guideline containing information that
FSIS has found to be relevant to control of Salmonella, particularly
for poultry.
FSIS intends to monitor closely the percent positive in
verification samples month-by-month over the course of a full calendar
year, beginning in 2006. After one year FSIS will evaluate these data,
reassess how it reports Salmonella results for each class of products,
and consider making additional changes in how it reports and publishes
results.
ADDRESSES: FSIS invites interested persons to submit comments on this
notice. Comments may be submitted by any of the following methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. FSIS prefers to
receive comments through the Federal eRulemaking Portal. Go to http://www.regulations.gov
and, in the ``Search for Open Regulations'' box,
select ``Food Safety and Inspection Service'' from the agency drop-down
menu, then click on ``Submit.'' In the Docket ID column, select the
FDMS Docket Number to submit or view public comments and to view
supporting and related materials available electronically. After the
close of the comment period, the docket can be viewed using the
``Advanced Search'' function in Regulations.gov.
Mail, including floppy disks or CD-ROMs, and hand-or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW.,
Room 102 Cotton Annex, Washington, DC 20250.
Electronic mail: fsis.regulationscomments@fsis.usda.gov.
All submissions received must include the Agency name and docket
number 04-026N.
All comments submitted in response to this Notice, as well as
research and background information used by FSIS in developing this
document, will be posted to the regulations.gov Web site. The
background information and comments also will be available for public
inspection in the FSIS Docket Room at the address listed above between
8:30 a.m. and 4:30 p.m., Monday through Friday.
DATES: Effective Date: May 30, 2006.
FOR FURTHER INFORMATION: For further information contact Daniel
Engeljohn, Ph.D., Deputy Assistant Administrator for Office of Policy,
Program and Employee Development, FSIS, U.S. Department of Agriculture,
Room 3147, South Building, 14th and Independence SW., Washington DC
20250-3700; telephone (202) 205-0495, fax (202) 401-1760, e-mail:
daniel.engeljohn@fsis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
On July 25, 1996, FSIS published ``Pathogen Reduction; Hazard
Analysis and Critical Control Point (PR/HACCP) Systems'' (61 FR 38806).
This final rule established, among other measures, pathogen reduction
performance standards for Salmonella bacteria for certain slaughter
establishments and for establishments producing certain raw ground
products. The performance standards are codified at 9 CFR 310.25(b)(1)
and 381.94(b)(1). These performance standards are based on the
prevalence of Salmonella found by the Agency's nationwide
microbiological baseline studies, which were conducted before the PR/
HACCP rule was adopted (http://www.fsis.usda.gov/Science/Baseline_Data/
). The performance standards set a maximum number of Salmonella-
positive samples allowable per sample set. Raw product classes covered
by performance standards are carcasses of cows/bulls, steers/heifers,
market hogs, broilers (young chickens), and ground beef, ground
chicken, and ground turkey.
FSIS selected Salmonella as the target organism because it is one
of the most common causes of foodborne illness associated with meat and
poultry products; it is present to varying degrees in all major
species; and interventions targeted at reducing the presence of this
pathogen may be beneficial in reducing contamination by other enteric
pathogens.
The sampling and testing of carcasses and raw products for
Salmonella is conducted by FSIS. The Agency verifies that
establishments are meeting the Salmonella standards by having federal
[[Page 9773]]
inspection personnel collect product samples from individual
establishments over the course of a defined number of sequential days
of production to complete a sample set. The product samples are sent to
FSIS laboratories for analysis. The number of samples in a sample set
varies by product class. The maximum number of positive samples allowed
in a set is based on data from the nationwide baseline studies. The
standards were defined on a product class basis so that an
establishment operating at the baseline level would have an 80% chance
of meeting the standard.
An initial sample set or a set that follows a passed set is termed
an ``A'' set; other codes (such as ``B'', ``C'', and ``D'') represent
sample sets collected from establishments in follow-up testing after a
failed set. All code ``A'' sample sets are collected at randomly
selected establishments, while code ``B,'' ``C,'' and ``D'' sets are
collected at establishments that failed a previous set. Generally, all
establishments within a product class are tested by FSIS once annually
for the ``A'' set. However, establishments that fail the performance
standard are scheduled for a follow-up sample set after the
establishment takes corrective action (i.e, the ``B,'' ``C,'' and ``D''
sets) resulting in one or more additional sample sets annually.
The overall percentage of positive results for Salmonella in ``A''
samples has been used to track progress in addressing control of
Salmonella. These aggregate data are based on large numbers of test
results. Although they provide a useful estimate of Salmonella control,
FSIS verification sampling is not designed to estimate national
prevalence of Salmonella by class of products. A ``true'' prevalence
can only be derived from randomly selected samples in a nationwide
baseline study designed within the boundaries of a specified
statistical confidence level.
To date, with a few exceptions, the Agency has reported Salmonella
test results to an establishment only when a sample set is completed.
The Agency has also published aggregate yearly data from ``A'' sets, by
product class (e.g., steers/heifers, broilers, ground beef) and plant
size as defined in the PR/HACCP final rule (large, small, and very
small).
FSIS has initiated an evaluation of how it uses and reports test
results from its Salmonella sampling program. In a Federal Register
Notice of April 16, 2003, we asked for comments on our established
policy for reporting sample results (68 FR 18593-18596; http://www.fsis.usda.gov/Regulations_&_Policies/2003_Notices_Index/index.asp
). In evaluating its policy, the Agency had concluded that
there would be value in making public more information about Salmonella
sampling results than just the annual reports. Additionally, in
response to that notice, several establishments stated that there would
be significant value in receiving the results of individual samples.
As the Agency considered the comments on the 2003 Notice and how
best to proceed, FSIS was influenced by recent epidemiological data
from the Centers for Disease Control and Prevention (CDC) that have
raised concern. In recent years, overall human infections from
Salmonella serotypes have decreased only slightly, from an incidence of
approximately 16 cases per 100,000 persons in the reference period
1996-98 to 14.7 cases per 100,000 persons in 2004. To put this
information in context, USDA and FSIS recognize the U.S. Department of
Health and Human Services National Food Safety Objectives--``Healthy
People 2010''--(http://www.healthypeople.gov/document/tableofcontents.htm
as appropriate for guiding strategic planning for
public health. Healthy People 2010 set a goal for 2010 of 6.8 cases/
100,000 persons, which is less than half the rate of current incidence.
FSIS recognizes that raw meat and poultry are not the only contributors
to the disease burden associated with Salmonella. However, when the
serotypes of Salmonella present on raw meat and poultry are considered,
particularly in comparison to those commonly associated with human
illness, FSIS believes that Salmonella-contaminated raw meat and
poultry are important sources of this pathogen.
Furthermore, while CDC data show the incidence of human Salmonella
Typhimurium (S. Typhimurium) infection as decreasing by 41% between the
1996-98 baseline and 2004, the incidence of two other leading
serotypes, S. Enteritidis and S. Heidelberg, did not change
significantly. Human infection incidence from S. Newport increased by
41%. Moreover, microbial resistance to antibiotics associated with
serotypes of Salmonella may be increasing. This change has been
particularly noted with S. Newport, which has emerged in recent years.
(See ``Preliminary FoodNet Data on the Incidence of Infection with
Pathogens Transmitted Commonly Through Food--10 Sites, United States,
2004'' from Morbidity and Mortality Weekly Review, CDC, April 15, 2005,
352-356; available at http://www.medscape.com/viewarticle/503230.)
Importantly, these same Salmonella serotypes and others also commonly
associated with human illness have been found in samples of raw meat
and poultry collected by FSIS.
Recent Agency data have shown the percentage positive in Salmonella
``A'' sets of broilers (young chickens) from establishments of all
sizes increasing from 11.5% in 2002 to 12.8% in 2003 to 13.5% in 2004.
Although the overall percentage of positive samples in verification
testing is still below the nationwide baseline prevalence figures, this
persistent upward trend in positive verification samples provides
reason for concern, particularly because of the associated increased
exposure of the public to serotypes of Salmonella that are commonly
associated with human illness. [See http://www.fsis.usda.gov/ophs/haccp/salm6year.htm.
] Other product classes have not shown such a
persistent upward trend, and the percentage of positive verification
samples has declined for all three beef product classes.
FSIS has found through assessments of food safety systems, in
establishments that failed to meet the performance standard that these
establishments have flaws in the design and execution of their control
procedures. Establishments with an elevated percentage of samples
positive for Salmonella in verification testing have not adequately
addressed the following specific issues: design flaws in HACCP plans
and Sanitation Standard Operating Procedures, failure to execute the
food safety system as designed, failure to ensure that corrective
actions are effective, and failure to reassess the food safety system
once changes are made.
FSIS has evidence, based on its experience with establishments that
failed one or more Salmonella sets that then implemented corrective
actions and came into compliance, that, when properly addressed in the
establishment's food safety system, Salmonella levels in regulatory
samples can be controlled. For example, Agency data show that those
establishments performing well--e.g., with percent positive Salmonella
samples at or less than 50% of a relevant standard or baseline for at
least five consecutive sets--do so with remarkable consistency and
predictability. Conversely, establishments with higher percent positive
results show much greater variability and inconsistency in their sample
results. Not only do establishments that have had at least one sample
set in which the percent of positive samples was greater than 50% of
the Salmonella standard have a higher average of percent positive
Salmonella samples, but, as a group, such establishments also
repeatedly exceed 50% of the standard. Most of
[[Page 9774]]
these establishments maintain an elevated average percentage of
positive Salmonella samples until FSIS conducts a food safety
assessment and identifies food safety system design and execution
weaknesses to the establishments. Based on experience, FSIS has found
that once these establishments implement effective control measures as
part of their HACCP system, they demonstrated an ability to maintain
good control of Salmonella. These patterns show that Salmonella in
regulatory sample results can be controlled consistently through
efforts by establishments to maintain process control. These HACCP-
related efforts, particularly in broiler operations, mirror the
outcomes realized by the beef industry for control of Escherichia coli
O157:H7 (E. coli O157:H7) when the beef industry began implementing
better process control for this pathogen.
For all these reasons, the Agency has concluded that it needs to
re-direct its Salmonella verification sampling program to ensure that
it is useful in providing enhanced public health protection.
Agency Decisions
FSIS is announcing several steps to increase public health
protection. First, the Agency will add results from individual
Salmonella verification sample tests to reports the Agency regularly
makes to meat and poultry establishments that have asked to be informed
of various test results. These Salmonella sample results will be sent
to establishments as soon as they become available. The National
Advisory Committee on Microbiological Criteria for Foods has noted that
Salmonella test results are useful measures of process control, and
establishments using Statistical Process Control (SPC) may find this
timely information to be particularly helpful in gauging the
effectiveness of their process control measures.
The Agency will also begin posting quarterly, rather than annually,
nationwide Salmonella data by product class on the Agency Web site.
As soon as possible in 2006, FSIS will issue instructions to
inspection program personnel and begin conducting sampling in
establishments slaughtering young turkeys, the subject of a recently-
published baseline study (see 70 FR 8058, February 17, 2005; http://www.fsis.usda.gov/Regulations_&_Policies/2005_Notices_Index/index.asp
). These baseline data will provide a useful guide for FSIS
Salmonella verification testing of turkey carcasses and evaluation of
process control by turkey slaughter establishments, which the Agency
has expected to control Salmonella levels on carcasses even in the
absence of a performance standard. FSIS will use the baseline results
to guide its testing of turkey carcasses in the same manner that it
will use the existing regulatory standards to guide its testing of
broilers and other classes of raw products.
Tables A and B show existing Salmonella performance standards and
recently-developed microbiological baseline guidance results for young
turkeys and geese.
Table A.--Salmonella Performance Standards
[See 9 CFR 310.25 and 381.94]
------------------------------------------------------------------------
Performance Maximum
standard Number of number of
Product class (percent samples positives
positive for tested to achieve
Salmonella) (n) standard
------------------------------------------------------------------------
Steers/heifers.................. 1.0% 82 1
Cows/bulls...................... 2.7% 58 2
Ground beef..................... 7.5% 53 5
Market hogs..................... 8.7% 55 6
Fresh pork sausages............. NA NA NA
Broilers........................ 20.0% 51 12
Ground chicken.................. 44.6% 53 26
Ground turkey................... 49.9% 53 29
Turkeys......................... NA NA NA
------------------------------------------------------------------------
Table B.--Salmonella Baseline Guidance Results for Young Turkeys and
Geese
------------------------------------------------------------------------
Baseline
prevalence Number of Maximum
Product class/method (percent samples number of
positive for in set positives
Salmonella)
------------------------------------------------------------------------
Young turkey carcasses/sponge... 19.6% 56 13
Goose carcasses/sponge.......... 13.7% 54 9
------------------------------------------------------------------------
Each completed sample set result will be recorded in one of three
categories in relation to the standard or baseline guideline:
Category 1. Consistent Process Control for Salmonella Reduction.
50% or less of the performance standard or baseline guidance,
demonstrating the best control for this pathogen.
Category 2. Variable Process Control for Salmonella Reduction. From
51% of the performance standard or regulatory guideline to the
performance standard or baseline guidance, demonstrating intermediate
control for this pathogen.
Category 3. Highly Variable Process Control for Salmonella
Reduction. Greater than the performance standard or baseline guidance,
demonstrating the least control for this pathogen.
Selection of the Category 1 versus Category 2 criteria was based,
in part, on the long-term evidence from regulatory samples collected
between 1998 and 2004 that there is a statistically significant
difference in the likelihood, calculated as an odds ratio, of serotypes
of Salmonella that are common causes
[[Page 9775]]
of human illness in the U.S., based on the high frequency of these
serotypes in products from establishments in Category 2 compared to
those in Category 1. FSIS has identified many of the most common
serotypes of human illness in broiler samples. These serotypes include
Salmonella Heidelberg, Typhimurium, Enteritidis, I 4,[5],12:i:-,
Montevideo, Newport, and Infantis.
FSIS believes that targeting its Salmonella sampling according to
these categories will enable it to maximize the effective use of its
resources. Since establishments that have not implemented effective
process controls for Salmonella may fluctuate between categories until
process control is assured, FSIS expects to consider the results of at
least two consecutive sample sets before categorizing the
establishment. By using more than one sample set to make this
categorization, FSIS will have a good basis on which to assess process
control. Furthermore, FSIS expects to use the most recent sample set
result, regardless of whether the sample set was an ``A,'' ``B,'' or
other set result, plus its next result in effecting this approach. FSIS
expects to assess the utility of this decision criterion at least
annually.
An individual establishment with results in Category 1 for at least
its last two sets will be considered by the Agency to have demonstrated
sustained good control of Salmonella presence in its product over time.
Thus, barring special circumstances (for example, eliminating an
antimicrobial treatment during the production process), such an
establishment will be tested no more than once a year, but at least
once every two years, unless it gets a result that puts it in Category
2 or 3. As stated earlier, until now, an establishment not exceeding
the performance standard generally was not scheduled for more than one
sample set annually.
Once any establishment receives a result from FSIS testing for
Salmonella that puts it in either Category 2 or 3, FSIS likely will
subject the establishment to retesting at any time. However,
establishments in Category 3 should expect that the retesting will be
sooner and more frequent within a calendar year than that for
establishments in Category 2. Moreover, the Agency will evaluate
Category 2 and 3 establishments on a case-by-case basis and determine
any further actions to take, which may include increased sampling
(e.g., at rehang, at pre-chill, and at post-chill to gather information
about changes in the microbiological profile during the same production
process), expedited serotyping, enhanced verification of the
establishment's food safety programs (e.g., intensified focus on
sanitation procedures and record keeping), and assessment of the
establishment's food safety system. Importantly, establishments in
Category 2 and 3 that demonstrate an inability to control for the on-
going presence of serotypes of Salmonella known to be associated with
common human illness will receive greater attention by FSIS regarding
the verification of the establishment's food safety programs.
FSIS data indicate that increased Agency scrutiny through food
safety assessments and verification testing leads to improved plant
performance in controlling Salmonella. (See Fulfilling the Vision:
Initiatives in Protecting Public Health, USDA/FSIS, July 2004; http://www.fsis.usda.gov/PDF/Fulfilling_the_Vision.pdf
). Less frequent
sampling of those establishments that have a relatively low percent
positive of Salmonella samples will free Agency resources for
application to establishments that are not performing as well.
In addition, FSIS is providing a new compliance guideline
particularly related to the broiler industry containing information
that FSIS has found to be relevant to the control of Salmonella. This
compliance guideline will be available on the Agency Web site and as a
document in the FSIS docket room. The document will present information
on control measures that can help reduce the prevalence of Salmonella.
FSIS will also be obtaining more timely Salmonella serotype
information for each positive test result from its verification program
and may intensify testing or scrutiny via a food safety assessment of
establishments that produce product with serotypes of epidemiological
concern. Serotype identification requires additional analysis and thus
is not likely to be available when establishments receive their initial
sample results, but serotype information will be made available by FSIS
to establishments as soon as possible. FSIS will also publish annual
aggregate results for serotypes.
As soon as possible, FSIS will pursue sub-typing, including pulsed-
field gel electrophoresis of Salmonella found in the FSIS testing
program. In addition, FSIS expects to further assess the current
procedures in place for phage-typing pathogens found in regulatory
samples. The Agency expects to pursue mechanisms to further share this
important public health-related information with public health partners
such as CDC, the Food and Drug Administration, and the States in order
to find timely ways to compare subtypes of Salmonella with strains from
other public health surveillance systems.
Furthermore, the Agency will be conducting baseline studies for
Salmonella and other pathogens and indicator organisms among specific
product classes. These baseline studies will be statistically designed
to measure the national prevalence of microorganisms on regulated raw
products and to ascertain whether continuous improvement for pathogen
reduction is evident, as intended by the PR/HACCP final rule. New
baseline studies will be used to inform risk management policies, and
could provide support for new performance standards or baseline
guidance. Isolates from positive samples, particularly for pathogens,
are expected to be serotyped and analyzed for patterns of resistance to
antibiotic drugs.
FSIS is exploring the information systems enhancements needed to
implement fully these risk-based policies for Salmonella sampling.
The main Agency focus will be on control of Salmonella in slaughter
and combined slaughter/processing establishments because these
operations have direct control over this pathogen during sanitary
dressing and further processing. While grinders are certainly of
interest to FSIS, the best way to control Salmonella levels in ground
product is through control over the Salmonella levels in the source
materials. Thus, the slaughter and slaughter/processing combination
plants are the Agency's first concern, but policy for grinders will be
assessed during that year as well.
Further Agency Considerations
FSIS intends to monitor the Salmonella percent positive in
verification samples by product class over the course of a full year
beginning in July 2006. The Agency's current thinking is that if the
percent positive of Salmonella in verification samples over that one-
year period for the great majority of establishments (e.g., 90%) in a
specific product class is not at or below half the performance
standard/baseline guidance level (i.e., Category 1), FSIS will consider
whether there are further actions that should be taken to ensure that
establishments improve their control of Salmonella and further enhance
public health protection.
For example, FSIS would consider actions that would provide an
incentive to industry to improve controls for Salmonella. One approach
that FSIS has considered and favors is posting on the Agency Web site
the ``A'' set results
[[Page 9776]]
from the completed Salmonella sample sets for each establishment
producing that product class, identified by establishment name and
number. Publishing the results of these FSIS Salmonella analyses, which
have been used by the Agency as one component for assessing
establishment performance, could serve as a valuable support to an
establishment's process control efforts.
A study by USDA's Economics Research Service (ERS) has shown that
increased public information on food safety performance measures can
offer incentives to establishments to invest in process control by
helping them realize benefits from their investments, and thus spur
industry innovation in food safety (see Food Safety Innovations in the
United States: Evidence from the Meat Industry by Elise Golan, Tanya
Roberts, Elisabete Salay, Julie Caswell, Michael Ollinger, and Danna
Moore, AER-831, USDA/ERS, April 2004; http://www.ers.usda.gov/publications/aer831/
). FSIS believes that this study has relevance
regarding the Salmonella strategy articulated above relative to
publishing establishment-specific information associated with
Salmonella control. For example, a further processor of ground product
who purchased carcasses from a slaughter operation would not know
whether the carcass was produced with the best or worst safety
procedures, even though the procedures were in compliance with the
minimum regulatory requirements. This situation reduces incentives by
manufacturers of the source material (e.g., carcasses) to invest in
food safety innovation. By addressing this asymmetry, that is,
providing more information about the process control performance of
establishments related to Salmonella, FSIS believes it would be
providing the appropriate incentive for the meat and poultry slaughter
industry to attain consistent, good control for Salmonella. FSIS is
especially interested in receiving comment on this approach to ensuring
pathogen reduction in all raw products regulated by FSIS.
The Agency will also consider other actions, such as modifying its
approach to inspection, if widespread industry performance provides a
basis for reducing Agency concern about control for pathogens in
classes of raw product. For example, the Agency is aware that limits on
linespeeds are a concern to both the young poultry slaughter and the
hog slaughter industries. If widespread action within these industries
controlled Salmonella contamination such that the Agency, in its
testing of carcasses, consistently found industry-wide results at half
or below half the current standard/baseline guidance, FSIS would be
prepared to consider allowing the industries to study whether
linespeeds could be increased above the current regulatory limits. FSIS
also would be interested in any impact that such changes may have on
other regulatory obligations of the establishments and the Agency, as
well as other pathogens of public health concern (e.g., Campylobacter),
particularly as the industries seek to demonstrate continuous
improvement in their performance over time. Such studies could be
conducted through existing regulatory provisions for a waiver of the
meat and poultry regulations (9 CFR 303.2 and 381.3).
Although FSIS has an establishment-specific approach for
inspection, FSIS believes that, ultimately, it will take an industry-
wide effort to ensure that there is effective Salmonella control in raw
classes of product. FSIS experience with the beef industry regarding
control for E. coli O157:H7 ultimately resulted in an industry-wide
approach to reassess their HACCP plans in order to ensure that each
establishment had effective food safety systems. FSIS requests comment
on these potential actions and any other incentives that would be
useful in encouraging control of Salmonella.
Response to Comments on the Federal Register Notice of April 16, 2003
In deciding how to proceed, the Agency considered the nine comments
that it received on the April 2003 Notice.
Reporting to Establishments
Four comments supported reporting individual sample results to
establishments as they become available. Two comments suggested that
establishments should receive individual sample results if they request
them.
FSIS response: The Agency agrees with these comments. Receiving
individual sample results soon after the samples are taken will help
establishments in their assessment of why a production lot of product
resulted in a positive sample. An establishment will be able to
determine whether it had a problem on the day in question, or whether
positives are associated with a particular supplier. On balance,
therefore, it now seems clear that making the information available to
establishments will be of value to the establishments in determining a
prompt and appropriate response. Accordingly, FSIS will add results
from individual Salmonella verification sample tests to reports that
the Agency regularly makes to meat and poultry establishments that have
asked to be informed of various test results.
Posting Individual Sample Results on the Agency Web Site
Three comments opposed posting individual sample results to the
Web, and one comment opposed posting results in general.
FSIS response: The Agency agrees that posting individual sample
results (as opposed to completed sample set results) to the Web would
be of little value to consumers, industry, or public health officials.
Moreover, it would impose a significant burden on the Agency.
Posting Completed Sample Set Results on the Agency Web Site
Two comments specifically supported posting completed sample set
results on the Agency Web site, identified by establishment. Two
comments suggested publishing aggregate data only, either monthly or
quarterly, and one of these comments asked that data be presented by
FSIS Inspection District.
FSIS response: The Agency has concluded that posting quarterly
nationwide data for Salmonella, presented by product class, on the
Agency Web site is most appropriate at this time. Doing so will provide
consumers with more timely, meaningful information about overall
industry performance in protecting public health. FSIS believes that
posting completed sets, in aggregate, would be appropriate because
sample sets, as a measure of controlling and reducing harmful bacteria
on raw meat and poultry, are intended to enable FSIS and the
establishment to verify the effectiveness of an establishment's HACCP
controls in reducing harmful bacteria as measured by the presence of
Salmonella.
Freedom of Information Act (FOIA) Exemption
One comment supported the Agency's long-standing position that
Salmonella sample results should be exempt from disclosure under the
FOIA. One comment stated that FOIA exemptions do not apply to
Salmonella sample results.
FSIS response: The Agency agrees that it has treated Salmonella
sample results as pre-decisional and has exempted such results from
disclosure under FOIA. FOIA exemptions are generally permissive and are
left to the appropriate discretion of the Agency involved. When FSIS
makes individual sample results available to
[[Page 9777]]
establishments, as described herein, the results can no longer be
considered pre-decisional. Given the potential value in making sample-
by-sample test results available, as described above, FSIS has decided
that it is reasonable to include individual Salmonella verification
sample results in reports to those establishments that request various
sample results and to make completed set results, in aggregate and
quarterly, available on the Agency Web site.
Salmonella as Basis for Performance Standard
Two comments questioned the appropriateness of Salmonella as an
indicator organism or as the basis for a performance standard, noting
that Salmonella occurs in food products other than the meat, poultry,
and eggs regulated by FSIS.
FSIS response: FSIS notes that the National Advisory Committee on
Microbiological Criteria for Foods in its report of August 8, 2002
(Final--Response to the Questions Posed by FSIS Regarding Performance
Standards with Particular Reference to Ground Beef Products; http://www.fsis.usda.gov/OPHS/NACMCF/2002/rep_stand2.pdf
) concluded that
Salmonella test results are useful measures of process control. The
Agency also notes its concern regarding recent increases in Salmonella
positives in some raw product classes and in human infections from
certain Salmonella serotypes that are associated with meat and poultry.
FSIS, furthermore, will be obtaining Salmonella serotype information
for each positive test result from its verification program in a more
timely manner and will consider intensifying testing and scrutiny of
establishments that produce products with serotypes of epidemiological
concern.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and, in particular, minorities, women, and persons with
disabilities are aware of this notice, FSIS will announce it on-line
through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2006_Notices_Index/index.asp.
The
Regulations.gov Web site is the central online rulemaking portal of the
United States government. It is being offered as a public service to
increase participation in the Federal government's regulatory
activities. FSIS participates in Regulations.gov and will accept
comments on documents published on the site. The site allows visitors
to search by keyword or Department or Agency for rulemakings that allow
for public comment. Each entry provides a quick link to a comment form
so that visitors can type in their comments and submit them to FSIS.
The Web site is located at http://www.regulations.gov/.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS web page. Through
Listserv and the web page, FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an email subscription service which
provides an automatic and customized notification when popular pages
are updated, including Federal Register publications and related
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/
and allows FSIS customers to sign up
for subscription options across eight categories. Options range from
recalls to export information to regulations, directives and notices.
Customers can add or delete subscriptions themselves and have the
option to password protect their account.
Done at Washington, DC, on February 21, 2006.
Barbara J. Masters,
Administrator.
[FR Doc. 06-1783 Filed 2-22-06; 1:15 pm]
BILLING CODE 3410-DM-P