[Federal Register Volume 73, Number 18 (Monday, January 28, 2008)]
[Notices]
[Pages 4767-4774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1432]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2006-0034]
Salmonella Verification Sampling Program: Response to Comments
and New Agency Policies
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice, response to comments, and request for comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
new policies for the Agency's Salmonella Verification Sampling Program
and related activities conducted in meat and poultry establishments.
These changes include publication of completed FSIS verification sample
set results for establishments that show inconsistency in their ability
to meet Salmonella performance standards, beginning with those from
young chicken slaughter establishments; a voluntary incentive-based
program for meat and poultry establishments that should yield
significant data on attribution of human illness to FSIS-regulated
products; and increasing the Agency's use of targeted sampling
approaches and collaborative serotype and subtype data. FSIS is taking
these actions to advance its efforts to achieve the Agency's public
health goal of significantly reducing human cases of salmonellosis.
This Notice explains the basis for these actions and responds to
comments received by the Agency on its Federal Register Notice of
February 27, 2006 (71 FR 9772-9777) on Salmonella policy.
DATES: Submit comments by February 27, 2008. The policies described in
the Notice are planned to take effect March 28, 2008.
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
[[Page 4768]]
Service'' and ``Notices'' from the agency drop-down menu and 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-ROM's, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture,
Food Safety and Inspection Service, 1400 Independence Avenue, SW., Room
2534 South Building, Washington, DC 20250.
Electronic mail: [email protected].
All submissions received must include the Agency name and FDMS
docket number FSIS-2006-0034.
All comments submitted in response to this Notice will be posted to
the regulations.gov Web site. Comments will also 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.
FOR FURTHER INFORMATION: For further information contact Daniel
Engeljohn, PhD, Deputy Assistant Administrator for Office of Policy,
Program and Employee Development, FSIS, U.S. Department of Agriculture,
Room 349-E, South Building, 14th and Independence SW., Washington, DC
20250-3700, (202) 205-0495, fax (202) 720-2025, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
Background
The actions announced in this Notice result from an Agency re-
evaluation of its verification sampling program for Salmonella in meat
and poultry establishments. Pertinent issues were raised in two
previous FSIS Federal Register Notices published in April 2003 (68 FR
18593-18596) and February 2006 (71 FR 9772-9777). The Notice of April
2003 asked for public comment on FSIS practices and its then-current
thinking about Salmonella. The February 2006 Notice responded to public
comments on the 2003 Notice, announced changes in how the Agency
schedules Salmonella verification sample sets and in how it reports
sample results, and discussed outstanding concerns and possible new
directions.
The Salmonella verification sampling program formally began with
the Agency's Final Rule on Pathogen Reduction; Hazard Analysis and
Critical Control Point (PR/HACCP) Systems that issued on July 25, 1996
(61 FR 38805-38989; http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf). Among other things, the PR/HACCP rule set Salmonella
performance standards for establishments that slaughter selected
classes of food animals or that produce selected classes of raw ground
products. FSIS uses the Salmonella performance standards 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. The microbiological performance
standards for reduction of Salmonella in raw products, coupled with
performance criteria for use with E. coli testing allow FSIS to verify
the effectiveness of process controls in slaughter establishments.
Raw products with established PR/HACCP performance standards
include carcasses of cows/bulls, steers/heifers, market hogs, and young
chickens (broilers). Processed products measured by performance
standards include ground beef, ground chicken, and ground turkey. The
performance standards for these product classes are based on the
prevalence of Salmonella as determined from nationwide microbiological
baseline studies that FSIS conducted before PR/HACCP was implemented.
In addition, FSIS established a guideline level for young turkey
carcasses, relying on a baseline study that the Agency published in
2005 (70 FR 8058-8060; http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/02-046N.pdf).
Under the Salmonella verification program as conducted from 1996 to
2006, the Agency verified that establishments are meeting a Salmonella
standard or guideline by having FSIS inspection program personnel
collect randomly-selected product samples from randomly-selected
individual establishments over the course of a defined number of
sequential days of production to complete a sample set. Generally,
these tests were conducted once each year for each establishment.
Procedures for doing this are described in Appendix E of the PR/HACCP
Final Rule (61 FR 38917-38928). 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.
The Agency's February 2006 Notice announced specific actions that
the Agency intended to take. FSIS has effected these actions over the
last eighteen months. The following is a list of these actions and
their current state of implementation:
1: Reporting results of each individual Salmonella test to
establishments as they become available.
Implemented in July 2006.
2: Posting quarterly nationwide Salmonella data by product class.
Implemented in June 2006 beginning with the first quarter of 2006.
See http://www.fsis.usda.gov/Science/Quarterly_Salmonella_Results/index.asp.
3: Collecting swab samples from turkey carcasses for Salmonella
analysis.
Implemented in June 2006.
4: Classifying establishments in three process control categories
according to their performance in completed sample sets relative to the
regulatory performance standard or baseline guidance level for
Salmonella percent positive in their product class, and scheduling
sample collection according to these categories:
Category 1:--Establishments with percent positive Salmonella
samples at 50% or less of the performance standard or guideline in the
two most recent completed sample sets.
Category 2:--Establishments with percent positive Salmonella
samples above 50% but not exceeding the standard/guideline in the most
recent completed sample set.
Category 3:--Establishments with percent positive Salmonella
samples exceeding the standard/guideline in the most recent completed
sample set.
Implemented in July 2006 when a new scheduling algorithm, based on
these process control categories, went into effect. The February 2006
Notice explained that a Category 1 ``establishment will [now] 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'' (71 FR at 9776). This
algorithm has the effect of placing greater emphasis on scheduling
young chicken establishments, which are currently the Agency's top
priority.
5: Conducting Food Safety Assessments (FSAs) in establishments in
Category 3 for Salmonella before sample set failure.
Implemented by FSIS Notice in August 2007.
6: Issuing a new compliance guideline on control of Salmonella for
young chicken slaughter establishments.
Implemented in August 2006 with publication of ``Compliance
Guideline
[[Page 4769]]
for Controlling Salmonella in Poultry, First Edition'' at http://www.fsis.usda.gov/PDF/Compliance_Guideline_Controlling_Salmonella_Poultry.pdf. A second edition, updated to include guidance for
controlling Campylobacter as well, is in development.
7: Obtaining serotype (species) data from isolates and timely
sharing of serotype data with establishments.
Implemented in May 2006. After one of the FSIS field service
laboratories reports the analysis results, isolates of Salmonella-
positive samples are serotyped to identify species at the USDA Animal
and Plant Health Inspection Service's National Veterinary Services
Laboratories in Ames, Iowa. In recent years virtually all samples
positive for Salmonella have been serotyped. Identified serotypes are
communicated to establishments as soon as they are reported by APHIS to
FSIS, usually within two weeks after a sample has been reported as
positive. A report listing aggregate identified serotypes by year was
posted in August 2007 on the Agency Web site at http://www.fsis.usda.gov/Science/Serotypes_Profile_Salmonella_Isolates/index.asp.
8: Obtaining timely access to pulsed field gel electrophoresis
(PFGE) subtype data identifying specific strains of Salmonella
serotypes.
Implemented in August 2007 when FSIS and the Agricultural Research
Service (ARS) signed a cooperative Memorandum of Agreement for subtype
data sharing. Under this agreement, PFGE subtype information on
Salmonella isolates collected by FSIS from meat and poultry products is
matched with subtype information from isolates associated with human
illness in PulseNet, a data base maintained by the Centers for Disease
Control and Prevention (CDC). FSIS has routine access to data for all
subtype isolates maintained by ARS, in a time frame short enough to be
relevant to in-plant and public health investigations.
9: Updating baseline studies to better measure improvements in
pathogen reduction in all classes of raw product.
Implemented; a new young chicken baseline began in June 2007, and a
young turkey baseline is scheduled for 2008. Additional baselines are
being planned for the future.
10: Monitoring process control changes and movement between
Categories 1, 2, and 3 by tracking Salmonella percent positive in
verification samples by product class over the course of a full year
beginning in July 2006.
Implemented. In the February 2006 Notice, the Agency established
its goal of having 90% of all meat and poultry establishments
manufacturing raw classes of product subject to Salmonella testing in
Category 1 by October 1, 2010. In addition, FSIS explained that it
would consider taking action to provide incentives for enhanced public
health protection if that benchmark had not been met by July 2007. As
of the benchmark date of June 30, 2007, Category 1 included 73% of
turkey establishments, 72% of young chicken establishments, 60% of
market hog establishments, 59% of cow/bull establishments, and 45% of
steer/heifer establishments. As of September 30, 2007, Category 1
included 84% of turkey establishments, 73.5% of young chicken
establishments, 63% of market hog establishments, 61% of cow/bull
establishments, and 45% of steer/heifer establishments. While these
results did not reach the July 2007 benchmark, they are encouraging
signs of progress. Though the Agency is encouraged by this progress, it
has continuing concerns about the adverse effects of Salmonella on
public health. FSIS has determined, therefore, that more robust
incentives, including publication of establishment verification
sampling results, are necessary to encourage the industry to improve
its performance in controlling Salmonella.
Public Health Concerns
To put the 2006-2007 results of the Salmonella verification program
cited above in perspective, CDC has reported that in 2006 Salmonella
serotypes accounted for 38.6% of all human foodborne infections, making
it the most common human foodborne pathogen (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5614a4.htm?s_cid=mm5614a4_e). Moreover, the U.S.
Department of Health and Human Services National Food Safety Objectives
``Healthy People 2010''--which USDA and FSIS use to guide strategic
planning for public health--set a goal of 6.8 cases of salmonellosis
per 100,000 persons by 2010 (http://www.healthypeople.gov/document/tableofcontents.htm). The 2006 rate for human Salmonella infections
reported by CDC is 14.81 cases per 100,000 persons, more than double
the target rate for Healthy People 2010. This represents only a slight
decrease in overall human infections from Salmonella serotypes from an
incidence of approximately 16.8 cases per 100,000 persons in the CDC
reference period of 1996-98.
Meat and poultry products contain some serotypes of Salmonella that
are rarely found in human patients suffering from salmonellosis, but
other serotypes found in various meat and poultry products are among
those often identified in human cases. The seven most commonly
identified Salmonella serotypes causing human infection in the United
States according to the CDC are Typhimurium, Enteriditis, Newport,
Javiana, Montevideo, Heidelberg, and I 4, [5], 12:i:-. Combined, these
serotypes accounted for 64% of human cases of salmonellosis. The CDC
notes that of these seven most common Salmonella serotypes found in
human infections in 2006, only Typhimurium has declined since the 1996-
98 baseline study, and its incidence since 2003 has been stable. S.
Enteriditis, however, has increased by 28% since 1996-98. S. Newport,
which has shown signs of mutation toward multi-drug resistance, has
increased by 42% since 1996-98.
Most importantly, the CDC has determined that poultry is an
effective vector for S. Enteriditis, a cause of human infections. A
FoodNet case-control study found that human infections that were
associated with eating chicken displayed Enteriditis bacteriophage type
(PT) strains that matched the predominant strains that are isolated
from chickens. This match in PT strains indicates that the association
in the cases between eating chicken and human illness was causal.
FSIS has reported its own data showing an increase during calendar
years 2000-2005 in the frequency of isolation in young chickens of
Salmonella, particularly S. Enteriditis (http://www.fsis.usda.gov/Science/Progress_Report_Salmonella_Testing/index.asp). The percent
positive of Salmonella samples in young chicken establishments tested
by the Agency's PR/HACCP verification program increased from 11.5% in
2002 to 12.8% in 2003, 13.5% in 2004, and 16.3% in 2005. In 2006,
however, the Agency's testing program showed the lowest percentage of
young chickens that had tested positive for Salmonella in several
years--11.4%. This 30% decrease in percent positive samples from 2005
is noteworthy, particularly given that beginning with 2006 FSIS has
directed its resources toward testing young chicken establishments with
variable or highly variable process control in order to reverse the
upward trend in percent positives seen in such establishments. This
one-year reversal is promising, though the change in FSIS sampling
direction in 2006 makes comparisons of percent positive samples with
previous years uncertain. The trend will need to be confirmed and of
course sustained.
[[Page 4770]]
During the 2000-2005 period, the annual number of S. Enteriditis
isolates found by FSIS increased more than four-fold, and the
percentage of establishments with sample isolates positive for
Enteriditis increased by nearly three-fold (http://www.cdc.gov/ncidod/EID/vol12no12/06-0653.htm). During 2000-2005, the number of states with
Enteriditis isolates found in young chickens sampled by FSIS increased
by 71%. Moreover, the predominant Enteriditis bacteriophage types found
were PT 13 and PT 8, strains isolated from human infections associated
with eating chicken as described in the CDC report cited above. FSIS
data from 2006 show that the proportion of Enteriditis found among all
poultry isolates of Salmonella jumped from 7.71% in 2005 to 13.66%, a
77.2% increase (http://www.fsis.usda.gov/PDF/Serotypes_Profile_Salmonella_Tables_&_Figures.pdf#page=61).
In addition, an emerging concern for the Agency is the Salmonella
serotype having the antigenic formula I 4,[5],12:i:-, which has been
increasingly recognized by CDC since the mid-1990's in human illness
cases. In 2006 the serotype was the 7th most commonly identified
serotype in U.S. human surveillance data. FSIS began reporting
antigenic formulas in 2004. In 2004 and 2005, I 4,[5],12:i:- was the
sixth most commonly identified serotype in young chicken isolates, and
in 2006 it was the fifth most commonly identified serotype in young
chicken isolates.
FSIS notes that product classes other than young chickens have not
shown such persistent upward trends, and the percentage of positive
verification samples has declined for all three beef product classes.
The Agency has become concerned, however, about the rise in human
illnesses attributable to S. Newport beginning in the late 1990's. S.
Newport, which has shown signs of developing resistance to antibiotics,
is found most notably in the cattle classes and especially ground beef
but has been detected in all FSIS-regulated commodities.
Posting of Completed Verification Sample Set Results
Given the concerns described above with serotypes of human health
significance and the fact that the goal of having 90% of establishments
in Category 1 was not reached by July 1, 2007, FSIS will begin
publishing completed Salmonella sample set results from young chicken
slaughter establishments with variable (Category 2) and highly variable
(Category 3) process control. This decision was foreshadowed in the
February 2006 Notice when the Agency stated that by providing
information on Salmonella performance:
FSIS believes it would be providing the appropriate incentive
for the meat and poultry slaughter industry to attain consistent,
good control for Salmonella. (71 FR at 9776)
The Agency believes that it is appropriate to begin by publishing the
results from young chicken slaughter establishments because the
Agency's consistent priority has been to address the adverse trends in
Salmonella percent positive samples seen in young chickens during 2000-
2005 and the serotypes of human health significance found in them. A
prototype table for Web posting of these results has been published on
the Agency Web site (http://www.fsis.usda.gov/PDF/Salmonella_Initiative_Prototype.pdf). Posting of these results will begin 60 days
after the publication of this Notice. Posting of results from Category
2 and 3 establishments slaughtering other product classes will begin
120 days after the publication of this Notice.
FSIS believes it important to publish results from establishments
in these categories of greater concern because targets set by the
agency have not been met, despite the Agency's allocation of a greater
amount of its verification sampling program resources to establishments
in Categories 2 and 3 since 2006. FSIS is still considering, however,
whether publishing completed verification sample set results from young
chicken slaughter establishments showing consistent (Category 1)
process control, as well as from other meat and poultry product
classes, would be useful in terms of creating incentives for greater
process control. FSIS will closely monitor Freedom of Information Act
(FOIA) requests related to this issue, as well as comments received,
and expand or modify the publication process as necessary. As with the
individual sample results that have been reported to establishments
since 2006, all unpublished completed sample set results are available
upon request under FOIA.
Salmonella Initiative Program (SIP)
FSIS stated in the February 2006 Federal Register Notice (71 FR at
9776):
[T]he 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. * * * 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).
Since the February 2006 Notice, poultry establishments have
expressed interest in specific waivers that would either permit an
increase in the volume of birds slaughtered or allow the chilling of
eviscerated carcasses in a different manner than is allowed by existing
time/temperature requirements.
The Agency has developed the Salmonella Initiative Program (SIP) to
offer such waivers to Category 1 establishments, which have already met
the current FSIS goals, as an incentive for volunteer meat and poultry
slaughter and processing establishments to increase process control
efforts for Salmonella and Campylobacter. Although the February 2006
Federal Register notice discussed specifically allowing young poultry
and hog slaughter industries to study whether linespeeds could be
increased above the current regulatory limits, all slaughter or
processing establishments that produce product subject to Salmonella
standards or guidelines would be eligible to apply for the SIP. The SIP
was published as a prototype on August 31, 2007 (http://www.fsis.usda.gov/PDF/Salmonella_Initiative_Program_Criteria.pdf).
The SIP is designed to facilitate definite improvements in ongoing
control for Salmonella in all classes of raw product subject to
Salmonella standards or guidelines, as stated in 9 CFR 303.1(h) and
381.3(b). The SIP will have the further benefit of providing key
microbial data to the Agency from sampling and analysis conducted by
establishments that would volunteer for the SIP. For SIP, the Agency
will waive provisions of the meat and poultry regulations so that new
procedures, equipment, or processing techniques can be tested. To
participate in the SIP, establishments must submit a request in
accordance with specific criteria.
Program Criteria
To be eligible, an establishment must be in Category 1 as a result
of FSIS Salmonella verification sample testing, with at least one of
the sample sets being completed since February 2006. An establishment
selected for the Program must provide FSIS with copies of relevant
information about its food safety system (e.g., interventions in use,
volume of production, evisceration equipment type, line speeds,
laboratory analytic procedures, and establishment sample set percent
positive rate).
Such establishments would be expected to operate under a waiver to
9
[[Page 4771]]
CFR 310.25 or 381.94 (Contamination with microorganisms; process
control verification criteria and testing; pathogen reduction
standards). An establishment selected for the SIP will be required to
take samples for microbial analysis on each line every day and during
each shift. The sample set is to be the same size as that used by FSIS
for verification testing of the specific product class, but, unlike
current FSIS practice, the establishment may take multiple samples on
one day. Each month establishments selected for the Program and
maintaining a Category 1 level of performance must, upon FSIS request,
provide the Agency with the Salmonella isolates from a randomly
selected establishment-collected set.
Each week poultry slaughter establishments selected for the SIP
will collect at least one sample at both rehang and post chill.
Establishments will collect the postchill sample at the approximate
time the carcass sampled at re-hang would move to postchill, so as to
reflect the time it takes for a carcass to pass from rehang to post
chill. The establishment is to analyze the samples for Campylobacter,
generic Escherichia coli, and Salmonella. At least monthly, at least
one rehang sample and one matched post-chill sample positive for any of
these microorganisms must be enumerated. The results must be provided
to FSIS at least quarterly.
The Salmonella percent positive rate for all sample sets collected
by either FSIS or the establishment will need to be maintained at or
below half the acceptable number of positive samples in the current
standard/guideline--e.g., 6 or fewer positive results from a randomly
selected set of 51 young chickens. If at any time the percent positive
rate, with either FSIS or establishment testing, exceeds half the
acceptable number of positive samples in the current standard/
guideline, the establishment must immediately suspend operating under
any waiver of the regulations, as well as intensify the frequency of
daily testing. A Category 1 level must be re-established within one
quarter for the establishment to remain in the SIP.
A selected establishment that at any time falls to a Category 2 or
3 level will have to provide FSIS with all Salmonella and Campylobacter
isolates from all establishment-collected sets for each week until it
meets the requirements for a Category 1 establishment, which must be
accomplished within one quarter. FSIS will conduct serotyping and PFGE
subtype pattern identification for the isolates and then, in
collaboration with CDC, assess the patterns against clinical isolate
patterns in PulseNet. FSIS will provide information to the
establishment about its samples monthly.
The Agency will check on establishment process control under SIP by
evaluating the laboratory performing microbial testing for an
establishment to ensure that the laboratory is following appropriate
procedures, reviewing establishment data to ensure that the
establishment is operating at a Category 1 level, and conducting
unannounced sampling. For such unannounced sampling, FSIS would obtain
a portion of the establishment's samples collected that day. For
samples resulting in the collection of rinsate, FSIS would gather 200
milliliters of the 400 milliliters of the rinse liquid used in
establishment sampling per the PR/HACCP final rule. For ground product
samples, FSIS would take one-half of the establishment collected
sample, of a weight sufficient for testing. These ``split samples''
would be analyzed by FSIS for Salmonella and used to determine whether
the establishment is maintaining effective and consistent process
control and whether its testing procedures are valid. Internal Agency
statistical analysis suggests that use of 12 samples per quarter would
not provide definite verification that the establishment is in fact
operating at a Category 1 level, but that given a certain number of
positive samples (e.g., 3 out of 12 for young chickens), it would be
sufficient to indicate that FSIS can no longer be confident that the
establishment is operating at a Category 1 level. Such results would
indicate that the processes to control Salmonella may be out of control
and therefore warrant further investigation and action by FSIS. As with
the individual sample results that have been reported to establishments
since 2006 and any unpublished completed sample set results, the
results from unannounced sampling are available upon request under
FOIA.
FSIS will terminate the Program in establishments that cannot
regain a Category 1 status within one quarter--i.e., an establishment
must have percent positive Salmonella samples at 50% or less of the
performance standard or baseline guideline.
Establishments must agree that they will provide FSIS with at least
30 days notice if they decide to terminate their participation in the
program.
Application Process
All SIP applications and requests for waivers should follow the
guidelines for submitting notifications and protocols for new
technologies posted on the FSIS Web site at http://www.fsis.usda.gov/regulations/New_Technology_Notification_&_Protocol_Submission/index.asp. Applications should be addressed to Dr. Isabel Arrington at:
[email protected].
FSIS foresees no limit on the number of slaughter or processing
establishments selected for the Program provided that no changes in
inspection would be required. The Agency, however, will select no more
than five establishments in which any waiver of regulatory requirements
may affect inspection whereby additional inspectors are needed.
Preference for selection of establishments where FSIS inspection
personnel would be increased will be given to those establishments 1)
with a positive rate for all sample sets collected by FSIS since
February 2006 of half the rate required to be in Category 1 (e.g., 5%
for young chickens), as well as for establishment-collected sample sets
completed within the past quarter, and 2) that in their HACCP plans
identify Salmonella as a hazard reasonably likely to occur or have
written controls in place to address Salmonella within the Sanitation
Standard Operating Procedures or other HACCP prerequisite programs.
Establishments requesting waivers that would require additional
inspectors will have 15 days after the publication of this Notice to
submit their requests. Establishments that have already submitted
applications before the publication of this Notice do not need to re-
submit their applications.
Establishments participating in the SIP can request waivers to FSIS
regulations if they can demonstrate that operating under such waivers
would facilitate definite improvements, as provided for in 9 CFR
303.1(h) or 381.3(b), whereby half the Category 1 criterion for
Salmonella is maintained. An establishment may further request a waiver
to any other regulatory requirement that it can demonstrate can be
appropriately waived under 9 CFR 303.1(h) or 381.3(b). The Agency will
respond to requests for waivers within 60 days.
Establishments that are currently operating under waived
regulations for On-Line Reprocessing (OLR) will have six months from
the date of publication of this Notice to decide if they wish to
continue under a waiver by applying for the SIP or otherwise revert to
operating without a waiver. After that six-month period, all OLR
waivers will be terminated. An establishment that chooses to terminate
its OLR waiver or has an OLR waiver terminated at six months after
publication of this Notice can apply for a waiver under SIP after
[[Page 4772]]
a waiting period of nine months after termination of the old waiver.
Establishments that are currently operating under waived
regulations for the HACCP-based Inspection Models Project (HIMP) will
also have six months from the date of publication of this Notice to
decide if they wish to continue receiving waivers by applying for the
SIP or otherwise revert to operating without a waiver. After that six-
month period, all HIMP waivers will be terminated. An establishment
that chooses to terminate its HIMP waiver or has an HIMP waiver
terminated at six months after publication of this Notice can apply for
a waiver under SIP after a waiting period of nine months after
termination of the old waiver.
FSIS plans to continue developing the SIP to collect data that
would allow the Agency to determine the appropriateness of a regulation
incorporating elements of the SIP into a public health based poultry
slaughter inspection system.
Restructuring the Salmonella Verification Program
Sampling and Testing Initiatives
To meet the complex challenge for public health protection
presented by Salmonella, FSIS has decided that it will need to sample
meat and poultry products targeted through the use of available data.
This type of targeted approach represents a shift from randomly based
sampling of all meat and poultry establishments, regardless of the
relative risk posed, that the Agency conducted before July 2006 when it
defined the three process control categories for meat and poultry
establishments according to their performance relative to a performance
standard or guideline.
Using the new sample scheduling algorithm adopted in 2006, each
month FSIS now schedules approximately 75 new verification sample sets
for Salmonella in raw classes of product. FSIS allocates its sampling
resources within classes of raw product based on consideration of
specified criteria. If criterion 1 (All new plants regardless of
product class) does not obligate all 75 available sample sets, then
criterion 2 (All Category 3 plants regardless of product class) is
fulfilled; when criterion 2 does not obligate all available sample
sets, then criterion 3 (All Category 2 plants, depending upon product
class) would be fulfilled, etc. (For a full discussion of the sample
scheduling algorithm, see http://www.fsis.usda.gov/Science/Scheduling_Criteria_Salmonella_Sets/index.asp.) As a result of allocating
resources in this way, rather than sampling randomly, FSIS is now able
to fulfill many of the higher priority criteria, i.e. the Agency is
able to complete current sampling of establishments of greater concern.
Because Category 1 establishments are normally not scheduled for
verification sampling until at least a year after their last set, the
Agency is developing an algorithm for random unannounced sampling to be
conducted at all Category 1 establishments during the period that may
extend up to two years between full Salmonella verification sets. The
purpose of this unannounced sampling algorithm is to ensure that
establishments currently in Category 1 maintain their performance. The
Agency's current thinking is that it will conduct quarterly, random
sampling at Category 1 establishments. As with the individual sample
results that have been reported to establishments since 2006 and any
unpublished completed sample set results, the results from unannounced
sampling are available upon request under FOIA.
The Agency has recognized that low-volume raw ground beef
producers, producing less than 1000 pounds of product per day,
constitute a large part of the sampling frame for establishments
eligible for verification sample set scheduling though they account for
a very small proportion of the raw ground beef supply. Since production
of ground beef at these establishments may not occur throughout a week
or month, sampling them for Salmonella may be extended for a year or
more before a set is completed, as opposed to no more than a couple of
months of sampling for higher volume establishments.
Consequently, FSIS is developing plans for modifying its sampling
procedures at very low-volume establishments. The Agency has determined
that a more practical approach for low volume establishments would be
to test the samples that are already being collected at these
establishments for E. coli O157:H7 for Salmonella as well. As a result,
these establishments will be removed from the PR/HACCP verification
sample set scheduling frame. The FSIS field service laboratories will
perform qualitative testing for the presence or absence of Salmonella
using the same methodology, discard criteria, and reporting as those in
place for Salmonella ground beef HACCP samples. Samples that screen
positive will be quantitatively analyzed, i.e. the Salmonella organisms
present will be enumerated, using the MPN (Most Probable Number)
procedure.
Import samples from ground beef or trim may also be tested for
Salmonella as well as other pathogens of public health concern, with
the PFGE patterns being entered into PulseNet for attribution purposes.
FSIS will exclude from the Salmonella verification testing program
schedule any slaughter establishment that processes all carcasses
slaughtered into ready-to-eat (RTE) product or diverts all of its raw
products to another official federally-inspected establishment for
further processing into a RTE product. If the establishment is
undergoing sampling for Salmonella, but then elects to send all
affected product to RTE, FSIS will continue to sample until the set is
completed. At the end of the set, FSIS will verify that all product
will be designated for further processing into RTE product within the
establishment or in another Federal establishment. If and when such
establishments again produce raw product for sale, they will be re-
scheduled for Salmonella verification sets.
In addition, FSIS will identify and sample all sub-groups of raw
classes of product that are not currently tested in full verification
sets. For example, FSIS intends to identify and sample all ratite or
religious-exempt operations, at least quarterly. FSIS will report
individual results back to establishments, determine the aggregate
percent positive rate for each sub-group of product classes, and post
the aggregate percent positive rate for the subgroup at the Agency Web
site. FSIS will also identify and implement a data analysis plan to
ensure that the Agency is aware of adverse trends in percent positive
samples. As with all pathogen-positive samples, isolates will be
further assessed for their PFGE patterns and the patterns will be
included in PulseNet for attribution purposes.
Data Usage
As noted above, the Agency committed in the last several years to
serotyping all isolates of Salmonella that it finds in sampling meat
and poultry products. In the past, sampling for Salmonella showed only
positive or negative results, indicating the presence or absence of
detectable Salmonella but not the specific dominant serotype present in
a positive sample. Salmonella includes at least 2500 serotypes, or
subspecies, and many of them are rarely associated with human illness.
As discussed above, isolates from Salmonella-positive samples are
sent from the FSIS Field Service laboratories to the USDA-APHIS
National Veterinary Services Laboratories (NVSL)
[[Page 4773]]
for bacteriophage serotyping. FSIS reports the identified serotypes
that NVSL finds in the product to the originating establishment after
it receives the results from APHIS. Obtaining and sharing serotype
information in this way enables both FSIS and meat and poultry
establishments to determine and monitor the serotypes of human health
significance that are appearing in Agency sampling. All identified
serotypes are now aggregated by year and reported on the Agency Web
site at http://www.fsis.usda.gov/Science/Serotypes_Profile_Salmonella_Isolates/index.asp.
The Agency is beginning to use the level of common serotypes of
human health significance, based on percentile distributions of
available serotype data, in evaluating establishment performance. For
young chickens, for example, 0-1 such serotypes of human health
significance in a verification set of 51 samples would be considered a
low level, 2-4 would be a medium level, and 5 or more would be a high
level. FSIS is now including the level of serotypes of human health
significance in the End of Set letter it sends to each establishment
upon completion of a verification sample set for Salmonella. This
serotype information will help an establishment in evaluating and
improving its process control performance.
The Agency schedules a Food Safety Assessment (FSA) at any
establishment with either a medium or high level of serotypes of human
health significance found in the most recent Salmonella verification
sample set. An FSA is scheduled as soon as possible for any
establishment that has failed a Salmonella verification set before the
full set has been completed, as was announced in the February 2006
Federal Register Notice on Salmonella policy.
Because the Agency is now able to complete sampling for many high
priority establishments, it is beginning to advance sample set
scheduling of Category 1 establishments based on the presence of
serotypes of human health significance in the product. In some cases,
this factor may mean that, even though an establishment is in Category
1, it will be tested within one year of the completion of its last
sample set.
Identifying the specific serotypes found in FSIS sampling was an
important advance in estimating the impact of meat and poultry products
on public health. A fundamental issue for the Agency has been what the
public health community calls ``the attribution gap''--the question of
the relationship between findings of Salmonella in meat and poultry
products and human cases of salmonellosis. In serotyping all samples
that are positive for Salmonella, FSIS has taken a key initial step
toward answering this question and intends to take further steps in the
near future.
An even more targeted approach that is now being used extensively
is subtyping, which identifies the specific genetic strains found in
positive samples. All FSIS sample isolates are PFGE-subtyped by the
Agricultural Research Service (ARS), which also tests isolates for
Anti-Microbial Resistance (AMR) as mentioned above in reference to S.
Newport.
As of August 2007, FSIS has continuous direct access to the ARS
VetNet database for PFGE subtypes. FSIS is now able to compare the PFGE
patterns from its positive samples to those available in the CDC
PulseNet database of cases of human illness. As a result, FSIS should
be able to get a clearer picture of whether, and the extent to which,
the products that it regulates are contributing to human illness.
The Agency is also exploring the possibilities for sharing and use
of industry data as a supplement to data gathered by FSIS and other
public organizations. On August 8-9, 2007, FSIS hosted a public meeting
of the National Advisory Committee on Meat and Poultry Inspection
(NACMPI) to review and discuss, among other things, mechanisms for
sharing industry data with FSIS (see http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2007-0027.htm). The SIP described above is designed in part to obtain data
from the industry beyond what FSIS is able to gather itself. The
serotyping and enumeration data obtained from the SIP may be
particularly useful in answering the question of to what degree human
illnesses result from FSIS-regulated products.
Response to Comments on the Federal Register Notice of February 27,
2006
In deciding how to proceed, the Agency considered the nine comments
it received during the comment period on the Notice it published in
February 2006 (one comment was sent twice in different formats and
registered twice). One additional comment that was received well after
the comment period closed involved an industry proposal for a specific
incentive program.
Categories
One comment stated that the performance categories should be
expanded to capture more nuances in plant performance over time. This
point was echoed by other commenters, who expressed concern that the 3-
category scheme is too broad.
FSIS Response: The Agency continues to believe that the 3-category
scheme is appropriate. It is easy to administer, and it captures the
most important information regarding Salmonella control in
establishments.
Quarterly Summary of Salmonella Positives
Several comments asserted that data presented as a quarterly
aggregate could be misleading since testing is ``biased'' toward plants
with marginal or substandard performance and because of seasonal
variation in Salmonella positives. On the other hand, another comment
stated that, since establishments will now receive individual sample
results as soon as they are available, they can adjust their processes
so as to avoid ``failing'' sets and thus may make performance appear to
be better than it is.
FSIS Response: The Agency's decision to sample a higher percentage
of establishments, as described above, and to present establishments in
performance categories relative to a standard or guideline removes
inherent ``bias'' that could have been introduced by simply presenting
gross percentages of positive samples. Sampling a higher percentage of
establishments captures better the relative performance of different
product classes, and categorizing establishments according to a
performance standard or guideline better defines the differences
between establishments.
Posting of Completed Sets by Establishment
One comment stated that posting such results will be confusing to
the public.
FSIS Response: The Agency believes that the 3-category system is
easily understandable, that it appropriately and effectively describes
significant differences between categories of establishments, and that
posting results will provide a valuable incentive to improve process
control. Should we find that the public is confused by the information,
we will revise our approach to ensure that the information is
meaningful and easily understood.
Testing Frequency
One comment stated that the current annual frequency of testing
will not provide adequate evidence of sustained process control,
particularly for Category 1 establishments, which may only be tested
once every two years. The
[[Page 4774]]
same comment raised questions as to how the Agency adjusts sampling for
establishment size and volume. Two other comments urged the Agency not
to reduce testing frequency for Category 1 establishments.
FSIS Response: The Agency has carefully considered all pertinent
factors to maximize testing and data productivity. FSIS intends to
stagger testing of Category 1 establishments so that a full 24 months
will not pass before an establishment is tested again. Further, the
Agency intends to conduct random, unannounced sampling of Category 1
establishments during the period between full verification sample sets.
For these reasons, FSIS believes that its frequency of testing will
ensure that the status of a Category 1 establishment is appropriately
tracked. It is also important to note that FSIS does not regard the
Salmonella results alone as an indication of ``adequate evidence of
sustained process control''. Verification of process control will rely
on an establishment's ability to meet Salmonella performance standards,
the establishment's own generic E. coli test results, FSIS inspectional
observations, reports of illness associated with product produced at an
establishment, and other factors.
Performance Standards
One comment noted that the performance standards should be
reevaluated through regularly updated baseline studies. Another comment
stressed that continual improvement sought by statistical process
control approaches requires the tightening of standards. On the other
hand, one comment argued that the Agency's focus on reducing
performance to a fraction of the standard or guideline ignores the
validity of the baseline-derived standard/guideline as an index of
realistic process capability.
FSIS Response: The Agency is committed to updating baseline studies
when needed. The Agency does not agree that establishing performance
objectives at one-half of the performance standard/guideline ignores a
baseline standard and that the Agency's objectives for process control
are realistic and necessary. FSIS believes that further knowledge of
attribution factors will show that continual improvement in reducing
occurrence of human pathogens in meat and poultry will reduce the
incidence of human salmonellosis.
Salmonella Subtyping Methodology
One commenter recommended phage-typing over pulsed field gel
electrophoresis (PFGE) for subtyping, and another commenter said more
discussion was needed before the Agency should choose to use PFGE data.
Another comment, on the other hand, recommended PFGE for subtyping.
FSIS Response: Phage-typing is primarily used in reference
laboratories and is impractical for regulatory purposes. The Agency
believes that PFGE has proven to be a valid and appropriate methodology
for obtaining subtype information from verification sampling and
baseline studies.
Enumeration of Salmonella and Attribution Questions
One comment urged the Agency to conduct enumeration analysis of its
verification samples in order to investigate the causal factors in
human salmonellosis related to dose level.
FSIS Response: Enumeration is very expensive and of doubtful value
for practical regulatory purposes that are qualitative in nature. FSIS,
however, is committed to exploring questions of attribution for human
disease and recognizes that enumeration of Salmonella would have a
positive role to play in such an investigation. For this reason, the
Agency is requiring participants in the Salmonella Initiative Program
to enumerate a portion of their Salmonella and Campylobacter isolates.
Incentives and Further Actions
One comment stated that the Agency should begin posting all
completed sample sets immediately rather than first allowing a one-year
period for collecting data to determine whether publication of
establishment results was necessary. Two comments urged the Agency not
to consider any modifications in inspection practices without strong
evidence of superior establishment performance.
FSIS Response: The Agency believes that the lead-time announced in
the February 2006 Notice of one year (from July 2006 to July 2007) for
tracking results was appropriate. The key point is that the Notice
informed the industry that process control improvements were crucial
and needed to be accomplished in a timely manner. The Agency agrees
that modifications in inspection should only occur if there is strong
evidence of superior establishment performance, and it is exploring
such possibilities in the Salmonella Initiative Program for Category 1
establishments described above.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that
minorities, women, and persons with disabilities are aware of this
notice, FSIS will announce it online through the FSIS Web page located
at http://www.fsis.usda.gov/regulations/2007_Notices_Index/. FSIS
will also 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, and other types of information
that could affect or would be of interest to constituents and
stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade groups,
consumer interest groups, health professionals, and other individuals
who have asked to be included. The Update is also available on the FSIS
Web page. Through the Listserv and Web page, FSIS is able to provide
information to a much broader and more diverse audience. In addition,
FSIS offers an e-mail subscription service which provides automatic and
customized access to selected food safety news and information. This
service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Options range from recalls to export information
to regulations, directives and notices. Customers can add or delete
subscriptions themselves, and they have the option to password protect
their accounts.
Done in Washington, DC on: January 22, 2008.
Alfred V. Almanza,
Administrator.
[FR Doc. E8-1432 Filed 1-25-08; 8:45 am]
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