[Federal Register Volume 75, Number 93 (Friday, May 14, 2010)]
[Notices]
[Pages 27288-27294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11545]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2009-0034]
New Performance Standards for Salmonella and Campylobacter in
Young Chicken and Turkey Slaughter Establishments; New Compliance
Guides
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
new performance standards for the pathogenic micro-organisms Salmonella
and Campylobacter for use in young chicken and turkey slaughter
establishments. The new performance standards were developed in
response to a charge from the Food Safety Working Group. The Agency
tentatively plans to implement these new performance standards for
chilled carcasses in July 2010. The new standards are based on recent
FSIS Nationwide Microbiological Baseline Data Collection Programs: The
Young Chicken Survey and the Young Turkey Survey. The Agency invites
comments on the new performance standards.
FSIS is also announcing that it has posted on its Web site the
third edition of the compliance guide for controlling Salmonella and
Campylobacter in poultry and a compliance guide on pre-harvest
management to reduce E. coli O157:H7 contamination in cattle. FSIS
issues guidance documents to present current Agency thinking on
specific topics related to food safety. Though Agency guidance
documents are recommendations rather than regulatory requirements and
are revised as new information becomes available, FSIS encourages meat
and poultry establishments to follow this guidance. FSIS requests
comments on these guidance documents.
DATES: Comments are due by July 13, 2010.
ADDRESSES: Comments may be submitted by either 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. Go to http://www.regulations.gov.
Follow the online instructions at that site for submitting comments.
Mail, including floppy disks or CD-ROMs, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture
(USDA), FSIS, Room 2-2127, George Washington Carver Center, 5601
Sunnyside Avenue, Mailstop 5474, Beltsville, MD 20705-5474.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2009-0034. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or to comments received,
go to 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 CONTACT: Daniel Engeljohn, Ph.D., Deputy
Assistant Administrator for Office of Policy and Program Development,
FSIS, U.S. Department of Agriculture, Room 349-E, Jamie Whitten
Building, 14th and Independence, SW., Washington, DC 20250-3700;
telephone (202) 205-0495, fax (202) 720-2025;
[email protected].
SUPPLEMENTARY INFORMATION:
Background
FSIS is the public health regulatory agency in the U.S. Department
of Agriculture (USDA) that is responsible for ensuring that the
nation's commercial supply of meat, poultry, and processed egg products
is safe, wholesome, and appropriately labeled and packaged. FSIS is a
participant in the President's Food Safety Working Group (FSWG), which
was created by President Obama in March 2009 to recommend improvements
to the U.S. food safety system. The FSWG is chaired by Secretary of
Agriculture Tom Vilsack and Health and Human Services Secretary
Kathleen Sebelius. In July 2009, the FSWG published Key Findings (FSWG
Key Findings) recommending a new, public health-focused approach to
food safety based on three core principles: Prioritizing prevention,
strengthening surveillance and enforcement, and improving response and
recovery.
The FSWG charged FSIS with ``cutting Salmonella risk in Poultry
Products'' by ``develop[ing] new standards to reduce
[[Page 27289]]
the prevalence of Salmonella in turkey and poultry'' and by
``establish[ing] a Salmonella verification program with the goal of
having 90 percent of poultry establishments meeting the new standards
by the end of 2010.'' These new Salmonella standards will be applied to
sample sets from establishments included in the Agency's Salmonella
Verification Program in the place of the performance standards for
young chickens (as broilers) codified at 9 CFR 381.94 and the standards
for turkeys announced in a Federal Register Notice of February 17,
2005. The FSWG further charged FSIS with ``develop[ing] a new
performance standard for Campylobacter for young chickens and
turkeys.'' This notice announces that FSIS has developed such
performance standards. The notice also describes the estimated public
health impact that is likely to result if these standards are met.
The performance standards for young chickens and turkeys set out in
this notice are based on the Agency's recent Nationwide Microbiological
Baseline Data Collection Programs: The Young Chicken Baseline Survey
(YCBS), and the Young Turkey Baseline Survey (YTBS).
From July 2007 to June 2008, the YCBS collected and analyzed 6,550
samples at 182 establishments that slaughtered young chickens and
produced whole carcasses under Federal inspection. Rinsate samples were
taken both at re-hang and post-chill locations, from whole carcasses
that were shaken in bags together with 400 mL of sample rinse solution.
``Re-hang'' refers to the location in the process after the picker and
prior to evisceration of the bird. ``Post-chill'' refers to the point
in the process where the carcasses exit the immersion chiller or other
chill media (such as ice) after all slaughter interventions have taken
place, but before entering coolers or proceeding to further processing.
These samples were analyzed by different methods to estimate the
prevalence or ``qualitative'' rate and the levels or ``quantitative''
measures (colony forming units per milliliter or cfu/mL) of two human
pathogens, Salmonella and Campylobacter, and four non-pathogenic
``indicator organisms'' that track process control: Generic Escherichia
coli, Aerobic Plate Count (APC), Enterobacteriaceae, and total
coliforms. Re-hang sample results were compared with post-chill sample
results, and the comparison confirmed that microbial loads are
significantly reduced by the time the carcasses reach post-chill.
The Agency has used the post-chill sample results from the YCBS,
weighted by volume, to estimate the prevalence of Salmonella and
Campylobacter on inspected and passed young chicken carcasses. These
prevalence estimates constitute the new performance standards announced
in this notice. These performance standards will apply to all young
chickens, including roasters and Cornish game hens. The Agency intends
to use the same sample collection and analysis procedures that it used
in the baseline.
The YTBS report is being prepared for publication. In the YTBS,
FSIS collected and analyzed 1,442 carcass sponge samples at the re-hang
and post-chill locations from young turkeys (including young breeder
turkeys) slaughtered in 58 Federal establishments from August 2008 to
July 2009. Inspection program personnel used two sponges, each
moistened with 25 mL of solution, for each carcass sampled at the two
locations. They swiped each sponge over 100 cm\2\ of the thigh and back
of one half of the carcass (50 cm\2\ on each part). One of the two
sponges used at each location was used to analyze for Salmonella and
the other for Campylobacter. For Salmonella samples, each sponge plus
the 25 mL of solution was enriched to determine the presence or absence
of Salmonella. For Campylobacter samples, from each 25 mL sponge sample
portion, 1-1.3 mL was extracted for the direct plating test, which is
referred to as the ``1 mL'' procedure.
The 1 mL procedure provides data on levels of organisms present but
is relatively insensitive because of the small size of the sample
portion analyzed and thus detects positive samples with higher levels
of organisms. The remaining 24 mL of solution, which contains the
sample sponge, was enriched so as to detect positive samples with low
levels of organisms and thus to help estimate prevalence. Thus, the
sample results were used to estimate the prevalence or ``qualitative''
rate and the levels or ``quantitative'' measures of the same organisms
as for the YCBS. The Agency used the post-chill sample results from the
YTBS, weighted by volume, to estimate the prevalence of Salmonella and
Campylobacter at post-chill. The Agency then used those estimates of
prevalence to develop the new performance standards announced in this
notice. The sample collection and analysis procedures used in assessing
compliance with the performance standard will be the same as used in
the baseline. A technical paper on the method used to develop the
performance standards is posted at the FSIS Web site with this notice
at http://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/index.asp.
These performance standards are derived from the poultry baseline
surveys and from 2008-2009 Salmonella Verification Program data. FSIS
estimated the potential public health impacts of the proposed
performance standards.\1\ For estimating potential public health
impacts regarding the Salmonella standards, the Agency used both the
baseline data and the more current verification data because of changes
observed in the industry since the collection of the baseline data,
which may lead to slight underestimates of prevalence relative to other
approaches. For estimating the potential impact of the Campylobacter
standards, only baseline data were available. Note that FSIS's
estimates of the potential reductions in human illnesses from
Salmonella and Campylobacter should be considered separately; it is not
appropriate from a scientific standpoint to add them together. A
technical paper on the method used to develop the potential public
health impacts is posted at the FSIS Web site with this notice at
http://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/index.asp.
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\1\ These estimates include a variety of assumptions. An area of
considerable uncertainty is the determination of the number of
attributed illness because the existence of Salmonella or
Campylobacter itself does not mean that there is a human health
impact because the true FSIS share of Salmonella and Campylobacter
illnesses caused from consumption of poultry is unknown.
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FSIS intends to conduct more frequent baseline studies, at
intervals not greater than every four years, and to make appropriate
adjustments to these performance standards based on the results of the
studies. Given the performance standards discussed in this notice, the
Agency requests comments on practical and realistic goals for reducing
the prevalence of microbial pathogens.
Salmonella Performance Standards
Salmonella bacteria are among the most frequently-reported causes
of foodborne illness. The bacteria live in the intestinal tract of
humans and other animals, including birds. Salmonella contamination of
raw meat and poultry products occurs during slaughter operations, as
well as during the live-animal rearing process (e.g., on-farm
contamination can coat the exterior of the bird and remain attached to
the skin). Currently, such events cannot be
[[Page 27290]]
eliminated, and contamination of raw carcasses will result unless a
lethality antimicrobial treatment is applied (e.g., irradiation). These
events, however, can be minimized. Salmonella and, to a lesser extent,
Campylobacter may increase on pre-cooked poultry if subjected to
temperature abuse. However, levels present on and in raw poultry
product would only survive on the product presented for human
consumption if it is not cooked thoroughly. Also, if poultry is
improperly handled, Salmonella and Campylobacter can cross-contaminate
other foods or food contact surfaces.
Among Salmonella-contaminated poultry carcasses, the number of
Salmonella organisms is generally low. It is thought that human cases
of salmonellosis likely result when those small numbers of Salmonella
bacteria are subject to conditions that allow them to grow to sizeable
doses between production and consumption. Because the occurrence of any
Salmonella on a carcass poses a potential hazard for consumers,
measuring contamination, and thus setting standards, refers to
estimated prevalence of Salmonella among samples collected from
facilities and not to the quantitative level of individual samples. A
different approach is needed for Campylobacter, as explained below. The
Appendix to this notice provides a detailed history of Agency actions
regarding Salmonella.
New Salmonella Standard for Young Chickens
The estimated prevalence of Salmonella in young chicken carcasses
at post-chill based on volume-weighted YCBS baseline data collected
from July 2007 through June 2008 is 7.5%. Based upon its evaluation of
this new baseline data, the Agency has concluded that it should revise
its performance standard to further improve establishment control of
Salmonella in young chickens in order to reduce illnesses attributed to
this product. The Agency will lower the performance standard to the
current level indicated by the new baseline data accordingly, revise
establishment categories, and continue to publish the names of
establishments that do not meet the new Category 1 criteria. The Agency
will continue its qualitative approach to analyzing Salmonella samples
for presence/absence under the new performance standard, leaving
unchanged the current sample procedures for Salmonella requiring 51
samples per set. Inspection program personnel will continue to collect
400 mL of rinsate for each sample, from which a 30 mL portion is
analyzed.
Under the new performance standard, the Agency will:
Establish a new performance standard of 7.5 percent based
on the estimated prevalence of Salmonella-positive results from the
2007-8 YCBS data.
Continue collecting and analyzing a 51-sample set.
Set 5 out of 51 positive samples as the maximum number of
positives allowed to achieve the new performance standard, which will
provide an 80 percent probability of an establishment meeting the
standard when operating at the 7.5% performance standard.
Continue the Category 1/2/3 approach as determined by an
establishment's most recent sets:
[cir] Category 1 = two consecutive sets with no more than two
positives;
[cir] Category 2T = two positives or fewer in last set, 3 or more
positives in prior set;
[cir] Category 2 = last set with 3-5 positives, any result in
prior set;
[cir] Category 3 = last set with six or more positives, any result
in prior set.
Continue publishing Category 2 and 3 establishments based
on the performance standard in effect when the last sample set was
begun. FSIS will continue to follow the criteria it uses to select
establishments for posting--Category 2 and 3 establishments are posted,
Category 1 and 2T establishments are not posted, and establishments in
a product class will not be published if 90 percent of its eligible
establishments are in Category 1 and no establishment is in Category 3.
Prioritize the scheduling of testing of young chicken
establishments that are not meeting the new standard.
Under the current performance standard, approximately 82 percent of
young chicken establishments eligible for the Salmonella Verification
Program are in Category 1. Under the new performance standard,
approximately 57 percent of eligible establishments would be in the new
Category 1, representing a significant tightening beyond the current
Category 1. Another 28 percent is in new Category 2, and 15 percent is
in new Category 3.
The Agency's experience after 2006 with the industry response to
Salmonella policies implemented that year leads the Agency to estimate
that approximately half of the 15 percent of establishments that would
not meet the new standard will improve their food safety systems to do
so during the first two years of implementation. Much of that
improvement, we believe, would likely occur in the first year. This
would result in a shift of 7-8 percent of establishments meeting the
new standard. This improved performance, when added to the 85 percent
of establishments that already meet the new standard, would result in
more than 90 percent of establishments meeting the new standard and
thus, meeting the FSWG goal to be accomplished by the end of 2010.
The Agency has applied a model to estimate the potential public
health impact of the proposed performance standards. The model contains
considerable uncertainty about the relationship between the rate of
contamination on raw carcasses and human illness as well as assumptions
about how establishments will change their behavior as a result of the
new guidance. Under the assumption that the 7-8 percent of
establishments improving performance to meet the new standard would
improve to the average of those establishments that already meet the
new standard, the Agency estimates that after the first two years of
implementation, it is possible that approximately 26,000 human
illnesses would be averted annually when compared to the period prior
to implementation of the standard. This would be a reduction of
approximately 12 percent of human illnesses from the current 220,000
attributed to this cause, as discussed in the public health impacts
paper referenced above. This would be a permanent structural reduction
of 26,000 illnesses averted for each future year as compared to before
implementation.
Additional public health benefits could potentially be realized as
more establishments move into the new Category 1 status. The Agency
will carefully analyze data on individual establishments to see if
further public health benefits can be projected if establishments
increasingly move into the new Category 1 status.
Campylobacter Performance Standard for Young Chickens
Campylobacter species, including C. jejuni, C. coli, and C. lari,
can be isolated from the intestinal tract of poultry and poultry
products. The two most frequently occurring Campylobacter species of
clinical significance for human consumption of food are C. jejuni and
C. coli. These species are the ones most often isolated in poultry
products.
Until the recent baselines, the Agency had limited data on
Campylobacter, in part because of difficulties with available
methodology to account for presence and numbers of this pathogen. In
2005, the National Advisory Committee on Microbiological Criteria for
Foods (NACMCF) was asked to
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address Campylobacter, particularly with regard to the analytical
utility of methodologies for the upcoming YCBS. In its final report
(NACMCF on Campylobacter methodology), the NACMCF recommended that FSIS
adapt the direct plating enumeration methodology to detect and
enumerate Campylobacter that had been developed by USDA's Agricultural
Research Service (ARS).
In the YCBS, accordingly, rinsate samples were analyzed using two
distinct procedures adapted from the ARS methodology. A quantitative
detection and enumeration procedure was used to analyze both re-hang
and post-chill rinsate samples, and a qualitative detection method,
which included an enrichment step, was used only with the rinsates
obtained from post-chill samples. FSIS is revising its Microbiology
Laboratory Guidebook, Section 41.00, to include these qualitative and
direct plating quantitative procedures for the isolation,
identification, and enumeration of C. jejuni/coli/lari present in
poultry rinses and sponges. FSIS will use these procedures in the
verification testing for Campylobacter that it intends to conduct, as
discussed in this notice.
With the methodology employed in the baseline and in the
verification testing described in this notice, all 51 samples taken for
a set are to be analyzed both for Salmonella, using the standard Agency
method, and Campylobacter. Each portion of sample rinsate used for
Campylobacter analysis will be subdivided into two portions, one of 1
mL and one of 30 mL. The 1 mL and the 30 mL portions of this test are
begun in the laboratory at the same time. The result for the 1 mL
portion is available before the result for the 30 mL portion. The 1 mL
portion is plated for both qualitative (presence/absence) and
quantitative (enumeration) results. The 30 mL portion is first enriched
and then plated for qualitative (presence/absence) results only. The 30
mL enrichment-based test laboratory procedure increases the practical
sensitivity of testing primarily by accommodating significantly larger
test portions. Thus it can detect as few as 1 bacterial cell (referred
to as Colony Forming Unit or CFU) per 30 mL portion. Therefore the
theoretical Limit of Detection (LOD) per portion is calculated as 0.03
CFU per mL.
The 1 mL direct plating test procedure, on the other hand, is
relatively less sensitive in practice because of its much smaller size
and has a LOD of 1 CFU per mL rather than 0.03 CFU per mL, which means
that direct plating with the 1 mL portion will tend to detect samples
with higher contamination. Detecting samples with higher contamination
is crucial to addressing the public health concerns with regard to
Campylobacter contamination. If the 1 mL portion is qualitatively
negative, then the 30 mL portion will be used to determine whether the
sample is positive or negative for Campylobacter. As the 1 mL procedure
is relatively less sensitive and detects samples with higher
contamination, positive 1 mL results are considered positive for the 30
mL procedure as well. This approach, which was used in the YCBS, will
conserve limited laboratory resources without having a negative impact
on the verification program.
The 1 mL procedure offers the benefit of providing quantitative
data by enumerating the organisms present in these higher-load samples,
thus informing the Agency about the prevalence of high-load samples.
The 30 mL procedure can detect lower-load samples when necessary but,
because of the enrichment step required, cannot provide meaningful
quantitative data on initial contamination levels.
New Performance Standard for Campylobacter in Young Chicken Carcasses
In light of the FSWG recommendations discussed above, FSIS has
concluded that it should foster and encourage improved establishment
control of Campylobacter in young chickens by setting a performance
standard based upon the YCBS prevalence. The performance standard for
Campylobacter comprises two factors based on YCBS prevalence: One
specifying the percentage of 1 mL portions that are positive, and the
other specifying the percentage of total sample-specific positive
results counting either the 1 mL or the 30 mL rinsate portions as
positive. Accordingly, the Agency will:
Test each of the 51 samples in a Salmonella verification
set for Campylobacter using the initial 1 mL quantitative portion. If
the 1 mL procedure is negative, the 30 mL procedure will be performed.
Establish a performance standard for the 1 mL portion at
10.4 percent, which is the YCBS estimated prevalence for 1 mL portions,
with no more than 8 positive samples from the 1 mL results.
Establish the performance standard for the sample-specific
positive results, which is the YCBS estimated sample-specific
prevalence for 1 mL and 30 mL results combined, at 46.7 percent with no
more than 27 of 51 samples positive in any combination of 30 mL and 1
mL results. As the 1 mL procedure is relatively less sensitive and
detects samples with higher contamination, positive 1 mL results will
be considered positive for the 30 mL procedure as well.
This standard will allow the Agency to gauge both overall frequency
of contamination and the frequency of greater than expected carcass
contamination levels. The 1 mL component of the standard was added
based on the Agency's understanding that higher than expected numbers
of Campylobacter on chicken carcasses present a different challenge to
public health than with Salmonella. Campylobacter is found more
frequently, but it is not able to grow at temperatures below
approximately 86 degrees Fahrenheit. Thus, high levels of this pathogen
are unlikely at the point of consumption, unless they were present at
high levels before the product left the establishment. Conversely,
Salmonella can grow at colder temperatures, but positive carcasses tend
to have low initial levels of contamination. This Campylobacter
performance standard therefore addresses the need to minimize the
frequency of greater than expected levels of Campylobacter
contamination on carcasses.
After 90 percent of eligible establishments have been sampled for
two full sets, which the Agency estimates will be accomplished by 2012,
the Agency will consider setting establishment categories 1/2/3 for
Campylobacter under the new performance standard (separate from
Salmonella) and publishing Campylobacter Category 2/3 establishments.
Based on the Agency's experience with the industry response to
Salmonella policies implemented in 2006 (discussed above), the Agency
estimates that 50 percent of establishments that at present would not
meet the new Campylobacter standard would likely improve their food
safety systems to meet the standard during the first two years of
implementation. Assuming 75 percent of establishments meeting the new
standard, the public health impact model for Campylobacter estimates
that after the first two years of implementation, it is possible, not
withstanding considerable uncertainty, that approximately 39,000 human
illnesses would be averted annually as compared to the period before
implementation, a reduction of approximately 10 percent from the
current 400,000 attributed to this cause, as discussed in the potential
public
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health impacts paper referenced above. This result could yield a
permanent structural reduction of 39,000 illnesses averted for each
future year as compared to before implementation. Note however that
past reductions in Salmonella prevalence do not necessarily imply that
industry has the resources and the technical ability to further reduce
pathogen levels. There is likely a lower limit to pathogen levels that
can be achieved with current technologies.
Additional public health benefits could potentially be realized if
the Agency decides to implement a Category 1/2/3 approach, and
establishments move into the new Category 1 status. As with the
Salmonella verification program, the Agency will analyze data on
individual establishments sampled in the YCBS to evaluate whether
further benefits could be predicted if establishments increasingly move
into a hypothetical Campylobacter Category 1 status.
This Campylobacter testing program would require additional funding
in fiscal year 2011 to implement because of its associated demand on
laboratory resources. New employees will need to be hired and trained,
and laboratory supplies purchased, to run the tests. The President's
budget request for fiscal year 2011 includes a funding request for this
testing.
Salmonella Performance Standard for Young Turkey Carcasses
The Agency has decided to take a different approach to Salmonella
in turkeys. Past FSIS sampling data suggest that the prevalence of
Salmonella-positive broiler and turkey carcasses was similar (FSIS 1995
Broiler chicken baseline study; FSIS 1998 Young turkey baseline study;
Baseline Data). FSIS sampling data from the YTBS suggest that the
prevalence of Salmonella-positive whole young turkey carcasses is now
substantially less than the prevalence of Salmonella-positive young
chicken carcasses. The prevalence estimate at post-chill for whole
young turkey carcasses was about 1.7 percent, more than a 10-fold
decrease from the prevalence estimated from the previous turkey
baseline. The Agency notes, furthermore, that under the Category 1/2/3
approach used since 2006, more than 90 percent of young turkey
slaughter establishments have been in Category 1 and none in Category
3. Thus, the Category 2 establishments from this class have not been
published.
At the very low positive rates seen in whole young turkey
carcasses, sample sets much larger than those currently collected
(i.e., many more than 56 samples per set) would be necessary to detect
real differences in establishment performance. The Agency believes that
resources that have been used in tracking category status for this
product can be better utilized to address more pressing public health
concerns, including pathogens found in ground turkey and turkey parts
that have an increasing market share for the young turkey product
class.
For these reasons, the Agency has decided to establish an
acceptable positive rate for whole young turkey carcasses that is lower
than the current acceptable positive rate, but high enough that an
establishment actually operating at the YTBS prevalence will have at
least a 99 percent probability of meeting the new standard. The 99
percent probability chosen for the new acceptable positive rate would
allow fewer positive results in a set of 56 samples than under the
current turkey carcass performance standard. This approach will permit
the Agency to better utilize its resources, to focus its activities on
public health issues, and, at the same time, to continue to monitor or
evaluate industry performance. Specifically, the Agency will:
Establish a new performance standard of 1.7 percent for
post-chill with no more than 4 positive samples in a 56-sample set,
providing an approximate 99.7 percent probability of an establishment
meeting the standard when actually operating at the performance
standard.
Continue the 56-sample set under the new standard.
Publish the names of establishments that do not meet the
performance standard in their last set based on that set having begun
after implementation of this new standard.
Exclude young turkey slaughter establishments from posting
if 90 percent of establishments meet the new performance standard.
Prioritize scheduling of testing at turkey establishments
not meeting the new standard.
Based on current FSIS Salmonella Verification Program data on
establishment performance levels, 82 percent of eligible establishments
would initially meet the new performance standard for turkeys with no
more than 4 positive samples out of 56 in the last set. This level of
performance would come close to meeting the FSWG goal of 90 percent of
establishments meeting the new standard by the end of 2010. Using our
public health impact model, the Agency estimates approximately 100
human illnesses averted annually after the first two years of
implementation as compared to the period before implementation, a
reduction of approximately 1.5 percent from the current 9,000
attributed to this cause, as discussed in the public health impacts
paper referenced above. This public health impact could yield a
permanent structural reduction in illnesses.
The Agency believes that this performance standard, setting a level
below the current standard for Category 1, will provide an incentive
for the turkey industry to continue to improve its process control. As
noted above, FSIS estimates that only 82 percent of turkey
establishments will meet the new standard under their current
performance levels. Since the Agency plans to begin publishing the
names of establishments that do not meet the new standard, the Agency
has concluded that a significant incentive will be established for
immediate improvement in the turkey industry and for consistent
maintenance of good performance. This new approach can be accomplished
under the current sampling and testing infrastructure and current
funding levels. The agency plans to commence publishing the names of
establishments that do not meet the standard in sets begun after
implementation of the new standard.
Campylobacter Performance Standard for Young Turkey Carcasses
The estimated prevalence of Campylobacter at post-chill derived
from the YTBS is about 1.1 percent. As it did with its approach to
Salmonella in young turkeys discussed above, the Agency is setting a
low performance standard for Campylobacter with an acceptable positive
rate that provides a higher probability of meeting the standard when an
establishment is actually operating at the standard. Unlike with
Campylobacter in young chickens, however, the percent positive in young
turkeys is so low, especially with the 24 mL results (as described
above), that a single performance standard is indicated for any
combination of 1 mL or 24 mL results. FSIS intends to:
Establish a new performance standard at the YTBS
prevalence of 1.1 percent with no more than 3 positive samples in a 56-
sample set from any combination of 1 mL or 24 mL results, providing an
approximate 99.7 percent probability of an establishment meeting the
standard when actually operating at the performance standard.
Continue the 56-sample set under the new standard.
Prioritize scheduling of testing at young turkey
establishments not meeting the new standard.
After 90 percent of establishments have been sampled for
two full sets
[[Page 27293]]
(estimated by 2012), post names of establishments that do not meet the
standard in the last set on the Agency Web site.
Exclude young turkey slaughter establishments from posting
if 90 percent of establishments meet the new standard.
Based on our estimates, 81 percent of eligible establishments would
initially meet the new performance standard. Using our public health
impact model, the Agency estimates that approximately half of the
establishments that would not now meet the new standard will improve
their performance to do so. This assumption provides an estimate of
approximately 100 human illnesses averted after the first two years of
implementation as a permanent structural reduction as compared to
before implementation. This result would be a reduction of
approximately five percent from the current 1,700 illnesses attributed
to this cause, as discussed in the potential public health impacts
paper referenced above.
The Agency plans to begin posting the names establishments that do
not meet the new standard in 2012. The Agency believes this plan
provides an incentive for further improvements in process control in
the turkey industry and for consistent maintenance of good performance.
Compliance Guides
The agency has posted on its Significant Guidance Documents Web
page (Significant Guidance) the third edition of a compliance guide for
poultry slaughter. The guide includes new pre-harvest recommendations
for controlling Salmonella and recommendations for controlling
Campylobacter in poultry. FSIS has also posted on its Significant
Guidance Documents Web page a compliance guide on known practices for
pre-harvest management to reduce E. coli O157:H7 contamination in
cattle. This guide focuses on the prevention of E. coli O157:H7 through
reduced fecal shedding and during live animal holding before slaughter.
These two compliance guides represent current FSIS thinking, and
FSIS encourages establishments to begin using them. The guides present
recommendations and not regulatory requirements.
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
document, FSIS will announce it online through the FSIS Web page
located at http://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/index.asp. 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, recalls, 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 and farm groups, consumer interest groups, health
professionals, and other individuals who have asked to be included. The
Update is available on the FSIS Web page. Through the Listserv and the
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 that 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
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Done, at Washington, DC, on May 10, 2010.
Alfred V. Almanza,
Administrator.
Appendix
Salmonella has been a major concern for the Agency for many
years. In 1996 FSIS published the final rule ``Pathogen Reduction;
Hazard Analysis and Critical Control Point (PR/HACCP) Systems'' (61
FR 38806; Jul. 25, 1996), which established, among other measures,
pathogen reduction performance standards for Salmonella bacteria for
certain slaughter establishments and for establishments producing
certain raw ground products (9 CFR 310.25(b)(1)and 381.94(b)(1)).
Salmonella was selected as the target organism because it was at
that time the most common cause of foodborne illness known to be
associated with meat and poultry products. It is present to varying
degrees in all major species, and interventions targeted at reducing
it may be beneficial in reducing contamination by other enteric
pathogens.
The pathogen reduction performance standards established for
Salmonella in the PR/HACCP Final Rule covered raw product classes
including carcasses of cows/bulls, steers/heifers, market hogs,
broilers (young chickens), and ground beef, ground chicken, and
ground turkey. The Agency later developed a performance standard for
turkeys based on a 1997 baseline survey (2005 Turkey Performance
Standard). In the PR/HACCP final rule, FSIS required that the
prevalence of Salmonella contamination in each of the major species
and in raw ground products be reduced by each establishment to a
level below the current national baseline prevalence.
These Salmonella performance standards reflected the estimated
prevalence found by the Agency's nationwide microbiological baseline
surveys, which were conducted before the PR/HACCP rule was adopted
(Baseline Data). Each performance standard was a target prevalence
for a given product class using the same sample portion and
collection and analytical procedures that were used in the baseline,
for example, 20 percent positive for whole young chicken carcasses
from 400-mL rinse samples collected at post-chill.
The PR/HACCP rule also established a Salmonella Verification
Program, in which FSIS inspection personnel assess industry
performance by collecting product samples from individual
establishments over the course of a defined number of sequential
days of production to complete a sample set, with product samples
being sent to FSIS laboratories for analysis. Establishments were
made subject to sampling if they produced sufficient product
annually to complete a sample set, which for young chicken slaughter
establishments means approximately 20,000 birds slaughtered per
year. The PR/HACCP rule further specified the maximum number of
Salmonella-positive samples acceptable per sample set consisting of
a specified number of samples.
The Agency selected the maximum number of positive samples
acceptable per set so as to meet two objectives. The Agency
determined a number that would provide a reasonable probability of
passing the set for an establishment that in actuality is operating
precisely at the performance standard. The Agency also wanted the
number chosen to provide a relatively high probability of failing
the set for an establishment that in actuality is operating
precisely at the performance standard. This relatively high
probability of failing the set was intended to encourage
establishments to minimize the chance of failure by aiming at
tighter process control and lower numbers of positives.
The Agency chose an ``80 percent rule''--i.e., an establishment
actually operating at the performance standard has an approximately
80 percent chance of passing the set and therefore an approximately
20 percent chance of failing. For young chickens, the baseline
prevalence was estimated to be 20.0 percent of carcasses positive
for Salmonella, and using the ``80 percent rule'' resulted in a
requirement that there be no more than 12 positive samples out of a
51-sample set. For turkeys, the baseline prevalence was estimated to
be about 19.6 percent of carcasses positive for Salmonella, and
using the ``80 percent rule'' resulted in a requirement that there
be no more than 13 positive samples out of a 56-sample set. This
same approach is used for the new performance standards announced in
this notice.
In the 1996 PR/HACCP rule, FSIS indicated that the pathogen
reduction
[[Page 27294]]
performance standards would be changed as new data became available,
and that the Agency would periodically repeat its baseline surveys
to obtain updated data. FSIS intends to use the new Salmonella
performance standard for young chickens that it is announcing in
this Notice in the place of the performance standard codified at 9
CFR 381.94.
In that regulation, FSIS stated that an establishment that
failed to meet the standard in three consecutive sample sets would
be considered to have failed to maintain sanitary conditions and to
maintain an adequate HACCP plan. The Agency said the failure would
cause it to suspend inspection at the establishment. In December
2001, the U.S. Court of Appeals for the Fifth Circuit (Supreme Beef
Processors, Inc. v. USDA, 275 F.3d 432) affirmed a ruling by the
U.S. District Court for the Northern District of Texas (Supreme Beef
Processors, Inc. v. USDA, 113 F. Supp. 2d 1048) that USDA did not
have the authority to suspend inspection at an establishment solely
on the basis of Salmonella test results for the raw meat product
produced at the establishment. FSIS had suspended inspection at
Supreme Beef Processors, Inc., for failing the standard in three
consecutive Agency sample sets. The District Court held that 21
U.S.C. 604(m)(4) focused on a processor's plant and not on the
condition of its meat. The Court further held that the presence of
Salmonella in the finished product did not render the product
``injurious to health'' within the meaning of Sec. 601(m)(4). The
Appellate Court agreed, and further held that 21 U.S.C. 601(m)(4),
and hence the Salmonella performance standards, cannot be used to
regulate the characteristics of incoming raw materials used in the
raw ground beef.
Since the Supreme Beef case, FSIS has used results from its
verification testing program as a measure of establishment process
control for reducing exposure of the public to pathogens. FSIS
expects establishments to control their processes to ensure that
public exposure to pathogens is minimized. The Agency has found that
using pathogen reduction performance standards in this way is
effective in encouraging improved establishment control of
pathogens.
After our review and evaluation of the testing results for
several years, in which the frequency with which Salmonella was
found in testing at young chicken establishments rose, FSIS
published a Federal Register Notice on February 27, 2006 (71 FR
9772-9777; Docket 04-026N). This notice, among other things,
announced a new Agency policy for reporting the results from the
Agency's Salmonella testing program and established three
performance categories for establishments. Performance Category 1
was set at an upper limit of no more than half the standard.
Category 2 was set at more than half but not exceeding the standard.
Category 3 was for establishments exceeding the standard. Thus, for
young chickens, Category 1 performance for a set was defined as no
more than six positive samples out of a 51-sample set, Category 2 as
more than six but no more than 12 positives, and Category 3 as more
than 12 positives in a set. For turkeys, Category 1 was defined as
no more than six positive samples out of a 56-sample set, Category 2
as more than six but no more than 13 positives, and Category 3 as
more than 13 positives in a set.
In the 2006 Federal Register Notice, FSIS stated that it
intended to track establishment performance with respect to the
different product classes sampled for Salmonella over the next year
and, after that time, publish the names of establishments in
Categories 2 and 3 for any product class that did not have 90
percent of its establishments in Category 1. After the 2006 Federal
Register notice, the Agency added a second feature to its Salmonella
testing and reporting program. In addition to having 90 percent of
eligible establishments in Category 1, in order to be exempt from
having any of its establishments published, a product class must not
have any establishment in Category 3.
In 2008, FSIS published a notice in the Federal Register (73 FR
4767-4774; Jan. 28, 2008) explaining certain policy decisions
relating to the Salmonella program and announcing that the Agency
would begin publishing monthly results of completed FSIS
verification sets for establishments in Categories 2 and 3,
beginning with young chicken slaughter establishments. In that
notice, the Agency clarified that Category 1 status requires two
successive sets at no more than half the standard, but that
Categories 2 and 3 are determined by the most recent set. Since
publishing that notice, the Agency has created a Category 2T for
establishments whose most recent set was at Category 1 level but
whose prior set was above half the standard. Such establishments are
counted in aggregate statistics but are not published individually.
Publication of Category 2 and 3 young chicken establishments began
in March 2008, and FSIS continues to publish the names of these
establishments on or about the 15th of each month. The production
class of whole young turkey carcasses has had more than 90 percent
of establishments in Category 1 and no establishments in Category 3
and thus has not had Category 2 establishments published. The Agency
believes that publishing Category 2 and 3 establishments has
provided an effective incentive for improving performance.
[FR Doc. 2010-11545 Filed 5-13-10; 8:45 am]
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