[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Pages 3940-3950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01323]
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Notices
Federal Register
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or proposed rules that are applicable to the public. Notices of hearings
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Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 /
Notices
[[Page 3940]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2014-0023]
Changes to the Salmonella and Campylobacter Verification Testing
Program: Proposed Performance Standards for Salmonella and
Campylobacter in Not-Ready-to-Eat Comminuted Chicken and Turkey
Products and Raw Chicken Parts and Related Agency Verification
Procedures and Other Changes to Agency Sampling
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice and request for comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
and requesting comment on new pathogen reduction performance standards
for Salmonella and Campylobacter in raw chicken parts and not-ready-to-
eat (NRTE) comminuted chicken and turkey products.
The Agency is also announcing its plans to begin sampling raw
chicken parts to gain additional information on the prevalence and the
microbiological characteristics of Salmonella and Campylobacter in
those products. In addition, FSIS intends to begin an exploratory
sampling of raw pork products for pathogens of public health concern,
as well as for indicator organisms.
Finally, FSIS is announcing that it plans to use routine sampling
throughout the year rather than infrequently sampling on consecutive
days to assess whether establishments' processes are effectively
addressing Salmonella and, where applicable, Campylobacter on poultry
carcasses and other products derived from these carcasses, including
chicken parts and comminuted chicken and turkey product. FSIS intends
to perform this assessment using a moving window of sampling results.
FSIS will proceed with implementing the routine sampling of raw
chicken parts and the changes to specified verification procedures on
the dates announced in this notice. However, FSIS is seeking comments
on its implementation strategy as part of its effort to continuously
assess and improve the effectiveness of Agency policy.
DATES: Submit comments on or before March 27, 2015. In March 2015, the
Agency plans to begin routine sampling of raw chicken parts as one of
the several routine verification testing programs. Also, in March 2015,
the Agency plans to begin using the moving window approach (explained
below) rather than the consecutive day approach for assessing all
verification testing.
In March 2015, FSIS intends to begin exploratory sampling of raw
pork products. In March 2015, FSIS also intends to begin sampling
imported poultry carcasses, imported raw chicken parts, and imported
NRTE comminuted chicken and turkey for Salmonella and Campylobacter.
Finally, in March 2015, FSIS will start posting aggregate reports
showing the category distribution for comminuted chicken and turkey
using historical data and new results based on the proposed standards
for comminuted product. As data become available following the new
testing that FSIS will begin in March, FSIS will also begin posting
aggregate reports showing the category distribution for chicken parts,
based on the proposed standards for parts.
After reviewing the comments received on this notice, beginning
July 1, 2015, the Agency plans to begin posting individual
establishment category information for poultry carcasses.
ADDRESSES: FSIS invites interested persons to submit comments on the
new performance standards and other issues identified in the notice for
comment. FSIS is not requesting comment on the new testing of imported
product, chicken parts, or pork products because FSIS needs to begin
this testing to gather additional information, and because FSIS is not
assessing whether establishments producing these product meet
performance standards at this time. Comments may be submitted by one 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 on-line instructions at that site for
submitting comments.
Mail, CD-ROMs: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 355
E Street SW., Mailstop 3782, Room 8-163B, Washington, DC 20250-3700.
Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3,
355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2014-0023. 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 Patriots Plaza 3, 355 E Street SW., Room
164-A, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m.,
Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 205-0495, or by Fax: (202) 720-2025.
Background
FSIS is responsible for verifying that the nation's commercial
supply of meat, poultry, and egg products is safe, wholesome, and
properly labeled and packaged.
Salmonella and Campylobacter bacteria are among the most frequent
causes of foodborne illness. These bacteria can reside in the
intestinal tract of animals, including birds. Salmonella and
Campylobacter contamination of raw 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, events that cause
contamination of raw carcasses cannot be eliminated through the
commercial
[[Page 3941]]
production and slaughter practices employed in the United States.
Contamination can be minimized, however, with the use of proper
sanitary dressing procedures and by the application of antimicrobial
interventions during slaughter and thereafter during fabrication of the
carcasses into parts and comminuted product.
Salmonella and, to a lesser extent, Campylobacter may increase on
raw poultry if the product is improperly stored at temperatures
conducive to their growth. Moreover, if these pathogens are present on
raw poultry, they will survive on the product if the product is not
subjected to a full lethality treatment such as thorough cooking before
being presented for human consumption. Also, if raw poultry is
improperly handled during food preparation, Salmonella and
Campylobacter can cross-contaminate other foods or food contact
surfaces.
The Salmonella verification testing program began with the Agency's
final rule ``Pathogen Reduction; Hazard Analysis and Critical Control
Point'' (PR/HACCP Rule), which was issued on July 25, 1996 (61 FR
38805). Among other things, the PR/HACCP Rule set Salmonella pathogen
reduction performance standards for establishments that slaughter
selected classes of food animals or that produce selected classes of
raw ground products. FSIS uses the pathogen reduction performance
standards to ensure that eligible establishments are consistently
controlling or reducing harmful bacteria on raw meat and poultry
products.
The microbiological performance standards for the reduction of
Salmonella in raw products allow FSIS to verify whether establishments
have effective process controls to address Salmonella. The sample sets
were designed to assess the presence of Salmonella in a specified
number of samples collected daily for a sufficient number of days to
discern an establishment's capability to sustain long term process
control. For example, the 2011 broiler carcass pathogen reduction
performance standard consisted of 51 samples with 5 positive samples
being the acceptable limit in the set positive for Salmonella.
Additionally, FSIS set criteria for which establishments were to be
included in the verification testing program. Only broiler
establishments that slaughter at least 20,000 birds annually are
currently subject to FSIS Salmonella sampling and testing. A lower
volume of birds would likely be slaughtered intermittently throughout
the year rather than daily, and thus it would likely take a year or
more to complete a set.
FSIS conducted the Nationwide Microbiological Baseline Data
Collection Programs: Raw Chicken Parts Baseline Survey (RCPBS) from
January 2012 to August 2012 to estimate the percent positive of various
raw chicken parts sampled and the levels of Salmonella, Campylobacter,
and indicator bacteria on these products. FSIS used this information to
estimate national prevalence of the two pathogens on raw chicken parts.
An overview of the RCPBS is available at http://www.fsis.usda.gov/wps/wcm/connect/a9837fc8-0109-4041-bd0c-729924a79201/Baseline_Data_Raw_Chicken_Parts.pdf?MOD=AJPERES.
Based on available data, about 85 percent of poultry products
available to consumers are chicken,\1\ and about 80 percent of the
chicken product is in the form of raw chicken parts fabricated from
broiler carcasses.\2\ The amount of chicken parts available from
fabricated broiler carcasses is larger than that of turkey carcasses
that are fabricated into raw turkey parts and available to consumers.
Also, there is more contamination of broiler carcasses with Salmonella
and Campylobacter compared to turkey carcasses. For example, in 2008,
FSIS found that broiler carcasses had a Salmonella prevalence of 7.5
percent,\3\ while in 2009 turkey carcasses had Salmonella prevalence of
1.7 percent.\4\ Given the higher percentages of these positives in
broiler carcasses and higher volume of raw chicken parts produced, FSIS
conducted its baseline on chicken parts only.
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\1\ ERS, http://www.ers.usda.gov/data-products/food-availability-(per-capita)-data-system.aspx.
\2\ NCC, 2011. Broiler Industry Marketing Survey Report, http://members.www.nationalchickencouncil.org/wp-content/uploads/2013/02/2011-Broiler-Industry-Survey-Report.pdf.
\3\ FSIS, 2009. The nationwide microbiological baseline data
collection program: Young chicken survey: July 2007- June 2008. U.
S. Department of Agriculture, Washington D.C.
\4\ FSIS, 2010. The nationwide microbiological baseline data
collection program: Young turkey survey. August 2008--July 2009. U.
S. Department of Agriculture, Washington D.C.
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In the Federal Register notice of December 6, 2012, (77 FR 72686),
FSIS informed establishments producing NRTE comminuted poultry products
\5\ that they were required to reassess their Hazard Analysis and
Critical Control Point (HACCP) plans for these products. In that same
notice, FSIS announced that it would expand its Salmonella sampling
beyond ground chicken and turkey to include all forms of non-breaded,
non-battered comminuted NRTE chicken or turkey products not destined
for further processing into ready-to-eat (RTE) products. In addition,
FSIS announced that it was moving its microbiological testing for
Salmonella and Campylobacter for these products from a 25-gram test
portion to 325 grams. Finally, FSIS explained that it would use the
sampling results to determine the prevalence of Salmonella and
Campylobacter in NRTE comminuted chicken and turkey and to develop
pathogen reduction performance standards for these products.
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\5\ FSIS considers ``NRTE comminuted poultry'' to be any NRTE
chicken or turkey product that has been ground, mechanically
separated, or hand- or mechanically deboned and further chopped,
flaked, minced or otherwise processed to reduce particle size (77 FR
72687).
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FSIS began sampling and testing NRTE comminuted chicken and turkey
products on June 1, 2013.\6\ FSIS has posted the aggregate results of
this testing for all finished products as part of its quarterly
Salmonella report.\7\
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\6\ This sampling and testing for Salmonella and Campylobacter
did not include heat-treated NRTE comminuted chicken or turkey.
\7\ http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/quarterly-reports-salmonella.
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On April 21, 2014, FSIS responded to all relevant comments received
on the December 2012 notice. As the April 2014 notice explains, after
carefully considering all of the comments, FSIS decided that it would
proceed as announced with analyzing the comminuted product testing data
to establish pathogen reduction performance standards for NRTE
comminuted chicken and turkey as originally planned. FSIS also provided
other updates, including the status of HACCP plan reassessments,
information on Food Safety Assessments (FSAs) in establishments
producing comminuted poultry product, and details on how FSIS intends
to evaluate the exploratory testing data and information gathered from
surveying its poultry inspection program personnel. A summary report of
this survey, the FSIS Poultry Checklist, which also showed that the
majority of establishments are not currently applying antimicrobials to
raw poultry parts and NRTE comminuted poultry product components, is
available on FSIS's Web site at http://www.fsis.usda.gov/wps/wcm/connect/902e9de8-712c-4d74-a223-c9ef4b37464a/poultry-checklist.pdf?MOD=AJPERES.
FSIS announced its Salmonella Action Plan (SAP) on December 4,
2013.\8\ In the plan, FSIS announced that
[[Page 3942]]
it would complete a risk assessment and develop pathogen reduction
performance standards for NRTE comminuted chicken and turkey and raw
chicken parts. FSIS also announced in the SAP that it would explore
developing a Salmonella sampling program for pork products. In March
2015, FSIS intends to begin an exploratory sampling of raw pork
products for pathogens of public health concern, as well as for
indicator organisms.
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\8\ http://www.fsis.usda.gov/salmonella.
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Pathogen Reduction Performance Standards
In general, illnesses should be reduced as establishments reduce
the occurrence of pathogens on their products. Thus, consistent with
the rationale discussed in the March 21, 2011 Federal Register
notice,\9\ reduced illnesses should result from the implementation of
pathogen reduction performance standards to reduce the occurrence of
pathogens on chickens and turkeys.
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\9\ 76 FR 15282.
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The Healthy People 2020 (HP2020) goal is to reduce human illness
from Salmonella by about 25 percent by the year 2020.\10\ In order to
meet this objective for all poultry products, the Agency is proposing a
pathogen reduction performance standard designed to achieve at least a
30 percent reduction in illnesses from Salmonella for chicken parts,
comminuted chicken, and comminuted turkey.
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\10\ Available at http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=14.
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The HP2020 goal for Campylobacter is to achieve a 33 percent
reduction in human illnesses from this pathogen. For chicken parts and
comminuted chicken, FSIS is proposing a pathogen reduction performance
standard designed to reduce illness from Campylobacter by about 33
percent. However, because FSIS found the prevalence for Campylobacter
in comminuted turkey to be especially low,\11\ the highest practical
reduction for this product was estimated to be 19 percent. Therefore,
for this one product-pathogen pair, comminuted turkey and
Campylobacter, FSIS is proposing a reduction less than its stated goal.
The methods for developing the pathogen reduction performance standards
and predictions for the public health effect of those standards are
described in Public Health Effects of Raw Chicken Parts and Comminuted
Chicken and Turkey Performance Standards (2015 Risk Assessment)(http://www.fsis.usda.gov/wps/wcm/connect/afe9a946-03c6-4f0d-b024-12aba4c01aef/Effects-Performance-Standards-Chicken-Parts-Comminuted.pdf?MOD=AJPERES). FSIS used the same methodology to estimate
the public health effects for the young chicken and turkey performance
standards in 2011.\12\
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\11\ Public Health Effects of Raw Chicken Parts and Turkey
Performance Standards, 2014. FSIS.
\12\ 76 FR 15282; Mar. 14, 2011.
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The 2015 Risk Assessment describes how Salmonella- and
Campylobacter-positive samples will be used to categorize
establishments as either meeting or not meeting the applicable
performance standard for chicken parts or comminuted chicken or turkey.
FSIS used a common analytical framework to estimate the improvements in
public health (illnesses averted) associated with six separate pathogen
reduction performance standards discussed as options considered in this
notice. FSIS, based on the risk assessment predictions, estimated the
reductions in salmonellosis and campylobacteriosis cases that would
result if establishments made changes in their processes that would
reduce the occurrence of these pathogenic bacteria in their products.
Should FSIS finalize these pathogen reduction performance
standards, once the Agency begins testing to implement the standards,
the risk assessment model presents different scenarios under which the
desired percent reduction in salmonellosis cases could be achieved
across both chicken parts and comminuted poultry products. The risk
assessment model also describes different scenarios under which
reductions in Campylobacter illnesses could occur.
Furthermore, despite a significant drop (a 9 percent decrease) in
human illnesses from Salmonella in recent years, salmonellosis remains
high in the U.S.\13\ About 33 percent of all food related salmonellosis
cases are associated with products regulated by FSIS. Of these FSIS-
associated illnesses, poultry represents about 58 percent of the cases
with 85 percent being associated with chicken and 15 percent being
associated with turkey.\14\ Of the illnesses from consuming chicken,
FSIS estimates that 81 percent were associated with parts, 13 percent
were associated with whole carcasses, and 6 percent were associated
with comminuted product.\15\
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\13\ http://www.cdc.gov/mmwr/pdf/wk/mm6315.pdf. These
surveillance data are for all foods, not just FSIS-regulated foods.
\14\ Painter, et al., 2013 available at http://wwwnc.cdc.gov/eid/article/19/3/11-1866_article.
\15\ Available at http://www.nationalchickencouncil.org/about-the-industry/statistics/how-broilers-are-marketed/.
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FSIS considered the results of the 2015 Risk Assessment and
selected performance standards for specified product-pathogen pairings
based on the most likely within-establishment contamination
distributions and a 50-percent compliance fraction for establishments
not initially meeting the performance standard. Furthermore, FSIS
chose, where feasible, performance standards expected to accomplish a
reduction in Salmonella and Campylobacter illnesses on a product-
pathogen pair basis of at least 30 percent and 33 percent,
respectively.
FSIS chose this objective for product-pathogen pairs for addressing
Salmonella in FSIS-regulated products as it will help increase the
likelihood that the HP2020 national goal of reducing human illness by
25 percent can be met across all poultry products. The proposed
pathogen reduction performance standards for Campylobacter are also
expected to achieve greater than a 30 percent reduction in
campylobacteriosis from chicken parts and comminuted chicken, and a 19
percent reduction in illnesses from comminuted turkey.
In combination, FSIS estimates that the implementation of
performance standards for chicken products (existing and those proposed
in this notice) may result in about a 31 percent reduction in
salmonellosis. The estimated combined impact of implementing
performance standards for turkey products (existing and those proposed
in this notice) is about a nine percent reduction in salmonellosis. The
overall estimated impact on salmonellosis is about a 28 percent
reduction for chicken and turkey products, thus satisfying the HP 2020
objective of 25 percent.
After it has considered comments received on this notice, FSIS will
announce the final standards in the Federal Register.
NRTE Comminuted Poultry--Salmonella
For the purpose of developing a pathogen reduction performance
standard for Salmonella in NRTE comminuted chicken and turkey products,
FSIS evaluated the first eight months of data generated by the new
sampling and testing program. FSIS chose to initiate development of a
proposed standard now, using the first eight months of data, in order
to expedite the process for proposing a new standard and for realizing
the projected public health benefits from a final standard. FSIS does
not expect there to be substantive differences in the first eight
months of data compared to the overall outcome of a baseline testing
[[Page 3943]]
period lasting at least one full year to more fully assess seasonal
variation. However, if substantial differences are seen, FSIS could
determine the effects of those differences on the standard prior to
implementation.
FSIS utilized its MLG 4.08 \16\ method to analyze samples of NRTE
comminuted chicken and turkey products and parts for Salmonella. FSIS
also used the 2015 Risk Assessment, which took into account the
establishment by establishment incidence of Salmonella in NRTE
comminuted chicken and turkey products and the predicted illnesses
averted as a consequence of reducing the percentage positive of these
pathogens. Because it is using an on-going sampling approach, FSIS will
be able to calculate national prevalence for Salmonella and
Campylobacter at least on an annual basis.
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\16\ MLG 4.08 is described at http://www.fsis.usda.gov/wps/wcm/connect/700c05fe-06a2-492a-a6e1-3357f7701f52/MLG-4.pdf?MOD=AJPERES.
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To obtain a better estimate of the overall prevalence of Salmonella
and Campylobacter than a simple percent positive estimate, FSIS
weighted the Salmonella and Campylobacter percent positive estimates by
the production volume of each establishment for which there were
sampling results. Using the first eight months of data, the national
prevalence for Salmonella in NRTE comminuted chicken is about 49
percent and in NRTE comminuted turkey is about 20 percent. The national
prevalence for Campylobacter in NRTE comminuted chicken is about three
percent, and in NRTE comminuted turkey is about one percent.
Given that mechanically separated chicken and turkey are typically
not added to NRTE comminuted poultry products, results for these
products were not used in developing the Salmonella contamination
distribution used in the risk assessment or the volume-weighted percent
positive prevalence (VWPP) estimates above. It is important to note
that the prevalence estimates were determined using the larger 325-gram
analytical portion--a 13-fold increase in size from the 25-gram portion
used to make prior prevalence determinations.
FSIS is proposing pathogen reduction performance standards that
would achieve at least a 30-percent reduction in salmonellosis on a
product-pathogen basis as a result of a reduction in exposure of the
public to this pathogen when handling and preparing the product for
consumption. To achieve this result for NRTE comminuted chicken, FSIS
is proposing a pathogen reduction performance standard for Salmonella
of 13 positives out of 52 samples.
Under this standard, the expected number of illnesses avoided would
be about 3,100 (uncertainty interval (UI): \17\ 2,000-4,700). Based on
the initial eight months of data collected, FSIS estimates that
approximately 62 percent of establishments will initially fail the
performance standard. As establishments make changes to meet the new
performance standard, FSIS estimates that the VWPP of 49 percent from
Salmonella in comminuted chicken would be reduced to 34 percent.
Evidence regarding FSIS's testing to assess whether establishments met
the chicken carcass Salmonella performance standard suggested an
approximate 50-percent increase in the share of industry that met the
performance standard after 24 months under the new performance
standard.\18\ Therefore, FSIS estimates that 50 percent of
establishments that initially do not meet the new performance standard
will meet it in about two years. FSIS expects the same for all products
under the new standards announced in this notice, as further elaborated
in the 2015 Risk Assessment.
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\17\ Uncertainty about total illnesses attributed to poultry is
simulated to generate 5th and 95th quantile values. These values are
multiplied by the predicted effects of the performance standards to
generate 5th and 95th percentile values for the annual number of
illnesses avoided by the performance standard.
\18\ http://www.sciencedirect.com/science/article/pii/S0956713512002393.
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For NRTE comminuted turkey, FSIS is proposing a performance
standard that would achieve at least a 30- percent reduction in
salmonellosis. FSIS is, therefore, proposing a pathogen reduction
performance standard for Salmonella of seven positives out of 52
samples for NRTE comminuted turkey. With that standard, FSIS estimates
that the expected number of illnesses avoided would be about 2,400 (UI:
1,500-3,600). Based on the initial eight months of data collected,
approximately 58 percent of establishments are predicted to initially
fail the performance standard. As establishments make changes to meet
the new performance standard, FSIS estimates that the VWPP of 20
percent of Salmonella in NRTE comminuted turkey will be reduced to 14
percent.
Raw Chicken Parts--Salmonella
FSIS developed the Salmonella pathogen reduction performance
standard for raw chicken parts using the RCPBS data. Based on the
baseline results, FSIS estimates that the national prevalence of
Salmonella in four pound portions of raw chicken parts is about 24
percent with a 95-percent confidence interval between 19 percent and 29
percent.
As stated above, FSIS is proposing at least a 30- percent reduction
in salmonellosis from raw chicken parts. To achieve this reduction,
FSIS is proposing a pathogen reduction performance standard for
Salmonella of eight positives out of 52 samples for raw chicken parts.
The expected number of illnesses avoided would be about 29,000 (UI:
18,900--45,400). Based on the 2012 chicken parts baseline data,
approximately 63 percent of establishments are predicted to initially
not meet the performance standard. As establishments make changes to
meet the new performance standard, FSIS estimates that the VWPP of 28
percent of Salmonella in four pound portions of raw chicken parts
(breasts, legs, and wings) will be reduced to 18 percent.
The RCPBS expressly excluded chicken parts that were marinated or
injected. The sampling of such products was not originally planned for
under the new performance standards. Although during the period of test
sampling before the baseline survey began (the shakedown period), FSIS
did respond to questions about injected product and identified that
products should not be sampled as part of the RCPBS. However, during
the baseline survey, inspectors at multiple establishments confirmed
that they collected sample parts that had been injected. In addition,
since the shakedown, FSIS has determined that the additional handling
of injected products marinated in a clear solution likely could cause
additional contamination, particularly of the exterior surface of the
poultry and that these products look no different to the consumer than
products not injected or marinated (when done with a clear solution
that may not be evident to the individual preparing the product) other
than through the ingredient statement. FSIS will clarify that such
products will be sampled as part of the exploratory chicken parts
sampling that will start in March 2015 (detailed below). In addition,
when the new performance standard for chicken parts is implemented,
such products would be subject to sampling. FSIS invites comment on
this issue.
Breasts, legs, and wings are the most frequently produced chicken
parts in the U.S. (>90 percent).\19\ During the
[[Page 3944]]
RCPBS, FSIS sampled additional parts, including necks, giblets, quarter
carcasses, and half carcasses. Because of their high production
representation, only breasts, legs, and wings were included in the risk
assessment, and the draft performance standard will only apply to these
parts. However, because the other types of chicken parts are available
to consumers and present an exposure potential for both Salmonella and
Campylobacter, FSIS recommends that industry put process controls in
place to reduce contamination on these products. In cases where FSIS is
concerned about the sanitary conditions in establishments, such as when
an establishment is implicated in a food-borne outbreak, FSIS may
collect samples of these other chicken parts to ascertain the level of
process control in the establishment. When FSIS determines that there
is reason to believe that the establishment is failing to maintain
sanitary conditions, FSIS will require the establishment to demonstrate
improved process control as evidenced by lower contamination incidence
in these other chicken parts.
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\19\ AMS, Northeast & Southern States Monthly Report Data
CY2013.
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In March 2015, the Agency plans to begin sampling raw chicken parts
on an on-going basis. As with all of the pathogen reduction performance
standards announced in this notice, FSIS will not begin applying the
pathogen reduction performance standard for raw chicken parts until
after it has considered comments received on this notice. Meanwhile,
FSIS will gain experience in scheduling, collecting, and analyzing raw
chicken parts for Salmonella and Campylobacter. In addition, FSIS will
report back to establishments periodically information about the
samples collected and found to be positive for Salmonella or
Campylobacter.
FSIS does not expect that data will change substantially and,
therefore, does not expect to re-propose the standards based on the new
data. However, FSIS will analyze the data and will discuss it in the
Federal Register notice announcing the final standards. If the data
change substantially based on the new testing so that FSIS determines
it should change the standards, FSIS would re-propose the standards.
As stated above, FSIS intends to establish its standards for parts
based on its sampling of breasts, legs, and wings in the RCPBS and thus
to focus its on-going sampling on those parts. However, because some
other parts were sampled very infrequently during the 2012 RCPBS, FSIS
has decided to also sample additional parts not only to ascertain the
level of process control in individual establishments but to estimate
that part's contribution to Salmonella and Campylobacter illnesses.
FSIS may ultimately decide that it is necessary to propose additional
pathogen reduction performance standards for these other chicken parts,
particularly if there is evidence that establishments are not
effectively controlling sanitary conditions associated with the
production of these parts.
NRTE Comminuted Poultry--Campylobacter
FSIS developed the new standards using the 2015 Risk Assessment,
which took into account the establishment by establishment prevalence
of Campylobacter in NRTE comminuted chicken and turkey products and
predicted illnesses averted as a consequence of reducing the prevalence
of these pathogens. For the purpose of developing these pathogen
reduction performance standards, as stated above, FSIS analyzed the
first eight months of data generated from the new sampling program.
For NRTE comminuted chicken, a pathogen reduction performance
standard for Campylobacter of one positive out of 52 samples should
result in about a 37-percent reduction in Campylobacter illnesses from
that product. The expected number of illnesses avoided would be about
1,300 (UI: 700-2,000). Approximately 24 percent of establishments are
predicted to initially not meet the performance standard. As
establishments make changes to meet the new performance standard, FSIS
estimates that the VWPP of Campylobacter of 3.4 percent in NRTE
comminuted chicken will be reduced to 2.1 percent.
For NRTE comminuted turkey, the current Campylobacter prevalence is
so low that the Agency determined a 33-percent reduction could not be
feasibly met. Thus, FSIS is proposing a pathogen reduction performance
standard for Campylobacter for NRTE comminuted turkey of one positive
out of 52 samples, which is estimated to result in about a 19-percent
reduction in Campylobacter illnesses. The expected number of illnesses
avoided as a result of such a reduction would be about 500 (UI: 300-
700). The risk assessment estimates approximately nine percent of
establishments will initially fail the performance standard. As
establishments make changes to meet the new performance standard, FSIS
estimates that the VWPP of Campylobacter of 1.2 in NRTE comminuted
turkey will be reduced to about one percent.
FSIS developed the above pathogen reduction performance standards
for Campylobacter using a direct plating laboratory method of analysis
with a 1 ml test portion. FSIS plans to assess establishment
performance relative to those standards based on the 1 ml portion size.
However, given the lower sensitivity of this test, this fiscal year
FSIS will begin concurrently analyzing a subset of NRTE comminuted
poultry samples it collects for verification testing using an
enrichment method of analysis with a larger test portion, a 30 ml test
portion for chickens (MLG 41.03).\20\ By increasing the potential for
growth and recovery of injured cells, FSIS anticipates the enrichment
method of analysis will detect more contamination. FSIS expects to
analyze testing data generated from both analytical approaches. This
analysis will allow FSIS to determine whether the pathogen reduction
performance standards for Campylobacter in NRTE comminuted chicken and
turkey should be revised from the above proposed standards to standards
based on an enrichment method, such as with a 30 ml test portion.
---------------------------------------------------------------------------
\20\ More details about the analytical method are available at
http://www.fsis.usda.gov/wps/wcm/connect/0273bc3d-2363-45b3-befb-1190c25f3c8b/MLG-41.pdf?MOD=AJPERES.
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Raw Chicken Parts--Campylobacter
The stated HP2020 national goal for percent reduction in
campylobacteriosis cases is 33 percent. Based on the baseline results,
FSIS estimates that the national prevalence of Campylobacter in four
pound portions of raw chicken parts is about 22 percent with a 95-
percent confidence interval between 19 percent and 25 percent. To meet
a 32-percent reduction in campylobacteriosis, the 2015 Risk Assessment
estimated that a pathogen reduction performance standard for
Campylobacter in raw chicken parts of four positives out of 52 samples
\21\ would be sufficient. The expected number of illnesses avoided
would be about 14,300 (UI: 8,400-23,100). Based on data generated from
the 2012 RCPBS, approximately 46 percent of establishments are
predicted to fail the performance standard. As establishments make
changes to meet the new performance standard, FSIS estimates that the
VWPP of 15.5 percent for Campylobacter in four pound
[[Page 3945]]
portions of raw chicken parts (breasts, legs, and wings) will be
reduced to 10 percent.
---------------------------------------------------------------------------
\21\ FSIS chose not to reduce the standard to three positives
out of 52 samples because it would exceed the HP2020 national goal
in excess of 10 percent.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum acceptable percent Performance standard
Salmonella Campylobacter positive -----------------------------------------------
Product prevalence prevalence ------------------------------------
(percent) (percent) Salmonella Campylobacter Salmonella Campylobacter
--------------------------------------------------------------------------------------------------------------------------------------------------------
Broiler Carcasses............. 7.5 10.4 9.8 15.7 5 of 51............... 8 of 51.
Turkey Carcasses.............. 1.7 0.79 7.1 5.4 4 of 56............... 3 of 56.
Comminuted Chicken............ [caret]* 49 [caret]* 3.4 25.0 1.9 13 of 52.............. 1 of 52.
Comminuted Turkey............. [caret]* 19.9 [caret]* 1.2 13.5 1.9 7 of 52............... 1 of 52.
Chicken Parts................. [caret]* 28 [caret]* 15.5 15.4 7.7 8 of 52............... 4 of 52.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[caret] volume-weighted percent positive
* based on eight months of data
Changes to Related Verification Sampling Procedures
On August 28, 2013, FSIS published in the Federal Register a notice
announcing changes to its Salmonella sampling program for raw beef
products (78 FR 53017). In the August 2013 notice, FSIS also announced
that it was considering alternatives to set-based sampling for
Salmonella, including routine sampling (similar to what FSIS uses for
Shiga toxin-producing Escherichia coli (STEC) sampling) with a moving
window approach to assess process control.
On June 5, 2014, in the Federal Register notice responding to
comments received on the August 2013 Federal Register notice, FSIS
reiterated that it was considering using on-going scheduled sampling
with a moving window approach to assess process control for all
Salmonella performance standards (79 FR 32436). FSIS is affirming those
plans for addressing Salmonella and will proceed with implementing
those plans. Below, FSIS is providing more explanation of how the
change will work when scheduling samples and assessing process control
in establishments.
FSIS does not collect imported raw poultry products for Salmonella
and Campylobacter analysis. However, on June 29, 2014, FSIS began
analyzing for Salmonella all imported raw beef samples it collects for
STEC analysis (79 FR 32436; Jun 5, 2014).
Thus, in March 2015, FSIS will begin analyzing for Salmonella (and
Campylobacter) imported raw broiler and turkey carcasses, NRTE
comminuted chicken and turkey products, and raw chicken parts. FSIS
will use enumeration and serotype data of this testing to identify
trends within the sampling data, to determine whether an isolate has a
historical association with human illness, and to identify clusters of
patterns. In addition, FSIS will post aggregate results of this testing
on the FSIS Web site as part of its quarterly report on Salmonella.
Salmonella is not an adulterant in raw poultry products. Therefore,
a positive test result for Salmonella in imported raw poultry product
sampled by FSIS import inspection personnel would not result in
regulatory control actions at port-of-entry. However, consistent
findings of Salmonella would raise concern about the effectiveness of
the country's food safety system, which could influence the focus and
timing of the next audit of the country or result in other appropriate
action.
Routine Sampling
Consistent with what it announced in its August 2013 Federal
Register notice, FSIS will replace its existing Salmonella sampling
set-approach with a routine sampling approach for all FSIS-regulated
products subject to Salmonella and Campylobacter verification testing.
This includes for broiler and turkey carcasses and chicken parts. FSIS
has already moved to routine sampling for comminuted poultry, ground
beef, and beef manufacturing trimmings.
FSIS has determined that its current set-based Salmonella sampling
program cannot be used to estimate prevalence for several reasons.\22\
First, FSIS's scheduling algorithm disproportionately focuses sample
collection based on past performance under the Salmonella performance
standards. As a result, FSIS may not sample from establishments
maintaining consistent process control (Category 1--establishments
continuously achieving 50 percent or less of the pathogen reduction
performance standard, i.e., meeting or surpassing the standard) for a
year or more, while those with highly variable process control
(Category 3--establishments that have exceeded the pathogen reduction
performance standard, i.e., not meeting the standard) could be
scheduled quite often. An establishment with variable process control
(Category 2--establishments that have not continuously achieved 50
percent or less of the pathogen reduction performance standard, nor
have they exceeded the standard) could be sampled at least annually.
Such disproportionate sample collection results in not all
establishments having a known probability of being selected for
sampling.
---------------------------------------------------------------------------
\22\ http://www.fsis.usda.gov/wps/wcm/connect/56b2ccbd-ad57-4311-b6df-289822d28115/Prevalence_Estimates_Report.pdf?MOD=AJPERES.
---------------------------------------------------------------------------
Second, once a sample set begins, an establishment is aware that it
will be sampled every day the product is produced over the next few
months (or longer for smaller plants that produce less frequently)
until the set is complete. This knowledge might create a bias because
establishments may, intentionally or not, adhere more conscientiously
to proper sanitary procedures during this time. This adherence could
result in lower numbers of positive Salmonella results than would occur
otherwise, and any prevalence calculation would be underestimated.
By sampling establishments with a proper frequency and continuously
throughout the year, FSIS would be able to calculate the national
prevalence of Salmonella and Campylobacter. FSIS intends to use the
ongoing estimation to monitor changes in prevalence over time and to
correlate those changes with the effectiveness of Agency policies and
procedures.
FSIS will begin using, in lieu of set-based sampling, routine
sampling for all products that it samples as part of its Salmonella
verification sampling program, such as broiler and turkey carcasses, as
well as those products for which new standards are contemplated, such
as ground beef at the 325-gram sample size and beef manufacturing
trimmings. Taking into account risk factors including production volume
and past establishment testing
[[Page 3946]]
performance (i.e., positive Salmonella and Campylobacter test results),
FSIS will sample eligible product from the largest-volume
establishments four or five times per month (once per week), on
average, and will decrease incrementally the number of samples it
collects from establishments producing less volume. FSIS may sample a
small number of establishments up to six times per month because the
risk factor for that particular volume category/product combination is
much higher than that for other combinations. FSIS has described its
overall strategy for directing its Salmonella and Campylobacter
sampling resources in its FY 2015 Annual Sampling Program Plan.\23\
---------------------------------------------------------------------------
\23\ Available at http://www.fsis.usda.gov/wps/wcm/connect/cb091bde-4900-45ec-8bf5-980dc9496bd1/Sampling-Program-Plan-FY2015.pdf?MOD=AJPERES.
---------------------------------------------------------------------------
Some large volume establishments, in particular young turkey
slaughter establishments, may produce eligible product for only a few
months of the year. Under the existing set-based Salmonella sampling
program, these establishments rarely complete a sampling set within the
year. To assess process control in establishments with concentrated
seasonal production, FSIS will intensify sampling at these
establishments when in production to obtain the samples needed to
assess process control using the moving window. FSIS will use
historical sampling data collected from the particular establishment to
determine the frequency of sampling.
FSIS does not currently sample eligible product for Salmonella from
poultry establishments that produce less than 1,000 pounds per day
(i.e., very small establishments) or from poultry slaughter
establishments that operate under a religious exemption. Therefore,
FSIS does not have Salmonella or Campylobacter data from these
establishments for young chickens, turkeys, NRTE comminuted chicken or
turkey, and raw chicken parts. At the time that the new pathogen
reduction performance standards are implemented, FSIS intends to begin
sampling eligible product 3-4 times per year from these establishments.
FSIS anticipates that it will begin sampling eligible product that had
been exempted from Salmonella verification testing in approximately 95
poultry slaughter establishments operating under a religious exemption,
and approximately 580 poultry establishments that produce less than
1,000 pounds per day. FSIS expects to eventually implement pathogen
reduction performance standards to assess process control at these
poultry establishments.
Before FSIS begins using these samples to assess process control at
establishments previously excluded from verification sampling, it will
provide notice in the Federal Register. Meanwhile, FSIS expects to
treat the low volume establishments as separate populations and to
report how well the population of establishments is performing,
including such information as percentage positive, 25th, 50th, and 75th
percentile.
Moving Window Approach
Without discrete sampling sets, a different approach is needed to
assess process control in establishments within a routine sampling
program. When assessing process control under a moving window approach,
FSIS intends to evaluate, over a certain period of time, a number of
sequential results from a single establishment. Thus, given the fixed
timeframe of one year (52 weeks) for which an establishment has been
sampled, FSIS would assess the first moving window by evaluating the
number of positive samples out of the number of samples taken within
the 52-week period. As an example, if an establishment has five
Salmonella positives within 52 samples (one sample per week for a
year), then the establishment passed the performance standard if the
performance standard allows five positive samples among 52 samples.
When the next sample is taken (week 53, in this example), the moving
window would shift forward the fixed timeframe of one year (52 weeks);
that is, the original week 1 (and the original first sample) is
excluded, while the most recent week is included in the new 52-week
moving window. This shifting is repeated with each new week and allows
FSIS to continuously assess the process control of an establishment.
FSIS chose a 52-week moving window because it will appropriately
average expected fluctuations, for example, those that result from
seasonal variation. Nevertheless, FSIS intends to periodically assess
its results to determine if adjustments to the 52-week moving window
are appropriate.
For highest-volume establishments, FSIS expects to collect 52
samples within the 52-week moving window. In this case, to assess
process control (at establishments producing products with performance
standards measured in 52 samples), one need only to count the number of
positives test results within the 52-week moving window. So, as an
example, the proposed performance standard for Salmonella in raw
chicken parts is eight positives out of 52 samples. Assuming 52 samples
were collected from the establishment within a 52-week moving window,
if the establishment has eight or fewer Salmonella positives within
that 52-week timeframe, then it would pass the performance standard.
If, on the other hand, the establishment has nine or more Salmonella
positives within that same 52-week timeframe, then it would fail the
performance standard.
The following table demonstrates what FSIS has determined to be the
minimum number of samples for each product class by pathogen.
----------------------------------------------------------------------------------------------------------------
Max Acceptable percent positive Minimum number of samples
Product -----------------------------------------------------------------------
Salmonella Campylobacter Salmonella Campylobacter
----------------------------------------------------------------------------------------------------------------
Broiler Carcass......................... 9.8 15.7 10 10
Turkey Carcass.......................... 7.1 5.4 14 19
Comminuted Chicken...................... 25.0 1.9 10 52
Comminuted Turkey....................... 13.5 1.9 10 52
Chicken Parts........................... 15.4 7.7 10 13
----------------------------------------------------------------------------------------------------------------
Previously, FSIS held the same standard to all eligible
establishments within a product class. However, FSIS found that some
lower volume establishments would take over a year and sometimes two
years to complete a set. Thus, to assess process control in
establishments that FSIS samples less often than weekly (i.e., lower
volume establishments), FSIS will assess establishment performance (as
percent positive) based on the (likely variable) number of samples
collected and positive results within the 52-week moving window.
[[Page 3947]]
To illustrate this point, if a small establishment producing raw
chicken parts is sampled fewer than 52 times in the 52-week moving
window, only 26 times, for example, with three of those samples testing
positive for Salmonella, 26 will be the denominator while three would
be the numerator. This gives the establishment a percent positive of
11.5 percent ((\3/26\) x 100 = 11.5%). In this example, the resulting
percent positive is less than 15.4 percent, the acceptable percent
positive for the proposed performance standard for Salmonella in raw
chicken parts ((\8/52\) x 100 = 15.4%). As such, the establishment
would pass the performance standard.
Given that Salmonella is not an adulterant in raw product, FSIS
determined that any performance standard for Salmonella or
Campylobacter should use one or greater as the acceptable number of
positives results. A performance standard of zero maximum acceptable
positives is actually a zero-tolerance standard. With one acceptable
positive as the numerator, FSIS used the following formula to estimate
the minimum number of samples (n) needed to assess process control at
an establishment:
n = (1/percent positive allowed) - 100.
So, for example, if the performance standard is 5 percent (the
percent positive allowed), then (\1/5.0\) - 100 = 20 samples is the
minimum number of samples required to assess process control. Although,
as another example, if the performance standard is 20 percent then (1/
20.0) - 100 = 5 samples is the minimum number of samples required to
assess process control. However, to decrease the margin of error, FSIS
has deemed 10 as the minimum number of samples required to assess
process control in an establishment.
FSIS acknowledges that less-than-weekly sampling plans may result
in a higher probability of mis-categorizations. However, FSIS chose the
above method for assessing process control in lower volume
establishments to limit the duration these establishments would remain
in Category 2 or 3, if effective corrective actions are taken by the
establishment. FSIS requests comment on how it plans to assess process
control in lower volume establishments.
A 52-week moving window does not necessarily mean that FSIS must
wait one year before it can determine whether an establishment has met
a performance standard. Using the broiler carcass performance standard
as an example (5 acceptable positives or fewer constitute passing while
6 or more is failing), if a high volume chicken slaughter establishment
that is sampled weekly gets six positives in less than 52 weeks, FSIS
can deem that establishment to have failed the performance standard no
matter how many uncollected samples remain in the establishment's 52-
week moving window.
Defining Categories
Under the existing set-based Salmonella verification sampling
program, FSIS classifies establishment performance relative to the
pathogen reduction performance standard (by product class) using the 3-
category establishment classification system announced on February 27,
2006 (71 FR 9772). FSIS will continue using this classification system
under routine sampling. However, for all products sampled under routine
Salmonella verification sampling, FSIS plans to modify the time
component of those definitions as follows:
I. Category 1. Consistent Process Control: Establishments that
have achieved 50 percent or less of the performance standard during
all completed 52-week moving windows over the last six months.
II. Category 2. Variable Process Control: Establishments that
meet the standard for all completed 52-week moving windows but have
results greater than 50 percent of the standard during any completed
52-week moving window over the last six months.
III. Category 3. Highly Variable Process Control: Establishments
that have exceeded the performance standard during any completed 52-
week moving window over the last six months.
Because of the potential for frequent changes in category status once
the first moving window is complete, FSIS felt a time component was
needed to provide stability. Upon completion of their first 52-week
moving window, FSIS intends to update the category status for each
eligible establishment, after the pathogen reduction performance
standards are finalized and implemented for that product category.
Thereafter, FSIS expects to re-categorize establishments monthly based
on their performance over the last six months. Finally, FSIS expects to
categorize establishments for Campylobacter process control similarly
as for Salmonella.
With the addition of the 6-month time period, establishments can
expect to remain in Category 2 or 3 no shorter than 26 weeks. This
lower bound is based on a scenario where an establishment's positive
results are clustered at the beginning of the 52-week moving window.
Alternatively, if an establishment's positive results are clustered at
the end of the 52-week moving window, it would take a minimum of 69
weeks to move out of that category. However, based on analysis of its
current set-based verification sampling results, FSIS does not believe
these extreme scenarios are likely. FSIS data suggests that positive
results would be more evenly distributed throughout the moving window
and not clustered.
FSIS has analyzed the 6-month time period and determined it to have
minimal impact on the categorization of establishments that are most
likely to meet the standard. Our analysis suggests that, depending on
the underlying pathogen prevalence at an establishment, the impact
could range from no increase in probability to about a 7-fold increase.
However, the higher-end increase is predominantly for those
establishments already with a low probability of not meeting the
standard, so the absolute probability of not meeting the standard
remains low. For example, if an establishment had a 0.1 percent chance
of not meeting a standard during a 52-week moving window, its
probability of not meeting the standard during the 6 months after
completion of that moving window would be about 0.7 percent. FSIS
requests comment on its planned modifications and the impact of the 6-
month time period on the categorization of establishments.
Web-Posting
The Agency's policy of web-posting establishments' process control
performance has stimulated improvement in industry performance, as was
shown in the Agency's experience after announcing in 2006 that it was
considering posting the names of broiler and turkey slaughter
establishments in Category 2 and 3. Within two years after the
announcement, but before names were actually posted, the number of
broiler slaughter establishments that had been in Category 3 decreased
by approximately 55 percent. Furthermore, the percentage of broiler
slaughter establishments in Category 1 increased by nearly 40 percent.
Once FSIS began posting establishment names and their process control
performance, the turkey slaughter establishments responded particularly
to the challenge that FSIS identified for the industry. The Agency said
that if 90 percent of the broiler or turkey industry attained Category
1 status with no establishments in Category 3, FSIS would no longer
publish the names or process control performance of the establishments.
The
[[Page 3948]]
turkey slaughter establishments met the challenge proffered by FSIS,
and FSIS stopped publishing the names of the turkey slaughter
establishments.
Another example of how the categorization of establishments was
used by the industry involved those establishments that produced a
product referred to as NRTE stuffed chicken breast that appeared as
RTE, such as Chicken Kiev. Multiple illnesses were traced to this
product containing raw chicken. As a mitigation strategy for reducing
the likelihood of the product being contaminated with Salmonella,
establishments that produced the product cited a purchase specification
requirement for using only chicken breast meat supplied by Category 1
establishments. Because FSIS was not posting the Category 1 status of
establishments, industry internally worked out how to address this
issue, but there was no verification of this specification provision by
FSIS. FSIS noted at the time that without posting Category 1 status,
there was confusion by consumers and industry as to whether
establishments not listed as Category 2 or Category 3 establishments
were actually Category 1 or had not yet been categorized.
Consequently, FSIS intends to post the category status for all
eligible establishments because web-posting provides greater
transparency, thereby providing the public with the tools and
information that it needs to make informed food safety decisions. After
reviewing the comments received on this notice, beginning July 1, 2015,
the Agency plans to begin web-posting individual establishment category
information for chicken and turkey carcasses. FSIS will finish sample
sets begun before February 2015 and will not begin any new sampling
until March, at which time FSIS will begin sampling chicken and turkey
carcasses using the moving window approach, rather than the set
approach. FSIS will assess what category establishments are in as of
July 1, using combined historical set data and sample results beginning
March 2015. In July, FSIS will then post the category establishments
are in. For example, once FSIS begins the new sampling approach in
March, FSIS may collect 24 samples from March 1 through June 30, 2015,
at some establishments. In July, FSIS will assess those 24 results and
the previous 28 results assessed under the set approach. Based on those
most recent 52 samples, FSIS will assess which category the
establishment is in and post that category. FSIS will then monthly re-
categorize establishments, based on the last 52 samples, until
sufficient data is available to look at the previous six months of
windows as described above.
Until July, FSIS will continue to web-post existing Category 3
poultry carcass establishments. In addition, the Agency will post
aggregate reports quarterly showing the Category 1/2/3 distribution for
each relevant product class subject to FSIS Salmonella and
Campylobacter testing, as applicable. Therefore, FSIS will continue to
post aggregate reports for chicken and turkey slaughter establishments
showing category distribution for current performance standards for
carcasses. In addition, starting in March, FSIS will begin posting
aggregate reports showing the category 1/2/3 distribution for chicken
parts as data become available, and comminuted chicken and turkey using
historical data and new results beginning in March based on the
proposed standards. FSIS invites comments on how it plans to web-post
establishments.
Agency Actions
FSIS has used the results from its verification testing program as
a measure of establishment process control for reducing exposure of the
public to pathogens. Under the HACCP regulations, establishments need
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, and that it has resulted in reduced
human illnesses.\24\
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\24\ http://www.sciencedirect.com/science/article/pii/S0956713512002393; http://online.liebertpub.com/doi/abs/10.1089/fpd.2011.0951.
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Under the new standards and under the new moving window approach,
when an establishment does not meet a performance standard (i.e., the
number of positive samples within a specified timeframe exceeds the
maximum acceptable for that product class), FSIS will immediately
conduct follow-up sampling. Follow-up samples will be analyzed for both
Salmonella and Campylobacter, where applicable. Because FSIS has
experience with follow-up samples associated with the Escherichia coli
O157 testing program, FSIS will assess whether this approach will work
for Salmonella and Campylobacter testing. In essence, either 16 or
eight follow-up samples are collected depending upon the size and
production volume of the establishment. FSIS will analyze follow-up
sampling data independent of the moving window approach to assess
whether the establishment is making or has made changes to its food
safety system to improve its process control.
As FSIS does now when establishments do not meet performance
standards, FSIS will conduct a for-cause FSA at the establishment that
produced the product. In addition, even when establishments meet the
performance standards, if FSIS Salmonella or Campylobacter verification
testing data from an establishment show a high number of positives or
serotypes of human health significance, FSIS may perform Incident
Investigation Team testing or conduct a for-cause FSA that includes
collection of samples or take other appropriate actions, such as
additional sanitary dressing verification procedures, at the
establishment that produced the product.
In May 2010, FSIS issued guidance on how establishments can address
Salmonella and Campylobacter in poultry.\25\ FSIS is updating this
guidance to include additional suggested pre-harvest and post-harvest
controls. The Agency intends to make the updated guidance available to
the establishments soon. In response to a Government Accountability
Office recommendation, FSIS will include information in the guidance on
the effectiveness of pre-harvest controls to reduce pathogens in live
poultry (USDA Needs to Strengthen its Approach to Protecting Human
Health from Pathogens in Poultry Products, September 2014 at http://www.gao.gov/assets/670/666231.pdf).
---------------------------------------------------------------------------
\25\ The Compliance Guideline for Controlling Salmonella and
Campylobacter in Poultry, Third Edition, May 2010, is available at
http://www.fsis.usda.gov/wps/wcm/connect/6732c082-af40-415e-9b57-90533ea4c252/Compliance_Guide_Controling_Salmonella_Campylobacter_Poultry_0510.pdf?MOD=AJPERES.
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Cost-Benefit Analysis
FSIS has considered the economic effects of new pathogen reduction
performance standards for Salmonella and Campylobacter in raw chicken
parts and NRTE comminuted poultry. The full analysis is published on
the FSIS Web site as supporting documentation to this notice. FSIS is
seeking comment on the accuracy of the information and assumptions used
in the cost-benefit analysis. A summary of the analysis is below.
Industry Costs
Establishments will incur costs as they make changes to their
processes in order to meet the new standards. FSIS estimates that
approximately 63 percent of raw chicken parts producing establishments,
62 percent of NRTE
[[Page 3949]]
comminuted chicken producing establishments, and 58 percent of NRTE
comminuted turkey producing establishments will not meet the new
Salmonella standards. FSIS estimates that approximately 46 percent of
raw chicken parts producing establishments, 24 percent of NRTE
comminuted chicken producing establishments, and 9 percent of NRTE
comminuted turkey producing establishments will not meet the new
Campylobacter standards.
Establishments that initially do not meet the standard but aspire
to do so will need to make changes to their production processes to
lower the prevalence of Salmonella and Campylobacter in their products.
Changes could include pre-harvest interventions, such as vaccination
programs, well-timed feed withdrawal, clean and dry litter and
transportation, and supplier contract guarantees of pathogen-free
flocks. During processing, establishments could add additional cleaning
procedures, apply chemical antimicrobials to parts and source materials
for comminuted poultry product and provide additional sanitation
training to employees. For the purposes of the cost-benefit analysis,
FSIS used the cost of adding antimicrobial solutions to poultry parts
as a proxy for the costs of interventions and changes that could be
implemented. FSIS used this approach based on information from FSAs in
response to broiler Salmonella sets not meeting the standards and
information from the FSIS Poultry Checklist explained above. Through
FSAs, FSIS found that the majority of establishments added
antimicrobials to the production process as a corrective action,
suggesting that an antimicrobial intervention would be the most likely
response should an establishment not meet the proposed performance
standards. Also, information from the FSIS Poultry Checklist showed
that the majority of establishments are not applying antimicrobials to
raw poultry parts and source materials for comminuted poultry product.
To account for uncertainty in the proportion of establishments
making changes to their production processes in order to meet the new
standards, FSIS provided cost estimates for a range (30, 40, and 50
percent) of establishments initially falling short of but eventually
meeting the standards in two years. These costs are summarized and
annualized over 10 years at a discount rate of 7 percent in Table 1.
Table 1--Total Industry Costs Annualized \1\
----------------------------------------------------------------------------------------------------------------
Primary
Compliance level of establishments not Cost component estimate Low estimate High estimate
meeting standard ($mil) ($mil) ($mil)
----------------------------------------------------------------------------------------------------------------
30%................................... Capital Equipment....... 2.15 .............. ..............
Antimicrobial Solution.. 6.54 4.61 8.46
Microbiological Sampling 9.27 6.18 12.36
HACCP Validation & (*) .............. ..............
Training.
-------------------------------------------------------------------------
Total Costs....................... 17.96................... 12.94 22.97
----------------------------------------------------------------------------------------------------------------
40%................................... Capital Equipment....... 2.86 .............. ..............
Antimicrobial Solution.. 8.72 6.14 11.28
Microbiological Sampling 9.82 6.52 13.05
HACCP Validation & (*) .............. (*)
Training.
-------------------------------------------------------------------------
Total Costs....................... 21.40................... 15.52 27.19
----------------------------------------------------------------------------------------------------------------
50%................................... Capital Equipment....... 3.58 .............. ..............
Antimicrobial Solution.. 10.89 7.68 14.12
Microbiological Sampling 10.40 6.91 13.81
HACCP Validation & (*) .............. ..............
Training.
-------------------------------------------------------------------------
Total Costs....................... ........................ 24.87 18.17 31.51
----------------------------------------------------------------------------------------------------------------
\1\ Costs annualized at a discount rate of 7 percent over 10 years.
* Approximately $3,800 at 30% compliance, $5,100 at 40% compliance, and $6,400 at 50% compliance--values too
small to display in table.
Agency Costs
FSIS does not expect to incur any additional costs as a result of
introducing new performance standards. FSIS allocates a fixed number of
samples by product class, sampling project, and pathogen each year.
FSIS does not anticipate the need to exclude any of the other testing
programs allocated to other product classes. FSIS intends to test
carcasses at the level that is needed. In order to accommodate the
proposed sampling programs, FSIS will adjust the currently allotted
young chicken (``Broiler'') and young turkey sampling programs for
Salmonella and Campylobacter to include testing of raw chicken parts
and not-ready-to-eat comminuted chicken and turkey. In this case,
samples that could be allocated to test carcasses will be moved closer
to the consumer and be used on parts and NRTE comminuted poultry
products. Therefore, FSIS will not expend additional resources to
implement the proposed performance standards.
Public Health Benefits
As establishments make changes to their production processes and
reduce the prevalence of Salmonella and Campylobacter in chicken parts
and NRTE comminuted poultry, public health benefits will be realized in
the form of averted illnesses. For each assumed compliance level FSIS
estimated the cost savings associated with the percentage reduction in
human illnesses as calculated in the 2015 Risk Assessment. The results
of this calculation were annualized over 10 years at a discount rate of
7 percent, and are displayed in Table 2.
[[Page 3950]]
Table 2--Public Health Benefits Annualized \1\
------------------------------------------------------------------------
Compliance level of Primary
establishments not estimate Low estimate High estimate
meeting the standard (%) ($mil) ($mil) ($mil)
------------------------------------------------------------------------
30...................... 50.87 31.84 79.89
40...................... 79.66 50.43 125.89
50...................... 109.10 68.80 171.24
------------------------------------------------------------------------
\1\ Benefits annualized over 10 years at a discount rate of 7 percent.
Summary of Net Benefits
Table 3 displays the total costs and benefits expected from the
implementation of performance standards for chicken parts and
comminuted poultry. All values have been annualized over 10 years at a
7 percent discount rate. For all compliance levels considered, the
performance standards result in net benefits.
Table 3--Summary of Net Benefits \1\
----------------------------------------------------------------------------------------------------------------
Primary
Compliance level of establishments Cost/benefit component estimate Low estimate High estimate
not meeting the standard (%) ($mil) ($mil) ($mil)
----------------------------------------------------------------------------------------------------------------
30.................................. Industry Costs......... (18.0) (12.9) (23.0)
FSIS Costs............. ............... ............... ...............
Public Health Benefits. 50.9 31.8 79.9
---------------------------------------------------------------------------
Net Benefits.................... ....................... 32.9 18.9 56.9
----------------------------------------------------------------------------------------------------------------
40.................................. Industry Costs......... (21.4) (15.5) (27.2)
FSIS Costs............. ............... ............... ...............
Public Health Benefits. 79.7 50.4 125.9
---------------------------------------------------------------------------
Net Benefits.................... ....................... 58.3 34.9 98.7
----------------------------------------------------------------------------------------------------------------
50.................................. Industry Costs......... (24.9) (18.2) (31.5)
FSIS Costs............. ............... ............... ...............
Public Health Benefits. 109.1 68.8 171.2
---------------------------------------------------------------------------
Net Benefits.................... ....................... 84.2 50.6 139.7
----------------------------------------------------------------------------------------------------------------
\1\ All costs and benefits annualized over 10 years at a 7 percent discount rate.
USDA Nondiscrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
Fax: (202)690-7442. Email: [email protected].
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.) should contact
USDA's TARGET Center at (202)720-2600 (voice and TDD).
Additional Public Notification
FSIS will announce this notice online through the FSIS Web page
located at http://www.fsis.usda.gov/federal-register.
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. In addition, FSIS offers an electronic 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/subscribe. Options range from recalls to export
information to regulations, directives, and notices. Customers can add
or delete subscriptions themselves, and have the option to password
protect their accounts.
Done at Washington, DC on: January 21, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-01323 Filed 1-23-15; 8:45 am]
BILLING CODE 3410-DM-P