[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
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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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \24\ http://www.sciencedirect.com/science/article/pii/S0956713512002393; http://online.liebertpub.com/doi/abs/10.1089/fpd.2011.0951.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

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