[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Notices]
[Pages 38203-38210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16765]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2018-0044]
Changes to the Campylobacter Verification Testing Program:
Revised Performance Standards for Campylobacter in Not-Ready-To-Eat
Comminuted Chicken and Turkey and Related Agency Procedures
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 proposing and
requesting comments on revised pathogen reduction performance standards
for Campylobacter in not-ready-to-eat (NRTE) comminuted chicken and
turkey products based on a microbiological method change from direct-
plating to enrichment. The Agency is taking this step because the
enrichment method more effectively recovers Campylobacter in
contaminated poultry samples as compared to the direct-plating method.
FSIS will consider comments received on this notice before
announcing the final standards in the Federal Register and assessing
whether establishments are meeting the standards.
After collecting sufficient data, FSIS plans to propose and request
comments on revised pathogen reduction performance standards for
Campylobacter in young chicken and turkey carcasses and in raw chicken
parts, also based on the enrichment method.
DATES: Submit comments on or before October 7, 2019.
ADDRESSES: FSIS invites interested persons to submit comments on this
notice. Comments may be submitted by one of the following methods:
Federal eRulemaking Portal: This website provides
commenters the ability to type short comments directly into the comment
field on the web page or to attach a file for lengthier comments. Go to
http://www.regulations.gov. Follow the on-line instructions at that
site for submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, 1400
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
Hand- or Courier-Delivered Submittals: Deliver to 1400
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2018-0044. 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 comments received,
call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant
Administrator, Office of Policy and Program Development by telephone at
(202) 205-0495.
SUPPLEMENTARY INFORMATION: 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.
Campylobacter is the most common bacterial cause of foodborne
illness in the United States. The Centers for Disease Control and
Prevention (CDC) estimate Campylobacter infections affect 1.3 million
people every year in the United States.\1\ During 2018, CDC's Foodborne
Diseases Active Surveillance Network, or FoodNet,\2\ reported that the
incidence of foodborne infection was highest for Campylobacter (19.5
per 100,000 population).\3\ Most non-dairy, outbreak-associated
Campylobacter illnesses are attributed to the consumption of
poultry.\4\ Campylobacter outbreaks are not commonly identified
considering how often people get sick from this bacteria, but the
frequency of outbreaks has been increasing.\5\
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\1\ https://www.cdc.gov/Campylobacter/faq.html.
\2\ https://www.cdc.gov/foodnet/index.html.
\3\ https://www.cdc.gov/mmwr/volumes/68/wr/mm6816a2.htm.
\4\ https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2016-report-TriAgency-508.pdf.
\5\ https://www.cdc.gov/Campylobacter/outbreaks/outbreaks.html.
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Poultry Carcasses and Raw Chicken Parts
FSIS finalized and announced Campylobacter performance standards
for establishments that produce young chicken carcasses and turkey
carcasses on May 14, 2010 (75 FR 27288). FSIS initially proposed to use
the results from both the 1-mL direct-plating analytical method and the
30-mL enrichment analytical method to assess whether establishments
were meeting the Campylobacter performance standards for young chicken
and turkey carcasses.\6\ However, on March 21, 2011, after further
analysis and in response to public comments, FSIS announced that it
would: Only use the direct-plating method results to assess whether
young chicken and turkey slaughter establishments were meeting the
performance standards; also concurrently analyze young chicken and
turkey carcass rinsates using the enrichment method; and conduct an
internal analysis of all of these results--direct-plating and
enrichment method generated results--to develop additional policy
options (76 FR 15282). In July 2011, FSIS began compiling sample sets
\7\ to generate data to assess whether young chicken and turkey
slaughter establishments were meeting the Campylobacter standards.
Poultry slaughter establishments subject to the Campylobacter
performance standards were assessed against the standards based solely
on the results generated using the direct-plating method. However,
samples collected as part of these sample sets were analyzed
concurrently using the enrichment method.
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\6\ FSIS's direct-plating and enrichment analytical methods are
described in the Microbiology Laboratory Guidebook, Chapter 41; at
https://www.fsis.usda.gov/wps/wcm/connect/0273bc3d-2363-45b3-befb-1190c25f3c8b/MLG-41.pdf?MOD=AJPERES.
\7\ At the time, FSIS inspection program personnel were
collecting poultry carcass samples over a defined number of
sequential days of production to complete a sample set. In May 2015,
FSIS began testing poultry carcasses using a continuous sampling
program and discontinued the previous set-based verification
projects.
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After FSIS completed two sample sets for nearly 90 percent of the
young chicken and turkey slaughter establishments, the results
generated using both the 1-mL direct-plating and
[[Page 38204]]
30-mL enrichment methods were evaluated. FSIS announced in the
Constituent Update on May 31, 2013 that it had evaluated the available
Campylobacter sample set data \8\ and the analysis at that time showed
that the direct-plating method was sufficiently sensitive to identify
poultry carcass establishments with substandard process control. Thus,
on June 3, 2013, FSIS suspended the use of the 30-mL enrichment method
for Campylobacter for young chicken and turkey carcasses.\9\
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\8\ http://www.fsis.usda.gov/wps/wcm/connect/9a3a7078-0ff4-4ebc-8de6-ad889382fd7f/Const_Update_053113.pdf?MOD=AJPERES.
\9\ FSIS announced full discontinuation of this analysis for
poultry carcasses on February 21, 2014 (79 FR 9875).
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However, in July 2016, when FSIS modified its sampling procedure
for young chicken and turkey carcasses and raw chicken parts by
replacing buffered peptone water (BPW) with neutralizing BPW (nBPW),
the Agency began to observe a marked and significant reduction in
Campylobacter recovery from turkey carcasses and chicken parts using
the 1-mL direct-plating method, suggesting nBPW affected Campylobacter
recovery in these products. In May 2018, FSIS further investigated this
effect by performing a side-by-side analysis of poultry carcasses and
raw chicken parts samples with the direct-plating and enrichment
methods and found significantly higher percentages of Campylobacter
positive samples, indicating more effective recovery of Campylobacter,
using the enrichment method as compared to the direct-plating method
for young chicken carcasses (18 percent compared to 1 percent), turkey
carcasses (1 percent compared to 0 percent) and chicken parts (16
percent compared to 2 percent). In the near future, FSIS also intends
to propose and request comments on revised Campylobacter performance
standards for these commodities based on the enrichment method.
Comminuted Poultry
On January 26, 2015, FSIS proposed new Campylobacter performance
standards for NRTE comminuted chicken and turkey products and raw
chicken parts, including a cost-benefit analysis (80 FR 3940), and
released a risk assessment estimating the effect of these new
performance standards on reducing Campylobacter illnesses attributed to
these products (2015 Risk Assessment).\10\ FSIS finalized the
performance standards on February 11, 2016 (81 FR 7285).
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\10\ The 2015 Risk Assessment is available at https://www.fsis.usda.gov/wps/wcm/connect/afe9a946-03c6-4f0d-b024-12aba4c01aef/Effects-Performance-Standards-Chicken-Parts-Comminuted.pdf?MOD=AJPERES.
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These Campylobacter performance standards were based on the 1-mL
direct-plating method and, for both NRTE comminuted chicken and turkey
products, specified one (1) allowable positive sample in 52 samples. In
2014, before these performance standards were announced, FSIS tested
NRTE comminuted chicken, but not NRTE comminuted turkey products using
the 30-mL enrichment method and found the enrichment method to have
greater Campylobacter recovery and thus generate more positive results.
In the February 2015 Federal Register notice, FSIS announced its
intention to continue to perform the 30-mL enrichment method
concurrently with the 1-mL direct-plating method for both NRTE
comminuted chicken and turkey products, and to analyze data generated
from both analytical approaches (81 FR at 7292). As part of this
effort, all NRTE comminuted chicken and turkey product samples
collected between June 2015 and May 2017 were analyzed for the presence
of Campylobacter using both the 1-mL direct-plating method and the 30-
mL enrichment method. In May 2017, FSIS suspended use of the enrichment
method while it analyzed the data. The Agency resumed using the
enrichment method concurrent with the direct-plating method on August
27, 2018.\11\ These results were not affected by the July 2016 switch
from BPW to nBPW because nBPW is not used to collect or test NRTE
comminuted poultry product samples.\12\
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\11\ https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/newsletters/constituent-updates/archive/2018/ConstUpdate082718.
\12\ The sampling procedures for NRTE comminuted chicken and
turkey products can be seen at https://www.fsis.usda.gov/wps/wcm/connect/801ffca3-a226-45c4-ac68-10670e3ac32b/NRTE-Comminuted-Poultry-Sampling-Program.pdf?MOD=AJPERES.
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Enrichment Method
As stated above, FSIS originally developed Campylobacter
performance standards for NRTE comminuted chicken and turkey products
using the 1-mL direct-plating method while simultaneously analyzing the
same samples using the 30-mL enrichment method. The enrichment method
enhances the probability of recovering Campylobacter from raw poultry
samples. For both methods, the test portion consists of 325 grams of
NRTE comminuted poultry suspended in 1625 mL of BPW. Because the
direct-plating method requires at least 1,950 colony forming units
(CFU) in the suspended mixture to be reasonably likely to detect a
positive Campylobacter sample, its theoretical limit of detection (LOD)
is 6 CFU/gram. The enrichment method requires at least 65 CFU in the
suspended mixture for Campylobacter to be detected, giving it a
theoretical LOD of 0.2 CFU/gram.
The enrichment method includes a two-day enrichment step, which may
allow for the repair of bacteria injured by exposure to extremes of pH,
temperature, pressure, antimicrobial compounds, or other injurious
conditions and growth of any viable bacteria present. Therefore, the
enrichment step increases the potential for the growth and recovery of
Campylobacter cells injured during comminuted poultry processing steps
as compared with the direct- plating method. The enrichment method for
Campylobacter is comparable to the enrichment method currently used to
assess the pathogen reduction performance standards for Salmonella in
raw poultry.
The enhanced recovery of the enrichment method compared to the
direct-plating method will improve FSIS's ability to distinguish
establishments that are meeting or not meeting the Campylobacter
performance standards. The Campylobacter performance standards proposed
in this notice were revised to account for a microbiological method
change and would retain the same potential benefits and costs as the
original, 1-mL direct-plating-based performance standards. A peer-
reviewed manuscript was published which explains the technical details
used to determine the mathematical equivalence between the 1-ml direct-
plating and 30-mL enrichment methods. The article uses the NRTE
comminuted chicken performance standard as an example.\13\ Brief
explanations of FSIS's process for developing the current Campylobacter
performance standards for NRTE comminuted chicken and turkey based on
the 1-mL direct-plating method and the revised performance standards
for NRTE comminuted chicken and turkey based on the 30-mL enrichment
method are provided below.
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\13\ Williams, M.S., Ebel, E.D., Golden, N.J., 2018. Revising a
Constrained 2-Class Attributes Sampling Plan When Laboratory Methods
are Changed. Microbial Risk Analysis; https://doi.org/10.1016/j.mran.2018.12.002.
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How FSIS Develops Campylobacter Performance Standards
The current FSIS Campylobacter and Salmonella performance standards
are based on a 2-class attributes sampling plan, which specifies a
maximum
[[Page 38205]]
number of positive samples out of a fixed number of total samples. This
can also be expressed as a maximum allowable percent positive. Positive
samples are those in which the pathogen is detectable using a
microbiological assay. Since 2011, FSIS has taken a common approach to
determine performance standards for each pathogen-product pair, and
this approach is described most recently in the January 26, 2015
Federal Register (80 FR at 3942). Briefly, FSIS measures the public
health effect of a performance standard as the number of illnesses
avoided each year.\14\ This effect is calculated from the volume-
weighted prevalence of a contaminated poultry product before and after
successfully implementing the performance standard. Volume-weighted
prevalence means that establishments with higher production volumes
have a greater influence on the overall prevalence estimates. Because
the volume-weighted prevalence after implementing a performance
standard cannot be known when the standard is proposed, FSIS models the
impact of the performance standard by assuming that a certain
percentage of establishments (and their production volume) would
initially not meet the standard but eventually do meet it. This is
referred to as the ``compliance fraction.''
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\14\ Ebel, Williams et al. 2012. Simplified framework for
predicting changes in public health from performance standards
applied in slaughter establishments. Food Control 28:250-257.
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Using the sampling and production volume data collected from each
eligible establishment, FSIS can estimate the impact of all possible
performance standards. Establishments are classified as meeting or not
meeting each possible performance standard. The compliance fraction is
then used to estimate the number of avoided or reduced illnesses.
FSIS's current performance standards for Campylobacter in poultry were
intended to achieve at least a 33-percent reduction in illnesses, a
target based on Healthy People 2020 goals.15 16 The
proportion of establishments and their production volume initially not
meeting the performance standard also allows FSIS to estimate the costs
associated with implementing the performance standard (i.e., the costs
to industry).
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\15\ HHS. (2010). ``Healthy People Topics & Objectives: Food
Safety.'' Reduce infections caused byCampylobacter species
transmitted commonly through food http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=14. Once the
Healthy People 2030 objectives have been finalized, FSIS intends to
assess whether changes to its performance standards are warranted.
\16\ Although the Healthy People 2020 goal of 33-percent
reduction in Campylobacter illnesses was achieved with other poultry
products, the most restrictive and achievable performance standard
for NRTE comminuted turkey is 1 positive in 52 samples, which would
achieve a 19-percent reduction in Campylobacter illnesses.
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How FSIS Developed the Current Campylobacter Performance Standards for
NRTE Comminuted Chicken and Turkey Using the 1-mL Direct-Plating Method
To estimate the illnesses reduced by the current NRTE comminuted
chicken and turkey Campylobacter performance standards, FSIS sampled
establishments producing NRTE comminuted chicken and/or turkey products
between June 2013 and May 2014. Each sample was tested for
Campylobacter using the 1-mL direct-plating method. Three important
factors varied across the establishments: Production volume, prevalence
of contaminated samples, and the number of samples collected.
Underlying all of the results is a statistical distribution of volume-
weighted establishment prevalence accounting for these factors.\17\
This distribution is demonstrated as the smooth line in Figure 1 (a).
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\17\ Williams, M.S., Ebel, E.D., Cao, Y., 2013. Fitting
distributions to microbial contamination data collected with an
unequal probability sampling design. Journal of Applied Microbiology
114, 152-160.
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The risk assessment model uses estimates from the statistical
distribution of volume-weighted prevalence and assumes a 50-percent
compliance fraction to predict the illness reduction. Figure 1 (b)
shows the predicted illnesses reduced by Campylobacter performance
standards based on 1-mL direct-plating data collected between 2013 and
2014. Using this curve, and FSIS's stated intent of at least a 33-
percent illness reduction for Campylobacter from NRTE comminuted
chicken, FSIS selected a performance standard of one (1) allowable
positive out of 52 samples, or a maximum allowable percent positive of
1.9. FSIS actually predicted a 37-percent reduction in the illness rate
for Campylobacter after implementing the NRTE comminuted chicken
performance standard, corresponding to an annual reduction of
approximately 1,300 illnesses.
The statistical distribution is also used to determine the
proportion of NRTE comminuted chicken product that would meet a
Campylobacter performance standard of one (1) positive out of 52
samples. Figure 1 (c) shows the proportion of product that would meet
the performance standard based on the 1-mL direct-plating data
collected from 2013-2014. With a performance standard of one (1)
positive out of 52 samples, 56 percent of all NRTE comminuted chicken
product (corresponding to 24 percent of eligible establishments) would
initially not meet the standard. FSIS used this information to estimate
the associated costs.
The same procedures were used to determine the Campylobacter
performance standard for NRTE comminuted turkey product. FSIS
determined that the direct-plating method-based performance standard of
one (1) allowable positive in 52 samples in NRTE comminuted turkey
product would provide a 19-percent illness reduction, and 20 percent of
production volume (which accounts for 9 percent of eligible
establishments) would initially not meet the standard.\18\
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\18\ FSIS initially intended for Campylobacter performance
standards to reduce illness by approximately 33 percent. However,
because FSIS found the prevalence for Campylobacter in comminuted
turkey to be especially low, the highest practical illness reduction
for this product was estimated to be 19 percent. The revised
standard based on the 30-mL enrichment method was therefore designed
to achieve the same predicted illness reduction of 19 percent.
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[GRAPHIC] [TIFF OMITTED] TN06AU19.045
How FSIS Revised the Campylobacter Performance Standards for NRTE
Comminuted Chicken and Turkey Using Data Generated Using the 30-mL
Enrichment Method
As is discussed above, from June 2015 through May 2017, FSIS tested
all NRTE comminuted chicken samples using both the 1-mL direct-plating
and 30-mL enrichment methods. There were approximately five times as
many samples that tested positive for Campylobacter using the 30-mL
enrichment method as compared to the 1-mL direct-plating method (i.e.,
267 versus 53). FSIS believes this increase was facilitated by a larger
test portion size (30-mL compared to 1-mL) and the potential for growth
and recovery of injured Campylobacter cells allowed by the enrichment
process.
FSIS developed a revised Campylobacter performance standard by
fitting a statistical distribution of the volume-weighted prevalence
and then finding the point that reaches the same illness reduction goal
determined for the current, 1-mL direct- plating-based performance
standard, which was a 37-percent reduction in illnesses. Figure 2 (a)
shows the predicted illnesses reduced by potential Campylobacter
performance standards based on the 30-mL enrichment data collected
between 2015 and 2017. A 37-percent reduction in illnesses could be
achieved with a 30-mL enrichment method-based standard of five (5)
positives in 52 samples. That is, the point on the 30-mL curve that
reaches a 37-percent reduction in illnesses corresponds to a
performance standard of five (5) positives in 52 samples.
Similarly, the 1-mL direct-plating and 30-mL enrichment-based
curves were used to determine the proportion of NRTE comminuted chicken
product that
[[Page 38207]]
would initially be classified as meeting/not meeting the standard.
Figure 2 (c) shows that a performance standard of five (5) allowable
positives in 52 samples would result in 44 percent of production volume
meeting the standard. That is, the point on the 30-mL curve
corresponding to five (5) positives in 52 samples results in 44 percent
of the production volume meeting the performance standard, and 56
percent not meeting it. A more detailed description of the methodology,
and the treatment of statistical uncertainty is presented in the peer-
reviewed technical manuscript (Williams et al, 2018; citation 12).
The same procedures were used to revise the Campylobacter
performance standard for NRTE comminuted turkey product. FSIS
determined that an enrichment method-based performance standard of five
(5) allowable positives in 52 samples would provide a 19-percent
illness reduction, and 20 percent of production volume (which accounts
for 9 percent of eligible establishments) would initially not meet the
revised performance standard.
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[GRAPHIC] [TIFF OMITTED] TN06AU19.046
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Revised Pathogen Reduction Performance Standards
FSIS is proposing revised performance standards to improve the
Agency's ability to identify Campylobacter contamination in NRTE
comminuted chicken and turkey products using the enrichment method. A
summary of the revised Campylobacter performance standards for NRTE
comminuted poultry products is provided in Table 1. Should FSIS
finalize these proposed performance standards, FSIS will announce the
final standards in the Federal Register before assessing whether
establishments meet the standards. Any changes to the performance
standards for Campylobacter in young chicken and turkey carcasses, and
in raw chicken parts, will be proposed in a separate Federal Register
notice.
As described above, FSIS has revised the pathogen reduction
performance standards for Campylobacter in NRTE
[[Page 38209]]
comminuted chicken and turkey products based on the 30-mL enrichment
method, such that the same public health objectives announced in 2015
for the 1-mL direct-plating method-based standards are achieved.
Minimum Number of Samples To Assess Performance
FSIS uses the following formula to estimate the minimum number of
samples (n) needed to assess establishment performance: n = (1/percent
positive allowed) x 100 (80 FR at 3947). Revising the Campylobacter
performance standard from one allowable positive per 52 samples (1.9
percent) to five allowable positive samples per 52 samples (9.6
percent) changes the minimum number of samples needed to assess
establishments from (\1/1\.9%) x 100), or 52 samples, to (\1/9\.6%) x
100, or 10.4 samples. Because samples are necessarily whole numbers, a
fractional number is rounded up to the next highest whole number.
Therefore, 11 samples would be the minimum number of samples needed to
assess performance for Campylobacter in both NRTE comminuted chicken
and comminuted turkey producing establishments under the revised
standards. Significantly, since the proposed revised performance
standards reduce the minimum number of samples needed to assess
establishment performance, FSIS would be able to assess performance for
a greater number of otherwise eligible establishments.
Table 1--Revised Performance Standards for Campylobacter in NRTE Comminuted Chicken and Turkey Products
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Revised
Revised maximum Revised
Product performance allowable minimum number
standard for percent of samples to
Campylobacter positive * assess
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NRTE Comminuted Chicken (325 g sample)....................... 5 of 52 9.6 11
NRTE Comminuted Turkey (325 g sample)........................ 5 of 52 9.6 11
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* Consistent with existing FSIS procedures, if the total number of samples in a 52-week moving window ranges
from 11 to 51, FSIS will subtract 1 from the number of positive samples to calculate the percent positive,
which is compared to the revised maximum acceptable percent positive determined by dividing 5 by 52 to
determine the Category. If the total number of samples in a moving window exceeds 51, FSIS will calculate a
percent positive without subtracting 1 from the number of positives.
Changes to Related Agency Procedures
Once FSIS begins assessing whether establishments meet the revised
Campylobacter performance standards, FSIS would use the categorization
methodology, as well as the web posting procedures announced in the
Federal Register on November 9, 2018 (83 FR 56046; Nov. 9, 2018). As
explained in the November 2018 Federal Register notice, the Category
status reported on the public website would be based on FSIS sample
results during the 52-week window ending the last Saturday of the
previous month, and would not include follow-up sampling results, if
any were collected and analyzed, as part of the window.
In addition, establishments would not be categorized as meeting or
not meeting as previously announced in the February 2016 Federal
Register notice. Instead, FSIS would categorize eligible establishments
using the same 3-category system it uses for poultry establishments
currently subject to a Salmonella pathogen reduction performance
standard. The criteria for each category are as follows:
Category 1: Establishments that have achieved 50 percent
or less of the maximum allowable percent positive during the most
recently completed 52-week moving window.
Category 2: Establishments that meet the maximum allowable
percent positive but have results greater than 50 percent of the
maximum allowable percent positive during the most recently completed
52-week moving window.
Category 3: Establishments that have exceeded the maximum
allowable percent positive during the most recently completed 52-week
moving window.
All other FSIS verification procedures outlined in the February
2016 Federal Register notice are unchanged.
Additional Information
Should these Campylobacter standards for comminuted poultry
products be finalized, FSIS will post aggregate Campylobacter sampling
results relative to categories and prevalence estimates for NRTE
comminuted chicken and turkey products, consistent with how FSIS
handles Salmonella postings.\19\ FSIS would also announce when it
expects to begin posting individual establishment category information
in the Federal Register notice that announces final Campylobacter
standards for comminuted poultry products.
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\19\ The information is posted at https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/aggregate-data.
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Cost-Benefit Analysis
The February 2016 Federal Register notice announcing pathogen
reduction performance standards for Salmonella and Campylobacter in
NRTE comminuted chicken and turkey products and raw chicken parts
included a supplementary cost-benefit analysis (2016 CBA).\20\ The 2016
CBA estimated the economic effects of the new pathogen reduction
performance standards for Salmonella and Campylobacter in both NRTE
comminuted poultry and raw chicken parts. The 2016 CBA used estimates
on whether establishments would meet the standards and illness
reduction estimates from the 2015 Risk Assessment, which relied on
results obtained using the direct-plating method.
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\20\ U.S. Department of Agriculture, Food Safety and Inspection
Service (FSIS). (2016). Final Cost-Benefit Analysis Chicken Parts
and Not Ready-To-Eat Comminuted Poultry Performance Standards;
available at: https://www.fsis.usda.gov/wps/wcm/connect/2f98f0a2-6a89-4316-aa95-86e5b103610f/CBA-Salmonella-Campy-2014-0023F-022016.pdf?MOD=AJPERES.
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As explained above, FSIS is proposing to revise the pathogen
reduction performance standards for Campylobacter in NRTE comminuted
chicken and turkey products based on an enrichment method. To ensure
the revised performance standards would be statistically equivalent to
the previously announced Campylobacter standards for these products,
FSIS analyzed 2015-2017 sample results generated using both the
enrichment and direct-plating methods. Based on this analysis, FSIS
concluded the revised pathogen reduction performance standards are
consistent with the previously announced standards in terms of the
estimated reduction in illnesses and the
[[Page 38210]]
percent of the industry expected to initially not meet the performance
standards (Williams et al, 2018; citation 12). Therefore, the
associated costs and public health benefits of the revised performance
standards remain unchanged from those estimated in the 2016 CBA.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication online through the FSIS web page located at:
http://www.fsis.usda.gov/federal-register.
FSIS also will announce and provide a link to it 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 our constituents and stakeholders. The
Constituent Update is available on the FSIS web page. Through the web
page, FSIS is able to provide information to a much broader, more
diverse audience. In addition, FSIS offers an email subscription
service which provides 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, regulations, directives, and notices. Customers can add or
delete subscriptions themselves, and have the option to password
protect their accounts.
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Done at Washington, DC:
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-16765 Filed 8-5-19; 8:45 am]
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