[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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BILLING CODE 3410-DM-P

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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

BILLING CODE 3410-DM-C

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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    Fax: (202) 690-7442.
    Email: program.intake@usda.gov.
    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).

    Done at Washington, DC:
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-16765 Filed 8-5-19; 8:45 am]
 BILLING CODE 3410-DM-P