[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56046-56049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24540]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2018-0043]


Changes to the Salmonella and Campylobacter Verification Testing 
Program: Revised Categorization and Follow-Up Sampling 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 announcing 
and requesting comments on revised categorization and follow-up 
sampling procedures relative to pathogen reduction performance 
standards. FSIS will proceed with web-posting individual 
establishments' category status for pathogen reduction performance 
standards for Salmonella in raw chicken parts and not-ready-to-eat 
(NRTE) comminuted chicken and turkey, as previously announced, and 
updating individual poultry carcass establishments' category status in 
November. However, the category status reported will be based on FSIS 
sample results during the 52-week window ending the last Saturday of 
the previous month, rather than on results during the last 13 completed 
52-week windows. At the same time, FSIS will no longer include follow-
up sampling results as part of the moving window when determining 
establishment category status. Finally, FSIS will update the individual 
establishments' category status on its website on a monthly basis and 
will maintain the last six months of historical establishment-specific 
categorization data on the website, as it becomes available, using the 
revised categorization procedures announced in this notice.
    FSIS intends to use the revised categorization procedures for all 
establishments subject to a pathogen reduction performance standard for 
Salmonella or Campylobacter, including

[[Page 56047]]

beef and pork establishments, in the future. FSIS will announce any 
expanded use of the revised procedures in the Federal Register and will 
request public comment.
    FSIS will proceed with implementing the changes on the date 
announced in this notice. However, FSIS is seeking comments on the 
changes as part of its effort to continuously assess and improve the 
effectiveness of Agency policy.

DATES: Submit comments on or before December 10, 2018. On November 23, 
2018, FSIS will:
     Web-post individual establishments' category status for 
pathogen reduction performance standards for Salmonella in raw chicken 
parts and NRTE comminuted chicken and turkey and update individual 
poultry carcass establishments' category status based on FSIS sample 
results during the 52-week window ending on October 27, 2018;
     Discontinue including follow-up sampling results as part 
of the moving window when determining category status for that 
establishment; and
     Begin updating individual establishments' category status 
on the FSIS website on a monthly basis using the revised procedures 
announced in this notice.

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 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, 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-2018-0043. 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 correctly packaged and labeled. In support of this 
mission, FSIS began its Salmonella verification testing program with 
the final rule entitled ``Pathogen Reduction; Hazard Analysis and 
Critical Control Point Systems'' (PR/HACCP Rule), published on July 25, 
1996 (61 FR 38805). Among other things, the PR/HACCP Rule established 
Salmonella pathogen reduction performance standards for establishments 
that slaughter selected classes of food animals and/or that produce 
selected classes of raw ground products. FSIS continues to use the 
pathogen reduction performance standards to ensure that eligible 
establishments are consistently controlling or reducing harmful 
bacteria on raw meat and poultry products.
    FSIS began posting individual establishment categories for 
Salmonella performance standards for poultry carcasses in May 2016.\1\ 
In November 2016, FSIS temporarily suspended the web posting of 
category status for individual carcass establishments to analyze the 
effect of the use of FSIS's new neutralizing Buffered Peptone Water on 
the Salmonella performance standards and to assess the implementation 
of follow-up sampling at Category 3 poultry carcass establishments 
(that is, establishments not meeting the standard). Upon conclusion of 
these analyses, FSIS resumed web posting of individual establishments' 
category status for Salmonella performance standards for poultry 
carcasses on January 23, 2018. As discussed in the February 11, 2016 
Federal Register notice, data support that public posting of 
establishment performance encourages establishments to make changes to 
address Salmonella (81 FR 7285).
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    \1\ https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/establishment-categories-cu.
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    FSIS also explained in the February 2016 Federal Register notice 
how it would assess establishment performance using a moving window of 
FSIS sampling results in poultry establishments subject to a pathogen 
reduction performance standard. For all establishments, FSIS defines an 
individual window as the results from FSIS sampling over 52 consecutive 
Sunday-to-Saturday weeks. Under the policy in the February 2016 Federal 
Register notice, FSIS used for each window all FSIS samples taken in 
any given week, including follow-up samples collected by FSIS to verify 
the adequacy of corrective actions taken by an establishment that was 
not meeting a performance standard. The category assigned to an 
establishment has been based on results in the 13 most recent completed 
52-week windows, which includes 64 weeks of data. If the establishment 
exceeded the performance standard in any of the last 13 completed 
windows, it was assigned to Category 3, i.e., designated as not meeting 
the standard (81 FR at 7287). Thus, under this policy, establishments 
that implemented effective corrective actions and demonstrated 
sustained process control remained in Category 3 until all 13 windows 
registered Category 1 or 2, i.e., reflected that the establishment was 
meeting the performance standard over 13 52-week windows.
    Although assessing 13 windows of data reduces the chance that an 
establishment's category status will change when there is no actual 
improvement in process control and improves FSIS's ability to assign 
small and very small establishments to a category,\2\ an 
establishment's category status may not necessarily reflect the current 
conditions in an establishment that has taken effective corrective 
actions. Under the current policy, even if an establishment has been in 
category 1 for multiple weeks, if it was in category 3 in any one of 
the last 13 52-week windows, FSIS would designate that establishment as 
category 3. Representatives from the poultry industry have raised these 
concerns to FSIS. In response to their concerns and internal concerns 
about whether the 13-window categorization procedure is accurately 
indicating the state of an establishment's process control following 
implementation of corrective actions, FSIS has reevaluated its 
policies.
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    \2\ Since there are 13 52-week windows, an establishment has 13 
chances to be categorized. With fewer windows, fewer establishments 
may be categorized. This is because there is a minimum number of 
samples needed to assess process control for each product class by 
pathogen (e.g., the minimum number of samples for Salmonella in 
broiler carcasses is 11).

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[[Page 56048]]

Changes to Categorization Procedure

    With the goal of encouraging sustained improvements in process 
control while still accurately reflecting current conditions in the 
establishment, FSIS has considered a full range of alternatives to the 
current 13-window categorization procedure. Based on the evaluation of 
available data, FSIS concluded that reducing the number of completed 
52-week windows assessed from 13 to one (1) is the best means to 
accomplish this goal. This approach will continue to minimize the 
effect of seasonal variation in pathogen incidence on category status, 
while providing a pathway for establishments to improve their category 
status after implementing effective corrective actions. This approach 
is far less complex than the current 13-window categorization 
procedure. This approach will not have an effect on public health.
    FSIS anticipates that the revised categorization procedure could 
reduce category stability over time, meaning that establishments could 
experience more frequent changes in category status. Using data 
analyzed over a 20-month period (from January 2017 to August 2018), 
FSIS compared the current 13-window categorization procedure to the 
revised 1-window categorization procedure and found the effect on 
stability of the revised categorization procedure for establishments 
was minimal for most establishments. The largest effect on stability 
was observed with establishments producing raw chicken parts. For these 
establishments, the number of establishments assigned to Category 3 two 
or more times over the 20-month period increased, from six 
establishments (1 percent) under the current 13-window categorization 
procedure, to 49 establishments (12 percent) using the revised 1-window 
categorization procedure. This finding could be due to the variability 
in the incidence of Salmonella in raw chicken parts compared to other 
products.
    In addition, available data suggests the revised categorization 
procedure has the greatest potential to reduce the time an 
establishment spends in Category 3 when it has taken effective 
corrective actions. FSIS evaluated the impact of the revised 
categorization procedure for eligible establishments producing chicken 
carcasses from January 2017 to August 2018. Under the revised 
procedure, the 75th percentile for time spent in Category 3 for these 
establishments was 156 days, compared to 234 days under the current 13-
window categorization procedure. This means that with the revised 
categorization procedure, 75 percent of these establishments remained 
in Category 3 for 156 days or less, compared to 234 days or less for 
the current 13-window categorization procedure.
    On November 23, 2018, FSIS will post on its website the category 
status of individual establishments for pathogen reduction performance 
standards for Salmonella in raw chicken parts and NRTE comminuted 
chicken and turkey, as previously announced,\3\ and updated individual 
poultry carcass establishments' category status. However, the category 
status reported will be based on FSIS sample results, excluding any 
follow-up sample results, during the 52-week window ending on October 
27, 2018, rather than on sample results, including follow-up sample 
results, in the last 13 completed 52-week windows. FSIS will categorize 
these establishments following the criteria below:
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    \3\ On May 4, 2018, FSIS announced an initial posting date for 
raw chicken parts and NRTE comminuted poultry products of ``October 
2018'' in the Constituent Update. Subsequently, the date was 
extended to ``November 2018 . . . after Thanksgiving.'' Webinar 
presented to stakeholders with new date is available at https://www.fsis.usda.gov/wps/wcm/connect/f059169f-5cb3-4ae5-9388-7de79b9fa217/Salmonella-Categorization-Webinar061318.pdf?MOD=AJPERES.
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     Category 1: Establishments that have achieved 50 percent 
or less of the maximum allowable percent positive during the most 
recent 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 recent completed 52-
week moving window.
     Category 3: Establishments that have exceeded the maximum 
allowable percent positive during the most recent completed 52-week 
moving window.
    Thereafter, FSIS will update category status on the FSIS website 
for these establishments using the revised categorization procedures on 
a monthly basis based on the category status for the 52-week window 
ending the last Saturday of the previous month.
    To be clear, the pathogen reduction performance standards for 
Salmonella in young chicken or turkey carcasses, raw chicken parts, and 
NRTE comminuted chicken and turkey products, and the minimum number of 
samples needed for FSIS to assess whether these establishments meet the 
standards have not changed.

Follow-Up Sampling

    FSIS also examined the role of follow-up samples established in the 
February 2016 Federal Register notice, where FSIS stated that follow-up 
samples would count towards the samples collected as part of the moving 
window for that establishment. FSIS established that policy because we 
thought it would more quickly assess whether establishments have 
reduced variability of process control. FSIS evaluated follow-up 
sampling results from establishments producing chicken carcasses since 
January 2017, when this sampling was introduced. The Agency concluded 
that follow-up sample results did not significantly influence the 
amount of time that establishments resided in Category 3 and that FSIS 
could effectively categorize establishments without including Agency 
follow-up sampling results.
    Therefore, starting with the data posted on November 23, 2018, FSIS 
will no longer include follow-up sampling results as part of the moving 
window when determining establishment category status. FSIS's 
evaluation of its follow-up sampling strategy is ongoing. Potential 
changes being considered include the timing and number of follow-up 
samples collected. While these and other potential changes are 
considered, FSIS will continue conducting follow-up sampling in 
establishments that do not meet a Salmonella pathogen reduction 
performance standard. However, to reduce the potential for redundant 
FSIS resource expenditure in establishments that undergo multiple 
changes in category status over a short period of time, FSIS will 
consider limiting the number of follow-up sets of samples \4\ and 
Public Health Risk Evaluations initiated when an establishment exceeds 
a pathogen reduction performance standard to no more than once every 
120 days. The justification for this is that an establishment is 
provided 30 days to implement corrective actions prior to assignment of 
the follow-up sample set in the Public Health Information System. 
Establishments then have 90 days to validate any changes to their 
Hazard Analysis and Critical Control Point (HACCP) system after being 
notified that it is in Category 3.
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    \4\ Depending on production volume, 16 or 8 samples would be 
collected as part of a follow-up sample set.
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Additional Information

    In addition to posting establishment-specific category status 
information, FSIS intends to begin maintaining historical individual 
establishment categorization data on the FSIS website. FSIS estimates 
providing six months of

[[Page 56049]]

historical categorization data for each establishment would be useful 
for those who want to make business decisions using the information. 
FSIS currently only maintains the most recent monthly individual 
establishment posting on its website. FSIS will also continue providing 
aggregate sampling results relative to categories for establishments 
producing young chicken or turkey carcasses, raw chicken parts, or NRTE 
comminuted chicken and turkey products.\5\ FSIS will continue to 
maintain the most recent year of aggregate data reports on its website 
as well.
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    \5\ Available 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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    FSIS intends to use the revised categorization and any follow-up 
sampling methodology, as well as the web posting procedures announced 
in this notice, for any establishment subject to a pathogen reduction 
performance standard for Salmonella or Campylobacter at a future time, 
including beef and pork establishments. FSIS will announce any expanded 
use of the revised procedures in the Federal Register and will request 
public comment.

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 make copies of this 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 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.

USDA Non-Discrimination 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.

How To File a Complaint of Discrimination

    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).

Carmen M. Rottenberg,
Administrator.
[FR Doc. 2018-24540 Filed 11-8-18; 8:45 am]
BILLING CODE 3410-DM-P