83_FR_56264 83 FR 56046 - Changes to the Salmonella and Campylobacter Verification Testing Program: Revised Categorization and Follow-Up Sampling Procedures

83 FR 56046 - Changes to the Salmonella and Campylobacter Verification Testing Program: Revised Categorization and Follow-Up Sampling Procedures

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 83, Issue 218 (November 9, 2018)

Page Range56046-56049
FR Document2018-24540

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 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.

Federal Register, Volume 83 Issue 218 (Friday, November 9, 2018)
[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56046-56049]
From the Federal Register Online  [www.thefederalregister.org]
[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.
---------------------------------------------------------------------------

    \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



                                               56046

                                               Notices                                                                                                       Federal Register
                                                                                                                                                             Vol. 83, No. 218

                                                                                                                                                             Friday, November 9, 2018



                                               This section of the FEDERAL REGISTER                    number and the agency informs                           Total Burden Hours: 433.
                                               contains documents other than rules or                  potential persons who are to respond to
                                               proposed rules that are applicable to the                                                                     Ruth Brown,
                                                                                                       the collection of information that such
                                               public. Notices of hearings and investigations,         persons are not required to respond to                Departmental Information Collection
                                               committee meetings, agency decisions and                                                                      Clearance Officer.
                                                                                                       the collection of information unless it
                                               rulings, delegations of authority, filing of                                                                  [FR Doc. 2018–24529 Filed 11–8–18; 8:45 am]
                                               petitions and applications and agency
                                                                                                       displays a currently valid OMB control
                                                                                                       number.                                               BILLING CODE 3410–05–P
                                               statements of organization and functions are
                                               examples of documents appearing in this                 Farm Service Agency
                                               section.
                                                                                                                                                             DEPARTMENT OF AGRICULTURE
                                                                                                          Title: Request for Aerial Photography.
                                                                                                          OMB Control Number: 0560–0176.                     Food Safety and Inspection Service
                                               DEPARTMENT OF AGRICULTURE
                                                                                                          Summary of Collection: The                         [Docket No. FSIS–2018–0043]
                                               Submission for OMB Review;                              information collection is needed to
                                               Comment Request                                         enable the Department of Agriculture to               Changes to the Salmonella and
                                                                                                       effectively administrate the Aerial                   Campylobacter Verification Testing
                                               November 6, 2018.                                                                                             Program: Revised Categorization and
                                                                                                       Photography Program. The Aerial
                                                 The Department of Agriculture has                     Photography Field Office (APFO) has                   Follow-Up Sampling Procedures
                                               submitted the following information                     the responsibility for conducting and
                                               collection requirement(s) to OMB for                                                                          AGENCY:  Food Safety and Inspection
                                                                                                       coordinating the FSA’s aerial                         Service, USDA.
                                               review and clearance under the
                                                                                                       photography, remote sensing programs,
                                               Paperwork Reduction Act of 1995,                                                                              ACTION: Notice and request for
                                                                                                       and the aerial photography flying
                                               Public Law 104–13. Comments are                                                                               comments.
                                                                                                       contract programs. The digital and film
                                               required regarding (1) whether the
                                                                                                       imagery secured by Farm Service                       SUMMARY:   The Food Safety and
                                               collection of information is necessary
                                                                                                       Agency (FSA) is public domain and                     Inspection Service (FSIS) is announcing
                                               for the proper performance of the
                                                                                                       reproductions are available at cost to                and requesting comments on revised
                                               functions of the agency, including
                                                                                                       any customer with a need. All receipts                categorization and follow-up sampling
                                               whether the information will have
                                                                                                       from the sale of aerial photography                   procedures relative to pathogen
                                               practical utility; (2) the accuracy of the
                                                                                                       products and services are retained by                 reduction performance standards. FSIS
                                               agency’s estimate of burden including
                                               the validity of the methodology and                     FSA. The FSA–441, Request for Aerial                  will proceed with web-posting
                                               assumptions used; (3) ways to enhance                   Photography, is the form FSA supplies                 individual establishments’ category
                                               the quality, utility and clarity of the                 to the customers for placing an order for             status for pathogen reduction
                                               information to be collected; and (4)                    aerial imagery products and services.                 performance standards for Salmonella
                                               ways to minimize the burden of the                      FSA also collects information using the               in raw chicken parts and not-ready-to-
                                               collection of information on those who                  following two FSA 441B, Customer                      eat (NRTE) comminuted chicken and
                                               are to respond, including through the                   Digital Print Form, and FSA 441C APFO                 turkey, as previously announced, and
                                               use of appropriate automated,                           Service Quality Survey.                               updating individual poultry carcass
                                               electronic, mechanical, or other                           Need and Use of the Information: FSA               establishments’ category status in
                                               technological collection techniques or                  will collect the name, address, contact               November. However, the category status
                                               other forms of information technology.                  name, telephone, fax, email, customer                 reported will be based on FSIS sample
                                                 Comments regarding this information                   code, agency code, purchase order                     results during the 52-week window
                                               collection received by December 10,                     number, credit card number/exp. date                  ending the last Saturday of the previous
                                               2018 will be considered. Written                        and amount remitted/PO amount.                        month, rather than on results during the
                                               comments should be addressed to: Desk                   Customers have the option of placing                  last 13 completed 52-week windows. At
                                               Officer for Agriculture, Office of                      orders by mail, fax, telephone, and                   the same time, FSIS will no longer
                                               Information and Regulatory Affairs,                     walk-in. Furnishing this information                  include follow-up sampling results as
                                               Office of Management and Budget                         requires the customer to research and                 part of the moving window when
                                               (OMB), New Executive Office Building,                   prepare their request before submitting               determining establishment category
                                               725—17th Street NW, Washington, DC                      it to APFO. Information collected is                  status. Finally, FSIS will update the
                                               20502. Commenters are encouraged to                     used to process fiscal obligations,                   individual establishments’ category
                                               submit their comments to OMB via                        communicate with the customer,                        status on its website on a monthly basis
                                               email to: OIRA_Submission@                              process the request, and ship the                     and will maintain the last six months of
                                               OMB.EOP.GOV or fax (202) 395–5806                       requested products.                                   historical establishment-specific
                                               and to Departmental Clearance Office,                      Description of Respondents: Farms;                 categorization data on the website, as it
                                                                                                                                                             becomes available, using the revised
khammond on DSK30JT082PROD with NOTICES




                                               USDA, OCIO, Mail Stop 7602,                             Individuals or household; Business or
                                               Washington, DC 20250–7602. Copies of                    other for-profit; Federal Government;                 categorization procedures announced in
                                               the submission(s) may be obtained by                    State, Local or Tribal Government.                    this notice.
                                               calling (202) 720–8958.                                                                                         FSIS intends to use the revised
                                                 An agency may not conduct or                             Number of Respondents: 1,465.                      categorization procedures for all
                                               sponsor a collection of information                        Frequency of Responses:                            establishments subject to a pathogen
                                               unless the collection of information                    Recordkeeping; Reporting; Annually;                   reduction performance standard for
                                               displays a currently valid OMB control                  Other (when ordering).                                Salmonella or Campylobacter, including


                                          VerDate Sep<11>2014   17:36 Nov 08, 2018   Jkt 247001   PO 00000   Frm 00001   Fmt 4703   Sfmt 4703   E:\FR\FM\09NON1.SGM   09NON1


                                                                            Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices                                                  56047

                                               beef and pork establishments, in the                    visit the FSIS Docket Room at 1400                    reduction performance standard. For all
                                               future. FSIS will announce any                          Independence Avenue SW, Room 6065,                    establishments, FSIS defines an
                                               expanded use of the revised procedures                  Washington, DC 20250–3700.                            individual window as the results from
                                               in the Federal Register and will request                FOR FURTHER INFORMATION CONTACT:                      FSIS sampling over 52 consecutive
                                               public comment.                                         Roberta Wagner, Assistant                             Sunday-to-Saturday weeks. Under the
                                                  FSIS will proceed with implementing                  Administrator, Office of Policy and                   policy in the February 2016 Federal
                                               the changes on the date announced in                    Program Development by telephone at                   Register notice, FSIS used for each
                                               this notice. However, FSIS is seeking                   (202) 205–0495.                                       window all FSIS samples taken in any
                                               comments on the changes as part of its                  SUPPLEMENTARY INFORMATION: FSIS is                    given week, including follow-up
                                               effort to continuously assess and                       responsible for verifying that the                    samples collected by FSIS to verify the
                                               improve the effectiveness of Agency                     nation’s commercial supply of meat,                   adequacy of corrective actions taken by
                                               policy.                                                 poultry, and egg products is safe,                    an establishment that was not meeting
                                               DATES:  Submit comments on or before                    wholesome, and correctly packaged and                 a performance standard. The category
                                               December 10, 2018. On November 23,                      labeled. In support of this mission, FSIS             assigned to an establishment has been
                                               2018, FSIS will:                                        began its Salmonella verification testing             based on results in the 13 most recent
                                                  • Web-post individual                                program with the final rule entitled
                                                                                                                                                             completed 52-week windows, which
                                               establishments’ category status for                     ‘‘Pathogen Reduction; Hazard Analysis
                                                                                                       and Critical Control Point Systems’’                  includes 64 weeks of data. If the
                                               pathogen reduction performance                                                                                establishment exceeded the
                                               standards for Salmonella in raw chicken                 (PR/HACCP Rule), published on July 25,
                                                                                                       1996 (61 FR 38805). Among other                       performance standard in any of the last
                                               parts and NRTE comminuted chicken
                                                                                                       things, the PR/HACCP Rule established                 13 completed windows, it was assigned
                                               and turkey and update individual
                                                                                                       Salmonella pathogen reduction                         to Category 3, i.e., designated as not
                                               poultry carcass establishments’ category
                                               status based on FSIS sample results                     performance standards for                             meeting the standard (81 FR at 7287).
                                               during the 52-week window ending on                     establishments that slaughter selected                Thus, under this policy, establishments
                                               October 27, 2018;                                       classes of food animals and/or that                   that implemented effective corrective
                                                  • Discontinue including follow-up                    produce selected classes of raw ground                actions and demonstrated sustained
                                               sampling results as part of the moving                  products. FSIS continues to use the                   process control remained in Category 3
                                               window when determining category                        pathogen reduction performance                        until all 13 windows registered Category
                                               status for that establishment; and                      standards to ensure that eligible                     1 or 2, i.e., reflected that the
                                                  • Begin updating individual                          establishments are consistently                       establishment was meeting the
                                               establishments’ category status on the                  controlling or reducing harmful bacteria              performance standard over 13 52-week
                                               FSIS website on a monthly basis using                   on raw meat and poultry products.                     windows.
                                               the revised procedures announced in                        FSIS began posting individual
                                                                                                       establishment categories for Salmonella                  Although assessing 13 windows of
                                               this notice.                                                                                                  data reduces the chance that an
                                               ADDRESSES: FSIS invites interested
                                                                                                       performance standards for poultry
                                                                                                       carcasses in May 2016.1 In November                   establishment’s category status will
                                               persons to submit comments on this                                                                            change when there is no actual
                                               notice. Comments may be submitted by                    2016, FSIS temporarily suspended the
                                                                                                       web posting of category status for                    improvement in process control and
                                               one of the following methods:                                                                                 improves FSIS’s ability to assign small
                                                  • Federal eRulemaking Portal: This                   individual carcass establishments to
                                                                                                       analyze the effect of the use of FSIS’s               and very small establishments to a
                                               website provides the ability to type
                                                                                                       new neutralizing Buffered Peptone                     category,2 an establishment’s category
                                               short comments directly into the
                                                                                                       Water on the Salmonella performance                   status may not necessarily reflect the
                                               comment field on this web page or
                                               attach a file for lengthier comments. Go                standards and to assess the                           current conditions in an establishment
                                               to http://www.regulations.gov. Follow                   implementation of follow-up sampling                  that has taken effective corrective
                                               the on-line instructions at that site for               at Category 3 poultry carcass                         actions. Under the current policy, even
                                               submitting comments.                                    establishments (that is, establishments               if an establishment has been in category
                                                  • Mail, including CD–ROMs, etc.:                     not meeting the standard). Upon                       1 for multiple weeks, if it was in
                                               Send to Docket Clerk, U.S. Department                   conclusion of these analyses, FSIS                    category 3 in any one of the last 13 52-
                                               of Agriculture, Food Safety and                         resumed web posting of individual                     week windows, FSIS would designate
                                               Inspection Service, 1400 Independence                   establishments’ category status for                   that establishment as category 3.
                                               Avenue SW, Mailstop 3758, Room 6065,                    Salmonella performance standards for                  Representatives from the poultry
                                               Washington, DC 20250–3700.                              poultry carcasses on January 23, 2018.                industry have raised these concerns to
                                                  • Hand- or courier-delivered                         As discussed in the February 11, 2016                 FSIS. In response to their concerns and
                                               submittals: Deliver to 1400                             Federal Register notice, data support                 internal concerns about whether the 13-
                                               Independence Avenue SW, Room 6065,                      that public posting of establishment                  window categorization procedure is
                                               Washington, DC 20250–3700.                              performance encourages establishments
                                                                                                                                                             accurately indicating the state of an
                                                  Instructions: All items submitted by                 to make changes to address Salmonella
                                                                                                                                                             establishment’s process control
                                               mail or electronic mail must include the                (81 FR 7285).
                                                                                                          FSIS also explained in the February                following implementation of corrective
                                               Agency name and docket number FSIS–                                                                           actions, FSIS has reevaluated its
                                               2018–0043. Comments received in                         2016 Federal Register notice how it
                                                                                                       would assess establishment                            policies.
                                               response to this docket will be made
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                                               available for public inspection and                     performance using a moving window of
                                                                                                                                                               2 Since there are 13 52-week windows, an
                                               posted without change, including any                    FSIS sampling results in poultry
                                                                                                                                                             establishment has 13 chances to be categorized.
                                               personal information, to http://                        establishments subject to a pathogen                  With fewer windows, fewer establishments may be
                                               www.regulations.gov.                                                                                          categorized. This is because there is a minimum
                                                                                                         1 https://www.fsis.usda.gov/wps/portal/fsis/        number of samples needed to assess process control
                                                  Docket: For access to background                     topics/data-collection-and-reports/microbiology/      for each product class by pathogen (e.g., the
                                               documents or comments received, call                    salmonella-verification-testing-program/              minimum number of samples for Salmonella in
                                               (202) 720–5627 to schedule a time to                    establishment-categories-cu.                          broiler carcasses is 11).



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                                               56048                        Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices

                                               Changes to Categorization Procedure                     categorization procedure, 75 percent of               2016 Federal Register notice, where
                                                  With the goal of encouraging                         these establishments remained in                      FSIS stated that follow-up samples
                                               sustained improvements in process                       Category 3 for 156 days or less,                      would count towards the samples
                                               control while still accurately reflecting               compared to 234 days or less for the                  collected as part of the moving window
                                               current conditions in the establishment,                current 13-window categorization                      for that establishment. FSIS established
                                               FSIS has considered a full range of                     procedure.                                            that policy because we thought it would
                                                                                                         On November 23, 2018, FSIS will post                more quickly assess whether
                                               alternatives to the current 13-window
                                                                                                       on its website the category status of                 establishments have reduced variability
                                               categorization procedure. Based on the
                                                                                                       individual establishments for pathogen                of process control. FSIS evaluated
                                               evaluation of available data, FSIS
                                                                                                       reduction performance standards for                   follow-up sampling results from
                                               concluded that reducing the number of
                                                                                                       Salmonella in raw chicken parts and                   establishments producing chicken
                                               completed 52-week windows assessed
                                                                                                       NRTE comminuted chicken and turkey,                   carcasses since January 2017, when this
                                               from 13 to one (1) is the best means to
                                                                                                       as previously announced,3 and updated                 sampling was introduced. The Agency
                                               accomplish this goal. This approach
                                                                                                       individual poultry carcass                            concluded that follow-up sample results
                                               will continue to minimize the effect of
                                                                                                       establishments’ category status.                      did not significantly influence the
                                               seasonal variation in pathogen
                                                                                                       However, the category status reported                 amount of time that establishments
                                               incidence on category status, while                     will be based on FSIS sample results,
                                               providing a pathway for establishments                                                                        resided in Category 3 and that FSIS
                                                                                                       excluding any follow-up sample results,               could effectively categorize
                                               to improve their category status after                  during the 52-week window ending on
                                               implementing effective corrective                                                                             establishments without including
                                                                                                       October 27, 2018, rather than on sample               Agency follow-up sampling results.
                                               actions. This approach is far less                      results, including follow-up sample                      Therefore, starting with the data
                                               complex than the current 13-window                      results, in the last 13 completed 52-                 posted on November 23, 2018, FSIS will
                                               categorization procedure. This approach                 week windows. FSIS will categorize                    no longer include follow-up sampling
                                               will not have an effect on public health.               these establishments following the
                                                  FSIS anticipates that the revised                                                                          results as part of the moving window
                                                                                                       criteria below:                                       when determining establishment
                                               categorization procedure could reduce                     • Category 1: Establishments that
                                               category stability over time, meaning                                                                         category status. FSIS’s evaluation of its
                                                                                                       have achieved 50 percent or less of the               follow-up sampling strategy is ongoing.
                                               that establishments could experience                    maximum allowable percent positive
                                               more frequent changes in category                                                                             Potential changes being considered
                                                                                                       during the most recent completed 52-                  include the timing and number of
                                               status. Using data analyzed over a 20-                  week moving window.                                   follow-up samples collected. While
                                               month period (from January 2017 to                        • Category 2: Establishments that                   these and other potential changes are
                                               August 2018), FSIS compared the                         meet the maximum allowable percent
                                               current 13-window categorization                                                                              considered, FSIS will continue
                                                                                                       positive but have results greater than 50             conducting follow-up sampling in
                                               procedure to the revised 1-window                       percent of the maximum allowable
                                               categorization procedure and found the                                                                        establishments that do not meet a
                                                                                                       percent positive during the most recent               Salmonella pathogen reduction
                                               effect on stability of the revised                      completed 52-week moving window.                      performance standard. However, to
                                               categorization procedure for                              • Category 3: Establishments that                   reduce the potential for redundant FSIS
                                               establishments was minimal for most                     have exceeded the maximum allowable
                                               establishments. The largest effect on                                                                         resource expenditure in establishments
                                                                                                       percent positive during the most recent               that undergo multiple changes in
                                               stability was observed with                             completed 52-week moving window.
                                               establishments producing raw chicken                                                                          category status over a short period of
                                                                                                         Thereafter, FSIS will update category
                                               parts. For these establishments, the                                                                          time, FSIS will consider limiting the
                                                                                                       status on the FSIS website for these
                                               number of establishments assigned to                                                                          number of follow-up sets of samples 4
                                                                                                       establishments using the revised
                                               Category 3 two or more times over the                                                                         and Public Health Risk Evaluations
                                                                                                       categorization procedures on a monthly
                                               20-month period increased, from six                                                                           initiated when an establishment exceeds
                                                                                                       basis based on the category status for the
                                               establishments (1 percent) under the                                                                          a pathogen reduction performance
                                                                                                       52-week window ending the last
                                               current 13-window categorization                                                                              standard to no more than once every
                                                                                                       Saturday of the previous month.
                                               procedure, to 49 establishments (12                       To be clear, the pathogen reduction                 120 days. The justification for this is
                                               percent) using the revised 1-window                     performance standards for Salmonella                  that an establishment is provided 30
                                               categorization procedure. This finding                  in young chicken or turkey carcasses,                 days to implement corrective actions
                                               could be due to the variability in the                  raw chicken parts, and NRTE                           prior to assignment of the follow-up
                                               incidence of Salmonella in raw chicken                  comminuted chicken and turkey                         sample set in the Public Health
                                               parts compared to other products.                       products, and the minimum number of                   Information System. Establishments
                                                  In addition, available data suggests                 samples needed for FSIS to assess                     then have 90 days to validate any
                                               the revised categorization procedure has                whether these establishments meet the                 changes to their Hazard Analysis and
                                               the greatest potential to reduce the time               standards have not changed.                           Critical Control Point (HACCP) system
                                               an establishment spends in Category 3                                                                         after being notified that it is in Category
                                                                                                       Follow-Up Sampling                                    3.
                                               when it has taken effective corrective
                                               actions. FSIS evaluated the impact of                     FSIS also examined the role of follow-              Additional Information
                                               the revised categorization procedure for                up samples established in the February
                                                                                                                                                               In addition to posting establishment-
                                               eligible establishments producing
                                                                                                         3 On May 4, 2018, FSIS announced an initial         specific category status information,
                                               chicken carcasses from January 2017 to
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                                                                                                       posting date for raw chicken parts and NRTE           FSIS intends to begin maintaining
                                               August 2018. Under the revised                          comminuted poultry products of ‘‘October 2018’’ in    historical individual establishment
                                               procedure, the 75th percentile for time                 the Constituent Update. Subsequently, the date was    categorization data on the FSIS website.
                                               spent in Category 3 for these                           extended to ‘‘November 2018 . . . after
                                                                                                       Thanksgiving.’’ Webinar presented to stakeholders     FSIS estimates providing six months of
                                               establishments was 156 days, compared
                                                                                                       with new date is available at https://
                                               to 234 days under the current 13-                       www.fsis.usda.gov/wps/wcm/connect/f059169f-             4 Depending on production volume, 16 or 8
                                               window categorization procedure. This                   5cb3-4ae5-9388-7de79b9fa217/Salmonella-               samples would be collected as part of a follow-up
                                               means that with the revised                             Categorization-Webinar061318.pdf?MOD=AJPERES.         sample set.



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                                                                            Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices                                          56049

                                               historical categorization data for each                 USDA Non-Discrimination Statement                        For Additional Information Contact:
                                               establishment would be useful for those                   No agency, officer, or employee of the              Jeff Hinton, DFO, at jhinton@usccr.gov
                                               who want to make business decisions                     USDA shall, on the grounds of race,                   or 1–202–499–0263.
                                               using the information. FSIS currently                   color, national origin, religion, sex,                SUPPLEMENTARY INFORMATION: Members
                                               only maintains the most recent monthly                  gender identity, sexual orientation,                  of the public can listen to the
                                               individual establishment posting on its                 disability, age, marital status, family/              discussion. This meeting is available to
                                               website. FSIS will also continue                        parental status, income derived from a                the public through the following toll-
                                               providing aggregate sampling results                    public assistance program, or political               free call-in number. An open comment
                                               relative to categories for establishments               beliefs, exclude from participation in,               period will be provided to allow
                                               producing young chicken or turkey                       deny the benefits of, or subject to                   members of the public to make a
                                               carcasses, raw chicken parts, or NRTE                   discrimination any person in the United               statement as time allows. The
                                               comminuted chicken and turkey                           States under any program or activity                  conference operator will ask callers to
                                               products.5 FSIS will continue to                        conducted by the USDA.                                identify themselves, the organizations
                                               maintain the most recent year of                                                                              they are affiliated with (if any), and an
                                               aggregate data reports on its website as                How To File a Complaint of                            email address prior to placing callers
                                               well.                                                   Discrimination                                        into the conference call. Callers can
                                                 FSIS intends to use the revised                          To file a complaint of discrimination,             expect to incur charges for calls they
                                               categorization and any follow-up                        complete the USDA Program                             initiate over wireless lines, and the
                                               sampling methodology, as well as the                    Discrimination Complaint Form, which                  Commission will not refund any
                                               web posting procedures announced in                     may be accessed online at http://                     incurred charges. Callers will incur no
                                               this notice, for any establishment                      www.ocio.usda.gov/sites/default/files/                charge for calls they initiate over land-
                                               subject to a pathogen reduction                         docs/2012/Complain_combined_                          line connections to the toll-free
                                               performance standard for Salmonella or                  6_8_12.pdf, or write a letter signed by               telephone number. Persons with hearing
                                               Campylobacter at a future time,                         you or your authorized representative.                impairments may also follow the
                                               including beef and pork establishments.                    Send your completed complaint form                 proceedings by first calling the Federal
                                               FSIS will announce any expanded use                     or letter to USDA by mail, fax, or email:             Relay Service at 1–800–977–8339 and
                                               of the revised procedures in the Federal                   Mail: U.S. Department of Agriculture,              providing the Service with the
                                               Register and will request public                        Director, Office of Adjudication, 1400                conference call number and conference
                                               comment.                                                Independence Avenue SW, Washington,                   ID number.
                                                                                                       DC 20250–9410.                                           Members of the public are also
                                               Additional Public Notification
                                                                                                          Fax: (202) 690–7442.                               entitled to submit written comments;
                                                 Public awareness of all segments of                      Email: program.intake@usda.gov.                    the comments must be received in the
                                               rulemaking and policy development is                       Persons with disabilities who require              regional office within 30 days following
                                               important. Consequently, FSIS will                      alternative means for communication                   the meeting. Written comments may be
                                               announce this Federal Register                          (Braille, large print, audiotape, etc.)               mailed to the Regional Program Unit
                                               publication online through the FSIS                     should contact USDA’s TARGET Center                   Office, U.S. Commission on Civil Rights,
                                               web page located at: http://                            at (202) 720–2600 (voice and TDD).                    230 S. Dearborn, Suite 2120, Chicago, IL
                                               www.fsis.usda.gov/federal-register.                                                                           60604. They may also be faxed to the
                                                 FSIS also will make copies of this                    Carmen M. Rottenberg,                                 Commission at (312) 353–8324, or
                                               publication available through the FSIS                  Administrator.                                        emailed to Regional Director, Jeffrey
                                               Constituent Update, which is used to                    [FR Doc. 2018–24540 Filed 11–8–18; 8:45 am]           Hinton at jhinton@usccr.gov. Persons
                                               provide information regarding FSIS                      BILLING CODE 3410–DM–P                                who desire additional information may
                                               policies, procedures, regulations,                                                                            contact the Regional Program Unit
                                               Federal Register notices, FSIS public                                                                         Office at (312) 353–8311.
                                               meetings, and other types of information                                                                         Records generated from this meeting
                                               that could affect or would be of interest               COMMISSION ON CIVIL RIGHTS                            may be inspected and reproduced at the
                                               to our constituents and stakeholders.                   Notice of Public Meeting of the North                 Regional Program Unit, as they become
                                               The Constituent Update is available on                  Carolina Advisory Committee                           available, both before and after the
                                               the FSIS web page. Through the web                                                                            meeting. Records of the meeting will be
                                               page, FSIS is able to provide                           AGENCY: U.S. Commission on Civil                      available via www.facadatabase.gov
                                               information to a much broader, more                     Rights.                                               under the Commission on Civil Rights,
                                               diverse audience. In addition, FSIS                     ACTION: Notice of meeting.                            North Carolina Advisory Committee
                                               offers an email subscription service,                                                                         link. Persons interested in the work of
                                               which provides automatic and                            SUMMARY:   Notice is hereby given,                    this Committee are directed to the
                                               customized access to selected food                      pursuant to the provisions of the rules               Commission’s website, http://
                                               safety news and information. This                       and regulations of the U.S. Commission                www.usccr.gov, or may contact the
                                               service is available at: http://                        on Civil Rights and the Federal                       Southern Regional Office at the above
                                               www.fsis.usda.gov/subscribe. Options                    Advisory Committee Act that the North                 email or street address.
                                               range from recalls to export information,               Carolina Advisory Committee will hold
                                                                                                       a meeting on Thursday, December 12,                   Agenda
                                               regulations, directives, and notices.
                                               Customers can add or delete                             2018, to discuss potential project topics.            Welcome and Introductions
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                                               subscriptions themselves, and have the                  DATES: The meeting will be held on
                                                                                                                                                               Thea Monet, Chair
                                               option to password protect their                                                                              North Carolina Advisory Committee
                                                                                                       Thursday, December 12, 2018, 12:00
                                               accounts.                                                                                                         discussion of potential project
                                                                                                       p.m. EST.
                                                                                                                                                                 topics
                                                                                                       ADDRESSES: The meeting will be by                       Thea Monet, Chair
                                                 5 Available at https://www.fsis.usda.gov/wps/

                                               portal/fsis/topics/data-collection-and-reports/
                                                                                                       teleconference. Toll-free call-in number:             Open Comment
                                               microbiology/salmonella-verification-testing-           1–855–710–4181, conference ID:                          Staff/Advisory Committee
                                               program/aggregate-data.                                 7959093.                                              Public Participation


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Document Created: 2018-11-09 03:34:39
Document Modified: 2018-11-09 03:34:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice and request for comments.
DatesSubmit comments on or before December 10, 2018. On November 23, 2018, FSIS will:
ContactRoberta Wagner, Assistant Administrator, Office of Policy and Program Development by telephone at (202) 205-0495.
FR Citation83 FR 56046 

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