Changes to the Salmonella and Campylobacter Verification Testing Program: Revised Categorization and Follow-Up Sampling Procedures, 56046-56049 [2018-24540]

Download as PDF 56046 Notices Federal Register Vol. 83, No. 218 Friday, November 9, 2018 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request khammond on DSK30JT082PROD with NOTICES November 6, 2018. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104–13. Comments are required regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments regarding this information collection received by December 10, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: OIRA_Submission@ OMB.EOP.GOV or fax (202) 395–5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250–7602. Copies of the submission(s) may be obtained by calling (202) 720–8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control VerDate Sep<11>2014 17:36 Nov 08, 2018 Jkt 247001 number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Total Burden Hours: 433. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. 2018–24529 Filed 11–8–18; 8:45 am] BILLING CODE 3410–05–P Farm Service Agency Title: Request for Aerial Photography. OMB Control Number: 0560–0176. Summary of Collection: The information collection is needed to enable the Department of Agriculture to effectively administrate the Aerial Photography Program. The Aerial Photography Field Office (APFO) has the responsibility for conducting and coordinating the FSA’s aerial photography, remote sensing programs, and the aerial photography flying contract programs. The digital and film imagery secured by Farm Service Agency (FSA) is public domain and reproductions are available at cost to any customer with a need. All receipts from the sale of aerial photography products and services are retained by FSA. The FSA–441, Request for Aerial Photography, is the form FSA supplies to the customers for placing an order for aerial imagery products and services. FSA also collects information using the following two FSA 441B, Customer Digital Print Form, and FSA 441C APFO Service Quality Survey. Need and Use of the Information: FSA will collect the name, address, contact name, telephone, fax, email, customer code, agency code, purchase order number, credit card number/exp. date and amount remitted/PO amount. Customers have the option of placing orders by mail, fax, telephone, and walk-in. Furnishing this information requires the customer to research and prepare their request before submitting it to APFO. Information collected is used to process fiscal obligations, communicate with the customer, process the request, and ship the requested products. Description of Respondents: Farms; Individuals or household; Business or other for-profit; Federal Government; State, Local or Tribal Government. Number of Respondents: 1,465. Frequency of Responses: Recordkeeping; Reporting; Annually; Other (when ordering). PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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 Food Safety and Inspection Service, USDA. ACTION: Notice and request for comments. AGENCY: 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-toeat (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 SUMMARY: E:\FR\FM\09NON1.SGM 09NON1 Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices 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. 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 https://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 https:// www.regulations.gov. Docket: For access to background documents or comments received, call (202) 720–5627 to schedule a time to khammond on DSK30JT082PROD with NOTICES DATES: VerDate Sep<11>2014 17:36 Nov 08, 2018 Jkt 247001 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). 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 1 https://www.fsis.usda.gov/wps/portal/fsis/ topics/data-collection-and-reports/microbiology/ salmonella-verification-testing-program/ establishment-categories-cu. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 56047 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 52week 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 13window categorization procedure is accurately indicating the state of an establishment’s process control following implementation of corrective actions, FSIS has reevaluated its policies. 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). E:\FR\FM\09NON1.SGM 09NON1 khammond on DSK30JT082PROD with NOTICES 56048 Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices 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 20month 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 13window categorization procedure. This means that with the revised VerDate Sep<11>2014 17:36 Nov 08, 2018 Jkt 247001 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 52week windows. FSIS will categorize these establishments following the criteria below: • Category 1: Establishments that have achieved 50 percent or less of the maximum allowable percent positive during the most recent completed 52week 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 followup samples established in the February 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/f059169f5cb3-4ae5-9388-7de79b9fa217/SalmonellaCategorization-Webinar061318.pdf?MOD=AJPERES. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 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. Additional Information In addition to posting establishmentspecific category status information, FSIS intends to begin maintaining historical individual establishment categorization data on the FSIS website. FSIS estimates providing six months of 4 Depending on production volume, 16 or 8 samples would be collected as part of a follow-up sample set. E:\FR\FM\09NON1.SGM 09NON1 Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices 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. 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. khammond on DSK30JT082PROD with NOTICES 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: https:// 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: https:// 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. 5 Available at https://www.fsis.usda.gov/wps/ portal/fsis/topics/data-collection-and-reports/ microbiology/salmonella-verification-testingprogram/aggregate-data. VerDate Sep<11>2014 17:36 Nov 08, 2018 Jkt 247001 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 https:// 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: program.intake@usda.gov. Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA’s TARGET Center at (202) 720–2600 (voice and TDD). Carmen M. Rottenberg, Administrator. [FR Doc. 2018–24540 Filed 11–8–18; 8:45 am] BILLING CODE 3410–DM–P COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the North Carolina Advisory Committee U.S. Commission on Civil Rights. ACTION: Notice of meeting. AGENCY: Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights and the Federal Advisory Committee Act that the North Carolina Advisory Committee will hold a meeting on Thursday, December 12, 2018, to discuss potential project topics. DATES: The meeting will be held on Thursday, December 12, 2018, 12:00 p.m. EST. ADDRESSES: The meeting will be by teleconference. Toll-free call-in number: 1–855–710–4181, conference ID: 7959093. SUMMARY: PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 56049 For Additional Information Contact: Jeff Hinton, DFO, at jhinton@usccr.gov or 1–202–499–0263. SUPPLEMENTARY INFORMATION: Members of the public can listen to the discussion. This meeting is available to the public through the following tollfree call-in number. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference operator will ask callers to identify themselves, the organizations they are affiliated with (if any), and an email address prior to placing callers into the conference call. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over landline connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1–800–977–8339 and providing the Service with the conference call number and conference ID number. Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Program Unit Office, U.S. Commission on Civil Rights, 230 S. Dearborn, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353–8324, or emailed to Regional Director, Jeffrey Hinton at jhinton@usccr.gov. Persons who desire additional information may contact the Regional Program Unit Office at (312) 353–8311. Records generated from this meeting may be inspected and reproduced at the Regional Program Unit, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, North Carolina Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission’s website, https:// www.usccr.gov, or may contact the Southern Regional Office at the above email or street address. Agenda Welcome and Introductions Thea Monet, Chair North Carolina Advisory Committee discussion of potential project topics Thea Monet, Chair Open Comment Staff/Advisory Committee Public Participation E:\FR\FM\09NON1.SGM 09NON1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://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).
---------------------------------------------------------------------------

    \1\ https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/establishment-categories-cu.
---------------------------------------------------------------------------

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

    \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).

---------------------------------------------------------------------------

[[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:
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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

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

    \5\ Available at https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/aggregate-data.
---------------------------------------------------------------------------

    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: 
https://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: https://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 https://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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.