Use of Whole Genome Sequence Analysis To Improve Food Safety and Public Health, 44378-44380 [2017-20247]

Download as PDF 44378 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices Improper Payments Information Act 2010 (31 U.S.C. 3301) Supplemental Nutrition Assistance Program: Disqualified Recipient Reporting and Computer Matching Requirements). State agencies are required to check for disqualified recipients in the Electronic Disqualified Recipient System, validate against a list of incarcerated people using the Social Security Administration’s Prisoner Verification System, verify applicant employment data through the National Directory of New Hires and confirm an individual is not in the Social Security Administration’s Death Master File. Additional program integrity tools and methods vary by State and can vary within States, particularly those that are decentralized and administer SNAP at the county level. Local offices may also conduct matches that vary from those used at the county or State level. Need and Use of the Information: This study will help FNS update the nationwide inventory of State SNAP data-matching and improve SNAP computer-matching efforts across the nation to maximize efficiencies and minimize fraud and waste. State agencies administering SNAP use data matching to verify information submitted at the application and recertification stages of the application process and to monitor changes in benefit recipients’ household circumstances. In order for USDA to make informed decisions, it is important to gather current information about how and to what extent SNAP agencies conduct computer data matching and systematically use that information to improve program integrity. Description of Respondents: State, Local and Tribal Agencies. Number of Respondents: 372. Frequency of Responses: Reporting: Annually. Total Burden Hours: 196. Food and Nutrition Service Title: Understanding the Anti-Fraud Measures of Large Supplemental Nutrition Assistance Program (SNAP) Retailers. OMB Control Number: 0584–NEW. Summary of Collection: This study is authorized under the Food and Nutrition Act of 2008 through the Agricultural Act of 2014 (Pub. L. 113– 79). The United States Department of Agriculture (USDA) has the authority to ‘‘undertake research that will help improve the administration and effectiveness of the supplemental nutrition assistance program in delivering nutrition-related benefits.’’ This is a new collection for the purpose of learning about the types of VerDate Sep<11>2014 18:11 Sep 21, 2017 Jkt 241001 Supplemental Nutrition Assistance Program (SNAP) related fraud activity observed by large retailers and the methods they use to prevent fraud and minimize their losses. Need and Use of the Information: This study will help FNS learn more about the types of SNAP fraud that occur in large retailer settings; document retailer practices to detect, deter, and deal with fraud (collectively known as loss prevention or loss prevention practices); and determine which practices could provide information that would help FNS in detecting and preventing SNAP fraud. Description of Respondents: Businesses-for-and-not-for-profit. Number of Respondents: 2,045. Frequency of Responses: Reporting: Annually. Total Burden Hours: 2,851.40. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. 2017–20206 Filed 9–21–17; 8:45 am] BILLING CODE 3410–30–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2017–0038] Use of Whole Genome Sequence Analysis To Improve Food Safety and Public Health Food Safety and Inspection Service, USDA. ACTION: Notification of public meeting. AGENCY: The Food Safety and Inspection Service (FSIS), with participation from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Center for Biotechnology Information (NCBI), and other stakeholders is hosting a public meeting to discuss FSIS’ and other agencies’ practices and plans for collecting and analyzing whole genome sequence (WGS) data of bacteria isolated from official samples, as well as the state of the science and other issues surrounding this technology. WGS analyses can determine sequence relatedness between bacterial isolates with higher resolution than other analytical methods, including pulsedfield gel electrophoresis (PFGE), FSIS’ current method of characterizing bacteria. In addition, WGS analyses can characterize genes and other features of bacterial genomes. Currently, FSIS, local, State, and Federal public health and regulatory partners submit WGS SUMMARY: PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 data to a Federal public database, readily accessible to Federal and state partners, and other stakeholders, including regulated industry and consumers. Using this common database, Federal food safety partners can share information and collaborate on issues related to food safety and public health. FSIS intends to analyze WGS data using thoroughly vetted and scientifically accepted procedures and standards, along with epidemiological information and industry production and distribution records on amenable product, to carry out its public health mission. Inclusion of WGS analyses in decision-making will enhance foodborne outbreak investigations, as well as general decisions related to the use of data from routine verification sampling of establishments under FSIS jurisdiction. Industry, interested individuals, organizations, and other stakeholders are invited to participate in the meeting and comment on FSIS approaches for using WGS data within a regulatory framework. DATES: The public meeting will be held on Thursday and Friday, October 26 and 27, 2017 from 8:00 a.m. to 4:45 p.m. EST. The meeting will be held at the Jefferson Auditorium in the South Building, U.S. Department of Agriculture (USDA), 1400 Independence Avenue SW., Washington, DC 20250. Attendance is free. Non-USDA employees must enter through the Wing 5 entrance on Independence Avenue. The South Building is a Federal facility and attendees should plan to take adequate time to pass through the security screening systems. Attendees must show a valid photo ID to enter the building. Attendees also must be preregistered for the meeting and check in onsite the day of the meeting. See the pre-registration instructions under ‘‘Registration and Meeting Materials.’’ Only registered attendees will be permitted to enter the building. FOR FURTHER INFORMATION CONTACT: Dr. Peter S. Evans, Office of Policy and Program Development, Risk Innovations and Management Staff; Telephone: (202) 690–6272; Fax: (202) 245–4793; Email: peter.evans@fsis.usda.gov. Note that the same week as the WGS public meeting, on October 24 and 25, 2017, and also in the USDA Jefferson Auditorium, a separate interagency public meeting will be held by the National Antimicrobial Resistance Monitoring System collaborators. FDA will publish a Federal Register Notice to announce this meeting. SUPPLEMENTARY INFORMATION: ADDRESSES: E:\FR\FM\22SEN1.SGM 22SEN1 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices I. Background FSIS routinely samples meat, poultry and egg products, environmental surfaces in slaughter and processing establishments, and animal cecal contents for specific microorganisms. FSIS uses microbiological test results for a number of purposes: To verify the effective implementation of process controls and sanitation programs by industry; to help develop pathogen reduction standards for raw products and assess whether product meets those standards; and to support surveillance, including surveillance related to antimicrobial resistance, risk assessment and attribution studies. Sampling results may also be used to assign additional sampling or inspection resources to establishments or products with higher risk of causing harm to consumers. In addition to routine sampling, the Agency may collect samples for cause to investigate foodborne illnesses, outbreaks, consumer complaints and other nonroutine events. Due to the rapid advances in DNA sequencing technology, its superior resolution, significant reductions in per sample cost, and the potential for a single workflow to replace current laboratory subtyping methods, WGS analysis is now considered an important tool for routinely sub-typing and characterizing bacterial pathogens. Unlike PFGE and other DNA-based technologies, which rely on the analysis of arrangements of fragments or portions of a genome sequence without actually knowing each nucleotide in the sequence arrangement, WGS analyses use almost the entire genomic sequence, about 1 to 10 million base units for a typical bacterium. WGS provides robust estimates of sequence relatedness, based on the presence, absence, substitution and arrangement of individual nucleotides in the genomic sequences, thus permitting further characterization of individual genes and other interesting features of bacterial genomes. In 2013, CDC, FDA, FSIS, and the NCBI collaborated with local, State, and international partners to implement a pilot study of WGS-based surveillance for Listeria monocytogenes (Lm).1 For the pilot study, Lm isolates from patients, food, and domestic food processing environments were analyzed using WGS. The resulting analyses were 1 Jackson, B.R., Tarr, C., Strain, E., Jackson, K.A., Conrad, A., Carleton, H., . . . Gerner-Smidt, P. (2016). Implementation of Nationwide Real-Time Whole-Genome Sequencing to Enhance Listeriosis Outbreak Detection and Investigation. Clinical Infectious Diseases, Volume 63, Issue 3, 1 August 2016, Pages 380–386, https://doi.org/10.1093/cid/ ciw242. VerDate Sep<11>2014 18:11 Sep 21, 2017 Jkt 241001 routinely made available to CDC epidemiologists and other public health and regulatory partners. The availability of WGS analyses transformed outbreak surveillance and response: More illness clusters were detected (14 clusters detected in the year before the pilot versus 19 and 21 clusters detected in the two years after implementing WGS). In addition, illness clusters were detected sooner, median cluster size was markedly reduced, and more outbreaks were resolved by linking Lm illness and food sources. This pilot shows the specific improvements that can be gained using WGS, as compared to the use of PFGE analyses. FSIS plans to expand its use of WGS analysis to bacteria isolated from FSIS sampling projects to aid in accurately identifying and responding to outbreaks, conducting efficient traceback, and studying the environmental harborage and movement of pathogens in regulated establishments. All WGS data will continue to be uploaded to a Federal database that is readily accessible to all food safety and public health partners and stakeholders, including consumers. Additionally, FSIS will analyze WGS data from FSIS samples and other food, environmental, and clinical samples contributed by other sources and organizations. Additionally, FSIS has begun to analyze WGS data to identify specific genes associated with characteristics of public health concern. In collaboration with Federal partners, FSIS uses an antimicrobial resistance (AMR) gene database to identify genes associated with emerging resistance to betalactamase, colistin, linezolid and other critically important antibiotics. In partnership with the National Antimicrobial Resistance Monitoring System (NARMS), FSIS is searching for additional genes linked to AMR within the genomes of bacteria recovered from FSIS-regulated and other product samples. Notably, FSIS and the Agricultural Research Service reported WGS analyses of an E. coli from the cecal contents of swine which contained a recently discovered resistance gene to the antibiotic colistin.2 In summary, FSIS expects that the application of WGS analyses will enhance Agency resource allocation and decision-making. From our Lm WGS pilot experience, it is anticipated that the application of WGS analyses will 2 Meinersmann, R.J., Ladely, S.R., Bono, J.L., Plumblee, J.R., Hall, M.C., Genzlinger, L.L., & Cook, K.L. (2016). Complete Genome Sequence of a Colistin Resistance Gene (mcr-1)-Bearing Isolate of Escherichia coli from the United States. Genome Announc, 4(6). http://genomea.asm.org/content/4/ 6/e01283-16.full. PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 44379 lead to greater efficiencies, by consolidating laboratory workflows into a single step for bacterial characterization. In addition, FSIS and partners will use WGS in conjunction with epidemiologic and traceback evidence to identify the sources of outbreaks more expeditiously and to potentially prevent such events by putting in place preventive actions, informed by WGS analyses. Also, FSIS and other public health partners may identify genes associated with virulence, AMR, and other characteristics of concern, as well as newly emerging pathogen sub-types that were previously indistinguishable from routinely isolated bacteria. With the increase in application of WGS, PFGE and other sub-typing methods are expected to be phased out by FSIS and its public health partners, and consequently it will be important to build WGS capacity to perform sequencing and develop analyses to adequately support the respective regulatory frameworks. To address this, FSIS, with speakers from FDA, CDC, NCBI, academic institutions and the domestic and international partners, is hosting a public meeting to discuss these concepts in greater detail. An agenda will be published online before the public meeting. General topics will include: • WGS technology: The global and local perspective and advantages and limitations; • Collaboration and data sharing among Federal and non-Federal entities; • Information on the GenomeTrakr and PulseNet databases; • International standards for WGS; • Information on the equivalency of methods used by different agencies and stakeholders; • Communicating WGS results to stakeholders; and • Transitioning from PFGE to WGS in PulseNet. II. Registration and Meeting Materials There is no fee to register for the public meeting, but pre-registration is mandatory for participants attending inperson. On-site registration will not be permitted. Early registration is recommended as space is limited. All attendees must register online at http:// www.fsis.usda.gov/wps/portal/fsis/ newsroom/meetings. Attendees requiring a sign language interpreter or other special accommodations should notify Ms. Evelyn Arce via telephone: 202–418–8903 or email: Evelyn.Arce@ fsis.usda.gov. As stated above, FSIS will finalize an agenda on or before the meeting dates E:\FR\FM\22SEN1.SGM 22SEN1 44380 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices and post it on the FSIS Web page at http://www.fsis.usda.gov/meetings. III. Public Comments and Participation in Meetings Public Comments: Oral Comments Stakeholders will have an opportunity to provide oral comments during the public meeting. Due to the anticipated high level of interest in the opportunity to make public comments and the limited time available to do so, FSIS will do its best to accommodate all persons who wish to express an opinion. FSIS encourages persons and groups who have similar interests to consolidate their information for presentation by a single representative. Public Comments: Written Comments Any Stakeholder wishing to submit written comments prior to the meeting may do so, and may also submit comments after the meeting, using any of the following methods: Electronically—go to http:// www.regulations.gov and follow the online instructions for submitting comments; Mail, including CD–ROMS— send to Docket Clerk, USDA, FSIS Docket Room, 1400 Independence Avenue SW., Patriots Plaza III, Mailstop 3782, Room 8–163A, Washington, DC 20250–3700; Hand- or courier-delivered items—deliver to the Docket Clerk, USDA, FSIS Docket Room at Patriots Plaza III, 355 E Street SW., Room 8–164, Washington, DC 20250, between 8:00 a.m. and 4:30 p.m., Monday through Friday. All items submitted by mail or electronic mail must include the Agency name and docket number FSIS–2017– 0038. Written 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. For access to background documents or written comments received, go to the FSIS Docket Room at Patriots Plaza III, 355 E Street SW., Room 8–164, Washington, DC 20250, 8:30 a.m. and 4:30 p.m., Monday through Friday. Question-and-Answer Periods: Time has been allotted for audience questions after most presentations delivered during the meeting. Participants will have the opportunity to ask questions via a microphone in the auditorium. IV. Transcripts The transcript of the proceedings from the public meeting will become part of the administrative record. As soon as the meeting transcripts are available they will be accessible on the FSIS Web VerDate Sep<11>2014 18:11 Sep 21, 2017 Jkt 241001 site at http://www.fsis.usda.gov/wps/ portal/fsis/newsroom/meetings. The transcripts may also be viewed at the FSIS Docket Room at the addressed listed above. 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 PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 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). Done at Washington, DC, on: September 19, 2017. Paul Kiecker, Acting Administrator. [FR Doc. 2017–20247 Filed 9–21–17; 8:45 am] BILLING CODE 3410–DM–P DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Notice of Intent To Request To Conduct a New Information Collection National Agricultural Statistics Service, USDA. ACTION: Notice and request for comments. AGENCY: In accordance with the Paperwork Reduction Act of 1995 this notice announces the intention of the National Agricultural Statistics Service (NASS) to seek approval to conduct a new information collection to gather data related to the number of producers, acreage, number of vines, age of vines, etc. of wine grape varieties. DATES: Comments on this notice must be received by November 21, 2017 to be assured of consideration. ADDRESSES: You may submit comments, identified by docket number 0535– NEW, by any of the following methods: • Email: ombofficer@nass.usda.gov. Include docket number above in the subject line of the message. • E-fax: (855) 838–6382. • Mail: Mail any paper, disk, or CD– ROM submissions to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW., Washington, DC 20250– 2024. • Hand Delivery/Courier: Hand deliver to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW., Washington, DC 20250–2024. FOR FURTHER INFORMATION CONTACT: R. Renee Picanso, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720–4333. Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance SUMMARY: E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44378-44380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20247]


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

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2017-0038]


Use of Whole Genome Sequence Analysis To Improve Food Safety and 
Public Health

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notification of public meeting.

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

SUMMARY: The Food Safety and Inspection Service (FSIS), with 
participation from the Food and Drug Administration (FDA), the Centers 
for Disease Control and Prevention (CDC), the National Center for 
Biotechnology Information (NCBI), and other stakeholders is hosting a 
public meeting to discuss FSIS' and other agencies' practices and plans 
for collecting and analyzing whole genome sequence (WGS) data of 
bacteria isolated from official samples, as well as the state of the 
science and other issues surrounding this technology. WGS analyses can 
determine sequence relatedness between bacterial isolates with higher 
resolution than other analytical methods, including pulsed-field gel 
electrophoresis (PFGE), FSIS' current method of characterizing 
bacteria. In addition, WGS analyses can characterize genes and other 
features of bacterial genomes. Currently, FSIS, local, State, and 
Federal public health and regulatory partners submit WGS data to a 
Federal public database, readily accessible to Federal and state 
partners, and other stakeholders, including regulated industry and 
consumers. Using this common database, Federal food safety partners can 
share information and collaborate on issues related to food safety and 
public health. FSIS intends to analyze WGS data using thoroughly vetted 
and scientifically accepted procedures and standards, along with 
epidemiological information and industry production and distribution 
records on amenable product, to carry out its public health mission. 
Inclusion of WGS analyses in decision-making will enhance foodborne 
outbreak investigations, as well as general decisions related to the 
use of data from routine verification sampling of establishments under 
FSIS jurisdiction. Industry, interested individuals, organizations, and 
other stakeholders are invited to participate in the meeting and 
comment on FSIS approaches for using WGS data within a regulatory 
framework.

DATES: The public meeting will be held on Thursday and Friday, October 
26 and 27, 2017 from 8:00 a.m. to 4:45 p.m. EST.

ADDRESSES: The meeting will be held at the Jefferson Auditorium in the 
South Building, U.S. Department of Agriculture (USDA), 1400 
Independence Avenue SW., Washington, DC 20250. Attendance is free. Non-
USDA employees must enter through the Wing 5 entrance on Independence 
Avenue. The South Building is a Federal facility and attendees should 
plan to take adequate time to pass through the security screening 
systems. Attendees must show a valid photo ID to enter the building. 
Attendees also must be pre-registered for the meeting and check in 
onsite the day of the meeting. See the pre-registration instructions 
under ``Registration and Meeting Materials.'' Only registered attendees 
will be permitted to enter the building.

FOR FURTHER INFORMATION CONTACT:  Dr. Peter S. Evans, Office of Policy 
and Program Development, Risk Innovations and Management Staff; 
Telephone: (202) 690-6272; Fax: (202) 245-4793; Email: 
peter.evans@fsis.usda.gov.
    Note that the same week as the WGS public meeting, on October 24 
and 25, 2017, and also in the USDA Jefferson Auditorium, a separate 
interagency public meeting will be held by the National Antimicrobial 
Resistance Monitoring System collaborators. FDA will publish a Federal 
Register Notice to announce this meeting.

SUPPLEMENTARY INFORMATION: 

[[Page 44379]]

I. Background

    FSIS routinely samples meat, poultry and egg products, 
environmental surfaces in slaughter and processing establishments, and 
animal cecal contents for specific microorganisms. FSIS uses 
microbiological test results for a number of purposes: To verify the 
effective implementation of process controls and sanitation programs by 
industry; to help develop pathogen reduction standards for raw products 
and assess whether product meets those standards; and to support 
surveillance, including surveillance related to antimicrobial 
resistance, risk assessment and attribution studies. Sampling results 
may also be used to assign additional sampling or inspection resources 
to establishments or products with higher risk of causing harm to 
consumers. In addition to routine sampling, the Agency may collect 
samples for cause to investigate foodborne illnesses, outbreaks, 
consumer complaints and other non-routine events.
    Due to the rapid advances in DNA sequencing technology, its 
superior resolution, significant reductions in per sample cost, and the 
potential for a single workflow to replace current laboratory subtyping 
methods, WGS analysis is now considered an important tool for routinely 
sub-typing and characterizing bacterial pathogens. Unlike PFGE and 
other DNA-based technologies, which rely on the analysis of 
arrangements of fragments or portions of a genome sequence without 
actually knowing each nucleotide in the sequence arrangement, WGS 
analyses use almost the entire genomic sequence, about 1 to 10 million 
base units for a typical bacterium. WGS provides robust estimates of 
sequence relatedness, based on the presence, absence, substitution and 
arrangement of individual nucleotides in the genomic sequences, thus 
permitting further characterization of individual genes and other 
interesting features of bacterial genomes.
    In 2013, CDC, FDA, FSIS, and the NCBI collaborated with local, 
State, and international partners to implement a pilot study of WGS-
based surveillance for Listeria monocytogenes (Lm).\1\ For the pilot 
study, Lm isolates from patients, food, and domestic food processing 
environments were analyzed using WGS. The resulting analyses were 
routinely made available to CDC epidemiologists and other public health 
and regulatory partners. The availability of WGS analyses transformed 
outbreak surveillance and response: More illness clusters were detected 
(14 clusters detected in the year before the pilot versus 19 and 21 
clusters detected in the two years after implementing WGS). In 
addition, illness clusters were detected sooner, median cluster size 
was markedly reduced, and more outbreaks were resolved by linking Lm 
illness and food sources. This pilot shows the specific improvements 
that can be gained using WGS, as compared to the use of PFGE analyses.
---------------------------------------------------------------------------

    \1\ Jackson, B.R., Tarr, C., Strain, E., Jackson, K.A., Conrad, 
A., Carleton, H., . . . Gerner-Smidt, P. (2016). Implementation of 
Nationwide Real-Time Whole-Genome Sequencing to Enhance Listeriosis 
Outbreak Detection and Investigation. Clinical Infectious Diseases, 
Volume 63, Issue 3, 1 August 2016, Pages 380-386, https://doi.org/10.1093/cid/ciw242.
---------------------------------------------------------------------------

    FSIS plans to expand its use of WGS analysis to bacteria isolated 
from FSIS sampling projects to aid in accurately identifying and 
responding to outbreaks, conducting efficient traceback, and studying 
the environmental harborage and movement of pathogens in regulated 
establishments. All WGS data will continue to be uploaded to a Federal 
database that is readily accessible to all food safety and public 
health partners and stakeholders, including consumers. Additionally, 
FSIS will analyze WGS data from FSIS samples and other food, 
environmental, and clinical samples contributed by other sources and 
organizations.
    Additionally, FSIS has begun to analyze WGS data to identify 
specific genes associated with characteristics of public health 
concern. In collaboration with Federal partners, FSIS uses an 
antimicrobial resistance (AMR) gene database to identify genes 
associated with emerging resistance to beta-lactamase, colistin, 
linezolid and other critically important antibiotics. In partnership 
with the National Antimicrobial Resistance Monitoring System (NARMS), 
FSIS is searching for additional genes linked to AMR within the genomes 
of bacteria recovered from FSIS-regulated and other product samples. 
Notably, FSIS and the Agricultural Research Service reported WGS 
analyses of an E. coli from the cecal contents of swine which contained 
a recently discovered resistance gene to the antibiotic colistin.\2\
---------------------------------------------------------------------------

    \2\ Meinersmann, R.J., Ladely, S.R., Bono, J.L., Plumblee, J.R., 
Hall, M.C., Genzlinger, L.L., & Cook, K.L. (2016). Complete Genome 
Sequence of a Colistin Resistance Gene (mcr-1)-Bearing Isolate of 
Escherichia coli from the United States. Genome Announc, 4(6). 
http://genomea.asm.org/content/4/6/e01283-16.full.
---------------------------------------------------------------------------

    In summary, FSIS expects that the application of WGS analyses will 
enhance Agency resource allocation and decision-making. From our Lm WGS 
pilot experience, it is anticipated that the application of WGS 
analyses will lead to greater efficiencies, by consolidating laboratory 
workflows into a single step for bacterial characterization. In 
addition, FSIS and partners will use WGS in conjunction with 
epidemiologic and traceback evidence to identify the sources of 
outbreaks more expeditiously and to potentially prevent such events by 
putting in place preventive actions, informed by WGS analyses. Also, 
FSIS and other public health partners may identify genes associated 
with virulence, AMR, and other characteristics of concern, as well as 
newly emerging pathogen sub-types that were previously 
indistinguishable from routinely isolated bacteria.
    With the increase in application of WGS, PFGE and other sub-typing 
methods are expected to be phased out by FSIS and its public health 
partners, and consequently it will be important to build WGS capacity 
to perform sequencing and develop analyses to adequately support the 
respective regulatory frameworks. To address this, FSIS, with speakers 
from FDA, CDC, NCBI, academic institutions and the domestic and 
international partners, is hosting a public meeting to discuss these 
concepts in greater detail. An agenda will be published online before 
the public meeting. General topics will include:
     WGS technology: The global and local perspective and 
advantages and limitations;
     Collaboration and data sharing among Federal and non-
Federal entities;
     Information on the GenomeTrakr and PulseNet databases;
     International standards for WGS;
     Information on the equivalency of methods used by 
different agencies and stakeholders;
     Communicating WGS results to stakeholders; and
     Transitioning from PFGE to WGS in PulseNet.

II. Registration and Meeting Materials

    There is no fee to register for the public meeting, but pre-
registration is mandatory for participants attending in-person. On-site 
registration will not be permitted. Early registration is recommended 
as space is limited. All attendees must register online at http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings. Attendees 
requiring a sign language interpreter or other special accommodations 
should notify Ms. Evelyn Arce via telephone: 202-418-8903 or email: 
Evelyn.Arce@fsis.usda.gov.
    As stated above, FSIS will finalize an agenda on or before the 
meeting dates

[[Page 44380]]

and post it on the FSIS Web page at http://www.fsis.usda.gov/meetings.

III. Public Comments and Participation in Meetings

Public Comments: Oral Comments

    Stakeholders will have an opportunity to provide oral comments 
during the public meeting. Due to the anticipated high level of 
interest in the opportunity to make public comments and the limited 
time available to do so, FSIS will do its best to accommodate all 
persons who wish to express an opinion. FSIS encourages persons and 
groups who have similar interests to consolidate their information for 
presentation by a single representative.

Public Comments: Written Comments

    Any Stakeholder wishing to submit written comments prior to the 
meeting may do so, and may also submit comments after the meeting, 
using any of the following methods: Electronically--go to http://www.regulations.gov and follow the online instructions for submitting 
comments; Mail, including CD-ROMS--send to Docket Clerk, USDA, FSIS 
Docket Room, 1400 Independence Avenue SW., Patriots Plaza III, Mailstop 
3782, Room 8-163A, Washington, DC 20250-3700; Hand- or courier-
delivered items--deliver to the Docket Clerk, USDA, FSIS Docket Room at 
Patriots Plaza III, 355 E Street SW., Room 8-164, Washington, DC 20250, 
between 8:00 a.m. and 4:30 p.m., Monday through Friday.
    All items submitted by mail or electronic mail must include the 
Agency name and docket number FSIS-2017-0038. Written 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. For access to background documents or 
written comments received, go to the FSIS Docket Room at Patriots Plaza 
III, 355 E Street SW., Room 8-164, Washington, DC 20250, 8:30 a.m. and 
4:30 p.m., Monday through Friday.
    Question-and-Answer Periods: Time has been allotted for audience 
questions after most presentations delivered during the meeting. 
Participants will have the opportunity to ask questions via a 
microphone in the auditorium.

IV. Transcripts

    The transcript of the proceedings from the public meeting will 
become part of the administrative record. As soon as the meeting 
transcripts are available they will be accessible on the FSIS Web site 
at http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings. The 
transcripts may also be viewed at the FSIS Docket Room at the addressed 
listed above.

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: program.intake@usda.gov.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington, DC, on: September 19, 2017.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2017-20247 Filed 9-21-17; 8:45 am]
 BILLING CODE 3410-DM-P