82_FR_44561 82 FR 44378 - Use of Whole Genome Sequence Analysis To Improve Food Safety and Public Health

82 FR 44378 - Use of Whole Genome Sequence Analysis To Improve Food Safety and Public Health

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 82, Issue 183 (September 22, 2017)

Page Range44378-44380
FR Document2017-20247

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.

Federal Register, Volume 82 Issue 183 (Friday, September 22, 2017)
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44378-44380]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20247]


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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.

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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: 
[email protected].
    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.
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    \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.
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    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\
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    \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.
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    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: 
[email protected].
    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: [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).

    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



     44378                       Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices

     Improper Payments Information Act                       Supplemental Nutrition Assistance                     data to a Federal public database,
     2010 (31 U.S.C. 3301) Supplemental                      Program (SNAP) related fraud activity                 readily accessible to Federal and state
     Nutrition Assistance Program:                           observed by large retailers and the                   partners, and other stakeholders,
     Disqualified Recipient Reporting and                    methods they use to prevent fraud and                 including regulated industry and
     Computer Matching Requirements).                        minimize their losses.                                consumers. Using this common
     State agencies are required to check for                  Need and Use of the Information:                    database, Federal food safety partners
     disqualified recipients in the Electronic               This study will help FNS learn more                   can share information and collaborate
     Disqualified Recipient System, validate                 about the types of SNAP fraud that                    on issues related to food safety and
     against a list of incarcerated people                   occur in large retailer settings;                     public health. FSIS intends to analyze
     using the Social Security                               document retailer practices to detect,                WGS data using thoroughly vetted and
     Administration’s Prisoner Verification                  deter, and deal with fraud (collectively              scientifically accepted procedures and
     System, verify applicant employment                     known as loss prevention or loss                      standards, along with epidemiological
     data through the National Directory of                  prevention practices); and determine                  information and industry production
     New Hires and confirm an individual is                  which practices could provide                         and distribution records on amenable
     not in the Social Security                              information that would help FNS in                    product, to carry out its public health
     Administration’s Death Master File.                     detecting and preventing SNAP fraud.                  mission. Inclusion of WGS analyses in
     Additional program integrity tools and                    Description of Respondents:                         decision-making will enhance
     methods vary by State and can vary                      Businesses-for-and-not-for-profit.                    foodborne outbreak investigations, as
     within States, particularly those that are                Number of Respondents: 2,045.                       well as general decisions related to the
     decentralized and administer SNAP at                      Frequency of Responses: Reporting:                  use of data from routine verification
     the county level. Local offices may also                Annually.                                             sampling of establishments under FSIS
     conduct matches that vary from those                      Total Burden Hours: 2,851.40.                       jurisdiction. Industry, interested
     used at the county or State level.                                                                            individuals, organizations, and other
       Need and Use of the Information:                      Ruth Brown,
                                                                                                                   stakeholders are invited to participate in
     This study will help FNS update the                     Departmental Information Collection                   the meeting and comment on FSIS
     nationwide inventory of State SNAP                      Clearance Officer.
                                                                                                                   approaches for using WGS data within
     data-matching and improve SNAP                          [FR Doc. 2017–20206 Filed 9–21–17; 8:45 am]
                                                                                                                   a regulatory framework.
     computer-matching efforts across the                    BILLING CODE 3410–30–P
                                                                                                                   DATES: The public meeting will be held
     nation to maximize efficiencies and                                                                           on Thursday and Friday, October 26 and
     minimize fraud and waste. State                                                                               27, 2017 from 8:00 a.m. to 4:45 p.m.
     agencies administering SNAP use data                    DEPARTMENT OF AGRICULTURE
                                                                                                                   EST.
     matching to verify information
                                                             Food Safety and Inspection Service                    ADDRESSES:   The meeting will be held at
     submitted at the application and
     recertification stages of the application               [Docket No. FSIS–2017–0038]                           the Jefferson Auditorium in the South
     process and to monitor changes in                                                                             Building, U.S. Department of
     benefit recipients’ household                           Use of Whole Genome Sequence                          Agriculture (USDA), 1400 Independence
     circumstances. In order for USDA to                     Analysis To Improve Food Safety and                   Avenue SW., Washington, DC 20250.
     make informed decisions, it is important                Public Health                                         Attendance is free. Non-USDA
     to gather current information about how                                                                       employees must enter through the Wing
                                                             AGENCY:  Food Safety and Inspection                   5 entrance on Independence Avenue.
     and to what extent SNAP agencies                        Service, USDA.
     conduct computer data matching and                                                                            The South Building is a Federal facility
                                                             ACTION: Notification of public meeting.               and attendees should plan to take
     systematically use that information to
     improve program integrity.                                                                                    adequate time to pass through the
                                                             SUMMARY:    The Food Safety and
       Description of Respondents: State,                                                                          security screening systems. Attendees
                                                             Inspection Service (FSIS), with
     Local and Tribal Agencies.                                                                                    must show a valid photo ID to enter the
                                                             participation from the Food and Drug
       Number of Respondents: 372.                                                                                 building. Attendees also must be pre-
       Frequency of Responses: Reporting:                    Administration (FDA), the Centers for
                                                                                                                   registered for the meeting and check in
     Annually.                                               Disease Control and Prevention (CDC),
                                                                                                                   onsite the day of the meeting. See the
       Total Burden Hours: 196.                              the National Center for Biotechnology
                                                                                                                   pre-registration instructions under
                                                             Information (NCBI), and other
     Food and Nutrition Service                                                                                    ‘‘Registration and Meeting Materials.’’
                                                             stakeholders is hosting a public meeting
                                                                                                                   Only registered attendees will be
        Title: Understanding the Anti-Fraud                  to discuss FSIS’ and other agencies’
                                                                                                                   permitted to enter the building.
     Measures of Large Supplemental                          practices and plans for collecting and
                                                             analyzing whole genome sequence                       FOR FURTHER INFORMATION CONTACT: Dr.
     Nutrition Assistance Program (SNAP)
     Retailers.                                              (WGS) data of bacteria isolated from                  Peter S. Evans, Office of Policy and
        OMB Control Number: 0584–NEW.                        official samples, as well as the state of             Program Development, Risk Innovations
        Summary of Collection: This study is                 the science and other issues                          and Management Staff; Telephone: (202)
     authorized under the Food and                           surrounding this technology. WGS                      690–6272; Fax: (202) 245–4793; Email:
     Nutrition Act of 2008 through the                       analyses can determine sequence                       peter.evans@fsis.usda.gov.
     Agricultural Act of 2014 (Pub. L. 113–                  relatedness between bacterial isolates                   Note that the same week as the WGS
     79). The United States Department of                    with higher resolution than other                     public meeting, on October 24 and 25,
     Agriculture (USDA) has the authority to                 analytical methods, including pulsed-                 2017, and also in the USDA Jefferson
     ‘‘undertake research that will help                     field gel electrophoresis (PFGE), FSIS’               Auditorium, a separate interagency
     improve the administration and                          current method of characterizing                      public meeting will be held by the
     effectiveness of the supplemental                       bacteria. In addition, WGS analyses can               National Antimicrobial Resistance
     nutrition assistance program in                         characterize genes and other features of              Monitoring System collaborators. FDA
     delivering nutrition-related benefits.’’                bacterial genomes. Currently, FSIS,                   will publish a Federal Register Notice
     This is a new collection for the purpose                local, State, and Federal public health               to announce this meeting.
     of learning about the types of                          and regulatory partners submit WGS                    SUPPLEMENTARY INFORMATION:



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                                   Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices                                           44379

     I. Background                                             routinely made available to CDC                         lead to greater efficiencies, by
        FSIS routinely samples meat, poultry                   epidemiologists and other public health                 consolidating laboratory workflows into
     and egg products, environmental                           and regulatory partners. The availability               a single step for bacterial
     surfaces in slaughter and processing                      of WGS analyses transformed outbreak                    characterization. In addition, FSIS and
     establishments, and animal cecal                          surveillance and response: More illness                 partners will use WGS in conjunction
     contents for specific microorganisms.                     clusters were detected (14 clusters                     with epidemiologic and traceback
     FSIS uses microbiological test results for                detected in the year before the pilot                   evidence to identify the sources of
     a number of purposes: To verify the                       versus 19 and 21 clusters detected in the               outbreaks more expeditiously and to
     effective implementation of process                       two years after implementing WGS). In                   potentially prevent such events by
     controls and sanitation programs by                       addition, illness clusters were detected                putting in place preventive actions,
     industry; to help develop pathogen                        sooner, median cluster size was                         informed by WGS analyses. Also, FSIS
     reduction standards for raw products                      markedly reduced, and more outbreaks                    and other public health partners may
     and assess whether product meets those                    were resolved by linking Lm illness and                 identify genes associated with
     standards; and to support surveillance,                   food sources. This pilot shows the                      virulence, AMR, and other
     including surveillance related to                         specific improvements that can be                       characteristics of concern, as well as
     antimicrobial resistance, risk assessment                 gained using WGS, as compared to the                    newly emerging pathogen sub-types that
     and attribution studies. Sampling                         use of PFGE analyses.                                   were previously indistinguishable from
     results may also be used to assign                           FSIS plans to expand its use of WGS                  routinely isolated bacteria.
     additional sampling or inspection                         analysis to bacteria isolated from FSIS                    With the increase in application of
     resources to establishments or products                   sampling projects to aid in accurately                  WGS, PFGE and other sub-typing
     with higher risk of causing harm to                       identifying and responding to outbreaks,                methods are expected to be phased out
     consumers. In addition to routine                         conducting efficient traceback, and                     by FSIS and its public health partners,
     sampling, the Agency may collect                          studying the environmental harborage                    and consequently it will be important to
     samples for cause to investigate                          and movement of pathogens in                            build WGS capacity to perform
     foodborne illnesses, outbreaks,                           regulated establishments. All WGS data                  sequencing and develop analyses to
     consumer complaints and other non-                        will continue to be uploaded to a                       adequately support the respective
     routine events.                                           Federal database that is readily                        regulatory frameworks. To address this,
        Due to the rapid advances in DNA                       accessible to all food safety and public                FSIS, with speakers from FDA, CDC,
     sequencing technology, its superior                       health partners and stakeholders,                       NCBI, academic institutions and the
     resolution, significant reductions in per                 including consumers. Additionally,                      domestic and international partners, is
     sample cost, and the potential for a                      FSIS will analyze WGS data from FSIS                    hosting a public meeting to discuss
     single workflow to replace current                        samples and other food, environmental,                  these concepts in greater detail. An
     laboratory subtyping methods, WGS                         and clinical samples contributed by                     agenda will be published online before
     analysis is now considered an important                   other sources and organizations.                        the public meeting. General topics will
     tool for routinely sub-typing and                            Additionally, FSIS has begun to
                                                                                                                       include:
                                                               analyze WGS data to identify specific
     characterizing bacterial pathogens.                                                                                  • WGS technology: The global and
     Unlike PFGE and other DNA-based                           genes associated with characteristics of
                                                                                                                       local perspective and advantages and
     technologies, which rely on the analysis                  public health concern. In collaboration
                                                                                                                       limitations;
                                                               with Federal partners, FSIS uses an
     of arrangements of fragments or portions
                                                               antimicrobial resistance (AMR) gene                        • Collaboration and data sharing
     of a genome sequence without actually                                                                             among Federal and non-Federal entities;
     knowing each nucleotide in the                            database to identify genes associated
                                                               with emerging resistance to beta-                          • Information on the GenomeTrakr
     sequence arrangement, WGS analyses                                                                                and PulseNet databases;
     use almost the entire genomic sequence,                   lactamase, colistin, linezolid and other
                                                               critically important antibiotics. In                       • International standards for WGS;
     about 1 to 10 million base units for a                                                                               • Information on the equivalency of
     typical bacterium. WGS provides robust                    partnership with the National
                                                               Antimicrobial Resistance Monitoring                     methods used by different agencies and
     estimates of sequence relatedness, based                                                                          stakeholders;
     on the presence, absence, substitution                    System (NARMS), FSIS is searching for
                                                               additional genes linked to AMR within                      • Communicating WGS results to
     and arrangement of individual                                                                                     stakeholders; and
     nucleotides in the genomic sequences,                     the genomes of bacteria recovered from
                                                               FSIS-regulated and other product                           • Transitioning from PFGE to WGS in
     thus permitting further characterization
                                                               samples. Notably, FSIS and the                          PulseNet.
     of individual genes and other interesting
     features of bacterial genomes.                            Agricultural Research Service reported                  II. Registration and Meeting Materials
        In 2013, CDC, FDA, FSIS, and the                       WGS analyses of an E. coli from the
                                                               cecal contents of swine which contained                    There is no fee to register for the
     NCBI collaborated with local, State, and
                                                               a recently discovered resistance gene to                public meeting, but pre-registration is
     international partners to implement a
                                                               the antibiotic colistin.2                               mandatory for participants attending in-
     pilot study of WGS-based surveillance
                                                                  In summary, FSIS expects that the                    person. On-site registration will not be
     for Listeria monocytogenes (Lm).1 For
                                                               application of WGS analyses will                        permitted. Early registration is
     the pilot study, Lm isolates from
                                                               enhance Agency resource allocation and                  recommended as space is limited. All
     patients, food, and domestic food
                                                               decision-making. From our Lm WGS                        attendees must register online at http://
     processing environments were analyzed
                                                               pilot experience, it is anticipated that                www.fsis.usda.gov/wps/portal/fsis/
     using WGS. The resulting analyses were
                                                               the application of WGS analyses will                    newsroom/meetings. Attendees
       1 Jackson, B.R., Tarr, C., Strain, E., Jackson, K.A.,
                                                                                                                       requiring a sign language interpreter or
     Conrad, A., Carleton, H., . . . Gerner-Smidt, P.            2 Meinersmann, R.J., Ladely, S.R., Bono, J.L.,        other special accommodations should
     (2016). Implementation of Nationwide Real-Time            Plumblee, J.R., Hall, M.C., Genzlinger, L.L., & Cook,   notify Ms. Evelyn Arce via telephone:
     Whole-Genome Sequencing to Enhance Listeriosis            K.L. (2016). Complete Genome Sequence of a              202–418–8903 or email: Evelyn.Arce@
     Outbreak Detection and Investigation. Clinical            Colistin Resistance Gene (mcr-1)-Bearing Isolate of
     Infectious Diseases, Volume 63, Issue 3, 1 August         Escherichia coli from the United States. Genome
                                                                                                                       fsis.usda.gov.
     2016, Pages 380–386, https://doi.org/10.1093/cid/         Announc, 4(6). http://genomea.asm.org/content/4/           As stated above, FSIS will finalize an
     ciw242.                                                   6/e01283-16.full.                                       agenda on or before the meeting dates


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     44380                       Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices

     and post it on the FSIS Web page at                     site at http://www.fsis.usda.gov/wps/                 Independence Avenue SW.,
     http://www.fsis.usda.gov/meetings.                      portal/fsis/newsroom/meetings. The                    Washington, DC 20250–9410.
                                                             transcripts may also be viewed at the                    Fax: (202) 690–7442.
     III. Public Comments and Participation                                                                           Email: program.intake@usda.gov.
                                                             FSIS Docket Room at the addressed
     in Meetings                                                                                                      Persons with disabilities who require
                                                             listed above.
     Public Comments: Oral Comments                                                                                alternative means for communication
                                                             Additional Public Notification                        (Braille, large print, audiotape, etc.),
       Stakeholders will have an opportunity                   Public awareness of all segments of                 should contact USDA’s TARGET Center
     to provide oral comments during the                     rulemaking and policy development is                  at (202) 720–2600 (voice and TDD).
     public meeting. Due to the anticipated                  important. Consequently, FSIS will
     high level of interest in the opportunity                                                                       Done at Washington, DC, on: September
                                                             announce this Federal Register                        19, 2017.
     to make public comments and the                         publication online through the FSIS
     limited time available to do so, FSIS                                                                         Paul Kiecker,
                                                             Web page located at: http://                          Acting Administrator.
     will do its best to accommodate all                     www.fsis.usda.gov/federal-register.
     persons who wish to express an                            FSIS also will make copies of this
                                                                                                                   [FR Doc. 2017–20247 Filed 9–21–17; 8:45 am]
     opinion. FSIS encourages persons and                    publication available through the FSIS                BILLING CODE 3410–DM–P
     groups who have similar interests to                    Constituent Update, which is used to
     consolidate their information for                       provide information regarding FSIS
     presentation by a single representative.                                                                      DEPARTMENT OF AGRICULTURE
                                                             policies, procedures, regulations,
     Public Comments: Written Comments                       Federal Register notices, FSIS public                 National Agricultural Statistics Service
                                                             meetings, and other types of information
        Any Stakeholder wishing to submit                    that could affect or would be of interest             Notice of Intent To Request To
     written comments prior to the meeting                   to our constituents and stakeholders.                 Conduct a New Information Collection
     may do so, and may also submit                          The Constituent Update is available on
     comments after the meeting, using any                   the FSIS Web page. Through the Web                    AGENCY:  National Agricultural Statistics
     of the following methods:                               page, FSIS is able to provide                         Service, USDA.
     Electronically—go to http://                            information to a much broader, more                   ACTION: Notice and request for
     www.regulations.gov and follow the                      diverse audience. In addition, FSIS                   comments.
     online instructions for submitting                      offers an email subscription service
     comments; Mail, including CD–ROMS—                                                                            SUMMARY:   In accordance with the
                                                             which provides automatic and                          Paperwork Reduction Act of 1995 this
     send to Docket Clerk, USDA, FSIS                        customized access to selected food
     Docket Room, 1400 Independence                                                                                notice announces the intention of the
                                                             safety news and information. This                     National Agricultural Statistics Service
     Avenue SW., Patriots Plaza III, Mailstop                service is available at: http://
     3782, Room 8–163A, Washington, DC                                                                             (NASS) to seek approval to conduct a
                                                             www.fsis.usda.gov/subscribe. Options                  new information collection to gather
     20250–3700; Hand- or courier-delivered                  range from recalls to export information,
     items—deliver to the Docket Clerk,                                                                            data related to the number of producers,
                                                             regulations, directives, and notices.                 acreage, number of vines, age of vines,
     USDA, FSIS Docket Room at Patriots                      Customers can add or delete
     Plaza III, 355 E Street SW., Room 8–164,                                                                      etc. of wine grape varieties.
                                                             subscriptions themselves, and have the
     Washington, DC 20250, between 8:00                                                                            DATES: Comments on this notice must be
                                                             option to password protect their
     a.m. and 4:30 p.m., Monday through                                                                            received by November 21, 2017 to be
                                                             accounts.
     Friday.                                                                                                       assured of consideration.
        All items submitted by mail or                       USDA Non-Discrimination Statement                     ADDRESSES: You may submit comments,
     electronic mail must include the Agency                   No agency, officer, or employee of the              identified by docket number 0535–
     name and docket number FSIS–2017–                       USDA shall, on the grounds of race,                   NEW, by any of the following methods:
     0038. Written comments received in                      color, national origin, religion, sex,                  • Email: ombofficer@nass.usda.gov.
     response to this docket will be made                    gender identity, sexual orientation,                  Include docket number above in the
     available for public inspection and                     disability, age, marital status, family/              subject line of the message.
     posted without change, including any                    parental status, income derived from a                  • E-fax: (855) 838–6382.
     personal information, to http://                        public assistance program, or political                 • Mail: Mail any paper, disk, or CD–
     www.regulations.gov. For access to                      beliefs, exclude from participation in,               ROM submissions to: David Hancock,
     background documents or written                         deny the benefits of, or subject to                   NASS Clearance Officer, U.S.
     comments received, go to the FSIS                       discrimination, any person in the                     Department of Agriculture, Room 5336
     Docket Room at Patriots Plaza III, 355 E                United States under any program or                    South Building, 1400 Independence
     Street SW., Room 8–164, Washington,                     activity conducted by the USDA.                       Avenue SW., Washington, DC 20250–
     DC 20250, 8:30 a.m. and 4:30 p.m.,                                                                            2024.
     Monday through Friday.                                  How To File a Complaint of                              • Hand Delivery/Courier: Hand
        Question-and-Answer Periods: Time                    Discrimination                                        deliver to: David Hancock, NASS
     has been allotted for audience questions                  To file a complaint of discrimination,              Clearance Officer, U.S. Department of
     after most presentations delivered                      complete the USDA Program                             Agriculture, Room 5336 South Building,
     during the meeting. Participants will                   Discrimination Complaint Form, which                  1400 Independence Avenue SW.,
     have the opportunity to ask questions                   may be accessed online at: http://                    Washington, DC 20250–2024.
     via a microphone in the auditorium.                     www.ocio.usda.gov/sites/default/files/                FOR FURTHER INFORMATION CONTACT: R.
                                                             docs/2012/Complain_combined_6_8_                      Renee Picanso, Associate Administrator,
     IV. Transcripts                                                                                               National Agricultural Statistics Service,
                                                             12.pdf, or write a letter signed by you
       The transcript of the proceedings from                or your authorized representative.                    U.S. Department of Agriculture, (202)
     the public meeting will become part of                    Send your completed complaint form                  720–4333. Copies of this information
     the administrative record. As soon as                   or letter to USDA by mail, fax, or email:             collection and related instructions can
     the meeting transcripts are available                     Mail: U.S. Department of Agriculture,               be obtained without charge from David
     they will be accessible on the FSIS Web                 Director, Office of Adjudication, 1400                Hancock, NASS—OMB Clearance


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Document Created: 2017-09-22 01:53:03
Document Modified: 2017-09-22 01:53:03
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
ActionNotification of public meeting.
DatesThe 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.
ContactDr. Peter S. Evans, Office of Policy and Program Development, Risk Innovations and Management Staff; Telephone: (202) 690-6272; Fax: (202) 245-4793; Email: [email protected]
FR Citation82 FR 44378 

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