A New Era of Smarter Food Safety; Public Meeting, Request for Comments, 49111-49114 [2019-20229]
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Federal Register / Vol. 84, No. 181 / Wednesday, September 18, 2019 / Notices
August 30, 2019, Volume 84, Number
169, pages 45765–45766.
The MATTERS TO BE CONSIDERED
should read as follows: The agenda will
include agency updates from CDC, the
Centers for Medicare and Medicaid
Services (CMS); and the Food and Drug
Administration (FDA). Presentations
and discussions will focus on a follow
up on CLIAC recommendations; an
update on the clinical laboratory
workforce; improving integration of
laboratory information systems with
electronic health records; and future
CLIAC topics. There will be an extended
public comment session focusing on
emerging technologies and the clinical
laboratory. Agenda items are subject to
change as priorities dictate.
FOR FURTHER INFORMATION CONTACT:
Nancy Anderson, MMSc, MT(ASCP),
Senior Advisor for Clinical Laboratories,
Division of Laboratory Systems, Center
for Surveillance, Epidemiology and
Laboratory Services, Office of Public
Health Scientific Services, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mailstop V24–3,
Atlanta, Georgia 30329–4027, telephone
(404) 498–2741; NAnderson@cdc.gov.
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Kalwant Smagh,
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Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4187]
A New Era of Smarter Food Safety;
Public Meeting, Request for Comments
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AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting entitled ‘‘A New Era of Smarter
Food Safety’’ to get input from a broad
SUMMARY:
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cross-section of stakeholders on a
modern approach the Agency is taking
to strengthen its protection of the food
supply. The purpose of this meeting is
to foster a dialogue with our domestic
and international regulatory and public
health partners, industry, consumers,
academia, and others. The input
received at this meeting, and in
comments submitted to the docket, will
be used to shape an FDA Blueprint for
a New Era of Smarter Food Safety. This
Blueprint will outline how this modern
approach will address public health
challenges, ranging from being able to
trace sources of contaminated foods, to
using new predictive analytics tools like
artificial intelligence to assess risks, and
help prioritize the Agency’s work and
resources.
DATES: The public meeting will be held
on October 21, 2019, from 8:30 a.m. to
5 p.m. Submit either electronic or
written comments on this public
meeting by November 20, 2019. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at the Hilton Washington DC/
Rockville Hotel and Executive Meeting
Center, 1750 Rockville Pike, Rockville,
MD 20852. For more information on the
hotel see https://www.fda.gov/food/
news-events-cfsan/workshops-meetingswebinars-food-and-dietary-supplements.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before November 20, 2019. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of November 20, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
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confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No.FDA–2019–
N–4187 for ‘‘A New Era of Smarter Food
Safety.’’ Received comments, those filed
in a timely manner (see ADDRESSES),
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
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as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
For questions about registering for the
meeting or to register by phone: Mark
Gifford, SIDEM, 1775 Eye St. NW, Suite
1150, Washington, DC 20006, telephone:
240–393–4496, Fax: 202–495–2091,
email: EventSupport@sidemgroup.com.
For general questions about the
meeting or for special accommodations
due to a disability: Juanita Yates, Center
for Food Safety and Applied Nutrition
(HFS–009), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, telephone:
240–402–1731, email: Juanita.yates@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
On April 30, 2019, FDA released a
joint statement from Acting FDA
Commissioner Ned Sharpless, M.D., and
Deputy Commissioner for Food Policy
and Response Frank Yiannas on the
New Era of Smarter Food Safety.
(https://www.fda.gov/news-events/
press-announcements/statement-actingfda-commissioner-ned-sharpless-mdand-deputy-commissioner-frankyiannas-steps-usher). This is a modern
approach to food safety that
incorporates the use of new and
emerging technologies, considers the
challenge of evolving business models,
and works to support the development
of food safety cultures throughout the
global supply chain. The New Era of
Smarter Food Safety will enhance the
Agency’s ongoing efforts to implement
the FDA Food Safety Modernization Act
(FSMA) by creating a more digital,
traceable, and safer system to help
protect consumers from contaminated
food.
FDA continues to build a modernized
regulatory framework that can help
ensure the safety of the food supply,
including innovations in food
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ingredients and processes. At the same
time, FDA will leverage the use of new
and emerging technologies to strengthen
predictive capabilities, support the
implementation of preventive controls,
and speed outbreak response.
Today’s technology-focused world has
changed the way our society operates,
creating a highly complex and globally
interconnected landscape. The food
system has evolved from a system that
sources foods from around the corner to
a system that brings in foods from
around the world and travels an everchanging ‘‘last mile’’ with the
emergence of direct-to-home delivery
models. Technology and market forces
have redefined how foods go from farm
to table as shown by the expansion of
e-commerce and the use of new
technologies to track foods and their
storage conditions along the supply
chain.
There will be significant innovation
in the agriculture, food production, and
food distribution systems in the next 10
years, which will continue to provide an
even greater variety of food sources,
food ingredients, and delivery
conveniences for American consumers.
With this ever-changing landscape, FDA
must continue preparing to take
advantage of new opportunities and
address potential risks.
Since FSMA was signed into law in
2011, FDA has proposed and finalized
critical regulations that have established
science- and risk-based standards for the
production, importation, and
transportation of foods. FDA has also
had great success leveraging technology
to advance food safety, especially in the
use of new analytical tools like Whole
Genome Sequencing. However, a lot has
changed since 2011.
When it comes to food traceability,
many in the food system still utilize a
largely paper-based based system of
taking one step forward to identify
where the food has gone and one step
back to identify the source. The use of
new and evolving digital technologies
envisioned in the New Era of Smarter
Food Safety will play a pivotal role in
tracing the origin of a contaminated
food to its source in minutes, or even
seconds, instead of days or weeks.
Access to information during an
outbreak about the origin of
contaminated food will facilitate more
timely root cause analyses and enable
FDA to prevent future contamination
incidents.
The Agency will look at technologies
and approaches that include those being
used in society and business sectors all
around us, such as distributed ledgers,
sensors, the Internet of Things, and
artificial intelligence. FDA will assess
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how these technologies could create a
more digital, transparent, and safe food
system while also addressing consumer
demands for quick access to information
about where their foods come from, how
they are produced, and if the food is the
subject of an ongoing recall.
As consumers are increasingly asking
for food to be delivered to their homes,
there are new methods, packaging
materials, temperature control
approaches, and delivery models in the
e-commerce system. These evolving
business models present food safety
challenges, as well as novel
considerations around regulatory
framework and oversight at the federal,
state, territorial, and local level.
The New Era of Smarter Food Safety
is about more than technology. It is also
about working within and outside of
FDA to foster a food safety culture that
transcends borders between the public
and private sector, as well as geographic
and commodity divides. The New Era of
Smarter Food Safety is also about
enhancing existing processes to make
them more effective and efficient. FDA
looks forward to participation in this
effort by food companies and
technology firms of all sizes, as well as
state, territorial, local, and federal
agencies and other stakeholders.
II. Topics for Discussion at the Public
Meeting
The public meeting will begin with a
plenary session, followed by breakout
sessions that will discuss key topics
relating to the New Era of Smarter Food
Safety. These topics will include
technologies and data streams that have
the potential to greatly reduce the time
it takes to trace the origin of a
contaminated food to its source and
how we might best use this information.
We will talk about how we can use
lessons learned from outbreaks to better
inform and enhance our prevention
efforts.
No matter how consumers get their
food, whether they are ordering online
or at their favorite restaurant, they
deserve to have confidence in the safety
of the food supply. We will talk about
advancing the safety of both new
business models, such as e-commerce
and home delivery of foods, and
traditional business models, such as
retail food establishments. Perhaps the
most fundamental topic that we will
address is the need to support and
strengthen food safety culture
throughout the supply chain from farms
to facilities through retail, which is the
foundation of food safety management.
We encourage public comments and
presentations at the public meeting. In
submitting comments, data, and
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information to the docket, please
identify available references for the data
and information, as well as the general
category area and, if appropriate, the
specific question listed below. We are
starting with several focus areas:
Traceability, smarter tools and
approaches for prevention, the
challenges of new business models and
retail food safety, and support for the
development of food safety cultures.
A. New and Evolving Digital
Technologies Will Play a Pivotal Role in
Tracing the Origin of a Contaminated
Food to Its Source in Minutes, or Even
Seconds, Instead of Days or Weeks
1. What are the most significant
actions FDA could undertake to enable
industry to enhance traceability across
the entire global food supply chain?
2. How could FDA make it more
likely that companies utilize new
technologies to enhance the traceability
of their products?
3. What can FDA do to facilitate and
expedite outbreak-related
communications between government
agencies, industry, and consumers?
4. Are there mechanisms FDA could
employ to incentivize adoption of realtime, end-to-end food traceability
throughout the food sector?
5. What are the challenges to creating
a more digital, traceable global food
supply, and how might FDA approach
this in a manner that creates shared
value for all participants?
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B. To Fully Realize a Preventive
Controls System That Rapidly
Incorporates New Knowledge, We Must
Also Ask if We Can We Make Processes
and Communications More Effective,
Efficient, and in Some Cases, Simpler
1. What are the most significant
actions FDA could undertake to
promote and support the use of smarter
tools for prevention?
2. What predictive analytical tools
and data streams are best suited to
helping identify a potential
contamination event?
3. What further steps can be taken to
advance the safety of domestic and
foreign commodities that have been the
subject of frequent contamination
incidents?
4. In what ways can FDA support the
use of environmental assessments and
root cause analyses in industry
prevention efforts?
5. Are there changes that FDA can and
should make in the way in which it
conducts environmental assessments
and root cause analyses, and reports its
findings to industry, to better facilitate
their use in industry prevention efforts?
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C. Evolving Business Models Present
Food Safety Challenges as Well as Novel
Considerations Around Regulatory
Framework and Oversight at the
Federal, State, Territorial, and Local
Level
1. What are the most significant
actions FDA could undertake to help
ensure the safety of foods delivered
under a variety of new business models,
such as e-commerce?
2. What research is available or
should be conducted to understand the
potential health risks posed by foods
provided by new business models, such
as e-commerce?
3. Are there specific collaborations
between FDA and industry that would
help to ensure the safety of these foods?
4. What are the most significant
actions that FDA, state, territorial, and
local agencies, and industry could take
to change practices in the retail food
industry that present risks to public
health?
D. We Want To Do More To Use and
Leverage Proven Organizational Culture
and Behavioral Science Principles and
Techniques To Enhance Organizational
and Employee Compliance With Desired
Food Safety Practices and Behaviors
1. What are the most significant
actions FDA could undertake to foster
and support the development of food
safety cultures globally?
2. How can FDA encourage and
support companies in the development
of food safety cultures throughout the
supply chain?
3. What are the obstacles to creating
food safety cultures throughout the
supply chain?
4. Are there changes that FDA can and
should take in how it approaches food
safety to place further emphasis on
prevention?
Approximately two weeks before the
meeting, we will post the public
meeting agenda and additional meeting
materials on the internet at: https://
www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-anddietary-supplements. In addition to the
opportunity to comment at the public
meeting, there will be an opportunity
for interested stakeholders to submit
written comments following the
meeting.
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: https://www.fda.gov/food/
news-events-cfsan/workshops-meetingswebinars-food-and-dietary-supplements.
Please provide complete contact
information for each attendee, including
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name, title, affiliation, address, email,
and telephone.
Registration is free and based on
space availability. Persons interested in
attending this public meeting must
register by 11:59 p.m. Eastern Time on
October 11, 2019. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public meeting.
For questions about registering for the
meeting or to register by phone, please
contact Mark Gifford (see FOR FURTHER
INFORMATION CONTACT).
If you need special accommodations
due to a disability, please contact
Juanita Yates, (see FOR FURTHER
INFORMATION CONTACT) no later than
October 2, 2019.
Requests for Oral Presentations:
During online or telephone registration
you may indicate if you wish to present
during a public comment session or
participate in a specific session, and
which topic(s) you wish to address. We
will do our best to accommodate
requests to make public comments.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. Following the
close of registration, we will determine
the amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants. All
requests to make oral presentations
must be received by October 2, 2019. No
commercial or promotional material
will be permitted to be presented or
distributed at the public meeting.
Persons notified that they will be
presenters are encouraged to arrive at
the meeting room early and check in at
the on-site registration table. Actual
presentation times may vary based on
how the meeting progresses in real time.
Persons attending FDA’s meetings are
advised that FDA is not responsible for
providing access to electrical outlets.
Streaming Webcast of the public
meeting: This public meeting will also
be webcast. Webcast participants are
asked to preregister at https://
www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-anddietary-supplements.
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Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/food/
news-events-cfsan/workshops-meetingswebinars-food-and-dietary-supplements.
Dated: September 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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October 29, 2019, 05:00 p.m., Residence
Inn Bethesda to October 28, 2019, 08:00
a.m. to October 28, 2019, 05:00 p.m.,
Residence Inn Bethesda. The meeting is
closed to the public.
Dated: September 12, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–20120 Filed 9–17–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Notice of
Closed Meetings
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, ZRG1
DDR–Y 07 October 11, 2019, Cambria
Hotel Rockville, 1 Helen Heneghan
Way, Rockville, MD 20850 which was
published in the Federal Register on
September 10, 2019, 84–FR PG 47528.
The meeting notice is amended to
change the meeting time from 8:00 a.m.–
10:00 a.m. to 11:00 a.m.–1:00 p.m. The
location remains the same. The meeting
is closed to the public.
Dated: September 12, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–20119 Filed 9–17–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Child Health and Human Development
Special Emphasis Panel, Research
Infrastructure for Centers Conducting
Population Dynamics Science FY2019
(P2C), October 28, 2019, 08:00 a.m. to
October 29, 2019, 05:00 p.m., Residence
Inn Bethesda, which was published in
the Federal Register on February 28,
2019, 84 FR 6808.
The date for this meeting has changed
from October 28, 2019, 08:00 a.m. to
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Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Community-Level Health Promotion Study
Section.
Date: October 21–22, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Marriott Georgetown,
1221 22nd Street NW, Washington, DC
20037.
Contact Person: Ping Wu, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 3166, Bethesda, MD 20892, 301–
451–8428, wup4@csr.nih.gov.
Name of Committee: Interdisciplinary
Molecular Sciences and Training Integrated
Review Group; Cellular and Molecular
Technologies Study Section.
Date: October 22–23, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: American Inn of Bethesda, 8130
Wisconsin Ave., Bethesda, MD 20814.
Contact Person: Tatiana V. Cohen, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5213,
Bethesda, MD 20892, 301–455–2364,
tatiana.cohen@nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
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Arthritis, Connective Tissue and Skin Study
Section.
Date: October 22–23, 2019.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton BWI (Baltimore), 1100 Old
Elkridge Landing Road, Baltimore, MD
21090.
Contact Person: Robert Gersch, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20817, 301–867–5309, robert.gersch@nih.gov.
Name of Committee: Vascular and
Hematology Integrated Review Group;
Vascular Cell and Molecular Biology Study
Section.
Date: October 22–23, 2019.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street NW, Washington, DC 20037.
Contact Person: Larry Pinkus, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4132,
MSC 7802, Bethesda, MD 20892, (301) 435–
1214, pinkusl@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Imaging
Technology Development Study Section.
Date: October 22–23, 2019.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian
Center, Gaithersburg, MD 20878.
Contact Person: Yuanna Cheng, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 435–
1195, Chengy5@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Electrical Signaling, Ion Transport,
and Arrhythmias Study Section.
Date: October 22, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
North Bethesda, MD 20852.
Contact Person: Sara Ahlgren, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, RM 4136,
Bethesda, MD 20892, 301–435–0904,
sara.ahlgren@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Predoctoral Training in Advanced Data
Analytics for Behavioral and Social Sciences
Research.
Date: October 22, 2019.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
E:\FR\FM\18SEN1.SGM
18SEN1
]]>Agencies
[Federal Register Volume 84, Number 181 (Wednesday, September 18, 2019)]
[Notices]
[Pages 49111-49114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20229]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4187]
A New Era of Smarter Food Safety; Public Meeting, Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``A New Era of Smarter
Food Safety'' to get input from a broad cross-section of stakeholders
on a modern approach the Agency is taking to strengthen its protection
of the food supply. The purpose of this meeting is to foster a dialogue
with our domestic and international regulatory and public health
partners, industry, consumers, academia, and others. The input received
at this meeting, and in comments submitted to the docket, will be used
to shape an FDA Blueprint for a New Era of Smarter Food Safety. This
Blueprint will outline how this modern approach will address public
health challenges, ranging from being able to trace sources of
contaminated foods, to using new predictive analytics tools like
artificial intelligence to assess risks, and help prioritize the
Agency's work and resources.
DATES: The public meeting will be held on October 21, 2019, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on this
public meeting by November 20, 2019. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public meeting will be held at the Hilton Washington DC/
Rockville Hotel and Executive Meeting Center, 1750 Rockville Pike,
Rockville, MD 20852. For more information on the hotel see https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 20, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 20, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket
No.FDA-2019-N-4187 for ``A New Era of Smarter Food Safety.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked
[[Page 49112]]
as ``confidential'' will not be disclosed except in accordance with 21
CFR 10.20 and other applicable disclosure law. For more information
about FDA's posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
For questions about registering for the meeting or to register by
phone: Mark Gifford, SIDEM, 1775 Eye St. NW, Suite 1150, Washington, DC
20006, telephone: 240-393-4496, Fax: 202-495-2091, email:
[email protected].
For general questions about the meeting or for special
accommodations due to a disability: Juanita Yates, Center for Food
Safety and Applied Nutrition (HFS-009), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, telephone: 240-402-1731,
email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On April 30, 2019, FDA released a joint statement from Acting FDA
Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food
Policy and Response Frank Yiannas on the New Era of Smarter Food
Safety. (https://www.fda.gov/news-events/press-announcements/statement-acting-fda-commissioner-ned-sharpless-md-and-deputy-commissioner-frank-yiannas-steps-usher). This is a modern approach to food safety that
incorporates the use of new and emerging technologies, considers the
challenge of evolving business models, and works to support the
development of food safety cultures throughout the global supply chain.
The New Era of Smarter Food Safety will enhance the Agency's ongoing
efforts to implement the FDA Food Safety Modernization Act (FSMA) by
creating a more digital, traceable, and safer system to help protect
consumers from contaminated food.
FDA continues to build a modernized regulatory framework that can
help ensure the safety of the food supply, including innovations in
food ingredients and processes. At the same time, FDA will leverage the
use of new and emerging technologies to strengthen predictive
capabilities, support the implementation of preventive controls, and
speed outbreak response.
Today's technology-focused world has changed the way our society
operates, creating a highly complex and globally interconnected
landscape. The food system has evolved from a system that sources foods
from around the corner to a system that brings in foods from around the
world and travels an ever-changing ``last mile'' with the emergence of
direct-to-home delivery models. Technology and market forces have
redefined how foods go from farm to table as shown by the expansion of
e-commerce and the use of new technologies to track foods and their
storage conditions along the supply chain.
There will be significant innovation in the agriculture, food
production, and food distribution systems in the next 10 years, which
will continue to provide an even greater variety of food sources, food
ingredients, and delivery conveniences for American consumers. With
this ever-changing landscape, FDA must continue preparing to take
advantage of new opportunities and address potential risks.
Since FSMA was signed into law in 2011, FDA has proposed and
finalized critical regulations that have established science- and risk-
based standards for the production, importation, and transportation of
foods. FDA has also had great success leveraging technology to advance
food safety, especially in the use of new analytical tools like Whole
Genome Sequencing. However, a lot has changed since 2011.
When it comes to food traceability, many in the food system still
utilize a largely paper-based based system of taking one step forward
to identify where the food has gone and one step back to identify the
source. The use of new and evolving digital technologies envisioned in
the New Era of Smarter Food Safety will play a pivotal role in tracing
the origin of a contaminated food to its source in minutes, or even
seconds, instead of days or weeks. Access to information during an
outbreak about the origin of contaminated food will facilitate more
timely root cause analyses and enable FDA to prevent future
contamination incidents.
The Agency will look at technologies and approaches that include
those being used in society and business sectors all around us, such as
distributed ledgers, sensors, the Internet of Things, and artificial
intelligence. FDA will assess how these technologies could create a
more digital, transparent, and safe food system while also addressing
consumer demands for quick access to information about where their
foods come from, how they are produced, and if the food is the subject
of an ongoing recall.
As consumers are increasingly asking for food to be delivered to
their homes, there are new methods, packaging materials, temperature
control approaches, and delivery models in the e-commerce system. These
evolving business models present food safety challenges, as well as
novel considerations around regulatory framework and oversight at the
federal, state, territorial, and local level.
The New Era of Smarter Food Safety is about more than technology.
It is also about working within and outside of FDA to foster a food
safety culture that transcends borders between the public and private
sector, as well as geographic and commodity divides. The New Era of
Smarter Food Safety is also about enhancing existing processes to make
them more effective and efficient. FDA looks forward to participation
in this effort by food companies and technology firms of all sizes, as
well as state, territorial, local, and federal agencies and other
stakeholders.
II. Topics for Discussion at the Public Meeting
The public meeting will begin with a plenary session, followed by
breakout sessions that will discuss key topics relating to the New Era
of Smarter Food Safety. These topics will include technologies and data
streams that have the potential to greatly reduce the time it takes to
trace the origin of a contaminated food to its source and how we might
best use this information. We will talk about how we can use lessons
learned from outbreaks to better inform and enhance our prevention
efforts.
No matter how consumers get their food, whether they are ordering
online or at their favorite restaurant, they deserve to have confidence
in the safety of the food supply. We will talk about advancing the
safety of both new business models, such as e-commerce and home
delivery of foods, and traditional business models, such as retail food
establishments. Perhaps the most fundamental topic that we will address
is the need to support and strengthen food safety culture throughout
the supply chain from farms to facilities through retail, which is the
foundation of food safety management.
We encourage public comments and presentations at the public
meeting. In submitting comments, data, and
[[Page 49113]]
information to the docket, please identify available references for the
data and information, as well as the general category area and, if
appropriate, the specific question listed below. We are starting with
several focus areas: Traceability, smarter tools and approaches for
prevention, the challenges of new business models and retail food
safety, and support for the development of food safety cultures.
A. New and Evolving Digital Technologies Will Play a Pivotal Role in
Tracing the Origin of a Contaminated Food to Its Source in Minutes, or
Even Seconds, Instead of Days or Weeks
1. What are the most significant actions FDA could undertake to
enable industry to enhance traceability across the entire global food
supply chain?
2. How could FDA make it more likely that companies utilize new
technologies to enhance the traceability of their products?
3. What can FDA do to facilitate and expedite outbreak-related
communications between government agencies, industry, and consumers?
4. Are there mechanisms FDA could employ to incentivize adoption of
real-time, end-to-end food traceability throughout the food sector?
5. What are the challenges to creating a more digital, traceable
global food supply, and how might FDA approach this in a manner that
creates shared value for all participants?
B. To Fully Realize a Preventive Controls System That Rapidly
Incorporates New Knowledge, We Must Also Ask if We Can We Make
Processes and Communications More Effective, Efficient, and in Some
Cases, Simpler
1. What are the most significant actions FDA could undertake to
promote and support the use of smarter tools for prevention?
2. What predictive analytical tools and data streams are best
suited to helping identify a potential contamination event?
3. What further steps can be taken to advance the safety of
domestic and foreign commodities that have been the subject of frequent
contamination incidents?
4. In what ways can FDA support the use of environmental
assessments and root cause analyses in industry prevention efforts?
5. Are there changes that FDA can and should make in the way in
which it conducts environmental assessments and root cause analyses,
and reports its findings to industry, to better facilitate their use in
industry prevention efforts?
C. Evolving Business Models Present Food Safety Challenges as Well as
Novel Considerations Around Regulatory Framework and Oversight at the
Federal, State, Territorial, and Local Level
1. What are the most significant actions FDA could undertake to
help ensure the safety of foods delivered under a variety of new
business models, such as e-commerce?
2. What research is available or should be conducted to understand
the potential health risks posed by foods provided by new business
models, such as e-commerce?
3. Are there specific collaborations between FDA and industry that
would help to ensure the safety of these foods?
4. What are the most significant actions that FDA, state,
territorial, and local agencies, and industry could take to change
practices in the retail food industry that present risks to public
health?
D. We Want To Do More To Use and Leverage Proven Organizational Culture
and Behavioral Science Principles and Techniques To Enhance
Organizational and Employee Compliance With Desired Food Safety
Practices and Behaviors
1. What are the most significant actions FDA could undertake to
foster and support the development of food safety cultures globally?
2. How can FDA encourage and support companies in the development
of food safety cultures throughout the supply chain?
3. What are the obstacles to creating food safety cultures
throughout the supply chain?
4. Are there changes that FDA can and should take in how it
approaches food safety to place further emphasis on prevention?
Approximately two weeks before the meeting, we will post the public
meeting agenda and additional meeting materials on the internet at:
https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements. In addition to the opportunity to comment
at the public meeting, there will be an opportunity for interested
stakeholders to submit written comments following the meeting.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
Registration is free and based on space availability. Persons
interested in attending this public meeting must register by 11:59 p.m.
Eastern Time on October 11, 2019. Early registration is recommended
because seating is limited; therefore, FDA may limit the number of
participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting will be provided
beginning at 8 a.m. We will let registrants know if registration closes
before the day of the public meeting.
For questions about registering for the meeting or to register by
phone, please contact Mark Gifford (see FOR FURTHER INFORMATION
CONTACT).
If you need special accommodations due to a disability, please
contact Juanita Yates, (see FOR FURTHER INFORMATION CONTACT) no later
than October 2, 2019.
Requests for Oral Presentations: During online or telephone
registration you may indicate if you wish to present during a public
comment session or participate in a specific session, and which
topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation, or submit
requests for designated representatives to participate in the focused
sessions. Following the close of registration, we will determine the
amount of time allotted to each presenter and the approximate time each
oral presentation is to begin, and will select and notify participants.
All requests to make oral presentations must be received by October 2,
2019. No commercial or promotional material will be permitted to be
presented or distributed at the public meeting. Persons notified that
they will be presenters are encouraged to arrive at the meeting room
early and check in at the on-site registration table. Actual
presentation times may vary based on how the meeting progresses in real
time.
Persons attending FDA's meetings are advised that FDA is not
responsible for providing access to electrical outlets.
Streaming Webcast of the public meeting: This public meeting will
also be webcast. Webcast participants are asked to preregister at
https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
[[Page 49114]]
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
Dated: September 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20229 Filed 9-17-19; 8:45 am]
BILLING CODE 4164-01-P
