[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: 
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:

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


