[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Proposed Rules]
[Pages 62632-62634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21935]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0053]


Requirements for Additional Traceability Records for Certain 
Foods; Proposed Rule; Public Meetings; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing three virtual public meetings entitled ``Requirements for 
Additional Traceability Records for Certain Foods; Proposed Rule.'' The 
purpose of the public meetings is to discuss the proposed rule entitled 
``Requirements for Additional Traceability Records for Certain Foods,'' 
which was issued under the FDA Food Safety Modernization Act (FSMA). 
These public meetings are intended to facilitate and support the 
public's evaluation and commenting process on the proposed rule.

DATES: The public meetings will be held on November 6, 2020, from 8:30 
a.m. Eastern Time to 3:30 p.m. Eastern Time; November 18, 2020 from 
9:30 a.m. Eastern Time to 4:30 p.m. Eastern Time; and December 2, 2020 
from 11:30 a.m. Eastern Time to 6:30 p.m. Eastern Time. Submit either 
electronic or written comments on the notice by January 21, 2021. See 
``How to Participate in the Public Meetings'' in the SUPPLEMENTARY 
INFORMATION section of this document for closing dates for advanced 
registration and other information regarding meeting participation.

ADDRESSES: Due to the impact of the COVID-19 pandemic, these meetings 
will be held virtually to help protect the public and limit the spread 
of the virus.
    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 January 21, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 21, 2021. 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

[[Page 62633]]

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-2014-N-0053 for ``Requirements for Additional Traceability Records 
for Certain Foods.'' 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, 240-402-7500.
     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 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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: For general questions about the public 
meetings 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, 240-402-
1731, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FSMA (Pub. L. 111-353), enacted in 2011, modernized U.S. food 
safety law to better ensure the safety and security of the nation's 
food supply. Section 204(d) of FSMA requires that FDA establish 
recordkeeping requirements for facilities that manufacture, process, 
pack, or hold foods that the Agency designates as high risk, to 
facilitate the rapid and effective traceability of such foods. These 
recordkeeping requirements will be in addition to the food traceability 
requirements under section 414 of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 350c) (added to the FD&C Act in title III, 
subtitle A, section 306, of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (Pub. L. 107-188)) and the 
implementing regulations in subpart J of part 1 of title 21 of the Code 
of Federal Regulations (21 CFR 1.326 to 1.368) (the subpart J 
regulations). Congress directed FDA to adopt the subpart J regulations 
recordkeeping requirements to allow the Agency to identify the 
immediate previous sources and immediate subsequent recipients of foods 
(commonly referred to as ``one-up, one-back'' recordkeeping) to address 
credible threats of serious adverse health consequences or death to 
humans or animals. In section 204(d)(1) of FSMA, Congress directed FDA 
to adopt additional recordkeeping requirements to prevent or mitigate 
foodborne illness outbreaks and address credible threats of serious 
adverse health consequences or death to humans or animals resulting 
from foods being adulterated under section 402 of the FD&C Act (21 
U.S.C. 342) or misbranded with respect to allergen labeling under 
section 403(w) of the FD&C Act (21 U.S.C. 343(w)).
    In the Federal Register of September 23, 2020 (85 FR 59984), FDA 
published the proposed rule entitled ``Requirements for Additional 
Traceability Records for Certain Foods''. The proposed additional 
recordkeeping requirements, when finalized, will fulfill Congress's 
directive in section 204(d)(1) of FSMA and will help FDA follow the 
movement of listed food products and ingredients both backward and 
forward throughout the supply chain.
    Section 204(d)(4) of FSMA states that, during the comment period 
for the proposed rule, FDA ``shall conduct not less than 3 public 
meetings in diverse geographical areas of the United States to provide 
persons in different regions an opportunity to comment.'' Due to the 
impact of the COVID-19 pandemic, these meetings will be held virtually 
to help protect the public and limit the spread of the virus.
    FDA is therefore announcing a series of virtual public meetings 
entitled ``Requirements for Additional Traceability Records for Certain 
Foods; Proposed Rule'' so that stakeholders can better evaluate and 
comment on the proposed rule. These meetings will be held during the 
formal comment period on the proposed rule. All three public meetings 
will cover the same agenda items and are intended to facilitate and 
support the public's evaluation and commenting process.
    While oral presentations from specific individuals and 
organizations will be necessarily limited due to time constraints 
during the public meetings, stakeholders may submit electronic or 
written comments discussing any issues of concern to the administrative 
record (the docket) for the proposed rule (Docket No. FDA-2014-N-0053). 
(See ADDRESSES).

II. Purpose and Format of the Public Meetings

    The purpose of the public meetings is to provide information and 
facilitate comment so that stakeholders can better evaluate and provide 
input on the proposed rule. We invite interested parties to provide 
information and offer comments related to the proposed rule. During the 
public meetings we will present information on the various sections of 
the proposed rule: General Provisions; Traceability Program Records; 
Records of Growing, Receiving, Transforming, Creating, and Shipping 
Food; Special Requirements for Certain Persons and Foods; Procedures 
for Modified Requirements and Exemptions; Waivers; Records Maintenance 
and Availability; and Updating the Food Traceability List. Stakeholder 
panels will provide discussion on the various issues. There will be an 
opportunity for questions, as well as an opportunity for open public 
comment.

III. How To Participate in the Public Meetings

    There will be a total of three virtual public meetings with 
different time frames, which will provide persons in different regions 
an opportunity to comment on the proposed rule.
    Table 1 provides information on participation in the public 
meetings.

[[Page 62634]]



 Table 1--Information on Participating in the Public Meetings and on Submitting Comments to the Proposed Rule on
                    Requirements for Additional Traceability Records for Certain Foods Docket
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             Activity                        Date              Electronic address          Other information
----------------------------------------------------------------------------------------------------------------
First public meeting..............  November 6, 2020;      Webcast information will    Webcast will have closed
                                     8:30 a.m.-3:30 p.m.    be sent upon completion     captioning.
                                     EST.                   of registration.
Advance registration..............  by October 28, 2020..  https://www.fda.gov/food/   There is no registration
                                                            news-events-cfsan/          fee for the public
                                                            workshops-meetings-         meetings. Early
                                                            webinars-food-and-dietary-  registration is
                                                            supplements.                recommended.
Request to make oral presentation.  by October 9, 2020...  https://www.fda.gov/food/   .........................
                                                            news-events-cfsan/
                                                            workshops-meetings-
                                                            webinars-food-and-dietary-
                                                            supplements.
Notice confirming opportunity to    by October 16, 2020..  ..........................  An Agency representative
 make oral presentation.                                                                will confirm the
                                                                                        opportunity to make an
                                                                                        oral presentation and
                                                                                        will provide the
                                                                                        approximate time on the
                                                                                        public meeting agenda to
                                                                                        do so.
Submitting either electronic or     Submit comments by     https://                    See ADDRESSES for
 written comments.                   January 21, 2021.      www.regulations.gov.        additional information
                                                                                        on submitting comments.
Second public meeting.............  November 18, 2020;     Webcast information will    Webcast will have closed
                                     9:30 a.m.-4:30 p.m.    be sent upon completion     captioning.
                                     EST.                   of registration.
Advance registration..............  by November 6, 2020..  https://www.fda.gov/food/   There is no registration
                                                            news-events-cfsan/          fee for the public
                                                            workshops-meetings-         meetings. Early
                                                            webinars-food-and-dietary-  registration is
                                                            supplements.                recommended.
Request to make oral presentation.  by October 16, 2020..  https://www.fda.gov/food/   .........................
                                                            news-events-cfsan/
                                                            workshops-meetings-
                                                            webinars-food-and-dietary-
                                                            supplements.
Notice confirming opportunity to    by October 23, 2020..  ..........................  An Agency representative
 make oral presentation.                                                                will confirm the
                                                                                        opportunity to make an
                                                                                        oral presentation and
                                                                                        will provide the
                                                                                        approximate time on the
                                                                                        public meeting agenda to
                                                                                        do so.
Submitting either electronic or     Submit comments by     https://                    See ADDRESSES for
 written comments.                   January 21, 2021.      www.regulations.gov.        additional information
                                                                                        on submitting comments.
Third public meeting..............  December 2, 2020;      Webcast information will    Webcast will have closed
                                     11:30 a.m.-6:30 p.m.   be sent upon completion     captioning.
                                     EST.                   of registration.
Advance registration..............  by November 18, 2020.  https://www.fda.gov/food/   There is no registration
                                                            news-events-cfsan/          fee for the public
                                                            workshops-meetings-         meetings. Early
                                                            webinars-food-and-dietary-  registration is
                                                            supplements.                recommended.
Request to make oral presentation.  by October 26, 2020..  https://www.fda.gov/food/   .........................
                                                            news-events-cfsan/
                                                            workshops-meetings-
                                                            webinars-food-and-dietary-
                                                            supplements.
Notice confirming opportunity to    by November 9, 2020..  ..........................  An Agency representative
 make oral presentation.                                                                will confirm the
                                                                                        opportunity to make an
                                                                                        oral presentation and
                                                                                        will provide the
                                                                                        approximate time on the
                                                                                        public meeting agenda to
                                                                                        do so.
Submitting either electronic or     Submit comments by     https://                    See ADDRESSES for
 written comments.                   January 21, 2021.      www.regulations.gov.        additional information
                                                                                        on submitting comments.
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IV. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at: https://www.regulations.gov. You may also view 
the transcript at the Dockets Management Staff (see ADDRESSES).

    Dated: September 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21935 Filed 10-2-20; 8:45 am]
BILLING CODE 4164-01-P