[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
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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