[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Proposed Rules]
[Pages 54888-54891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2018-D-3631]


Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption; Draft Guidance for Industry; Public 
Meetings; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing four public meetings to discuss ``Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption; 
Draft Guidance for Industry.'' The purpose of the public meetings is to 
discuss the draft guidance for compliance and implementation of the 
``Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption'' rule, which was issued under the FDA 
Food Safety Modernization Act.

DATES: Submit either electronic or written comments on the notice by 
April 22, 2019. See ``How to Participate in the Public Meetings'' in 
the SUPPLEMENTARY INFORMATION section of this document for dates and 
times of the public meetings, closing dates for advance registration, 
requesting special accommodations due to disability, and other 
information regarding meeting participation.

ADDRESSES: 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 April 22, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 22, 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-2018-D-3631 for ``Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption; Draft Guidance for 
Industry.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket

[[Page 54889]]

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 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 meetings or to register by 
phone: Melissa Schroeder, SIDEM, 1775 Eye St. NW, Suite 1150, 
Washington, DC 20006, 240-393-2901, [email protected].
    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

    ``The Standards for the Growing, Harvesting, Packing, and Holding 
of Produce for Human Consumption'' rule (the produce safety rule, 
published in the Federal Register of November 27, 2015 (80 FR 74354) 
(https://www.fda.gov/fsma)) establishes science-based minimum standards 
for the safe growing, harvesting, packing, and holding of fruits and 
vegetables grown for human consumption. The rule is part of the 
Agency's ongoing efforts to implement the FDA Food Safety Modernization 
Act (FSMA; Pub. L. 111-353). FSMA also requires FDA to issue guidance 
for the safe production and harvesting of fresh produce (section 
419(e)(1) of the FD&C Act (21 U.S.C. 350h(e)(1))) and to also conduct 
at least three public meetings in diverse geographical areas of the 
United States as part of an effort to conduct education and outreach 
regarding the guidance for interested stakeholders (section 419(e)(2) 
of the FD&C Act).
    In the Federal Register of October 22, 2018 (83 FR 53196), we 
announced the availability of the ``Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption; 
Draft Guidance for Industry'' (https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM623178.pdf). The draft guidance provides information on and 
recommendations for compliance with the requirements of the produce 
safety rule, which produce and farms are covered by the rule, and 
whether certain produce or farms may be eligible for exemptions.
    FDA is announcing a series of public meetings entitled ``Standards 
for the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption; Draft Guidance for Industry'' so that stakeholders can 
better evaluate and comment on the draft guidance. These meetings will 
be held during the formal comment period on the draft guidance.\1\ All 
four public meetings will cover the same agenda items and are intended 
to facilitate and support the public's evaluation and commenting 
process.
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    \1\ Under FDA's Good Guidance Practices regulation, anyone may 
comment on an FDA guidance document at any time (see 21 CFR 
10.115(g)(5)).
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    While oral presentations \2\ 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 draft guidance (Docket No. FDA-2018-D-
3631).
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    \2\ Requests to make oral presentations must be made in advance. 
Please see table 1 for deadlines to request making an oral 
presentation for each meeting.
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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 draft guidance. We invite interested parties to provide 
information and offer comments related to the produce safety rule draft 
guidance. During the public meetings we will present information on the 
various chapters of the draft guidance: General provisions; personnel 
qualifications and training; health and hygiene; biological soil 
amendments of animal origin; domesticated and wild animals; growing, 
harvesting, packing, and holding activities on a farm; equipment, 
tools, buildings, and sanitation; records; and variances.\3\ 
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.
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    \3\ We have proposed to extend the compliance dates related to 
the requirements of subpart E of the produce safety rule, which 
addresses agricultural water, and have provided enforcement 
discretion until the finalization of that rulemaking (82 FR 42963, 
42965; September 13, 2017). Accordingly, the draft guidance does not 
contain any recommendations related to subpart E, and agricultural 
water is not on the agenda for these public meetings. Also not on 
the agenda for these public meetings is the draft guidance issued in 
January 2017 entitled ``Compliance with and Recommendations for 
Implementation of the Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption for Sprout 
Operations.''
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III. How To Participate in the Public Meetings

    There will be a total of four public meetings held in diverse 
geographical areas of the United States to provide persons in different 
regions an opportunity to comment on the draft guidance.
    Table 1 provides information on participation in the public 
meetings.

[[Page 54890]]



  Table 1--Information on Participating in the Public Meetings and on Submitting Comments to the Produce Safety
                                           Rule Draft Guidance Docket
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            Activity                     Date         Electronic address        Address        Other information
----------------------------------------------------------------------------------------------------------------
First public meeting............  November 27, 2018;  ..................  Hilton Portland
                                   8:30 a.m.-5 p.m.                        Downtown, 921 SW
                                                                           Sixth Ave.,
                                                                           Portland, OR
                                                                           97204.
View webcast....................  November 27, 2018;  Individuals who     ..................  The webcast will
                                   8:30 a.m.-5 p.m.    wish to                                 have closed
                                                       participate by                          captioning.
                                                       webcast are asked
                                                       to preregister at
                                                       https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Advance registration............  by November 16,     https://            We encourage you    There is no
                                   2018.               www.fda.gov/Food/   to use electronic   registration fee
                                                       NewsEvents/         registration if     for the public
                                                       WorkshopsMeetings   possible \1\.       meetings. Early
                                                       Conferences/                            registration is
                                                       default.htm.                            recommended
                                                                                               because seating
                                                                                               is limited.\1\
Request to make an oral           by November 9,      https://            Requests to make
 presentation.                     2018.               www.fda.gov/Food/   oral
                                                       NewsEvents/         presentations
                                                       WorkshopsMeetings   must be made in
                                                       Conferences/        advance to https:/
                                                       default.htm.        /www.fda.gov/Food/
                                                                           NewsEvents/
                                                                           WorkshopsMeetings
                                                                           Conferences/
                                                                           default.htm.
Submitting either electronic or   Submit comments by  https://            Dockets Management  See ADDRESSES for
 written comments.                 April 22, 2019.     www.regulations.g   Staff (HFA-305),    information on
                                                       ov.                 Food and Drug       submitting
                                                                           Administration,     comments.
                                                                           5630 Fishers
                                                                           Lane, Rm. 1061,
                                                                           Rockville, MD
                                                                           20852.
Request special accommodations    by November 9,      ..................  See FOR FURTHER
 due to a disability.              2018.                                   INFORMATION
                                                                           CONTACT.
Second Public Meeting...........  November 29, 2018;  ..................  DoubleTree Suites
                                   8:30 a.m.-5 p.m..                       by Hilton Anaheim
                                                                           Resort-Convention
                                                                           Center, 2085 S
                                                                           Harbor Blvd.,
                                                                           Anaheim, CA 92802.
View webcast....................  November 29, 2018;  Individuals who     ..................  The webcast will
                                   8:30 a.m.-5 p.m.    wish to                                 have closed
                                                       participate by                          captioning.
                                                       webcast are asked
                                                       to preregister at
                                                       https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Advance registration............  by November 16,     https://            We encourage you    There is no
                                   2018.               www.fda.gov/Food/   to use electronic   registration fee
                                                       NewsEvents/         registration if     for the public
                                                       WorkshopsMeetings   possible \1\.       meetings. Early
                                                       Conferences/                            registration is
                                                       default.htm.                            recommended
                                                                                               because seating
                                                                                               is limited.\1\
Request to make an oral           by November 9,      https://            Requests to make
 presentation.                     2018.               www.fda.gov/Food/   oral
                                                       NewsEvents/         presentations
                                                       WorkshopsMeetings   must be made in
                                                       Conferences/        advance to https:/
                                                       default.htm.        /www.fda.gov/Food/
                                                                           NewsEvents/
                                                                           WorkshopsMeetings
                                                                           Conferences/
                                                                           default.htm.
Submitting either electronic or   Submit comments by  https://            Dockets Management  See ADDRESSES for
 written comments.                 April 22, 2019.     www.regulations.g   Staff (HFA-305),    information on
                                                       ov.                 Food and Drug       submitting
                                                                           Administration,     comments.
                                                                           5630 Fishers
                                                                           Lane, Rm. 1061,
                                                                           Rockville, MD
                                                                           20852.
Request special accommodations    by November 9,      ..................  See FOR FURTHER
 due to a disability.              2018.                                   INFORMATION
                                                                           CONTACT.
Third Public Meeting............  December 11, 2018;  ..................  Hilton Albany, 40
                                   8:30 a.m.-5 p.m.                        Lodge St.,
                                                                           Albany, NY 12207.
View webcast....................  December 11, 2018;  Individuals who     ..................  The webcast will
                                   8:30 a.m.-5 p.m.    wish to                                 have closed
                                                       participate by                          captioning.
                                                       webcast are asked
                                                       to preregister at
                                                       https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Advance registration............  by November 23,     https://            We encourage you    There is no
                                   2018.               www.fda.gov/Food/   to use electronic   registration fee
                                                       NewsEvents/         registration if     for the public
                                                       WorkshopsMeetings   possible \1\.       meetings. Early
                                                       Conferences/                            registration is
                                                       default.htm.                            recommended
                                                                                               because seating
                                                                                               is limited.\1\
Request to make an oral           by November 16,     https://            Requests to make
 presentation.                     2018.               www.fda.gov/Food/   oral
                                                       NewsEvents/         presentations
                                                       WorkshopsMeetings   must be made in
                                                       Conferences/        advance to https:/
                                                       default.htm.        /www.fda.gov/Food/
                                                                           NewsEvents/
                                                                           WorkshopsMeetings
                                                                           Conferences/
                                                                           default.htm.
Submitting either electronic or   Submit comments by  https://            Dockets Management  See ADDRESSES for
 written comments.                 April 22, 2019.     www.regulations.g   Staff (HFA-305),    information on
                                                       ov.                 Food and Drug       submitting
                                                                           Administration,     comments.
                                                                           5630 Fishers
                                                                           Lane, Rm. 1061,
                                                                           Rockville, MD
                                                                           20852.
Request special accommodations    by November 16,     ..................  See FOR FURTHER
 due to a disability.              2018.                                   INFORMATION
                                                                           CONTACT.
Fourth Public Meeting...........  December 13, 2018;  ..................  Embassy Suites
                                   8:30 a.m.-5 p.m.                        Atlanta at
                                                                           Centennial
                                                                           Olympic Park, 267
                                                                           Marietta St.,
                                                                           Atlanta, GA 30313.

[[Page 54891]]

 
View webcast....................  December 13, 2018;  Individuals who     ..................  The webcast will
                                   8:30 a.m.-5 p.m.    wish to                                 have closed
                                                       participate by                          captioning.
                                                       webcast are asked
                                                       to preregister at
                                                       https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Advance registration............  by November 23,     https://            We encourage you    There is no
                                   2018.               www.fda.gov/Food/   to use electronic   registration fee
                                                       NewsEvents/         registration if     for the public
                                                       WorkshopsMeetings   possible \1\.       meetings. Early
                                                       Conferences/                            registration is
                                                       default.htm.                            recommended
                                                                                               because seating
                                                                                               is limited.\1\
Request to make an oral           by November 16,     https://            Requests to make
 presentation.                     2018.               www.fda.gov/Food/   oral
                                                       NewsEvents/         presentations
                                                       WorkshopsMeetings   must be made in
                                                       Conferences/        advance to https:/
                                                       default.htm.        /www.fda.gov/Food/
                                                                           NewsEvents/
                                                                           WorkshopsMeetings
                                                                           Conferences/
                                                                           default.htm.
Submitting either electronic or   Submit comments by  https://            Dockets Management  See ADDRESSES for
 written comments.                 April 22, 2019.     www.regulations.g   Staff (HFA-305),    information on
                                                       ov.                 Food and Drug       submitting
                                                                           Administration,     comments.
                                                                           5630 Fishers
                                                                           Lane, Rm. 1061,
                                                                           Rockville, MD
                                                                           20852.
Request special accommodations    by November 16,     ..................  See FOR FURTHER
 due to a disability.              2018.                                   INFORMATION
                                                                           CONTACT.
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\1\ You may also register via email, mail, or Fax. Please include your name, title, firm name, address, and
  phone and Fax numbers in your registration information and send to: Melissa Schroeder, SIDEM, 1775 Eye St. NW,
  Suite 1150, Washington, DC 20006, 240-393-4496, Fax: 202-495-2901, [email protected]. Onsite
  registration will be available at all four meetings, however, please note that if we have reached capacity, we
  will not be able to accommodate those who have not pre-registered.

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: October 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23868 Filed 10-31-18; 8:45 am]
 BILLING CODE 4164-01-P


