Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Public Meetings; Request for Comments, 54888-54891 [2018-23868]
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Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules
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Congress intended to preclude: the
adoption of standards that would
achieve higher efficiency by eliminating
currently available ‘‘performance
characteristics’’ (including ‘‘features’’)
that are important to many purchasers.
Conclusion
DOE’s rulemaking proceedings
concerning standards for residential
furnaces and commercial water heaters
have been fatally undermined by their
failure to recognize that EPCA precludes
the adoption of standards that would
effectively eliminate fuel gas products
that do not use condensing combustion
technology. Petitioners believe that
prompt action to correct that failure is
both warranted and necessary to
facilitate any reasonably efficient path
forward in those rulemaking
proceedings. Accordingly, Petitioners
respectfully request that DOE—after
soliciting and appropriately considering
public comment on this Petition—
promptly take final action by:
• Issuing an interpretive rule
confirming that energy conservation
standards limiting the market for
natural gas and/or propane gas
furnaces or water heaters to products
using condensing combustion
technology would result in the
unavailability of ‘‘performance
characteristics’’ within the meaning of
42 U.S.C. §§ 6295(0)(4) and
6313(a)(6)(B)(iii)(II), and
• Withdrawing its proposed standards
for residential furnaces and
commercial water heaters on the
grounds of appropriate written
findings as specified by 42 U.S.C.
§§ 6295(0)(4) and 6313(a)(6)(B)(iii)(II),
respectively.
Further deliberation in the two
pending rulemaking proceedings can
then occur, with appropriate
consideration—as EPCA requires—of
any need for separate standards (and
separate product classes) for products
that use condensing combustion
technology and those that do not.26
Respectfully submitted,
Mark Darrell,
Senior VP, General Counsel & Chief
Compliance Officer,
Spire Inc., 700 Market Street, St. Louis,
MO 63101
Email: mark.darrell@spireenergy.com.
Dena E. Wiggins,
President and CEO, Natural Gas Supply
Association, 1620 Eye St NW, Suite 700,
Washington, D.C. 20006, 202.326.9300
E-mail: dena.wiggins@ngsa.org.
Mike Caldarera,
Vice President, Regulatory & Technical
Services, National Propane Gas
26 See
42 U.S.C. § 6295(q)(1).
VerDate Sep<11>2014
20:21 Oct 31, 2018
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Association, 1899 L Street, NW, Ste 350,
Washington, D.C. 20036, (202) 466–7200
Email: mcaldarera@npga.org.
Bert Kalisch,
President & CEO, American Public Gas
Association, 201 Massachusetts Avenue,
NE, Suite C–4, Washington, DC 20002,
202.464.2742
Email: bkalisch@apga.org.
Mike Murray,
General Counsel, American Gas
Association, 400 North Capitol Street
NW, Suite 450, Washington, DC 20001,
202.824.7000
Email: mmurray@aga.org.
[FR Doc. 2018–23885 Filed 10X–31–18; 8:45 am]
BILLING CODE 6450–01–P
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.
Notification of public meetings;
request for comments.
ACTION:
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.
SUMMARY:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
ADDRESSES:
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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
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Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules
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/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
meetings or to register by phone:
Melissa Schroeder, SIDEM, 1775 Eye St.
NW, Suite 1150, Washington, DC 20006,
240–393–2901, EventSupport@
Sidemgroup.com.
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
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Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1731,
Juanita.Yates@fda.hhs.gov.
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 sciencebased 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/
GuidanceDocumentsRegulatory
Information/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
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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54889
support the public’s evaluation and
commenting process.
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).
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.
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.
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.
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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TABLE 1—INFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PRODUCE
SAFETY RULE DRAFT GUIDANCE DOCKET
Activity
Date
Electronic address
First public meeting
November 27,
2018; 8:30 a.m.–
5 p.m.
November 27,
2018; 8:30 a.m.–
5 p.m.
..............................................................
Hilton Portland Downtown, 921 SW
Sixth Ave., Portland, OR 97204.
Individuals who wish to participate by
webcast are asked to preregister at
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetings
Conferences/default.htm.
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
..............................................................
The webcast will have closed captioning.
We encourage you to use electronic
registration if possible 1.
There is no registration fee for the
public meetings. Early registration is
recommended because seating is
limited.1
View webcast .........
Advance registration.
by November 16,
2018.
Request to make
an oral presentation.
by November 9,
2018.
Submitting either
electronic or written comments.
Submit comments
https://www.regulations.gov .................
by April 22, 2019.
Request special ac- by November 9,
commodations
2018.
due to a disability.
Second Public
November 29,
Meeting.
2018; 8:30 a.m.–
5 p.m..
View webcast ......... November 29,
2018; 8:30 a.m.–
5 p.m.
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
..............................................................
..............................................................
Individuals who wish to participate by
webcast are asked to preregister at
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetings
Conferences/default.htm.
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
Advance registration.
by November 16,
2018.
Request to make
an oral presentation.
by November 9,
2018.
Submitting either
electronic or written comments.
Submit comments
https://www.regulations.gov .................
by April 22, 2019.
Request special ac- by November 9,
commodations
2018.
due to a disability.
Third Public MeetDecember 11,
ing.
2018; 8:30 a.m.–
5 p.m.
View webcast ......... December 11,
2018; 8:30 a.m.–
5 p.m.
amozie on DSK3GDR082PROD with PROPOSALS1
Address
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
..............................................................
We encourage you to use electronic
registration if possible 1.
Requests to make oral presentations
must be made in advance to https://
www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
See FOR FURTHER INFORMATION
CONTACT.
The webcast will have closed captioning.
There is no registration fee for the
public meetings. Early registration is
recommended because seating is
limited.1
See ADDRESSES for information on
submitting comments.
Individuals who wish to participate by
webcast are asked to preregister at
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetings
Conferences/default.htm.
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
..............................................................
The webcast will have closed captioning.
We encourage you to use electronic
registration if possible 1.
There is no registration fee for the
public meetings. Early registration is
recommended because seating is
limited.1
Request to make
an oral presentation.
by November 16,
2018.
Submitting either
electronic or written comments.
Submit comments
https://www.regulations.gov .................
by April 22, 2019.
20:21 Oct 31, 2018
DoubleTree Suites by Hilton Anaheim
Resort-Convention Center, 2085 S
Harbor Blvd., Anaheim, CA 92802.
..............................................................
See ADDRESSES for information on
submitting comments.
Hilton Albany, 40 Lodge St., Albany,
NY 12207.
by November 23,
2018.
VerDate Sep<11>2014
Requests to make oral presentations
must be made in advance to https://
www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
See FOR FURTHER INFORMATION
CONTACT.
..............................................................
Advance registration.
Request special ac- by November 16,
commodations
2018.
due to a disability.
Fourth Public Meet- December 13,
ing.
2018; 8:30 a.m.–
5 p.m.
Other information
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
..............................................................
..............................................................
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Requests to make oral presentations
must be made in advance to https://
www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
See FOR FURTHER INFORMATION
CONTACT.
See ADDRESSES for information on
submitting comments.
Embassy Suites Atlanta at Centennial
Olympic Park, 267 Marietta St., Atlanta, GA 30313.
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54891
TABLE 1—INFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PRODUCE
SAFETY RULE DRAFT GUIDANCE DOCKET—Continued
Activity
Date
Electronic address
Address
View webcast .........
December 13,
2018; 8:30 a.m.–
5 p.m.
..............................................................
The webcast will have closed captioning.
Advance registration.
by November 23,
2018.
Individuals who wish to participate by
webcast are asked to preregister at
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetings
Conferences/default.htm.
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
We encourage you to use electronic
registration if possible 1.
There is no registration fee for the
public meetings. Early registration is
recommended because seating is
limited.1
Request to make
an oral presentation.
by November 16,
2018.
Submitting either
electronic or written comments.
Submit comments
https://www.regulations.gov .................
by April 22, 2019.
Request special ac- by November 16,
commodations
2018.
due to a disability.
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
..............................................................
Other information
Requests to make oral presentations
must be made in advance to https://
www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
See FOR FURTHER INFORMATION
CONTACT.
See ADDRESSES for information on
submitting comments.
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, EventSupport@
Sidemgroup.com. 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
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 179
[Docket No. FDA–2018–F–3932]
Bonamar Corp.; Filing of Food Additive
Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of petition.
The Food and Drug
Administration (FDA or we) is
announcing that we have filed a
petition, submitted by Bonamar Corp.,
proposing that we amend our food
additive regulations to provide for the
safe use of sources of ionizing radiation
to control food-borne pathogens in
finfish and flatfish.
DATES: The food additive petition was
filed on September 27, 2018.
amozie on DSK3GDR082PROD with PROPOSALS1
SUMMARY:
VerDate Sep<11>2014
20:21 Oct 31, 2018
For access to the docket to
read background documents or
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:
Molly A. Harry, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1075.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(section 409(b)(5) (21 U.S.C. 348(b)(5))),
we are giving notice that we have filed
a food additive petition (FAP 8M4822),
submitted by Bonamar Corp., c/o Robert
P. Smith, Department of Biological
Sciences, Nova Southeastern University,
3301 College Ave., Fort Lauderdale, FL
33314. The petition proposes to amend
the food additive regulations in § 179.26
(21 CFR 179.26) Ionizing radiation for
the treatment of food to provide for the
safe use of sources of ionizing radiation
to control food-borne pathogens in: (1)
Chilled or frozen raw finfish and
flatfish; and (2) frozen, raw vacuumpacked finfish and flatfish.
The petitioner has claimed that this
action is categorically excluded from the
need to prepare an environmental
assessment or an environmental impact
statement under 21 CFR 25.32(j),
because the petition requests approval
for a source of irradiation which is a
piece of permanent equipment intended
ADDRESSES:
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).
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for repeated use. In addition, the
petitioner has stated that, to the
petitioner’s knowledge, no
extraordinary circumstances exist. If
FDA determines a categorical exclusion
applies, neither an environmental
assessment nor an environmental
impact statement is required. If FDA
determines a categorical exclusion does
not apply, we will request an
environmental assessment and make it
available for public inspection.
Dated: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23946 Filed 10–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 807, 1002, 1010, and 1040
[Docket Nos. FDA–2011–N–0070 and FDA–
2016–N–2491]
RIN 0910–AG79 and 0910–AF87
Withdrawal of the Laser Products;
Proposed Amendment to Performance
Standard and the Electronic
Submission of Labeling for Certain
Home-Use Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule; withdrawal.
The Food and Drug
Administration (FDA, Agency, we) is
SUMMARY:
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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)).
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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
