[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Proposed Rules]
[Pages 6762-6764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02089]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, 106, 110, 112, 114, 117, 120, 123, 129, 179,
and 211
[Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921]
Food and Drug Administration Food Safety Modernization Act:
Proposed Rules To Establish Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption and for Current
Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Human Food; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss the proposed rules to establish standards for the
growing, harvesting, packing, and holding of produce for human
consumption (the produce safety proposed rule) and for current good
manufacturing practice and hazard analysis and risk-based preventive
controls for human food (the preventive controls proposed rule), which
are the first of several proposed rules that would establish the
foundation of, and central framework for, the modern food safety system
envisioned by Congress in the FDA Food Safety Modernization Act (FSMA).
The purpose of the public meeting is to solicit oral stakeholder and
public comments on the proposed rules and to inform the public about
the rulemaking process (including how to submit comments, data, and
other information to the rulemaking dockets), and to respond to
questions about the proposed rules.
[[Page 6763]]
DATES: See section II ``How to Participate in the Public Meeting'' in
the SUPPLEMENTARY INFORMATION section of this document for date and
time of the public meeting, closing dates for advance registration, and
information on deadlines for submitting either electronic or written
comments to FDA's Division of Dockets Management.
ADDRESSES: See section II ``How to Participate in the Public Meeting''
in the SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: For questions about registering for
the meeting, to register by phone, or to submit a notice of
participation by mail, fax, or email: Courtney Treece, Planning
Professionals, Ltd., 1210 West McDermott Dr., suite 111, Allen, TX
75013, 704-258-4983, FAX: 469-854-6992, email:
ctreece@planningprofessionals.com.
For general questions about the meeting, to request an opportunity
to make an oral presentation at the public meeting, to submit the full
text, comprehensive outline, or summary of an oral presentation, or for
special accommodations due to a disability, contact: Juanita Yates,
Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1731, email: Juanita.yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FSMA (Pub. L. 111-353), was signed into law by President Obama on
January 4, 2011, to better protect public health by helping to ensure
the safety and security of the food supply. FSMA amends the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation
of a modernized, prevention-based food safety system. Among other
things, FSMA requires FDA to issue regulations requiring preventive
controls for human and animal food and set standards for produce
safety.
FSMA was the first major legislative reform of FDA's food safety
authorities in more than 70 years, even though FDA has increased the
focus of its food safety efforts on prevention over the past several
years. For example, applying the concept of Hazard Analysis and
Critical Control Point (HACCP) that was pioneered by industry in the
late 1960s, FDA established HACCP-based regulations for seafood (21 CFR
part 123) in 1995 (60 FR 65096, December 18, 1995) and for juice (21
CFR part 120) in 2001 (66 FR 6138, January 19, 2001). Similarly, in
1996, the U.S. Department of Agriculture's Food Safety and Inspection
Service instituted HACCP-based rules for meat and poultry (9 CFR part
417) (61 FR 38806, July 25, 1996).
In the Federal Register of January 16, 2013 (78 FR 3503 and 78 FR
3646), FDA announced the establishment of two dockets so that the
public can review the produce safety proposed rule and the preventive
controls proposed rule and submit comments to the Agency. These
proposed rulemakings are the first of several key proposals in
furtherance of FSMA's food safety mandate. The produce safety proposed
rule would establish science-based minimum standards for the safe
growing, harvesting, packing, and holding of produce, meaning fruits
and vegetables, grown for human consumption. The produce safety
proposed rule would set forth procedures, processes, and practices that
FDA expects would reduce foodborne illness associated with the
consumption of produce. The produce safety proposed rule and related
fact sheets are available on FDA's FSMA Web page located at http://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
The preventive controls proposed rule would apply to human food and
require domestic and foreign facilities that are required to register
under the FD&C Act to have written plans that identify hazards, specify
the steps that will be put in place to minimize or prevent those
hazards, monitor results, and act to correct problems that arise. The
preventive controls proposed rule and related fact sheets are available
on FDA's FSMA Web page located at http://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
FDA is announcing a series of public meetings entitled ``The Food
Safety Modernization Act Public Meeting on Proposed Rules for Produce
Safety and for Preventive Controls for Human Food'' so that the food
industry, consumers, foreign governments, and other stakeholders can
evaluate and comment on the proposals. The Washington, DC public
meeting is the first of three that the Agency will hold during the
proposed rules' comment period. We intend to hold the additional public
meetings in Chicago, IL and Portland, OR. Specific locations, dates,
and registration information for these meetings will appear in a
separate Federal Register document to publish shortly. All three public
meetings will have the same agenda and are intended to facilitate and
support the proposed rules' evaluation and commenting process.
II. How To Participate in the Public Meeting
FDA is holding the public meeting on the produce safety proposed
rule and the preventive controls proposed rule to inform the public
about the rulemaking process, including how to submit comments, data,
and other information to the rulemaking docket; to respond to questions
about the proposed rules; and to provide an opportunity for interested
persons to make oral presentations. Due to limited space and time, FDA
encourages all persons who wish to attend the meeting to register in
advance. There is no fee to register for the public meeting, and
registration will be on a first-come, first-served basis. Early
registration is recommended because seating is limited. Onsite
registration will be accepted, as space permits, after all
preregistered attendees are seated.
Those requesting an opportunity to make an oral presentation during
the time allotted for public comment at the meeting are asked to submit
a request and to provide the specific topic or issue to be addressed.
Due to the anticipated high level of interest in presenting public
comment and limited time available, FDA is allocating 3 minutes to each
speaker to make an oral presentation. Speakers will be limited to
making oral remarks; there will not be an opportunity to display
materials such as slide shows, videos, or other media during the
meeting. If time permits, individuals or organizations that did not
register in advance may be granted the opportunity to make an oral
presentation. FDA would like to maximize the number of individuals who
make a presentation at the meeting and will do our best to accommodate
all persons who wish to make a presentation or express their opinions
at the meeting.
FDA encourages persons and groups who have similar interests to
consolidate their information for presentation by a single
representative. After reviewing the presentation requests, FDA will
notify each participant before the meeting of the approximate time
their presentation is scheduled to begin, and remind them of the
presentation format (i.e., 3-minute oral presentation without visual
media).
While oral presentations from specific individuals and
organizations will be necessarily limited due to time constraints
during the public meeting, stakeholders may submit electronic or
written comments discussing any issues of concern to the administrative
record (the docket) for the rulemaking. All relevant data and
documentation should
[[Page 6764]]
be submitted with the comments to the relevant docket (i.e., for the
produce safety proposed rule, Docket No. FDA-2011-N-0921; and for the
preventive controls proposed rule, Docket No. FDA-2011-N-0920).
Table 1 of this document provides information on participation in
the public meetings:
Table 1--Information on Participation in the Meetings and on Submitting Comments to the Rulemaking Dockets
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Date Electronic address Address Other information
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Public meeting................. February 28, ...................... Jefferson Onsite
2013, from 8:30 Auditorium U.S. registration
a.m. to 5 p.m. Department of both days from 8
and March 1, Agriculture a.m. to 8:30
2013, from 8:30 (USDA), Wing 5 a.m.
a.m. to 12 p.m. Entrance, 14th
and Independence
Ave. SW.,
Washington, DC
20024. Photo ID
Required.
Advance registration........... By February 20, Individuals who wish We encourage you There is no
2013. to participate in to use registration fee
person are asked to electronic for the public
preregister at http:// registration if meetings. Early
www.fda.gov/Food/ possible\1\. registration is
NewsEvents/ recommended
WorkshopsMeetingsConf because seating
erences/default.htm. is limited.
Request to make an oral By February 8, http://www.fda.gov/ Requests made on
presentation. 2013. Food/NewsEvents/ the day of the
WorkshopsMeetingsConf meeting to make
erences/default.htm an oral
\2\. presentation
will be granted
as time permits.
Information on
requests to make
an oral
presentation may
be posted
without change
to http://www.regulations.gov gov, including
any personal
information
provided.
Request special accommodations By February 15, Juanita Yates, email: See FOR FURTHER
due to a disability. 2013. Juanita.yates@fda.hhs INFORMATION
.gov. CONTACT.
Submit electronic or written By May 16, 2013.. Docket Nos. FDA-2011-N-
comments. 0920 and FDA-2011-N-
0921.
Preventive Controls
for Human Food
Proposed Rule: http://www.regulations.gov/#!docketDetail;D=FDA-
2011-N-0920.
Produce Safety
Proposed Rule: http://www.regulations.gov/#!docketDetail;D=FDA-
2011-N-0921.
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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 Courtney Treece (see FOR FURTHER
INFORMATION CONTACT). Onsite registration will also be available.
\2\ You may also request to make an oral presentation at the public meeting via email. Please include your name,
title, firm name, address, and phone and fax numbers as well as the full text, comprehensive outline, or
summary of your oral presentation, and send to Juanita Yates (see FOR FURTHER INFORMATION CONTACT).
III. Comments, Transcripts, and Recorded Video
Information and data submitted voluntarily to FDA during the public
meeting will become part of the administrative record for the relevant
rulemaking and will be accessible to the public at http://www.regulations.gov. The transcript of the proceedings from the public
meeting will become part of the administrative record for each of the
rulemakings. Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov and at
FDA's FSMA Web site at http://www.fda.gov/Food/FoodSafety/FSMA/. It may
also be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. A transcript will also be available in either hardcopy or on CD-
ROM, after submission of a Freedom of Information request. Written
requests are to be sent to the Division of Freedom of Information
(ELEM-1029), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Additionally, FDA will be video recording the public meeting. Once the
recorded video is available, it will be accessible at FDA's FSMA Web
site at http://www.fda.gov/Food/FoodSafety/FSMA/.
Dated: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02089 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P