[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Proposed Rules]
[Pages 6762-6764]
From the Federal Register Online via the Government Publishing 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: 
[email protected].
    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: [email protected].

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
----------------------------------------------------------------------------------------------------------------
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.              [email protected]   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