[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Proposed Rules]
[Pages 10107-10110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03316]


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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 providing public 
meeting registration information for two FSMA related public meetings 
announced in the January 31, 2013, Federal Register. These public 
meetings will be held along with the February 28 to March 1, 2013, 
Washington, DC 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). These proposed rules 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 
meetings 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.

DATES: See section II ``How to Participate in the Public Meeting'' in 
the SUPPLEMENTARY INFORMATION section of this document for dates and 
times of the Chicago, IL and Portland, OR public meetings, 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 
these meetings, 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 these meetings, to request an 
opportunity to make an oral presentation at one of the public meetings, 
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.
    In the Federal Register of January 31, 2013 (78 FR 6762), FDA 
announced the first public meeting in a series of three 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. FDA also noted 
that the Agency intended to hold

[[Page 10108]]

additional public meetings in Chicago, IL and Portland, OR and that 
those specific locations, dates, and registration information for these 
meetings would appear in a separate Federal Register document to 
publish shortly. It was also noted that all three public meetings would 
have the same agenda and are intended to facilitate and support the 
proposed rules' evaluation and commenting process.
    In this document, FDA is providing the locations, dates, and 
registration information for the Chicago, IL and Portland, OR public 
meetings.

II. How To Participate in the Public Meeting

    FDA is holding the public meetings 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 public meetings to 
register in advance. There is no fee to register for the public 
meetings, 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 meetings 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 meetings 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 at a single location. 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 be submitted with the comments to the relevant 
docket (i.e., for the produce safety proposed rule, http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921; and for the 
preventive controls proposed rule, http://www.regulations.gov/#!docketDetail;D=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
----------------------------------------------------------------------------------------------------------------
                                     Date        Electronic address          Address          Other information
----------------------------------------------------------------------------------------------------------------
Washington, DC Public meeting  February 28,                           Jefferson             Onsite registration
                                2013, from                             Auditorium, U.S.      both days from 8
                                8:30 a.m. to 5                         Department of         a.m. to 8:30 a.m.
                                p.m. and March                         Agriculture (USDA),
                                1, 2013, from                          Wing 5 Entrance,
                                8:30 a.m. to                           14th and
                                12 noon.                               Independence Ave.
                                                                       SW., Washington, DC
                                                                       20024. Photo ID
                                                                       Required.
Washington, DC Advance         By February 20,  Individuals who wish  We encourage you to   There is no
 registration.                  2013.            to participate in     use electronic        registration fee
                                                 person are asked to   registration if       for the public
                                                 preregister at        possible.\1\          meetings. Early
                                                 http://www.fda.gov/                         registration is
                                                 Food/NewsEvents/                            recommended because
                                                 WorkshopsMeetingsCo                         seating is limited.
                                                 nferences/
                                                 default.htm.
Washington, DC Request to      By February 8,   http://www.fda.gov/                         Requests made on the
 make an oral presentation.     2013.            Food/NewsEvents/                            day of the meeting
                                                 WorkshopsMeetingsCo                         to make an oral
                                                 nferences/                                  presentation will
                                                 default.htm.\2\                             be granted as time
                                                                                             permits.
                                                                                             Information on
                                                                                             requests to make an
                                                                                             oral presentation
                                                                                             may be posted
                                                                                             without change to
                                                                                             http://
                                                                                             www.regulations.gov
                                                                                             , including any
                                                                                             personal
                                                                                             information
                                                                                             provided.
Washington, DC Request         By February 15,  Juanita Yates,        See FOR FURTHER
 special accommodations due     2013.            email:                INFORMATION CONTACT.
 to a disability.                                Juanita.yates@fda.hhs.gov.

[[Page 10109]]

 
Chicago, IL Public meeting...  March 11, 2013,                        The Westin-Michigan   Onsite registration
                                from 8:30 a.m.                         Avenue, 909 North     both days from 8
                                to 5 p.m. and                          Michigan Ave.,        a.m. to 8:30 a.m.
                                March 12,                              Chicago, IL 60611.
                                2013, from
                                8:30 a.m. to
                                12 noon.
Chicago, IL Advance            By March 1,      Individuals who wish  We encourage you to   There is no
 registration.                  2013.            to participate in     use electronic        registration fee
                                                 person are asked to   registration if       for the public
                                                 preregister at        possible.\1\          meetings. Early
                                                 http://www.fda.gov/                         registration is
                                                 Food/NewsEvents/                            recommended because
                                                 WorkshopsMeetingsCo                         seating is limited.
                                                 nferences/
                                                 default.htm.
Chicago, IL Request to make    By February 21,  http://www.fda.gov/                         Requests made on the
 an oral presentation.          2013.            Food/NewsEvents/                            day of the meeting
                                                 WorkshopsMeetingsCo                         to make an oral
                                                 nferences/                                  presentation will
                                                 default.htm.\2\                             be granted as time
                                                                                             permits.
                                                                                             Information on
                                                                                             requests to make an
                                                                                             oral presentation
                                                                                             may be posted
                                                                                             without change to
                                                                                             http://
                                                                                             www.regulations.gov
                                                                                             , including any
                                                                                             personal
                                                                                             information
                                                                                             provided.
Chicago, IL Request special    By February 21,  Juanita Yates,        See FOR FURTHER
 accommodations due to a        2013.            email:                INFORMATION CONTACT.
 disability.                                     Juanita.yates@fda.hhs.gov.
Portland, OR Public meeting..  March 27, 2013,                        Crown Plaza Portland  Onsite registration
                                from 8:30 a.m.                         Downtown Convention   both days from 8
                                to 5 p.m. and                          Center, 1441 NE 2nd   a.m. to 8:30 a.m.
                                March 28,                              Ave., Portland, OR
                                2013, from                             97232.
                                8:30 a.m. to
                                12 noon.
Portland, OR Advance           By March 18,     Individuals who wish  We encourage you to   There is no
 registration.                  2013.            to participate in     use electronic        registration fee
                                                 person are asked to   registration if       for the public
                                                 preregister at        possible.\1\          meetings. Early
                                                 http://www.fda.gov/                         registration is
                                                 Food/NewsEvents/                            recommended because
                                                 WorkshopsMeetingsCo                         seating is limited.
                                                 nferences/
                                                 default.htm.
Portland, OR Request to make   By March 8,      http://www.fda.gov/                         Requests made on the
 an oral presentation.          2013.            Food/NewsEvents/                            day of the meeting
                                                 WorkshopsMeetingsCo                         to make an oral
                                                 nferences/                                  presentation will
                                                 default.htm.\2\                             be granted as time
                                                                                             permits.
                                                                                             Information on
                                                                                             requests to make an
                                                                                             oral presentation
                                                                                             may be posted
                                                                                             without change to
                                                                                             http://
                                                                                             www.regulations.gov
                                                                                             , including any
                                                                                             personal
                                                                                             information
                                                                                             provided.
Portland, OR Request special   By March 8,      Juanita Yates,        See FOR FURTHER
 accommodations due to a        2013.            email:                INFORMATION CONTACT.
 disability.                                     Juanita.yates@fda.hhs.gov.
Submit electronic or written   By May 16, 2013  Docket Nos. FDA-2011-
 comments.                                       N-0920 and FDA-2011-
                                                 N-0921.
                                                Preventive Controls
                                                 for Human Food
                                                 Proposed Rule:
                                                 http://www.regulations.gov/#!docketDetail;D=FD
                                                 A-2011-N-0920.

[[Page 10110]]

 
                                                Produce Safety
                                                 Proposed Rule:
                                                 http://www.regulations.gov/#!docketDetail;D=FD
                                                 A-2011-N-0921.
----------------------------------------------------------------------------------------------------------------
\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 
meetings 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 
meetings 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 for each public meeting 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 
first public meeting in Washington, DC. 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: February 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03316 Filed 2-12-13; 8:45 am]
BILLING CODE 4160-01-P