[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Proposed Rules]
[Pages 20588-20590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2011-N-0251]


FDA Food Safety Modernization Act: Focus on Preventive Controls 
for Facilities; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comment.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``FDA Food Safety Modernization Act: Focus on 
Preventive Controls for Facilities.'' The purpose of the public meeting 
is to provide interested persons an opportunity to discuss 
implementation of the preventive controls for facilities provisions of 
the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is 
seeking information on preventive controls used by facilities to 
identify and address hazards associated with specific types of food and 
specific processes. The public will have an opportunity to provide 
information and share views that will inform the development of 
guidance and regulations on preventive controls for food facilities 
that manufacture, process, pack or hold human food or animal food and 
feed (including pet food).

DATES: See ``How to Participate in the Meeting'' in the SUPPLEMENTARY 
INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Patricia M. Kuntze, Office of External 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 5322, Silver Spring, MD 20993, 301-796-8641, 
<a href="/cdn-cgi/l/email-protection#e9b9889d9b808a8088c7a29c879d938ca98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="fdad9c898f949e949cd3b68893898798bd9b999cd395958ed39a928b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FSMA (Pub. L. 111-353) amends the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) to establish the foundation for a modernized, 
prevention-based food safety system and gives FDA for the first time a 
legislative mandate to require comprehensive, science-based preventive 
controls across the food supply.
    In particular, section 103 of FSMA requires the owner, operator, or 
agent in charge of a facility that is required to register under 
section 415 of the FD&C Act (21 U.S.C. 350d) to take certain preventive 
actions, including to evaluate the hazards that could affect food 
manufactured, processed, packed, or held by the facility, and to 
identify and implement preventive controls to significantly minimize or 
prevent the occurrence of such hazards. FDA is required to develop 
regulations to establish science-based standards for conducting a 
hazard analysis, documenting hazards, implementing preventive controls, 
and documenting their implementation.
    In addition, FDA is required to issue guidance with respect to 
hazard analysis and preventive controls. Given the diversity of 
registered facilities and regulated foods, FDA will use the guidance to 
assist the food and feed industries in complying with the preventive 
controls regulations, when they are finalized. FDA will leverage, where 
appropriate, best practices for hazards and controls identified by 
industry for specific types of food and feed and specific methods in 
manufacturing, processing, packing, and holding food and feed. FDA is 
interested in making appropriate best practices publicly available. FDA 
is particularly interested in preventive control practices that are 
applicable and practical for small and very small businesses to 
implement.

II. Purpose and Format of the Meeting

    If you wish to attend and/or present at the meeting scheduled for 
April 20, 2011, please register by e-mail at http://www.blsmeetings.net/FDAPreventiveControls by April 15, 2011. FDA is 
holding the public meeting on section 103 of FSMA to receive input from 
the public to inform the development of the regulations and guidance 
identified previously in this document. FDA will also consider input it 
has received previously through its engagement of stakeholders as part 
of the process to examine and update current good manufacturing 
practice requirements and to develop an animal feed safety system.
    In general, the meeting format will include introductory 
presentations by FDA. Listening to our stakeholders is the primary 
purpose of this meeting. In order to meet this goal, FDA will provide 
multiple opportunities for individuals to actively express their views 
by making presentations at the meeting, participating in a total of 
three 75-minute break-out sessions on the provisions discussed at the 
meeting, and submitting written comments to the docket within 30 days 
after this meeting. (Participants can select up to three of the 
following five break-out sessions: Preventive Controls Guidance, On-
Farm Manufacturing and Small Business, Product Testing and 
Environmental Monitoring, Training and Technical Assistance, and 
Preventive Controls and the Relationship to cGMPs.) There will be an 
interactive Webcast; see section III of this document, ``How to 
Participate in the Meeting.'' In order to provide Webcast participants 
with information before and after the meeting, we request attendees 
provide their name, their affiliation, and email when registering.

III. How To Participate in the Meeting

    Stakeholders will have an opportunity to provide oral comments. Due 
to limited space and time, FDA encourages all persons who wish to 
attend the meeting, including those requesting an opportunity to make 
an oral presentation during the time allotted for public comment at the 
meeting, to register in advance and to provide the specific topic or 
issue to be addressed and the approximate desired length of their 
presentation. Depending on the number of requests for such oral 
presentations, there may be a need to limit the time of each oral 
presentation (e.g., 3 minutes each). If time permits, individuals or 
organizations that did not register in advance may be granted the 
opportunity for such an oral presentation. FDA would like to maximize 
the number of stakeholders 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 views at the meeting. FDA anticipates 
that there will be several opportunities to speak in break-out sessions 
and an interactive Webcast will also be available for stakeholders who 
are not onsite.
    FDA encourages persons and groups who have similar interests to 
consolidate their information for presentation through a single 
representative. After reviewing the presentation requests, FDA will 
notify each participant before the meeting of the amount of time 
available and the

[[Page 20589]]

approximate time their presentation is scheduled to begin.
    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 after all preregistered attendees are seated.
    Table 1 of this document provides information on participating in 
the meeting and on submitting comments to the docket.

                  Table 1--Information on Participation in the Meeting and Submitting Comments
----------------------------------------------------------------------------------------------------------------
                                                                             Address (non-
                                         Date         Electronic address      electronic)      Other information
----------------------------------------------------------------------------------------------------------------
Date of Public Meeting..........  April 20, 2011, 9   ..................  FDA White Oak       Registration
                                   a.m. to 5:30 p.m.                       Campus, The Great   begins at 7:30
                                                                           Room, Bldg. 31,     a.m.
                                                                           rm. 1503, 10903
                                                                           New Hampshire
                                                                           Ave., Silver
                                                                           Spring, MD 20993.
Webcast.........................  April 20, 2011, 9   https://            ..................  <bullet> If you
                                   a.m. to 5:30 p.m.   collaboration.fda                       have never
                                                       .gov/                                   attended a
                                                       preventivecontrol                       ConnectPRO
                                                       s/.                                     meeting: Test
                                                                                               your connection:
                                                                                               https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
                                                                                               . Get a quick
                                                                                               overview: http://www.adobe.comgo/connectpro_overview iew.\1\
                                                                                              <bullet> The
                                                                                               webcast will
                                                                                               provide closed
                                                                                               captioning.
Advance Registration............  By April 15, 2011.  http://             ..................  Registration to
                                                       www.blsmeetings.n                       attend the
                                                       et/                                     meeting will also
                                                       FDAPreventiveCont                       be accepted
                                                       rols.                                   onsite on the day
                                                                                               of the meeting,
                                                                                               as space permits.
                                                                                               Registration
                                                                                               information may
                                                                                               be posted without
                                                                                               change to http://www.regulations.gov ov, including any
                                                                                               personal
                                                                                               information
                                                                                               provided.
Request special accommodations    By April 15, 2011.  ..................  Patricia M.         ..................
 due to disability.                                                        Kuntze, 301-796-
                                                                           8641, email:
                                                                           <a href="/cdn-cgi/l/email-protection#d787b6a3a5beb4beb6f99ca2b9a3adb297b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="26764752544f454f47086d5348525c4366404247084e4e5508414950">[email protected]</span></a>.
Make a request for oral           By April 15, 2011.  http://             ..................  Requests made on
 presentation.                                         www.blsmeetings.n                       the day of the
                                                       et/                                     meeting to make
                                                       FDAPreventiveCont                       an oral
                                                       rols.                                   presentation may
                                                                                               be granted as
                                                                                               time permits.
                                                                                               Information on
                                                                                               requests to make
                                                                                               an oral
                                                                                               presentation may
                                                                                               be posted without
                                                                                               change to http://www.regulations.gov ov, including any
                                                                                               personal
                                                                                               information
                                                                                               provided.
Provide a brief description of    By April 15, 2011.  http://             ..................  Written material
 the oral presentation and any                         www.blsmeetings.n                       associated with
 written material for the                              et/                                     an oral
 presentation.                                         FDAPreventiveCont                       presentation
                                                       rols.                                   should be
                                                                                               submitted in
                                                                                               Microsoft
                                                                                               PowerPoint,
                                                                                               Microsoft Word,
                                                                                               or Adobe Portable
                                                                                               Document Format
                                                                                               (PDF) and may be
                                                                                               posted without
                                                                                               change to http://www.regulations.gov ov, including any
                                                                                               personal
                                                                                               information
                                                                                               provided.
Submit electronic or written      Submit comments by  Federal             FAX: 301-827-6870.  All comments must
 comments.                         May 20, 2011.       eRulemaking         Mail/Hand           include the
                                                       Portal: http://     delivery/Courier    Agency name and
                                                       www.regulations.g   (for paper, disk,   the docket number
                                                       ov. Follow the      or CD-ROM           in brackets in
                                                       instructions for    submissions):       the heading of
                                                       submitting          Division of         this document.
                                                       comments.           Dockets             All received
                                                                           Management (HFA-    comments may be
                                                                           305), Food and      posted without
                                                                           Drug                change to http://
                                                                           Administration,     www.regulations.g
                                                                           5630 Fishers        ov, including any
                                                                           Lane, rm. 1061,     personal
                                                                           Rockville, MD       information
                                                                           20852.              provided. FDA
                                                                                               encourages the
                                                                                               submission of
                                                                                               electronic
                                                                                               comments by using
                                                                                               the Federal
                                                                                               eRulemaking
                                                                                               Portal. For
                                                                                               additional
                                                                                               information on
                                                                                               submitting
                                                                                               comments, see the
                                                                                               ``Comments''
                                                                                               heading of the
                                                                                               SUPPLEMENTARY
                                                                                               INFORMATION
                                                                                               section of this
                                                                                               document.
----------------------------------------------------------------------------------------------------------------
\1\ Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe
  Systems Incorporated in the United States and/or other countries.


[[Page 20590]]

IV. Comments

    Regardless of attendance at the public meeting, interested persons 
may submit to the Division of Dockets Management (see table 1 of this 
document) either electronic or written comments for consideration at or 
after the meeting in addition to, or in place of, a request for an 
opportunity to make an oral presentation. It is only necessary to send 
one set of comments. It is no longer necessary to send two copies of 
mailed comments. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov and http://www.fda.gov/Food/FoodSafety/FSMA/default.htm. It may 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 
Division of Freedom of Information (HFI-35), Office of Management 
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, 
Rockville, MD 20857.

    Dated: April 7, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-8785 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P


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