[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15612-15614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0797]


The Food and Drug Administration Food Safety Modernization Act: 
Focus on Implementation Strategy for Prevention-Oriented Food Safety 
Standards; Public Meeting and Establishment of Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and establishment of docket.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
establishment of a docket to obtain comments that will inform our 
development of FDA Food Safety Modernization Act (FSMA) implementation 
work plans. FDA is also announcing a public meeting entitled ``FDA Food 
Safety Modernization Act: Focus on Implementation Strategy for 
Prevention-Oriented Food Safety Standards.'' At the public meeting, we 
will share our current thinking on our operational strategy for 
implementation work plans. We will also provide interested persons an 
opportunity to provide input on this operational strategy and the risk-
based industry oversight framework that is at the core of FSMA.

DATES: See section III, ``How to Participate in the Public Meeting'' in 
the SUPPLEMENTARY INFORMATION section of this document for dates and 
times of the public meeting, closing dates for advance registration, 
requesting special accommodations due to disability, and information on 
deadlines for submitting either electronic or written comments to FDA's 
Division of Dockets Management.

ADDRESSES: See section III, ``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 or to register by phone: Courtney Treece, Planning 
Professionals Ltd., 1210 West McDermott Dr., suite 111, Allen, TX 
75013, 704-258-4983, FAX: 469-854-6992, email: 
<a href="/cdn-cgi/l/email-protection#3f5c4b4d5a5a5c5a7f4f535e51515651584f4d50595a4c4c5650515e534c115c5052"><span class="__cf_email__" data-cfemail="9af9eee8fffff9ffdaeaf6fbf4f4f3f4fdeae8f5fcffe9e9f3f5f4fbf6e9b4f9f5f7">[email protected]</span></a>.
    For general questions about the meeting or for special 
accommodations due to a disability: 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: 
<a href="/cdn-cgi/l/email-protection#efa59a8e81869b8ec1968e9b8a9caf898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="6f251a0e01061b0e41160e1b0a1c2f090b0e4107071c41080019">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), 
signed into law by President Obama on January 4, 2011, enables FDA 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 to establish the foundation of a modernized, prevention-
based food safety system. Among other things, FSMA requires FDA to 
issue regulations regarding produce safety, preventive controls for 
foods for humans and animals, intentional adulteration, the foreign 
supplier verification program (FSVP), and the FDA third-party 
accreditation program.
    While FSMA reinforces industry's primary role and responsibility 
for food safety, it also builds on and strengthens FDA's oversight role 
in establishing food safety standards, fostering compliance with those 
standards through guidance and technical assistance, and enforcing the 
standards to protect public health when problems occur. In fact, more 
so than ever before, we are called upon by FSMA to play a central 
leadership and operational role in the future global food safety 
system. Meeting this challenge--and successfully implementing FSMA's 
new prevention-oriented, systems approach to food safety--necessitates 
a new strategy for how we perform our food safety role and meet our new 
responsibilities.
    On May 2, 2014, we released our ``Operational Strategy for 
Implementing the FDA Food Safety Modernization Act (FSMA),'' available 
electronically at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm, to guide the next phase of FSMA implementation. The 
operational strategy broadly outlines our approach to food safety and 
the operational strategy for our food safety program and implementation 
of FSMA after the rulemaking is complete. Within the ``Operational 
Strategy for Implementing FSMA,'' there is an appendix that outlines 
guiding principles for how the operational strategy can be implemented 
with respect to food and feed facilities, produce safety standards, and 
import oversight. The guiding principles include the following: 
Expanding inspection and surveillance; administering new administrative 
enforcement tools; developing guidance, education, and technical 
assistance tools; and building a prevention-oriented import system.

[[Page 15613]]

    The public meeting is an opportunity for interested persons to 
share views concerning how FDA should address the operational aspects 
of FSMA implementation as suggested by the guiding principles. However, 
the guiding principles do not lay out an exhaustive list of operational 
issues to be considered. Therefore, interested persons will have an 
opportunity at the public meeting to share views and suggest new ideas 
on a range of operational issues that FDA might consider in our FSMA 
implementation approach. Furthermore, the public meeting is an 
opportunity for FDA to share our current thinking on our implementation 
plans. We encourage interested persons to provide feedback on any ideas 
that we present at the public meeting related to the operational 
aspects of FSMA implementation. We are also establishing a docket to 
obtain comments that will inform our development of FSMA implementation 
work plans. The agenda and other documents will be accessible on our 
FSMA Web site at http://www.fda.gov/FSMA before the public meeting.

II. Purpose and Format of the Public Meeting

    FDA is holding this public meeting on FSMA implementation to 
provide an update on current planning efforts and to receive input from 
the public to inform the development of operational work plans in the 
areas of produce safety, preventive controls for foods for humans and 
animals, measures to address intentional adulteration, FSVP, and the 
FDA third-party accreditation program. Please note that input received 
previously through our continued engagement with interested parties as 
part of the FSMA proposed rules' rulemaking process will also be 
considered in the development of operational work plans. However, the 
Agency will not accept any new information or data submitted during the 
public meeting or through the docket to inform any rulemaking.
    FDA will provide multiple opportunities for individuals to actively 
express their views. At the meeting, following introductory 
presentations by FDA, stakeholders will have an opportunity to 
participate in their choice of breakout sessions on the topics 
discussed at the meeting and engage in an open comment and question and 
answer session. Interested parties may also submit electronic or 
written comments to the docket by May 26, 2015. Breakout sessions will 
cover operational aspects of produce safety, preventive controls for 
human and animal food, intentional adulteration, FSVP, and the FDA 
third-party accreditation program, as well as overarching topics. We 
invite the public to provide information, share experiences, and raise 
issues on topics that will be addressed in the breakout sessions 
including (but limited to): increasing awareness/reaching the regulated 
community, potential partners on outreach and implementation, state of 
readiness, barriers to implementation, training and education for 
industry and regulators, guidance needs, promotion of best practices, 
technical assistance, data needs, inspection changes/approaches, 
compliance and enforcement issues, and long-term implementation 
success.
    There will be an opportunity for stakeholders who are unable to 
participate in person to join the meeting via Web cast. (See section 
III of this document for more information on the Web cast option.)

III. How To Participate in the Public Meeting

    FDA is holding the public meeting on April 23, 2015, from 8:30 a.m. 
to 5:30 p.m. and April 24, 2015, from 8:30 a.m. to 12:30 p.m. Due to 
limited space and time, we encourage 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. Onsite registration will be accepted, as space permits, after 
all preregistered attendees are seated. While there is not a formal 
comment session planned for the public meeting, it is anticipated that 
stakeholders will have ample opportunity to provide comments and 
opinions during the public meeting through their participation in 
breakout sessions and in the dialogue and question and answer session.
    Table 1 of this document provides information on participation in 
the public meeting.

          Table 1--Information on Participation in the Meeting and on Submitting Comments to the Docket
----------------------------------------------------------------------------------------------------------------
                                    Dates       Electronic addresses        Addresses         Other information
----------------------------------------------------------------------------------------------------------------
Attend public meeting........  April 23, 2015,  Please preregister    Washington Marriott   Registration check-
                                from 8:30 a.m.   at http://            at Metro Center,      in begins at 8 a.m.
                                to 5:30 p.m.,    www.fda.gov/Food/     775 12th St. NW.,
                                and April 24,    NewsEventsWorkshops   Washington, DC
                                2015, from       MeetingsConferences/  20005.
                                8:30 a.m. to     default.htm.
                                12:30 p.m.
View Web cast................  April 23, 2015,  Individuals who wish  ....................  The Web cast will
                                from 8:30 a.m.   to participate by                           have closed
                                to 5:30 p.m.,    Web cast are asked                          captioning.
                                and April 24,    to preregister at
                                2015, from       http://www.fda.gov/
                                8:30 a.m. to     Food/NewsEvents/.
                                12:30 p.m.      WorkshopsMeetingsCon
                                                 ferences/
                                                 default.htm.
Preregister..................  Register by      Individuals who wish  We encourage the use  There is no
                                April 16, 2015.  to participate in     of electronic         registration fee
                                                 person are asked to   registration, if      for the public
                                                 preregister at        possible.\1\.         meeting.
                                                 http://www.fda.gov/Food/NewsEvents/ Food/NewsEvents/.
                                                WorkshopsMeetingsCon
                                                 ferences/
                                                 default.htm.
Request special                Request by       Juanita Yates,        See FOR FURTHER       ....................
 accommodations due to          April 8, 2015.   email:                INFORMATION CONTACT.
 disability.                                     <a href="/cdn-cgi/l/email-protection#5a102f3b34332e3b74233b2e3f291a3c3e3b74323229743d352c"><span class="__cf_email__" data-cfemail="49033c2827203d286730283d2c3a092f2d286721213a672e263f">[email protected]</span></a>.

[[Page 15614]]

 
Submit electronic or written   Submit comments  Federal eRulemaking   Mail/Hand delivery/   Identify your
 comments.                      by May 26,       Portal: http://       Courier (for paper    comments with the
                                2015.            www.regulations.gov   submissions):         docket number
                                                 . Follow the          Division of Dockets   listed in brackets
                                                 instructions for      Management (HFA-      in the heading of
                                                 submitting comments.  305), Food and Drug   this document. We
                                                                       Administration,       encourage you to
                                                                       5630 Fishers Lane,    submit electronic
                                                                       rm. 1061,             comments by using
                                                                       Rockville, MD 20852.  the Federal
                                                                                             eRulemaking Portal.
----------------------------------------------------------------------------------------------------------------
\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, Planning Professionals
  Ltd., 1210 West McDermott Dr., suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email:
  <a href="/cdn-cgi/l/email-protection#ccafb8bea9a9afa98cbca0ada2a2a5a2abbcbea3aaa9bfbfa5a3a2ada0bfe2afa3a1"><span class="__cf_email__" data-cfemail="4d2e393f28282e280d3d212c232324232a3d3f222b283e3e2422232c213e632e2220">[email protected]</span></a>.

IV. Comments, Transcripts, and Recorded Video

    Regardless of attendance at the public meeting, interested persons 
may submit to FDA's Division of Dockets Management (see Addresses in 
table 1 of this document) either electronic or written comments on FSMA 
implementation issues. You only need to send one set of comments. 
Identify the comments with the docket number listed in brackets in the 
heading of this document. However, we will not use any information or 
data submitted during the public meeting or through the docket to 
inform any FSMA rulemakings where the comment periods have closed.
    With respect to transcripts, 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/FSMA. You may also view the transcript 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. Send written requests to the Division of Freedom 
of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857.
    Additionally, we 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/FSMA.

    Dated: March 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06656 Filed 3-23-15; 8:45 am]
BILLING CODE 4164-01-P


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