[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Proposed Rules]
[Pages 28035-28037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, and 111

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


The Food and Drug Administration Food Safety Modernization Act: 
Focus on Strategic Implementation of Prevention-Oriented Import Safety 
Programs; Public Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
three one-day public meetings in different regions throughout the 
United States to provide importers and other interested persons an 
opportunity to have an in-depth discussion on the implementation of the 
FDA Food Safety Modernization Act (FSMA) import safety programs (i.e., 
foreign supplier verification programs (FSVPs) for importers of food 
for humans and animals, accreditation of third-party certification 
bodies, and FDA's Voluntary Qualified Importer Program (VQIP)). During 
these meetings, participants and key FDA subject matter experts will 
discuss the next phase of FSMA implementation related to import safety 
programs, which includes establishing the operational framework for 
these programs and plans for guidance documents, training, education, 
and technical assistance. The purpose of the regional outreach public 
meetings is to continue the dialogue with the importer community on 
FSMA and elicit ideas that will help to inform FDA and our stakeholders 
on how to continue to work together to successfully comply with FSMA 
mandates and regulations.

DATES: See section III for dates and times of the regional outreach 
meetings, closing dates for advance registration, and requests for 
special accommodations due to disability.

ADDRESSES: See section III for meeting locations.

FOR FURTHER INFORMATION CONTACT: 

[[Page 28036]]

    For questions about registering for the meeting, or to register by 
phone: Peggy Walker, Planning Professionals Ltd., 1210 West McDermott 
St., Suite 111, Allen, TX 75013, 214-384-0667, FAX: 469-854-6992, 
email: [email protected].
    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: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On May 2, 2014, we released our ``Operational Strategy for 
Implementing the FDA Food Safety Modernization Act (FSMA),'' 
electronically at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm, to guide the next phase of FSMA implementation following 
the establishment of regulations and relevant programs. 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.
    On April 23, 2015, FDA hosted a public meeting as 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. We provided an update on current planning efforts 
and received 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. In addition, we established a docket to obtain comments on a 
range of operational issues that we might consider in our FSMA 
implementation approach.
    On March 21, 2016, FDA hosted a kick-off public meeting to brief 
participants on the key components of the FSVP and third-party 
certification final rules; brief participants on the status of the 
VQIP; discuss the plans for guidance documents related to import 
safety, as well as training, education, and technical assistance; 
provide an update on the development of a risk-based industry oversight 
framework that is at the core of FSMA; and answer questions about these 
import programs. The public meeting was an opportunity for FDA to share 
its current thinking on implementation plans for programs related to 
import safety. During that public meeting, we mentioned plans to 
continue dialogue on implementation of these import safety programs 
with a series of regional meeting across the United States.
    The agendas, recordings, and transcripts for the FSMA 
implementation and prevention-oriented import system public meetings 
are accessible on our FSMA Web site at http://www.fda.gov/FSMA.

II. Purpose and Format of the Regional Outreach Meetings

    FDA plans to hold three one-day public meetings in different 
regions throughout the United States to provide importers and other 
interested persons an opportunity to have an in-depth discussion on the 
implementation of FSMA import safety programs (i.e., FSVPs for 
importers of food for humans and animals, accreditation of third-party 
certification bodies, and FDA's VQIP). We invite the public to provide 
information, share experiences, and raise issues on implementation 
topics related to import safety including (but not 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, 
compliance and enforcement issues, and long-term implementation 
success. The purpose of the regional outreach meetings is to continue 
the dialogue with the importer community and elicit ideas that will 
help to inform FDA and the regulated population on how to continue to 
work together to successfully comply with FSMA mandates and 
regulations.

III. How To Participate in the Public Meeting

    We are holding three one-day public meetings in different regions 
throughout the United States.
    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 regional outreach meetings, and registration will be on a 
first-come, first-served basis. Early registration is recommended 
because seating is very limited.
    Table 1 provides information on participation in the regional 
outreach meetings.

                                                  Table 1--Information on Participation in the Meeting
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                                                                                                                         Special
   Regional outreach meetings           Date               Address          Preregister       Electronic address      accommodations   Other information
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California Regional Outreach     June 7, 2016, from  The Hilton Costa    May 26, 2016:      Please preregister at   May 25, 2016:      Registration
 Meeting.                         8:30 a.m. to 3      Mesa, 3050          Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  p.m. PDT.           Bristol Street,     Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Costa Mesa, CA                         WorkshopsMeetingsConf   accommodations
                                                      92626.                                 erences/default.htm.    due to a
                                                                                                                     disability.
New Jersey Regional Outreach     June 15, 2016,      Renaissance         June 3, 2016:      Please preregister at   June 2, 2016:      Registration
 Meeting.                         from 8:30 a.m. to   Meadowlands         Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  3 p.m. EDT.         Hotel, 801          Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Rutherford                             WorkshopsMeetingsConf   accommodations
                                                      Avenue,                                erences/default.htm.    due to a
                                                      Rutherford, NJ                                                 disability.
                                                      07070.

[[Page 28037]]

 
Michigan Regional Outreach       June 21, 2016,      Double Tree Suites  June 10, 2016:     Please preregister at   June 9, 2016:      Registration
 Meeting.                         from 8:30 a.m. to   by Hilton Hotel     Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  3 p.m. EDT.         Detroit_Downtown   Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Fort Shelby, 525                       WorkshopsMeetingsConf   accommodations
                                                      W Lafayette                            erences/default.htm.    due to a
                                                      Blvd., Detroit,                                                disability.
                                                      MI 48226.
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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: Peggy Walker, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 214-384-0667, FAX: 469-854-
  6992, email: [email protected].


    Dated: May 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10799 Filed 5-6-16; 8:45 am]
 BILLING CODE 4164-01-P