[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Rules and Regulations]
[Pages 9761-9763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04127]


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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]
RIN 0910-AG64 and 0910-AG66


The Food and Drug Administration Food Safety Modernization Act: 
Prevention-Oriented Import System Regulations and Implementation; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing a 
public meeting entitled ``FDA Food Safety Modernization Act: 
Prevention-Oriented Import System Regulations and Implementation.'' The 
public meeting will provide importers and other interested persons an 
opportunity to discuss import safety regulations and programs, 
including final rules for foreign supplier verification programs 
(FSVPs) for importers of food for humans and animals (the FSVP final 
rule) and accreditation of third-party certification bodies (the third-
party certification final rule). Participants will also be briefed on 
the status of FDA's Voluntary Qualified Importer Program (VQIP), which 
is still in development. Additionally, the public meeting will provide 
importers and other interested persons an opportunity to discuss FDA's 
comprehensive planning effort for the next phase of the FDA Food Safety 
Modernization Act implementation relating to import safety programs, 
which includes establishing the operational framework for these 
programs and plans for guidance documents, training, education, and 
technical assistance.

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, 
and requesting special accommodations due to disability.

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 St., Suite 111, Allen, TX 
75013, 704-258-4983, 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

    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 (the FD&C Act) to establish the foundation of a 
modernized, prevention-based food safety system. Among other things, 
FSMA directs FDA to issue regulations requiring preventive controls for 
human food and animal food, setting standards for produce safety, and 
requiring importers to perform certain activities to help ensure that 
the food they bring into the United States is produced in a manner 
consistent with U.S. safety standards.
    In the Federal Register of November 27, 2015, we published the FSVP 
final rule (80 FR 74225) and the third-party certification final rule 
(80 FR 74569).
    The FSVP final rule requires importers of food to verify that their 
foreign suppliers use processes and procedures that provide the same 
level of public health protection as the preventive controls and 
produce safety regulations, where applicable, and also to verify that 
the food they import is not adulterated and is not misbranded with 
respect to food allergen labeling.
    The third-party certification final rule adopts regulations to 
provide for accreditation of third-party certification bodies to 
conduct food safety audits of foreign entities, including registered 
foreign food facilities, and to issue food and facility certifications 
under FSMA. Certification will be required to establish VQIP 
eligibility. To prevent potentially harmful food from reaching U.S. 
consumers, in specific circumstances FDA also may require a food 
offered for import to be accompanied by a certification.
    On June 5, 2015, we published a notice of availability of a draft 
guidance for industry on VQIP for importers of human or animal food (80 
FR 32136). The draft guidance describes and answers questions about 
VQIP. To ensure that we consider comments on the draft guidance before 
we complete a final version of the guidance, we invited electronic or 
written comments on the draft guidance by August 19, 2015.
    The FSVP and third-party certification final rules and related fact 
sheets are available on FDA's FSMA Web page located at http://www.fda.gov/FSMA.
    The FSVP and third-party certification final rules are two of 
several final rules that will establish the foundation of, and central 
framework for, the modern food safety system envisioned by Congress in 
FSMA.

II. Purpose and Format of the Public Meeting

    FDA is holding the public meeting on FSMA's prevention-oriented 
import system 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 are at the core of FSMA; and answer 
questions about these import programs.
    The public meeting is an opportunity for FDA to share its current 
thinking on implementation plans for programs related to import safety. 
We encourage interested persons to provide feedback during the meeting 
on any ideas that we present at the public meeting related to the 
operational aspects of FSMA

[[Page 9762]]

implementation. The agenda and other documents will be accessible on 
our FSMA Web site at http://www.fda.gov/FSMA before the public meeting.
    There will be an opportunity for stakeholders who are unable to 
participate in person to join the meeting via Webcast. (See section III 
for more information on the Webcast option.)
    Following the public meeting, FDA plans to continue dialogue on 
implementation of these import safety programs with a series of 
regional meetings across the United States.

III. How To Participate in the Public Meeting

    We are holding the public meeting on March 21, 2016, from 8:30 a.m. 
until 5 p.m., at FDA's Center for Food Safety and Applied Nutrition, 
Wiley Auditorium, 5100 Paint Branch Parkway, College Park, MD 20740. 
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. 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 focus 
their remarks on the implementation or operational aspects of the 
import safety programs. To make such a presentation, please submit a 
request and provide the specific topic or issue to be addressed. Due to 
the anticipated high level of interest in presenting public comment and 
the limited time available, we are 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. We 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.
    We encourage persons and groups who have similar interests to 
consolidate their information for presentation by a single 
representative. After reviewing the presentation requests, we 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).
    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.
    Table 1 provides information on participation in the public 
meeting.

                              Table 1--Information on Participation in the Meeting
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                                                                                                      Other
                                      Date          Electronic address          Address            Information
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Attend public meeting.........  March 21, 2016,   Please preregister at  FDA Center for Food    Registration
                                 from 8:30 a.m.    http://www.fda.gov/    Safety and Applied     check-in begins
                                 to 5 p.m. ET.     Food/NewsEvents/       Nutrition, Wiley       at 8 a.m.
                                                   WorkshopsMeetingsCon   Auditorium, 5100
                                                   ferences/default.htm.  Paint Branch
                                                                          Parkway, College
                                                                          Park, MD 20740.
View Webcast..................  March 21, 2016,   Individuals who wish   .....................  The Webcast will
                                 from 8:30 a.m.    to participate by                             have closed
                                 to 5 p.m. ET.     Webcast are asked to                          captioning.
                                                   preregister at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Preregister...................  Register by       Individuals who wish   We encourage the use   There is no
                                 March 14, 2016.   to participate in      of electronic          registration
                                                   person are asked to    registration, if       fee for the
                                                   preregister at http:/  possible\1\.           public meeting.
                                                   /www.fda.gov/Food/
                                                   NewsEvents/
                                                   WorkshopsMeetingsCon
                                                   ferences/default.htm.
Request to make a public        Request by March  Individuals who wish   .....................  ................
 comment.                        7, 2016.          to make a public
                                                   comment during the
                                                   Open Public Comment
                                                   and Q&A Session are
                                                   asked to submit
                                                   request at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Request special accommodations  Request by March  Juanita Yates, email:  See FOR FURTHER        ................
 due to a disability             7, 2016.          [email protected]   INFORMATION CONTACT.
                                                   s.gov.
Submit electronic questions     ................  Submit questions to    .....................  For more
 about the FSMA final rules.                       the FDA FSMA                                  information
                                                   Technical Assistance                          about the FDA
                                                   Network at http://                            FSMA Technical
                                                   www.fda.gov/Food/                             Assistance
                                                   GuidanceRegulation/                           Network, visit
                                                   FSMA/ucm459719.htm.                           http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.
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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, Planning Professionals
  Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email:
  [email protected].


[[Page 9763]]

IV. Transcripts and Recorded Video

    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. The Freedom of 
Information office address is available on FDA's Web site at http://www.fda.gov. 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: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04127 Filed 2-25-16; 8:45 am]
 BILLING CODE 4164-01-P