[Federal Register Volume 78, Number 159 (Friday, August 16, 2013)]
[Proposed Rules]
[Pages 49988-49990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19961]



[[Page 49988]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 16

[Docket Nos. FDA-2011-N-0143 and FDA-2011-N-0146]


Food and Drug Administration Food Safety Modernization Act: 
Proposed Rules on Foreign Supplier Verification Programs and the 
Accreditation of Third-Party Auditors/Certification Bodies; 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 to discuss two proposed rules aimed at strengthening 
assurances that imported food meets the same safety standards as food 
produced domestically. The Foreign Supplier Verification Programs 
(FSVP) proposal establishes requirements for importers to verify that 
their foreign suppliers are implementing the modern, prevention-
oriented food safety practices called for by the Food Safety 
Modernization Act (FSMA) and achieving the same level of food safety as 
domestic growers and processors. The second proposed rule on the 
Accreditation of Third-Party Auditors/Certification Bodies would 
strengthen the quality, objectivity, and transparency of foreign food 
safety audits on which many U.S. food companies and importers currently 
rely to help manage the safety of their global food supply chains. The 
purpose of the public meeting 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 Meetings'' in 
the SUPPLEMENTARY INFORMATION section for dates and times of the public 
meeting, 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 
Meetings'' in the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: For questions about registering for 
the meeting, to register by phone, or to submit a notice of 
participation by mail, fax, or email: Peggy Walker, Planning 
Professionals, Ltd., 1210 West McDermott Dr., Suite 111, Allen, TX 
75013, telephone: 469-854-6991, FAX: 469-854-6992, email: 
[email protected].
    For general questions about the meeting, to request an opportunity 
to make an oral presentation at the public meeting, 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, 
telephone: 240-402-1731, email: [email protected].

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 food and animal food, set standards for produce 
safety, and require importers to have a program to verify that the food 
products they bring into the United States are produced in a manner 
consistent with U.S. standards.
    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. 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 for human food and submit comments to the 
Agency. These proposed rulemakings were the first of several key 
proposals in furtherance of FSMA's food safety mandate. For information 
on the produce safety proposed rule, the preventive controls proposed 
rule and related fact sheets see FDA's FSMA Web page located at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.
    In the Federal Register of July 29, 2013 (78 FR 45729 and 78 FR 
45781) FDA announced the second set of FSMA proposed rules and the 
establishment of two additional dockets so that the public can review 
the proposals on FSVP and the Accreditation of Third-Party Auditors/
Certification Bodies and submit comments to the Agency. Under the 
proposed FSVP rule, those importing FDA-regulated food into the United 
States will be held accountable for verifying that their suppliers 
produce food in a manner consistent with U.S. standards. Under the 
proposed rule that would establish the Accreditation of Third-Party 
Auditors/Certification Bodies program, FDA would recognize 
accreditation bodies based on certain criteria such as competency and 
impartiality. The accreditation bodies, which could be foreign 
governments or their agencies or private companies, would in turn 
accredit third-party auditors to audit and issue certifications for 
foreign food facilities and food.
    FDA is announcing a series of public meetings entitled ``The Food 
Safety Modernization Act Public Meeting on Proposed Rules for Foreign 
Supplier Verification Programs (FSVP) and for the Accreditation of 
Third-Party Auditors/Certification Bodies for Imported Food Public 
Meeting'' so that the food industry, consumers, foreign governments, 
and other stakeholders can better evaluate and comment on the 
proposals. The Washington, DC public meeting is the first of three that 
the Agency plans to hold during the proposed rules' comment period. We 
intend to hold the additional public meetings in diverse geographical 
regions of the United States. Specific locations, dates, and 
registration information for these meetings will appear in a separate 
Federal Register notice to publish shortly. All three public meetings 
will have the same agenda and are intended to facilitate and support 
the proposed rules' evaluation and commenting process.

II. How To Participate in the Public Meetings

    FDA is holding the public meetings on the FSVP and the 
Accreditation of Third-Party Auditors/Certification Bodies proposed 
rules 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 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

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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 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 meeting 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. 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., FSVP, Docket No. FDA-2011-N-0143, or accreditation of 
third-party auditors, Docket No. FDA-2011-N-0146.
    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 Rulemaking Dockets
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                                         Date         Electronic address        Address        Other information
----------------------------------------------------------------------------------------------------------------
Public meeting..................  September 19,                           Omni Shoreham       Onsite
                                   2013, from 8:30                         Hotel, 2500         registration both
                                   a.m. to 5 p.m.                          Calvert St. NW.     days from 8 a.m.
                                   and September 20,                       (at Connecticut     to 8:30 a.m.
                                   2013, from 8:30                         Ave.),
                                   a.m. to 12:30 p.m.                      Washington, DC
                                                                           20008.
Advance registration............  By September 10,    Individuals who     We encourage you    There is no
                                   2013.               wish to             to use electronic   registration fee
                                                       participate in      registration if     for the public
                                                       person are asked    possible.\1\        meetings. Early
                                                       to preregister at                       registration is
                                                       http://                                 recommended
                                                       www.fda.gov/Food/                       because seating
                                                       NewsEvents/                             is limited.
                                                       WorkshopsMeetings
                                                       Conferences/
                                                       default.htm.
Request to make an oral           By August 29, 2013  http://www.fda.gov/ ..................  Requests made on
 presentation.                                         Food/NewsEvents/                        the day of the
                                                       WorkshopsMeetings                       meeting to make
                                                       Conferences/                            an oral
                                                       default.htm.\2\                         presentation will
                                                                                               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.
Request special accommodations    By August 29, 2013  Juanita Yates,      See FOR FURTHER     ..................
 due to a disability.                                  email:              INFORMATION
                                                       Juanita.yates@fda   CONTACT.
                                                       .hhs.gov.
Submit electronic or written      By November 26,     Docket Nos. FDA-                        ..................
 comments.                         2013.               2011-N-0143 and
                                                       FDA-2011-N-0146.
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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 Dr., suite 111, Allen, TX 75013, telephone: 469-854-6991, FAX: 469-854-6992, e-mail:
  [email protected]. Onsite registration will also be available.
\2\ You may also request to make an oral presentation at the public meetingv 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, Center for Food Safety and Applied Nutrition,
  Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740, telephone: 240-402-1731, email:
  [email protected].

III. Comments, Transcripts, and Recorded Video

    Information and data submitted voluntarily to FDA during the public 
meeting 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 
meeting 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/GuidanceRegulation/FSMA/default.htm. 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 will also be available in 
either hardcopy or on CD-ROM, after submission of a Freedom of

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Information request. Written requests are to be sent to the Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857. Additionally, FDA 
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/Food/GuidanceRegulation/FSMA/default.htm.

    Dated: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19961 Filed 8-15-13; 8:45 am]
BILLING CODE 4160-01-P