[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Proposed Rules]
[Pages 57320-57323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22655]


=======================================================================
-----------------------------------------------------------------------

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 
Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing two 
public meetings 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 these public meetings 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 Meeting'' in 
the SUPPLEMENTARY INFORMATION section of this document for date and 
time of the public meetings, 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 Meeting'' 
in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: For questions about registering for 
the meetings, to register by phone, or to submit a notice of 
participation by mail, FAX, or email: Lauren Montgomery, Teya 
Technologies, LLC, 101 East 9th Ave., Suite 9B, Anchorage, Alaska 
99501, 443-833-4297, FAX: 907-562-5497, email: 
[email protected].
    For general questions about the meetings, to request an opportunity 
to make an oral presentation at the public meetings, 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, 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

[[Page 57321]]

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 for more than a decade. 
In the Federal Register of January 16, 2013 (78 FR 3504 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 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 45730 and 78 FR 
45782), 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, the 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 Meetings on Proposed Rules for Foreign 
Supplier Verification Programs (FSVP) and for the Accreditation of 
Third-Party Auditors/Certification Bodies for Imported Food'' so that 
the food industry, consumers, foreign governments, and other 
stakeholders can better evaluate and comment on the proposals. These 
meetings, following the Washington, DC public event on September 19 and 
20, 2013, are the final two meetings FDA plans to hold during the 
proposed rules' comment period. 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 
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 meetings:

   Table 1--Information on Participation in the Meetings and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
                                        Date          Electronic address         Address       Other information
----------------------------------------------------------------------------------------------------------------
Public meeting.................  October 10, 2013,                          Hyatt Regency      Onsite
                                  from 8:30 a.m.                             Miami, 400 SE      registration
                                  to 5 p.m. and                              Second Ave.,       both days from 8
                                  October 11,                                Miami, FL 33131.   a.m.-8:30 a.m.
                                  2013, from 8:30
                                  a.m. to 12:30
                                  p.m.
Advance registration...........  by October 1,      Individuals who wish    We encourage you   There is no
                                  2013.              to participate in       to use             registration fee
                                                     person are asked to     electronic         for the public
                                                     preregister at http://  registration if    meetings. Early
                                                     www.fda.gov/Food/       possible \1\.      registration is
                                                     NewsEvents/                                recommended
                                                     WorkshopsMeetingsConf                      because seating
                                                     erences/default.htm.                       is limited.

[[Page 57322]]

 
Request to make a Public         by September 24,   http://www.fda.gov/                        Requests made on
 Comment.                         2013.              Food/NewsEvents/                           the day of the
                                                     WorkshopsMeetingsConf                      meeting to make
                                                     erences/default.htm                        an oral
                                                     \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 gov, including
                                                                                                any personal
                                                                                                information
                                                                                                provided.
Request special accommodations   by September 24,   Juanita Yates, email:   See FOR FURTHER    .................
 due to a disability.             2013.              [email protected]   INFORMATION
                                                     .gov.                   CONTACT.
Submit electronic or written     November 26, 2013  Docket Nos. FDA-2011-N-
 comments.                                           0143 and FDA-2011-N-
                                                     0146.
Public meeting.................  October 22, 2013,                          Hilton Long Beach  Onsite
                                  from 8:30 a.m.                             & Executive        registration
                                  to 5 p.m. and                              Meeting Center,    both days from 8
                                  October 23,                                701 West Ocean     a.m.-8:30 a.m.
                                  2013, from 8:30                            Blvd., Long
                                  a.m. to 12:30                              Beach, CA 90831.
                                  p.m..
Advance registration...........  by October 8,      Individuals who wish    We encourage you   There is no
                                  2013.              to participate in       to use             registration fee
                                                     person are asked to     electronic         for the public
                                                     preregister at http://  registration if    meetings. Early
                                                     www.fda.gov/Food/       possible \1\.      registration is
                                                     NewsEvents/                                recommended
                                                     WorkshopsMeetingsConf                      because seating
                                                     erences/default.htm.                       is limited.
Request to make a Public         by October 1,      http://www.fda.gov/                        Requests made on
 Comment.                         2013.              Food/NewsEvents/                           the day of the
                                                     WorkshopsMeetingsConf                      meeting to make
                                                     erences/default.htm                        an oral
                                                     \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 gov, including
                                                                                                any personal
                                                                                                information
                                                                                                provided.
Request special accommodations   by October 1,      Juanita Yates, e-mail:  See FOR FURTHER
 due to a disability.             2013.              [email protected]   INFORMATION
                                                     .gov.                   CONTACT.
Submit electronic or written     November 26th,     Docket Nos. FDA-2011-N-
 comments.                        2013.              0143 and FDA-2011-N-
                                                     0146.
----------------------------------------------------------------------------------------------------------------
\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: Lauren Montgomery, Teya Technologies, LLC,
  101 East 9th Ave., Suite 9B, Anchorage, Alaska 99501, 443-833-4297, FAX: 907-562-5497, email:
  [email protected]. Onsite registration will also be available.
\2\ You may also request to make an oral presentation at the public meeting 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, 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 
Information request. Written requests are to be sent to the Division of 
Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857.


[[Page 57323]]


    Dated: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22655 Filed 9-17-13; 8:45 am]
BILLING CODE 4160-01-P