[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13643-13645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-N-0144, FDA-
2011-N-0145, and FDA-2011-N-0146]


FDA Food Safety Modernization Act: Title III--A New Paradigm for 
Importers; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comment.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``FDA Food Safety Modernization Act: Title III--A New 
Paradigm for Importers.'' The purpose of the public meeting is to 
provide interested persons an opportunity to discuss implementation of 
the import safety provisions of the recently enacted FDA Food Safety 
Modernization Act (FSMA). FDA is seeking information on importer 
verification, the Voluntary Qualified Importer Program, import 
certifications for food, and third-party accreditation. In a separate 
notice published elsewhere in this issue of the Federal Register, FDA 
is announcing a public hearing to provide stakeholders the opportunity 
to discuss FDA's use of international comparability assessments as a 
mechanism to enhance the safety of imported foods and animal feed and 
lessons learned through equivalence determinations. The public hearing 
will include a separate discussion of FDA's efforts to gather 
information from regulators in other countries regarding the regulatory 
policies, practices, and programs they currently use to ensure the 
safety of foods and animal feed imported into their countries.

DATES: See ``How to Participate in the Meeting'' in the SUPPLEMENTARY 
INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Patricia M. Kuntze, Office of External 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 5322, Silver Spring, MD 20993, 301-796-8641, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FSMA (Pub. L. 111-353) amends the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) to establish the foundation for a modernized, 
prevention-based food safety system that emphasizes accountability for 
domestic and foreign food and animal feed firms in the supply chain 
from farm to U.S. table. In particular, title III of FSMA significantly 
enhances FDA's authority for oversight of the millions of food products 
that enter the United States each year and, among other things, 
requires FDA to develop regulations, guidance, and to otherwise 
implement the following provisions:
    Section 301. Foreign Supplier Verification Program (FSVP) requires 
importers to conduct risk-based foreign supplier verification 
activities to verify that imported food is not adulterated under 
section 402 of the FD&C Act (21 U.S.C. 342) or misbranded under section 
403(w) of the FD&C Act (21 U.S.C. 343(w)) (relating to allergens) and 
is produced in compliance with FDA's preventive controls requirements 
and produce safety standards, where applicable. Facilities in 
compliance with FDA's seafood, juice, or low-acid canned food products 
requirements are exempted in whole or in part from the FSVP 
requirements. The statute directs FDA to exempt, by notice in the 
Federal Register, importers of food imported into the United States in 
small quantities for research uses or for personal consumption. The 
statute further directs FDA to issue implementing regulations and 
guidance on FSVPs.
    Section 302. Voluntary qualified importer program (VQIP) requires 
FDA to establish a voluntary, user-fee funded program to expedite entry 
into the United States of imported food from eligible, qualified 
importers. To be eligible to participate in VQIP, an importer must 
offer food for importation from a facility that has a certification by 
an accredited third party. FDA will qualify eligible importers to 
participate in VQIP based on risk considerations. The statute directs 
FDA to issue guidance on participation in and compliance with VQIP.
    Section 303. Authority to require import certifications for food 
authorizes FDA, based on risk considerations, to require an article of 
food offered for import into the United States to be accompanied by 
certifications or other assurances that the food complies with relevant 
provisions of the FD&C Act. Certifications may be issued by designated 
foreign governments or accredited third parties.
    Section 307. Accreditation of third-party auditors directs FDA to 
establish a system for the recognition of accreditation bodies that 
accredit third-party auditors to issue certifications for purposes of 
the import certification for food and VQIP provisions described 
previously in this document. Foreign

[[Page 13644]]

governments, foreign cooperatives, and any other third parties 
(including private entities) are eligible to be considered for 
accreditation as third-party auditors. The statute further provides 
that if FDA has not, within a specified timeframe, identified and 
recognized an accreditation body to meet the requirements of this 
provision, FDA may directly accredit third-party auditors. The statute 
directs FDA to issue implementing regulations, including provisions on 
conflicts of interest, financial ties, and unannounced audits, as well 
as model accreditation standards, including requirements for regulatory 
audit reports.
    In a separate notice published elsewhere in this issue of the 
Federal Register, FDA is announcing a public hearing March 30 and 31, 
2011, to provide stakeholders the opportunity to discuss FDA's use of 
international comparability assessments as a mechanism to enhance the 
safety of imported foods and animal feed and lessons learned through 
equivalence determinations. In addition, there will be a separate 
discussion of FDA's efforts to gather information from regulators in 
other countries regarding the regulatory policies, practices, and 
programs they currently use to ensure the safety of foods and animal 
feed imported into their countries.

II. Purpose and Format of the Meeting

    If you wish to attend and/or present at the meeting scheduled for 
March 29, 2011, please register by e-mail to http://www.blsmeetings.net/FDAImportSafety by March 22, 2011. FDA is holding 
the public meeting on the FSMA imports provisions to receive input from 
the public to inform the development of the regulations and guidance 
identified previously in this document. In general, the meeting format 
will include introductory presentations by FDA. Listening to our 
stakeholders is the primary purpose of this meeting. In order to meet 
this goal, FDA will provide multiple opportunities for individuals to 
actively express their views by making presentations at the meeting, 
participating in break-out sessions on the provisions discussed at the 
meeting, and submitting written comments to the docket(s) (see table 2 
of this document for a list of docket numbers and corresponding 
sections of FSMA) within 30 days after this meeting. There will be an 
interactive webcast; see section III of this document, ``How to 
Participate in the Meeting.''

III. How To Participate in the Meeting

    Stakeholders will have an opportunity to provide oral comments. Due 
to limited space and time, FDA encourages all persons who wish to 
attend the meeting, including those requesting an opportunity to make 
an oral presentation during the time allotted for public comment at the 
meeting, to register in advance and to provide the specific topic or 
issue to be addressed and the approximate desired length of their 
presentation. Depending on the number of requests for such oral 
presentations, there may be a need to limit the time of each oral 
presentation (e.g., 3 minutes each). If time permits, individuals or 
organizations that did not register in advance may be granted the 
opportunity for such an oral presentation. FDA would like to maximize 
the number of stakeholders 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 views at the meeting. FDA anticipates 
that there will be several opportunities to speak in break-out sessions 
and an interactive webcast will also be available for stakeholders who 
are not onsite. FDA encourages persons and groups who have similar 
interests to consolidate their information for presentation through a 
single representative. After reviewing the presentation requests, FDA 
will notify each participant before the meeting of the amount of time 
available and the approximate time their presentation is scheduled to 
begin.
    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.
    Table 1 of this document provides information on participating in 
the meeting and on submitting comments to the docket (see table 2 of 
this document for a list of docket numbers and corresponding sections 
of FSMA).

                                     Table 1--Information on Participation in the Meeting and on Submitting Comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Date              Electronic address       Address (non-electronic)             Other information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date of Public Meeting.............  March 29, 2011, 9      ..........................  FDA White Oak Campus, The   Registration begins at 7:30 a.m.
                                      a.m. to 5 p.m.                                     Great Room, Bldg. 31, rm.
                                                                                         1503, 10903 New Hampshire
                                                                                         Ave., Silver Spring, MD
                                                                                         20993.
Webcast............................  March 29, 2011, 9      https://                    ..........................   If you have never attended
                                      a.m. to 5 p.m.         collaboration.fda.gov/                                  a ConnectPRO meeting: Test your
                                                             foodsafety/.                                            connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm Get a
                                                                                                                     quick overview: http://www.adobe.com/go/connectpro_overview overview \1\
                                                                                                                     The webcast will provide
                                                                                                                     closed captioning.
Advance Registration...............  By March 22, 2011....  http://www.blsmeetings.net/ ..........................  Registration to attend the meeting
                                                             FDAImportSafety.                                        will also be accepted onsite on the
                                                                                                                     day of the meeting, as space
                                                                                                                     permits. Registration information
                                                                                                                     may be posted without change to
                                                                                                                     http://www.regulations.gov,
                                                                                                                     including any personal information
                                                                                                                     provided.
Request special accommodations due   By March 22, 2011....  ..........................  Patricia M. Kuntze, 301-    ....................................
 to disability.                                                                          796-8641, email:
                                                                                         [email protected].

[[Page 13645]]

 
Make a request for oral              By March 22, 2011....  http://www.blsmeetings.net/ ..........................  Requests made on the day of the
 presentation.                                               FDAImportSafety.                                        meeting to make an oral
                                                                                                                     presentation may be granted as time
                                                                                                                     permits. Information on requests to
                                                                                                                     make an oral presentation may be
                                                                                                                     posted without change to http://www.regulations.gov, including any
                                                                                                                     personal information provided.
Provide a brief description of the   By March 22, 2011....  http://www.blsmeetings.net/ ..........................  Written material associated with an
 oral presentation and any written                           FDAImportSafety.                                        oral presentation should be
 material for the presentation.                                                                                      submitted in Microsoft PowerPoint,
                                                                                                                     Microsoft Word, or Adobe Portable
                                                                                                                     Document Format (PDF) and may be
                                                                                                                     posted without change to http://www.regulations.gov, including any
                                                                                                                     personal information provided.
Submit electronic or written         Submit comments by     Federal eRulemaking         FAX: 301-827-6870. Mail/    All comments must include the Agency
 comments.                            April 29, 2011.        Portal: http://             Hand delivery/Courier       name and the docket number
                                                             www.regulations.gov.        (for paper, disk, or CD-    corresponding with the section of
                                                             Follow the instructions     ROM submissions):           FSMA on which you are commenting
                                                             for submitting comments.    Division of Dockets         (see table 2 of this document for a
                                                                                         Management (HFA-305),       list of docket numbers and
                                                                                         Food and Drug               corresponding sections of FSMA).
                                                                                         Administration, 5630        All received comments may be posted
                                                                                         Fishers Lane, rm. 1061,     without change to http://
                                                                                         Rockville, MD 20852.        www.regulations.gov, including any
                                                                                                                     personal information provided. FDA
                                                                                                                     encourages the submission of
                                                                                                                     electronic comments by using the
                                                                                                                     Federal eRulemaking Portal. For
                                                                                                                     additional information on
                                                                                                                     submitting comments, see the
                                                                                                                     ``Comments'' heading of the
                                                                                                                     SUPPLEMENTARY INFORMATION section
                                                                                                                     of this document.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States
  and/or other countries.

IV. Comments

    Regardless of attendance at the public meeting, interested persons 
may submit to the Division of Dockets Management (see table 1 of this 
document) either electronic or written comments for consideration at or 
after the meeting in addition to, or in place of, a request for an 
opportunity to make an oral presentation. It is only necessary to send 
one set of comments. It is no longer necessary to send two copies of 
mailed comments. Because multiple docket numbers are associated with 
this document, please include with your comments the docket number(s) 
that corresponds with the section of FSMA on which you are commenting 
(see table 2 of this document for a list of docket numbers and 
corresponding sections of FSMA).

                                                     Table 2
----------------------------------------------------------------------------------------------------------------
             Section of FSMA                           Topic                             Docket No.
----------------------------------------------------------------------------------------------------------------
301.....................................  Foreign supplier verification    FDA-2011-N-0143
                                           program.
302.....................................  Voluntary qualified importer     FDA-2011-N-0144
                                           program.
303.....................................  Authority to require import      FDA-2011-N-0145
                                           certifications for food.
307.....................................  Accreditation of third-party     FDA-2011-N-0146
                                           auditors.
----------------------------------------------------------------------------------------------------------------

    Comments that address more than one docket must be filed with each 
docket to ensure consideration. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov and http://www.fda.gov/Food/FoodSafety/FSMA/default.htm. It may 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 
Division of Freedom of Information (HFI-35), Office of Management 
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, 
Rockville, MD 20857.

    Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5942 Filed 3-10-11; 4:15 pm]
BILLING CODE 4160-01-P