[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Pages 30017-30018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12209]



Food and Drug Administration

[Docket No. FDA-2012-N-0437]

International Capacity Building With Respect to Food Safety; 
Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


    The Food and Drug Administration (FDA or Agency) is announcing a 
public meeting entitled ``International Capacity Building with Respect 
to Food Safety.'' This public meeting will provide interested persons 
an opportunity to discuss FDA's comprehensive plan to expand the 
technical, scientific, and regulatory capacity of foreign governments 
and their respective food industries in countries that export foods to 
the United States (the ``capacity-building plan''). FDA is developing 
this plan under the Food Safety Modernization Act (FSMA). More 
specifically, the public will have an opportunity to provide 
information and share views that will inform FDA's development of the 
capacity-building plan. FDA is also establishing a docket to collect 
comments, data, and information relevant to the capacity-building plan.
    Date and Time: 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 information on deadlines for submitting either 
electronic or written comments to FDA's Division of Dockets Management.
    Contact Persons: For questions about registering for the meeting, 
to register orally, or to submit a notice of participation by mail, 
Fax, or email: Courtney Treece, Planning Professionals, Ltd., 1210 West 
McDermott, Suite 111, Allen, TX 75013, 704-258-4983, Fax: 469-854-6992, 
email: ctreece@planningprofessionals.com.
    For questions about the content of the public meeting or if special 
accommodations are needed 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: Juanita.Yates@fda.hhs.gov.


[[Page 30018]]

I. Background

    FSMA (Pub. L. 111-353) establishes the foundation for a modernized 
food safety system that provides FDA with more authorities to address 
the increasingly globalized food supply and prevent problems before 
they occur. The legislation comes at a time when FDA has identified 
strengthening the safety and integrity of the global supply chain as a 
key Agency priority. Indeed, two recent reports have focused on the 
challenges of global supply chains: FDA's ``Pathway to Global Product 
Safety and Quality,'' and the Institute of Medicine's report ``Ensuring 
Safe Foods and Medical Products through Regulatory Systems Abroad,'' 
which was commissioned by FDA. FSMA enhances FDA's efforts to increase 
the safety of the global supply chain, by, among other things, 
recognizing the importance of partnerships in the area of imports. 
Critically, the legislation directs FDA to focus on international food 
safety capacity--a key prevention-oriented activity. FSMA requires that 
the Secretary (by delegation, FDA) develop a plan to increase the 
technical, scientific, and regulatory food safety capacity of foreign 
governments and their respective food industries in countries that 
export foods to the United States (Pub. L. 111-353, sec. 305). (To see 
the full text of section 305 of FSMA, visit: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm#SEC305.).
    Further, FDA is required to develop the capacity-building plan in 
consultation with certain stakeholders, including representatives of 
the food industry, foreign government officials, nongovernmental 
organizations that represent the interests of consumers, and certain 
Federal officials. The Federal officials include the Secretary of 
Agriculture, the Secretary of State, the Secretary of the Treasury, the 
Secretary of Homeland Security, the U.S. Trade Representative, and the 
Secretary of Commerce. FDA is also required to consult with other 
    The capacity-building plan must include, as appropriate:
    1. Recommendations for bilateral and multilateral arrangements and 
agreements, including providing for responsibilities of exporting 
countries to ensure food safety;
    2. Provisions for secure electronic data sharing;
    3. Provisions for mutual recognition of inspection reports;
    4. Training of foreign governments and food producers on U.S. 
requirements for safe food;
    5. Recommendations on whether and how to harmonize requirements 
under the Codex Alimentarius; and
    6. Provisions for multilateral acceptance of laboratory methods and 
testing and detection techniques.
    The public meeting is an opportunity for interested persons and 
stakeholders to share views concerning how FDA should address the six 
elements in the capacity-building plan. Although section 305 identified 
these six elements, the list need not be exclusive. Therefore, 
interested persons may also share views as to whether FDA should 
consider additional issues in developing the plan. Furthermore, the 
public meeting is an opportunity for FDA to share the Agency's current 
thinking on the capacity-building plan. FDA encourages interested 
persons to provide feedback on any proposals that FDA presents at the 
public meeting. FDA is also establishing a docket to obtain comments, 
data, and evidence that will inform the Agency's development of the 
capacity-building plan. FDA will make available the agenda and other 
documents prior to the public meeting.

II. Purpose and Format of the Meeting

    FDA is holding the public meeting to receive input from the public 
and from stakeholders to inform FDA's development of the capacity-
building plan. This 1-day public meeting will open with a discussion of 
the context for international food safety capacity building and then 
proceed with more specific discussions about the capacity-building 
plan. Throughout the meeting, FDA will provide opportunities for 
individuals to share their views.
    Prior to the public meeting, FDA will post the agenda for the 
meeting on the Agency's Web site. Interested persons may access the 
agenda at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. In addition to posting the 
agenda, FDA may also make available additional information about the 
capacity-building plan at this Web site. For general information, 
interested persons may visit FDA's FSMA International Capacity Building 
Web page located at http://www.fda.gov/Food/FoodSafety/FSMA/ucm301708.htm.

III. How to Participate in the Public Meeting

    Stakeholders and interested persons will have the opportunity to 
provide oral comments. The public meeting will be held from 9 a.m. to 5 
p.m. on June 19, 2012, at the L'Enfant Plaza Hotel, 480 L'Enfant Plaza 
SW., Washington, DC The meeting is open to the public and on-site 
registration will be available, beginning at 8 a.m. However, attendees 
are encouraged to register in advance because seating is limited. 
Individuals who wish to attend the meeting can obtain information on 
how to register online at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. There is no fee for 
    Regardless of attendance at the public meeting, individuals may 
also share their views by submitting electronic or written comments to 
FDA's Division of Dockets Management. The deadline for submitting 
comments to the docket is July 20, 2012. Please note the following 
important dates:
     June 11, 2012: Closing date for advance registration and 
requesting special accommodations due to a disability.
     July 20, 2012: Closing date to submit either electronic or 
written comments to FDA's Division of Dockets Management.

IV. Request for Comments

    When submitting electronic or written comments to FDA's Division of 
Dockets Management, please include the docket number found in brackets 
in the heading of this document. All comments received by the Agency 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

V. 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/Food/FoodSafety/FSMA/ucm301708.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. 
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/FoodSafety/FSMA/ucm301708.htm.

    Dated: May 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12209 Filed 5-18-12; 8:45 am]