[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13638-13642]
[FR Doc No: 2011-5943]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0135]

Ensuring the Safety of Imported Foods and Animal Feed:
Comparability of Food Safety Systems and Import Practices of Foreign
Countries; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing regarding new FDA initiatives for ensuring the safety of foods
and animal feed imported into the United States. The purpose of the
public hearing is 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. In a separate
notice published elsewhere in this issue of the Federal Register, FDA
is announcing a 1-day public meeting to discuss implementation of the
imports provisions found in the FDA Food Safety Modernization Act
(FSMA).

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

FOR FURTHER INFORMATION CONTACT: For questions about registration, to
register orally, or to submit a notice of participation by mail, fax,
or by e-mail: Courtney Treece, Planning Professionals Ltd., 1210 W.
McDermott, suite 111, Allen, TX 75013,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>    For questions about the hearing, if special accommodations are
needed due to a disability, to request onsite parking, or to submit the
full text, comprehensive outline, or summary of an oral presentation:
Juanita Yates, Center for Food Safety and Applied Nutrition, Food and
Drug Administation, 5100 Paint Branch Pkwy., College Park, MD 20740,
301-436-1731, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Government and the food industry are pursuing proactive
efforts to reduce the incidence of food borne illness. The President's
Food Safety Working Group (FSWG) has recommended that food regulators
shift towards prioritizing prevention and move aggressively to
implement sensible measures designed to prevent problems before they
occur (Ref. 1). The newly enacted FSMA (Pub. L. 111-353) also embodies
the principle of prevention by requiring those who produce and import
food to have systems of preventive controls in place and empowering FDA
to hold them accountable to meet their new responsibilities.
    FDA recognizes that to ensure the safety of imported foods and
animal feed and fulfill its public health mission in a global age, it
must embrace new approaches that take into account the entire supply
chain and its complexity. Consistent with FSMA and the recommendation
of the President's FSWG, FDA is focusing on preventing problems at
appropriate points along the global food supply chain. This public
hearing is an opportunity for the Agency to obtain views from
interested persons concerning certain key aspects of these food safety
initiatives: (1) International comparability assessments and (2)
gathering information on the policies, practices, and programs used by
foreign regulators to ensure the safety of imported foods and animal
feed. The public hearing will be conducted in accordance with part 15
(21 CFR part 15), as described in the following paragraphs. (See
``Notice of Hearing Under Part 15'' in section III of this document.)
    FDA's initiatives discussed at the 2-day public hearing align with
and help support FSMA implementation. Day One of the hearing will open
with a general discussion of FSMA from the perspectives of consumers,
industry, legislators, and U.S. trading partners. Day Two will cover
policies, practices, and programs used by foreign regulators to ensure
the safety of imported foods and animal feed. In a separate notice
published elsewhere in this issue of the Federal Register, FDA is
announcing a 1-day public meeting to discuss implementation of the
imports provisions found in title III of FSMA.

II. Topics for Discussion at the Hearing

A. Day One of Hearing: International Comparability Assessments

    Under FDA's proposed model, FDA will consider the food safety
system of a foreign country to be ``comparable'' to

the U.S. food safety system if, based on a complete assessment, FDA
determines the foreign food safety system is: (1) Similar, though not
identical, to the U.S. food safety system, (2) comprises elements that
are analogous to those within the U.S. food safety system, and (3) a
system for which FDA has determined provides the same level of public
health protection as that of the United States. To help set regulatory
priorities and improve the efficient use of FDA resources for import
safety, FDA has developed a tool it proposes to use in assessing the
overall food safety systems of other countries and comparing them to
the U.S. food safety system. FDA will post the agenda prior to the
hearing at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm243781.htm.
    At this hearing, FDA will seek public comment on FDA's proposed
comparability assessment process. In particular, FDA will be inviting
the public to share its views on the following topic areas:
Comparability as a Tool
    1. What are the perceived benefits and/or disadvantages to FDA's
proposed comparability model?
    2. What would be reasonable incentives for a country to participate
in a comparability assessment?
    3. What are the potential costs to the country undergoing a
comparability determination and what would make the investment
worthwhile?
    4. Is there a more appropriate term for comparability? If so, what
is the more appropriate term and why is it more appropriate?
    5. How should comparability findings relate to the FSMA import
safety provisions in title III (e.g., the importer verification and
accredited third party provisions)?
Maintaining Comparability Status
    1. For cases where a country's food safety system has been
determined to be comparable: How often should FDA review assessments?
Are there specific changes to a food safety system or regulatory system
that should trigger a visit to the country?
    2. Under what circumstances should comparability be revoked, and by
what process?
    3. What are reasonable expectations for ongoing communication,
updating, and affirmation of a comparability determination?
Lessons Learned Through Equivalence
    The Agency recognizes that comparability determinations represent a
novel construct, albeit there may be corollaries with certain
equivalence determinations, such as those made by the United States
Department of Agriculture's Food Safety and Inspection Service under
its statutory authorities.
    To gain insight from earlier work on equivalence and to inform
efforts to assess comparability, FDA is requesting that countries share
information on their experience with equivalence. FDA seeks information
on the following issues:
    1. What measures do other countries take to ensure transparency
throughout the equivalence determination process?
    2. What are the current practices in requesting translation of
documents?
    3. What are the perceived resource savings associated with finding
a country equivalent?
    4. Are cost benefit analyses available on equivalence
determinations?
    5. Have any equivalence determinations been reversed, and, if so,
under what circumstances?
    6. Are there data that demonstrate that equivalence determinations
provide meaningful public health protections?

B. Day One of Hearing: Update on Pilot: Comparability Review of New
Zealand

    The United States and New Zealand have several Cooperative
Arrangements with each other relating to food safety. To facilitate the
renewal of existing Arrangements between the United States and New
Zealand, the New Zealand Food Safety Authority agreed to participate in
a pilot comparability assessment using FDA's proposed model for
international comparability assessment. An update on this comparability
assessment process will be provided during the public hearing.

C. Day One of Hearing: Update on European Union (EU) Molluscan Bivalve
Equivalence Determination With Comparability Component

    During bilateral discussions early in 2010, the United States and
the EU addressed issues related to possible approaches to equivalence
assessments. During these discussions, it was noted that the Codex
Guidelines on the Judgment of Equivalence of Sanitary Measures
Associated with Food Inspection and Certification systems (CAC/GL 53/
2003) (Ref. 2) provides guidance on equivalence determinations. It was
determined that the comparability framework would allow FDA to apply
the Codex concept to its equivalence determinations, by providing an
objective basis for documenting the knowledge, experience, and
confidence that can be used to underpin further equivalence
determinations. Currently, the United States and EU are in the process
of conducting equivalence assessments of each other's systems for
shellfish. An update on the United States and EU equivalence
assessments of each other's systems for shellfish will be provided at
the public hearing.

D. Day Two of Hearing: Policies, Practices, and Programs Used by
Foreign Regulators To Ensure the Safety of Imported Foods and Animal
Feed

    FDA is interested in learning more about the policies, practices,
and programs (including import and export certification programs) used
by foreign regulators to ensure the safety of foods and animal feed
imported into their countries and will engage directly with countries
over the next several months to learn about their programs. Through
these conversations with regulators from other countries, FDA is also
interested in learning how countries measure the effectiveness of their
import control and export certification activities. The information
obtained from these conversations will allow FDA to explore using the
innovation and improvements that are being adopted in other countries
to improve the safety of imported food and animal feed products. For
example, FDA seeks to better understand the control systems used by
other countries for importation of ingredients used in processed food
as well as the control systems for transshipment of products.
    During Day Two of the public hearing, FDA will seek input from
countries and international organizations that have undertaken
activities to gather information on currently implemented import
policies, practices, and programs, and to provide capacity building
assistance in support of safe imports.

III. Notice of Hearing Under Part 15

    The Commissioner of Food and Drugs (the Commissioner) is announcing
that the public hearing will be held in accordance with part 15. The
hearing will be conducted by a presiding officer, accompanied by FDA
senior management and staff with relevant expertise.
    Persons who wish to participate in the hearing (either by making an
oral presentation or as a member of the audience) must file a notice of
participation. (See table 1 and FOR FURTHER INFORMATION CONTACT of this
document, and ``How to Participate in the Hearing'' in section IV of
this document.) By delegation from the Commissioner (Staff Manual Guide
1410.21, section 1(G)(5)), the Assistant Commissioner for Policy has

determined under Sec.  15.20(c) that advance submissions of oral
presentations are necessary for the panel to formulate useful questions
to be posed at the hearing under Sec.  15.30(e), and that the
submission of a comprehensive outline or summary is an acceptable
alternative to the submission of the full text of the oral
presentation. FDA requests that individuals and organizations with
common interests consolidate their requests for oral presentations and
request time for a joint presentation through a single representative.
After reviewing the notices of participation and accompanying
information, the Agency will schedule each oral presentation and notify
each participant of the time allotted to the presenter and the
approximate time that the presentation is scheduled to begin. If time
permits, interested persons who attend the hearing but did not submit a
notice of participation in advance may be permitted to make an oral
presentation at the conclusion of the hearing. The hearing schedule
will be available at the hearing. After the hearing, the hearing
schedule and a list of participants will be placed on file at the
Division of Dockets Management (see table 1 of this document) under the
docket number listed in brackets in the heading of this notice. To
ensure timely handling of any mailed notices of participation,
presentations, or comments, any outer envelope should be clearly marked
with the docket number listed in brackets in the heading of this notice
along with the statement ``Ensuring the Safety of Imported Foods and
Animal Feed; Comparability of Food Safety Systems; Public Hearing
Request for Comments.'' Under Sec.  15.30(f), the hearing is informal,
and the rules of evidence do not apply. No participant may interrupt
the presentation of another participant. Only the presiding officer and
panel members may question any person during or at the conclusion of
each presentation.
    Public hearings under part 15 are subject to the Agency's policy
and procedures for electronic media coverage of public administrative
proceedings in part 10, subpart C (21 CFR part 10, subpart C). Under
Sec.  10.205, representatives of the electronic media may be permitted,
subject to the procedures and limitations in Sec.  10.206, to
videotape, film, or otherwise record Agency public administrative
proceedings, including presentations by participants. The hearing will
be transcribed as stipulated in Sec.  15.30(b).
    Any persons requiring special accommodations to attend the hearing
due to a disability should direct those needs to the contact person
(see FOR FURTHER INFORMATION CONTACT).
    To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of these provisions as specified in Sec. Sec.
10.19 and 15.30(h). In particular, Sec.  15.21(a) states that the
notice of hearing will provide persons an opportunity to file a written
notice of participation with the Division of Dockets Management within
a specified period of time. If the public interest requires, e.g., if a
hearing is to be conducted within a short period of time, the notice
may name a specific FDA employee and telephone number to whom an oral
notice of participation may be given. If the public interest requires,
the notice may also provide for submitting notices of participation at
the time of the hearing. In this document, the conditions for the
hearing specify that notices of participation be submitted
electronically to an Agency Internet site, to a contact person (outside
of FDA) who will accept notices of participation by mail, telephone,
fax, or e-mail, or in person on the day of the hearing (as space
permits). FDA is using these procedures for submitting notices of
participation, rather than providing for the submission of notices of
participation to the Division of Dockets Management, because the
hearing is to be conducted within a short period of time and these
procedures are more efficient. In addition, these procedures provide
more flexibility to persons who wish to participate in the hearing than
would be provided if participants were required to submit the notice of
participation in writing to the Division of Dockets Management. By
delegation from the Commissioner (Staff Manual Guide 1410.21, section
1(G)(5)), the Assistant Commissioner for Policy finds under Sec.  10.19
that no participant will be prejudiced, the ends of justice will
thereby be served, and the action is in accordance with law if notices
of participation are submitted by the procedures listed in this notice
rather than to the Division of Dockets Management.

IV. How To Participate in the Hearing

    Advance registration by submission of a notice of participation is
necessary to ensure participation and will be accepted on a first-come,
first-served basis. Notices of participation may be submitted
electronically (see table 1 of this document); FDA encourages the use
of electronic means of advance registration. Notices of participation
may also be submitted orally or by mail, fax, or e-mail (see FOR
FURTHER INFORMATION CONTACT). See table 1 of this document for the
dates by which notices of participation must be submitted. A single
copy of any notice of participation is sufficient.

                                     Table 1--Information on Participation in the Hearing and on Submitting Comments
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                                               Date                Electronic address        Address (non-electronic)           Other information
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Date of Hearing.....................  March 30, 2011, 9 a.m.  ...........................  Harvey W. Wiley Building,    Registration begins at 8:30 a.m.
                                       to 5 p.m.                                            First Floor Auditorium,
                                      March 31, 2011, 9 a.m.                                Center for Food Safety and
                                       to 1 p.m.                                            Applied Nutrition, Food
                                                                                and Drug Administration,
                                                                                5100 Paint Branch Pkwy.,
                                                                                College Park, MD 20740-
                                                                                3835.
                                                                                Across the street from the
                                                                                College Park/University of
                                                                                Maryland Metro Station
                                                                                (Green Line).

Advance Registration................  By March 21, 2011.....  http://www.fda.gov/Food/     FDA encourages the use of    Registration to attend the
                                                               NewsEvents/                  electronic registration,     hearing will also be accepted
                                                               WorkshopsMeetingsConferenc   if possible.\1\.             onsite on the day of the
                                                               es/ucm243781.htm.                                         hearing, 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 21, 2011.....  ...........................  Juanita Yates, 301-436-      ................................
 to disability.                                                                             1731, email:
<EMAIL_ADDRESS>Make a request for onsite parking...  By March 23, 2011.....  ...........................  Juanita Yates (see previous  ................................
                                                                                row in the fourth column
                                                                                of this table).
Make a request for oral               By March 14, 2011.....  ...........................  ...........................  Requests made on the day of the
 presentations.                                                                                hearing 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.
Provide a brief description of the    By March 23, 2011.....  ...........................  Juanita Yates, 301-436-      Written material associated with
 oral presentation and any written                                                          1731, email:                 an oral presentation may be
 material for the presentation<EMAIL_ADDRESS>  posted without change to http://www.regulations.gov.
Submit written comments.............  Submit comments by      Federal eRulemaking Portal:  FAX:<PHONE_NUMBER>, Mail/     All comments must include the
                                       June 30, 2011.          http://                      Hand delivery/Courier (for   Agency name and the docket
                                                               www.regulations.gov.         paper, disk, or CD-ROM       number found in brackets in the
                                                               Follow the instructions      submissions): Division of    heading of this document. All
                                                               for submitting comments.     Dockets Management (HFA-     comments received may be posted
                                                                                305), Food and Drug          without change to http://
                                                                                Administration, 5630         www.regulations.gov, including
                                                                                Fishers Lane rm. 1061,       any personal information
                                                                                Rockville, MD 20852.         provided. FDA encourages the
                                                                                submission of electronic
                                                                                comments by using the Federal
                                                                                eRulemaking Portal. For
                                                                                additional information on
                                                                                submitting comments, see the
                                                                                ``Request for Comments''
                                                                                heading of the SUPPLEMENTARY
                                                                                INFORMATION section of this
                                                                                document.
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\1\ Registrations or requests to make an oral presentation may be submitted by mail, fax, e-mail, or telephone by providing registration information
  (including name, title, business affiliation (if applicable), address, telephone number, fax number (if available), and e-mail address (if available))
  (see FOR FURTHER INFORMATION CONTACT).

    The notice of participation must include the participant's name,
title, business affiliation (if applicable), address, telephone number,
fax number (if available), and e-mail address (if available). If the
participant wishes to request an opportunity to make an oral
presentation during the open public comment period of the hearing,
their notice of participation also must include the title of their
presentation, the sponsor of the oral presentation (e.g., the
organization paying travel expenses or fees), if any; and the
approximate amount of time requested for the presentation.
Presentations must be limited to the questions and subject matter
identified in this document.
    Under Sec.  15.20(c), if an opportunity to make an oral
presentation is requested, the presentation must be submitted (either
as the full text of the presentation, or as a comprehensive outline or
summary). This may be done by e-mail or in writing. See table 1 of this
document for the dates by which a presentation must be submitted. See
table 1 and FOR FURTHER INFORMATION CONTACT of this document for
information on where to send a presentation.
    Individuals who request an opportunity to make an oral presentation
will be notified of the scheduled time for their presentation prior to
the hearing. Depending on the number of oral presentations, FDA may
need to limit the time allotted for each oral presentation (e.g., 5
minutes each). Depending on the content of the presentations, the time
allotted for oral presentations may vary. The Agency requests that
interested persons and groups having similar interests consolidate
their requests for oral presentation and present them through a single
representative. If special accommodations are needed due to a
disability, please inform the Agency (see table 1 and FOR FURTHER
INFORMATION CONTACT of this document).
    FDA will also accept registration onsite; however, space is
limited. Onsite registration will be accepted on a first-come, first-
served basis and will be closed when the maximum seating capacity is
reached. Requests for an opportunity to make a presentation from
individuals or organizations that did not register in advance to make
an oral

presentation may be granted if time permits.
    Persons who registered in advance for the hearing should check in
at the onsite registration desk between 8:30 a.m. and 9 a.m. Persons
who wish to register onsite on the day of the hearing should do so at
the registration desk between 8:30 a.m. and 9 a.m. FDA encourages all
participants to attend the entire hearing.

V. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see table 1 of this document) either electronic or written comments
regarding this document. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. 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.

VII. References

    The following references are on display at the Division of Dockets
Management (see Transcripts), between 9 a.m. and 4 p.m., Monday through
Friday. (FDA has verified the following Web site addresses, but FDA is
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)
    1. President's Food Safety Working Group findings, http://www.foodsafetyworkinggroup.gov/ContentKeyFindings/HomeKeyFindings.htm.
    2. Codex Guidelines on the Judgment of Equivalence of Sanitary
Measures Associated with Food Inspection and Certification systems
(CAC/GL 53/2003): http://www.codexalimentarius.net/download/standards/10047/CXG_053e.pdf.

    Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5943 Filed 3-10-11; 4:15 pm]
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