[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13638-13642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 704-258-4983, FAX: 469-854-6992, 
e-mail: [email protected].
    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 protected].

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

[[Page 13639]]

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

[[Page 13640]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).

[[Page 13641]]

 
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 protected].
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 protected].   posted without change to http://www.regulations.gov.
Submit written comments.............  Submit comments by      Federal eRulemaking Portal:  FAX: 301-827-6870, 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

[[Page 13642]]

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]
BILLING CODE 4160-01-P