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, 13638-13642 [2011-5943]
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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
Internet for easy access to information
including text, graphics, and files that
you may download to a personal
computer with access to the Internet.
Updated on a regular basis, the CDRH
home page includes the guidance as
well as the current list of recognized
standards and other standards related
documents. After publication in the
Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 026’’ will be available on the
CDRH home page. You may access the
CDRH home page at https://www.fda.gov/
MedicalDevices.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for ‘‘FDA Recognized Consensus
Standards’’ at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/Standards.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) 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. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
026. These modifications to the list or
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: March 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5815 Filed 3–11–11; 8:45 am]
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BILLING CODE 4160–01–P
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.
Notice of public hearing; request
for comments.
ACTION:
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:
ctreece@planningprofessionals.com.
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:
Juanita.Yates@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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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 2day 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
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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 https://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:
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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
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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
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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
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determined under § 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 § 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
§ 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 § 10.205,
representatives of the electronic media
may be permitted, subject to the
procedures and limitations in § 10.206,
to videotape, film, or otherwise record
Agency public administrative
proceedings, including presentations by
participants. The hearing will be
transcribed as stipulated in § 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 §§ 10.19
and 15.30(h). In particular, § 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 § 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
Date
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Date of Hearing
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Electronic address
Address (non-electronic)
March 30,
2011, 9 a.m.
to 5 p.m.
March 31,
2011, 9 a.m.
to 1 p.m.
...................................................
Harvey W. Wiley Building, First
Floor Auditorium, Center for
Food Safety and 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).
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Other information
Registration begins at 8:30 a.m.
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TABLE 1—INFORMATION ON PARTICIPATION IN THE HEARING AND ON SUBMITTING COMMENTS—Continued
Date
Electronic address
Address (non-electronic)
Other information
Registration to attend the hearing will
also be accepted onsite on the day
of the hearing, as space permits.
Registration information may be posted without change to https://
www.regulations.gov, including any
personal information provided.
Advance Registration.
By March 21,
2011.
https://www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/ucm243781.htm.
FDA encourages the use of
electronic registration, if possible.1.
Request special
accommodations due to
disability.
Make a request
for onsite
parking.
Make a request
for oral presentations.
By March 21,
2011.
...................................................
Juanita Yates, 301–436–1731,
email:
juanita.yates@fda.hhs.gov.
By March 23,
2011.
...................................................
By March 14,
2011.
...................................................
Juanita Yates (see previous
row in the fourth column of
this table).
...................................................
Provide a brief
description of
the oral presentation and
any written
material for
the presentation.
Submit written
comments.
By March 23,
2011.
...................................................
Juanita Yates, 301–436–1731,
email:
juanita.yates@fda.hhs.gov.
Submit comments by
June 30,
2011.
Federal eRulemaking Portal:
https://www.regulations.gov.
Follow the instructions for
submitting comments.
FAX:
301–827–6870,
Mail/
Hand delivery/Courier (for
paper, disk, or CD–ROM
submissions): Division of
Dockets Management (HFA–
305), Food and Drug Administration, 5630 Fishers Lane
rm. 1061, Rockville, MD
20852.
Requests made on the day of the 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 https://www.regulations.gov,
including any personal information.
Written material associated with an oral
presentation may be posted without
change to https://www.regulations.gov.
All comments must include the Agency
name and the docket number found
in brackets in the heading of this
document. All comments received
may be posted without change to
https://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 ‘‘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 § 15.20(c), if an opportunity to
make an oral presentation is requested,
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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
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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 firstcome, 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
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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 https://
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.
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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, https://
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):
https://www.codexalimentarius.net/
download/standards/10047/
CXG_053e.pdf.
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Town Hall Discussion With the Director
of the Center for Devices and
Radiological Health and Other Senior
Center Management
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public meeting
entitled ‘‘Town Hall Discussion With the
Director of the Center for Devices and
Radiological Health and Other Senior
Center Management.’’ The purpose of
this public meeting in the Orlando, FL,
area is to engage in a dialogue about
issues of importance to FDA’s Center for
Devices and Radiological Health (CDRH)
and to members of the public, including
the medical device industry, health care
professionals, patients, and consumers.
Date and Time: The public meeting
will be held on May 5, 2011, from 8 a.m.
to 12 noon EST.
Location: The public meeting will be
held at the Sheraton Orlando Downtown
Hotel, 400 West Livingston St., Orlando,
FL 32801. Attendees requiring sleeping
rooms should call 401–843–6664 and
request the group rate for the ‘‘Food &
Drug Administration Town Hall
Meeting’’ room block. The meeting will
not be videotaped or Web cast.
Contact: Heather Howell, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4320,
Silver Spring, MD 20993, 301–796–
5718, e-mail:
heather.howell@fda.hhs.gov.
Registration and Requests for Oral
Presentations: If you wish to attend the
public meeting, you must register online
at https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm244462.htm. Persons without
Internet access may call Heather Howell
at 301–796–5718 to register for the
meeting.
Provide complete contact information
for each attendee, including name, title,
company or organization, address,
email, and telephone and fax number.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Registration requests must be received
by 5 p.m. EST on Friday, April 22, 2011.
If you wish to make an oral
presentation during any of the sessions
at the meeting (see section II of this
document), you must indicate this at the
time of registration. FDA will do its best
to accommodate requests to speak.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin.
Registration is free and will be on a
first-come-first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration the day of the public
meeting will be provided on a spaceavailable basis beginning at 7 a.m. EST.
If you need special accommodations
due to a disability, please contact Susan
Monahan, 301–796–5661 or
susan.monahan@fda.hhs.gov, at least 7
days in advance of the meeting.
Comments: FDA is holding this public
meeting to share information and
discuss issues of importance to the
public, including the medical device
industry, health care professionals,
patients, and consumers.
Regardless of attendance at the public
meeting, interested persons may submit
either electronic or written comments.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. 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.
SUPPLEMENTARY INFORMATION:
I. Background
In 2010, CDRH held three Town Hall
meetings in Minneapolis, MN, Boston,
MA, and Los Angeles, CA, to provide
the public with a new venue to discuss
issues of interest with the Center. Any
member of the public was invited to
provide comments to or ask questions of
CDRH participants. We received
positive feedback on these meetings and
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13638-13642]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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: ctreece@planningprofessionals.com.
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: Juanita.Yates@fda.hhs.gov.
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 https://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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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..... https://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 https://www.regulations.gov, including
any personal information
provided.
Request special accommodations due By March 21, 2011..... ........................... Juanita Yates, 301-436- ................................
to disability. 1731, email:
juanita.yates@fda.hhs.gov.
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 https://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. juanita.yates@fda.hhs.gov. posted without change to https://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. https:// 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 https://
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 https://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, https://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): https://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
