Public Hearing: Strategic Partnerships To Enhance the Safety of Imported Foods: Capacity Building, Risk-Based Decisionmaking, Recognition of Commodity Food Control Programs, and Systems Recognition; Request for Comments, 4896-4899 [2017-00821]
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
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Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00820 Filed 1–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4662]
Public Hearing: Strategic Partnerships
To Enhance the Safety of Imported
Foods: Capacity Building, Risk-Based
Decisionmaking, Recognition of
Commodity Food Control Programs,
and Systems Recognition; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA or we) is
announcing a public hearing regarding
FDA initiatives for enhancing the safety
of foods (for humans and animals)
imported into the United States. The
hearing will focus on partnerships to
improve safety capabilities through
capacity building; partnerships that
incorporate information from private
entities and foreign competent
authorities to inform risk-based
decisionmaking; partnerships that
recognize commodity-specific export
programs; and partnerships that
recognize the robustness of a nation’s
entire food safety system. In addition,
we are seeking information from a
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SUMMARY:
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variety of viewpoints, including from
competent authorities in other countries
and from private entities, to help inform
FDA regarding risk-based
decisionmaking, commodity-specific
export control programs in other
countries, and systems recognition.
DATES: See ‘‘How to Participate in the
Hearing’’ in the SUPPLEMENTARY
INFORMATION section of this document
for dates and times of the public
meetings, closing dates for advance
registration, requesting special
accommodations due to disability,
closing date to submit comments to the
docket, and other information regarding
meeting participation.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
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Instructions: All submissions received
must include the Docket No. FDA–
2016–N–4662 for ‘‘Public Hearing:
Strategic Partnerships to Enhance the
Safety of Imported Foods: Capacity
Building, Risk-Based Decisionmaking,
Recognition of Commodity Food Control
Programs, and Systems Recognition.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Wade Woolfolk, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition (HFS–550), 5001
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Campus Dr., College Park, MD 20740,
240–402–6411, FAX: 301–436–2618,
email: wade.woolfolk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
On March 30–31, 2011, we held a
public hearing to discuss our use of
international comparability assessments
as a mechanism to help enhance the
safety of imported foods (see ‘‘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’’ (76 FR 13638,
March 14, 2011; available at https://
www.regulations.gov, in docket FDA–
2011–N–0135)). At the public hearing
we presented information on our food
safety capacity building efforts related
to the FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353). We also
held a public meeting on June 19, 2012,
to discuss our comprehensive plan to
expand the technical, scientific, and
regulatory capacity of foreign
governments and their respective food
industries in countries that export foods
to the United States (see ‘‘International
Capacity Building with Respect to Food
Safety Public Meeting’’ (77 FR 30017,
May 21, 2012; available at https://
www.regulations.gov, in docket FDA–
2011–N–0135)). This meeting invited
discussion on the International Capacity
Building plan development under
FSMA. Following these discussions we
issued the final International Capacity
Building Plan in February 2013. See
https://www.fda.gov/food/
guidanceregulation/fsma/
ucm301708.htm.
FSMA has enabled us to better protect
public health through new authorities to
help ensure that imported foods meet
the same safety standards as foods
produced in the United States.
In implementing FSMA, we recognize
the importance of strengthening the
existing collaborations among food
safety regulators (U.S. Federal, State,
local, territorial, tribal, and foreign) to
achieve our public health goals. We
continue to engage in a variety of
partnerships that, collectively, are
intended to enhance the safety of foods
imported into the United States.
At the public hearing that is the
subject of this notice, we will provide
an update on our food safety capacity
building efforts, as well as additional
updates and information on the
approach we will use to help ensure the
safety of imported foods. In addition,
the public hearing will provide an
opportunity for FDA to obtain testimony
from diverse stakeholder groups as we
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seek to develop, expand, or refine key
partnership activities.
We seek input from a variety of
perspectives on the following topics:
• How to expand performance
measurement for FDA’s capacity
building activities to ensure that we
collaborate effectively with other
nations, multilateral organizations,
donor organizations, and industry.
• How to operationalize the concept
of ‘‘same level of public health
protection’’ that is part of the rule on
Foreign Supplier Verification Programs
(FSVP) (80 FR 74226, November 27,
2015) and what types of partnerships
facilitate application of this concept.
(The FSVP regulation requires importers
to implement FSVPs to provide
adequate assurances that the importer’s
foreign suppliers produce food in
compliance with processes and
procedures, including risk-based
preventive controls, that provide the
same level of public health protection as
those required under section 418
(concerning hazard analysis and
preventive controls) or 419 (concerning
produce safety) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as appropriate, and in compliance with
sections 402 (concerning adulteration)
and 403(w) (concerning misbranding
regarding allergen labeling) of the FD&C
Act.)
• Whether and how we should
consider private standards in risk-based
decisionmaking, including how other
competent authorities use information,
such as third-party certifications or
other assurances, from private entities.
• Whether and how we should
expand our systems recognition
framework to include consideration of
the recognition of commodity-specific
export control programs.
The initiatives that will be discussed
at the public hearing align with and
support FSMA implementation. Day one
of the hearing will seek input on
partnerships to improve food safety
capabilities in other countries, tools to
inform FDA’s risk based
decisionmaking, and methods to assess
the effectiveness of our capacity
building efforts. We also seek input on
whether and how best to incorporate
input from private entities and other
competent authorities into our riskbased decisionmaking framework. Day
two will seek input on partnerships that
recognize the robustness of commodityspecific export programs including
export certification programs and
whether and how we should consider
such programs. In addition, we seek
input on the implementation of the
systems recognition program. Interested
parties may submit comments, data, and
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supporting information on the issues
described in part II of this document.
II. Purpose and Format of the Public
Hearing
A. Day One of Hearing
1. Partnerships To Improve Food Safety
Capabilities: International Capacity
Building
Section 305 of FSMA requires the
Secretary of Health and Human Services
to develop a comprehensive plan to
expand the technical, scientific, and
regulatory food safety capacity of
foreign governments, and their
respective food industries, from which
foods are exported to the United States.
This authority was delegated to FDA,
and we developed an International Food
Safety Capacity Building Plan (the
Plan). The Plan gives us a strategic
framework to expand the technical,
scientific, and regulatory capacity of
foreign governments and their food
industries. We developed the Plan in
consultation with many partners, such
as officials from other parts of the U.S.
government; foreign government
officials; non-governmental
organizations (NGOs) that represent
consumer interests; food industry
representatives; and others. We seek
input on successful models for
continuing capacity building to further
implement the plan. At this hearing, we
will seek comment on food safety
capacity building and development and
invite comment, particularly
publications and data, on food safety
performance monitoring regimes; how
donor organizations minimize
duplication and support leveraged
partnerships; how providers of training
programs assure affordable, accessible,
and culturally specific information is
available to various regions of the
world; how development agencies
interface with food industry supply
chain management programs; and
whether we and industry can leverage
each other’s efforts.
2. Partnerships To Incorporate
Information From Competent
Authorities and Private Entities To
Inform Risk-Based Decisionmaking
In the Federal Register of November
27, 2015 (80 FR 74570), we published a
final rule entitled, ‘‘Accreditation of
Third-Party Certification Bodies To
Conduct Food Safety Audits and To
Issue Certifications.’’ The final rule
established a voluntary program for the
accreditation of third-party certification
bodies to conduct food safety audits of
foreign food facilities and to issue food
and facility certifications. The
requirements in the final rule will help
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ensure the competence and
independence of the accreditation
bodies and third-party certification
bodies participating in the program. We
are aware that other countries
incorporate information from private
entities into their regulatory
decisionmaking. We are interested in
learning more about the policies,
practices, and programs used by foreign
regulators to ensure the safety of food
imported into their countries. We seek
comment and examples on how other
countries use information from private
entities; how other countries ensure
parity in audit, inspectional,
verification, and overall oversight
between domestic and import activities;
and how transparency can be best
achieved.
B. Day Two of Hearing
1. Partnerships That Recognize
Commodity-Specific Exports and
Programs
We are interested in identifying
successful models that recognize
commodity specific food safety control
systems (including export certification
programs), how they are established,
and how they operate.
We seek comment and views on the
best practices, strengths and weaknesses
of commodity export programs or export
certification systems; how commodity
recognition programs factor into riskbased inspectional systems; and once
adopted, how the programs are
monitored over time.
2. Partnerships That Recognize the
Robustness of the Entire Food Safety
System: Systems Recognition
FDA’s systems recognition assessment
process established in 2011 has
progressed from a pilot to a robust
program that has resulted in signed
arrangements with New Zealand’s
Ministry for Primary Industries (2012)
and Canada’s Canadian Food Inspection
Agency (CFIA) and the Department of
Health Canada (Health Canada) (2016).
We seek comment on what indicators
we should consider to determine
whether the program meets expected
outcomes and best practices on how to
identify robust food safety systems.
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 (21 CFR part
15). The hearing will be conducted by
a presiding officer(s), accompanied by
FDA senior management and staff from
the relevant centers/offices (FDA
panelists/experts).
Under § 15.30(f), the hearing is
informal, and the rules of evidence do
not apply. We encourage interested
parties to submit comments to the
docket. We also have invited certain
members of the public to participate as
guest presenters. Only the presiding
officer(s) and FDA panelists/experts
may question any person during or at
the conclusion of each presentation by
the FDA and guest presenters
(§ 15.30(e)). At their discretion, the
presiding officer(s) may permit
questions to be submitted from the
audience for response by FDA or other
persons attending the hearing
(§ 15.30(e)). Finally, time permitting,
stakeholders may be allowed to provide
testimony at the hearing. Time will be
limited to 2 minutes and requests to
make an oral presentation must be
written and received by February 8,
2017. Please include the details of your
presentation when making your request.
All testimony will be entered into the
docket. Public hearings under part 15
are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (21 CFR part 10, subpart C)
(§ 10.203(a)). Under § 10.205,
representatives of the electronic media
may be permitted, subject to certain
limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b) (see part IV of this
document). To the extent that the
conditions for the hearing as described
in this document conflict with any
provisions set out in part 15, this notice
acts as a waiver of those provisions as
specified in § 15.30(h).
Comments may also be submitted
after the hearing. The docket will
remain open for such comments until
May 16, 2017.
IV. How To Participate in the Public
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 email (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 of this document provides
information on participation in the
public meetings.
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING
Date
Electronic address
Address
Attend Public Hearing .......
February 14–15, 2017,
from 9 a.m. to 5:00 p.m.
February 14–15, 2017,
from 9 a.m. to 5:00 p.m.
FDA Center for Food
Safety and Applied Nutrition, Wiley Auditorium,
5001 Campus Dr., College Park, MD 20740.
We encourage you to use
electronic registration if
possible.
Advance registration ..........
Register by February 8,
2017.
Please preregister at
www.fda.gov/Food/News
Events/Workshops/Meetings/Conferences/default.htm.
Individuals who wish to participate by Webcast are
asked to preregister at
www.fda.gov/Food/News
Events/WorkshopsMeetings/Conferences/default.htm.
www.fda.gov/Food/
NewsEvents/Workshops/
Meetings Conferences/
default.htm.
Registration check-in begins at 8 a.m.
View Webcast ....................
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Activity
We encourage you to use
electronic registration if
possible 1.
There is no registration
fee for the public hearing. Early registration is
recommended because
seating is limited.1
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Other information
The Webcast will have
closed captioning.
Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
4899
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING—Continued
Activity
Date
Electronic address
Request to make an oral
presentation.
Request by February 8,
2017.
Submitting either electronic
or written comments.
Submit all other comments
by May 16, 2017.
Request special accommodations due to a disability.
Request by February 8,
2017.
1 Onsite
Individuals who wish to
make a public comment
during the designated
times in the hearing are
asked to submit request
and presentation at
IASEvents@fda.hhs.gov.
https://www.regulations.gov
Wade Woolfolk, email:
wade.woolfolk@
fda.hhs.gov.
Other information
See FOR FURTHER INFORMATION CONTACT.
Division of Dockets Management (HFA–305),
Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
See FOR FURTHER INFORMATION CONTACT.
See ADDRESSES for information on submitting
comments.
registration will not be available at the meeting site.
V. 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
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on FDA’s Web site at https://
www.fda.gov.
Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00821 Filed 1–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; National Hospital Organ
Donation Campaign’s Activity
Scorecard
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA has submitted an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB) for review and approval.
Comments submitted during the first
SUMMARY:
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Address
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public review of this ICR will be
provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
DATES: Comments on this ICR should be
received no later than February 16,
2017.
Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
National Hospital Organ Donation
Campaign’s Activity Scorecard OMB
No. 0915–0373—Revision.
Abstract: HRSA’s Healthcare Systems
Bureau, Division of Transplantation,
administers the Workplace Partnership
for Life (WPFL) program under the
authority of Section 377A(a) of the
Public Health Service (PHS) Act, (42
U.S.C. 274f–1). The WPFL seeks to
involve workplaces and other
organizations in a national effort to
increase the number of registered organ,
eye, and tissue donors and to increase
awareness about organ donation. In
2011, HRSA launched the National
Hospital Organ Donation Campaign
(Hospital Campaign) and issued a
challenge to hospitals nationwide to
assist in this effort by conducting donor
education and donor registry enrollment
events in their hospitals and
communities. The nation’s 58 organ
procurement organizations (OPOs),
which already work with hospitals on
ADDRESSES:
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clinical aspects of transplantation,
participate in the Hospital Campaign to
provide assistance to hospitals in their
service areas as they implement
strategies and activities to increase the
number of enrollments in state donor
registries. HRSA supports the Hospital
Campaign by providing
communications materials, facilitating
the sharing of best practices, leveraging
the influence of national associations
and organizations related to hospitals
and organ donation as Campaign
National Partners, and offering the
additional incentive of national-level
recognition to hospitals.
Need and Proposed Use of the
Information: The Hospital Campaign’s
Activity Scorecard is a key component
of this effort. It provides a menu of over
40 ideas for outreach activities. The
Activity Scorecard also provides
incentive for hospitals to participate by
laying the foundation for recognition.
Each activity on the programmable PDF
is assigned a particular number of
points based on the activity’s potential
for generating registrations. Recognition
is awarded to hospitals that have annual
points which qualify them for one of the
following recognition levels: bronze,
silver, gold, and platinum.
Hospitals can complete the Activity
Scorecard and submit it annually via
email or fax to HRSA or to their local
OPO or Donate Life America (DLA)
affiliate to be considered for recognition.
This is a voluntary activity and
hospitals may participate in the
campaign without using or submitting a
completed Activity Scorecard. However,
most hospitals enrolled in the campaign
(currently 2,038) have submitted a
completed Activity Scorecard to become
eligible for recognition.
Hospitals that achieve specific
outlined levels are recognized annually
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]]>Agencies
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Pages 4896-4899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00821]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4662]
Public Hearing: Strategic Partnerships To Enhance the Safety of
Imported Foods: Capacity Building, Risk-Based Decisionmaking,
Recognition of Commodity Food Control Programs, and Systems
Recognition; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
public hearing regarding FDA initiatives for enhancing the safety of
foods (for humans and animals) imported into the United States. The
hearing will focus on partnerships to improve safety capabilities
through capacity building; partnerships that incorporate information
from private entities and foreign competent authorities to inform risk-
based decisionmaking; partnerships that recognize commodity-specific
export programs; and partnerships that recognize the robustness of a
nation's entire food safety system. In addition, we are seeking
information from a variety of viewpoints, including from competent
authorities in other countries and from private entities, to help
inform FDA regarding risk-based decisionmaking, commodity-specific
export control programs in other countries, and systems recognition.
DATES: See ``How to Participate in the Hearing'' in the SUPPLEMENTARY
INFORMATION section of this document for dates and times of the public
meetings, closing dates for advance registration, requesting special
accommodations due to disability, closing date to submit comments to
the docket, and other information regarding meeting participation.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-4662 for ``Public Hearing: Strategic Partnerships to Enhance
the Safety of Imported Foods: Capacity Building, Risk-Based
Decisionmaking, Recognition of Commodity Food Control Programs, and
Systems Recognition.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Division of Dockets Management. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Wade Woolfolk, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-550),
5001
[[Page 4897]]
Campus Dr., College Park, MD 20740, 240-402-6411, FAX: 301-436-2618,
email: wade.woolfolk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On March 30-31, 2011, we held a public hearing to discuss our use
of international comparability assessments as a mechanism to help
enhance the safety of imported foods (see ``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'' (76 FR 13638, March 14, 2011; available at https://www.regulations.gov, in docket FDA-2011-N-0135)). At the public hearing
we presented information on our food safety capacity building efforts
related to the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-
353). We also held a public meeting on June 19, 2012, to discuss our
comprehensive plan to expand the technical, scientific, and regulatory
capacity of foreign governments and their respective food industries in
countries that export foods to the United States (see ``International
Capacity Building with Respect to Food Safety Public Meeting'' (77 FR
30017, May 21, 2012; available at https://www.regulations.gov, in
docket FDA-2011-N-0135)). This meeting invited discussion on the
International Capacity Building plan development under FSMA. Following
these discussions we issued the final International Capacity Building
Plan in February 2013. See https://www.fda.gov/food/guidanceregulation/fsma/ucm301708.htm.
FSMA has enabled us to better protect public health through new
authorities to help ensure that imported foods meet the same safety
standards as foods produced in the United States.
In implementing FSMA, we recognize the importance of strengthening
the existing collaborations among food safety regulators (U.S. Federal,
State, local, territorial, tribal, and foreign) to achieve our public
health goals. We continue to engage in a variety of partnerships that,
collectively, are intended to enhance the safety of foods imported into
the United States.
At the public hearing that is the subject of this notice, we will
provide an update on our food safety capacity building efforts, as well
as additional updates and information on the approach we will use to
help ensure the safety of imported foods. In addition, the public
hearing will provide an opportunity for FDA to obtain testimony from
diverse stakeholder groups as we seek to develop, expand, or refine key
partnership activities.
We seek input from a variety of perspectives on the following
topics:
How to expand performance measurement for FDA's capacity
building activities to ensure that we collaborate effectively with
other nations, multilateral organizations, donor organizations, and
industry.
How to operationalize the concept of ``same level of
public health protection'' that is part of the rule on Foreign Supplier
Verification Programs (FSVP) (80 FR 74226, November 27, 2015) and what
types of partnerships facilitate application of this concept. (The FSVP
regulation requires importers to implement FSVPs to provide adequate
assurances that the importer's foreign suppliers produce food in
compliance with processes and procedures, including risk-based
preventive controls, that provide the same level of public health
protection as those required under section 418 (concerning hazard
analysis and preventive controls) or 419 (concerning produce safety) of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as
appropriate, and in compliance with sections 402 (concerning
adulteration) and 403(w) (concerning misbranding regarding allergen
labeling) of the FD&C Act.)
Whether and how we should consider private standards in
risk-based decisionmaking, including how other competent authorities
use information, such as third-party certifications or other
assurances, from private entities.
Whether and how we should expand our systems recognition
framework to include consideration of the recognition of commodity-
specific export control programs.
The initiatives that will be discussed at the public hearing align
with and support FSMA implementation. Day one of the hearing will seek
input on partnerships to improve food safety capabilities in other
countries, tools to inform FDA's risk based decisionmaking, and methods
to assess the effectiveness of our capacity building efforts. We also
seek input on whether and how best to incorporate input from private
entities and other competent authorities into our risk-based
decisionmaking framework. Day two will seek input on partnerships that
recognize the robustness of commodity-specific export programs
including export certification programs and whether and how we should
consider such programs. In addition, we seek input on the
implementation of the systems recognition program. Interested parties
may submit comments, data, and supporting information on the issues
described in part II of this document.
II. Purpose and Format of the Public Hearing
A. Day One of Hearing
1. Partnerships To Improve Food Safety Capabilities: International
Capacity Building
Section 305 of FSMA requires the Secretary of Health and Human
Services to develop a comprehensive plan to expand the technical,
scientific, and regulatory food safety capacity of foreign governments,
and their respective food industries, from which foods are exported to
the United States. This authority was delegated to FDA, and we
developed an International Food Safety Capacity Building Plan (the
Plan). The Plan gives us a strategic framework to expand the technical,
scientific, and regulatory capacity of foreign governments and their
food industries. We developed the Plan in consultation with many
partners, such as officials from other parts of the U.S. government;
foreign government officials; non-governmental organizations (NGOs)
that represent consumer interests; food industry representatives; and
others. We seek input on successful models for continuing capacity
building to further implement the plan. At this hearing, we will seek
comment on food safety capacity building and development and invite
comment, particularly publications and data, on food safety performance
monitoring regimes; how donor organizations minimize duplication and
support leveraged partnerships; how providers of training programs
assure affordable, accessible, and culturally specific information is
available to various regions of the world; how development agencies
interface with food industry supply chain management programs; and
whether we and industry can leverage each other's efforts.
2. Partnerships To Incorporate Information From Competent Authorities
and Private Entities To Inform Risk-Based Decisionmaking
In the Federal Register of November 27, 2015 (80 FR 74570), we
published a final rule entitled, ``Accreditation of Third-Party
Certification Bodies To Conduct Food Safety Audits and To Issue
Certifications.'' The final rule established a voluntary program for
the accreditation of third-party certification bodies to conduct food
safety audits of foreign food facilities and to issue food and facility
certifications. The requirements in the final rule will help
[[Page 4898]]
ensure the competence and independence of the accreditation bodies and
third-party certification bodies participating in the program. We are
aware that other countries incorporate information from private
entities into their regulatory decisionmaking. We are interested in
learning more about the policies, practices, and programs used by
foreign regulators to ensure the safety of food imported into their
countries. We seek comment and examples on how other countries use
information from private entities; how other countries ensure parity in
audit, inspectional, verification, and overall oversight between
domestic and import activities; and how transparency can be best
achieved.
B. Day Two of Hearing
1. Partnerships That Recognize Commodity-Specific Exports and Programs
We are interested in identifying successful models that recognize
commodity specific food safety control systems (including export
certification programs), how they are established, and how they
operate.
We seek comment and views on the best practices, strengths and
weaknesses of commodity export programs or export certification
systems; how commodity recognition programs factor into risk-based
inspectional systems; and once adopted, how the programs are monitored
over time.
2. Partnerships That Recognize the Robustness of the Entire Food Safety
System: Systems Recognition
FDA's systems recognition assessment process established in 2011
has progressed from a pilot to a robust program that has resulted in
signed arrangements with New Zealand's Ministry for Primary Industries
(2012) and Canada's Canadian Food Inspection Agency (CFIA) and the
Department of Health Canada (Health Canada) (2016). We seek comment on
what indicators we should consider to determine whether the program
meets expected outcomes and best practices on how to identify robust
food safety systems.
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 (21 CFR
part 15). The hearing will be conducted by a presiding officer(s),
accompanied by FDA senior management and staff from the relevant
centers/offices (FDA panelists/experts).
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. We encourage interested parties to submit
comments to the docket. We also have invited certain members of the
public to participate as guest presenters. Only the presiding
officer(s) and FDA panelists/experts may question any person during or
at the conclusion of each presentation by the FDA and guest presenters
(Sec. 15.30(e)). At their discretion, the presiding officer(s) may
permit questions to be submitted from the audience for response by FDA
or other persons attending the hearing (Sec. 15.30(e)). Finally, time
permitting, stakeholders may be allowed to provide testimony at the
hearing. Time will be limited to 2 minutes and requests to make an oral
presentation must be written and received by February 8, 2017. Please
include the details of your presentation when making your request. All
testimony will be entered into the docket. Public hearings under part
15 are subject to FDA's policy and procedures for electronic media
coverage of FDA's public administrative proceedings (21 CFR part 10,
subpart C) (Sec. 10.203(a)). Under Sec. 10.205, representatives of
the electronic media may be permitted, subject to certain limitations,
to videotape, film, or otherwise record FDA's public administrative
proceedings, including presentations by participants. The hearing will
be transcribed as stipulated in Sec. 15.30(b) (see part IV of this
document). To the extent that the conditions for the hearing as
described in this document conflict with any provisions set out in part
15, this notice acts as a waiver of those provisions as specified in
Sec. 15.30(h).
Comments may also be submitted after the hearing. The docket will
remain open for such comments until May 16, 2017.
IV. How To Participate in the Public 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 email (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 of this document provides information on participation in
the public meetings.
Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
Activity Date Electronic address Address Other information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attend Public Hearing............... February 14-15, 2017, Please preregister at www.fda.gov/Food/ FDA Center for Food Registration check-in
from 9 a.m. to 5:00 NewsEvents/Workshops/Meetings/ Safety and Applied begins at 8 a.m.
p.m. Conferences/default.htm. Nutrition, Wiley
Auditorium, 5001
Campus Dr., College
Park, MD 20740.
View Webcast........................ February 14-15, 2017, Individuals who wish to participate by We encourage you to The Webcast will have
from 9 a.m. to 5:00 Webcast are asked to preregister at use electronic closed captioning.
p.m. www.fda.gov/Food/NewsEvents/ registration if
WorkshopsMeetings/Conferences/ possible.
default.htm.
Advance registration................ Register by February 8, www.fda.gov/Food/NewsEvents/Workshops/ We encourage you to There is no
2017. Meetings Conferences/default.htm. use electronic registration fee for
registration if the public hearing.
possible \1\. Early registration is
recommended because
seating is
limited.\1\
[[Page 4899]]
Request to make an oral presentation Request by February 8, Individuals who wish to make a public See FOR FURTHER
2017. comment during the designated times in INFORMATION CONTACT.
the hearing are asked to submit request
and presentation at
IASEvents@fda.hhs.gov.
Submitting either electronic or Submit all other https://www.regulations.gov.............. Division of Dockets See ADDRESSES for
written comments. comments by May 16, Management (HFA-305), information on
2017. Food and Drug submitting comments.
Administration, 5630
Fishers Lane, Rm.
1061, Rockville, MD
20852.
Request special accommodations due Request by February 8, Wade Woolfolk, email: See FOR FURTHER
to a disability. 2017. wade.woolfolk@fda.hhs.gov. INFORMATION CONTACT.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Onsite registration will not be available at the meeting site.
V. 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 (see ADDRESSES). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. The Freedom of Information office
address is available on FDA's Web site at https://www.fda.gov.
Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00821 Filed 1-13-17; 8:45 am]
BILLING CODE 4164-01-P
