Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies; Public Meetings, 57320-57323 [2013-22655]
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Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Proposed Rules
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By direction of the Commission.
Donald S. Clark,
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[FR Doc. 2013–22638 Filed 9–17–13; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1 and 16
[Docket Nos. FDA–2011–N–0143 and FDA–
2011–N–0146]
Food and Drug Administration Food
Safety Modernization Act: Proposed
Rules on Foreign Supplier Verification
Programs and the Accreditation of
Third-Party Auditors/Certification
Bodies; Public Meetings
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of public meetings.
The Food and Drug
Administration (FDA or we) is
announcing two public meetings to
discuss two proposed rules aimed at
strengthening assurances that imported
food meets the same safety standards as
food produced domestically. The
Foreign Supplier Verification Programs
(FSVP) proposal establishes
requirements for importers to verify that
their foreign suppliers are implementing
the modern, prevention-oriented food
safety practices called for by the Food
Safety Modernization Act (FSMA) and
achieving the same level of food safety
as domestic growers and processors.
The second proposed rule on the
Accreditation of Third-Party Auditors/
Certification Bodies would strengthen
the quality, objectivity, and
transparency of foreign food safety
SUMMARY:
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audits on which many U.S. food
companies and importers currently rely
to help manage the safety of their global
food supply chains. The purpose of
these public meetings is to solicit oral
stakeholder and public comments on
the proposed rules and to inform the
public about the rulemaking process
(including how to submit comments,
data, and other information to the
rulemaking dockets), and to respond to
questions about the proposed rules.
DATES: See section II, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document for date and time of the
public meetings, closing dates for
advance registration, and information
on deadlines for submitting either
electronic or written comments to FDA’s
Division of Dockets Management.
ADDRESSES: See section II, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT: For
questions about registering for the
meetings, to register by phone, or to
submit a notice of participation by mail,
FAX, or email: Lauren Montgomery,
Teya Technologies, LLC, 101 East 9th
Ave., Suite 9B, Anchorage, Alaska
99501, 443–833–4297, FAX: 907–562–
5497, email: lauren.montgomery@
teyatech.com.
For general questions about the
meetings, to request an opportunity to
make an oral presentation at the public
meetings, to submit the full text,
comprehensive outline, or summary of
an oral presentation, or for special
accommodations due to a disability,
contact: Juanita Yates, Center for Food
Safety and Applied Nutrition (HFS–
009), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 240–402–1731, email:
juanita.yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FSMA (Pub. L. 111–353), was signed
into law by President Obama on January
4, 2011, to better protect public health
by helping to ensure the safety and
security of the food supply. FSMA
amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to
establish the foundation of a
modernized, prevention-based food
safety system. Among other things,
FSMA requires FDA to issue regulations
requiring preventive controls for human
food and animal food, set standards for
produce safety, and require importers to
have a program to verify that the food
products they bring into the United
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Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Proposed Rules
States are produced in a manner
consistent with U.S. standards.
FSMA was the first major legislative
reform of FDA’s food safety authorities
in more than 70 years, even though FDA
has increased the focus of its food safety
efforts on prevention for more than a
decade. In the Federal Register of
January 16, 2013 (78 FR 3504 and 78 FR
3646), FDA announced the
establishment of two dockets so that the
public can review the produce safety
proposed rule and the preventive
controls proposed rule for human food
and submit comments to the Agency.
These proposed rulemakings were the
first of several key proposals in
furtherance of FSMA’s food safety
mandate. For information on the
produce safety proposed rule, the
preventive controls rule, and related fact
sheets, see FDA’s FSMA Web page
located at https://www.fda.gov/Food/
GuidanceRegulation/FSMA/
default.htm.
In the Federal Register of July 29,
2013 (78 FR 45730 and 78 FR 45782),
FDA announced the second set of FSMA
proposed rules and the establishment of
two additional dockets so that the
public can review the proposals on
FSVP and the Accreditation of ThirdParty Auditors/Certification Bodies and
submit comments to the Agency. Under
the proposed FSVP rule, those
importing FDA-regulated food into the
United States will be held accountable
for verifying that their suppliers
produce food in a manner consistent
with U.S. standards. Under the
proposed rule that would establish the
Accreditation of Third-Party Auditors/
Certification Bodies program, the FDA
would recognize accreditation bodies
based on certain criteria such as
competency and impartiality. The
accreditation bodies, which could be
foreign governments or their agencies or
private companies, would in turn
accredit third-party auditors to audit
and issue certifications for foreign food
facilities and food.
FDA is announcing a series of public
meetings entitled ‘‘The Food Safety
Modernization Act Public Meetings on
Proposed Rules for Foreign Supplier
Verification Programs (FSVP) and for
the Accreditation of Third-Party
Auditors/Certification Bodies for
Imported Food’’ so that the food
industry, consumers, foreign
governments, and other stakeholders
can better evaluate and comment on the
proposals. These meetings, following
the Washington, DC public event on
September 19 and 20, 2013, are the final
two meetings FDA plans to hold during
the proposed rules’ comment period. All
three public meetings will have the
same agenda and are intended to
facilitate and support the proposed
rules’ evaluation and commenting
process.
II. How To Participate in the Public
Meetings
FDA is holding the public meetings
on the FSVP and the Accreditation of
Third-Party Auditors/Certification
Bodies proposed rules to inform the
public about the rulemaking process,
including how to submit comments,
data, and other information to the
rulemaking docket; to respond to
questions about the proposed rules; and
to provide an opportunity for interested
persons to make oral presentations. Due
to limited space and time, FDA
encourages all persons who wish to
attend the meetings to register in
advance. There is no fee to register for
the public meetings, and registration
will be on a first-come, first-served
basis. Early registration is recommended
because seating is limited. Onsite
registration will be accepted, as space
permits, after all preregistered attendees
are seated.
Those requesting an opportunity to
make an oral presentation during the
time allotted for public comment at the
57321
meeting are asked to submit a request
and to provide the specific topic or
issue to be addressed. Due to the
anticipated high level of interest in
presenting public comment and limited
time available, FDA is allocating 3
minutes to each speaker to make an oral
presentation. Speakers will be limited to
making oral remarks; there will not be
an opportunity to display materials such
as slide shows, videos, or other media
during the meeting. If time permits,
individuals or organizations that did not
register in advance may be granted the
opportunity to make an oral
presentation. FDA would like to
maximize the number of individuals
who make a presentation at the meeting
and will do our best to accommodate all
persons who wish to make a
presentation or express their opinions at
the meeting.
FDA encourages persons and groups
who have similar interests to
consolidate their information for
presentation by a single representative.
After reviewing the presentation
requests, FDA will notify each
participant before the meeting of the
approximate time their presentation is
scheduled to begin, and remind them of
the presentation format (i.e., 3-minute
oral presentation without visual media).
While oral presentations from specific
individuals and organizations will be
necessarily limited due to time
constraints during the public meeting,
stakeholders may submit electronic or
written comments discussing any issues
of concern to the administrative record
(the docket) for the rulemaking. All
relevant data and documentation should
be submitted with the comments to the
relevant docket i.e., FSVP, Docket No.
FDA–2011–N–0143, or accreditation of
third-party auditors, Docket No. FDA–
2011–N–0146.
Table 1 of this document provides
information on participation in the
public meetings:
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING
DOCKETS
Date
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Public meeting ...........
Advance registration ..
VerDate Mar<15>2010
Electronic address
October 10, 2013,
from 8:30 a.m. to 5
p.m. and October
11, 2013, from 8:30
a.m. to 12:30 p.m.
by October 1, 2013 ....
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Address
Other information
Hyatt Regency Miami,
400 SE Second
Ave., Miami, FL
33131.
Individuals who wish to participate in person
are asked to preregister at https://
www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
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Onsite registration
both days from 8
a.m.–8:30 a.m.
We encourage you to
use electronic registration if possible 1.
There is no registration fee for the public meetings. Early
registration is recommended because
seating is limited.
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Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Proposed Rules
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING
DOCKETS—Continued
Date
Electronic address
Address
Request to make a
Public Comment.
by September 24,
2013.
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm 2.
Request special accommodations due
to a disability.
Submit electronic or
written comments.
Public meeting ...........
by September 24,
2013.
Juanita
Yates,
fda.hhs.gov.
November 26, 2013 ...
Other information
Docket Nos. FDA–2011–N–0143 and FDA–
2011–N–0146.
Advance registration ..
October 22, 2013,
from 8:30 a.m. to 5
p.m. and October
23, 2013, from 8:30
a.m. to 12:30 p.m..
by October 8, 2013 ....
email:
juanita.yates@
Individuals who wish to participate in person
are asked to preregister at https://
www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Request to make a
Public Comment.
by October 1, 2013 ....
by October 1, 2013 ....
Juanita
Yates,
fda.hhs.gov.
November 26th, 2013
See FOR FURTHER
INFORMATION
CONTACT.
Hilton Long Beach &
Executive Meeting
Center, 701 West
Ocean Blvd., Long
Beach, CA 90831.
We encourage you to
use electronic registration if possible 1.
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm 2.
Request special accommodations due
to a disability.
Submit electronic or
written comments.
Requests made on
the day of the meeting to make an oral
presentation will 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
provided.
Onsite registration
both days from 8
a.m.–8:30 a.m.
There is no registration fee for the public meetings. Early
registration is recommended because
seating is limited.
Requests made on
the day of the meeting to make an oral
presentation will 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
provided.
Docket Nos. FDA–2011–N–0143 and FDA–
2011–N–0146.
e-mail:
juanita.yates@
See FOR FURTHER
INFORMATION
CONTACT.
1 You may also register via email, mail, or FAX. Please include your name, title, firm name, address, and phone and FAX numbers in your registration information and send to: Lauren Montgomery, Teya Technologies, LLC, 101 East 9th Ave., Suite 9B, Anchorage, Alaska 99501, 443–
833–4297, FAX: 907–562–5497, email: lauren.montgomery@teyatech.com. Onsite registration will also be available.
2 You may also request to make an oral presentation at the public meeting via email. Please include your name, title, firm name, address, and
phone and FAX numbers as well as the full text, comprehensive outline, or summary of your oral presentation and send to: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1731,
email: juanita.yates@fda.hhs.gov.
emcdonald on DSK67QTVN1PROD with PROPOSALS
III. Comments, Transcripts, and
Recorded Video
Information and data submitted
voluntarily to FDA during the public
meeting will become part of the
administrative record for the relevant
rulemaking and will be accessible to the
public at https://www.regulations.gov.
The transcript of the proceedings from
the public meeting will become part of
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the administrative record for each of the
rulemakings. Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov and at FDA’s
FSMA Web site at: https://www.fda.gov/
Food/GuidanceRegulation/FSMA/
default.htm. It may also be viewed at the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
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MD 20852. A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. Written requests
are to be sent to the Division of Freedom
of Information (ELEM–1029), 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857.
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Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Proposed Rules
Dated: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22655 Filed 9–17–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF DEFENSE
Department of the Army, Corps of
Engineers
33 CFR Part 334
York River and the Naval Weapons
Station Yorktown-Cheatham Annex,
Yorktown, Virginia; Danger Zone
AGENCY:
U.S. Army Corps of Engineers,
DoD.
Notice of proposed rulemaking
and request for comments.
ACTION:
The Corps of Engineers is
proposing to establish a danger zone in
the waters of the York River off
Cheatham Annex, in York County,
Virginia. The Cheatham Annex Small
Arms Training Center is used by more
than 50 active Navy, reserve Navy and
active Marine Corps units. The
proposed danger zone is necessary to
protect the public from hazards
associated with the small arms fire
operations.
SUMMARY:
Written comments must be
submitted on or before October 18,
2013.
DATES:
You may submit comments,
identified by docket number COE–
2013–0012, by any of the following
methods:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Email: david.b.olson@usace.army.mil.
Include the docket number, COE–2013–
0012, in the subject line of the message.
Mail: U.S. Army Corps of Engineers,
Attn: CECW–CO–R (David B. Olson),
441 G Street NW., Washington, DC
20314–1000.
Hand Delivery/Courier: Due to
security requirements, we cannot
receive comments by hand delivery or
courier.
Instructions: Direct your comments to
docket number COE–2013–0012. All
comments received will be included in
the public docket without change and
may be made available on-line at
https://www.regulations.gov, including
any personal information provided,
unless the commenter indicates that the
comment includes information claimed
to be Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute. Do
emcdonald on DSK67QTVN1PROD with PROPOSALS
ADDRESSES:
VerDate Mar<15>2010
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not submit information that you
consider to be CBI, or otherwise
protected, through regulations.gov or
email. The regulations.gov Web site is
an anonymous access system, which
means we will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email directly to the
Corps without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the public docket and made available on
the Internet. If you submit an electronic
comment, we recommend that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If we cannot read your
comment because of technical
difficulties and cannot contact you for
clarification, we may not be able to
consider your comment. Electronic
comments should avoid the use of any
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: For access to the docket to
read background documents or
comments received, go to
www.regulations.gov. All documents in
the docket are listed. Although listed in
the index, some information is not
publicly available, such as CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form.
FOR FURTHER INFORMATION CONTACT: Mr.
David Olson, Headquarters, Operations
and Regulatory Community of Practice,
Washington, DC at 202–761–4922, or
Mr. Robert Berg, Corps of Engineers,
Norfolk District, Regulatory Branch, at
757–201–7793.
SUPPLEMENTARY INFORMATION: Pursuant
to its authorities in Section 7 of the
Rivers and Harbors Act of 1917 (40 Stat.
266; 33 U.S.C. 1) and Chapter XIX of the
Army Appropriations Act of 1919 (40
Stat. 892; 33 U.S.C. 3), the Corps of
Engineers is proposing amendments to
regulations in 33 CFR Part 334 to add
a permanent danger zone, in the waters
of the York River off Cheatham Annex,
York County, Virginia. The proposed
danger zone is necessary to protect the
public from hazards associated with
small arms fire operations.
Procedural Requirements
a. Review Under Executive Order 12866
This proposed rule is issued with
respect to a military function of the
Department of Defense and the
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57323
provisions of Executive Order 12866 do
not apply.
b. Review Under the Regulatory
Flexibility Act
This proposed rule has been reviewed
under the Regulatory Flexibility Act
(Pub. L. 96–354) which requires the
preparation of a regulatory flexibility
analysis for any regulation that will
have a significant economic impact on
a substantial number of small entities
(i.e., small businesses and small
governments). Unless information is
obtained to the contrary during the
public notice comment period, the
Corps expects that the proposed danger
zone would have practically no
economic impact on the public, no
anticipated navigational hazard, or
interference with existing waterway
traffic. This proposed rule, if adopted,
will have no significant economic
impact on small entities.
c. Review Under the National
Environmental Policy Act
Due to the administrative nature of
this action and because there is no
intended change in the use of the area,
the Corps expects that this regulation, if
adopted, will not have a significant
impact to the quality of the human
environment and, therefore, preparation
of an environmental impact statement
will not be required. An environmental
assessment will be prepared after the
public notice period is closed and all
comments have been received and
considered.
d. Unfunded Mandates Act
This proposed rule does not impose
an enforceable duty among the private
sector and, therefore, it is not a Federal
private sector mandate and it is not
subject to the requirements of either
Section 202 or Section 205 of the
Unfunded Mandates Act. We have also
found under Section 203 of the Act, that
small governments will not be
significantly and uniquely affected by
this rulemaking.
List of Subjects in 33 CFR Part 334
Danger zones, Marine safety,
Navigation (water), Restricted areas,
Waterways.
For the reasons set out in the
preamble, the Corps proposes to amend
33 CFR part 334 as follows:
PART 334—DANGER ZONE AND
RESTRICTED AREA REGULATIONS
1. The authority citation for 33 CFR
part 334 continues to read as follows:
■
Authority: 40 Stat. 266 (33 U.S.C. 1) and
40 Stat. 892 (33 U.S.C. 3).
E:\FR\FM\18SEP1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Proposed Rules]
[Pages 57320-57323]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22655]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1 and 16
[Docket Nos. FDA-2011-N-0143 and FDA-2011-N-0146]
Food and Drug Administration Food Safety Modernization Act:
Proposed Rules on Foreign Supplier Verification Programs and the
Accreditation of Third-Party Auditors/Certification Bodies; Public
Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meetings.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing two
public meetings to discuss two proposed rules aimed at strengthening
assurances that imported food meets the same safety standards as food
produced domestically. The Foreign Supplier Verification Programs
(FSVP) proposal establishes requirements for importers to verify that
their foreign suppliers are implementing the modern, prevention-
oriented food safety practices called for by the Food Safety
Modernization Act (FSMA) and achieving the same level of food safety as
domestic growers and processors. The second proposed rule on the
Accreditation of Third-Party Auditors/Certification Bodies would
strengthen the quality, objectivity, and transparency of foreign food
safety audits on which many U.S. food companies and importers currently
rely to help manage the safety of their global food supply chains. The
purpose of these public meetings is to solicit oral stakeholder and
public comments on the proposed rules and to inform the public about
the rulemaking process (including how to submit comments, data, and
other information to the rulemaking dockets), and to respond to
questions about the proposed rules.
DATES: See section II, ``How to Participate in the Public Meeting'' in
the SUPPLEMENTARY INFORMATION section of this document for date and
time of the public meetings, closing dates for advance registration,
and information on deadlines for submitting either electronic or
written comments to FDA's Division of Dockets Management.
ADDRESSES: See section II, ``How to Participate in the Public Meeting''
in the SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: For questions about registering for
the meetings, to register by phone, or to submit a notice of
participation by mail, FAX, or email: Lauren Montgomery, Teya
Technologies, LLC, 101 East 9th Ave., Suite 9B, Anchorage, Alaska
99501, 443-833-4297, FAX: 907-562-5497, email:
lauren.montgomery@teyatech.com.
For general questions about the meetings, to request an opportunity
to make an oral presentation at the public meetings, to submit the full
text, comprehensive outline, or summary of an oral presentation, or for
special accommodations due to a disability, contact: Juanita Yates,
Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1731, email: juanita.yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FSMA (Pub. L. 111-353), was signed into law by President Obama on
January 4, 2011, to better protect public health by helping to ensure
the safety and security of the food supply. FSMA amends the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation
of a modernized, prevention-based food safety system. Among other
things, FSMA requires FDA to issue regulations requiring preventive
controls for human food and animal food, set standards for produce
safety, and require importers to have a program to verify that the food
products they bring into the United
[[Page 57321]]
States are produced in a manner consistent with U.S. standards.
FSMA was the first major legislative reform of FDA's food safety
authorities in more than 70 years, even though FDA has increased the
focus of its food safety efforts on prevention for more than a decade.
In the Federal Register of January 16, 2013 (78 FR 3504 and 78 FR
3646), FDA announced the establishment of two dockets so that the
public can review the produce safety proposed rule and the preventive
controls proposed rule for human food and submit comments to the
Agency. These proposed rulemakings were the first of several key
proposals in furtherance of FSMA's food safety mandate. For information
on the produce safety proposed rule, the preventive controls rule, and
related fact sheets, see FDA's FSMA Web page located at https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.
In the Federal Register of July 29, 2013 (78 FR 45730 and 78 FR
45782), FDA announced the second set of FSMA proposed rules and the
establishment of two additional dockets so that the public can review
the proposals on FSVP and the Accreditation of Third-Party Auditors/
Certification Bodies and submit comments to the Agency. Under the
proposed FSVP rule, those importing FDA-regulated food into the United
States will be held accountable for verifying that their suppliers
produce food in a manner consistent with U.S. standards. Under the
proposed rule that would establish the Accreditation of Third-Party
Auditors/Certification Bodies program, the FDA would recognize
accreditation bodies based on certain criteria such as competency and
impartiality. The accreditation bodies, which could be foreign
governments or their agencies or private companies, would in turn
accredit third-party auditors to audit and issue certifications for
foreign food facilities and food.
FDA is announcing a series of public meetings entitled ``The Food
Safety Modernization Act Public Meetings on Proposed Rules for Foreign
Supplier Verification Programs (FSVP) and for the Accreditation of
Third-Party Auditors/Certification Bodies for Imported Food'' so that
the food industry, consumers, foreign governments, and other
stakeholders can better evaluate and comment on the proposals. These
meetings, following the Washington, DC public event on September 19 and
20, 2013, are the final two meetings FDA plans to hold during the
proposed rules' comment period. All three public meetings will have the
same agenda and are intended to facilitate and support the proposed
rules' evaluation and commenting process.
II. How To Participate in the Public Meetings
FDA is holding the public meetings on the FSVP and the
Accreditation of Third-Party Auditors/Certification Bodies proposed
rules to inform the public about the rulemaking process, including how
to submit comments, data, and other information to the rulemaking
docket; to respond to questions about the proposed rules; and to
provide an opportunity for interested persons to make oral
presentations. Due to limited space and time, FDA encourages all
persons who wish to attend the meetings to register in advance. There
is no fee to register for the public meetings, and registration will be
on a first-come, first-served basis. Early registration is recommended
because seating is limited. Onsite registration will be accepted, as
space permits, after all preregistered attendees are seated.
Those requesting an opportunity to make an oral presentation during
the time allotted for public comment at the meeting are asked to submit
a request and to provide the specific topic or issue to be addressed.
Due to the anticipated high level of interest in presenting public
comment and limited time available, FDA is allocating 3 minutes to each
speaker to make an oral presentation. Speakers will be limited to
making oral remarks; there will not be an opportunity to display
materials such as slide shows, videos, or other media during the
meeting. If time permits, individuals or organizations that did not
register in advance may be granted the opportunity to make an oral
presentation. FDA would like to maximize the number of individuals who
make a presentation at the meeting and will do our best to accommodate
all persons who wish to make a presentation or express their opinions
at the meeting.
FDA encourages persons and groups who have similar interests to
consolidate their information for presentation by a single
representative. After reviewing the presentation requests, FDA will
notify each participant before the meeting of the approximate time
their presentation is scheduled to begin, and remind them of the
presentation format (i.e., 3-minute oral presentation without visual
media).
While oral presentations from specific individuals and
organizations will be necessarily limited due to time constraints
during the public meeting, stakeholders may submit electronic or
written comments discussing any issues of concern to the administrative
record (the docket) for the rulemaking. All relevant data and
documentation should be submitted with the comments to the relevant
docket i.e., FSVP, Docket No. FDA-2011-N-0143, or accreditation of
third-party auditors, Docket No. FDA-2011-N-0146.
Table 1 of this document provides information on participation in
the public meetings:
Table 1--Information on Participation in the Meetings and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
Date Electronic address Address Other information
----------------------------------------------------------------------------------------------------------------
Public meeting................. October 10, 2013, Hyatt Regency Onsite
from 8:30 a.m. Miami, 400 SE registration
to 5 p.m. and Second Ave., both days from 8
October 11, Miami, FL 33131. a.m.-8:30 a.m.
2013, from 8:30
a.m. to 12:30
p.m.
Advance registration........... by October 1, Individuals who wish We encourage you There is no
2013. to participate in to use registration fee
person are asked to electronic for the public
preregister at https:// registration if meetings. Early
www.fda.gov/Food/ possible \1\. registration is
NewsEvents/ recommended
WorkshopsMeetingsConf because seating
erences/default.htm. is limited.
[[Page 57322]]
Request to make a Public by September 24, https://www.fda.gov/ Requests made on
Comment. 2013. Food/NewsEvents/ the day of the
WorkshopsMeetingsConf meeting to make
erences/default.htm an oral
\2\. presentation
will be granted
as time permits.
Information on
requests to make
an oral
presentation may
be posted
without change
to https://www.regulations.gov gov, including
any personal
information
provided.
Request special accommodations by September 24, Juanita Yates, email: See FOR FURTHER .................
due to a disability. 2013. juanita.yates@fda.hhs INFORMATION
.gov. CONTACT.
Submit electronic or written November 26, 2013 Docket Nos. FDA-2011-N-
comments. 0143 and FDA-2011-N-
0146.
Public meeting................. October 22, 2013, Hilton Long Beach Onsite
from 8:30 a.m. & Executive registration
to 5 p.m. and Meeting Center, both days from 8
October 23, 701 West Ocean a.m.-8:30 a.m.
2013, from 8:30 Blvd., Long
a.m. to 12:30 Beach, CA 90831.
p.m..
Advance registration........... by October 8, Individuals who wish We encourage you There is no
2013. to participate in to use registration fee
person are asked to electronic for the public
preregister at https:// registration if meetings. Early
www.fda.gov/Food/ possible \1\. registration is
NewsEvents/ recommended
WorkshopsMeetingsConf because seating
erences/default.htm. is limited.
Request to make a Public by October 1, https://www.fda.gov/ Requests made on
Comment. 2013. Food/NewsEvents/ the day of the
WorkshopsMeetingsConf meeting to make
erences/default.htm an oral
\2\. presentation
will be granted
as time permits.
Information on
requests to make
an oral
presentation may
be posted
without change
to https://www.regulations.gov gov, including
any personal
information
provided.
Request special accommodations by October 1, Juanita Yates, e-mail: See FOR FURTHER
due to a disability. 2013. juanita.yates@fda.hhs INFORMATION
.gov. CONTACT.
Submit electronic or written November 26th, Docket Nos. FDA-2011-N-
comments. 2013. 0143 and FDA-2011-N-
0146.
----------------------------------------------------------------------------------------------------------------
\1\ You may also register via email, mail, or FAX. Please include your name, title, firm name, address, and
phone and FAX numbers in your registration information and send to: Lauren Montgomery, Teya Technologies, LLC,
101 East 9th Ave., Suite 9B, Anchorage, Alaska 99501, 443-833-4297, FAX: 907-562-5497, email:
lauren.montgomery@teyatech.com. Onsite registration will also be available.
\2\ You may also request to make an oral presentation at the public meeting via email. Please include your name,
title, firm name, address, and phone and FAX numbers as well as the full text, comprehensive outline, or
summary of your oral presentation and send to: Juanita Yates, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1731, email:
juanita.yates@fda.hhs.gov.
III. Comments, Transcripts, and Recorded Video
Information and data submitted voluntarily to FDA during the public
meeting will become part of the administrative record for the relevant
rulemaking and will be accessible to the public at https://www.regulations.gov. The transcript of the proceedings from the public
meeting will become part of the administrative record for each of the
rulemakings. Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov and at
FDA's FSMA Web site at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm. It may also be viewed at the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to the Division of
Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
[[Page 57323]]
Dated: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22655 Filed 9-17-13; 8:45 am]
BILLING CODE 4160-01-P
