Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Public Meeting, 10107-10110 [2013-03316]
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Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Proposed Rules
other producers, in a combined total
volume that is equal to 25 percent or
more of the producer’s own production;
or the combined total volume of
watermelon handled by the producer
from the producer’s own production
and purchased from other producer’s
production is more than 50 percent of
the producer’s own production:
Provided further, That a person who
both imports and handles watermelons
may vote and serve as an importer if
that person identifies that their vote be
considered as an importer.
*
*
*
*
*
Dated: February 5, 2013.
David R. Shipman,
Administrator.
[FR Doc. 2013–02975 Filed 2–12–13; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, 106, 110, 112, 114,
117, 120, 123, 129, 179, and 211
[Docket Nos. FDA–2011–N–0920 and FDA–
2011–N–0921]
Food and Drug Administration Food
Safety Modernization Act: Proposed
Rules To Establish Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption and for Current Good
Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive
Controls for Human Food; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of public meeting.
The Food and Drug
Administration (FDA) is providing
public meeting registration information
for two FSMA related public meetings
announced in the January 31, 2013,
Federal Register. These public meetings
will be held along with the February 28
to March 1, 2013, Washington, DC
public meeting to discuss the proposed
rules to establish standards for the
growing, harvesting, packing, and
holding of produce for human
consumption (the produce safety
proposed rule) and for current good
manufacturing practice and hazard
analysis and risk-based preventive
controls for human food (the preventive
controls proposed rule). These proposed
rules are the first of several proposed
rules that would establish the
foundation of, and central framework
srobinson on DSK4SPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Mar<15>2010
16:24 Feb 12, 2013
Jkt 229001
for, the modern food safety system
envisioned by Congress in the FDA
Food Safety Modernization Act (FSMA).
The purpose of the 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 dates and times of the
Chicago, IL and Portland, OR 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 these
meetings, to register by phone, or to
submit a notice of participation by mail,
fax, or email: Courtney Treece, Planning
Professionals, Ltd., 1210 West
McDermott Dr., Suite 111, Allen, TX
75013, 704–258–4983, FAX: 469–854–
6992, email:
ctreece@planningprofessionals.com.
For general questions about these
meetings, to request an opportunity to
make an oral presentation at one of 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
and animal food and set standards for
produce safety.
FSMA was the first major legislative
reform of FDA’s food safety authorities
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10107
in more than 70 years, even though FDA
has increased the focus of its food safety
efforts on prevention over the past
several years. For example, applying the
concept of Hazard Analysis and Critical
Control Point (HACCP) that was
pioneered by industry in the late 1960s,
FDA established HACCP-based
regulations for seafood (21 CFR part
123) in 1995 (60 FR 65096, December
18, 1995) and for juice (21 CFR part 120)
in 2001 (66 FR 6138, January 19, 2001).
Similarly, in 1996, the U.S. Department
of Agriculture’s Food Safety and
Inspection Service instituted HACCPbased rules for meat and poultry (9 CFR
part 417) (61 FR 38806, July 25, 1996).
In the Federal Register of January 16,
2013 (78 FR 3503 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
and submit comments to the Agency.
These proposed rulemakings are the
first of several key proposals in
furtherance of FSMA’s food safety
mandate. The produce safety proposed
rule would establish science-based
minimum standards for the safe
growing, harvesting, packing, and
holding of produce, meaning fruits and
vegetables, grown for human
consumption. The produce safety
proposed rule would set forth
procedures, processes, and practices
that FDA expects would reduce
foodborne illness associated with the
consumption of produce. The produce
safety proposed rule and related fact
sheets are available on FDA’s FSMA
Web page located at https://www.fda.gov/
Food/FoodSafety/FSMA/default.htm.
The preventive controls proposed rule
would apply to human food and require
domestic and foreign facilities that are
required to register under the FD&C Act
to have written plans that identify
hazards, specify the steps that will be
put in place to minimize or prevent
those hazards, monitor results, and act
to correct problems that arise. The
preventive controls proposed rule and
related fact sheets are available on
FDA’s FSMA Web page located at
https://www.fda.gov/Food/FoodSafety/
FSMA/default.htm.
In the Federal Register of January 31,
2013 (78 FR 6762), FDA announced the
first public meeting in a series of three
public meetings entitled ‘‘The Food
Safety Modernization Act Public
Meeting on Proposed Rules for Produce
Safety and for Preventive Controls for
Human Food’’ so that the food industry,
consumers, foreign governments, and
other stakeholders can evaluate and
comment on the proposals. FDA also
noted that the Agency intended to hold
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Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Proposed Rules
additional public meetings in Chicago,
IL and Portland, OR and that those
specific locations, dates, and
registration information for these
meetings would appear in a separate
Federal Register document to publish
shortly. It was also noted that all three
public meetings would have the same
agenda and are intended to facilitate
and support the proposed rules’
evaluation and commenting process.
In this document, FDA is providing
the locations, dates, and registration
information for the Chicago, IL and
Portland, OR public meetings.
II. How To Participate in the Public
Meeting
FDA is holding the public meetings
on the produce safety proposed rule and
the preventive controls proposed rule 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 public 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
meetings 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
meetings 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
at a single location. 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., for the produce
safety proposed rule, https://
www.regulations.gov/
#!docketDetail;D=FDA-2011-N-0921;
and for the preventive controls
proposed rule, https://
www.regulations.gov/
#!docketDetail;D=FDA-2011-N-0920).
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
Washington, DC
Public meeting.
Washington, DC
Advance registration.
Electronic address
February 28,
2013, from
8:30 a.m. to 5
p.m. and
March 1,
2013, from
8:30 a.m. to
12 noon.
By February 20,
2013.
srobinson on DSK4SPTVN1PROD with PROPOSALS
Washington, DC
Request to
make an oral
presentation.
By February 8,
2013.
Washington, DC
Request special
accommodations due to a
disability.
By February 15,
2013.
VerDate Mar<15>2010
16:24 Feb 12, 2013
Address
Other information
Jefferson Auditorium, U.S. Department
of
Agriculture
(USDA), Wing 5 Entrance,
14th and Independence Ave.
SW., Washington, DC 20024.
Photo ID Required.
Onsite registration both
from 8 a.m. to 8:30 a.m.
Individuals who wish to participate in person are asked to
preregister
at
https://
www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/default.htm.
https://www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/default.htm.2
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.
Juanita Yates, email:
nita.yates@fda.hhs.gov.
See FOR FURTHER INFORMATION CONTACT.
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days
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.
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Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Proposed Rules
10109
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING
DOCKETS—Continued
Date
Chicago, IL Public
meeting.
Chicago, IL Advance registration.
Electronic address
March 11, 2013,
from 8:30 a.m.
to 5 p.m. and
March 12,
2013, from
8:30 a.m. to
12 noon.
By March 1,
2013.
Chicago, IL Request to make
an oral presentation.
By February 21,
2013.
Chicago, IL Request special
accommodations due to a
disability.
Portland, OR Public meeting.
By February 21,
2013.
Portland, OR Advance registration.
March 27, 2013,
from 8:30 a.m.
to 5 p.m. and
March 28,
2013, from
8:30 a.m. to
12 noon.
By March 18,
2013.
Address
The Westin–Michigan Avenue,
909 North Michigan Ave., Chicago, IL 60611.
Onsite registration both
from 8 a.m. to 8:30 a.m.
Individuals who wish to participate in person are asked to
preregister
at
https://
www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/default.htm.
https://www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/default.htm.2
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.
Juanita Yates, email:
nita.yates@fda.hhs.gov.
See FOR FURTHER INFORMATION CONTACT.
Jua-
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
from 8 a.m. to 8:30 a.m.
Individuals who wish to participate in person are asked to
preregister
at
https://
www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/default.htm.
https://www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/default.htm.2
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.
See FOR FURTHER INFORMATION CONTACT.
By March 8,
2013.
Portland, OR Request special
accommodations due to a
disability.
Submit electronic
or written comments.
By March 8,
2013.
Juanita Yates, email:
nita.yates@fda.hhs.gov.
By May 16,
2013.
Docket Nos. FDA–2011–N–0920
and FDA–2011–N–0921.
Jua-
16:24 Feb 12, 2013
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days
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.
Preventive Controls for Human
Food Proposed Rule: https://
www.regulations.gov/
#!docketDetail;D=FDA-2011-N0920.
VerDate Mar<15>2010
days
Crown Plaza Portland Downtown
Convention Center, 1441 NE
2nd Ave., Portland, OR 97232.
Portland, OR Request to make
an oral presentation.
srobinson on DSK4SPTVN1PROD with PROPOSALS
Other information
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Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Proposed Rules
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING
DOCKETS—Continued
Date
Electronic address
Address
Other information
Produce Safety Proposed Rule:
https://www.regulations.gov/
#!docketDetail;D=FDA-2011-N0921.
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 Courtney Treece (see FOR FURTHER INFORMATION CONTACT). 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 (see
FOR FURTHER INFORMATION CONTACT).
III. Comments, Transcripts, and
Recorded Video
Information and data submitted
voluntarily to FDA during the public
meetings 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 meetings 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/FoodSafety/FSMA/. 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
for each public meeting 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. Additionally, FDA will be
video recording the first public meeting
in Washington, DC. Once the recorded
video is available, it will be accessible
at FDA’s FSMA Web site at https://
www.fda.gov/Food/FoodSafety/FSMA/.
Dated: February 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03316 Filed 2–12–13; 8:45 am]
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BILLING CODE 4160–01–P
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ARCHITECTURAL AND
TRANSPORTATION BARRIERS
COMPLIANCE BOARD
36 CFR Part 1190
[Docket No. ATBCB–2013–0002]
RIN 3014–AA26
Accessibility Guidelines for Pedestrian
Facilities in the Public Right-of-Way;
Shared Use Paths
Architectural and
Transportation Barriers Compliance
Board.
ACTION: Supplemental notice of
proposed rulemaking.
AGENCY:
We, the Architectural and
Transportation Barriers Compliance
Board (Access Board), issued an
advance notice of proposed rulemaking
(ANPRM) announcing our intent to
develop accessibility guidelines for
shared used paths. Shared use paths are
multi-use paths designed primarily for
use by bicyclists and pedestrians,
including pedestrians with disabilities,
for transportation and recreation
purposes. Shared use paths are
physically separated from motor vehicle
traffic by an open space or barrier, and
are either within the highway right-ofway or within an independent right-ofway. We noted in the ANPRM that we
are considering including accessibility
guidelines for shared use paths in the
accessibility guidelines that we are
developing for sidewalks and other
pedestrian facilities in the public rightof-way. We subsequently issued a notice
of proposed rulemaking (NPRM)
requesting comments on proposed
accessibility guidelines for pedestrian
facilities in the public right-of-way. The
NPRM did not include specific
provisions for shared use paths. We are
issuing this supplemental notice of
proposed rulemaking (SNPRM) to
include specific provisions for shared
use paths in the proposed accessibility
guidelines for pedestrian facilities in the
public right-of-way. The proposed
SUMMARY:
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accessibility guidelines would apply to
the design, construction, and alteration
of pedestrian facilities in the public
right-of-way, including shared use
paths, covered by the Americans with
Disabilities Act and the Architectural
Barriers Act, and would ensure that the
facilities are readily accessible to and
usable by individuals with disabilities.
DATES: Submit comments by May 14,
2013.
ADDRESSES: Submit comments by any of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Regulations.gov ID for this docket is
ATBCB–2013–0002.
• Email: docket@access-board.gov.
Include docket number ATBCB 2013–
0002 in the subject line of the message.
• Fax: 202–272–0081.
• Mail or Hand Delivery/Courier:
Scott Windley, Access Board, 1331 F
Street NW., Suite 1000, Washington, DC
20004–1111.
All comments will be posted without
change to https://www.regulations.gov,
including any personal information
provided.
FOR FURTHER INFORMATION CONTACT:
Scott Windley, Access Board, 1331 F
Street NW., Suite 1000, Washington, DC
20004–1111. Telephone (202) 272–0025
(voice) or (202) 272–0028 (TTY). Email
address row@access-board.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
1. Executive Summary
2. Background
3. Proposed Supplements to Proposed
Accessibility Guidelines for Pedestrian
Facilities in the Public Right-of-Way
4. Comparison of Proposed Technical
Provisions Applicable to Shared Use
Paths and AASHTO Guide
5. Conflicts Between Shared Path Users
6. Regulatory Analyses
In this preamble, ‘‘we,’’ ‘‘us,’’ and
‘‘our’’ refer to the Architectural and
Transportation Barriers Compliance
Board (Access Board).
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]]>Agencies
[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Proposed Rules]
[Pages 10107-10110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03316]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, 106, 110, 112, 114, 117, 120, 123, 129, 179,
and 211
[Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921]
Food and Drug Administration Food Safety Modernization Act:
Proposed Rules To Establish Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption and for Current
Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Human Food; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing public
meeting registration information for two FSMA related public meetings
announced in the January 31, 2013, Federal Register. These public
meetings will be held along with the February 28 to March 1, 2013,
Washington, DC public meeting to discuss the proposed rules to
establish standards for the growing, harvesting, packing, and holding
of produce for human consumption (the produce safety proposed rule) and
for current good manufacturing practice and hazard analysis and risk-
based preventive controls for human food (the preventive controls
proposed rule). These proposed rules are the first of several proposed
rules that would establish the foundation of, and central framework
for, the modern food safety system envisioned by Congress in the FDA
Food Safety Modernization Act (FSMA). The purpose of the 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 dates and
times of the Chicago, IL and Portland, OR 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
these meetings, to register by phone, or to submit a notice of
participation by mail, fax, or email: Courtney Treece, Planning
Professionals, Ltd., 1210 West McDermott Dr., Suite 111, Allen, TX
75013, 704-258-4983, FAX: 469-854-6992, email:
ctreece@planningprofessionals.com.
For general questions about these meetings, to request an
opportunity to make an oral presentation at one of 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 and animal food and set standards for produce
safety.
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 over the past several
years. For example, applying the concept of Hazard Analysis and
Critical Control Point (HACCP) that was pioneered by industry in the
late 1960s, FDA established HACCP-based regulations for seafood (21 CFR
part 123) in 1995 (60 FR 65096, December 18, 1995) and for juice (21
CFR part 120) in 2001 (66 FR 6138, January 19, 2001). Similarly, in
1996, the U.S. Department of Agriculture's Food Safety and Inspection
Service instituted HACCP-based rules for meat and poultry (9 CFR part
417) (61 FR 38806, July 25, 1996).
In the Federal Register of January 16, 2013 (78 FR 3503 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 and submit comments to the Agency. These
proposed rulemakings are the first of several key proposals in
furtherance of FSMA's food safety mandate. The produce safety proposed
rule would establish science-based minimum standards for the safe
growing, harvesting, packing, and holding of produce, meaning fruits
and vegetables, grown for human consumption. The produce safety
proposed rule would set forth procedures, processes, and practices that
FDA expects would reduce foodborne illness associated with the
consumption of produce. The produce safety proposed rule and related
fact sheets are available on FDA's FSMA Web page located at https://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
The preventive controls proposed rule would apply to human food and
require domestic and foreign facilities that are required to register
under the FD&C Act to have written plans that identify hazards, specify
the steps that will be put in place to minimize or prevent those
hazards, monitor results, and act to correct problems that arise. The
preventive controls proposed rule and related fact sheets are available
on FDA's FSMA Web page located at https://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
In the Federal Register of January 31, 2013 (78 FR 6762), FDA
announced the first public meeting in a series of three public meetings
entitled ``The Food Safety Modernization Act Public Meeting on Proposed
Rules for Produce Safety and for Preventive Controls for Human Food''
so that the food industry, consumers, foreign governments, and other
stakeholders can evaluate and comment on the proposals. FDA also noted
that the Agency intended to hold
[[Page 10108]]
additional public meetings in Chicago, IL and Portland, OR and that
those specific locations, dates, and registration information for these
meetings would appear in a separate Federal Register document to
publish shortly. It was also noted that all three public meetings would
have the same agenda and are intended to facilitate and support the
proposed rules' evaluation and commenting process.
In this document, FDA is providing the locations, dates, and
registration information for the Chicago, IL and Portland, OR public
meetings.
II. How To Participate in the Public Meeting
FDA is holding the public meetings on the produce safety proposed
rule and the preventive controls proposed rule 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 public 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 meetings 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 meetings 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 at a single location. 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., for the produce safety proposed rule, https://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921; and for the
preventive controls proposed rule, https://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0920).
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
----------------------------------------------------------------------------------------------------------------
Washington, DC Public meeting February 28, Jefferson Onsite registration
2013, from Auditorium, U.S. both days from 8
8:30 a.m. to 5 Department of a.m. to 8:30 a.m.
p.m. and March Agriculture (USDA),
1, 2013, from Wing 5 Entrance,
8:30 a.m. to 14th and
12 noon. Independence Ave.
SW., Washington, DC
20024. Photo ID
Required.
Washington, DC Advance By February 20, Individuals who wish We encourage you to There is no
registration. 2013. to participate in use electronic registration fee
person are asked to registration if for the public
preregister at possible.\1\ meetings. Early
https://www.fda.gov/ registration is
Food/NewsEvents/ recommended because
WorkshopsMeetingsCo seating is limited.
nferences/
default.htm.
Washington, DC Request to By February 8, https://www.fda.gov/ Requests made on the
make an oral presentation. 2013. Food/NewsEvents/ day of the meeting
WorkshopsMeetingsCo to make an oral
nferences/ presentation will
default.htm.\2\ 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.
Washington, DC Request By February 15, Juanita Yates, See FOR FURTHER
special accommodations due 2013. email: INFORMATION CONTACT.
to a disability. Juanita.yates@fda.hhs.gov.
[[Page 10109]]
Chicago, IL Public meeting... March 11, 2013, The Westin-Michigan Onsite registration
from 8:30 a.m. Avenue, 909 North both days from 8
to 5 p.m. and Michigan Ave., a.m. to 8:30 a.m.
March 12, Chicago, IL 60611.
2013, from
8:30 a.m. to
12 noon.
Chicago, IL Advance By March 1, Individuals who wish We encourage you to There is no
registration. 2013. to participate in use electronic registration fee
person are asked to registration if for the public
preregister at possible.\1\ meetings. Early
https://www.fda.gov/ registration is
Food/NewsEvents/ recommended because
WorkshopsMeetingsCo seating is limited.
nferences/
default.htm.
Chicago, IL Request to make By February 21, https://www.fda.gov/ Requests made on the
an oral presentation. 2013. Food/NewsEvents/ day of the meeting
WorkshopsMeetingsCo to make an oral
nferences/ presentation will
default.htm.\2\ 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.
Chicago, IL Request special By February 21, Juanita Yates, See FOR FURTHER
accommodations due to a 2013. email: INFORMATION CONTACT.
disability. Juanita.yates@fda.hhs.gov.
Portland, OR Public meeting.. March 27, 2013, Crown Plaza Portland Onsite registration
from 8:30 a.m. Downtown Convention both days from 8
to 5 p.m. and Center, 1441 NE 2nd a.m. to 8:30 a.m.
March 28, Ave., Portland, OR
2013, from 97232.
8:30 a.m. to
12 noon.
Portland, OR Advance By March 18, Individuals who wish We encourage you to There is no
registration. 2013. to participate in use electronic registration fee
person are asked to registration if for the public
preregister at possible.\1\ meetings. Early
https://www.fda.gov/ registration is
Food/NewsEvents/ recommended because
WorkshopsMeetingsCo seating is limited.
nferences/
default.htm.
Portland, OR Request to make By March 8, https://www.fda.gov/ Requests made on the
an oral presentation. 2013. Food/NewsEvents/ day of the meeting
WorkshopsMeetingsCo to make an oral
nferences/ presentation will
default.htm.\2\ 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.
Portland, OR Request special By March 8, Juanita Yates, See FOR FURTHER
accommodations due to a 2013. email: INFORMATION CONTACT.
disability. Juanita.yates@fda.hhs.gov.
Submit electronic or written By May 16, 2013 Docket Nos. FDA-2011-
comments. N-0920 and FDA-2011-
N-0921.
Preventive Controls
for Human Food
Proposed Rule:
https://www.regulations.gov/#!docketDetail;D=FD
A-2011-N-0920.
[[Page 10110]]
Produce Safety
Proposed Rule:
https://www.regulations.gov/#!docketDetail;D=FD
A-2011-N-0921.
----------------------------------------------------------------------------------------------------------------
\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 Courtney Treece (see FOR FURTHER
INFORMATION CONTACT). 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 (see FOR FURTHER INFORMATION CONTACT).
III. Comments, Transcripts, and Recorded Video
Information and data submitted voluntarily to FDA during the public
meetings 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
meetings 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/FoodSafety/FSMA/. 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 for each public meeting 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. Additionally, FDA will be video recording the
first public meeting in Washington, DC. Once the recorded video is
available, it will be accessible at FDA's FSMA Web site at https://www.fda.gov/Food/FoodSafety/FSMA/.
Dated: February 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03316 Filed 2-12-13; 8:45 am]
BILLING CODE 4160-01-P
