Source: https://regulations.justia.com/regulations/fedreg/2013/02/13/2013-03316.html
Timestamp: 2020-08-04 21:26:35
Document Index: 209300848

Matched Legal Cases: ['arts 1', 'art 123', 'art 120', 'art 417', 'art 1190', 'arts 1', 'art 123', 'art 120', 'art\n417']

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] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration 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]
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]
Download as PDF 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 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 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 http://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 http://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 E:\FR\FM\13FEP1.SGM 13FEP1 10108 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, http:// www.regulations.gov/ #!docketDetail;D=FDA-2011-N-0921; and for the preventive controls proposed rule, http:// 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 http:// www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConferences/default.htm. http://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. Jkt 229001 PO 00000 Frm 00005 Jua- Fmt 4702 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 http:// www.regulations.gov, including any personal information provided. Sfmt 4702 E:\FR\FM\13FEP1.SGM 13FEP1 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 http:// www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConferences/default.htm. http://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 http:// 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 http:// www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConferences/default.htm. http://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 Jkt 229001 PO 00000 Frm 00006 Fmt 4702 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 http:// www.regulations.gov, including any personal information provided. Preventive Controls for Human Food Proposed Rule: http:// 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 Sfmt 4702 E:\FR\FM\13FEP1.SGM 13FEP1 10110 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: http://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 http://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 http:// www.regulations.gov and at FDA’s FSMA Web site at http://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 http:// 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] srobinson on DSK4SPTVN1PROD with PROPOSALS BILLING CODE 4160–01–P VerDate Mar<15>2010 16:24 Feb 12, 2013 Jkt 229001 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: PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 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: http:// 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 http://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). E:\FR\FM\13FEP1.SGM 13FEP1
[Pages 10107-10110]
[FR Doc No: 2013-03316]
21 CFR Parts 1, 16, 106, 110, 112, 114, 117, 120, 123, 129, 179,
[Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921]
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
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
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''
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.
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
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 http://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 http://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
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
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.
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
FDA encourages persons and groups who have similar interests to
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, http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921; and for the
preventive controls proposed rule, http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0920).
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.
20024. Photo ID
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
http://www.fda.gov/                         registration is
Food/NewsEvents/                            recommended because
WorkshopsMeetingsCo                         seating is limited.
Washington, DC Request to      By February 8,   http://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
requests to make an
may be posted
, including any
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.
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.
Chicago, IL Advance            By March 1,      Individuals who wish  We encourage you to   There is no
Chicago, IL Request to make    By February 21,  http://www.fda.gov/                         Requests made on the
an oral presentation.          2013.            Food/NewsEvents/                            day of the meeting
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.
Portland, OR Advance           By March 18,     Individuals who wish  We encourage you to   There is no
Portland, OR Request to make   By March 8,      http://www.fda.gov/                         Requests made on the
Portland, OR Request special   By March 8,      Juanita Yates,        See FOR FURTHER
Submit electronic or written   By May 16, 2013  Docket Nos. FDA-2011-
comments.                                       N-0920 and FDA-2011-
N-0921.
http://www.regulations.gov/#!docketDetail;D=FD
A-2011-N-0920.
A-2011-N-0921.
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).
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 http://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 http://www.regulations.gov and at
FDA's FSMA Web site at http://www.fda.gov/Food/FoodSafety/FSMA/. It may
also be viewed at the Division of Dockets Management (HFA-305), Food
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 http://www.fda.gov/Food/FoodSafety/FSMA/.
[FR Doc. 2013-03316 Filed 2-12-13; 8:45 am]