[Federal Register Volume 79, Number 31 (Friday, February 14, 2014)]
[Proposed Rules]
[Pages 8907-8910]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2013-N-0013]


Sanitary Transportation of Human and Animal Food; Public Meetings 
on Proposed Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
three public meetings to discuss the proposed rule that would establish 
requirements for shippers, carriers by motor vehicle and rail vehicle, 
and receivers engaged in the transportation of food, including food for 
animals, to use sanitary transportation practices to help ensure the 
safety of the food they transport. The proposed rule is part of our 
larger effort to focus on prevention of food safety problems throughout 
the food chain and is part of our implementation of the Sanitary Food 
Transportation Act of 2005 (2005 SFTA) and the FDA Food Safety 
Modernization Act (FSMA). The purpose of the public meetings is to 
inform the public of the provisions of the proposed rule and the 
rulemaking process (including how to submit comments, data, and other 
information to the rulemaking docket) as well as solicit oral 
stakeholder and public comments on the proposed rule and to respond to 
questions about the rule.

DATES: See section II, ``How to Participate in the Public Meetings,'' 
in the SUPPLEMENTARY INFORMATION section for dates and times 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 
Meetings,'' in the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: For questions about registering for 
the meeting, to register by phone, or to

[[Page 8908]]

submit a notice of participation by mail, fax, or email, contact: Nick 
Cane, Nakamoto Group, Inc., 11820 Parklawn Dr., Suite 240, Rockville, 
MD 20852, 240-357-1176, FAX: 301-468-6536, email: 
nick.cane@nakamotogroup.com. For general questions about the meeting; 
to request an opportunity to make an oral presentation at the public 
meeting; 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. 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. Among other 
things, FSMA requires FDA to implement the 2005 SFTA. The 2005 SFTA 
requires FDA to issue regulations requiring shippers, carriers by motor 
vehicle or rail vehicle, receivers, and other persons engaged in the 
transportation of food to use sanitary transportation practices to help 
ensure that food is not transported under conditions that may render 
the food adulterated. Isolated incidents of insanitary transportation 
practices for human and animal food and outbreaks and illnesses caused 
by contamination of these foods during transport there have resulted in 
concerns over the past decades about the potential that food can become 
contaminated during transportation. The goal of the proposed rule is to 
help ensure that transportation practices do not create food safety 
risks.
    FDA is announcing two public meetings entitled ``The Food Safety 
Modernization Act Public Meeting on Focused Mitigation Strategies to 
Protect Food Against Intentional Adulteration and Sanitary 
Transportation of Human and Animal Food'' and a third public meeting 
entitled ``The Food Safety Modernization Act Public Meeting on Sanitary 
Transportation of Human and Animal Food'' so that the food industry, 
consumers, foreign governments, and other stakeholders can evaluate and 
comment on the proposals. As stated, the first two meetings will cover 
both the focused mitigation strategies to protect food against 
international adulteration and sanitary transportation of human and 
animal food proposed rules and will be held in Chicago, IL, and 
Anaheim, CA; the third meeting in College Park, MD, will cover only the 
sanitary transport proposed rule during the proposed rule comment 
period. All three public meetings 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 sanitary transport 
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 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 the 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 meetings, 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 Docket No. FDA-
2013-N-0013.
    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
----------------------------------------------------------------------------------------------------------------
                                                               Electronic                             Other
                                           Date                  address           Address         information
----------------------------------------------------------------------------------------------------------------
Chicago, IL, Public Meeting,   February 27, 2014..........  http://           Hilton Chicago,   Onsite
 Transport Session.                                          www.fda.gov/      720 South         registration
                                                             Food/             Michigan Ave.,    from 8 a.m. to
                                                             GuidanceRegulat   Chicago, IL       8:30 a.m.
                                                             ion/FSMA/         60605.
                                                             ucm247568.htm
Chicago, IL, Advance           Until February 18, 2014....  http://           We encourage you  There is no
 Registration.                                               www.fda.gov/      to use            registration
                                                             Food/             electronic        fee for the
                                                             GuidanceRegulat   registration if   public
                                                             ion/FSMA/         possible.\1\      meetings. Early
                                                             ucm247568.htm                       registration is
                                                                                                 recommended
                                                                                                 because seating
                                                                                                 is limited.

[[Page 8909]]

 
Chicago, IL, Request to Make   February 10, 2014..........  http://                             Requests made on
 a Public Comment.                                           www.fda.gov/                        the day of the
                                                             Food/                               meeting to make
                                                             GuidanceRegulat                     an oral
                                                             ion/FSMA/                           presentation
                                                             ucm247568.htm                       will be granted
                                                             \2\                                 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.
Chicago, IL, Request Special   February 10, 2014..........  Juanita Yates,    See FOR FURTHER
 Accommodations Due to a                                     email:            INFORMATION
 Disability.                                                 Juanita.yates@f   CONTACT
                                                             da.hhs.gov
Chicago, IL, Closing Date for  May 31, 2014...............  Docket No. FDA-                     ................
 Electronic or Written                                       2013-N-0013.
 Comments.
Anaheim, CA, Public Meeting,   March 13, 2014.............  http://           Sheraton Park     Onsite
 Transport Session.                                          www.fda.gov/      Hotel, 1855       registration
                                                             Food/             South Harbor      from 8 a.m. to
                                                             GuidanceRegulat   Blvd., Anaheim,   8:30 a.m.
                                                             ion/FSMA/         CA 92802.
                                                             ucm247568.htm
Anaheim, CA, Advance           Until March 4, 2014........  http://           We encourage you  There is no
 Registration.                                               www.fda.gov/      to use            registration
                                                             Food/             electronic        fee for the
                                                             GuidanceRegulat   registration if   public
                                                             ion/FSMA/         possible.\1\      meetings. Early
                                                             ucm247568.htm                       registration is
                                                                                                 recommended
                                                                                                 because seating
                                                                                                 is limited.
Anaheim, CA, Request to make   February 18, 2014..........  http://                             Requests made on
 a Public Comment.                                           www.fda.gov/                        the day of the
                                                             Food/                               meeting to make
                                                             GuidanceRegulat                     an oral
                                                             ion/FSMA/                           presentation
                                                             ucm247568.htm                       will be granted
                                                             \2\                                 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.
Anaheim, CA, Request Special   February 18, 2014..........  Juanita Yates,    See FOR FURTHER   ................
 Accommodations Due to a                                     email:            INFORMATION
 Disability.                                                 Juanita.yates@f   CONTACT
                                                             da.hhs.gov
Anaheim, CA, Closing Date for  May 31, 2014...............  Docket No. FDA-                     ................
 Electronic or Written                                       2013-N-0013.
 Comments.
College Park, MD, Public       March 20, 2014.............  http://           Wiley Building,   Onsite
 Meeting.                                                    www.fda.gov/      5100 Paint        registration
                                                             Food/             Branch Pkwy.,     from 8 a.m. to
                                                             GuidanceRegulat   College Park,     8:30 a.m.
                                                             ion/FSMA/         MD 20740.
                                                             ucm247568.htm
College Park, MD, Advance      Until March 13, 2014.......  http://           We encourage you  There is no
 Registration.                                               www.fda.gov/      to use            registration
                                                             Food/             electronic        fee for the
                                                             GuidanceRegulat   registration if   public
                                                             ion/FSMA/         possible.\1\      meetings. Early
                                                             ucm247568.htm                       registration is
                                                                                                 recommended
                                                                                                 because seating
                                                                                                 is limited.
College Park, MD, Request to   February 28, 2014..........  http://                             Requests made on
 Make a Public Comment.                                      www.fda.gov/                        the day of the
                                                             Food/                               meeting to make
                                                             GuidanceRegulat                     an oral
                                                             ion/FSMA/                           presentation
                                                             ucm247568.htm                       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.
Closing Date of Docket.......  May 31, 2014...............  Docket No. FDA-                     ................
                                                             2013-N-0013.
College Park, MD, Request      February 28, 2014..........  Juanita Yates,    See FOR FURTHER   ................
 Special Accommodations Due                                  email:            INFORMATION
 to a Disability.                                            Juanita.yates@f   CONTACT
                                                             da.hhs.gov
Closing Date for Electronic    May 31, 2014...............  Docket No. FDA-                     ................
 or Written Comments to be                                   2013-N-0013.
 Included in Docket.
----------------------------------------------------------------------------------------------------------------
\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: Nick Cane, Nakamoto Group, Inc., 11820
  Parklawn Dr., Suite 240, Rockville, MD 20852, 240-357-1176, FAX: 301-468-6536, email:
  nick.cane@nakamotogroup.com. Onsite registration will also be available.

[[Page 8910]]

 
\2\ You may also request to make an oral presentation at the public meetings 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 
meetings will become part of the administrative record for the 
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 the 
rulemaking. 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/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. Additionally, FDA will be video recording and live 
Web casting all of the public meetings. Once the recorded video is 
available, it will be accessible at FDA's FSMA Web site at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.

    Dated: February 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03277 Filed 2-13-14; 8:45 am]
BILLING CODE 4160-01-P