[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Proposed Rules]
[Pages 63346-63348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 16, 112, 117, and 507

[Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, and 
FDA-2011-N-0143]
RIN 0910-AG36, RIN 0910-AG35, RIN 0910-AG10, and RIN 0910-AG64


Food and Drug Administration Food Safety Modernization Act; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss proposed revisions to four rules originally proposed 
in 2013 to implement the FDA Food Safety Modernization Act (FSMA). In 
response to the comments received on these foundational FSMA proposed 
rules, FDA issued supplemental notices of proposed rulemaking that 
propose significant changes to four of the proposed rules including: 
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based 
Preventive Controls for Human Food (Preventive Controls for Human 
Food); Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption (Produce Safety); Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Food for Animals (Preventive Controls for Animal Food); 
and Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals (Foreign Supplier Verification Programs). The 
purpose of the public meeting is to solicit oral stakeholder and public 
comments on the new content of the supplemental 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 supplemental proposed rules.

DATES: See section II, ``How to Participate in the Public Meeting,'' in 
the SUPPLEMENTARY INFORMATION section of this document for the date and 
time of the public meeting, 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

[[Page 63347]]

the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:
    For questions about registering for the meeting; to register by 
telephone; or to submit a notice of participation by mail, FAX, or 
email: Courtney Treece, Planning Professionals Ltd., 1210 W. McDermott 
St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, 
email: [email protected].
    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: 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: [email protected].

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 U.S. food supply. FSMA amends the 
Federal Food, Drug, and Cosmetic Act to establish the foundation of a 
modernized, prevention-based food safety system. Among other things, 
FSMA requires FDA to issue regulations requiring preventive controls 
for human food and animal food, setting standards for produce safety, 
and requiring importers to verify that their foreign suppliers produce 
food that is as safe as food produced in the United States.
    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. Since January 2013, FDA has proposed seven foundational rules to 
implement FSMA: Produce Safety, Preventive Controls for Human Food, 
Preventive Controls for Animal Food, Foreign Supplier Verification 
Programs, Accreditation of Third-Party Auditors/Certification Bodies to 
Conduct Food Safety Audits and to Issue Certifications, Focused 
Mitigation Strategies to Protect Food Against Intentional Adulteration, 
and Sanitary Transportation of Human and Animal Food. FDA conducted 
extensive outreach to industry, growers, academia, consumer groups, 
tribal governments, and the Agency's counterparts at the Federal, State 
and local levels, and received thousands of comments on the proposals.
    In response to the comments received on some of the foundational 
FSMA proposed rules, which FDA continues to review, FDA issued 
supplemental notices of proposed rulemaking that propose significant 
changes to four of the proposed rules: Preventive Controls for Human 
Food, Produce Safety, Preventive Controls for Animal Food, and Foreign 
Supplier Verification Programs. FDA's proposed changes are intended to 
provide more flexible, practical, and targeted approaches to ensuring a 
safe food supply system.
    In the Federal Register of September 29, 2014 (79 FR 58523, 58433, 
58475, and 58573), FDA announced the reopening of these four dockets so 
that the public can review the supplemental proposed rules and submit 
comments to the Agency. The Agency is accepting comments on the revised 
provisions of all four proposed rules until December 15, 2014. No 
additional comments will be accepted on the original proposed rules.
    FDA is announcing a public meeting entitled ``Food and Drug 
Administration Food Safety Modernization Act'' so that the food 
industry, consumers, foreign governments, and other stakeholders can 
evaluate and comment on the supplemental proposals. The meeting is 
intended to facilitate and support the supplemental proposed rules' 
evaluation and commenting process.
    For information on the supplemental proposed rules and related fact 
sheets, see FDA's FSMA Web page located at http://www.fda.gov/Food/FoodSafety/FSMA/default.htm.

II. How To Participate in the Public Meeting

    FDA is holding the public meeting on the supplemental proposed 
rules to inform the public about the rulemaking process, including how 
to submit comments, data, and other information to the rulemaking 
dockets; to respond to questions about the supplemental 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 meeting 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. Live 
Webcasting of the event is also being offered through the registration 
process.
    Those requesting an opportunity to make an oral presentation during 
the time allotted for public comment at the meeting are asked to submit 
a request and to provide the specific topic or issue to be addressed. 
Due to the anticipated high level of interest in presenting public 
comment and the number of supplemental proposals being addressed at the 
public meeting, time for making public comment is necessarily limited. 
FDA is allocating 3 minutes to each speaker to make an oral 
presentation. Speakers will be limited to making oral remarks; there 
will not be an opportunity to display materials such as slide shows, 
videos, or other media during the meeting. If time permits, individuals 
or organizations that did not register in advance may be granted the 
opportunity to make an oral presentation. FDA would like to maximize 
the number of individuals who make a presentation at the meeting and 
will do our best to accommodate all persons who wish to make a 
presentation or express their opinions at the meeting.
    FDA encourages persons and groups who have similar interests to 
consolidate their information for presentation by a single 
representative. After reviewing the presentation requests, FDA will 
notify each participant before the meeting of the approximate time 
their presentation is scheduled to begin and remind them of the 
presentation format (i.e., 3-minute oral presentation without visual 
media).
    While oral presentations from specific individuals and 
organizations will be necessarily limited due to time constraints 
during the public meeting, stakeholders may submit electronic or 
written comments discussing any issues of concern to the administrative 
record (the docket) for the relevant rulemaking. All relevant data and 
documentation should be submitted with the comments to the appropriate 
docket (Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, 
and FDA-2011-N-0143).
    Table 1 of this document provides information on participation in 
the public meeting:

[[Page 63348]]



    Table 1--Information on Participation in the Meeting and on Submitting Comments to the Rulemaking Dockets
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                                                               Electronic                             Other
                                           Date                  address           Address         information
----------------------------------------------------------------------------------------------------------------
Public meeting...............  November 13, 2014            http://           Wiley Building,   Onsite
                                                             www.fda.gov/      5100 Paint        registration
                                                             Food/NewsEvents/  Branch Pkwy.,     from 8 a.m.-
                                                             WorkshopsMeetin   College Park,     8:30 a.m.
                                                             gsConferences/    MD 20740.
                                                             default.htm.
Advance registration.........  By November 7, 2014          Individuals who   We encourage you  There is no
                                                             wish to           to use            registration
                                                             participate in    electronic        fee for the
                                                             person are        registration if   public
                                                             asked to          possible.\1\      meetings. Early
                                                             preregister at                      registration is
                                                             http://                             recommended
                                                             www.fda.gov/                        because seating
                                                             Food/NewsEvents/                    is limited.
                                                             WorkshopsMeetin
                                                             gsConferences/
                                                             default.htm.
Request to make an oral        By October 27, 2014          http://           ................  Requests made on
 presentation.                                               www.fda.gov/                        the day of the
                                                             Food/NewsEvents/                    meeting to make
                                                             WorkshopsMeetin                     an oral
                                                             gsConferences/                      presentation
                                                             default.htm \2\.                    will be granted
                                                                                                 only if 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.
Request special                By October 27, 2014          Juanita Yates,    See FOR FURTHER   ................
 accommodations due to a                                     email:            INFORMATION
 disability.                                                 Juanita.yates@f   CONTACT.
                                                             da.hhs.gov.
Submit electronic or written   By December 15, 2014         Docket Nos. FDA-  Division of       ................
 comments.                                                   2011-N-0920,      Dockets
                                                             FDA-2011-N-0921   Management (HFA-
                                                             , FDA-2011-N-     305), Food and
                                                             0922, and FDA-    Drug
                                                             2011-N-0143;      Administration,
                                                             http://           5630 Fishers
                                                             www.regulations   Lane, rm. 1061,
                                                             .gov.             Rockville, MD
                                                                               20852.
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\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, Planning Professionals
  Ltd., 1210 W. McDermott St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email:
  [email protected]. Onsite registration will also be available.
\2\ You may also request to make an oral presentation at the public meeting via email. Please include your name,
  title, firm name, address, and phone and FAX numbers as well as the full text, comprehensive outline, or
  summary of your oral presentation and send to: Juanita Yates, Center for Food Safety and Applied Nutrition,
  Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1731, email:
  [email protected].

III. Comments, Transcripts, and Recorded Video

    Information and data submitted voluntarily to FDA during the public 
meeting will become part of the administrative record for the relevant 
rulemaking and will be accessible to the public at http://www.regulations.gov. The transcript of the proceedings from the public 
meeting will become part of the administrative record for each of the 
rulemakings. Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov and at 
FDA's FSMA Web site at: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247568.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), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857. Additionally, FDA 
will be live Webcasting the event. When available, the Webcast video 
recording of the public meeting will be accessible at FDA's FSMA Web 
site at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247568.htm.

    Dated: October 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25261 Filed 10-22-14; 8:45 am]
BILLING CODE 4164-01-P