
[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Proposed Rules]
[Pages 13593-13598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 112

[Docket No. FDA-2011-N-0921]
RIN 0910-AG35


Environmental Impact Statement for the Proposed Rule, Standards 
for Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption; Public Meeting on Scoping of Environmental Impact 
Statement and Extension of Comment Period for Environmental Impact 
Statement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public scoping meeting; extension of comment 
period for the Environmental Impact Statement.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
extension of the public scoping period for Environmental Impact 
Statement (EIS), as well as a public scoping meeting to discuss the 
scope of the EIS for the proposed rule to establish standards for 
growing, harvesting, packing, and holding of produce for human 
consumption. FDA is holding a public scoping meeting as part of our 
ongoing efforts to seek public input on the issues and alternatives 
that we should consider when preparing the EIS and to provide 
information about the EIS process (including how to submit comments, 
data, and other information to the rulemaking docket), to solicit oral 
stakeholder and public comments on the scope of the EIS, and to respond 
to questions about the EIS.

DATES: See section II, ``How to Participate in the Public Meeting'' in 
the SUPPLEMENTARY INFORMATION section of this document for date and 
time of the public meeting, closing dates for advance registration, and 
information on deadlines for submitting either electronic or written 
comments to FDA's Division of Dockets Management.
    Comments on the scope of issues the Agency should include in the 
EIS may be submitted until April 18, 2014.

ADDRESSES: See section II, ``How to Participate in the Public Meeting'' 
in the SUPPLEMENTARY INFORMATION section of this document. You may 
submit comments on the scope of issues the Agency should include in the 
EIS, identified by Docket No. FDA-2011-N-0921 and/or Regulatory 
Information Number (RIN) 0910-AG35, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2011-N-0921, and RIN 0910-AG35 for this rulemaking. 
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For 
additional information on submitting comments, see the ``Request for 
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For questions about registering for 
the meeting, to register by phone, or to submit a notice of 
participation by mail, FAX or email: Rick Williams, c/o FDA EIS, 72 
Loveton Circle, Sparks, MD 21152, 410-316-2377; FAX: 410-472-3289, 
email: RWilliams@jmt.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: Cynthia Wise, Center for 
Food Safety and Applied Nutrition (HFS-009), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1357, email: cynthia.wise@fda.hhs.gov.
    For further information about comments for the docket: Annette 
McCarthy, Center for Food Safety and Applied Nutrition (HFS-205), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1200.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), 
signed into law by President Obama on January 4, 2011, enables FDA 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. As part of our 
implementation of FSMA, we published the Proposed Rule, Standards for 
the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption (hereafter referred to as ``the Produce Safety proposed 
rule'') to establish science-based minimum standards for the safe 
growing, harvesting, packing, and holding of produce (78 FR 3503, 
January 16, 2013). We recently announced plans to propose revised rule 
language for key parts of the Produce Safety proposed rule, including 
those related to water quality and the use of raw manure and compost 
(Ref. 1).
    In publishing the Produce Safety proposed rule, we relied on a 
categorical exclusion from the need to prepare an Environmental 
Assessment or EIS under 21 CFR 25.30(j) (78 FR 3503 at 3616). However, 
on August 19, 2013, we issued a Notice of Intent to Prepare an 
Environmental Impact Statement for the Proposed Rule, Standards for 
Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption (NOI), based on additional information, including comments 
received, and upon further analysis. In the NOI, we explained that FDA 
has determined that the proposed action may significantly affect the 
quality of the human environment (21 CFR 25.22(b)), and therefore, an 
EIS is necessary for the final rule (78 FR 50358, August 19, 2013). In 
the NOI, FDA also announced the beginning of the scoping process and 
solicited public comments to identify issues to be analyzed in an EIS. 
The NOI asked for public comment by

[[Page 13594]]

November 15, 2013, and FDA later extended the deadline for the public 
scoping period to March 15, 2014 (78 FR 69006, November 18, 2013). FDA 
is again extending the public scoping period to allow FDA to hold an 
upcoming public scoping meeting.
    In this Federal Register notice, we are addressing the scope of 
issues for discussion at the public scoping meeting for the purpose of 
assisting us in determining which issues are significant and will be 
analyzed in depth in the EIS (see 40 CFR 1501.7). Based on a 
preliminary review of comments, currently available information, and 
our analysis of the proposed provisions, we summarize in this document 
those provisions of the Produce Safety proposed rule that may 
significantly affect the quality of the human environment, which 
provisions we would include for detailed study in the EIS. In addition, 
as required under the National Environmental Policy Act (NEPA) and its 
implementing regulations, we also identify a range of potential 
alternatives for each issue that we plan to consider in the EIS. These 
are set out in table 1. We note that this EIS process is required under 
NEPA and is distinct from and in addition to the process FDA has 
announced to revise parts of the propose rule and seek comment on the 
revisions.

1. Microbial Standard for Agricultural Water Used During Growing 
Activities for Covered Produce (Other Than Sprouts) Using a Direct 
Water Application Method

    Proposed Sec.  112.44(c) states, ``When agricultural water is used 
during growing activities for covered produce (other than sprouts) 
using a direct water application method you must test the quality of 
water in accordance with one of the appropriate analytical methods in 
subpart N. If you find that there is more than 235 colony forming units 
(CFU) (or most probable number (MPN), as appropriate) generic 
Escherichia coli per 100 mL for any single sample or a rolling 
geometric mean (n=5) of more than 126 CFU (or MPN, as appropriate) per 
100 mL of water, you must immediately discontinue use of that source of 
agricultural water and/or its distribution system for the uses 
described in this paragraph. Before you may use the water source and/or 
distribution system again for the uses described in this paragraph, you 
must either re-inspect the entire agricultural water system under your 
control, identify any conditions that are reasonably likely to 
introduce known or reasonably foreseeable hazards into or onto covered 
produce or food-contact surfaces, make necessary changes, and retest 
the water to determine if your changes were effective; or treat the 
water in accordance with the requirements of Sec.  112.43.'' (Proposed 
Sec.  112.3(c) defines ``direct water application method'' as using 
agricultural water in a manner whereby the water is intended to, or is 
likely to, contact covered produce or food-contact surfaces during use 
of the water.) In addition, proposed Sec.  112.43 includes requirements 
for treating agricultural water.
    As noted in the NOI, public comments state that, in some regions, 
current irrigation practices use water that is unlikely to meet the 
proposed microbial standards for much, if not all, of the growing 
season. Consequently, if such standards are finalized, ground water is 
likely to be explored as a viable alternative water source for 
irrigation in these regions. Given recently highlighted concerns of 
ground water depletion in certain regions, FDA has determined that an 
increased use of ground water for irrigation, in response to the 
microbial standard in Sec.  112.44(c), may significantly affect the 
quality of the human environment in those regions (78 FR 50358 at 
50359).
    In addition, our proposed requirements for treatment of water in 
Sec.  112.43, in the context of the microbial standard, may result in 
changes in current practices that may significantly affect the quality 
of the human environment (for example, if treated tail waters are not 
contained or if treated effluent is not properly discharged). 
Therefore, we plan to consider the possible environmental impacts in 
the EIS resulting from these proposed provisions in addition to the 
environmental impacts from a range of potential alternatives to the 
water quality microbial standard proposed in Sec.  112.44(c).

2. Minimum Application Intervals for Biological Soil Amendments of 
Animal Origin

    Proposed Sec.  112.56 states, in part, ``If the biological soil 
amendment of animal origin is untreated, then the biological soil 
amendment of animal origin must be applied in a manner that does not 
contact covered produce during application and minimizes the potential 
for contact with covered produce after application, and then the 
minimum application interval is 9 months'' (proposed Sec.  
112.56(a)(1)(i)); and ``if the biological soil amendment of animal 
origin is treated by a composting process in accordance with the 
requirements of Sec.  112.54(c) to meet the microbial standard in Sec.  
112.55(b), then the biological soil amendment of animal origin must be 
applied in a manner that minimizes the potential for contact with 
covered produce during and after application, and then the minimum 
application interval is 45 days'' (proposed Sec.  112.56(a)(4)(i)). 
Proposed Sec.  112.54 includes provisions for acceptable treatment 
processes for biological soil amendments of animal origin.
    Several comments received thus far have urged FDA to reevaluate the 
application restrictions for biological soil amendments of animal 
origin, which are based on the likelihood of the soil amendment 
harboring pathogens. As noted in the NOI, these proposed requirements, 
if finalized, are expected to result in changes in current use of 
treated and untreated biological soil amendments of animal origin or 
potentially greater use of synthetic fertilizers (78 FR 50358 at 
50359). Changes in the type or handling of soil amendments, in response 
to the minimum application intervals, may significantly affect the 
quality of the human environment. Therefore, we plan to consider the 
possible environmental impacts in the EIS resulting from these proposed 
provisions in addition to the environmental impacts from a range of 
potential alternatives to the minimum application intervals proposed in 
Sec.  112.56(a)(1)(i) and (a)(4)(i).

3. Measures Related to Animal Grazing and Animal Intrusion

    Proposed Sec.  112.82 states, in part, ``At a minimum, if you allow 
animals to graze or use them as working animals in fields where covered 
produce is grown, and under the circumstances there is a reasonable 
probability that grazing or working animals will contaminate covered 
produce, you must take the following measures: (a) An adequate waiting 
period between grazing and harvesting for covered produce in any 
growing area that was grazed to ensure the safety of the harvested 
crop.''
    Proposed Sec.  112.83(b) states, ``If animal intrusion, as made 
evident by observation of significant quantities of animals, animal 
excreta or crop destruction via grazing, occurs, you must evaluate 
whether the covered produce can be harvested in accordance with the 
requirements of Sec.  112.112.'' Further, proposed Sec.  112.112 
states: ``You must take all measures reasonably necessary to identify, 
and not harvest, covered produce that is reasonably likely to be 
contaminated with a known or reasonably foreseeable hazard, including 
steps to identify and not harvest covered produce that is visibly 
contaminated with animal excreta.''

[[Page 13595]]

    We have received comments stating that these proposed requirements 
could potentially result in changes in current practices that would not 
be consistent with wildlife conservation practices and, thus, may 
adversely affect wildlife, including endangered and threatened species. 
Therefore, we plan to consider the possible environmental impacts in 
the EIS resulting from these proposed provisions in addition to the 
environmental impacts from a range of potential alternatives to the 
measures proposed in Sec.  112.82(a) and Sec.  112.83(b).

4. Scope of Proposed Rule and Implications to Land Use and Land 
Management

    Under proposed Sec.  112.4(a), farms with $25,000 or less of annual 
value of food sold are excluded from coverage of the rule. Comments to 
the Produce Safety proposed rule that raised environmental concerns in 
relation to the Produce Safety proposed rule requested that we consider 
increasing the $25,000 threshold to exclude a larger number of farms 
from the proposed rule and, thus, reduce overall environmental impacts 
of the rule. Comments also suggested that the Produce Safety rule, if 
finalized as proposed, would cause small farmers to go out of business 
and potentially result in negative environmental impacts due to changes 
in land use or land management. Therefore, we plan to consider the 
possible environmental impacts in the EIS resulting from this proposed 
provision in addition to the environmental impacts of potential 
alternatives to the $25,000 threshold for out-of-scope farms proposed 
in Sec.  112.4(a).
    Table 1 provides a list of potential alternatives to each of the 
issues discussed previously. This table is not intended to provide a 
comprehensive list of issues and potential alternatives, but rather is 
intended to provide a range of options for environmental consideration 
in the EIS. We invite comment, as part of the scoping process, on 
whether there are other issues we should consider for indepth analysis 
in the EIS and any alternatives to those issues.

 Table 1--List of Issues and Corresponding Potential Alternatives To Be
 Considered in the Environmental Impact Statement for the Produce Safety
                                  Rule
------------------------------------------------------------------------
                                                          Potential
            Issue                Proposed action        alternatives
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1. Microbial standard for     A. Proposed Sec.      i. No action.
 agricultural water.           112.44(c), which     ii. As proposed,
                               states:               i.e., no more than
                              ``When agricultural    235 colony forming
                               water is used         units (CFU) (or
                               during growing        most probable
                               activities for        number (MPN), as
                               covered produce       appropriate)
                               (other than           generic E. coli per
                               sprouts) using a      100 mL for any
                               direct water          single sample or a
                               application method    rolling geometric
                               you must test the     mean (n=5) of more
                               quality of water in   than 126 CFU (or
                               accordance with one   MPN, as
                               of the appropriate    appropriate) per
                               analytical methods    100 mL of water.
                               in subpart N. If     iii. A detectable
                               you find that there   generic limit E.
                               is more than 235      coli per 100 mL
                               colony forming        less stringent than
                               units (CFU) (or       proposed.
                               most probable        iv. A flexible water
                               number (MPN), as      quality standard
                               appropriate)          that allows for
                               generic E. coli per   adjustment to a
                               100 mL for any        specified microbial
                               single sample or a    quality standard
                               rolling geometric     based on mitigation
                               mean (n=5) of more    steps that occur
                               than 126 CFU (or      after application
                               MPN, as               of agricultural
                               appropriate) per      water and prior to
                               100 mL of water,      consumption. For
                               you must              example, the World
                               immediately           Health Organization
                               discontinue use of    recommends a
                               that source of        minimum microbial
                               agricultural water    quality for water
                               and/or its            of 1,000 CFU
                               distribution system   generic E. coli per
                               for the uses          100 mL for water
                               described in this     used on root crops
                               paragraph''.          that are eaten raw,
                              See discussion in 78   and 10,000 CFU
                               FR 3503 at 3568-      generic E. coli per
                               3569..                100 mL for water
                              (Proposed Sec.         used on leaf crops,
                               112.3(c) defines      which is dependent
                               ``direct water        upon a 2-log
                               application           reduction due to
                               method'' as using     die-off between
                               agricultural water    last irrigation and
                               in a manner whereby   consumption
                               the water is          (includes die-off
                               intended to, or is    in the field and
                               likely to, contact    during
                               covered produce or    distribution) and a
                               food-contact          1-log reduction
                               surfaces during use   attributed to
                               of the water.).       washing prior to
                                                     consumption.
                                                    v. For each of the
                                                     options mentioned,
                                                     consider the
                                                     environmental
                                                     impacts of two
                                                     different
                                                     interpretations of
                                                     the definition of
                                                     ``direct water
                                                     application
                                                     method'' in Sec.
                                                     112.3(c): (1) To
                                                     include root crops
                                                     that are drip
                                                     irrigated; and (2)
                                                     to exclude root
                                                     crops that are drip
                                                     irrigated.
2. Minimum application        A. Proposed Sec.      i. No action.
 intervals for biological      112.56(a)(1)(i),     ii. As proposed,
 soil amendments of animal     which states:         i.e., applied in a
 origin.                      ``If the biological    manner that does
                               soil amendment of     not contact covered
                               animal origin is      produce during
                               untreated, then the   application and
                               biological soil       minimizes the
                               amendment of animal   potential for
                               origin must be        contact with
                               applied in a manner   covered produce
                               that does not         after application,
                               contact covered       and then the
                               produce during        minimum application
                               application and       interval is 9
                               minimizes the         months.
                               potential for        iii. Applied in a
                               contact with          manner that does
                               covered produce       not contact covered
                               after application,    produce during
                               and then the          application and
                               minimum application   minimizes the
                               interval is 9         potential for
                               months''.             contact with
                              See discussion in 78   covered produce
                               FR 3503 at 3581,      after application,
                               3582..                and then the
                                                     minimum application
                                                     interval is 0 days.
                                                    iv. U.S. Department
                                                     of Agriculture's
                                                     National Organic
                                                     Program (USDA/NOP)
                                                     application
                                                     intervals for the
                                                     use of raw manure
                                                     as a soil
                                                     amendment, i.e., 90
                                                     days or 120 days
                                                     before harvest,
                                                     depending on
                                                     whether or not the
                                                     edible portion of
                                                     the crop has direct
                                                     contact with the
                                                     soil (as specified
                                                     in 7 CFR
                                                     205.203(c)(1)).

[[Page 13596]]

 
                                                    v. Applied in a
                                                     manner that does
                                                     not contact covered
                                                     produce during
                                                     application and
                                                     minimizes the
                                                     potential for
                                                     contact with
                                                     covered produce
                                                     after application,
                                                     and then the
                                                     minimum application
                                                     interval is 6
                                                     months.
                                                    vi. Applied in a
                                                     manner that does
                                                     not contact covered
                                                     produce during
                                                     application and
                                                     minimizes the
                                                     potential for
                                                     contact with
                                                     covered produce
                                                     after application,
                                                     and then the
                                                     minimum application
                                                     interval is 12
                                                     months.
                              B. Proposed Sec.      i. No action.
                               112.56(a)(4)(i),
                               which states:
                              ``If the biological   ii. As proposed,
                               soil amendment of     i.e., applied in a
                               animal origin is      manner that
                               treated by a          minimizes the
                               composting process    potential for
                               in accordance with    contact with
                               the requirements of   covered produce
                               Sec.   112.54(c) to   during and after
                               meet the microbial    application, and
                               standard in Sec.      then the minimum
                               112.55(b), then the   application
                               biological soil       interval is 45
                               amendment of animal   days.
                               origin must be       iii. Applied in a
                               applied in a manner   manner that
                               that minimizes the    minimizes the
                               potential for         potential for
                               contact with          contact with
                               covered produce       covered produce
                               during and after      during and after
                               application, and      application, and
                               then the minimum      then the minimum
                               application           application
                               interval is 45        interval is 0 days.
                               days''.              iv. Applied in a
                              See discussion in 78   manner that
                               FR 3503 at 3583..     minimizes the
                                                     potential for
                                                     contact with
                                                     covered produce
                                                     during and after
                                                     application, and
                                                     then the minimum
                                                     application
                                                     interval is 90
                                                     days.
3. Measures related to        A. Proposed Sec.      i. No action.
 animal grazing and animal     112.82(a), which     ii. As proposed,
 intrusion.                    states:               i.e., an adequate
                              ``An adequate          waiting period
                               waiting period        between grazing and
                               between grazing and   harvesting.
                               harvesting for       iii. A minimum
                               covered produce in    waiting period of 9
                               any growing area      months, consistent
                               that was grazed to    with proposed Sec.
                               ensure the safety      112.56(a)(1)(i)
                               of the harvested      for the use of raw
                               crop''.               manure as a soil
                              See discussion in 78   amendment.
                               FR 3503 at 3587..    iv. A minimum
                                                     waiting period of
                                                     90 days and 120
                                                     days, consistent
                                                     with the USDA/NOP-
                                                     specified
                                                     application
                                                     intervals for the
                                                     use of raw manure
                                                     as a soil
                                                     amendment.
                              B. Proposed Sec.      i. No action.
                               112.83(b), which     ii. As proposed,
                               states:               i.e., if animal
                                                     intrusion occurs,
                                                     you must evaluate
                                                     whether the covered
                                                     produce can be
                                                     harvested, and you
                                                     must take all
                                                     measures reasonably
                                                     necessary to
                                                     identify, and not
                                                     harvest, covered
                                                     produce that is
                                                     reasonably likely
                                                     to be contaminated.
                                                    iii. If animal
                                                     intrusion is
                                                     reasonably likely
                                                     to occur, take
                                                     measures to exclude
                                                     animals from fields
                                                     where covered
                                                     produce is grown.
                              ``If animal
                               intrusion, as made
                               evident by
                               observation of
                               significant
                               quantities of
                               animals, animal
                               excreta or crop
                               destruction via
                               grazing, occurs,
                               you must evaluate
                               whether the covered
                               produce can be
                               harvested in
                               accordance with the
                               requirements of
                               Sec.   112.112''.
                              See discussion in 78
                               FR 3503 at 3587..
4. Scope of proposed rule     A. Proposed Sec.      i. No action.
 and implications to land      112.4(a), which      ii. As proposed,
 use.                          excludes farms with   i.e., farms with
                               $25,000 or less of    $25,000 or less of
                               annual value of       annual value of
                               food sold from        food sold are
                               coverage of the       excluded from
                               rule.                 coverage of the
                              See discussion in 78   rule.
                               FR 3503 at 3549..    iii. Farms with
                                                     $50,000 or less of
                                                     annual value of
                                                     food sold are
                                                     excluded from
                                                     coverage of the
                                                     rule.
                                                    iv. Farms with
                                                     $100,000 or less of
                                                     annual value of
                                                     food sold are
                                                     excluded from
                                                     coverage of the
                                                     rule.
                                                    v. Farms with
                                                     $25,000 or less of
                                                     annual value of
                                                     covered produce
                                                     sold are excluded
                                                     from coverage of
                                                     the rule.
------------------------------------------------------------------------

II. How To Participate in the Public Meeting

    FDA is holding the public meeting on the scope of the EIS for the 
proposed rule to establish standards for growing, harvesting, packing, 
and holding of produce for human consumption to inform the public of 
the provisions of the proposed rule that may significantly affect the 
quality of the human environment and anticipated alternatives we plan 
to consider in the EIS, to provide information about the EIS process 
(including how to submit comments, data, and other information to the 
rulemaking docket), to solicit oral stakeholder and public comments on 
the scope of the EIS, and to respond to questions about the EIS. The 
meeting will be held on April 4, 2014, from 1 p.m. until 5 p.m., at 
Wiley Auditorium,

[[Page 13597]]

Harvey W. Wiley Federal Bldg., 5100 Paint Branch Pkwy., College Park, 
MD 20740. Due to limited space and time, FDA encourages all persons who 
wish to attend the meeting to register early and in advance of the 
meeting. There is no fee to register for the public meeting, and 
registration will be on a first-come, first-served basis. Onsite 
registration will be accepted, as space permits, after all 
preregistered attendees are seated.
    Those requesting an opportunity to make an oral presentation during 
the time allotted for public comment at the meeting are asked to submit 
a request in advance and to provide information about the specific 
topic or issue to be addressed. Due to the anticipated high level of 
interest in presenting public comments and the limited time available, 
FDA is allocating 4 minutes to each speaker to make an oral 
presentation. FDA will provide opportunities to submit written comments 
at the meeting; 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. A court 
recorder will be available on the meeting premises to accept additional 
oral remarks.
    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., 4-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 Docket No. FDA-
2011-N-0921.
    Table 2 of this document provides information on participation in 
the public meetings:

   Table 2--Information on Participation in the Meetings and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
                                         Date         Electronic address        Address        Other information
----------------------------------------------------------------------------------------------------------------
College Park, MD Public meeting.  April 4, 2014,      http://www.fda.gov/ Wiley Auditorium,
                                   from 1 p.m. to 5    Food/NewsEvents/    Harvey W. Wiley
                                   p.m.                WorkshopsMeetings   Federal Bldg.,
                                                       Conferences/        5100 Paint Branch
                                                       default.htm.        Pkwy., College
                                                                           Park, MD 20740.
Deadline for registration.......  March 28, 2014....  http://www.fda.gov/ We encourage you    There is no
                                                       Food/NewsEvents/    to use electronic   registration fee
                                                       WorkshopsMeetings   registration if     for the public
                                                       Conferences/        possible.\1\        meetings. Early
                                                       default.htm                             registration is
                                                       Docket No. FDA-                         recommended
                                                       2011-N-0921.                            because seating
                                                                                               is limited.
Request to make a Public Comment  March 28, 2014....  http://www.fda.gov/ ..................  Requests made on
                                                       Food/NewsEvents/                        the day of the
                                                       WorkshopsMeetings                       meeting to make
                                                       Conferences/                            an oral
                                                       default.htm.\2\                         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 ov, including any
                                                                                               personal
                                                                                               information
                                                                                               provided.
Request special accommodations    March 28, 2014....  Cynthia Wise,       See FOR FURTHER
 due to a disability.                                  email:              INFORMATION
                                                       cynthia.wise@fda.   CONTACT.
                                                       hhs.gov.
Closing date for comments.......  April 18, 2014.
----------------------------------------------------------------------------------------------------------------
\1\ For questions about registering for the meeting, to register by phone, or to submit a notice of
  participation by mail, FAX or email, contact: Rick Williams, c/o FDA EIS, 72 Loveton Circle, Sparks, MD 21152;
  410-316-2377; FAX: 410-472-3289; email: RWilliams@jmt.com.
\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: Cynthia Wise, Center for Food Safety and Applied Nutrition,
  Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740, 240-402-1357, email:
  cynthia.wise@fda.hhs.gov.

III. Comments, Transcripts, and Recorded Video

    Information and data submitted voluntarily to FDA during the public 
meeting will become part of the administrative record for the relevant 
rulemaking and will be accessible to the public at http://www.regulations.gov. The transcript of the proceedings from the public 
meeting will become part of the administrative record for each relevant 
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 (see ADDRESSES). 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 live Webcasting and 
recording the public meeting. Once the recorded video is available, it 
will be accessible at FDA's FSMA Web site at http://www.fda.gov/Food/

[[Page 13598]]

GuidanceRegulation/FSMA/default.htm.

IV. Request for Comments

    Interested persons may submit either electronic comments regarding 
the issues to be included in the EIS for the proposed rule to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday and is 
available electronically at http://www.regulations.gov.

    1. Statement from FDA Deputy Commissioner for Foods and 
Veterinary Medicine, Michael Taylor, on Key Provisions of the 
Proposed FSMA Rules Affecting Farmers. December 19, 2013, available 
from http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

    Dated: March 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05181 Filed 3-10-14; 8:45 am]
BILLING CODE 4160-01-P


