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
Federal Register, Volume 79 Issue 47 (Tuesday, March 11, 2014)
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:
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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
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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: (
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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.''
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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
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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)).
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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.
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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.
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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.
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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
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Date Electronic address Address Other information
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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.
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\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.
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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/
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GuidanceRegulation/FSMA/default.htm.
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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.
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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
