[Federal Register Volume 80, Number 9 (Wednesday, January 14, 2015)]
[Proposed Rules]
[Pages 1852-1854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00564]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / 
Proposed Rules  

[[Page 1852]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2014-N-2244]
RIN 0910-AG35


Draft Environmental Impact Statement for the Proposed Rule, 
Standards for Growing, Harvesting, Packing, and Holding of Produce for 
Human Consumption; Notice for Public Meeting on Draft Environmental 
Impact Statement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting.

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SUMMARY: The Food and Drug Administration (FDA or we) has made 
available for public review and comment the Draft Environmental Impact 
Statement (EIS) for the proposed rule establishing standards for the 
growing, harvesting, packing, and holding of produce for human 
consumption. The document is available in Docket No. FDA-2014-N-2244. 
FDA is also announcing a public meeting to discuss the Draft EIS. The 
purpose of the public meeting is to inform the public of the findings 
in the Draft EIS, to provide information about the EIS process 
(including how to submit comments, data, and other information to the 
docket), to solicit oral stakeholder and public comments on the Draft 
EIS, and to provide clarification, as needed, about the contents of the 
Draft 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 on the Draft EIS.

ADDRESSES: You may submit comments 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): 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 Docket No. 
FDA-2014-N-2244. All comments received may be posted without change to  
http://www.regulations.gov, including any personal information 
provided.
    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.
    Public Meeting: See section II, ``How to Participate in the Public 
Meeting'' in SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: 
    For questions about the Draft Environmental Impact Statement, or 
submitting comments contact: Annette McCarthy, Center for Food Safety 
and Applied Nutrition (HFS-205), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1057.
    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; telephone: 410-316-2377; FAX: 410-472-3289; 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, contact: Cynthia Wise, 
Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 
telephone: 240-402-1357, email: [email protected].

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 2013 proposed rule'') to 
establish science-based minimum standards for the safe growing, 
harvesting, packing, and holding of produce (78 FR 3504, January 16, 
2013). On September 29, 2014, FDA issued a supplemental notice of 
proposed rulemaking (``the supplemental proposed rule''), amending 
certain specific provisions of the 2013 proposed rule (79 FR 58434). 
Taken together, these publications constitute FDA's proposed standards 
for the growing, harvesting, packing, and holding of produce for human 
consumption (``the Produce Safety Proposed Rule'').
    FDA announced a ``Notice of Intent'' (NOI) to prepare an EIS to 
evaluate the potential environmental effects of the Produce Safety 
Proposed Rule in the Federal Register on August 19, 2013 (78 FR 50358). 
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 November 15, 2013, and FDA later 
extended the deadline for the comment period to April 18, 2014 (79 FR 
13593; March 11, 2014). A public scoping meeting was held on April 4, 
2014, in College Park, MD.
    In the Produce Safety Proposed Rule, FDA proposed science-based 
minimum standards for the safe production and harvesting of produce. As 
discussed in the Draft EIS (Ref. 1), out of these standards, we 
identified four provisions that could potentially significantly affect 
the quality of the human

[[Page 1853]]

environment, if finalized (hereinafter referred to as ``potentially 
significant provisions''). For each of the potentially significant 
provisions, FDA then identified alternative provisions to consider. The 
potentially significant provisions are: (1) Standards directed to 
agricultural water, (2) standards directed to biological soil 
amendments (BSA) of animal origin, (3) standards directed to 
domesticated and wild animals, and (4) general provisions (i.e., 
cumulative impacts). Additionally, an overarching ``No Action'' 
Alternative was considered for the purpose of evaluating conditions in 
the absence of any final rule.
    For standards directed to agricultural water, we considered the 
following alternatives: (1) As proposed by FDA, i.e., a statistical 
threshold value (STV) not exceeding 410 colony forming units (CFU) of 
generic Escherichia coli per 100 ml of water and a geometric mean (GM) 
not exceeding 126 CFU of generic E. coli per 100 ml of water, along 
with options to achieve the standard by applying either a time interval 
between last irrigation and harvest using a microbial die-off rate of 
0.5 log per day and/or a time interval between harvest and end of 
storage using an appropriate microbial die-off or removal rates, 
including during activities such as commercial washing (proposed 21 CFR 
112.44(c)); (2) a microbial quality standard of no more than 235 CFU 
(or most probable number (MPN), as appropriate) generic E. coli per 100 
ml for any single sample or a rolling GM (n=5) of more than 126 CFU (or 
MPN, as appropriate) per 100 ml of water, as was proposed in the 2013 
proposed rule; (3) as proposed (i.e., Alternative 1), but with an 
additional criterion establishing a maximum generic E. coli threshold ; 
and (4) for each of the alternatives above, consider the environmental 
impacts of two different interpretations of the definition of ``direct 
water application method'' in proposed Sec.  112.3(c): (a) To include 
root crops that are drip irrigated and (b) to exclude root crops that 
are drip irrigated.
    For standards directed to BSAs of animal origin, FDA considered 
standards for both untreated and treated BSAs. For untreated BSAs of 
animal origin, the alternatives considered included a range of minimal 
application intervals (the time between application and harvest) when 
the BSA is applied in a manner that does not contact covered produce 
during application and minimizes the potential for contact with covered 
produce after application. The alternative application intervals 
evaluated were: (1) 9 months, (2) 0 months, (3) 90 and 120 days, 
consistent with the National Organic Programs' regulations in 7 CFR 
205.203(c)(1), (4) 6 months, and (5) 12 months. For standards directed 
to treated BSAs, the alternatives considered included a range of 
application intervals when the BSA is composted in accordance with the 
requirements proposed in Sec.  112.54(c) and applied in a manner that 
minimizes the potential for contact with covered produce during and 
after application. The application intervals evaluated were: (1) As 
proposed by FDA, 0 days (proposed Sec.  112.56(a)(4)(i)), (2) 45 days, 
and (3) 90 days.
    For standards directed at domesticated animals, we considered 
alternatives under which, if working animals are used in a growing area 
where a crop has been planted, measures would be required to prevent 
the introduction of known or reasonably foreseeable hazards into or 
onto covered produce with the waiting period between grazing and 
harvesting varying by alternative. The following alternatives were 
evaluated: (1) As proposed by FDA, 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.  
112.82(a)); (2) a minimum waiting period of 9 months; and (3) a minimum 
waiting period of 90 days and 120 days before harvest, depending upon 
whether the edible portion of the crop contacts the soil (applying the 
timeframes for raw manure set forth in the National Organic Programs' 
regulations in 7 CFR 205.203(c)(1)). For standards directed to wild 
animals, we considered alternatives to the proposed requirement that 
under circumstances when there is a reasonable probability that animal 
intrusion will contaminate covered produce, the grower would be 
required to monitor those areas that are used for a covered activity 
for evidence of animal intrusion: (1) As needed during the growing 
season based on (i) the grower's covered produce and (ii) the grower's 
observations and experience; and (2) immediately prior to harvest. The 
alternatives evaluated were: (1) As proposed by FDA, if animal 
intrusion occurs--as made evident by observation of significant 
quantities of animals, animal excreta or crop destruction via grazing--
the grower must evaluate whether the covered produce can be harvested 
in accordance with the requirements of proposed Sec.  112.112 (proposed 
Sec.  112.83(a) and (b)) and (2) if animal intrusion is reasonably 
likely to occur, the grower must take measures to exclude animals from 
fields where covered produce is grown.
    The cumulative impacts of the proposed rule were considered using a 
range of alternatives to the general provision in proposed Sec.  112.4, 
which would specify the farms that would be covered under the rule 
based on the farm's annual sales of produce. The alternatives evaluated 
were to cover those farms that have: (1) As proposed by FDA, an average 
annual monetary value of produce sold during the previous 3-year period 
of more than $25,000 (on a rolling basis) (proposed Sec.  112.4); (2) 
an average annual monetary value of food sold during the previous 3-
year period of more than $50,000 (on a rolling basis); (3) an average 
annual monetary value of food sold during the previous 3-year period of 
more than $100,000 (on a rolling basis); and (4) an average annual 
monetary value of covered produce sold during the previous 3-year 
period of more than $25,000 (on a rolling basis).
    FDA has made this Draft EIS available for public review and comment 
in Docket No. FDA-2014-N-2244 (See Ref. 1).

II. How To Participate in the Public Meeting

    FDA is holding the public meeting on February 10, 2015, from 1 p.m. 
until 4 p.m., at Wiley Auditorium, Harvey W. Wiley Federal Bldg., 5100 
Paint Branch Pkwy., College Park, MD 20740, to discuss the Draft EIS 
for the proposed rule to establish standards for growing, harvesting, 
packing and holding of produce for human consumption. Due to limited 
space and time, FDA encourages all persons who wish to attend the 
meetings 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

[[Page 1854]]

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., 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). All relevant data and documentation should be 
submitted with the comments to Docket No. FDA-2014-N-2244.
    Table 1 provides information on participation in the public 
meeting:

          Table 1--Information on Participation in the Meeting and on Submitting Comments to the Docket
----------------------------------------------------------------------------------------------------------------
                                         Date         Electronic address        Address        Other information
----------------------------------------------------------------------------------------------------------------
College Park, MD Public Meeting.  February 10, 2015,  http://www.fda.gov/ Wiley Auditorium,
                                   1 p.m. to 4 p.m.    Food/NewsEvents/    Harvey W. Wiley
                                                       WorkshopsMeetings   Federal Bldg.,
                                                       Conferences/        5100 Paint Branch
                                                       default.htm.        Pkwy., College
                                                                           Park, MD 20740.
Deadline for Registration.......  February 3, 2015..  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
                                                       2014-N-2244                             because seating
                                                                                               is limited.
Request to Make a Public Comment  February 3, 2015..  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    February 3. 2015..  Cynthia Wise        See FOR FURTHER
 Due to a Disability.                                  email:              INFORMATION
                                                       cynthia.wise@fda.   CONTACT.
                                                       hhs.gov.
Closing Date for Written          March 13, 2015....
 Comments.
----------------------------------------------------------------------------------------------------------------
\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; telephone: 410-316-2377; FAX: 410-472-3289; email: [email protected].
\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, telephone: 240-402-1357, 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 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. Please be advised that as soon as a transcript 
is available, it will be accessible at http://www.regulations.gov and 
at FDA's FSMA Web site at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm. It may also be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. A transcript will also be available in 
either hardcopy or on CD-ROM, after submission of a Freedom of 
Information request. Written requests are to be sent to the Division of 
Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. Additionally, FDA will be 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/GuidanceRegulation/FSMA/default.htm.

IV. Reference

1. Draft Environmental Impact Statement for the Proposed Rule: 
Standards for Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption.

    Dated: January 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00564 Filed 1-12-15; 4:15 pm]
BILLING CODE 4164-01-P