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, 1478-1481 [2015-00205]

Download as PDF 1478 Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Proposed Rules notice of data availability (NODA) in the Federal Register to make available and invite comments on its provisional analysis regarding energy conservation standards for commercial and industrial fans and blowers. 79 FR 73246. The NODA provided for the written submission of comments by January 26, 2015. The Air Movement and Control Association International (AMCA) and the Appliance Standards Awareness Project (ASAP) requested an extension of the public comment period by 45 days. Stakeholders stated that additional time is necessary to review of the published analysis in order to provide, prepare, and submit comments accordingly. DOE has determined that extending the comment period to allow additional time for interested parties to submit comments is appropriate based on the foregoing reason. However, DOE believes a 30 day extension, providing a total comment period of 75 days, allows sufficient time for submitting comments. Accordingly, DOE will consider any comments received by midnight of February 25, 2015, and deems any comments received by that time to be timely submitted. Issued in Washington, DC, on December 31, 2014. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy. [FR Doc. 2015–00234 Filed 1–9–15; 8:45 am] BILLING CODE 6450–01–P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 284 [Docket No. RM14–2–000] Coordination of the Scheduling Processes of Interstate Natural Gas Pipelines and Public Utilities Federal Energy Regulatory Commission, DOE. ACTION: Notice of proposed rulemaking; notice of extension of time. AGENCY: On December 12, 2014, pursuant to authority delegated to the Director, Office of Energy Policy and Innovation, a data request was issued to each ISO and RTO regarding the effect on the reliable and efficient operations of natural gas-fired generators of the current 9 a.m. CCT start to the Gas Day. The requests seek data from the ISOs/ RTOs with respect to derates by natural gas generators during the morning ramp mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 17:35 Jan 09, 2015 Jkt 235001 Dated: January 7, 2015. Kimberly D. Bose, Secretary. period. This notice extends the deadline to submit answers in response to these data requests. DATES: Responses to the data request must be filed on or before January 22, 2015 in Docket No. RM14–2–000. Comments on the responses to the data request must be filed in the same docket within 10 days of the data request response, on or before February 2, 2015. ADDRESSES: Responses and Comments, identified by docket number, may be filed in the following ways: • Electronic Filing through https:// www.ferc.gov. Documents created electronically using word processing software should be filed in native applications or print-to-PDF format and not in a scanned format. • Mail/Hand Delivery: Those unable to file electronically may mail or handdeliver comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426. Instructions: For detailed instructions on submitting responses and comments, see the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: Anna Fernandez (Legal Information), Federal Energy Regulatory Commission, Office of the General Counsel, 888 First Street NE., Washington, DC 20426, 202– 502–6682. Caroline Daly Wozniak (Technical Information), Federal Energy Regulatory Commission, Office of Energy Policy and Innovation, 888 First Street NE., Washington, DC 20426, 202–502–8931. SUPPLEMENTARY INFORMATION: On January 5, 2015, the ISO/RTO Council (IRC) filed a motion requesting a 10-day extension of time (motion) until January 22, 2015 to submit answers to the data requests issued on December 12, 2014, as requested by the Office of Energy Policy and Innovation, in the abovereferenced proceeding.1 In its motion, IRC states that the additional time is needed due to the amount of source data required to review, the intervening holidays, and other intervening data response commitments. Upon consideration, notice is hereby given to all parties that IRC’s motion is granted, extending the deadline to submit answers to and including January 22, 2015; and to submit comments in response to those answers, to and including February 2, 2015. 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. 1 Letters requesting a response to the data requests under RM14–2–000 were issued to the following ISOs and RTOs: ISO New England, New York Independent System Operator, Inc., California Independent System Operator, Southwest Power Pool, Inc., PJM Interconnection, L.L.C., and Midcontinent Independent System Operator, Inc. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 [FR Doc. 2015–00263 Filed 1–9–15; 8:45 am] BILLING CODE 6717–01–P 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. SUMMARY: E:\FR\FM\12JAP1.SGM 12JAP1 Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS 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 https:// www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received, go to https:// 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: 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, 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: cynthia.wise@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The FDA Food Safety Modernization Act (FSMA) (Public Law 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 VerDate Sep<11>2014 17:35 Jan 09, 2015 Jkt 235001 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 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, PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 1479 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 § 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 § 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 § 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 E:\FR\FM\12JAP1.SGM 12JAP1 1480 Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Proposed Rules 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 § 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 § 112.112 (proposed § 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 § 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 § 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 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 mstockstill on DSK4VPTVN1PROD with PROPOSALS College Park, MD Public Meeting. Deadline for Registration ....... VerDate Sep<11>2014 17:35 Jan 09, 2015 Electronic address February 10, 2015—1 p.m. to 4 p.m. February 3, 2015. Jkt 235001 Address https://www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConferences/default.htm. https://www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConferences/default.htm Docket No. FDA–2014–N–2244. Wiley Auditorium, Harvey W. Wiley Federal Bldg., 5100 Paint Branch Pkwy., College Park, MD 20740. We encourage you to use electronic registration if possible 1. PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\12JAP1.SGM Other information 12JAP1 There is no registration fee for the public meetings. Early registration is recommended because seating is limited. Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Proposed Rules 1481 TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET— Continued Date Electronic address Address Other information Requests made on the day of the meeting to make an oral presentation will be granted as time permits. Information on requests to make an oral presentation may be posted without change to https:// www.regulations.gov, including any personal information provided. Request to Make a Public Comment. February 3, 2015. https://www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConferences/default.htm 2. ................................................ Request Special Accommodations Due to a Disability. Closing Date for Written Comments. February 3, 2015. March 13, 2015. Cynthia Wise email: cynthia.wise@fda.hhs.gov. See FOR FURTHER INFORMATION CONTACT. 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: 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, telephone: 240–402– 1357, email: cynthia.wise@fda.hhs.gov. mstockstill on DSK4VPTVN1PROD with PROPOSALS III. Comments, Transcripts, and Recorded Video Packing, and Holding of Produce for Human Consumption. 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 https:// 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 https://www.regulations.gov and at FDA’s FSMA Web site at https:// 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 https:// www.fda.gov/Food/ GuidanceRegulation/FSMA/ default.htm. Dated: January 6, 2015. Leslie Kux, Associate Commissioner for Policy. IV. Reference 1. Draft Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, VerDate Sep<11>2014 17:46 Jan 09, 2015 Jkt 235001 [FR Doc. 2015–00205 Filed 1–9–15; 8:45 am] BILLING CODE 4164–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R07–OAR–2014–0163; FRL–9921–18– Region 7] Approval and Promulgation of Implementation Plans; State of Iowa Environmental Protection Agency. ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve revisions to the State Implementation Plan (SIP) for the State of Iowa. The purpose of these revisions is to update the Polk County Board of Health Rules and Regulations, Chapter V, Air Pollution. These proposed revisions reflect updates to the Iowa statewide rules previously approved by EPA and will ensure consistency between the applicable local agency rules and Federally-approved rules. On April 15, 2014, the state amended their request and notified EPA that it is withdrawing their requests to approve to adopt greenhouse gases definition and sections relating to greenhouse gas emissions. This withdrawal request is in SUMMARY: PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 recognition of the July 12, 2013, U.S. Court of Appeals for the District of Columbia decision which vacated the regulation known as the ‘‘biogenic deferral rule’’. On October 31, 2014, the state requested that EPA withdraw their request to approve the definition of anaerobic lagoon. DATES: Comments on this proposed action must be received in writing by February 11, 2015. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–R07– OAR–2014–0163 by mail to: Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219. Comments may also be submitted electronically or through hand delivery/courier by following the detailed instructions in the ADDRESSES section of the direct final rule located in the rules section of this Federal Register. FOR FURTHER INFORMATION CONTACT: Heather Hamilton at (913) 551–7039, or by email at Hamilton.heather@epa.gov. SUPPLEMENTARY INFORMATION: In the final rules section of this Federal Register, EPA is approving the state’s SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial revision amendment and anticipates no relevant adverse comments to this action. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated in relation to this action. If EPA receives relevant adverse comments, the direct E:\FR\FM\12JAP1.SGM 12JAP1

Agencies

[Federal Register Volume 80, Number 7 (Monday, January 12, 2015)]
[Proposed Rules]
[Pages 1478-1481]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00205]


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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.

-----------------------------------------------------------------------

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: https://www.regulations.gov. 
Follow the instructions for submitting comments.

[[Page 1479]]

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 
https://www.regulations.gov, including any personal information 
provided.
    Docket: For access to the docket to read background documents or 
comments received, go to https://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: 
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, 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: cynthia.wise@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Public Law 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 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

[[Page 1480]]

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 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        February 10,     https://www.fda.gov/   Wiley Auditorium,
 Meeting.                       2015_1 p.m.     Food/NewsEvents/      Harvey W. Wiley
                                to 4 p.m.        WorkshopsMeetingsCo   Federal Bldg., 5100
                                                 nferences/            Paint Branch Pkwy.,
                                                 default.htm.          College Park, MD
                                                                       20740.
Deadline for Registration....  February 3,      https://www.fda.gov/   We encourage you to   There is no
                                2015.            Food/NewsEvents/      use electronic        registration fee
                                                 WorkshopsMeetingsCo   registration if       for the public
                                                 nferences/            possible \1\.         meetings. Early
                                                 default.htm Docket                          registration is
                                                 No. FDA-2014-N-2244.                        recommended because
                                                                                             seating is limited.

[[Page 1481]]

 
Request to Make a Public       February 3,      https://www.fda.gov/   ....................  Requests made on the
 Comment.                       2015.            Food/NewsEvents/                            day of the meeting
                                                 WorkshopsMeetingsCo                         to make an oral
                                                 nferences/                                  presentation will
                                                 default.htm \2\.                            be granted as time
                                                                                             permits.
                                                                                             Information on
                                                                                             requests to make an
                                                                                             oral presentation
                                                                                             may be posted
                                                                                             without change to
                                                                                             https://www.regulations.gov
                                                                                             , including any
                                                                                             personal
                                                                                             information
                                                                                             provided.
Request Special                February 3,      Cynthia Wise email:   See FOR FURTHER
 Accommodations Due to a        2015.            cynthia.wise@fda.hh   INFORMATION CONTACT.
 Disability.                                     s.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: 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, telephone: 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 and will be 
accessible to the public at https://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 https://www.regulations.gov and 
at FDA's FSMA Web site at https://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 https://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 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00205 Filed 1-9-15; 8:45 am]
BILLING CODE 4164-01-P
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