[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Proposed Rules]
[Pages 50358-50359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20087]



Food and Drug Administration

21 CFR Part 112

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Intent.


SUMMARY: Under the National Environmental Policy Act of 1969 (NEPA), as 
implemented by the Council on Environmental Quality (CEQ) regulations, 
the Food and Drug Administration (FDA) announces its intent to prepare 
an Environmental Impact Statement (EIS) to evaluate the potential 
environmental effects of the proposed rule, Standards for Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption. By 
this notice, FDA is announcing the beginning of the scoping process to 
solicit public comments and identify issues to be analyzed in an EIS. 
Information on the proposed rule may be accessed using the docket 
number found in brackets in the heading of this document.

DATES: This notice initiates the public scoping process for the EIS 
which will close on November 15, 2013. The Agency will consider 
comments in response to this notice to determine the need for any 
public scoping meetings prior to the preparation of the Draft EIS. In 
order to be considered during the preparation of the Draft EIS, all 
comments must be received prior to the close of the public scoping 
period. All relevant and substantive comments submitted to Docket No. 
FDA-2011-N-0921 in response to the proposed rule will be considered as 
part of the scoping process. FDA will provide additional opportunities 
for public participation upon publication of the Draft EIS.

ADDRESSES: You may submit comments, 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 or CD-ROM 
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.
    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.

[[Page 50359]]

FOR FURTHER INFORMATION CONTACT: Annette McCarthy, Center for Food 
Safety and Applied Nutrition (HFS-205), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1200.

SUPPLEMENTARY INFORMATION: To minimize the risk of serious adverse 
health consequences or death from consumption of contaminated produce, 
FDA has published the proposed rule, Standards for Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption (``the produce 
safety rule'' or ``the proposed rule'') to establish science-based 
minimum standards for the safe growing, harvesting, packing, and 
holding of produce, meaning fruits and vegetables grown for human 
consumption (78 FR 3504, January 16, 2013). FDA has proposed these 
standards as part of our implementation of the FDA Food Safety 
Modernization Act (FSMA). These standards would not apply to produce 
that is rarely consumed raw, produce for personal or on-farm 
consumption, or produce that is not a raw agricultural commodity. In 
addition, produce that receives commercial processing that adequately 
reduces the presence of microorganisms of public health significance 
would be eligible for exemption from the requirements of this rule. The 
proposed rule would set forth procedures, processes, and practices that 
minimize the risk of serious adverse health consequences or death, 
including those reasonably necessary to prevent the introduction of 
known or reasonably foreseeable biological hazards into or onto produce 
and to provide reasonable assurances that the produce is not 
adulterated on account of such hazards. We expect that the proposed 
rule, if finalized as proposed, would reduce foodborne illness 
associated with the consumption of contaminated produce.
    For the proposed rule, the Agency relied on a categorical exclusion 
from the need to prepare an Environmental Assessment or EIS under 21 
CFR 25.30(j). Based on currently available information, including 
comments received, and upon further analysis, 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. For example, switching from surface to ground water was 
originally considered a cost- and time-prohibitive option that was 
unlikely to occur to any significant extent given that monitoring data 
available prior to the publication of the proposed rule showed that 
Escherichia. coli exceedance of the proposed standard occurred during 5 
percent of the monitoring period with 55 percent of the incidents being 
no more than 2 days, as discussed in the categorical exclusion memo 
(see Ref. 266 of the proposed rule). Public comment, subsequent to the 
publication of the proposed rule, has indicated 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 more viable alternative water source for 
irrigation in these regions than previous information had indicated. 
Given recently highlighted concerns of ground water depletion (Ref. 1), 
FDA has determined that the use of ground water for irrigation, in 
response to a microbial standard, may significantly affect the quality 
of the human environment. Similarly, comments received caused FDA to 
reevaluate the proposed requirements for biological soil amendments of 
animal origin, which propose an increasingly stringent set of 
application restrictions based on the likelihood of the soil amendment 
harboring pathogens. 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. Changes in the type or handling of soil 
amendments may significantly affect the quality of the human 
    The purpose of the public scoping process for the EIS is to 
determine relevant issues that will influence the scope of the 
environmental analysis, including potential alternatives, and the 
extent to which those issues and impacts will be analyzed in the EIS. 
The EIS will be prepared in accordance with section 102(2)(C) of NEPA 
(Pub. L. 91-190), FDA's NEPA implementing regulations (21 CFR Part 25), 
and the CEQ regulations for implementing NEPA (40 CFR Parts 1500-1508). 
Federal, State, and local Agencies, along with tribes and other 
stakeholders that may be interested in or affected by the produce 
safety rule are invited to participate in the scoping process. Some 
Federal Agencies may request or be requested by the FDA to participate 
in the development of the environmental analysis as a cooperating 
agency. FDA has previously sought comment on potential environmental 
effects as part of the public comment period for the proposed rule, 
including specific questions regarding agricultural water, biological 
soil amendments of animal origin, and wildlife (78 FR 3504 at 3616, 
3619-3620). FDA believes that these questions are still relevant to the 
environmental analysis and will consider comments received. FDA 
encourages additional comments, as part of this scoping process, on 
what specific issues, alternatives, mitigation measures, or other 
information FDA should include for further analysis in the EIS for the 
produce safety rule.


    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. (FDA has 
verified the Web site address, but FDA is not responsible for any 
subsequent changes to the Web site after this document publishes in the 
Federal Register.)

    1. U.S. Geological Survey. 2013. Groundwater Depletion in the 
United States (1900-2008). Scientific Investigation Report 2013-
5079. Available at: http://pubs.usgs.gov/sir/2013/5079/SIR2013-5079.pdf. Accessed July 30, 2013.

    Dated: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20087 Filed 8-16-13; 8:45 am]