[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Notices]
[Page 2910-2912]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja08-48]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1163; FRL-8347-5]
Guidance for Conducting Prospective Ground-Water Studies
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is issuing for
public comment guidance for conducting prospective ground-water (PGW)
studies. This study, which is required by EPA on a case-by-case basis,
is conducted in a controlled setting and provides EPA with data for
evaluating the impact of legal pesticide use on ground water quality.
The PGW guidance document describes how to conduct a PGW monitoring
study, milestones for consulting with EPA, and how to report results to
EPA. Data generated from these field studies have proven valuable to
EPA scientists and risk managers as they are specifically designed to
relate pesticide use indicated on the label to measurements of the
pesticide and its degradates in ground water used as a source of
drinking water.
DATES: Comments must be received on or before March 17, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-1163, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-1163. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be
[[Page 2911]]
publicly available only in hard copy form. Publicly available docket
materials are available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Betsy Behl, Environmental Fate and
Effects Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6128; fax number: (703) 305-6309; e-
mail address: behl.betsy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in FIFRA, section 2(y).
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
The PGW study, which is required on a case-by-case basis (40 CFR
158.1300(d) OPPTS Harmonized Guideline 835.7100), is conducted in a
controlled setting and provides the Agency with data for evaluating the
impact of legal pesticide use on ground water quality. After assessing
the overall environmental fate of a pesticide, the Agency may require
the pesticide manufacturer (registrant) to conduct a PGW study, with
input from EPA on key aspects of the study design. The Agency's
assessment is based on a review of laboratory data on mobility and
persistence of the compound, estimates of potential exposure, available
monitoring and modeling information, and a consideration of the
potential for risk from drinking water exposure. Data generated from
these field studies have proven valuable to EPA scientists and risk
managers as they are specifically designed to relate pesticide use
indicated on the label to measurements of the pesticide and its
degradates in ground water used as a source of drinking water. The
document provides guidance on how to conduct a PGW monitoring study,
describes milestones for consulting with EPA, and describes how results
should be reported to EPA.
EPA uses the results of PGW monitoring studies to help answer
questions such as:
1. Will the pesticide leach in portions of the pesticide use area
that are similar to the study area?
2. How do pesticide residues change over time?
3. What measures might be effective in mitigating the pesticide
leaching?
Monitoring data generated in these studies provide a time-series of
concentrations that can be used in exposure and risk assessments as a
reasonable surrogate for pesticide concentrations in drinking water
drawn from shallow private wells in agricultural areas. PGW studies
have been used to test alternative mitigation strategies for pesticides
that have adversely affected ground water quality to determine, for
example, if a reduction in application rate or specific irrigation
technology will reduce or eliminate the impact. Data from these studies
have also been used to develop the EPA regression screening model SCI-
GROW, (http://www.epa.gove/oppefed1/models/water/models4.htm#scigrow),
which is used to estimate screening-level pesticide concentrations in
ground water used as a source of drinking water. Currently, the results
of these studies are being used to evaluate models of subsurface
pesticide transport, and as a basis for model scenarios for estimating
pesticide concentrations in shallow ground water.
The original draft guidance for PGW monitoring studies was
developed primarily in the early 1990s and has been subjected to
substantial public review and comment, including a public workshop
sponsored by EPA in 1995 and a Scientific Advisory Panel (SAP) review
in 1998. The comments received during the workshop and SAP meeting
provided valuable suggestions from both a technical and practical
perspective and were used to revise this guidance document and to
address other issues identified in the Agency's review of studies
conducted for the registration of over 50 pesticides. EPA incorporated
comments solicited from industry, academia, and consultants into the
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revised guidance document. The recommendations in the guidance document
also represent the Agency's substantial experience, over the last
decade, in developing and articulating effective procedures for
collecting high quality data on pesticide movement into ground water.
B. What is the Agency's Authority for Taking this Action?
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
section 3.
List of Subjects
Environmental protection, prospective ground-water monitoring
studies.
Dated: January 10, 2008.
Donald J. Brady,
Acting Director, Environmental Fate and Effects Division, Office of
Pesticide Programs.
[FR Doc. E8-653 Filed 1-15-08; 8:45 am]
BILLING CODE 6560-50-S