Document ID: EPA-HQ-OPP-2007-1163-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-01-16T05:00Z

[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]                         

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

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.

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

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

[[Page 2912]]

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