[Federal Register Volume 73, Number 200 (Wednesday, October 15, 2008)]
[Notices]
[Pages 61115-61117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24414]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1163; FRL-8383-2]


Guidance for Conducting Prospective Ground-Water Monitoring 
Studies, Response to Public Comments and Final Guidance; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This document announces the availability of the final Guidance 
for Conducting Prospective Ground-Water (PGW) Monitoring Studies and 
EPA's response to public comments on the development of the final PGW 
monitoring studies guidance. This PGW monitoring study, which is 
required 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.

FOR FURTHER INFORMATION CONTACT: Betsy Behl, Environmental Fate and 
Effects Division (7507P), 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: <a href="/cdn-cgi/l/email-protection#9ffdfaf7f3b1fdfaebece6dffaeffeb1f8f0e9"><span class="__cf_email__" data-cfemail="117374797d3f7374656268517461703f767e67">[email protected]</span></a>.

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

[[Page 61116]]

affected entities may include, but are not limited to:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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. 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2007-1163. 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 Office of Pesticide Programs (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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr.

II. Background

A. What Action is the Agency Taking?

    The PGW monitoring study, which is required on a case-by-case basis 
(40 CFR 158.1300), 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 monitoring study, with input from EPA on 
key aspects of the PGW monitoring 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 PGW guidance document describes 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 field 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 PGW monitoring 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 monitoring 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 PGW monitoring studies have also been used to develop 
the EPA regression screening model, Screening Concentration in Ground 
Water (SCI-GROW) (http://www.epa.gov/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 PGW monitoring 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 (Ref. 1), a Scientific Advisory Panel (SAP) 
review in 1998 (Ref. 2), and a request for final public comments in 
January 2008 (Ref. 3). From the January 2008 final request for 
comments, two public comments were received: California Department of 
Pesticide Regulation and Florida Department of Agriculture and Consumer 
Services (Ref. 4). Conference calls were held with these two commenters 
to discuss proposed revisions in response to their comments. The 
comments received during the workshop (Ref. 1) and SAP meeting (Ref. 2) 
provided valuable suggestions from both a technical and practical 
perspective and were used to revise the PGW monitoring studies guidance 
document and to address other issues identified in the Agency's review 
of PGW monitoring studies conducted for the registration of over 50 
pesticides. EPA incorporated comments solicited from industry, 
academia, and consultants into the revised PGW monitoring studies 
guidance document. The recommendations in the PGW monitoring studies 
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?

    This action is issued under the authority of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), section 3.

III. References

    1. EPA. Prospective Ground-Water Monitoring Study 1995 Workshop 
Notes. Document Number: EPA-HQ-OPP-2007-1163-0009. Available on-line 
at: http://www.regulations.gov.
    2. EPA. FIFRA Scientific Advisory Panel Meeting, October 14-15, 
1998, Report. SAP Report No. 98-01. I--Review of Guidance Document for 
Small-Scale Prospective Ground-Water Monitoring Studies. November 19, 
1998. Available on-line at: http://www.epa.gov/scipoly/sap/meetings/1998/october/final.pdf.
    3. EPA. Guidance for Conducting Prospective Ground-Water Studies; 
Notice. Federal Register (73 FR 2910, January 16, 2008) (FRL-8347-5). 
Available on-line at: http://www.epa.gov/fedrgstr.
    4. EPA. Response to Public Comments Document on the Guidance for 
Conducting Prospective Ground-Water Monitoring Studies. Document 
Number: EPA-HQ-OPP-2007-1163-0005. Available on-line at: http://www.regulations.gov.

[[Page 61117]]

List of Subjects

    Environmental protection, Ground-water monitoring studies, 
Pesticides and pests.

    Dated: October 8, 2008.
Donald J. Brady,
Director, Environmental Fate and Effects Division, Office of Pesticide 
Programs.
[FR Doc. E8-24414 Filed 10-14-08; 8:45 am]
BILLING CODE 6560-50-S


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