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Notice

Guidance for Conducting Prospective Ground-Water Studies

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Information about this document as published in the Federal Register.

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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 Start Printed Page 2911publicly 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.

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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.

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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 Start Printed Page 2912revised 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.

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List of Subjects

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Dated: January 10, 2008.

Donald J. Brady,

Acting Director, Environmental Fate and Effects Division, Office of Pesticide Programs.

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[FR Doc. E8-653 Filed 1-15-08; 8:45 am]

BILLING CODE 6560-50-S