[Federal Register Volume 70, Number 114 (Wednesday, June 15, 2005)]
[Notices]
[Pages 34758-34761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11830]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0129; FRL-7713-7]


NAFTA Guidance for Conducting Terrestrial Field Dissipation 
Studies

AGENCY: Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  Under the North American Free Trade Agreement (NAFTA), EPA 
and the Canadian Pest Management Regulatory Agency (PMRA) have agreed

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to harmonize their testing guidelines so that one set of tests can be 
used for the registration of pesticides in Canada and the United 
States. The NAFTA harmonized guidance for terrestrial field dissipation 
(TFD) studies are conducted to demonstrate the transformation, 
transport, and fate of pesticides under representative actual use 
conditions. These field studies are needed to substantiate the 
physicochemical, mobility, and biotransformation data from laboratory 
studies. Environmental fate studies have shown that pesticide 
dissipation may proceed at different rates under field conditions and 
may result in degradates forming at levels different from those 
observed in laboratory studies. The objective of this revised guidance 
document is to help ensure that TFD studies are conducted in a manner 
that will provide risk assessors and risk managers with more confidence 
in the data generated and with a better understanding of the 
assumptions and limitations of the data and estimated half-lives of the 
pesticide. The revised guidance can be found at: http://www.epa.gov/oppefed1/ecorisk_ders/efed_final_draft_tfd_guidance.pdf.

DATES: Comments, identified by docket ID number OPP-2005-0129, must be 
received on or before August 1, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Mark Corbin, Environmental Fate and 
Effects Division (7507C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-605-0033; fax number: 703-305-6309; e-mail 
address: [email protected].

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. 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 an official public docket for this 
action under docket identification (ID) number OPP-2005-0129. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
docket 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 athttp://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please

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follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail 
to submit CBI or information protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. 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.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets athttp://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2005-0129. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to[email protected], 
Attention: Docket ID Number OPP-2005-0129. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures youre-mail address. E-mail addresses that 
are automatically captured by EPA'se-mail system are included as part 
of the comment that is placed in the official public docket, and made 
available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0129.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0129. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
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 CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any 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 and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide any technical information and/or data you used that 
support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at your estimate.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternatives.
    7. Make sure to submit your comments by the comment period deadline 
identified.
    8. To ensure proper receipt by EPA, identify the appropriate docket 
ID number in the subject line on the first page of your response. It 
would also be helpful if you provided the name, date, and Federal 
Register citation related to your comments.

II. Background

A. What Action is the Agency Taking?

    The Terrestrial Field Dissipation study has been a basic 
requirement for registrants of new and existing pesticides since 1982. 
While laboratory environmental fate studies are designed to address one 
dissipation process at a time, terrestrial field dissipation studies 
address pesticide loss as a combined result of chemical and biological 
processes (e.g., hydrolysis, photolysis, microbial transformation) and 
physical migration (e.g., volatilization, leaching, plant uptake). Data 
from these studies can reduce potential overestimation of exposure and 
risk and can confirm assumptions of low levels of toxic degradates. 
Results can be used to propose scenario-specific effective risk 
mitigation.
    In general, the terrestrial field dissipation study results should 
allow the risk assessor to:
     Compare predicted routes of dissipation identified in the 
laboratory with those measured in the field.
     Characterize the rates of dissipation of the parent 
compound and formation and decline of the major and/or toxicologically 
significant transformation products under field conditions.
     Characterize the rates and relative importance of the 
different transport processes, including leaching, runoff, and 
volatilization.
     Establish the distribution of the parent compound and the 
major transformation products in the soil profile.
     Characterize the persistence of the parent compound and 
major transformation products in soil, including retention and residue 
carryover in the soil to the following crop season.
     Characterize the effect(s) of different typical pesticide 
formulation categories, where applicable.
    EPA and PMRA have developed harmonized guidance for conducting

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terrestrial field dissipation studies so that one set of tests can be 
used for registration of a pesticide in Canada, the United States, and 
Mexico. In developing this guidance document, EPA and PMRA conducted an 
extensive outreach and review program, soliciting input from 
stakeholders and the technical community through several forums: three 
symposia, one Scientific Advisory Panel (SAP) meeting, and one 
workshop. Working closely with its stakeholders, PMRA and EPA developed 
a conceptual model for designing terrestrial studies that will evaluate 
the overall dissipation of a pesticide in the field. The conceptual 
model, which is specific for each pesticide, is based on the chemical's 
physicochemical properties, laboratory environmental fate studies, 
formulation type and intended use pattern. At this time, the Agency is 
soliciting input from the public on the draft harmonized guidance and 
conceptual model, which can be found at the following address: http://www.epa.gov/oppefed1/ecorisk_ders/efed_final_draft_tfd_guidance.pdf.

B. What is the Agency's Authority for Taking this Action?

    This action is being taken under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA).

List of Subjects

    Environmental protection, Terrestrial field dissipation, Harmonized 
guidance.


    Dated: May 9, 2005.
Steven Bradbury,
Director, Environmental Fate and Effects Division, Office of Pesticide 
Programs.

[FR Doc. 05-11830 Filed 6-14-05 8:45 am]
BILLING CODE 6560-50-S