[Federal Register: June 15, 2005 (Volume 70, Number 114)]
[Notices]
[Page 34758-34761]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn05-62]
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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
[[Page 34759]]
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: mark.corbin@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. 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
[[Page 34760]]
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 toopp-docket@epa.gov,
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
[[Page 34761]]
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