[Federal Register Volume 71, Number 155 (Friday, August 11, 2006)]
[Notices]
[Pages 46226-46227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13042]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0129; FRL-8071-9]
Final 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 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 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 proposed guidance document
for TFD studies was published in the Federal Register on June 15, 2005
(FRL-7713-7). After reviewing the public comments for this Notice, EPA
developed a final guidance document, which can be found at: http://
www.epa. gov/oppefed1/ecorisk--ders/terrestrial-- field-- dissipation--
guidance.pdf. EPA's response to public comments can be found in the
public docket: EPA-HQ-OPP-2005-0129.
FOR FURTHER INFORMATION CONTACT: Mark Corbin, Environmental Fate and
Effects Division (7507P), 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 a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2005-0129. 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 Building), 2777 S.
Crystal Drive, 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 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 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:
[[Page 46227]]
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; and
Characterize the effect(s) of different typical pesticide
formulation categories, where applicable.
EPA and PMRA have developed harmonized guidance for conducting
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. On June 15, 2005, the Agency
published the draft harmonized guidance and conceptual model in the
Federal Register and asked for comments. After reviewing all the
comments, PMRA and EPA developed the final guidance, which can be found
at the following address: http://www.epa.gov/ oppefed1/ecorisk--ders/
terrestrial--field--dissipation-- 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, NAFTA
harmonized guidance.
Dated: August 3, 2006.
Steven Bradbury,
Director, Environmental Fate and Effects Division, Office of Pesticide
Programs.
FR Doc. E6-13042 Filed 8-10-06; 8:45 am]
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