[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Notices]
[Pages 34341-34342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16273]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0935; FRL-8408-5]
Guidance for Submission of Probabilistic Human Health Exposure
Assessments Science Policy; Notice of Withdrawal
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA announces the withdrawal of the pesticide science policy
document ``Guidance for Submission of Probabilistic Human Health
Exposure Assessments to the Office of Pesticide Programs.'' This
science policy document was developed to establish guidance for
submission and review of probabilistic human health exposure
assessments to the Agency's Office of Pesticide Programs. This guidance
has been superseded by EPA's ``Guidance on Cumulative Risk Assessment
of Pesticide Chemicals That Have a Common Mechanism of Toxicity,'' and
by the ``Guidance for Performing Aggregate Exposure and Risk
Assessment.''
FOR FURTHER INFORMATION CONTACT: David J. Miller, Health Effects
Division, Office of Pesticide Programs (7509P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5352; fax number: (703) 305-5147; e-
mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action,
however, may be of interest to persons who produce or formulate
pesticides or who register pesticide products. Since other entities may
also be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action. 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-2008-0935. 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
The Food Quality Protection Act of 1996 (FQPA) significantly
amended the
[[Page 34342]]
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA). Among other changes, FQPA
established a stringent health-based standard (``a reasonable certainty
of no harm'') for pesticide residues in foods to assure protection from
unacceptable pesticide exposure and strengthened health protections for
infants and children from pesticide risks.
During 1998 and 1999, EPA and the United States Department of
Agriculture (USDA) established a subcommittee of the National Advisory
Council for Environmental Policy and Technology (NACEPT), the Tolerance
Reassessment Advisory Committee (TRAC), to address FFDCA issues and
implementation. TRAC comprised more than 50 representatives of affected
user, producer, consumer, public health, environmental, states, and
other interested groups. The TRAC met from May 27, 1998, through April
29, 1999.
In order to continue the constructive discussions about FFDCA, EPA
and USDA established, under the auspices of NACEPT, the Committee to
Advise on Reassessment and Transition (CARAT). The CARAT provided a
forum for a broad spectrum of stakeholders to consult with and advise
the Agency and the Secretary of Agriculture on pest and pesticide
management transition issues related to the tolerance reassessment
process. The CARAT was intended to further the valuable work initiated
by earlier advisory committees toward the use of sound science and
greater transparency in regulatory decision-making, increased
stakeholder participation, and reasonable transition strategies that
reduce risks without jeopardizing American agriculture and farm
communities.
As a result of the 1998 and 1999 TRAC process, EPA decided that the
implementation process and related policies would benefit from
providing notice and comment on major science policy issues. The TRAC
identified nine science policy areas it believed were key to
implementation of tolerance reassessment. EPA agreed to provide one or
more documents for comment on each of the nine issues by announcing
their availability in the Federal Register. In a notice published in
the Federal Register of October 29, 1998 (63 FR 58038) (FRL-6041-5),
EPA described its intended approach. Since then, EPA has issued a
series of draft and revised documents concerning the nine science
policy issues. Publication of this notice is intended to update the
public on the status of the science paper ``Guidance for Submission of
Probabilistic Human Health Exposure Assessments to the Office of
Pesticide Programs.''
III. Why this Policy is No Longer Needed
Historically, assessment of the potential health risks associated
with exposure to pesticides has focused upon single pathways of
exposure (e.g., from pesticide residues in food, water, or residential/
non-occupational uses) for individual chemicals, and not on the
potential for individuals to be exposed to multiple pesticides by all
pathways concurrently. In 1996, the FQPA required EPA to consider
potential human health risks from all pathways of dietary and non-
dietary exposures to more than one pesticide acting through a common
mechanism of toxicity.
The ``Guidance for Submission of Probabilistic Human Health
Exposure Assessments to the Office of Pesticide Programs'' was issued
in 1998; http://www.epa.gov/fedrgstr/EPA-PEST/1998/November/Day-05/6021.pdf. The ``Guidance for Submission of Probabilistic Human Health
Exposure Assessments'' provided general guidance on the conduct of
probabilistic risk assessments. The guidance was intended to be used
chiefly by persons conducting human health exposure assessments for
purposes of registration or reregistration of pesticides.
EPA is withdrawing the ``Guidance for Submission of Probabilistic
Human Health Exposure Assessments to the Office of Pesticide Programs''
because it has been superseded by several other EPA policy and guidance
documents. These include: (1) ``General Principles for Performing
Aggregate Exposure and Risk Assessments,'' http://www.epa.gov/pesticides/trac/science/aggregate.pdf, and (2) ``Guidance on Cumulative
Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of
Toxicity,'' http://epa.gov/pesticides/trac/science/cumulative_guidance.pdf.
The ``General Principles for Performing Aggregate Exposure and Risk
Assessments'' focus upon describing principles to guide the way in
which aggregate exposure and risk assessment may be performed when more
extensive distributional data and more sophisticated exposure
assessment, methods and tools are available.
The ``Guidance on Cumulative Risk Assessment of Pesticide Chemicals
That Have a Common Mechanism of Toxicity'' provides guidance for OPP
scientists for evaluating and estimating the potential human risks
associated with such multi-chemical and multi-pathway exposures to
pesticides.
The policies and guidance mentioned above reflect EPA's most recent
guidance, thus superseding the information in ``Guidance for Submission
of Probabilistic Human Health Exposure Assessments to the Office of
Pesticide Programs.'' While the information in the document we are
withdrawing is not necessarily inaccurate, it is outdated.
This action is also responsive to the recommendations made by EPA's
Office of Inspector General during its review of EPA's implementation
of FQPA. In its report ``Opportunities to Improve Data Quality and
Children's Health through the FQPA'' issued January 10, 2006 http://www.epa.gov/oig/reports/2006/20060110-2006-P-00009.pdf the Office of
Inspector General Recommended that EPA should update the status of its
science policy issue papers. This Federal Register notice updates the
public on the status of one of the science policy papers which has been
superseded by other guidance.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: June 30, 2009.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E9-16273 Filed 7-14-09; 8:45 am]
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