
[Federal Register: July 15, 2009 (Volume 74, Number 134)]
[Notices]               
[Page 34341-34342]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy09-92]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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has been superseded by EPA's ``Guidance on Cumulative Risk Assessment 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: miller.davidj@epa.gov.

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]

BILLING CODE 6560-50-S
