[Federal Register Volume 75, Number 188 (Wednesday, September 29, 2010)]
[Notices]
[Pages 60113-60114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24307]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0935; FRL-8804-7]
Pesticide 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 ``Use of the Pesticide Data Program (PDP) in Acute Risk
Assessment.'' In estimating dietary exposure to pesticides, the Agency
uses a variety of data and different models. This science policy
document was developed to explain a particular statistical methodology,
known as decomposition, for using information from the U.S. Department
of Agriculture's (USDA) Pesticide Data Program (PDP) in risk
assessments of acute exposure to pesticide residues in food. EPA is
withdrawing this policy because EPA has been using a less resource-
intensive and generally comparable method of analyzing data on
pesticide residues. This action is in response to the recommendations
made by EPA's Office of Inspector General during its review of EPA's
implementation of the Food Quality and Protection Act (FQPA). In its
report ``Opportunities to Improve Data Quality and Children's Health
through the FQPA'' issued January 10, 2006, 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 those papers. EPA is withdrawing this policy
because EPA has been using a less resource-intensive and generally
comparable method of analyzing data on pesticide residues.
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. Discussion
A. Background on the Food Quality Protection Act of 1996
The Food Quality Protection Act of 1996 (FQPA) significantly
amended the 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
[[Page 60114]]
health protections for infants and children from pesticide risks.
During 1998 and 1999, EPA and the U.S. 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.
As a result of the 1998 and 1999 TRAC process, EPA decided that the
FQPA implementation process and related policies would benefit from
providing notice and comment on the major science policy issues. The
TRAC identified nine science policy areas it believed were key to
implementation of tolerance reassessment. EPA agreed to provide an
opportunity for public 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 today's notice is intended to update the
public on the status of the science paper ``Use of the Pesticide Data
Program (PDP) in Acute Risk Assessment.''
B. EPA's Use of a Decomposition Methodology for Acute Dietary Risk
Assessment
In May 1999, EPA published the policy paper ``Use of the Pesticide
Data Program (PDP) in Acute Risk Assessment'' (http://www.epa.gov/fedrgstr/EPA-PEST/1999/May/Day-26/p13034.htm) for public comment. This
science policy document was developed to explain a particular
statistical methodology, known as decomposition, for using information
from the U.S. Department of Agriculture's (USDA) PDP in risk
assessments of acute exposure to pesticide residues in food. The PDP
tests commodities in the U.S. food supply for pesticide residues. The
decompositing methodology consists of extrapolating from data on
pesticide residues in composite samples of fruits and vegetables to
residue levels in single units of fruits and vegetables.
Prior to publishing this policy, EPA policy did not use PDP residue
data in acute dietary exposure assessments because of a concern that
using these composite results could produce exposure estimates that
would be biased low, underestimating high-end pesticide residues, and
therefore would be inappropriate for human health risk assessments.
Using a decompositing methodology could address these concerns.
OPP consulted the FIFRA Scientific Advisory Panel (SAP) in 1999 and
2000 on a variety of decomposition methodologies and technical issues
surrounding the use of those methodologies. The SAP reports from those
meetings are available at: http://www.epa.gov/scipoly/SAP/meetings/1999/may/final.pdf and http://www.epa.gov/scipoly/sap/meetings/2000/february/partialfinalreport06292000.pdf. The SAP recommended that the
Agency use decompositing and stated that ``for acute dietary exposure
estimation, it is the residues in single items of produce that are of
interest rather than ``average'' residues measured in composited
samples.'' The Panel concluded that overall, a methodology called
MaxLIP was the preferred method, but recommended additional studies and
validation using actual individual samples of residues to develop a
more complete understanding of methods of analysis.
For a time, OPP incorporated decomposition into risk assessment of
acute exposure to pesticide residues in food. However, due to the time-
consuming nature of the analysis, combined with the perception that
utilizing decomposition was not making much of a difference in terms of
risk estimates, the practice was discontinued. OPP has continued to
evaluate the impact of conducting acute dietary risk assessments using
residue levels measured in composite samples versus residue levels
estimated to be present in decomposited samples. The key question has
been the degree to which use of composite samples may underestimate
risk at the high end of the exposure distribution. This assessment,
though still exploratory, confirms OPP's initial impression that
decomposition does not have a critical influence on the risk
assessment. While, as expected, the results vary for each pesticide-
commodity combination, findings suggest that use of composite residues
may result in estimated exposures that are reasonably similar to those
resulting from single-units (i.e., decomposited results).
III. International Interest in Working Together on Dietary Risk
Assessment Analysis
EPA's evaluation of the impact of decompositing is ongoing.
Currently, EPA is in the process of comparing results from the
decomposition methodology to a method known as the ``variability
factor'' used in other countries, including the member States in the
European Union. EPA anticipates working collaboratively with the
European Union, through the European Food Safety Authority (EFSA), to
share data, to better characterize the differences between the two
methodologies, and to better understand the risk assessment and risk
management implications. EPA believes that seeking to develop a
globally harmonized approach in this aspect of dietary risk assessment
will benefit all involved by increasing understanding and facilitating
the sharing of data as well as the assessments derived from those data.
In addition, the process will facilitate better understanding and
resolutions of trade questions and issues that may result from
differences in approach.
IV. Withdrawing this Science Policy is Responsive to EPA's Office of
Inspector General's Recommendations
This action is 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.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: September 22, 2010.
Steve A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2010-24307 Filed 9-28-10; 8:45 am]
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