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[Federal Register: September 29, 2010 (Volume 75, Number 188)]
[Notices]               
[Page 60113-60114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se10-63]                         

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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: 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. 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]
BILLING CODE 6560-50-S
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