Document ID: EPA-HQ-OPP-2007-0218-0001
Agency: epa
Document Type: Notice
Title: Pesticides; Science Policy; Notice of Withdrawal
Posted Date: 2007-08-01T04:00Z

[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Notices]               
[Page 42082-42083]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au07-60]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0218; FRL-8130-2]

 
Pesticides; Science Policy; Notice of Withdrawal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  EPA announces the withdrawal of the revised version of the 
pesticide science policy document ``Standard Operating Procedures for 
Incorporating Screening-Level Estimates of Drinking Water Exposure into 
Aggregate Risk Assessments'' http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
 This science policy document was developed during the 

implementation of the new safety standard in section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA). EPA's assessment of exposure to 
pesticide residues in drinking water no longer involves performing 
screening level assessments as described in this policy paper. 
Accordingly, EPA is withdrawing this science policy document. Instead, 
the Agency now routinely develops estimates of exposure to pesticides 
in drinking water using the more advanced

[[Page 42083]]

methods that EPA has described in other science policy papers.

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-2007-0218. 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

    On August 3, 1996, FQPA was signed into law. The FQPA significantly 
amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
and 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 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.
    In order to continue the constructive discussions about FFDCA, in 
2000 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 two of the FQPA science policy papers.

III. Summary: Why the Policy Is No Longer Needed

    As a result of the new procedures for estimating concentrations of 
pesticide residues in drinking water, this notice announces the 
withdrawal of ``Standard Operating Procedures for Incorporating 
Screening-Level Estimates of Drinking Water Exposure into Aggregate 
Risk Assessments'' http://www.epa.gov/fedrgstr/EPA-PEST/2000/October/Day-11/p25934.htm
.

    In assessing the risks of pesticide exposure, scientists frequently 
use mathematical models to predict pesticide concentrations in food, 
water, residential, and occupational environments. This notice pertains 
to how the Agency determines pesticide risk from drinking water. (For 
more information on the models the Agency uses to estimate 
concentrations of pesticides in drinking water see http://www.epa.gov/oppefed1/models/water/models4.htm
). This approach provides a more 

realistic estimate of exposure through drinking water since actual 
drinking water consumption data and reported body weight from the 
Combined Survey of Food Intake by Individuals (CSFII) are used, rather 
than the standard assumptions used in the Drinking Water Level of 
Comparison approach.
    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/oigearth/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 rendered obsolete by the availability of more robust data and 
models.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.

    Dated: July 20, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. E7-14685 Filed 7-31-07; 8:45 am]

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