[Federal Register Volume 64, Number 217 (Wednesday, November 10, 1999)]
[Notices]
[Pages 61346-61348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29451]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00577A; FRL-6389-7]
Pesticides; Policy Issues Related to the Food Quality Protection
Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: EPA is announcing the availability of the revised version of
the pesticide science policy document entitled ``Estimating the
Drinking Water Component of a Dietary Exposure Assessment.'' This
notice is the fourteenth in a series concerning science policy
documents related to the Food Quality Protection Act and developed
through the Tolerance Reassessment Advisory Committee.
FOR FURTHER INFORMATION CONTACT: Nelson Thurman or Sid Abel,
Environmental Protection Agency (7506C), 401 M St., SW., Washington, DC
20460; telephone numbers: (703) 308-0465 or (703) 305-7346; fax: (703)
305-6309; e-mail: thurman.nelson@epa.gov and abel.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture
or formulate pesticides. Potentially affected categories and entities
may include, but are not limited to:
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Examples of
Category NAICS potentially
affected entities
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Pesticide producers 32532 Pesticide
manufacturers
Pesticide
formulators
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed could also be affected. The
North American Industrial Classification System (NAICS) codes have been
provided to assist you and others in determining whether or not this
action affects certain entities. 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 Additional Information, Including Copies of this
Document or Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, the science policy documents, and certain other related
documents that might be available electronically, from the Office of
Pesticide Programs' Home Page at http://www.epa.gov/pesticides/. On the
Office of Pesticide Programs' Home Page select ``FQPA'' and then look
up the entry for this document under ``Science Policies.'' You can also
go directly to the listings at the EPA Home Page at http://
www.epa.gov/. On the Home Page select ``Laws and Regulations'' and then
look up the entry to this document under ``Federal Register --
Environmental Documents.'' You can go directly to the Federal Register
listings http://www.epa.gov/fedrgstr/.
2. Fax on demand. You may request to receive a faxed copy of the
revised science policy paper, as well as supporting information, by
using a faxphone to call (202) 401-0527. Select item 6044 for the paper
entitled ``Estimating the Drinking Water Component of a Dietary
Exposure Assessment.'' You may also follow the automated menu.
3. In person. The Agency has established an official record for
this action under docket control number OPP-00577A. In addition, the
documents referenced in the framework notice, which published in the
Federal Register on October 29, 1998 (63 FR 58038) (FRL-6041-5) have
also been inserted in the docket under docket control number OPP-00557.
The official record consists of the documents specifically referenced
in this action, any public comments received during an applicable
comment period, and other information related to this action, including
any information claimed as Confidential Business Information (CBI).
This official record includes the documents that are physically located
in the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background for the Tolerance Reassessment Advisory Committee
(TRAC)
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA)
was signed into law. Effective upon signature, the 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; provided
heightened health protections for infants and children from pesticide
risks; required expedited review of new, safer pesticides; created
incentives for the development and maintenance of effective crop
protection tools for farmers; required reassessment of existing
tolerances over a 10-year period; and required periodic re-evaluation
of pesticide registrations and tolerances to ensure that scientific
data
[[Page 61347]]
supporting pesticide registrations will remain up-to-date in the
future.
Subsequently, the Agency established the Food Safety Advisory
Committee (FSAC) as a subcommittee of the National Advisory Council for
Environmental Policy and Technology (NACEPT) to assist in soliciting
input from stakeholders and to provide input to EPA on some of the
broad policy choices facing the Agency and on strategic direction for
the Office of Pesticide Programs. The Agency has used the interim
approaches developed through discussions with FSAC to make regulatory
decisions that met FQPA's standard, but that could be revisited if
additional information became available or as the science evolved. As
EPA's approach to implementing the scientific provisions of FQPA has
evolved, the Agency has sought independent review and public
participation, often through presentation of many of the science policy
issues to the FIFRA Scientific Advisory Panel (SAP), a group of
independent, outside experts who provide peer review and scientific
advice to OPP.
In addition, as directed by Vice President Albert Gore, EPA has
been working with the U.S. Department of Agriculture (USDA) and another
subcommittee of NACEPT, the TRAC, chaired by the EPA Deputy
Administrator and the USDA Deputy Secretary, to address FQPA issues and
implementation. TRAC comprises more than 50 representatives of affected
user, producer, consumer, public health, environmental, states and
other interested groups. The TRAC has met six times as a full committee
from May 27, 1998 through April 29, 1999.
The Agency has been working with the TRAC to ensure that its
science policies, risk assessments of individual pesticides, and
process for decision making are transparent and open to public
participation. An important product of these consultations with TRAC is
the development of a framework for addressing key science policy
issues. The Agency decided that the FQPA implementation process and
related policies would benefit from initiating notice and comment on
the major science policy issues.
The TRAC identified nine science policy issue areas it believes
were key to implementation of FQPA and tolerance reassessment. The
framework calls for EPA to provide one or more documents for comment on
each of the nine issues by announcing their availability in the Federal
Register. In accordance with the framework described in a separate
notice published in the Federal Register of October 29, 1998 (63 FR
58038), EPA is announcing through the Federal Register the availability
of a series of draft documents concerning nine science policy issues
identified by the TRAC related to the implementation of FQPA. After
receiving and reviewing comments from the public and others, EPA is
also issuing revised science policy documents which reflect changes
made in response to comments. In addition to comments received in
response to these Federal Register notices, EPA will consider comments
received during the TRAC meetings. Each of these issues is evolving and
in a different stage of refinement. Accordingly, as the issues are
further refined by EPA in consultation with USDA and others, they may
also be presented to the SAP.
III. Summary of Revised Science Policy Guidance Document
This Federal Register notice announces the availability of a
revised version of the Office of Pesticide Programs' (OPP) science
policy guidance document that has been re-titled ``Estimating the
Drinking Water Component of a Dietary Exposure Assessment.'' This
science policy paper describes changes in OPP's approach to estimating
pesticide concentrations in drinking water as part of its assessment of
dietary exposures to pesticides. This document was developed from the
science policy paper entitled ``Science Policy 5: Estimating the
Drinking Water Component of a Dietary Exposure Assessment (12/22/98
Draft),'' that was released for public comment on January 4, 1999 (64
FR 162) (FRL-6054-8). The Agency received comments from various
organizations. Each of the commentors offered recommendations for
improving the science policy. All comments were extensively evaluated
and considered by the Agency. This revised version embodies many
recommendations of the commentors, as well as recommendations from a
May 1999 FIFRA Scientific Advisory Panel which evaluated the proposed
approach for incorporating a ``crop area adjustment factor'' along with
a drinking water reservoir scenario in the Agency's surface water
screening models. The public comments, as well as a detailed summary of
the Agency's response to the comments are also available in the docket
for this notice.
For some time the Agency has been using screening models to
estimate pesticide concentrations in ground water and surface water to
identify those food-use pesticides that are not expected to contribute
enough exposure via drinking water to result in unacceptable levels of
aggregate risk. The Agency uses monitoring data, where available and
reliable, to refine its assessments in those cases where the use of the
screening models does not result in ``clearing'' (i.e., indicate a low
risk) the pesticide from a drinking water perspective. This paper's
description of the models and approaches EPA generally intends to
follow is not meant to restrict interested parties from commenting on
the appropriateness of these models and approaches, either generally or
in regard to a specific application, or from proposing new or different
models or approaches.
In response to public comments, OPP made a number of significant
changes to its drinking water assessment approaches, primarily to
refine existing screening methods for identifying pesticides which may
be present in drinking water at levels of concern. These refinements
will enable OPP to more accurately determine whether a pesticide has
the potential to result in significant risks to the public and
sensitive populations such as infants and children. Specifically, in
1999, OPP will change its screening level drinking water assessment by
replacing the ``farm field pond'' scenario in its surface water
screening models with a ``drinking water reservoir'' scenario and will
begin incorporating into the model a factor to account for the area
surrounding the reservoir that is cropped. To start, percent cropped
area factors will be used for corn, soybeans, cotton, and wheat.
Additional factors for other major crops will be added in late 1999 and
early 2000. These changes will improve EPA's initial screening
assessment by making it more accurate. The Agency is also evaluating
several watershed-scale surface water models for use in future drinking
water assessments.
EPA will also continue to use SCI-GROW (Screening Concentration In
GROund Water) as an initial screening model for ground water sources of
drinking water. An evaluation of models and procedures for a second-
tier assessment of pesticide exposure in ground water is beginning. In
the meantime, the Agency will rely on ground water monitoring studies
to estimate concentrations in ground water for those pesticides which
do not pass through the SCI-GROW screen.
The Agency believes its risk assessments would be strengthened by
additional monitoring data and is working on a number of levels to fill
in the gaps in monitoring data and acquire more high quality data on
pesticide concentrations in drinking water sources. Efforts range from
requesting monitoring and runoff studies on
[[Page 61348]]
individual pesticides to working with the U.S. Geological Survey (USGS)
to obtain more regional- and national-scale monitoring data on multiple
pesticides to exploring design considerations for a national survey of
pesticides in drinking water with various government agencies and
industry groups and associations.
Also as a result of the comments, OPP has identified two issues
regarding drinking water that will be addressed in separate science
policy papers within the next 6 months. EPA plans to issue papers on
the following issues: (1) approaches for utilizing available data and
models to develop quantitative estimates of pesticide concentrations in
drinking water and estimates of people exposed for pesticides which
pose a particularly high potential for contaminating drinking water;
and (2) the effectiveness of water treatment in reducing pesticide
levels in drinking water and an approach for addressing treatment
issues in the assessment process.
IV. Issues Raised in Comments
EPA published a draft version of the document described in Unit
III. on January 4, 1999 (64 FR 162) and comments were filed under
docket control number OPP-00577. The public comment period ended on
February 26, 1999. The Agency received comments from eight different
organizations. All comments were considered by the Agency in revising
the document.
Many of the comments were similar in content, and pertained to
general issues concerning the proposed policy or specific sections
within the draft document. The comments addressed a broad range of
issues and, in many instances, provided no general consensus. These
differences in opinion highlight the difficulties the Agency faces in
improving its existing science-based policy for estimating pesticide
concentrations in drinking water. The Agency grouped the comments
according to the nature of the comment and the issue or section of the
document which they addressed. For the substantive comments that
follow, contrasting opinions are presented, along with EPA's response.
The full text of the Agency's comments and response to the comments
document is available as described in Unit I.B.1.
V. Policies Not Rules
The policy document discussed in this notice is intended to provide
guidance to EPA personnel and decision-makers, and to the public. As a
guidance document and not a rule, the policy in this guidance is not
binding on either EPA or any outside parties. Although this guidance
provides a starting point for EPA risk assessments, EPA will depart
from its policy where the facts or circumstances warrant. In such
cases, EPA will explain why a different course was taken. Similarly,
outside parties remain free to assert that a policy is not appropriate
for a specific pesticide or that the circumstances surrounding a
specific risk assessment demonstrate that a policy should be abandoned.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: November 2, 1999.
Susan H. Wayland,
Deputy Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-29451 Filed 11-9-99; 8:45 am]
BILLING CODE 6560-50-F
