[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: [email protected] and [email protected].

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:


------------------------------------------------------------------------
                                                          Examples of
            Category                     NAICS            potentially
                                                       affected entities
------------------------------------------------------------------------
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