[Federal Register Volume 64, Number 24 (Friday, February 5, 1999)]
[Notices]
[Pages 5796-5799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2781]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00542B; FRL-6060-7]
Pesticides; Science 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 originally entitled ``Guidance
for Identifying Pesticide Chemicals That Have a Common Mechanism of
Toxicity, for Use in Assessing the Cumulative Toxic Effects of
Pesticides.'' This document was made available as a draft document on
August 6, 1998, for public comment (63 FR 42031) (FRL-5797-7). The
title of the document has been changed to ``Guidance for Identifying
Pesticide Chemicals and Other Substances That Have a Common Mechanism
of Toxicity.'' The revised guidance document describes the approach
that EPA will use for identifying and categorizing pesticide chemicals
and other substances that cause a common toxic effect by a common
mechanism, for purposes of assessing the cumulative toxic effects of
such substances. Interested parties may request a copy of the Agency's
revised guidance document and responses to public comments as set forth
in Unit I. of this document. This notice is the fifth in a series of
science policy issues related to the Tolerance Reassessment Advisory
Committee (TRAC).
FOR FURTHER INFORMATION CONTACT: For questions concerning the revised
document ``Guidance for Identifying Pesticide Chemicals and Other
Substances That Have a Common Mechanism of Toxicity,'' contact by mail:
Dr. Stephen C. DeVito, Office of Pesticide Programs, Health Effects
Division (7509C), Environmental Protection Agency, 401 M St., SW,
Washington, DC 20460; telephone number: (703) 308-9584; fax number
(703) 308-7157; e-mail: [email protected] .
SUPPLEMENTARY INFORMATION:
I. General Information
A. How Can I Get Additional Information or Copies of This Document or
Other Documents?
1. Electronically. You may obtain electronic copies of this
document and the science policy paper at http://www.epa.gov/
pesticides/. On the Office of Pesticide Program Home Page select
``TRAC'' and then look up the entry for this document. You can also go
directly to the listings at the EPA Home page at the Federal Register
-- Environmental Documents entry for this document under ``Laws and
Regulations'' (http://www.epa.gov/fedrgstr/) to obtain this notice and
the science policy paper.
2. Fax on Demand. You may request to receive a faxed copy of this
document, as well as supporting information, by using a faxphone to
call (202) 401-0527 and selecting item 6055 for ``Guidance for
Identifying Pesticide Chemicals and Other Substances That Have a Common
Mechanism of Toxicity.'' You may also follow the automated menu.
3. In person or by phone. If you have any questions or need
additional information about this action, you may contact the
appropriate technical person identified in the ``FOR FURTHER
INFORMATION CONTACT'' section of this document. In addition, the
official record for the science policy paper listed in the SUMMARY
section of this document, including the public versions, has been
established under the docket control number OPP-00542. A detailed
summary of the comments and of the Agency's response to the comments is
available in the same docket file. A public version of each record,
including printed, paper versions of any electronic comments, which
does not include any information claimed as Confidential Business
Information (CBI), is available for inspection in 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 Public
Information and Records Integrity Branch telephone number is 703-305-
5805.
II. Background
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 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 EPA's Office of Pesticide Programs (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 Tolerance Reassessment Advisory Committee
(TRAC), chaired by the EPA Deputy Administrator and the USDA Deputy
Secretary, to address FQPA issues and implementation. TRAC
[[Page 5797]]
comprises more than 50 representatives of affected user, producer,
consumer, public health, environmental, states and other interested
groups. The TRAC has met five times as a full committee from May 27
through September 16, 1998.
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 would
benefit from initiating notice and comment on the major science policy
issues.
The TRAC identified nine science policy issue areas they believe
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 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.
In accordance with the framework described in a separate notice
published in the Federal Register of October 29, 1998 (63 FR 58038)
(FRL-6041-5), EPA is issuing a series of draft documents concerning
nine science policy issues identified by the TRAC related to the
implementation of FQPA.
III. Summary of Revised Science Policy Guidance Document
This Federal Register notice announces the availability of a
revised version of the EPA pesticide science policy guidance document
that has been retitled ``Guidance for Identifying Pesticide Chemicals
and Other Substances That Have a Common Mechanism of Toxicity.'' The
guidance document describes the approach that EPA will use for
identifying and categorizing pesticide chemicals and other substances
that cause a common toxic effect by a common mechanism, for purposes of
assessing the cumulative toxic effects of such substances.
Specifically, the guidance document describes:
1. EPA's interpretation of common mechanism of toxicity with
respect to making a determination of safety under FFDCA as amended by
FQPA.
2. The specific steps that need to be taken for identifying
mechanisms of toxicity of pesticides and other substances that cause a
common toxic effect.
3. The types of data (and their sources) that are needed for doing
so.
4. How these data are to be used in reaching conclusions regarding
commonality of mechanisms of toxicity.
5. Criteria the Agency will use for categorizing pesticides and
other substances for purposes of conducting cumulative risk
assessments.
The Agency plans to use this guidance as the initial step in its
process to assess the possibility of cumulative toxicity to human
health that may be caused by pesticides and other substances that are
toxic from a common mechanism. The Agency is currently developing
guidance for conducting cumulative risk assessments that it will use to
characterize the potential for cumulative toxicity to human health that
may result from exposure to pesticides and other substances that have a
common mechanism of toxicity. That guidance will be made available for
public comment in June, 1999.
IV. Summary of Agency's Response to Public Comments
In the Federal Register of August 6, 1998 (63 FR 42031)(FRL-5797-
7), EPA announced the availability of a draft version of the document
described in Unit III. of this document and solicited public comment.
The original public comment period ended on September 6, 1998, but was
extended to October 8, 1998, at 63 FR 47290, September 4, 1998 (FRL-
6028-7). The Agency received comments from 16 different organizations.
The Agency would like to thank these organizations for critically
reviewing the document, and for providing recommendations to improve
the science policy described therein. All comments were considered by
the Agency in revising the document. The comments and the Agency's
responses to these comments are briefly summarized below.
Many of the public comments were similar in content, and pertained
to general issues dealing with grouping chemicals for purposes of
cumulative risk assessment, or specific sections within the draft
document. To facilitate review and consideration of the comments for
purposes of revising the document, the Agency grouped the comments in
accordance to nature of the comment, or issue or section of the
document with which they addressed. Hence, comments were grouped as
follows: Purpose and introduction of the guidance document; exposure
issues; consideration of substances other than pesticides; definitions
of terms; and assessing cumulative toxicity. Following is a brief
summary of the more significant comments received in these areas, along
with EPA's general responses. A more detailed summary of the comments
and the Agency's response to the comments is available as described in
Unit I. of this document.
A. Purpose and Introduction of the Guidance Document
Several commentors appear to have misunderstood the purpose of the
document. These commentors were of the impression that the primary
purpose of the document is to describe the approach EPA will use to
assess cumulative toxicity and risk from pesticides that have a common
mechanism of toxicity. However, the purpose of the document, as stated
in the draft version, is to describe the process that EPA will use for
identifying pesticides and other substances that cause a common toxic
effect by a common mechanism of toxicity.
B. Exposure Issues
A number of commentors raised the issue of exposure. One commentor
suggested that grouping of chemicals should be based only on causing a
common toxic effect by a common mechanism, excluding exposure as a
criterion for grouping. Other commentors suggested that EPA should do
an exposure assessment first and use exposure as a basis for grouping.
The Agency will not use exposure as a criterion for grouping chemicals
that cause a common toxic effect by a common mechanism. Exposure will
be considered, however, during the assessment and characterization of
cumulative effects of pesticides that have a common mechanism of
toxicity.
Several commentors stated that there is a lack of detail or
discussion on how the Agency plans to assess exposure when conducting
cumulative risk assessments on chemicals that have been grouped by
common mechanism of toxicity. Some commentors stated that the document
needs to be expanded to include more detail on how the Agency will
conduct cumulative risk assessments on pesticides that have a common
mechanism of toxicity. Two commentors suggested that the guidance
document should be revised to include examples on how the Agency will:
Apply the common mechanism guidelines; assess cumulative toxicity; and
conduct cumulative risk
[[Page 5798]]
assessments. The Agency's response to these comments is as follows.
First, the Agency will make available in the near future specific
examples of how it will apply its guidance for identifying pesticide
chemicals that have a common mechanism of toxicity. Secondly, the
primary purpose of the document is to describe the approach that EPA
will use to identify pesticides that have a common mechanism of
toxicity, and not how the Agency will assess exposure to such
pesticides and the cumulative risks that they may pose. The Agency is
currently preparing a document that will describe the approach it will
use to conduct cumulative risk assessments. That document will provide
details on exposure analyses.
Some commentors stated that EPA should not restrict cumulative risk
assessments to only those pesticides within a common mechanism group
for which there is concomitant (i.e., simultaneous) exposure (as stated
in the draft version), whereas other commentors stated that the Agency
should restrict cumulative risk assessments to only those pesticides
within a group for which there is concomitant exposure. The Agency
agrees that cumulative toxicity may result from exposures that are not
concomitant, and cumulative risk assessments performed by the Agency on
pesticides within a common mechanism group should not be restricted to
only those for which there is concomitant exposure. In addition to
concomitant exposure, the Agency will also consider other factors that
may affect the potential for two or more chemicals that cause a common
toxic effect by a common mechanism to cause cumulative toxicity.
C. Consideration of Substances Other than Pesticides
One commentor suggested that the guidance document needs to be
expanded to include guidance on how the Agency will conduct cumulative
risk assessments on pesticides that are not toxic via a common
mechanism of toxicity. The Agency did not include such guidance because
it is beyond the scope of the document. Some commentors pointed out
that the focus of the guidance document is only on identifying
pesticides that have a common mechanism of toxicity, and not on
identifying other (i.e., non-pesticide) substances that have a
mechanism of toxicity common with that of a given pesticide or
pesticides. The Agency agrees that the focus of the draft document is
on identifying and grouping pesticide substances that have a common
mechanism of toxicity. Although the Agency intends to use the approach
described in the document to identify pesticide substances and other
substances that cause a common toxic effect by a common mechanism, this
intent was not made clear in the draft version. The Agency has changed
the title of the document and has made other editorial changes
throughout the document that broaden its scope to include substances
not used as pesticides. The Agency wishes to make clear that it will
include other substances that are toxic from a mechanism common with
that of a given pesticide or pesticides in a cumulative risk
assessment.
D. Definitions of Terms
A number of commentors questioned the Agency's definitions of
certain terms used in the document, and had opposing opinions on how
these terms should be defined. For example, several commentors
questioned the Agency's definitions of ``mechanism of toxicity'' and
``common mechanism of toxicity.'' Some commentors believe that the
Agency's definitions for these terms are either too broad, unclear, or
need to be made more simple and rigorous. Other commentors believe that
the Agency's definitions are too narrow. Another commentor believes
that the Agency's definition is clear and appropriate. The Agency
reviewed its definitions of the terms listed in Section II
(``Definitions of Specific Terms...'' ) of the document, and believes
that its definitions of the terms ``mechanism of toxicity'' and
``common mechanism of toxicity'' are clear and consistent with the
intent of FQPA. However, the Agency has included additional discussion
in the revised version in Section III that adds further clarification
to these terms. One commentor disagreed with the Agency's definition of
``cumulative toxic effect.'' This commentor stated that there does not
need to be an overall increase in toxicity to be cumulative, and
suggested that the Agency remove the part of its definition that states
there is an overall increase in toxicity. The Agency agrees with the
commentor, and has clarified its original definition of ``cumulative
toxic effect'' in the revised version of the document.
E. Assessing Cumulative Toxicity.
Some of the commentors had comments pertaining to Section IV of the
document: ``Policies for Assessing the Cumulative Toxic Effects Posed
by Two or More Pesticides That Are Toxic By a Common Mechanism.'' One
commentor wanted the Agency to clarify this section. Several commentors
questioned the example that poses a hypothetical pharmacokinetic
interaction between two substances and describes how EPA will consider
such an interaction in its evaluation of cumulative toxicity. The
Agency has revised this section of the document. As mentioned above,
the Agency is currently developing a document that will describe in
detail and provide examples of how the Agency will accumulate toxicity
and assess cumulative risks posed by pesticides that are toxic from a
common mechanism. The document will discuss the policies, practices and
factors the Agency will use or consider in the assessment of cumulative
toxicity.
V. Policies Not Rules
The draft science 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 pesticide 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.
The ``revised'' guidance is not an unalterable document. Once a
``revised'' guidance document is issued, EPA will continue to treat it
as guidance, not a rule. Accordingly, on a case-by-case basis EPA will
decide whether it is appropriate to depart from the guidance or to
modify the overall approach in the guidance.
VI. Contents of Docket
Document that are referenced in this notice will be inserted in the
docket under the docket control number OPP-00542. In addition, the
documents referenced in the framework notice, which published in the
Federal Register on October 29, 1998 (63 FR 58038) have also been
inserted in the docket under docket control number OPP-00557.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, pesticides and pests.
[[Page 5799]]
Dated: January 29, 1999.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-2781 Filed 2-4-99; 8:45 am]
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