[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Pages 15330-15333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7126]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00593A; FRL-6484-5]
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 ``Choosing a Percentile
of Acute Dietary Exposure as a Threshold of Regulatory Concern.'' This
notice is the fifteenth in a series concerning science policy documents
related to Food Quality Protection Act and developed through the
Tolerance Reassessment Advisory Committee.
FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Environmental
Protection Agency (7509C), 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-2857; fax number: (703) 305-5147; e-mail
address: [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:
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Examples of
Categories 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
[[Page 15331]]
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 revised science policy document, and certain other
related documents that might be available 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 at
http://www.epa.gov/fedrgstr/. The document entitled ``Responses to
Public Comments on the Office of Pesticide Program's Draft Science
Policy Document'' is available on EPA's Home Page with the Federal
Register document at the above web site.
2. Fax on demand. You may request a faxed copy of the revised
science policy document, as well as supporting information, by using a
faxphone to call (202) 401-0527. Select item 6046 for the document
entitled ``Choosing a Percentile of Acute Dietary Exposure as a
Threshold of Regulatory Concern.'' 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-00593A. 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, 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 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 the 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 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 seven times as a full
committee from May 27, 1998 through October 21, 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
EPA is responsible for regulating the nature and amount of
pesticide residues in food under FFDCA. FFDCA section 408 authorizes
EPA to set a tolerance or
[[Page 15332]]
an exemption from the requirement of a tolerance if the Agency
determines that the residues would be ``safe.'' The Agency performs
various types of risk assessments to evaluate the safety of pesticides
in food, including analyses to determine the nature and the amounts of
pesticides that people might be exposed to over a single day. This
science policy document discusses how EPA generally applies the
statutory safety standard to acute dietary risk assessments as to
pesticide residues in foods.
The Environmental Protection Agency's Office of Pesticide Programs
previously announced that, on an interim basis, it intended to use the
99.9th percentile of the distribution of estimated acute dietary food
exposures for calculating a threshold of concern when probabilistic
assessment techniques are used to model the distribution. OPP stated
that it would compare this percentile of estimated exposure to the
Population Adjusted Dose (PAD), a value that reflects an amount of a
pesticide to which a person may safely be exposed in one day. The
Agency published a notice in the Federal Register on April 7, 1999 (64
FR 16962) (FRL-6074-7), citing the availability of an interim policy
and requested public comment so that the views of all interested
parties would be considered (US EPA, 1999a).
Based in part on the comments received, this science policy
document was revised and is now being issued in its revised format.
This revised document explains OPP's policy and details some of the
various concerns that have been raised, additional associated public
health-related issues, as well as OPP's plans for further evaluation
and implementation. This policy has broad applicability to many
pesticides and a potentially significant impact on the assessment of
these pesticides.
OPP's current approach with respect to assessing and regulating the
food uses of pesticides, when using a probabilistic method of
estimating acute dietary exposure, is as follows:
If the 99.9th percentile of acute exposure from food, as estimated
by probabilistic (e.g., Monte Carlo) analysis, is equal to or less than
the acute Population Adjusted Dose (aPAD) for the pesticide, then OPP
would generally consider its threshold of concern in applying that the
safety standard of FFDCA section 408(B)(2)(A) not to be exceeded with
respect to acute risk from food. However, if the analysis indicates
that estimated exposure at the 99.9th percentile exceeds the PAD, OPP
would generally conduct a sensitivity analysis to determine to what
extent the estimated exposures at the high-end percentiles may be
affected by unusually high food consumption or residue values. To the
extent that one or a few values from the input data sets seem to
``drive'' the exposure estimates at the high end of exposure, OPP would
consider whether these values are representative and should be used as
the primary basis for regulatory decision making. In either scenario,
EPA would consider submissions by interested parties that question the
appropriateness of the use of the 99.9th percentile in calculating the
threshold of concern for the particular risk assessment in question or
question its use generally.
It is important to note here that the above position refers to the
99.9th percentile of exposure and not consumption. The 99.9th
percentile of exposure represents the joining of each individual's
consumption data set with randomly selected residue values from the
residue data set. The consumption values associated with the 99.9th
percentile of exposure do not necessarily represent the 99.9th
percentile of consumption since it is both the selected consumption
value and residue concentration which is responsible for determining
exposure.
At this time, OPP's current policy is used only with daily
exposures to a single chemical through the food pathway only. Estimates
of exposure through drinking water and residential uses are not
sufficiently developed to warrant inclusion in a probabilistic
assessment. Establishing the threshold of concern for the food pathway
using the 99.9th percentile of exposure is considered to be a ``first
step'' toward regulation of exposures on an aggregate, and then
cumulative, basis.
OPP recognizes that different types of risk assessments will
generally be needed for aggregate and cumulative evaluations and that
these assessments might also be associated with different regulatory
thresholds. Although OPP is moving toward regulating on the basis of
probabilistic aggregate and cumulative exposure assessments, a decision
has not yet been made regarding how the appropriate threshold of
concern should be calculated for these types of assessments. When
exposures through drinking water and residential uses are sufficiently
refined to be incorporated into probabilistic evaluations, they will be
aggregated and assessed, and may use a different population percentile.
Section I of this provides an overview of OPP's present practice
for acute dietary risk assessment for residues in food. It describes
the statutory, regulatory, and policy framework for this policy, as
well as prior reviews and comments. In addition, this section provides
background information on dietary risk assessment in general and
explains how the previous system (DRES--Dietary Risk Evaluation System)
and the current system (DEEM--Dietary Exposure Evaluation Model) work,
as well as what input data sources are used and how.
Section II addresses some of the specific issues and concerns
raised about using exposures at the estimated 99.9th percentile in
calculating the threshold of concern. One issue is whether the nature
of the data bases available (i.e., robustness, adequacy, etc.) should
preclude the use of the estimated 99.9th percentile for regulatory
purposes since some consider the uncertainties associated with this
population percentile to be too great. Examples of data used are USDA's
food consumption survey data, registrant crop field trials, USDA
Pesticide Data Program (PDP) data, FDA monitoring data, market basket
surveys, etc. Other issues include the treatment of data ``outliers,''
representativeness and adequacy of the data bases, and the impact of
Agency default values on exposure estimates. Concerns, therefore, exist
about whether the estimates of the 99.9th percentile of exposure are
sufficiently representative of actual exposure to be meaningful. This
science policy document summarizes these concerns and how OPP has
addressed them.
Section III addresses the issue of protectiveness of the estimated
99.9th percentile of exposure with respect to the general public
health. One view is that using the estimated 99.9th percentile of
exposure is insufficiently conservative because very large numbers of
people could be exposed every day to pesticide intakes which are
estimated to exceed the Agency's ``level of concern.'' This section
also explores the contrary view that the policy is over-protective
because of the conservative assumptions used in the estimation methods
and the retention of potentially unrepresentative values in the data
base. The section discusses as well the view that, whether it over-
estimates or under-estimates actual exposure, the estimated 99.9th
percentile of exposure is simply too uncertain to be used in risk
management decisions.
Section III also explains that OPP weighs a number of factors in
considering which percentile to use: The size of the exposed population
and the proportion that might receive daily doses above the benchmark
of safety,
[[Page 15333]]
the aPAD; the level of confidence OPP has in its exposure estimates;
and the extent to which such estimates may overstate potential exposure
because they incorporate conservative assumptions or rely on atypical
and unrealistic data. Further, to the extent understood, OPP considers
by how much individual exposures would be estimated to exceed the aPAD.
Section IV briefly addresses the issues associated with exploratory
analysis conducted by OPP with the DEEM software and the 99.9th
percentile issue. Further details and specifics of this analysis are
provided in the associated response to public comments.
Section V provides a list of the documents referenced in this
science policy document.
The Appendix, entitled ``Primer on Interpretation of Exposure
Distribution Curves,'' is a ``plain English'' guide to Monte Carlo
analysis and interpretation of its results.
IV. Issues Raised in Comments
EPA published a draft version of the document described in Unit
III. under SUPPLEMENTARY INFORMATION on April 7, 1999 (64 FR 16962) and
comments were filed in docket control number OPP-00593. The public
comment period ended on June 7, 1999. The Agency received comments from
numerous 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. 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 response to
the comments is available as described in Units I.B.1. and I.B.2. under
SUPPLEMENTARY INFORMATION.
V. Policies Not Rules
The revised 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 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: March 16, 2000
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 00-7126 Filed 3-21-00; 8:45 am]
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