[Federal Register Volume 66, Number 229 (Wednesday, November 28, 2001)]
[Notices]
[Pages 59428-59430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29386]
[[Page 59428]]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00732; FRL-6792-8]
Pesticide Science Policy: Guidance for Performing Aggregate
Exposure and Risk Assessments; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: EPA announces the availability of the revised version of the
pesticide science policy document entitled ``Guidance for Performing
Aggregate Exposure and Risk Assessments.'' This notice is one in a
series concerning science policy documents related to the
implementation of the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
FOR FURTHER INFORMATION CONTACT: Beth Doyle, Environmental Protection
Agency (7503C), 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-2722; fax number: (703) 305-0871; 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:
------------------------------------------------------------------------
Examples of
Categories NAICS codes 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
notice 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 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,''
``Regulations and Proposed Rules,'' 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.
2. Fax-on-demand. You may request a faxed copy of the science
policy documents, as well as supporting information, by using a
faxphone to call (202) 401-0527. Select item 6087 for the document
entitled ``Guidance for Performing Aggregate Exposure and Risk
Assessments.'' 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-00732. In addition, the
documents referenced in the framework notice, which published in the
Federal Register of October 29, 1998 (63 FR 58038) (FRL-6041-5), under
docket control number OPP-00557, are considered as part of the official
record for this action under docket control number OPP-00732 even
though not placed in the official record. 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 Hwy., 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 Information
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.
Thereafter, 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 the broad policy
choices facing the Agency and on strategic direction for the Office of
Pesticide Programs (OPP). The Agency has used the interim approaches
developed through discussions with FSAC to make regulatory decisions
that meet the new FFDCA standard, but that could be revisited if
additional information became available or as the science evolved. In
addition, the Agency seeks independent review and public participation,
generally through presentation of the science policy issues to the
FIFRA Scientific Advisory Panel, a group of independent, outside
experts who provide peer review and scientific advice to OPP.
During 1998 and 1999, EPA and the U.S. Department of Agriculture
(USDA) established a second subcommittee of 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, EPA
and USDA have established, under the auspices of NACEPT, the Committee
to Advise on Reassessment and Transition (CARAT). The CARAT provides 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 is intended to further the valuable work initiated
by the FSAC and TRAC toward the use of sound science and greater
transparency in regulatory decisionmaking, increased stakeholder
participation, and
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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), EPA described
its intended approach. Since then, EPA has been issuing a series of
draft documents concerning the nine science policy issues. This notice
announces the availability of the revised science policy document
concerning aggregate exposure and risk assessment.
III. Summary of ``Guidance for Performing Aggregate Exposure and
Risk Assessments''
EPA is responsible for regulating pesticide residues in food under
the FFDCA. In 1996, Congress passed the FQPA which amended FFDCA. The
FQPA amendments to the FFDCA directed EPA to consider ``aggregate
exposure'' in its decisionmaking. Aggregate exposure and risk
assessment involve the analysis of exposure to a single chemical by
multiple pathways and routes of exposure. The pathways of exposure
considered in this guidance document include the potential for
pesticide residues in food and drinking water, as well as residues from
pesticide use in residential, non-occupational environments. The
pathway of exposure refers to how human behavioral patterns potentially
interact with pesticides in the environment. All potential, relevant
routes of exposure are analyzed within an aggregate exposure
assessment. These include the oral, dermal (absorption), and inhalation
routes of exposure. Thus, OPP was required by the FQPA amendments to
modify its exposure and risk assessment methods to consider that
pesticide chemicals may enter the body through various pathways
(through food, drinking water, and residential uses) and routes
(ingestion, dermal, and inhalation).
In response to the FQPA mandates to consider aggregate exposure,
OPP implemented HED SOP 97.2 Interim Guidance for Conducting Aggregate
Exposure and Risk Assessments (November 26, 1997) (Stasikowski, 1997a)
(Interim Guidance) in 1996 for assessing aggregate exposure and risk.
This guidance uses a mix of data as point estimates and data in a
distributional form. According to the interim guidance, most frequently
the ``high-end'' or ``upper bound'' point estimates from the drinking
water and residential exposure pathways are added to an estimate of
food ingestion exposure from food (for acute exposures, the 99.9th
percentile on the distribution of daily exposures). The aggregate
guidance presented in this document supports a different approach. This
guidance expands upon the interim guidance to include the way in which
aggregate exposure and risk assessment may be performed when ``ideal''
data, methods and tools are available.
The current guidance document discusses the interim guidance
methods, but emphasizes an expanded approach which looks beyond the
interim guidance to encompass the use of distributional data for all
pathways of exposure when data are available. A distributional data
analysis (as opposed to a point estimate approach) is preferred because
this tool allows an aggregate exposure assessor to more fully evaluate
exposure and resulting risk across the entire population, not just the
exposure of a single, high-end individual. The expanded guidance
encourages assessment techniques which, using a combination of data,
models, and reasonable judgements, represent each potentially exposed
``individual'' in the population over calendar time. A baseline
requirement of this approach is that the exposure parameters associated
with each hypothetical individual must be coherent, consistent, and
logical. This means the hypothetical individual's temporal exposure
characteristics, spatial exposure characteristics, and demographic and
behavioral exposure characteristics should be consistent and reasonable
for each type of individual, for each day in the assessment, over all
days in the assessment. The use of distributional data sets which
comprise the aggregate exposures to many individuals in the population
of interest and the principle that the individual's aggregate exposure
be consistent in temporal, spatial and demographic characteristics are
two central components to this expanded aggregate exposure and risk
guidance document. Using this approach OPP and others in the risk
assessment community can move toward using a distribution of total
aggregate exposures to many types of individuals potentially exposed in
a population of interest.
A version of the aggregate guidance was presented to the FIFRA
Scientific Advisory Panel (SAP) in February of 1999. SAP member
comments were incorporated into the guidance document where
appropriate. On November 10, 1999, the availability of the draft
``Guidance for Performing Aggregate Exposure and Risk Assessment''
(Aggregate Guidance) was published in the Federal Register (64 FR
61343) (FRL-6388-8), and public comments were requested on the overall
content of the document as well as seven specific questions. Based in
part on the comments received, this science policy paper was revised
and is now being issued in its revised format. In addition, OPP has
prepared a separate Response-to-Comment document which specifically
addresses comments received.
This revised document is organized to present an overview of
aggregate exposure and risk assessment highlighting revised and
expanded concepts. Section I describes the regulatory background of
aggregate assessment, gives a brief introduction to the scope and
organization of the document, and provides a review of some of the key
terms and definitions in this document. Section II of the document
provides a description of current practices and data sources utilized
in conducting aggregate exposure analysis, including an explanation of
the combination of probabilistic (food pathway only at this time) and
deterministic types of exposure assessments. Section III provides a
general framework and set of key concepts for the refinements put forth
in the Aggregate Guidance. Pathway-specific considerations based upon
the revised guidance are for performing aggregate exposure and risk
assessment, expanding upon the Interim Guidance for Conducting
Aggregate Exposure and Risk Assessment. Following this section, there
are recommendations for future data and research needs (Section V) as
well as an acknowledgment of the limitations in conducting aggregate
exposure assessments (Section VI). The last section of the document,
Section VII, describes approaches to model validation and verification,
an important part of evaluating aggregate exposure and risk
assessments, as assumptions embedded in any model and/or method and
uncertainties and variability in the input data can be significant to
the outcome of the assessment.
The current guidance document is one of a series of documents that
OPP is issuing with specific emphasis on
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addressing new facets of the risk assessment process as required by
FQPA. In particular, the current document relies heavily on the
Exposure Factors Handbook (USEPA, 1997b), the Residential SOPs (USEPA,
1997a), the Interim Guidance (Stasikowski, 1997a) and Guidance for
Submission of Probabilistic Human Health Exposure Assessments to the
Office of Pesticide Programs (USEPA, 1998c). These earlier documents
provide substantial background to the information provided.
IV. Policies Not Rules
The policy document discussed in this notice is intended to provide
guidance to EPA personnel and decisionmakers, 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 not be
applied.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: November 16, 2001.
Susan B. Hazen,
Assistant, Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 01-29386 Filed 11-27-01; 8:45 am]
BILLING CODE 6560-50-S