[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