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Grantee Research Project Results
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Science to Achieve Results (STAR) Program
CLOSED - FOR REFERENCES PURPOSES ONLY
Aggregate Exposure Assessment for Pesticides: Longitudinal Case Studies
October 30, 2000
Closing Date: March 7, 2001
The Food Quality Protection Act of 1996 (FQPA) requires the consideration of cumulative risk and variability factors in the risk assessment process used by EPA to make decisions concerning the safety of pesticides for both agricultural and residential uses. FQPA directs EPA in its assessments of pesticide safety to focus in part on aggregate exposure (total exposure occurring via all routes and pathways) in its assessment of pesticide risk. It also requires the consideration of the cumulative effects of multiple pesticides and other substances that have a common mechanism of toxicity. In addition to FQPA, various reports have stated concern that EPA's current approaches to risk assessment do not adequately account for risks arising from complex exposure patterns. These reports include the National Research Council report entitled, Pesticides in the Diets of Infants and Children (National Academy Press, Washington, DC, 1993), the report on Science and Judgment in Risk Assessment (National Academy Press, Washington, DC, 1994), and the 1996 draft report by the Presidents Commission on Risk Assessment & Risk Management titled, "Risk Assessment and Risk Management in Regulatory Decision-Making."
The FQPA and these reports reflect
an emerging body of evidence that suggests
person-to-person differences in exposure play an important role in the variability and uncertainty associated with pesticide risk assessments. The traditional standard default approaches used in pesticide risk assessment often do not effectively evaluate inter-individual variation and may underestimate the impact of pesticides on particular groups of individuals. Traditional approaches also do not adequately account for temporal variation in factors that contribute to complex exposure patterns (e.g., pesticide concentrations and human activities) involving multiple, acute, intermittent exposures.
The EPA will support longitudinal case studies designed to assess aggregate, non-occupational exposures to pesticides in defined populations aimed at addressing important public health issues. These issues may concern the toxicity of a particular chemical or class of chemicals and/or relate to a health endpoint and its potential link to pesticide exposures. Specifically, there is a need for information on aggregate human exposures to commercial pesticide chemicals such as, but not limited to, pyrethroid insecticides, triazine herbicides, and residential-use pesticides. The EPA is seeking grant proposals that describe studies for assessing pesticide exposure that incorporate estimates of temporal and inter-individual variability. Successful proposals will be those that effectively include and address as many of the following as possible in longitudinal studies:
- The identification of study hypotheses
that are supported by rationales for the selection of the population
of concern (characteristics and numbers) and the target pesticides
in relation to the environmental and public health issues associated
with their use.
- The development of approaches
for assessing pesticide exposures via multiple pathways and routes
(e.g., inhalation, dietary and non-dietary ingestion, and dermal
contact). This research should emphasize temporal variation
in exposure and exposure-related factors.
- The development of improved methods
for assessing exposures to specific classes of pesticides.
This should include methods to determine the temporal nature of
various sources and the resulting impact on exposure.
- The evaluation of exposures to
pesticides resulting from various sources (e.g., agricultural
application to food crops, residential lawn treatment, indoor
residential uses, pet uses) and apportionment of the exposures
- The development of methods to
account for short-term, intermittent exposures to pesticides,
and evaluation of the importance of aggregate exposures under
- The development of assessments of pesticide exposure that include evaluations of the uncertainty and variability associated with the exposure estimates.
Up to $6 million is expected to be available in fiscal year 2001 for awards in this program area. The projected award range is $250,000 to 350,000 per year, including direct and indirect costs, for up to 4 years.
Academic and not-for-profit institutions located in the U.S., and state or local governments, are eligible under all existing authorizations. Profit-making firms are not eligible to receive grants from EPA under this program. Federal agencies and national laboratories funded by federal agencies (Federally-funded Research and Development Centers, FFRDCs) may not apply.
Federal employees are not eligible to serve in a principal leadership role on a grant. FFRDC employees may cooperate or collaborate with eligible applicants within the limits imposed by applicable legislation and regulations. They may participate in planning, conducting, and analyzing the research directed by the principal investigator, but may not direct projects on behalf of the applicant organization or principal investigator. The principal investigator's institution may provide funds through its grant from EPA to a FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research. However, salaries for permanent FFRDC employees may not be provided through this mechanism.
Federal employees may not receive salaries or in other ways augment their agency's appropriations through grants made by this program. However, federal employees may interact with grantees so long as their involvement is not essential to achieving the basic goals of the grant.1 The principal investigators institution may also enter into an agreement with a federal agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere, etc. A written justification for federal involvement must be included in the application, along with an assurance from the federal agency involved which commits it to supply the specified service.
1EPA encourages interaction between its own laboratory scientists and grant principal investigators for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. However, this interaction must be incidental to achieving the goals of the research under a grant. Interaction that is incidental is not reflected in a research proposal and involves no resource commitments.
Potential applicants who are uncertain
of their eligibility should contact Dr. Robert E. Menzer in NCER,
phone (202) 564-6849, email: firstname.lastname@example.org.
STANDARD INSTRUCTIONS FOR SUBMITTING AN APPLICATION
A set of special instructions on how applicants should apply for a STAR grant is found on the NCER web site, http://www.epa.gov/ncerqa. Standard Instructions for Submitting a STAR Application and the necessary forms for an application will be found on this web site. Please note that for this solicitation only the research plan may be as long as 25 pages, rather than the 15 pages stated in the Standard Instructions.
The need for a sorting code to be used in the application and for mailing is described in the Standard Instructions for Submitting a STAR Application. The sorting code for applications submitted in response to this solicitation is 2001-STAR-G1.
The deadline for receipt of applications by NCER is no later than 4:00 p.m. ET, March 7, 2001.
Further information, if needed, may be obtained from the EPA official indicated below. E-mail inquiries are preferred.