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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: Longitudinal Surveys of Human Exposure-Related Behavior
Opening Date: January 7, 2003
Closing Date: May 8, 2003
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Aggregate Exposure Assessment: Longitudinal Surveys of Human Exposure-Related Behavior
Synopsis of Program:
The U.S. Environmental Protection Agency (EPA), as part of its Science
to Achieve Results (STAR) program, is seeking applications for longitudinal
case studies to quantify the behavioral factors that lead to nonoccupational
human exposures to toxic chemicals in the United States. This request
for applications invites research proposals that develop approaches for
collecting data on: 1) exposure related activities in terms of time, location,
and level of activity or exertion (activity-specific energy use or equivalent
metric), as a function of an individual's life stage, and/or, 2) dietary
consumption, including the types and quantity of foods and beverages consumed,
and/or 3) the frequency and duration of consumer product use including
pesticides; household cleaners and solvents; combustion products, such
as gas, kerosene, and wood stoves, and fireplaces; and personal care,
tobacco and other products that may be sources of toxic chemicals in and
around the home. Proposals must address: (1) the development of a survey
platform and approach for collecting behavioral data; (2) approaches for
testing this platform through hypotheses-driven surveys; and (3) the design
features of these surveys.
Chris Saint; Phone: 202-564-9839; email: email@example.com
Applicable Catalog of Federal Domestic Assistance (CFDA) Number(s):
See full announcement for eligibility information.
Anticipated Type of Award: Grant.
Estimated Number of Awards: Two categories: 1) Approximately 1-2 that
include collection of activity, food consumption, and consumer product
use data. 2) Approximately 2-3 that include the collection of only one
type of data (e.g., activity, food consumption, or consumer product use).
Anticipated Funding Amount: Approximately $10 million.
Potential Funding per Grant: Two categories: 1) Proposals that include
the collection of activity, food consumption, and consumer product use
data - $1,000,000 to $1,250,000 per year total costs, for up to 4 years.
No more than a total of $5,000,000, including direct and indirect costs.
2) Proposals that include the collection of only one type of data - $300,000
to $500,000 per year total costs, for up to 4 years. No more than a total
of $2,000,000, including direct and indirect costs.
The sorting code for applications submitted in response to this solicitation
Letter of Intent Due Date(s): None.
Application Proposal Due Date: May 8, 2003.
In recent years, aggregate exposure and cumulative risk have become critical factors in human health risk assessment. Aggregate exposure is defined as the sum of all exposures of a single substance occurring via all routes (air, water, food, etc.) and pathways (inhalation, ingestion and dermal contact). Cumulative risk can be defined as the risk resulting from the aggregate exposures to multiple substances. Both human exposure and the resulting health risks are a function of the numbers and concentrations of substances in the environment and the frequency and duration of behaviors that bring humans into contact with these substances. Information on behavioral activities is a key component in gaining a true understanding of aggregate exposures and cumulative risks; however, there is a need for additional research. The results of this research will benefit a wide range of scientists and environmental managers as they address legislative requirements to take multichemical, multipathway exposures into consideration when setting environmental standards.
The growing concern among policy-makers and scientists that the uncertainty currently associated with risk assessments causes an unacceptable lack of confidence in environmental decision-making have lead to an increased interest in collecting better data to assess aggregate and cumulative exposures (1). For example, the Food Quality Protection Act of 1996 (FQPA) requires the consideration of cumulative risk and variability factors in the risk assessment process used by the EPA to make decisions concerning the safety of pesticides for both agricultural and residential uses. FQPA directs the EPA's Office of Pesticide Programs, in its assessments of pesticide safety, to focus, in part, on aggregate exposure 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.
Other EPA programs also take cumulative exposures into consideration in their risk assessments. The Superfund program began to develop risk assessments for mixtures at hazardous waste sites as early as the 1980s and this has since expanded into a more comprehensive approach to multichemical, multipathway cumulative assessments. The EPA's Office of Air Quality Planning and Standards (OAQPS) is performing a national-scale cumulative assessment of human health risks posed by exposures to a set of 33 priority chemicals in urban outdoor air. The EPA's regional offices are beginning to consider issues associated with evaluating cumulative risk associated with pesticides on foods, pollutants in the air, trihalomethanes in water, and leaded paint in older housing.
In 1997, the EPA Science Policy Council issued guidance on planning cumulative risk assessments which discusses a framework to recognize and assess environmental risks from concomitant exposure to multiple chemicals (or stressors)(2). An EPA technical panel, under the aegis of the Risk Assessment Forum (3), is now working to more fully develop this framework for cumulative risk assessment which is intended to identify the basic elements of the cumulative risk assessment process. In addition, the National Research Council reports (4, 5) "Pesticides in the Diets of Infants and Children" and "Science and Judgment in Risk Assessment," and the 1997 report by the Presidential/Congressional Commission on Risk Assessment and Risk Management (6), "Risk Assessment and Risk Management in Regulatory Decision-Making," have stated concerns that current approaches to risk assessment do not adequately account for risks arising from complex exposure patterns.
Furthermore, there is an emerging body of evidence that suggests that both person-to-person (interindividual) and within-person (intraindividual) temporal variations in exposure may be important contributors to the overall variability associated with environmental risk assessments. Traditional approaches to risk assessment usually combine information on exposure and effects and rely heavily on the use of default assumptions when sufficient data are not available. These traditional approaches often ignore temporal variations by either repeating an individual's short-term exposure patterns over multiple consecutive days or simulating an individual's long-term exposure by compositing the short-term exposures of multiple individuals. These approaches may either underestimate or overestimate the impact of chemical exposures on particular groups of individuals.
The consideration of temporal variability in exposure is particularly important when combining exposure and effects information in a risk assessment. When considering a chronic effect, a continual, low-level exposure accumulated over time may be more important in determining whether a potential health effect occurs than a series of short-term exposures. Conversely, intermittent high-level exposures may be very important when assessing the risk associated with an acute effect or one that is influenced by threshold doses. Therefore, assessing temporal exposure patterns that repeat or are correlated over time may be important factors in reducing the uncertainty associated with the risk assessments used to set environmental standards.
Recent field-based studies (7, 8, 9) have improved the amount and quality of information available to assess both exposure and risk. One such study (10), evaluated dietary exposures to selected pesticides for seven sequential days that were repeated six times during a one-year time period (i.e., six cycles of seven sequential days each). The results of this study demonstrated the importance of understanding the variability in human behavioral factors that can lead to exposure. Because human activities impact the timing, location, and degree of pollutant contact, they play a key role in explaining temporal variation in human exposure. The National Human Activity Pattern Survey (NHAPS) (11) and several other field-based surveys have improved the amount and quality of information available on human activities. Data from these surveys are included in the EPA's Consolidated Human Activity Database (CHAD) (12) However, most of these studies have concentrated on collecting short-term data, and have not placed a heavy emphasis on collecting the longitudinal data that would allow the evaluation of intraindividual variability over time. Therefore, there is a need for longitudinal human activity pattern data, including information on consumer product use and food consumption, that will provide scientists and risk assessors with the tools necessary to incorporate estimates of temporal variability in their exposure assessments, thereby reducing the uncertainty associated with their risk assessments.
Human activity patterns can change rather quickly in today's society because of new technologies and lifestyle pattens. A single one-year activity pattern survey may not be sufficient to provide the data necessary to effectively account for the variation in exposure over time. As such, there is likely to be an ongoing need for information on activity patterns, product use, and dietary consumption. To address this issue, innovative survey platforms are needed to efficiently collect data as patterns of behavior change and as specific exposure modeling and assessment needs are identified. Sampling platforms are informational structures that allow the identification of probability-based samples of individuals and the repeated collection of information from these samples over time. Innovative research is needed to develop platforms of this type and approaches for collecting and reporting activity pattern, product use, and dietary consumption data on an ongoing basis.
NCER is interested in supporting national or regional scale surveys to develop approaches for collecting longitudinal human behavioral (activity) patterns and dietary data from statistically representative sets of individuals that can be used in assessments and models for estimating aggregate and cumulative exposures to chemicals in the environment. NCER is interested in supporting research to develop approaches for collecting data on:
- Exposure related activities in terms of time, location, and level of activity or exertion (activity-specific energy use or equivalent metric), as a function of an individual's life stage, and/or
- Dietary consumption, including the types and quantity of foods and beverages consumed, and/or
- The frequency and duration of consumer product use including pesticides; household cleaners and solvents; combustion products, such as gas, kerosene, and wood stoves, and fireplaces; and personal care, tobacco and other products that may be sources of toxic chemicals in and around the home.
Of particular interest are studies incorporating methods that integrate the collection of long-term human activity pattern data, along with consumer product use and food consumption information from a statistically-representative set of individuals sampled repeatedly throughout a specified time period. Proposals responding to this RFA must address: (1) the development of a survey platform and approach for collecting behavioral data; (2) approaches for testing this platform through hypotheses-driven surveys; and (3) the design features of these surveys.
Development of a Data Collection Platform
Innovative research is needed to develop a platform and an approach for collecting and reporting activity pattern, product use, and dietary consumption data on an ongoing basis. For example, "Web TV" provides probability samples that are currently available and may provide an efficient and effective platform for collecting this information (13, 14). Applicants should describe a proposed data collection platform that will:
- Allow the identification of probability-based samples of individuals that can be stratified by life-stage;
- Facilitate repeated measurements (longitudinal data collection) over multiple years while minimizing the level of participant drop-out and other sources of potential bias in the sample;
- Allow data collection throughout the year to describe how exposures change over days, weeks, months, and seasons;
- Minimize, estimate, and "correct for" the measurement errors usually associated with longitudinal data gathering efforts; and
- Efficiently integrate the field sampling methods needed to obtain different types of information (human activities, and/or dietary consumption, and/or consumer product use) while minimizing respondent burden.
The data collection platform and survey approach should be tested by hypothesis-driven surveys of activity patterns, consumer product use, and/or dietary consumption rates. Applicants should identify data needs and/or testable study hypotheses that are supported by rationales for the selection of a population of concern in terms of sample size and characteristics, geographic distribution, and temporal coverage so that intra- and interindividual variation can be adequately addressed over time. Potential testable study hypotheses include, but are not limited to:
- The degree to which single day or short term diary data on activities are representative of and can be used to predict longer term activity patterns;
- The extent to which two day dietary data (collected 3-10 days apart) under USDA's Continuing Survey of Food Intakes by Individuals (CSFII) (15) is representative of and can be used to predict longer-term consumption patterns;
- The degree to which exposure-related human behaviors within an individual remain consistent or are correlated when repeated over time; and
- The extent to which human behavioral patterns related to environmental exposure varies with the season or time of the year.
Survey Design Features
Successful proposals will be those that incorporate in their approach methods for collecting behavioral data that are less invasive and burdensome on the participant than methods used heretofore. In addition, successful proposals will:
- Discuss how the field data-gathering effort will be organized and undertaken;
- Describe how the pilot testing of the methods will be undertaken, and how the results of these tests will be analyzed and evaluated (including the evaluation criteria that will be used);
- Discuss the data analyses that will be undertaken and what statistical and other techniques will be used to assess the intra and interindividual variability inherent in the factors of interest; and
- Propose credible approaches for providing public access to the data collected or for providing data to the EPA in a format compatible with the CHAD database so they can be made publicly available. Successful applicants may be required to submit quality-assured data in an electronic format as part of their annual reporting requirements.
In summary, the purposes of this effort are threefold:
- Develop sampling platforms that can be implemented nationally to collect long-term data on human behavioral patterns that may lead to exposures to toxic chemicals in the environment, including human activities, pesticide and consumer product usage, and dietary consumption;
- Compile data on multi-year exposure-related human behavior that are publicly available and can be easily accessed by exposure and risk assessors, modelers and decision-makers; and
- Provide information on the intra- and interindividual variability inherent in human activity patterns of a targeted population over a multi-year time frame.
1 Sexton, K. 1996. Presidential Address to the International Society of Exposure Analysis. J. Expos. Anal. Environ. Epidemiol. 6(2): 119-122.
2 For information see http://www.epa.gov/osp/spc/2cumrisk.htm
3 For information see http://cfpub.epa.gov/ncea/raf/
4 National Research Council. 1993. Pesticides in the Diets of Infants and Children. Landrigan, P., ed. National Academy Press: Washington, DC.
5 National Research Council. 1994. Science and Judgment in Risk Assessment, Isselbacher, K. and Upton, A., eds. National Academy Press: Washington, DC..
6 Presidential/Congressional Commission on Risk Assessment and Risk Management. 1997. Risk Assessment and Risk Management in Regulatory Decision-Making. Final Report. Volume 2. or see http://www.riskworld.com/Nreports/1996/risk_rpt/RR6ME001.HTM
7 Pellazzari, E., Lioy, P. Quackenboss, J., Whitmore, R., Clayton, A., Freeman, N., Waldman, J., Thomas, K., Rodes, C., and Wilcosky, T. 1995. J. Expos. Anal. Environ. Epidemiol. 5(3): 327-358.
8 Robertson, G., Lebowitz, M., O'Rourke, M., Gordan, S., and Moschandreas, D. 1999. J. Expos. Anal. Environ. Epidemiol. 9: 427-434.
9 Sexton, K.,Kleffman, D., and Callahan, M. 1995. J. Expos. Anal. Environ. Epidemiol. 5(3): 229-232.
10 MacIntosh, D., Kabiru, C., and Ryan, B. 2001. Environ. Health Perspect. 109(2) 145-150.
11 Klepeis, N., Nelson, W., Ott, W., Robinson, J., Tsang, A., Switzer, P., Behar, J., Hern, S., and Engelmann, W. 2001. J. Expos. Anal. Environ. Epidemiol.11: 231-252.
12 For information and data access see http://www.epa.gov/chadnet1/.
13 Jill T, Freeze. 1997. "Introducing Web TV." Microsoft Press.
14 Erica Sadun. 2000. "Teach Yourself Web TV." Hungry Minds, Incorporated.
15 For information see http://www.nps.ars.usda.gov/projects/projects.htm?ACCN_NO=401783
It is anticipated that a total of approximately $10 million will be awarded, depending on the availability of funds. Depending on the hypotheses proposed and the scope of data collection activities, the funding requirements of the proposals are anticipated to fall into two categories:
- Proposals that include collection of all three types of data (activity,
food consumption, and consumer product use) are expected to range from
$1,000,000-1,250,000 per year total costs, for up to 4 years. EPA anticipates
funding 1-2 of these proposals. Requests for amounts in excess of a
total of $5,000,000, including direct and indirect costs, will not be
- Proposals that include the collection of only one type of data are expected to range from $300,000-500,000 per year total costs, for up to 4 years. EPA anticipates funding 2-3 of these proposals. Requests for amounts in excess of a total of $2,000,000, including direct and indirect costs, will not be considered.
Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state and local governments, are eligible to apply. Profit-making firms are not eligible to receive grants from EPA under this program.
National laboratories funded by federal agencies (Federally-funded Research and Development Centers, "FFRDCs") may not apply. 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, organization, or governance 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 agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on a grant, and 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. EPA 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. This interaction must be incidental to achieving the goals of the research under a grant. Interaction that is "incidental" does not involve resource commitments.
The principal investigator's institution may 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. 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.
Potential applicants who are uncertain of their eligibility should contact Jack Puzak in NCER, phone (202) 564-6825, email:firstname.lastname@example.org
The Standard Instructions for Submitting a STAR Application including
the necessary forms will be found on the NCER web site, http://www.epa.gov/ncer/rfa/forms/.
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
The deadline for receipt of the applications by NCER is no later than 4:00 p.m. ET, May 8, 2003.
Further information, if needed, may be obtained from the EPA official
indicated below. Email inquiries are preferred.
Chris Saint (202) 564-6909