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
New Methods in 21st Century Exposure Science
This is the initial announcement of this funding opportunity.
Funding Opportunity Number: EPA-G2013-STAR-K1
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509
Solicitation Opening Date: June 19, 2013
Solicitation Closing Date: September 17, 2013, 11:59:59 pm Eastern Time
Eligibility Contact: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov); phone: 703-308-7224
Technical Contact: Pasky Pascual (pascual.pasky@epa.gov); phone: 703-347-8056
Access Standard STAR Forms (Forms and Standard Instructions Download Page)
View research awarded under previous solicitations (Funding Opportunities: Archive Page)
SUMMARY OF PROGRAM REQUIREMENTS
Synopsis of Program:
In the recently released report, "Exposure Science in the 21st Century: A Vision and A Strategy," the National Academies' National Research Council (NRC) has called for scientific researchers and risk assessors to modernize data collection and study of exposure science. The report authors note that information about exposure is vital to understanding and preventing human and environmental risks. The NRC vision for exposure science calls for development and application of new technologies to efficiently collect data that will support a more comprehensive understanding of the science. The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing innovative research to advance methods for characterizing real-world human exposure to chemicals associated with consumer products in indoor environments. Current understanding of human exposure to the chemical constituents of consumer products is limited due to inadequate information on formulations, emissions, and persistence in indoor environments associated with the diversity of usage scenarios. Methodological limitations currently impede collection of robust exposure information that is necessary to provide context for the results of a growing body of high throughput toxicity testing results and to characterize risk to human health for the general population and vulnerable groups.
This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research. Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects). This includes the Common Rule at subpart A and prohibitions and additional protections for pregnant women and fetuses, nursing women, and children at subparts B, C, and D. Research meeting the regulatory definition of intentional exposure research found in subpart B is prohibited by that subpart in pregnant women, nursing women, and children. Research meeting the regulatory definition of observational research found in subparts C and D is subject to the additional protections found in those subparts for pregnant women and fetuses (subpart C) and children (subpart D). All applications must include a Human Subjects Research Statement (HSRS, as described in Section IV.B.5.c), and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.C and V.D of this solicitation.
Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:
Ethics, Regulations, and Policies (https://www.epa.gov/osainter/phre/policy.htm)
Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements (https://www.epa.gov/osainter/phre/phre_course/index.htm)
Award Information:
Anticipated Type of Award: Grant or cooperative agreement
Estimated Number of Awards: Approximately 5 awards
Anticipated Funding Amount: Approximately $4.5 million total for all awards
Potential Funding per Award: Up to a total of $900,000, including direct and indirect costs, with a maximum duration of 3 years. Cost-sharing is not required. Proposals with budgets exceeding the total award limits will not be considered.
Eligibility Information:
Public nonprofit institutions/organizations (includes public institutions of higher education and hospitals) and private nonprofit institutions/organizations (includes private institutions of higher education and hospitals) located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. See full announcement for more details.
Application Materials:
To apply under this solicitation, use the application package available at Grants.gov (for further submission information see Section IV.E. “Submission Instructions and other Submission Requirements”). The necessary forms for submitting a STAR application will be found on the National Center for Environmental Research (NCER) web site, Forms and Standard Instructions Download Page (https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms). If your organization is not currently registered with Grants.gov, you need to allow approximately one week to complete the registration process. This registration, and electronic submission of your application, must be performed by an authorized representative of your organization.
If you do not have the technical capability to utilize the Grants.gov application submission process for this solicitation, send a webmail message at least 15 calendar days before the submission deadline to assure timely receipt of alternate submission instructions. In your message provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available. Alternate instructions will be emailed whenever possible. Any applications submitted through alternate submission methods must comply with all the provisions of this Request for Applications (RFA), including Section IV, and be received by the solicitation closing date identified above.
Agency Contacts:
Eligibility Contact: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov); phone: 703-308-7224
Technical Contact: Pasky Pascual (pascual.pasky@epa.gov); phone: 703-347-8056
I. FUNDING OPPORTUNITY DESCRIPTION
A. Introduction
Improved understanding of human exposure to chemicals in consumer products is a high priority research area identified by the EPA Office of Research and Development (ORD). A wide variety of consumer and residential use products (e.g., cleaning products, personal care products, cosmetics, plastics and electronics) are used extensively indoors. These products and articles contain and release an array of chemicals to which consumers may be exposed through direct or indirect contact (Rudel et al., 2003; Schettler, 2006; Weschler, 2009; Dodson et al., 2012). A more sophisticated understanding of sources, usage patterns, emissions, and exposure pathways throughout the chemical life cycle is needed. Moreover, comprehensive data on occurrence of chemicals in products and proximate environments and methods for quantifying low-level exposures to mixtures of chemicals that may perturb common biological pathways and contribute toward a common health risk are urgently needed by the scientific community. In particular, innovative methods are needed to advance scientific and practical understandings of real-world human exposure among vulnerable population groups resulting from the use of consumer products. Advances in exposure science will provide tools to assess the potential impacts of chemicals in consumer products, enhance the capability to safely manage risks to human health, and generate information that individuals and communities can use to make informed choices about safe chemical and product use.
This solicitation seeks to support research that will:
- Develop and/or apply innovative technologies and methods to characterize presence and co-occurrence of suites of semivolatile chemicals (dozens to hundreds) in real-world indoor environments associated with emissions from and use of consumer products;
- Generate data to advance the scientific basis of exposure predictions by providing values for key model parameters, building confidence in model assumptions, and confirming model predictions for relevant pathways;
- Develop and/or apply innovative technologies and methods to profile chemicals and related metabolites associated with consumer products in biological media.
This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research. Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects). This includes the Common Rule at subpart A and prohibitions and additional protections for pregnant women and fetuses, nursing women, and children at subparts B, C, and D. Research meeting the regulatory definition of intentional exposure research found in subpart B is prohibited by that subpart in pregnant women, nursing women, and children. Research meeting the regulatory definition of observational research found in subparts C and D is subject to the additional protections found in those subparts for pregnant women and fetuses (subpart C) and children (subpart D). All applications must include a Human Subjects Research Statement (HSRS, as described in Section IV.B.5.c), and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.C and V.D of this solicitation.
Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:
Ethics, Regulations, and Policies (https://www.epa.gov/osainter/phre/policy.htm)
Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements (https://www.epa.gov/osainter/phre/phre_course/index.htm)
B. Background
Potential risks to human health arise from the manufacture and use of thousands of chemicals (Collins et al., 2008; Rudén et al., 2010). The bulk of the understanding of human exposure to chemicals arises from scientific activities closely associated with environmental policy legislation that was passed between 1969 and 1976 in the early days of the modern environmental era. Since that time, chemical production has increased nearly 10-fold, accompanied by a constant expansion of not only the chemical portfolio but also of the types of products manufactured from those chemicals (Murmann, 2003; Wilson and Scharzman, 2009). These products and articles contain and release an array of chemicals to which consumers may be exposed through direct or indirect contact (Rudel et al., 2003; Schettler, 2006; Weschler and Nazaroff, 2008; Weschler, 2009; Dodson et al., 2012). Indoor concentrations of pollutants derived from consumer products may also be driven by a range of factors such as residential physical structure and design and socioeconomic factors that help determine residential behaviors and activity patterns (Adamkiewicz et al., 2011). Vulnerable populations also experience disparities in indoor environmental exposures from consumer products due to a multitude of factors including differences in indoor residential environmental quality, size, housing density, and ventilation (Adamkiewicz et al., 2011).
The last decade has witnessed a shift in the scientific understanding of the potential impact of environmental contamination on human health. Largely as a result of human biomonitoring surveys there is now greater awareness of widespread human exposure to manufactured chemicals (Calafat and McKee, 2006; Fromme et al., 2007). There is recognition that one’s health potentially may be impacted not only by acute exposure to a single compound (or a related class of compounds), but also by chronic, low-level simultaneous exposure to a wide variety of chemicals. Moreover, there is also recognition that the most important pathways of exposure are not necessarily those involving chemicals emitted to the outdoor environment, but instead may be associated with chemicals originating from indoor use of consumer products and articles (Jayjock et al. 2008). Exposures to chemicals associated with consumer products may also be differentiated by social and economic factors (Zota et al., 2008, 2010; Rose et al., 2010; Windham et al., 2010).
Among the diverse chemicals that have been found in consumer products, semivolatile organic compounds (SVOCs) constitute an important class, with examples including flame retardants, fragrances, and plasticizers. SVOCs are of concern because they are ubiquitous, abundant and often persistent contaminants, found in indoor air and on airborne particles, settled dust, indoor surfaces, clothing, human hair, and human skin. Biomonitoring has revealed increasing body burdens of some SVOCs (Sjödin et al., 2004; Woodruff et al., 2011). Several SVOCs have been categorized as endocrine disrupting compounds (EDCs) because of potential to mimic or interfere with natural hormones that regulate development, behavior, fertility and maintenance of homeostasis (Matsumoto et al., 2008; Neel and Sargis, 2012).
Exposures are strongly influenced by the types of materials and products that contain the chemicals, and the ways in which the materials and products are used. For example, certain compounds are used as additives in polymer materials and textile products, while others are used as solvents in personal care products such as perfume, eye shadow, moisturizer, and nail polish. Compounds may also be found in food as a result of contact with materials used in processing and packaging (Muncke, 2009), with exposure to these chemicals strongly controlled by diet.
Currently available measurement tools may be inadequate for characterizing exposure and identifying sources for large numbers of chemicals with such varied sources and pathways. The tools that have been perfected for quantifying trace amounts of specific suites of chemicals in various exposure-related media with exceedingly high precision (and cost) may not be ideal for observing and quantifying hundreds, much less thousands, of chemicals (Webster et al., 2009; Egeghy et al., 2012; Park et al., 2012). Target chemicals for these measurement methods may be narrowed through a better understanding of the composition of consumer products, but information on the composition of most consumer products is elusive (Jayjock et al., 2008). Available data are limited in scope and may not be representative of the wide range of chemicals to which people are exposed today. Developing and maintaining current data is a challenge given rapid changes in product formulations, imports and consumer use patterns. Information on consumer behavior is equally important as chemical composition in order to conduct scientifically relevant exposure risk assessments for chemicals found in consumer products (Weegels et al., 2001). The most comprehensive studies on consumer product use are surveys (Westat, 1987a, 1987b, 1987c; U.S. EPA, 1996) with a narrow focus (e.g., household cleaning products, solvents, and paints), and only limited data are available on personal care products (e.g., lipstick, body lotion, shampoo). Together, these factors underscore the need for more generalizable methods for understanding the key determinants of exposure based on product or product use characteristics and consumer behavior that are necessary for predicting exposure potential and rapid cost-effective methods for surveillance. An enhanced understanding of the inherent spatial and temporal variability of chemical exposure, and of the role of human activities in precipitating exposure demands novel, innovative measurement tools, methods, and strategies.
The specific Strategic Goal and Objective from the EPA’s Strategic Plan that relate to this solicitation are:
Goal 4: Ensuring the Safety of Chemicals and Preventing Pollution, Objective 4.1: Ensure Chemical Safety.
More information can be found in EPA’s FY 2014-2018 Strategic Plan
C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609, the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r, and the Clean Air Act, Section 103, 42 U.S.C. 7403.
For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102(2)(F).
Note that a project’s focus is to consist of activities within the statutory terms of EPA’s financial assistance authorities; specifically, the statute(s) listed above. Generally, a project must address the causes, effects, extent, prevention, reduction, and elimination of air pollution, water pollution, solid/hazardous waste pollution, toxic substances control, or pesticide control depending on which statute(s) is listed above. These activities should relate to the gathering or transferring of information or advancing the state of knowledge. Proposals should emphasize this “learning” concept, as opposed to “fixing” an environmental problem via a well-established method. Proposals relating to other topics which are sometimes included within the term “environment” such as recreation, conservation, restoration, protection of wildlife habitats, etc., must describe the relationship of these topics to the statutorily required purpose of pollution prevention and/or control.
Applicable regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants). Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220, OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225, and OMB Circular A-122 (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230.
D. Specific Research Areas of Interest/Expected Outputs and Outcomes
Note to applicant: The term “output” means an environmental activity or effort, and associated work products, related to a specific environmental goal(s), (e.g., testing a new methodology), that will be produced or developed over a period of time under the agreement. The term “outcome” means the result, effect, or consequence that will occur from the above activit(ies) that is related to an environmental or health-related objective.
The Agency is soliciting research that proposes development and application of innovative, rapid, and cost-effective measurement methods to advance understanding of potential exposures to large sets of chemicals in consumer products. Proposed studies should develop the methodology and data required to characterize and predict: chemical sources related to consumer product use, distribution and co-occurrence of associated chemicals in indoor environments, magnitude of human exposure to real-world mixtures of chemicals resulting from consumer product use, and/or drivers of high exposures or exposure disparities among population groups. Results of research proposed under this solicitation should provide tools to support assessment of the potential cumulative impacts of semivolatile chemicals (particularly those identified as endocrine disrupting compounds) in consumer products and improved decision making to safely manage risks to human health. When developing their research proposals, applicants should note that they will be asked to verify that the proposed research conforms to EPA’s regulations on human subjects research (see Section IV.B.5.c below).
Specifically, EPA is soliciting proposals that:
- Develop and/or apply innovative technologies and methods to characterize presence and co-occurrence of suites of semivolatile chemicals (dozens to hundreds) in real-world indoor environments associated with emissions from and use of consumer products;
- Generate data to advance the scientific basis of exposure predictions by providing values for key model parameters, building confidence in model assumptions, and confirming model predictions for relevant pathways;
- Develop and/or apply innovative technologies and methods to profile chemicals and related metabolites associated with consumer products in biological media.
Examples of relevant research components include:
- Development of tools to characterize potential for indoor occurrence of chemical constituents of consumer products based on chemical properties;
- Development and/or application and evaluation of methods for rapid, high throughput measurement of chemical occurrence in indoor environmental media (e.g., air, house dust);
- Use of banked samples to develop and evaluate approaches for rapid, high throughput analysis of chemicals and metabolites in biological media;
- Analysis of “chemical space” to identify target chemicals based on function and intended use (see Stenberg et al., 2009);
- Novel techniques to rapidly and efficiently measure key parameters (e.g., VP, Kow, Koa, Henry’s Law constant) for hundreds of chemicals to improve and validate Quantative Structure-Activity Relationships (QSAR) calculators;
- Experimental studies to develop input parameters (e.g., chemical half lives in indoor media) and validate predictions of indoor near-field models;
- Data on emission rates (and the change in rates over time) for common household products;
- Development of approaches for mining extant or collection of new sociometric data on consumer behavior for modeling consumer product usage and for identifying social disparities in exposure (including approaches for collecting data to support systems-based and network modeling approaches) (see Spaargaren and Vliet, 2000);
- Development of approaches for mining extant consumer and social network data to identify product use patterns. Development of tools to rapidly create and update these use profiles;
- Development of novel approaches to using social media to elicit community engagement in research to enhance our knowledge of potentially unique exposure pathways, unintended consumer product uses, and interactions that may heighten exposures to chemicals in consumer products and facilitate effective translation of research results.
The outputs of the proposed projects include novel methods for surveillance of semivolatile chemicals, innovative approaches for identifying potentially highly exposed groups and validation of extant models for confident prediction of exposure to chemicals from consumer products. Outputs will include reports, presentations and peer reviewed journal publications describing the development and demonstration of such models and approaches. Outputs will also include a suite of methods and tools for efficient and effective exposure characterization that can be implemented in future environmental health studies, can be applied to improve assessment of potential cumulative risks from exposure to large sets of chemicals in proximate environments, and will inform decision making and safe chemical use. The expected outcome of this research is an improvement in risk assessment, especially the phase of risk assessment that investigates how people are exposed to toxic chemicals.
To the extent practicable, research proposals must embody innovation and sustainability. Innovation for the purposes of this RFA is defined as the process of making changes; a new method, custom or device. Innovative research can take the form of wholly new applications or applications that build on existing knowledge and approaches for new uses. Research proposals must include a discussion on how the proposed research is innovative (see Section IV.B.5.a). The concept of sustainability is based on language in the U.S. National Environmental Policy Act of 1969 (NEPA). This definition is reiterated in Executive Order 13514, Federal Leadership in Environment, Energy, and Economic Performance, stating that the goal of sustainability is to, “create and maintain conditions, under which humans and nature can exist in productive harmony, that permit fulfilling the social, economic, and other requirements of present and future generations.” Research proposals must include a discussion on how the proposed research will seek sustainable solutions that protect the environment and strengthen our communities (see Section IV.B.5.a). ORD will draw from all of the above-mentioned innovation and sustainability definitions in the review/evaluation process of recommending research proposals (see Section V.A).
E. References
Adamkiewicz G, Zota AR, Fabian MP, Chahine T, Julien R, Spengler JD, Levy JI. Moving environmental justice indoors: understanding structural influences on residential exposure patterns in low-income communities. Am J Public Health. 2011; 101(Suppl 1):S238-45.
Calafat AM, McKee RH. Integrating biomonitoring exposure data into the risk assessment process: phthalates [diethyl phthalate and di(2-ethylhexyl) phthalate] as a case study. Environ Health Perspect. 2006; 114(11):1783-9.
Collins FS, Gray GM, Bucher JR. Transforming environmental health protection. Science. 2008; 319(5865):906-7.
Dodson RE, Nishioka M, Standley LJ, Perovich LJ, Brody JG, Rudel RA. Endocrine disruptors and asthma-associated chemicals in consumer products. Environ Health Perspect. 2012; 120(7):935-43.
Egeghy PP, Judson R, Gangwal S, Mosher S, Smith D, Vail J, Cohen Hubal EA. The exposure data landscape for manufactured chemicals. Sci Total Environ. 2012; 414:159-166.
Fromme H, Albrecht M, Angerer J, Drexler H, Gruber L, Schlummer M, Parlar H, Körner W, Wanner A, Heitmann D, Roscher E, Bolte G. Integrated exposure assessment survey (INES): Exposure to persistent and bioaccumulative chemicals in Bavaria, Germany. Int J Hyg Environ Health. 2007; 210(3-4):345-9.
Jayjock MA, Chaisson CF, Franklin CA, Arnold S, Price PS. Using publicly available information to create exposure and risk-based ranking of chemicals used in the workplace and consumer products. J Expo Sci Environ Epidemiol. 2009; 19(5):515-24.
Matsumoto M, Hirata-Koizumi M, Ema M. Potential adverse effects of phthalic acid esters on human health: A review of recent studies on reproduction. Regul Toxicol Pharmacol. 2008;50(1):37-49.
Muncke J. Exposure to endocrine disrupting compounds via the food chain: Is packaging a relevant source? Sci Tot Environ. 2009; 407(16):4549-59.
Murmann JP. Chemical industries after 1850. In: Mokyr J, editor. The Oxford Encyclopedia of Economic History. New York: Oxford University Press; 2003.
Neel BA, Sargis RM. The paradox of progress: environmental disruption of metabolism and the diabetes epidemic. Diabetes. 2011; 60(7):1838-48.
Park YH, Lee K, Soltow QA, Strobel FH, Brigham KL, Parker RE, Wilson ME, Sutliff RL, Mansfield KG, Wachtman LM, Ziegler TR, Jones DP. High-performance metabolic profiling of plasma from seven mammalian species for simultaneous environmental chemical surveillance and bioeffect monitoring. Toxicology. 2012; 295(1-3):47-55.
Rose M, Bennett DH, Bergman Å, Fängström B, Pessah IN, Hertz-Picciotto I. PBDEs in 2−5 Year-Old Children from California and Associations with Diet and Indoor Environment. Environ Sci Technol. 2010; 44(7):2648-53.
Rudel RA, Camann DE, Spengler JD, Korn LR, Brody JG. Phthalates, alkylphenols, pesticides, polybrominated diphenyl ethers, and other endocrine-disrupting compounds in indoor air and dust. Environ Sci Technol. 2003; 37(20):4543-53.
Rudén C, Hansson SO. Registration, evaluation, and authorization of chemicals (REACH) is but the first step –How far will it take us? Six further steps to improve the European chemicals legislation. Environ. Health Perspect. 2010; 118(1):6-10.
Spaargaren, G. and B. Van Vliet (2000). "Lifestyles, consumption and the environment: The ecological modernization of domestic consumption." Environmental Politics 9(1): 50-76.
Schettler T. Human exposure to phthalates via consumer products. Int J Androl. 2006; 29(1):134-9.
Sjödin A, Jones RS, Focant JF, Lapeza C, Wang RY, McGahee EE 3rd, Zhang Y, Turner WE, Slazyk B, Needham LL, Patterson DG Jr. Retrospective time-trend study of polybrominated diphenyl ether and polybrominated and polychlorinated biphenyl levels in human serum from the United States. Environ Health Perspect. 2004; 112(6):654-8.
Stenberg M, Linusson A, Tysklind M, Andersson PL. A multivariate chemical map of industrial chemicals—assessment of various protocols for identification of chemicals of potential concern. Chemosphere. 2009; 76(7):878-84.
Thomas T, Thomas K, Sadrieh N, Savage N, Adair P, Bronaugh R. Research strategies for safety evaluation of nanomaterials, part VII: evaluating consumer exposure to nanoscale materials. Toxicol Sci. 2006; 91(1):14-9.
U.S. EPA (Environmental Protection Agency). Descriptive statistics tables from a detailed analysis of the National Human Activity Pattern Survey (NHAPS) data. Office of Research and Development, Washington, DC: EPA/600/R-96/148, 1996.
Webster TF, Harrad S, Millette JR, Holbrook RD, Davis JM, Stapleton HM, Allen JG, McClean MD, Ibarra C, Abdallah MA, Covaci A. Identifying transfer mechanisms and sources of decabromodiphenyl ether (BDE 209) in indoor environments using environmental forensic microscopy. Environ Sci Technol. 2009; 43(9):3067-72.
Weegels MF, van Veen MP. Variation of consumer contact with household products: A preliminary investigation. Risk Anal. 2001; 21(3):499–511.
Weschler CJ, Nazaroff WW. Semivolatile organic compounds in indoor environments. Atmos Environ. 2008; 42(40):9018-40.
Weschler CJ. Changes in indoor pollutants since the 1950s. Atmos Environ. 2009; 43(1):156-72.
Westat. Household solvent products – A national usage survey. Prepared for U.S. Environmental Protection Agency, Washington, DC. Available from the National Technical Information Service, Springfield, VA; PB88-132881. 1987a.
Westat. National usage survey of household cleaning products. Prepared for U.S. Environmental Protection Agency, Office of Toxic Substances and Office of Pesticides and Toxic Substances, Washington, DC. 1987b.
Westat. National household survey of interior painters. Prepared for U.S. Environmental Protection Agency, Office of Toxic Substances and Office of Pesticides and Toxic Substances, Washington, DC. 1987c.
Wilson MP, Schwarzman MR. Toward a new U.S. chemicals policy: rebuilding the foundation to advance new science, green chemistry, and environmental health. Environ Health Perspect. 2009; 117(8):1202-9.
Windham GC, Pinney SM, Sjodin A, Lum R, Jones RS, Needham LL, Biro FM, Hiatt RA, Kushi LH. Body burdens of brominated flame retardants and other persistent organo-halogenated compounds and their descriptors in US girls. Environ Res. 2010; 110(3):251-7.
Woodruff TJ, Zota AR, Schwartz JM. Environmental chemicals in pregnant women in the United States: NHANES 2003-2004. Environ Health Perspect. 2011; 119(6):878-85.
Zota AR, Rudel RA, Morello-Frosch RA, Brody JG. Elevated house dust and serum concentrations of PBDEs in California: unintended consequences of furniture flammability standards? Environ Sci Technol. 2008; 42(21):8158-64.
Zota AR, Adamkiewicz G, Morello-Frosch RA. Are PBDEs an environmental equity concern? Exposure disparities by socioeconomic status. Environ Sci Technol. 2010; 44(15):5691-2.
F. Special Requirements
Agency policy and ethical considerations prevent EPA technical staff and managers from providing applicants with information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA RFAs. EPA employees cannot endorse any particular application.
Multiple Investigator applications may be submitted as: (1) a single Lead Principal Investigator (PI) application with Co-PI(s) or (2) a Multiple PI application (with a single Contact PI). If you choose to submit a Multiple PI application, you must follow the specific instructions provided in Sections IV. and V. of this RFA. For further information, please see the EPA Implementation Plan for Policy on Multiple Principal Investigators.
This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research. There are many scientific and ethical considerations that must be addressed in such studies by the study sponsor and research team, including, but not limited to, those related to recruitment, retention, participant compensation, third-party issues, researcher-participant interactions, researcher-community interactions, communications, interventions, and education. All such research must comply with the requirements of 40 CFR Part 26, and any human observational exposure studies must also adhere to the principles set forth in the >Scientific and Ethical Approaches for Observational Exposure Studies (SEAOES) (EPA/600/R-08/062) document. SEAOES, which was published by researchers in EPA and which discusses the principles for the ethical conduct of human research studies, serves as a resource for applicants interested in applying under this solicitation. References to “SEAOES Principles” in this solicitation refers, in general, to the issues of interest in conducting human subjects research studies that maintain the highest scientific and ethical standards and safety during the conduct of these studies. All applications must include a Human Subjects Research Statement (HSRS; described in Section IV.B.5.c) and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.C and V.D of this solicitation.
The application shall include a plan (see “Data Plan” in section IV.B.5.d) to make available to the NCER project officer all data generated (first produced under the award) from observations, analyses, or model development used under an agreement awarded from this RFA. The data must be available in a format and with documentation such that they may be used by others in the scientific community.
It is anticipated that a total of approximately $4.5 million will be awarded under this announcement, depending on the availability of funds, quality of applications received, and other applicable considerations. The EPA anticipates funding approximately 5 awards under this RFA. Requests for amounts in excess of a total of $900,000, including direct and indirect costs, will not be considered. The total project period requested in an application submitted for this RFA may not exceed 3 years.
The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA. The EPA reserves the right to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made. Any additional selections for awards will be made no later than six months after the original selection decisions.
EPA may award both grants and cooperative agreements under this announcement.
Under a grant, EPA scientists and engineers are not permitted to be substantially involved in the execution of the research. However, EPA encourages interaction between its own laboratory scientists and grant Principal Investigators after the award of an EPA grant 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.
Where appropriate, based on consideration of the nature of the proposed project relative to the EPA’s intramural research program and available resources, the EPA may award cooperative agreements under this announcement. When addressing a research question/problem of common interest, collaborations between EPA scientists and the institution’s principal investigators are permitted under a cooperative agreement. These collaborations may include data and information exchange, providing technical input to experimental design and theoretical development, coordinating extramural research with in-house activities, the refinement of valuation endpoints, and joint authorship of journal articles on these activities. Proposals may not identify EPA cooperators or interactions; specific interactions between EPA’s investigators and those of the prospective recipient for cooperative agreements will be negotiated at the time of award.
A. Eligible Applicants
Public nonprofit institutions/organizations (includes public institutions of higher education and hospitals) and private nonprofit institutions/organizations (includes private institutions of higher education and hospitals) located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. Profit-making firms are not eligible to receive assistance agreements from the EPA under this program.
Eligible nonprofit organizations include any organizations that meet the definition of nonprofit in OMB Circular A-122, located at 2 CFR Part 230. However, nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.
Foreign governments, international organizations, and non-governmental international organizations/institutions are not eligible to apply.
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 applicant, but may not direct projects on behalf of the applicant organization. The institution, organization, or governance receiving the award may provide funds through its assistance agreement from the EPA to an 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 an assistance agreement, and may not receive salaries or augment their Agency’s appropriations in other ways through awards made under this program.
The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector to the extent authorized by law. Examples are purchase of satellite data, 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. In addition, an appropriate form of assurance that documents the commitment, such as a letter of intent from the Federal Agency involved, should be included.
Potential applicants who are uncertain of their eligibility should contact Ron Josephson (josephson.ron@epa.gov) in NCER, phone: 703-308-0442.
B. Cost-Sharing
Institutional cost-sharing is not required.
C. Other
Applications must substantially comply with the application submission instructions and requirements set forth in Section IV of this announcement or they will be rejected. In addition, where a page limitation is expressed in Section IV with respect to parts of the application, pages in excess of the page limit will not be reviewed. Applications must be submitted through grants.gov or by other authorized alternate means (see Section IV.E. “Submission Instructions and Other Submission Requirements” for further information) on or before the solicitation closing date and time in Section IV of this announcement or they will be returned to the sender without further consideration. Also, applications exceeding the funding limits or project period term described herein will be returned without review. Further, applications that fail to demonstrate a public purpose of support or stimulation (e.g., by proposing research which primarily benefits a Federal program or provides a service for a Federal agency) will not be funded.
Applications deemed ineligible for funding consideration will be notified within fifteen calendar days of the ineligibility determination.
IV. APPLICATION AND SUBMISSION INFORMATION
Additional provisions that apply to this solicitation and/or awards made under this solicitation, including but not limited to those related to confidential business information, contracts and subawards under grants, and proposal assistance and communications, can be found at EPA Solicitation Clauses
These, and the other provisions that can be found at the website link, are important, and applicants must review them when preparing applications for this solicitation. If you are unable to access these provisions electronically at the website above, please communicate with the EPA contact listed in this solicitation to obtain the provisions.
Formal instructions for submission through Grants.gov follow in Section E.
A. Internet Address to Request Application Package
Use the application package available at Grants.gov (see Section E. “Submission Instructions and Other Submission Requirements”). Note: With the exception of the current and pending support form (available at Forms and Standard Instructions Download Page (https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms)), all necessary forms are included in the electronic application package.
An email will be sent by NCER to the Lead/Contact PI and the Administrative Contact (see below) to acknowledge receipt of the application and transmit other important information. The email will be sent from receipt.application@epa.gov; emails to this address will not be accepted. If you do not receive an email acknowledgment within 30 days of the submission closing date, immediately inform the Eligibility Contact shown in this solicitation. Failure to do so may result in your application not being reviewed. See Section E. “Submission Instructions and Other Submission Requirements” for additional information regarding the application receipt acknowledgment.
B. Content and Form of Application Submission
The application is made by submitting the materials described below. Applications must contain all information requested and be submitted in the formats described.
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Standard Form 424
The applicant must complete Standard Form 424. Instructions for completion of the SF424 are included with the form. (However, note that EPA requires that the entire requested dollar amount appear on the SF424, not simply the proposed first year expenses.) The form must contain the signature of an authorized representative of the applying organization.
Applicants are required to provide a “Dun and Bradstreet Data Universal Numbering System” (DUNS) number when applying for federal grants or cooperative agreements. Organizations may receive a DUNS number by calling 1-866-705-5711 or by visiting the web site at Dun and Bradstreet.
Executive Order 12372, “Intergovernmental Review of Federal Programs,” does not apply to the Office of Research and Development's research and training programs unless EPA has determined that the activities that will be carried out under the applicants' proposal (a) require an Environmental Impact Statement (EIS), or (b) do not require an EIS but will be newly initiated at a particular site and require unusual measures to limit the possibility of adverse exposure or hazard to the general public, or (c) have a unique geographic focus and are directly relevant to the governmental responsibilities of a State or local government within that geographic area.
If EPA determines that Executive Order 12372 applies to an applicant's proposal, the applicant must follow the procedures in 40 CFR Part 29. The applicant must notify their state's single point of contact (SPOC). To determine whether their state participates in this process, and how to comply, applicants should consult Intergovernmental Review (SPOC List). If an applicant is in a State that does not have a SPOC, or the State has not selected research and development grants for intergovernmental review, the applicant must notify directly affected State, area wide, regional and local entities of its proposal.
EPA will notify the successful applicant(s) if Executive Order 12372 applies to its proposal prior to award.
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Key Contacts
The applicant must complete the “Key Contacts” form found in the Grants.gov application package. An “Additional Key Contacts” form is also available at Forms and Standard Instructions Download Page (https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms). The Key Contacts form should also be completed for major sub-agreements (i.e., primary investigators). Do not include information for consultants or other contractors. Please make certain that all contact information is accurate.
For Multiple PI applications: The Additional Key Contacts form must be completed (see Section I.F. for further information). Note: The Contact PI must be affiliated with the institution submitting the application. EPA will direct all communications related to scientific, technical, and budgetary aspects of the project to the Contact PI; however, any information regarding an application will be shared with any PI upon request. The Contact PI is to be listed on the Key Contact Form as the Project Manager/Principal Investigator (the term Project Manager is used on the Grants.gov form, the term Principal Investigator is used on the form located on NCER’s web site). For additional PIs, complete the Major Co-Investigator fields and identify PI status next to the name (e.g., “Name: John Smith, Principal Investigator”).
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Table of Contents
Provide a list of the major subdivisions of the application indicating the page number on which each section begins.
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Abstract (1 page)
The abstract is a very important document in the review process. Therefore, it is critical that the abstract accurately describes the research being proposed and conveys all the essential elements of the research. Also, the abstracts of applications that receive funding will be posted on the NCER web site.
The abstract should include the information described below (a-h). Examples of abstracts for current grants may be found on the NCER web site.
- Funding Opportunity Title and Number for this proposal.
- Project Title: Use the exact title of your project as it appears in the application. The title must be brief yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, use more commonly understood terminology. Do not use general phrases such as “research on.”
- Investigators: For applications with multiple investigators, state whether this is a single Lead PI (with co-PIs) or Multiple PI application (see Section I.F.). For Lead PI applications, list the Lead PI, then the name(s) of each co-PI who will significantly contribute to the project. For Multiple PI applications, list the Contact PI, then the name(s) of each additional PI. Provide a web site URL or an email contact address for additional information.
- Institution(s): In the same order as the list of investigators, list the name, city and state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
- Project Period and Location: Show the proposed project beginning and ending dates and the performance site(s)/geographical location(s) where the work will be conducted.
- Project Cost: Show the total funding requested from the EPA (include direct and indirect costs for all years).
- Project Summary: Provide three subsections addressing: (1) the objectives of the study (including any hypotheses that will be tested), (2) the experimental approach to be used (a description of the proposed project), and (3) the expected results (outputs/outcomes) of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
- Supplemental Keywords: Without duplicating terms already used in the text of the abstract, list keywords to assist database searchers in finding your research. A list of suggested keywords may be found at: Forms and Standard Instructions Download Page (https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms).
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Research Plan, Quality Assurance Statement, Human Subjects Research Statement, Data Plan, and References
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Research Plan (15 pages)
Applications should focus on a limited number of research objectives that adequately and clearly demonstrate that they meet the RFA requirements. Explicitly state the main hypotheses that you will investigate, the data you will create or use, the analytical tools you will use to investigate these hypotheses or analyze these data, and the results you expect to achieve. Research methods must be clearly stated so that reviewers can evaluate the appropriateness of your approach and the tools you intend to use. A statement such as: “we will evaluate the data using the usual statistical methods” is not specific enough for peer reviewers.
This description must not exceed fifteen (15) consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. While these guidelines establish the minimum type size requirements, applicants are advised that readability is of paramount importance and should take precedence in selection of an appropriate font for use in the proposal.
The description must provide the following information:
- Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important and how it fulfills the requirements of the solicitation. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to expand upon research supported by an existing or former assistance agreement awarded under the STAR program, indicate the number of the agreement and provide a brief report of progress and results achieved under it.
- Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above.
- Innovation: Describe how your project shifts current research or engineering paradigms by using innovative theoretical concepts, approaches or methodologies, instrumentation or interventions applicable to one or more fields of research.
- Sustainability: Describe how your project embodies the principles of sustainability and seeks sustainable solutions that protect the environment and strengthen our communities. The sustainability primer (PDF) (2 pp, 195 K) provides examples of research activities that promote and incorporate sustainability principles.
- Expected Results, Benefits, Outputs, and Outcomes: Describe the results you expect to achieve during the project (outputs) and the potential benefits of the results (outcomes). This section should also discuss how the research results will lead to solutions to environmental problems and improve the public’s ability to protect the environment and human health. A clear, concise description will help NCER and peer reviewers understand the merits of the research.
- Project Management: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules with associated milestones and target dates, proposed management, interactions with other institutions, etc. Describe the approach, procedures, and controls for ensuring that awarded grant funds will be expended in a timely and efficient manner and detail how project objectives will be successfully achieved within the grant period. Describe how progress toward achieving the expected results (outputs and outcomes) of the research will be monitored and measured. Applications for multi-investigator projects must identify project management and the functions of each investigator in each team and describe plans to communicate and share data.
- Appendices may be included but must remain within the 15-page limit.
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Quality Assurance Statement (3 pages)
For projects involving environmental data collection or processing, conducting surveys, modeling, method development, or the development of environmental technology (whether hardware-based or via new techniques), provide a Quality Assurance Statement (QAS) regarding the plans for processes that will be used to ensure that the products of the research satisfy the intended project objectives. Follow the guidelines provided below to ensure that the QAS describes a system that complies with ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. Do not exceed three consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.
NOTE: If selected for award, applicants will be expected to provide additional quality assurance documentation.
Address each applicable section below by including the required information, referencing the specific location of the information in the Research Plan, or explaining why the section does not apply to the proposed research. (Not all will apply.)
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Identify the individual who will be responsible for the quality assurance (QA) and quality control (QC) aspects of the research along with a brief description of this person’s functions, experience, and authority within the research organization. Describe the organization’s general approach for conducting quality research. (QA is a system of management activities to ensure that a process or item is of the type and quality needed for the project. QC is a system of activities that measures the attributes and performance of a process or item against the standards defined in the project documentation to verify that they meet those stated requirements.)
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Discuss project objectives, including quality objectives, any hypotheses to be tested, and the quantitative and/or qualitative procedures that will be used to evaluate the success of the project. Include any plans for peer or other reviews of the study design or analytical methods.
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Address each of the following project elements as applicable:
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Collection of new/primary data:
(Note: In this case the word “sample” is intended to mean any finite part of a statistical population whose properties are studied to gain information about the whole. If certain attributes listed below do not apply to the type of samples to be used in your research, simply explain why those attributes are not applicable.)- Discuss the plan for sample collection and analysis. As applicable, include sample type(s), frequency, locations, sample
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The perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Conclusions drawn by the principal investigators have not been reviewed by the Agency.