FY20 Soil and Dust RFA Final.pdf

COVID-19 Update: EPA is providing flexibilities to applicants experiencing challenges related to COVID-19. Please see the Flexibilities Available to Organizations Impacted by COVID-19 clause in Section IV of EPA’s Solicitation Clauses.

OVERVIEW INFORMATION

U.S. Environmental Protection Agency Office of Science Advisor, Policy and Engagement Office of Research and Development Science to Achieve Results (STAR) Program

Estimating Children’s Soil and Dust Ingestion Rates for Exposure Science

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2020-STAR-D1, Estimating Children’s Soil and Dust Ingestion Rates for Exposure Science

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: May 21, 2020 Solicitation Closing Date: August 5, 2020: 11:59:59 pm Eastern Time

Table of Contents

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program Award Information Eligibility Information Application Materials Agency Contacts

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction

B. Background C. Authority and Regulations D. Specific Areas of Interest/Expected Outputs and Outcomes E. References F. Special Requirements

II. AWARD INFORMATION

III. ELIGIBILITY INFORMATION

A. Eligible Applicants https://www.epa.gov/grants/epa-solicitation-clauses

B. Cost Sharing C. Other

IV. APPLICATION AND SUBMISSION INFORMATION

A. Grants.gov Submittal Requirements and Limited Exception Procedures B. Application Package Information C. Content and Form of Application Submission D. Submission Dates and Times E. Funding Restrictions F. Submission Instructions and Other Submission Requirements

V. APPLICATION REVIEW INFORMATION

A. Peer Review B. Relevancy Review C. Past Performance History Review D. Human Subjects Research Statement (HSRS) Review E. Evaluation of the Scientific Data Management Plan F. Funding Decisions G. Additional Provisions for Applicants Incorporated into the Solicitation

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices B. Disputes C. Administrative and National Policy Requirements

VII. AGENCY CONTACTS

Access Standard STAR Forms (https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms) View research awarded under previous solicitations (https://www.epa.gov/research-grants/research-grant-areas)

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program:

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is asking the scientific community to propose transdisciplinary research to develop or apply innovative approaches/methods to improve the estimates, better characterize the variability, and reduce the uncertainty concerning chemical exposures via soil and dust ingestion for children aged 6 months through 6 years.

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 https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms https://www.epa.gov/research-grants/research-grant-areas https://www.epa.gov/research-grants/research-grant-areas 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.C.6.c of this solicitation), 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.D and V.F of this solicitation.

Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:

https://www.epa.gov/osa/basic-information-about-human-subjects-research-0 https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title40/40cfr26_main_02.tpl

The STAR Program’s goal is to stimulate and support scientific and engineering research that advances EPA’s mission to protect human health and the environment. It is a competitive, peer-reviewed, extramural research program that provides access to the nation’s best scientists and engineers in academic and other nonprofit research institutions. STAR funds research on the environmental and public health effects of air quality, environmental changes, water quality and quantity, hazardous waste, toxic substances, and pesticides.

Award Information:

Anticipated Type of Award: Grant or cooperative agreement Estimated Number of Awards: Approximately six awards Anticipated Funding Amount: Approximately $8.1 million total for all awards Potential Funding per Award: Up to a total of $1.35 million, including direct and indirect costs, with a maximum duration of 3 years. Cost-sharing is not required. Applications with budgets exceeding the total award limits will not be considered.

Eligibility Information:

Public and private nonprofit institutions/organizations, public and 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.F. “Submission Instructions and other Submission Requirements”). Note: With the exception of the current and pending support form (available at https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms), all necessary forms are included in the electronic application package. Make sure to include the current and pending support form in your Grants.gov submission.

If your organization is not currently registered with Grants.gov, you need to allow approximately one month to complete the registration process. Please note that the registration process also requires that your organization have a unique entity identifier (e.g., ‘DUNS number’) and a current registration with the System for Award Management (SAM) and the process of obtaining both could take a month or more. Applicants must ensure that all registration requirements are https://www.epa.gov/osa/basic-information-about-human-subjects-research-0 https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title40/40cfr26_main_02.tpl https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms met in order to apply for this opportunity through Grants.gov and should ensure that all such requirements have been met well in advance of the submission deadline. 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, see Section IV.A below for additional guidance and instructions.

Agency Contacts:

Technical Contact: Intaek Hahn; phone: 202-564-4377; email: hahn.intaek@epa.gov Eligibility Contact: Ron Josephson; phone: 202-564-7823; email: josephson.ron@epa.gov Electronic Submissions Contact: Debra M. Jones; phone: 202-564-7839; email:

jones.debram@epa.gov

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction As part of EPA’s mission to protect human health and the environment, a major research priority of the EPA’s Office of Research and Development (ORD) is to advance exposure science to achieve more accurate, confident, and comprehensive exposure estimates of chemicals present in our environment. In October 2019, EPA released Progress Report on the Federal Action Plan to Reduce Childhood Lead Exposures and Associated Health Impacts. The Federal Action Plan’s Goal 1 is to “reduce children’s exposure to lead sources.”

Chemicals found in our everyday environment may pose health risks to humans via various exposure pathways. For children, soil and dust ingestion is a major route of exposure for environmental toxicants such as lead, mercury, polychlorinated biphenyls (PCBs), polybrominated diphenyl ethers (PBDEs), polycyclic aromatic hydrocarbons (PAHs), arsenic, asbestos, and other chemicals deposited after air emission or windblown from mine waste and other contaminated sites (1-7). Accurate, comprehensive multimedia metrics for soil and dust ingestion are critical for exposure assessments included in effective risk assessment, reduction, mitigation, and prevention measures. However, the extent to which chemicals present in soil and dust are ingested is an understudied area in exposure science and an essential research gap that must be filled for holistic multimedia, multipathway approaches that yield accurate assessments and recommendations for risk management decisions.

One of the provisions of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Chemical Safety Act) amendment to the Toxic Substances Control Act (TSCA) called for the chemical risk assessment of susceptible population groups (https://www.epa.gov/sites/production/files/2017- 04/documents/2017.03.30_chpac_tsca_letter.pdf). The scientific data for estimating exposure rates of children from the ingestion of harmful chemicals such as lead, per- and polyfluoroalkyl substances (PFAS), and metals contained in soil and dust are crucial components in establishing accurate risk assessments for susceptible groups such as young children.

mailto:hahn.intaek@epa.gov mailto:josephson.ron@epa.gov mailto:jones.debram@epa.gov https://www.epa.gov/sites/production/files/2019-10/documents/lead_action_plan_booklet_v8_004.pdf https://www.epa.gov/sites/production/files/2019-10/documents/lead_action_plan_booklet_v8_004.pdf https://www.epa.gov/laws-regulations/summary-toxic-substances-control-act https://www.epa.gov/sites/production/files/2017-04/documents/2017.03.30_chpac_tsca_letter.pdf https://www.epa.gov/sites/production/files/2017-04/documents/2017.03.30_chpac_tsca_letter.pdf

Accurate and reliable data for distributional estimates of soil and dust ingestion for all lifestages are important for exposure assessment, dose model input, and risk assessment. These, in turn, support evidence-based decisions for the remediation of contaminated media and help reduce risk posed by pollutants in the environment. An extensive database of published literature has been compiled by the exposure science community (8), but the data are limited and the ingestion rates corresponding to specific lifestages for all age groups remain to be scientifically established and verified (9). Children from 6 months through 6 years of age are of significant interest because their unique developmental, behavioral, and social activities could make them more susceptible or vulnerable to exposures of potentially significant amounts of contaminants through ingestion of soil and dust from their surrounding environments. For example, ingestion of soil and dust particulates, especially by children (specifically aged 6 months through 6 years for the purposes of this announcement), can be the dominant route of exposure to contaminants.

To improve the ability to assess chemical exposure via soil and dust ingestion, four key pieces of information should be considered: the chemical content of location-specific soil and dust;

quantities of soil and dust ingested; frequency of soil and dust ingestion episodes; and prevalence of soil and dust ingestion among a specific age group (8). For the age group of 6 months through 6 years, it will be important to consider all possible ingestion routes (intentional1, unintentional, or habitual, including pica-like behavior, but not geophagy2) and rates in association with the individual, environmental, social and/or cultural factors that may make them more susceptible and vulnerable3. What toxicants children are exposed to during early lifestages may be crucial determinants of their lifetime health (10-13). EPA considers the risks to children consistently and explicitly as part of risk assessments generated during its decision-making process, including the setting of standards to protect public health and the environment (https://www.epa.gov/children/epas-policy-evaluating-risk-children).

When scientifically verified and accurate data on ingestion rates of soil and dust for specific age groups are combined with other relevant individual, environmental, social and cultural data, more accurate exposure and dose estimates and risk assessments may be possible. For example, targeted or non-targeted examination of soil and dust from places (homes, cars, backyards, school or daycare playgrounds, and classrooms) where children aged 6 months through 6 years spend most of their time (14), coupled with children’s behavioral, activity, or socioeconomic data for specific age groups, could lead to more accurate estimates. Accurate ingestion rates of

1 Note that this only refers to observing a child who intentionally ingests that soil or dust (i.e. pica behavior). Investigators are prohibited under this announcement from experimental designs that require a child, pregnant women, or nursing women to ingest soil or dust.

2 Soil pica is the recurrent ingestion of unusually high amounts (i.e., grams per day) of soil. Geophagy is the intentional ingestion of soil, particularly clays, for medicinal or cultural purposes.

3 Susceptibility – Differences in risk resulting from variation in both toxicity response (sensitivity) and exposure (as a result of gender, lifestage, and behavior); Vulnerability – Differences in risk resulting from the combination of both intrinsic differences in susceptibility and extrinsic social stress factors such as low socioeconomic status, crime and violence, lack of community resources, crowding, access to health care, education, poverty, segregation, geography, etc.

https://www.epa.gov/children/epas-policy-evaluating-risk-children soil and dust will significantly improve the estimates and assessments of real-world exposures to chemicals of interest.

This Request for Applications (RFA) asks the scientific community to submit a transdisciplinary research project to develop or apply innovative approaches and methodologies to determine scientifically verifiable and accurate chemical exposures via ingestion rates of soil and dust for children from 6 months through 6 years of age in association with relevant individual, environmental, social and/or cultural factors. Investigators are encouraged to use a holistic research framework or approach, such as the total environment (built, natural, and social) framework (https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.rfatext/rfa_id/630)

(11) to ensure comprehensive examination of all key relevant factors that may affect soil and dust ingestion rates by children and exposure to environmental toxicants via ingestion.

Investigators are also encouraged to develop a collaborative team to consider geographic and demographic parameters (e.g., location, soil type, climate, urban/rural/suburban, socio-economic) regarding soil and dust ingestion rates in children. The research scope could include integration with any available data (state, local, national) pertaining to health (e.g., health records, epidemiological, or biomonitoring) and the environment (e.g., built, social, and natural environmental data such as housing, income, education) that may be relevant to children aged 6 months through 6 years of age.

Research designs incorporating intentional exposures to children, pregnant, and breast-feeding women are prohibited. To the extent possible, the research results or findings should produce innovative yet practical outputs that are applicable or generalizable to other communities across the nation.

EPA recognizes that it is important to engage all available minds to address the environmental challenges the Nation faces. At the same time, EPA seeks to expand the environmental conversation by including members of communities which may have not previously participated in such dialogues to participate in EPA programs. For this reason, EPA strongly encourages all eligible applicants identified in Section III, including minority serving institutions (MSIs), to apply under this opportunity.

For purposes of this solicitation, the following are considered MSIs:

1. Historically Black Colleges and Universities, as defined by the Higher Education Act (20 U.S.C. § 1061). A list of these schools can be found at Historically Black Colleges and Universities;

2. Tribal Colleges and Universities (TCUs), as defined by the Higher Education Act (20 U.S.C. § 1059c(b)(3) and (d)(1)). A list of these schools can be found at American Indian Tribally Controlled Colleges and Universities;

3. Hispanic-Serving Institutions (HSIs), as defined by the Higher Education Act (20 U.S.C. § 1101a(a)(5)). A list of these schools can be found at Hispanic-Serving Institutions;

https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.rfatext/rfa_id/630 https://sites.ed.gov/whhbcu/one-hundred-and-five-historically-black-colleges-and-universities/ https://sites.ed.gov/whhbcu/one-hundred-and-five-historically-black-colleges-and-universities/ https://sites.ed.gov/whiaiane/tribes-tcus/tribal-colleges-and-universities/ https://sites.ed.gov/whiaiane/tribes-tcus/tribal-colleges-and-universities/ https://www2.ed.gov/about/offices/list/ope/idues/hsi-eligibles-2016.pdf

4. Asian American and Native American Pacific Islander-Serving Institutions; (AANAPISIs), as defined by the Higher Education Act (20 U.S.C. § 1059g(a)(2)). A list of these schools can be found at Asian American and Native American Pacific Islander-Serving Institutions; and

5. Predominately Black Institutions (PBIs), as defined by the Higher Education Act of 2008, 20 U.S.C. 1059e(b)(6). A list of these schools can be found at Predominately Black Institutions.

B. Background

The ingestion of soil and dust is a potential route of exposure for environmental toxicants such as heavy metals (e.g., lead, mercury, cadmium, arsenic) and organic chemicals (e.g., herbicides, insecticides, combustion products from industrial activities, coal burning, motor vehicle emissions, waste incineration). Children may ingest significant quantities of chemicals via soil and dust due to their tendency to play on the floor indoors and on the ground outdoors and their tendency to place objects or their hands in their mouths. Understanding soil and dust ingestion is an important part of estimating overall exposures to environmental chemicals. Here, the focus is on better quantification of the entire range of soil and dust ingestion by U.S. children aged 6 months through 6 years. Note that the extent of pica or pica-like behavior needs to be better understood as to its impact on the distribution of intake; however, “in children under two years of age, mouthing objects—or putting small objects in their mouth—is a normal part of development, allowing the child to explore their senses. Mouthing may sometimes result in ingestion. However, in order to exclude developmentally normal mouthing, children under two years of age should not be diagnosed with pica” (https://www.nationaleatingdisorders.org/learn/by-eating-disorder/other/pica).

Researchers are encouraged to utilize recent innovations in exposure science, such as non-targeted analysis to identify a novel compound(s) that might be a suitable tracer to accurately estimate dust and soil ingestion rates. Investigators may also propose novel methods that use the latest advancements in sensors, informatics, data science, etc., to improve ingestion rate estimates. Researchers can propose to estimate children’s soil and dust ingestion rates through retrospective analyses of site- or community-specific blood or urine level biomonitoring data and generalize the results to other sites or communities with similar environmental parameters (https://ehp.niehs.nih.gov/doi/10.1289/ehp.1510144).4 Another improvement would be a scientific method or technology to distinguish between soil and dust that may further discern, for example, exposure estimates for chemicals found in consumer products used indoors that are adsorbed onto household dust (https://pubs.acs.org/doi/abs/10.1021/acs.est.7b05767) and exposure estimates for chemicals in soil that are from nearby outdoor sources.

Researchers are also encouraged to improve upon three current approaches/methodologies for estimating soil and dust ingestion rates described in the scientific literature: tracer studies, activity pattern studies, and biokinetic modeling comparison studies.

4 Note: studies conducted under research projects supported under this announcement cannot involve intentional exposures.

https://www.google.com/maps/d/viewer?mid=1XVkOWKMDORm53pvU0L8EPsrJC94&msa=0&ie=UTF8&t=m&z=3&source=embed&ll=40.58644586187277%2C-148.28228249999984 https://www.google.com/maps/d/viewer?mid=1wlIi3j7gtlNq_w-0NKAb2bF2VmY&ie=UTF&msa=0&ll=37.35160769312532%2C-96.17229800000001&z=4 https://www.nationaleatingdisorders.org/learn/by-eating-disorder/other/pica https://ehp.niehs.nih.gov/doi/10.1289/ehp.1510144 https://pubs.acs.org/doi/abs/10.1021/acs.est.7b05767

Tracer studies5 estimate soil and dust ingestion using a mass-balance of tracer elements present in soil and dust from children’s residences and/or play areas, and the children’s urine and feces.

It can be challenging to characterize soil and dust ingestion using this approach, as elemental tracers are found in other items that children ingest (e.g., food, toothpaste, soil) and the variability and uncertainty of the calculations is dependent on the chosen tracer.

Activity pattern studies combine information on hand-to-mouth and object-to-mouth activities with assumptions about transfer of soil and dust to hands and from hands to mouth and other exposure factors (e.g., frequency of hand washing) to derive soil and dust ingestion estimates.

Micro-activity information is usually obtained using observational methods. Activity pattern models often have gaps in the data needed for estimation.

Biokinetic modeling comparison studies compare direct measurements of a biomarker with predictions from a biokinetic model (e.g., EPA’s Integrated Exposure Uptake BioKinetic [IEUBK] model of blood lead level in children). The comparison of the model predicted blood lead levels with actual blood lead levels can be used to back calculate probable ingestion rates of soil and dust.

A major limitation of all three methods is that they do not lend themselves to broad application due to lack of data that address variability and uncertainty in geographic, seasonal, socio-demographic and other factors as described in this solicitation (14). The available soil and dust ingestion data based on these three study types have been compiled and reviewed in detail by the exposure science community (8,15), but the ingestion estimates lack a high level of confidence given the associated uncertainty and variability in available data, and ingestion rates are not available for all child-specific age ranges. Hence, innovative ways to improve and enhance the three methods/approaches to overcome limitations, reduce uncertainties and improve confidence in soil and dust ingestion rates are desired. Researchers are encouraged to investigate how multiple approaches, e.g., tracer, activity pattern, biokinetic modeling, and/or other innovative approaches, can be integrated to improve the estimates for children’s soil and dust ingestion rates.6

C. Authority and Regulations The authority for this RFA and resulting awards is contained in the Toxic Substances Control Act, 15 U.S.C. 2609, Section 10, as amended by P.L. 106-74; and the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136r, Section 20, as amended by P.L. 106-74.

For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102(2)(F).

5 Note: tracer studies conducted under research projects supported under this announcement cannot involve intentional exposures.

6 Note: Experimental designs in which children are intentionally exposed to a known concentration of a tracer or soil are not allowed. It is not the intent of this RFA to promote, encourage or facilitate ingestion of contaminated soil and dust by children, even if accidental or incidental. Researchers should incorporate plans to educate parents on the hazards and toxicity of chemicals at the onset of the project, including discussion in the consent process.

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. Further note applications dealing with any aspect of or related to hydraulic fracking will not be funded by EPA through this program.

Additional applicable regulations include: 2 CFR Part 200, 2 CFR Part 1500, and 40 CFR Part 40 (Research and Demonstration Grants).

D. Specific Areas of Interest/Expected Outputs and Outcomes Note to applicant: The term “output” means an environmental activity, effort, and/or associated work products related to an environmental goal or objective, that will be produced or provided over a period of time or by a specified date. The term “outcome” means the result, effect, or consequence that will occur from carrying out an environmental program or activity that is related to an environmental or programmatic goal or objective.

The activities to be funded under this announcement support EPA’s FY 2018-22 Strategic Plan (https://www.epa.gov/planandbudget/strategicplan.html). Activities to be funded under this announcement support Goal 3: Greater Certainty, Compliance, and Effectiveness, Objective 3.3:

Prioritize Robust Science, of EPA’s FY 2018-22 Strategic Plan. Awards made under this announcement will further EPA’s priorities supporting robust science for Sustainable and Healthy Communities. All applications must be for projects that support the goal and objective identified above.

EPA also requires that grant applicants adequately describe environmental outputs and outcomes to be achieved under assistance agreements (see EPA Order 5700.7A1, Environmental Results under Assistance Agreements, https://www.epa.gov/grants/epa-order-57007a1-epas-policy-environmental-results-under-epa-assistance-agreements). Applicants must include specific statements describing the environmental results of the proposed project in terms of well-defined outputs and, to the maximum extent practicable, well-defined outcomes that will demonstrate how the project will contribute to the priorities described above.

EPA is asking the scientific community to propose transdisciplinary research to better characterize the variability and reduce uncertainty in the estimates of chemical exposures via soil and dust ingestion rates for children aged 6 months through 6 years by developing or applying innovative approaches/methods to estimate soil and dust ingestion rates.

Research Area:

Innovative approaches/methods to estimate children’s soil and dust ingestion rates:

Develop or apply innovative methods to estimate soil and dust ingestion. These can include improving and enhancing existing ingestion rate methodologies or new methodologies, such as the non-targeted analysis approach. Understanding the chemicals (toxicant content) that are present in soil and dust and how much those chemicals would be ingested is the main research https://www.epa.gov/planandbudget/strategicplan.html https://www.epa.gov/grants/epa-order-57007a1-epas-policy-environmental-results-under-epa-assistance-agreements https://www.epa.gov/grants/epa-order-57007a1-epas-policy-environmental-results-under-epa-assistance-agreements focus. The proposed research plan should include new or existing analysis or screening of chemicals present in the soil and dust being studied.

When developing the research plan for innovative approaches/methods to estimate soil and dust ingestion rates, applications should consider the following factors that determine or influence soil and dust ingestion rates:

a) Children’s behavioral variability or differences to better understand the prevalence and frequency of ingestion, including pica or pica-like behavior (i.e., recurring or repeated ingestion of non-food substances such as dirt or paint chips) and its contribution to exposure to environmental toxicants. For this research area, researchers should specify the age groups that are corresponding to the behavioral variability or differences (e.g., 6 months through 12 months, 1 year through 3 years, 3 years through 6 years).

b) Environmental (built, natural, social, chemical/non-chemical) variables that determine soil and dust ingestion rates in children.

c) Geographic parameters (e.g., location, soil type, climate, urban/rural/suburban) that may influence or determine soil and dust ingestion rates in children and toxicant content in soil and/or dust.

d) Demographic and/or socio-economic factors that may influence the prevalence and rate of soil and dust ingestion in children.

e) Seasonality, wet/dry hands, etc., that may be important in soil and dust ingestion rate estimation.

f) Statistical relevance, confidence, and uncertainty in understanding the unique characteristics and distribution of exposure in children aged 6 months through 6 years. (8, 9, 12)

g) Methodology to distinguish soil from dust ingestion for children and distinguish indoor

vs. outdoor sources.

h) Parameters for representativeness.

Expected Outputs: Expected outputs include innovative approaches/methods to better estimate chemical exposures via soil and dust ingestion rates and updated distributional estimates of exposure factors and data that are arrayed by life stage/age group which can be used by environmental exposure risk assessors, public health professionals, and environmental remediators.

Expected Outcomes: The most significant outcome EPA anticipates from research supported by this RFA is an increase in the ability and capacity to protect children from chemical exposure via soil and dust ingestion. For example, with changes in knowledge, action, or condition, the scientific community can make better informed decisions to improve and implement individual-level and population-level approaches to minimize/prevent chemical exposures and promote health. In turn, this could inform potential prevention.

To the extent practicable, research applications must embody innovation. 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 applications must include a discussion on how the proposed research is innovative (see Section IV.C.6.a). Reviewers will draw from the above-mentioned innovation definition in the review/evaluation process of research applications (see Section V.A).

E. References

1. Bjorklund JA, Thuresson K, De Wit CA. Perfluoroalkyl compounds (PFCs) in indoor dust:

concentrations, human exposure estimates, and sources. Environ Sci Technol. 43(7):2276-81.

(2009)

2. Bennett DH, Moran RE, Wu XM, Tulve NS, Clifton MS, Colon M, et al. Polybrominated diphenyl ether (PBDE) concentrations and resulting exposure in homes in California:

relationships among passive air, surface wipe and dust concentrations, and temporal variability.

Indoor Air. 25(2):220-9. (2015)

3. Trunnelle KJ, Bennett DH, Tulve NS, Clifton MS, Davis MD, Calafat AM, et al. Urinary pyrethroid and chlorpyrifos metabolite concentrations in Northern California families and their relationship to indoor residential insecticide levels, part of the Study of Use of Products and Exposure Related Behavior (SUPERB). Environ Sci Technol. 48(3):1931-9. (2014)

4. Geens T, Roosens L, Neels H, Covaci A. Assessment of human exposure to Bisphenol-A, Triclosan and Tetrabromobisphenol-A through indoor dust intake in Belgium. Chemosphere.

76(6):755-60. (2009)

5. Lu XW, Zhang XL, Li LY, Chen H. Assessment of metals pollution and health risk in dust from nursery schools in Xi'an, China. Environ Res. 128:27-34. (2014)

6. Moschet C, Anumol T, Lew BM, Bennett DH, Young TM. Household dust as a repository of chemical accumulation: new insights from a comprehensive high-resolution mass spectrometric study. Environ Sci Technol. 52(5):2878-87. (2018)

7. Rager JE, Strynar MJ, Liang S, McMahen RL, Richard AM, Grulke CM, et al. Linking high resolution mass spectrometry data with exposure and toxicity forecasts to advance high-throughput environmental monitoring. Environ Int. 88:269-80. (2016)

8. U.S. EPA. Exposure Factors Handbook Chapter 5 (Update): Soil and Dust Ingestion. (2017) https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=337521.

9. U.S. EPA. 630-P-03-003F. Guidance on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants, (2005)

10. U.S. EPA. Children's Environmental Health Research Roadmap. U.S. Environmental Protection Agency, Office of Research and Development, Washington, DC. (2015) https://www.epa.gov/sites/production/files/2015-11/documents/researchroadmap_ceh_508.pdf.

https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=337521 https://www.epa.gov/sites/production/files/2015-11/documents/researchroadmap_ceh_508.pdf

11. Tulve, N.S., Ruiz, J.D.C., Lichtveld, K., Darney, S.P., & Quackenboss, J.J. Development of a conceptual framework depicting a child's total (built, natural, social) environment in order to optimize health and well-being. Journal of Environment and Health Science, 2(2):1-8. (2016)

12. Cohen Hubal, E.A., deWet, T., DuToit, L., Firestone, M.P., Ruchirawat, M., van Engelen, J., & Vickers, C. Identifying important life stages for monitoring and assessing risks from exposures to environmental contaminants: Results of a World Health Organization review.

Regulatory Toxicology and Pharmacology, 69(1):113-124. (2014)

13. Currie, J., Zivin. J.G., Mullins, J., & Neidell, M. What do we know about short- and long-term effects of early-life exposure to pollution? Annual Review of Resource Economics, 6:217–

47. (2014)

14. Moschet, C., Anumol, T., Lew, B.M., Bennett, D.H., & Young, T.M. Household dust as a repository of chemical accumulation: new insights from a comprehensive high-resolution mass spectrometric study. Environmental Science and Technology, 52(5):2878-2887. (2018) https://pubs.acs.org/doi/abs/10.1021/acs.est.7b05767.

15. Moya, J. & Phillips, L. A review of soil and dust ingestion studies for children. Journal of Exposure Science and Environmental Epidemiology, 24(6):545-55. (2014)

F. Special Requirements

It is EPA Policy to ensure that the results of EPA-funded extramural scientific research are accessible to the public to the greatest extent feasible consistent with applicable law; policies and Orders; the Agency’s mission; resource constraints; and U.S. national, homeland and economic security. This entails maximizing, at no charge, access by the public to peer-reviewed, scientific research journal publications or associated author manuscripts, and their underlying digital research data, created in whole or in part with EPA funds, while protecting personal privacy;

recognizing proprietary interests, confidential business information and intellectual property rights; and avoiding significant negative impact on intellectual property rights, innovation and U.S. competitiveness. EPA’s Policy for Increasing Access to Results of EPA-Funded Extramural Scientific Research may be accessed at: https://www.epa.gov/research/non-epa-researcher-requirements. Terms and conditions implementing this policy may be accessed at:

https://www.epa.gov/research/non-epa-researcher-requirements.

Applications submitted under this announcement shall include a Scientific Data Management Plan (SDMP) that addresses public access to EPA-funded scientific research data. See the SDMP clause in Section IV for details on the content of an SDMP. Applicants will also be asked to provide past performance information on whether journal publications or associated author manuscripts, and the associated underlying scientific research data and metadata, under prior assistance agreements were made publicly accessible. These items will be evaluated prior to award.

https://pubs.acs.org/doi/abs/10.1021/acs.est.7b05767 https://www.epa.gov/research/non-epa-researcher-requirements

Reasonable, necessary, and allocable costs for data management and public access as discussed in EPA’s Policy for Increasing Access to Results of EPA-Funded Extramural Scientific Research, may be included in extramural research applications and detailed in the budget justification described in Section IV.

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 (https://www.epa.gov/research-grants/research-grants-guidance-and-policies).

This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research. All applications must include a Human Subjects Research Statement (HSRS; described in Section IV.C.6.c of this solicitation). 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.D and V.F of this solicitation.

Groups of two or more eligible applicants may choose to form a consortium and submit a single application for this assistance agreement. The application must identify which organization will be the recipient of the assistance agreement and which organizations(s) will be subawardees of the recipient.

These awards may involve the collection of “Geospatial Information,” which includes information that identifies the geographic location and characteristics of natural or constructed features or boundaries on the Earth or applications, tools, and hardware associated with the generation, maintenance, or distribution of such information. This information may be derived from, among other things, a Geographic Positioning System (GPS), remote sensing, mapping, charting, and surveying technologies, or statistical data.

II. AWARD INFORMATION

It is anticipated that a total of approximately $8.1 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 six awards under this RFA. Requests for amounts in excess of a total of $1.35 million 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.

In appropriate circumstances, EPA reserves the right to partially fund applications by funding discrete portions or phases of proposed projects. If EPA decides to partially fund an application, it will do so in a manner that does not prejudice any applicants or affect the basis upon which the application, or portion thereof, was evaluated and selected for award, and therefore maintains the integrity of the competition and selection process.

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 rather than substantial to achieving the goals of the research under a grant. Interaction that is “incidental” does not involve resource commitments by EPA.

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. Applications 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.

III. ELIGIBILITY INFORMATION

A. Eligible Applicants

Public and private nonprofit institutions/organizations, public and 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 and individuals are not eligible to apply.

Non-profit organization, as defined by 2 CFR 200.70, means any corporation, trust, association, cooperative, or other organization that: (1) is operated primarily for scientific, educational, service, charitable, or similar purposes in the public interest; (2) is not organized primarily for profit; and (3) uses its net proceeds to maintain, improve, and/or expand its operations. Note that 2 CFR 200.70 specifically excludes Institutions of Higher Education from the definition of non-profit organization because they are separately defined in the regulation. While not considered to be a non-profit organization(s) as defined by 2 CFR 200.70, public or nonprofit Institutions of Higher Education are, nevertheless, eligible to submit applications under this RFA. Hospitals operated by state, tribal, or local governments or that meet the definition of nonprofit at 2 CFR

200.70 are also eligible to apply as nonprofits or as instrumentalities of the unit of government depending on the applicable law. For-profit colleges, universities, trade schools, and hospitals are ineligible. 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. Federal employees may not receive salaries or augment their Agency’s appropriations through awards made under this program unless authorized by law to receive such funding.

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 in ORD, phone: 202-564-7823, email: josephson.ron@epa.gov.

B. Cost sharing

Institutional cost-sharing is not required.

mailto:josephson.ron@epa.gov

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. In addition, applications must be submitted through Grants.gov as stated in Section IV of this announcement (except in the limited circumstances where another mode of submission is specifically allowed for as explained in Section IV) on or before the application submission deadline published in Section IV of this announcement. Applicants are responsible for following the submission instructions in Section IV of this announcement (see Section IV.F. “Submission Instructions and Other Submission Requirements” for further information) to ensure that their application is submitted timely.

Applications submitted after the submission deadline will be considered late and deemed ineligible without further consideration unless the applicant can clearly demonstrate that it was late due to EPA mishandling or because of technical problems associated with Grants.gov or relevant SAM.gov system issues. An applicant’s failure to timely submit their application through Grants.gov because they did not timely or properly register in SAM.gov or Grants.gov will not be considered an acceptable reason to consider a late submission.

Also, applications exceeding the funding limits or project period term described herein will be rejected 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 https://www2.epa.gov/grants/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 are in Section F.

A. Grants.gov Submittal Requirements and Limited Exception Procedures Applicants, except as noted below, must apply electronically through Grants.gov under this funding opportunity based on the grants.gov instructions in this announcement. If an applicant https://www.grants.gov/ https://www.grants.gov/ http://www.sam.gov/ https://www.grants.gov/ http://www.sam.gov/ https://www.grants.gov/ https://www2.epa.gov/grants/epa-solicitation-clauses https://www.grants.gov/ does not have the technical capability to apply electronically through grants.gov because of limited or no internet access which prevents them from being able to upload the required application materials to Grants.gov, the applicant must contact OMS-ARM- OGDWaivers@epa.gov or the address listed below in writing (e.g., by…