FY20 SSWR Viral Risk in Water Reuse RFA Extended.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.

*Notice: The closing date of this opportunity has been extended to January 13, 2021

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

VIRAL PATHOGEN AND SURROGATE APPROACHES

FOR ASSESSING TREATMENT PERFORMANCE IN

WATER REUSE

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2021-STAR-A1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: October 29, 2020 Solicitation Closing Date: January 13, 2021: 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 https://www.epa.gov/grants/epa-solicitation-clauses

F. Special Requirements

II. AWARD INFORMATION

III. ELIGIBILITY INFORMATION

A. Eligible Applicants 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 seeking applications proposing to conduct research on existing and novel surrogates for the detection and monitoring of the presence of human enteric viral pathogens and surrogates in water reuse applications, where wastewater is the source water. Additionally, proposals should aim to identify quantitative reductions of infectious viral pathogens and surrogates across unit treatment processes and full treatment trains to improve viral risk assessments; viral log reduction targets; and unit process credits for water reuse applications.

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 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

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.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 Estimated Number of Awards: Approximately 5 awards Anticipated Funding Amount: Approximately $6,200,000 total for all awards Potential Funding per Award: Up to a total of $1,240,000, 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.

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

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 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 appropriate internet access 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: Sarah Ludwig-Monty; phone: 202-566-1072; email: Ludwig-monty.sarah@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

A high-priority research area identified by the Environmental Protection Agency (EPA) Office of Research and Development (ORD) is to expand the understanding of the human health risks posed by pathogenic human enteric viruses in water reuse applications, where wastewater is the source water. EPA is issuing this Request for Applications (RFA) to support research into the development of standardized approaches to identify, characterize, and validate suitable viral surrogates and enumeration methods for quantifying the potential human health risks posed by the levels of human enteric viral pathogens found in reclaimed wastewater. Information on the concentrations of infectious viral pathogens relative to the concentrations of viral surrogates is also needed. Additionally, data on the inactivation or removal of viral pathogens and surrogates are needed to: 1) establish and verify viral pathogen log-reduction values for individual unit treatment processes and through treatment trains, 2) inform monitoring, and 3) optimize treatment train performance.

For the purpose of this RFA, viral surrogates are defined as an organism, particle, or compound used to study the fate of a pathogen in a given environment (1). Viral surrogates may include nonpathogenic (e.g., coliphage, pepper mild mottle virus [PMMoV], etc.) or pathogenic viruses (e.g., adenovirus, norovirus, etc.) and/or other types of indicators demonstrated to predict the presence of and/or risk of illness from human pathogenic viruses (e.g., enterococcus qPCR [EPA mailto:Ludwig-monty.sarah@epa.gov mailto:Ludwig-monty.sarah@epa.gov mailto:josephson.ron@epa.gov mailto:jones.debram@epa.gov

Method 1609], the human marker HF183, etc.) via co-occurrence studies and quantitative microbial risk assessments.

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(2)). 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;

4. Asian American and Native American Pacific Islander-Serving Institutions; (AANAPISIs), as defined by the Higher Education Act (20 U.S.C. § 1059g(b)(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 Water Environment Federation (2) estimates that approximately 33 billion gallons of municipal wastewater are produced each day in the U.S. Of that volume, approximately 2.2 billion gallons per day are recovered and reused leaving a major opportunity for reclamation and reuse. Municipal wastewater offers the potential to significantly increase the nation’s total available water resources (3). However, wastewater as a potential source water remains both a technical and economic challenge due to the potential variety of contaminants that can be present such as metals, salts, organic chemicals, nutrients, pathogens and emerging contaminants. For purposes of this RFA, treated wastewater or reclaimed water refers to the reuse of municipal 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 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 treated wastewater, urban stormwater, grey water1, and yellow water2 with considerations for planned and unplanned reuse, including direct and indirect potable and non-potable applications.

Safe and reliable water supplies for human consumption, agriculture, business, industry, recreation, and healthy ecosystems are critical to our nation’s communities and economy.

Communities, agriculture, and businesses are looking to diversify their supply portfolios to meet current and future needs. Water reuse (also commonly known as water recycling or water reclamation) represents a major opportunity to enhance the sustainability and effective use of water resources to assure the quality of and supplement existing water supplies. Water reuse is a well-established practice in some areas of the United States and internationally, yet substantial opportunities exist to expand its consideration and application for many different purposes and benefits. In February 2020, EPA released the National Water Reuse Action Plan: Collaborative Implementation Version 1 (the “WRAP”) (4) representing the coordinated and collaborative effort across the water user community. The “WRAP” includes 37 specific developed actions and over 200 implementation milestones supported by more than 80 partners across 11 strategic themes. The WRAP seeks to promote the consideration of water reuse by implementing these actions to help communities, policymakers, water resource planners and practitioners, and other stakeholders match potential sources of water with identified applications at the quantity and quality needed.

The use of reclaimed water is increasing in some cases due to local or temporal water scarcity and associated increasing demand. The EPA incorporated eleven guiding principles in the WRAP, including protecting public health, the environment and ecosystem health. A central tenet of EPA’s approach to water reuse is that the source of water for potential reuse must be appropriately treated and verified to meet applicable fit-for-purpose specifications to protect public health, the environment, and any other particular end user needs or quality endpoint (4).

The WRAP seeks to promote the consideration of water reuse by implementing actions that will help communities, policymakers, water resource planners and practitioners, and other stakeholders match potential sources of water that can be provided at a quantity and quality needed for identified applications. The scope of this RFA could generate information that addresses four of the eleven strategic themes in the WRAP:

1) Science and Specifications: Compile and refine fit-for-purpose specifications;

2) Technology Development and Validation: Promote technology development, deployment, and validation;

3) Water Information Availability: Improve availability of water (quality and quantity) information; and,

4) Integrated Research: Integrate and coordinate research on water reuse.

Results from studies funded by this RFA could provide information that could help refine the understanding of fit-for-purpose specifications related to multiple applications of recycled water.

The same information could be used to develop and validate unit treatment processes and understand treatment performance to help promote water reuse opportunities. Data on improved

1 Grey water - Household wastewater from bathroom sinks, showers, bathtubs, and clothes washers.

2 Yellow water – urine surrogates and methods provide better information on the quality, and perhaps the quantity, of water available for reuse, thus potentially increasing the opportunities for reuse applications.

Finally, the RFA can enhance the coordination of water reuse research to optimize its value, better identify critical science gaps, and accelerate the opportunities for reuse.

When recycling wastewater, a chief public health concern is the risk posed by the presence of viral pathogens, which are less well attenuated by traditional sewage treatment approaches, compared to pathogenic bacteria and the fecal indicator bacteria typically used to gauge effluent quality. Waterborne human enteric viruses such as noroviruses, adenoviruses, and enteroviruses are excreted in high densities in the feces of infected individuals, infectious at relatively low doses, and documented to cause illness after exposure to effluent-affected waters via incidental ingestion.

Enteric viruses can be found in waters affected by both untreated or treated sewage discharges, with highest densities found in wastewater or sludge samples. Generally, concentration methods are required to detect the lower densities of pathogenic viruses in surface, ground and drinking water samples. Improved recovery efficiencies of enteric viruses are a crucial need for optimizing their detection and enumeration, and for better characterizing their removal across treatments (5). Monitoring and validating viral removal during treatment is limited by the effectiveness of existing detection methods. Focusing solely on viral pathogens for monitoring treatment performance is limited given their often low and variable occurrence. For example, coliphage, a non-pathogenic viral surrogate, has shown promise in the evaluation of treatment efficacy for infectious viruses.

Enumeration of surrogates can help address the challenges with quantifying low densities of viral pathogens, but an improved understanding of good indicator candidates, their response to treatment relative to the pathogens, and their relationship to risk needs to be further characterized in water reuse scenarios (6). For example, monitoring alternative targets within the diverse virome of wastewater or other targets as surrogates for pathogenic virus removal/inactivation is one approach as it eliminates the costs of spiking treatment systems with exogenous markers.

The success of this approach depends on identifying viral surrogates within wastewater which consistently occur at levels sufficiently high enough to consistently detect and perform similarly or conservatively to the viral pathogens during relevant treatment processes. Evaluation of gene targets for treatment performance can be affected by the availability of standardized methods to assess infectious forms of the given virus and the ability to relate the removal efficiencies of the viral surrogates to the pathogenic virus.

While specific gene targets can be used to quantify the presence of a range of viral pathogens of concern, these approaches may underestimate removal during treatment since the presence of the gene may not reflect potential attenuation of infectious viruses by the treatment process. Health studies characterizing human exposure to surface waters receiving secondary treated effluent demonstrate the potential for significantly elevated viral illness, but more information is needed on the attenuation of infectious viruses across the additional treatment employed for reuse applications and the performance of viral indicators in these processes. Development of such methods would greatly improve the ability to assess viral risks associated with planned water reuse systems as well as wastewater impacts on drinking water (i.e., de facto reuse) and recreational waters.

Recent guidelines for estimating reduction of pathogens in source water for non-potable onsite reuse have adopted a risk-based, fit-for-purpose approach (5,7,8). These approaches include quantitative microbial risk assessment (QMRA)-based analyses to model pathogen log reduction targets (LRTs) for specific combinations of source waters and water reuse applications based on initial pathogen load, potential exposure volume, and a defined health benchmark (e.g., 10-4 infections per person/year) (8,9). Given critical gaps in the understanding of the variability of source waters, treatment response, and infectivity, conservative LRTs are typically developed for each major microbial class (bacteria, protozoa, and viruses), using available data for reference pathogens within each class. This approach ensures, based on currently available scientific information and transparent risk assessment assumptions, systems achieving the calculated LRTs can be protective of human health. However, practical application of this approach requires information on the log reduction values (LRVs) of unit processes and treatment trains for comparison with required LRTs in reuse scenarios of interest. An initial assessment and validation of treatment technologies to determine respective LRVs as well as in-place monitoring to confirm ongoing performance are needed (7,10).

The use of genomic sequencing of environmental samples and particularly metagenomics has uncovered useful new targets such as crAssphage and PMMoV (6,11,12,13,14), which are abundant in human fecal waste but are not themselves, human pathogens. These bypass some of the problems associated with use of pathogenic viruses, but they are not currently culturable and alone they lack the ability to show public health risks. It is important to understand the relationships between reduction of viral surrogates during treatments and the log reductions of the enteric viral pathogens. This has been studied for some markers (15,16), but additional information on the surrogate performance during treatments would be informative to decision-making.

More research is needed to improve quantification of viral pathogens in source waters and/or identify suitable indicators and surrogates to estimate quantities of viral pathogens in reclaimed water. Additionally, improved cost-effective methods are necessary for quantifying the reduction and inactivation of the infectious states of viral pathogens and surrogates.

C. Authority and Regulations

The authority for this RFA and resulting awards is contained in the Safe Drinking Water Act, 42 U.S.C. 300j-1, Section 1442, and the Clean Water Act, 33 U.S.C. 1254, Section 104(b)(3).

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. 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). 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 Safe and Sustainable Water Resources. All applications must be for projects that support the goal and objective identified above. The Agency is seeking new information to improve risk-based treatment assessment for human enteric viral pathogens within reclaimed water sources and reuse applications.

This RFA seeks to minimize uncertainties associated with risk-based treatment performance for water reuse applications and gain new information on novel and existing surrogates for: 1) detecting and monitoring human enteric viral pathogens in wastewater, a potential source water for reuse; 2) validating viral reductions during unit treatment processes required for various fit-for-purpose applications; and 3) assessing potential human health risks associated with reuse applications (e.g., potable water, different types of food crop irrigation scenarios, non-food crop irrigation scenarios where human exposure is probable, and non-potable indoor reuse). This RFA also seeks new information on viral pathogens, surrogates, and methods for their detection, including information on the quantitative reduction and inactivation of infectious viral pathogens to support human health risks assessments related to human enteric viruses in reuse scenarios.

The proposed research should result in information that will enable wastewater operators, reuse projects, and state and local regulators ensure public health protection from viral pathogens when reusing municipal wastewater for various reuse applications.

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.

https://www.epa.gov/planandbudget/strategicplan 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

There are two distinct areas of research covered by this solicitation. Applicants should address at least one of the two research areas described below. Applications may respond to one research area in detail or integrate across the two research areas. Applications should clearly identify which research area(s) the application is addressing. Proposals that address more than one of the research areas below will not necessarily be rated more highly than those that address just one of the areas.

Research Area #1 – Viral Surrogates for Assessing Treatment Performance Viral surrogates are needed for assessing and monitoring risk-based treatment performance during treatment for water reuse applications. More research is needed to identify, characterize and validate suitable surrogates for pathogenic enteric viruses. Topics of interest include:

• Identifying and characterizing appropriate candidate surrogates for viral enteric pathogens in wastewater and during water reuse treatment; and

• Understanding the impacts of source water type (e.g., urban stormwater, graywater, treated wastewater or combined wastewater), treatment trains (e.g., conventional vs.

advanced treatment and disinfection), end use (e.g., non-potable, indirect potable, or direct potable), and/or scale of implementation (e.g., centralized, decentralized, or onsite reuse) on surrogate applicability.

Research Area #2 – Identifying Quantitative Reductions of Viral Pathogens and Surrogates across Unit Treatment Processes and Full Treatment Trains for Water Reuse Applications Methods are needed to establish and verify viral pathogen log-reduction values for individual unit treatment processes and through treatment trains, with successful surrogates demonstrating representative reductions and associated uncertainties relative to viral reference pathogens. This requires both targeted measurement techniques and scalable approaches for LRV validation and monitoring in real-world systems. Topics of interest include:

• Analytical methods for detecting and measuring viral pathogens and surrogates in wastewater matrices and across treatment, including infectious viruses (i.e., a better understanding of removal and/or inactivation of culturable norovirus);

• Comparing densities and reductions of viral pathogens and surrogates in untreated wastewaters, across relevant water reuse treatment processes, and/or in reclaimed effluents; and

• Technical frameworks for determining and validating treatment process LRVs, unit treatment log-reduction credits, and/or monitoring ongoing treatment performance.

Expected Outputs Outputs expected from this solicitation may include publications of research results in peer-reviewed journals, guidance documents, standard operating procedures (SOPs), decision support tools, demonstration and case studies, reports, and presentations. The outputs should demonstrate potential for translational impacts, i.e., practical application to real-world water reuse treatment systems. It is expected that outputs will provide tangible products contributing to a toolbox approach for water reuse treatment assessment. This toolbox should include novel surrogates, analytical methods for viral reductions across treatments, improved log reduction targets (or credits) for viruses, information on viral inactivation (via infectivity measures), and scalable approaches to performance validation and monitoring.

Expected Outcomes The expected outcome of this solicitation is new information on novel and existing surrogates for detecting and monitoring human enteric viral pathogens in wastewater that will result in a better understanding of treatment performance assessment tools for water reuse that will support different scenarios (e.g., potable water, different types of food crop irrigation scenarios, non-food crop irrigation scenarios where human exposure is probable, and non-potable indoor reuse, etc.).

Developed surrogates and methods should advance the science of applied water reuse by providing necessary tools to validate and monitor treatment performance under risk-based specifications. This will facilitate practical implementation of fit-for-purpose water reuse approaches, promoting further development of water reuse resources while maintaining protection of public health.

E. References

(1) Sinclair RG, Rose JB, Hashsham SA, Gerba CP, Haas CN. (2012). Criteria for selection of surrogates used to study the fate and control of pathogens in the environment. Applied and environmental microbiology 78:1969-1977.

(2) Rauch-Williams, T; Marshall, MR; Davis, DJ. (2018). Baseline data to establish the current amount of resource recovery from WRRFs. Water Environment Federation. Available at:

https://www.wef. org/globalassets/assets-wef/direct-download-library/public/03---resources/WSEC-2018-TR-003.

(3) USEPA (2019). Draft National Water Reuse Action Plan. United States Environmental Protection Agency, Washington, DC.

(4) USEPA (2020). National Water Reuse Action Plan: Collaborative Implementation Version

1. United States Environmental Protection Agency, Washington, DC.

(5) Haramoto, E., Kitajima, M., Hata, A., Torrey, J. R., Masago, Y., Sano, D., & Katayama, H.

(2018). A review on recent progress in the detection methods and prevalence of human enteric viruses in water. Water Research, 135, 168–186. Available at:

https://doi.org/10.1016/j.watres.2018.02.004

(6) Tandukar, S., Sherchan, S. P., & Haramoto, E. (2020). Applicability of crAssphage, pepper mild mottle virus, and tobacco mosaic virus as indicators of reduction of enteric viruses during wastewater treatment. Scientific Reports, 10(1), 1-8.

(7) SWRCB (2019). A proposed framework for regulating direct potable reuse in California, second edition. State Water Resources Control Board, Sacramento, CA.

(8) Sharvelle, S., Ashbolt, N., Clerico, E., Hultquist, R., Leverenz, H., Olivieri, A. (2017).

Risk-based framework for the development of public health guidance for decentralized non-potable water systems. Prepared by the National Water Research Institute for the Water Environment & Reuse Foundation, Alexandria, VA.

(9) NRMMC, EPHC, and AHMC (2006). Australian guidelines for water recycling: managing health and environmental risks (phase 1). Natural Resource Management Ministerial Council, Environment Protection and Heritage Council, and Australian Health Ministers Conference, Canberra, Australia.

https://doi.org/10.1016/j.watres.2018.02.004

(10) Schoen, M. E., Ashbolt, N. J., Jahne, M. A., & Garland, J. (2017). Risk-based enteric pathogen reduction targets for non-potable and direct potable use of roof runoff, stormwater, and greywater. Microbial Risk Analysis, 5, 32-43.

(11) Petterson, S. R., & Ashbolt, N. J. (2016). QMRA and water safety management: review of application in drinking water systems. Journal of Water and Health, 14(4), 571-589.

(12) Rosario, K., Symonds, E. M., Sinigalliano, C., Stewart, J., & Breitbart, M. (2009). Pepper mild mottle virus as an indicator of fecal pollution. Appl. Environ. Microbiol., 75(22), 7261-7267.

(13) Bibby, K., & Peccia, J. (2013). Identification of viral pathogen diversity in sewage sludge by metagenome analysis. Environmental science & technology, 47(4), 1945-1951.

(14) Zhang, T., Breitbart, M., Lee, W. H., Run, J. Q., Wei, C. L., Soh, S. W. L., ... & Ruan, Y.

(2005). RNA viral community in human feces: prevalence of plant pathogenic viruses.

PLoS Biol, 4(1), e3.

(15) Dutilh, B. E. et al. (2014). A highly abundant bacteriophage discovered in the unknown sequences of human faecal metagenomes. Nat. Commun. 5, 4498.

(16) Kitajima, M., Iker, B. C., Pepper, I. L., & Gerba, C. P. (2014). Relative abundance and treatment reduction of viruses during wastewater treatment processes—identification of potential viral indicators. Science of the Total Environment, 488, 290-296.

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.

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, https://www.epa.gov/research/non-epa-researcher-requirements https://www.epa.gov/research/non-epa-researcher-requirements https://www.epa.gov/research/non-epa-researcher-requirements 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 $6.2 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 $1,240,000, 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.

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 intends to award only grants 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.

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.

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 mailto:josephson.ron@epa.gov https://www.grants.gov/ 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 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 hard copy, email) at least 15 calendar days prior to the submission deadline under this announcement to request approval to submit their application materials through an alternate method.

Mailing Address:

OGD Waivers c/o Jessica Durand USEPA Headquarters William Jefferson Clinton Building 1200 Pennsylvania Ave., N. W.

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/ https://www.grants.gov/ mailto:OMS-ARM-OGDWaivers@epa.gov mailto:OMS-ARM-OGDWaivers@epa.gov

Mail Code: 3903R Washington, DC 20460

Courier Address:

OGD Waivers c/o Jessica Durand Ronald Reagan Building 1300 Pennsylvania Ave., N.W.

Rm # 51278 Washington, DC 20004

In the request, the applicant must include the following information:

Funding Opportunity Number (FON) Organization Name and Unique Entity Identifier (e.g., DUNS) Organization’s Contact Information (email address and phone number) Explanation of how they lack the technical capability to apply electronically through Grants.gov because of: 1) limited internet access or 2) no internet access which prevents them from being able to upload the required application materials through Grants.gov.

EPA will only consider alternate submission exception requests based on the two reasons stated above and will timely respond to the request -- all other requests will be denied. If an alternate submission method is approved, the applicant will receive documentation of this approval and further instructions on how to apply under this announcement.