NP Coronavirus RFA OCT 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

NATIONAL PRIORITIES: INNOVATIVE SAMPLING

DESIGNS FOR PUBLIC HEALTH SURVEILLANCE OF

CORONAVIRUSES AND OTHER PATHOGENS IN

WASTEWATER

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2022-ORD-B1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.511

Solicitation Opening Date: October 20, 2021 Solicitation Closing Date: December 15, 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 F. Special Requirements

II. AWARD INFORMATION

III. ELIGIBILITY INFORMATION

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

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

For Updates and Additional Information (https://www.epa.gov/research-grants/research-funding-opportunities) Access Standard 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 COVID-19 pandemic has highlighted the need for effective tools to monitor the emergence and spread of infectious diseases. The U.S. Environmental Protection Agency (EPA) is seeking applications proposing innovative research to inform effective wastewater sampling network designs which allow for early detection and can provide evidence of spread of infection from national to local levels in a form that can be readily used by public health agencies nationwide to address current and future epidemics/pandemics. Wastewater sampling has been widely deployed during the pandemic as a cost-effective, screening-level approach to assess infection levels in the community. In addition to improved analytical detection methods and understanding of pathogen fate and transport in sewer systems, advancing wastewater-based monitoring will require well-designed sampling networks and public health data integration approaches.

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 https://www.epa.gov/research-grants/research-funding-opportunities https://www.epa.gov/research-grants/research-funding-opportunities 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

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

Award Information:

Anticipated Type of Award: Grant Estimated Number of Awards: 1 Anticipated Funding Amount: Approximately $1,000,000 total in federal funds Potential Federal Funding per Award: Up to a total of $1,000,000 in federal funds, including direct and indirect costs, with a maximum duration of 3 years. Each applicant must contribute a minimum 25% non-federal cost share/match of the federal funds awarded which may include in-kind contributions (see Section III.B. for more details).

Cost-sharing is required. Applications with budgets including a federal contribution exceeding the total maximum federal award limit will not be considered. Each applicant must contribute a minimum non-federal cost share/match of 25% of the federal funds awarded. This is equivalent at a minimum to 20% of the total project costs. Cost share may include in-kind contributions. In order to be eligible for funding consideration, applicants must demonstrate in their applications how they will meet the required minimum 25% cost share/match in accordance with 2 CFR §200.306. The minimum 25% non-federal cost share/match, equal to a minimum of $250,000 (assuming the applicant requests $1,000,000 in EPA funds) must be included. Including matching, total project costs can exceed $1,250,000 (if the applicant proposes more than the minimum required non-federal cost share/match), however the federally funded portion of the budget must not exceed $1,000,000.

Eligibility Information:

Public and private nonprofit institutions and public and private universities and colleges located in the United States and its territories or possessions are eligible. Foreign entities, States, the District of Columbia, State and local government departments, territories, possessions, and Federally Recognized Indian Tribal Governments of the U.S., are not eligible to apply under this Request for Applications (RFA). Profit-making firms and individuals are not eligible to receive assistance agreements from the EPA under this program. See full announcement for more details.

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

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 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: Rich Callan; phone: 202-564-4191; email: callan.richard@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 The COVID-19 pandemic has created the need for public health agencies to understand where the disease is spreading to quickly identify hotspots and communities at risk. As the pandemic proceeded, it became apparent that sampling municipal wastewater can be a viable method to detect and measure the spread of the SARS-CoV-2 virus (the virus that causes COVID-19), with the virus in some situations being detected more than a week prior to confirmed cases within a community (e.g., Randazzo et al., 2020). This provides a promising pathway for communities to detect the presence and spread of the virus. While a lack of detection of viral RNA cannot be used to rule out the presence of infections in a community, the presence of the virus in wastewater can be an important leading indicator when monitoring higher-risk communities with no known cases (CDC 2021a). The demonstrated ability to detect viral RNA highlights the need for a scientifically supported and optimized wastewater sampling network design to rapidly respond to future events. Given the current pandemic, it is also important to recognize lessons learned and apply them to responses to future epidemics/pandemics. This National Priorities Request for Applications (RFA) solicits innovative research that advances understanding of how wastewater monitoring data can be rapidly and effectively deployed in a sampling network 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 mailto:callan.richard@epa.gov mailto:josephson.ron@epa.gov mailto:jones.debram@epa.gov design by public health agencies across the U.S. to address current and future epidemics/pandemics.

The Office of Research and Development’s (ORD) Consolidated Research/Training/Fellowships program supports research and development to: (1) determine the environmental effects of air quality, drinking water, water quality, hazardous waste, toxic substances, and pesticides; (2) identify, develop, and demonstrate effective pollution control techniques; (3) perform risk assessments to characterize the potential adverse health effects of human exposures to environmental hazards; and (4) facilitate training and program participant support in these areas.

Awards made under this program further EPA’s priorities supporting robust science for air quality, safe and sustainable water resources, sustainable and healthy communities, chemical safety, and human health risk assessment. The national priorities competition under this program supports high-priority water quality and availability research.

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 COVID-19 and Wastewater Monitoring The COVID-19 global pandemic has made clear the need for public health infrastructure that is resilient, comprehensive and capable of rapid response. Because of the time, costs, and inequities of widespread clinical testing, there is an urgent need for alternative ways to collect and utilize 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://sites.ed.gov/hispanic-initiative/hispanic-serving-institutions-hsis/ 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 data related to cases and transmissibility. As early as March 2020, researchers began detecting SARS-CoV-2 in wastewater and suggested the potential for wastewater-based monitoring to provide community-scale information and facilitate public health decisions (Medema et al., 2020, Daughton 2020, Randazzo et al., 2020, Wu et al., 2020). This was made possible by the fact that SARS-CoV-2, the virus that causes COVID-19, is shed in the feces of at least some infected individuals (Jones et al., 2020). Furthermore, viral RNA appears to be sufficiently stable in wastewater for detection in sewersheds of various scales and residence times, and a number of studies nationwide and worldwide have taken advantage of this to sample and quantify its presence over time (e.g., Collivignarelli et al., 2020; Medema et al., 2020; Wu et al., 2020;

Randazzo et al., 2020; Wurtzer et al., 2020). Beyond PCR-based quantification, sequencing is now being used to detect mutations associated with variants of concern (Crits-Christoph et al., 2021, Nemudryi et al., 2020). Sequencing-based surveillance has a different set of considerations and limitations, including a possibly higher threshold for detection.

Wastewater monitoring has been leveraged into successful public health surveillance and decisions in the past. For example, detection of poliovirus in wastewater has been used to track and prevent resurgences of polioviruses (e.g., Nakamura et al. 2015). These experiences have also led to recommendations about effective communication and community response once outbreaks have been identified (Kaliner et al., 2014) and models of how surveillance networks can better represent populations sampled (Wang et al., 2020). The World Health Organization has published guidelines for sampling, processing, reporting, and interpreting environmental surveillance data (WHO 2003). During the COVID-19 pandemic, some universities have implemented wastewater testing of individual dormitories as a means of identifying infected students rather than testing each individual (Betancourt et al., 2020; Gibas et al., 2020). These programs have been successful in identifying dormitories where asymptomatic but infected individuals, who were not identified by the individual testing program, were present, allowing the universities to direct resources and implement quarantines.

On a broader geographic and population scale, public utilities have partnered with public health departments in a number of localities. For example, U.S. EPA Office of Research and Development researchers in Cincinnati, Ohio have participated in a statewide Ohio wastewater monitoring network, where concentrations of the N2 gene are quantified from 64 sites on a twice weekly basis and reported to the state health department. Local health districts are contacted when sustained (i.e., 2-3 days) 10-fold increases are observed, and are provided information on how to interpret the data (see https://coronavirus.ohio.gov/wps/portal/gov/covid-19/healthcare-providers-and-local-health-district/for-local-health-districts-and-governments.) Notifications have occurred over 100 times to date, providing local communities with data to inform local public health decisions and access to additional state testing services. More broadly, an online dashboard has been developed displaying sites across the globe that are involved in wastewater-based monitoring for SARS-CoV-2 (COVID-19 WBE Collaborative 2020). Also, the U.S.

Department of Health and Human Services (HHS) plans to fund wastewater assessment at up to 340 sewage treatment plants to cover about 30% of the U.S. population in at least 42 states as a proof-of-concept for sewage disease surveillance. The data generated is to be submitted to the National Wastewater Surveillance System (NWSS) and the results provided to state and local public health agencies to support the COVID-19 response.

https://coronavirus.ohio.gov/wps/portal/gov/covid-19/healthcare-providers-and-local-health-district/for-local-health-districts-and-governments https://coronavirus.ohio.gov/wps/portal/gov/covid-19/healthcare-providers-and-local-health-district/for-local-health-districts-and-governments

Developing Wastewater Sampling Networks A critical feature of successful monitoring systems is their ability to provide practical information for public health response. This includes all elements of the study design process, from sample site and methods selection through data interpretation, reporting, and use.

Important considerations include the objective(s) of monitoring (e.g., sentinel detection and/or tracking of prevalence/incidence); the type of data to be utilized by the end user for decision making (e.g., new detections in communities, quantitative concentrations/loads, trend analyses, absolute prevalence/incidence estimates); and practical limitations of cost and required timeliness. These constraints will guide selection of appropriate sampling scales (e.g., building, neighborhood, or municipal treatment plant level); number and location of chosen sites; and required meta-information for interpretation of results (e.g., characteristics of the sewer network and contributing population) (Medema et al. 2020; Zhu et al 2021). Since modeling (statistical or process-based) is generally required to translate wastewater concentrations to informative public health metrics (e.g., prevalence/incidence rates), model applicability and input requirements should be considered during study design. Likewise, communication and data sharing structures must be developed in advance to ensure effective implementation when response is needed.

An appropriately designed sampling network should be rapidly deployable and include a large population and high-risk and vulnerable populations. Key to the design of an effective sampling network is inclusion of locations where rapid spread is more likely. For example, some of the largest outbreaks in the country have occurred in sectors like meat production, where many workers are confined to high-density factory lines or other settings (Steinberg et al., 2020).

Outbreaks and spread associated with these types of workplaces are strongly linked with racial inequities, reduced access to healthcare, and inability to telework. For example, a study of manufacturing, wholesale trade, and construction-associated workplace outbreaks in Utah found that 73% of COVID-19 cases were in Hispanic or non-white individuals, despite this group comprising only 24% of the workforce (Bui et al, 2020). Because of a history of fostering outbreaks that can subsequently impact local communities (Steinberg et al., 2020), these types of workplaces would be strong candidates for “sentinel sites,” and sentinel surveillance can provide a feasible means of early detection of a disease outbreak (e.g., Bushman et al. 2020, Zwald et al., 2020).

It has been demonstrated that racial and socioeconomic inequities have contributed to worse health outcomes for minority and low-income communities throughout the course of the pandemic. Large-scale analyses have found that Native Hawaiian/Pacific Islander, American Indian/Alaska Native, Hispanic/Latino, and Black COVID-19 death rates through March 2021 are disproportionately high relative to the White and Asian population (Simmons et al., 2021).

Also factors beyond socioeconomic status (SES) appear to contribute to COVID-19 disparities (CDC 2021c). Wastewater-based surveillance cannot substitute for the need for better distribution of clinical testing and health care to vulnerable populations, but may allow for some level of monitoring where resources are scarce. Given the disproportionately high number of minority and low-income communities impacted, it is important for wastewater-based public health networks and/or models to incorporate racial and socioeconomic geographical data into the design, data interpretation, and application to better evaluate the impact on these communities.

Communication structures should consider underserved communities as part of the broader public health framework. For purposes of this solicitation and the evaluation of applications, “underserved communities” refers to populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life, including people/communities of color, low-income, tribal and indigenous populations, and other vulnerable populations such as the elderly, children and those who have pre-existing medical conditions.

At the time of this solicitation, SARS-CoV-2 infections and transmission events remain widespread in the United States. As vaccination campaigns and other mitigation efforts continue to improve these conditions, wastewater surveillance may remain useful for monitoring progress and resurgences, such as due to variants which are not as readily addressed by current vaccines.

However, it is essential that these systems are designed prospectively such that they are rapidly implementable in the event of future epidemic/pandemic pathogen threats for which fecal shedding is reported. Likewise, they may be used to track other relevant public health concerns such as antimicrobial resistance (Hendriksen et al. 2019). To realize these abilities and effectively respond to future monitoring needs, work is needed to develop infrastructure, including sample site network designs and communication/data translation approaches. This requires coordination among wastewater utilities, laboratories, and public health agencies responsible for actionable response.

This solicitation seeks to provide funding for innovative research that explores how a wastewater monitoring network can be rapidly and effectively deployed to address current and future pandemics. In further developing a wastewater-based public health network, agencies across the federal government are partnering to support a coordinated federal effort to assist state, tribal, local, and territorial communities to implement wastewater-based COVID-19 disease surveillance, see https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/wastewater-surveillance/federal-coordination-partnering-wastewater-surveillance.html. The National Institutes of Health (NIH), the National Science Foundation (NSF) and the Centers for Disease Control and Prevention (CDC) have funded a number of projects in this research area and applicants are strongly encouraged to leverage existing research resources whenever possible, including existing datasets from coronavirus research and results from national wastewater surveys for COVID-19.

Data Quality and Quality Assurance The rapid onset and extent of the COVID-19 pandemic has underscored the importance of having quality data, analyses, and forecasting models describing the potential trajectory of COVID-19. In attempts to collect timely data concerning population infection/mortality rates, existing models have been inundated with data collected by multiple jurisdictions using varying analytical methodologies. These unproven data collection strategies limit the ability to accurately compare findings between sampling locations and timepoints. The effect of data quality and collection strategies on the accuracy and precision of forecasting models, have recently been summarized in a General Accounting Office (GAO) report (GAO 2020). Therefore, it is important to highlight some important quality assurance/quality control practices that will mitigate this effect by ensuring that the best available practices for data collection, data quality criteria evaluation and analysis are being https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/wastewater-surveillance/federal-coordination-partnering-wastewater-surveillance.html https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/wastewater-surveillance/federal-coordination-partnering-wastewater-surveillance.html utilized, and these practices should be documented in progress reports.

This proposal seeks research to inform wastewater monitoring sampling designs rather than standardization of methods. However, evaluation of proposed designs using existing data collected during the pandemic is strongly encouraged. This evaluation should include the following considerations:

1) use of established data collection methods while acknowledging limitations of data reported,

2) use of standardized approaches for analyzing COVID-19 data, and

3) understanding and reporting limitations of forecast models for COVID-19 using wastewater surveillance, including factors affecting SARS-CoV-2 in wastewater independent of infection rates (e.g., stormwater inflows in combined sewers, extended residence time and greater decay, industrial inputs caused by dilution, decay, and inhibition)

In performance of these tasks, it is strongly recommended that the literature reviews and the subsequent meta-analyses data adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, specifically the items identified in the “Methods” section of the PRISMA 2020 checklist (Page et al., 2021).

Furthermore, when examining individual studies and datasets for purposes of evaluating proposed sampling designs, it is recommended that the National Wastewater Surveillance System guidelines for wastewater surveillance testing methods, developed by the Centers for Disease Control and Prevention (CDC) (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/wastewater-surveillance.html) and the U.S. Department of Health and Human Services (HHS), in collaboration with agencies throughout the federal government, are followed (CDC 2021b). Some examples of these data quality control checks should include the following:

1) establishment of method efficacy through use of matrix recovery control,

2) human fecal normalization,

3) quantitative measurement controls,

4) assay inhibition assessment, and

5) negative controls.

These laboratory controls are especially important to document when comparing SARS-CoV-2 wastewater concentrations generated using different methods.

C. Authority and Regulations The authorities for this RFA and resulting awards are contained in the Safe Drinking Water Act, 42 U.S.C. 300j-1, Section 1442, the Clean Water Act, 33 U.S.C. 1254, Section 104(b)(3), and the Consolidated Appropriations Act, 2021, Public Law 116–260.

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

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/wastewater-surveillance.html https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/wastewater-surveillance.html

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 1: A Cleaner, Healthier Environment, Objective 1.2: Provide for Clean and Safe Water, of EPA’s FY 2018-22 Strategic Plan. All applications must be for projects that support the goal and objective identified above. The award made under this announcement will advance the goals of the Consolidated Research/Training/Fellowships program by furthering EPA’s priorities supporting robust science for safe and sustainable water resources and promoting high-priority water quality and availability research. The Agency is seeking applications proposing innovative research to inform effective water sampling network designs which allow for early detection and can provide evidence of spread of infection from national to local levels in a form that can be readily used by public health agencies nationwide to address current and future epidemics/pandemics.

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.

The proposed research should be national in scope and should also focus on water quality (by looking at the impact pathogen contamination in wastewater has on identifying areas of concern); and water availability (measuring the extent to which wastewater is contaminated with biopathogens can improve drinking water availability to the public). Applications are most responsive to this RFA if they are national in scope. Applications that are national in scope may be rated more highly than those that are not.

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According to the CDC (CDC 2021a), development of a wastewater surveillance sampling monitoring strategy should include:

1) an assessment of public health data needs, such as detecting the presence of the pathogen and monitoring trends, including reported and unreported cases;

2) evaluating wastewater sampling and testing capacity; and

3) developing a sampling plan, including what and where to sample and how often to take samples.

This RFA is soliciting innovative research to inform the design of an optimal wastewater sampling plan, which could lead to development of effective wastewater sampling networks.

The proposed research could develop guidelines for design and implementation of wastewater sampling networks for public health surveillance that could assist communities, including state and local public health officials, to monitor for potential pathogens of concern. This may include wastewater from municipal treatment plants, sewer network locations representing targeted communities, or individual buildings/facilities (e.g., “sentinel sites” such as transit hubs, or high-risk settings such as workplaces, nursing homes and hospitals). The design should include a mechanism to make a rapid determination to activate wastewater monitoring, such as considering whether biomarkers of the virus/pathogen are shed in feces and can be found at sufficient levels in wastewater and address how the microbiology of the pathogen could affect the design.

Determination of sample site number, sampling frequency, and sample type (e.g., grab or composite) should be considered, as should planned analytical and modeling methods.

The proposed research should focus on new approaches and the type of data to be generated, and the translation of this data to inform public health response. Methods for network design, sampling, analysis, modeling, and communication should be driven by the desired end use of data. These uses may change with collection scale or phase of the epi/pandemic or based on pathogen properties and infection dynamics. The proposed research should focus on developing a thorough and representative sampling strategy to make the best use of data collected as part of a wastewater monitoring program. The monitoring strategy should be rapidly deployable and able to account for the contributing population. The research should include an approach for how the data could be used for actionable public health applications and how a sampling plan would interface with potential decision-makers. The research should include a real-world evaluation of the wastewater monitoring strategy and sampling network design.

Research Areas

The proposed research project should address all three research areas described below.

Applications that do not address all three research areas may not be rated as highly as those that

do. Research questions are listed under each research area for applicants to consider in shaping their research project. Applicants are not required to respond to all of the questions or limit the research scope to these questions. Utilization of existing data and best practices from the SARS- CoV-2 pandemic to evaluate proposed sampling designs is strongly encouraged.

Research Area 1: Develop appropriate survey design(s)/sampling strategies to optimize wastewater monitoring networks for detection and monitoring of emerging nationwide threats (i.e., the next epidemic/pandemic).

• How can sewershed-level monitoring networks and strategic sampling approaches be designed to be most effective as part of an early warning system for emerging threats?

• How can an effective sampling plan be designed to include frameworks for strategic placement of early warning sites?

• Is a probabilistic survey design suitable for representing a specific percentage (e.g., 10%, 25%) of the U.S. population? Is a targeted survey design focused on potential hotspot locations such as international hubs or tourist centers more appropriate? Is there a blend of probabilistic and targeted survey designs that should be used for monitoring emerging threats?

• What would be the most effective wastewater monitoring strategy at different spatial scales (e.g., national, regional, local, sewershed, sub-sewershed, congregate facilities/shared housing, facilities, buildings)?

• How do analytical methods that can provide screening for potentially dangerous or emerging pathogens, such as broader metagenomic sequencing, analytes and markers, and bioinformatics and machine learning, affect the sampling design?

• What is the most appropriate wastewater monitoring sampling design that can be rapidly employed as an epidemic begins and progresses and what factors would affect the effectiveness of the program during the course of the epidemic?

Research Area 2: Develop a framework for adapting the wastewater monitoring strategies based on characteristics of the pathogen, its infection, transmission processes, and target population(s).

• How do the characteristics of the pathogen and its transmission affect the overall sampling design for a pathogen monitoring program for wastewater?

• How does the nature of the pathogen affect the selection of “sentinel sites” to aid in the detection of emerging threats? Sentinel sites may target ports of entry or initial infections, workplaces, or other environments with high transmission potential, and/or vulnerable populations such as underserved communities, including children and older adults.

• What are the characteristics of hotspots (e.g., at-risk communities) and how can this be used to develop a strategy for early detection of a pathogen in wastewater?

• How can population demographics be used to inform a sampling design and wastewater monitoring program to effectively identify populations that are more likely to be affected by outbreaks that lead to more wide-scale transmission (e.g., the CDC’s Social Vulnerability Index)?

• How would a sampling design address concerns related to underserved communities, including observed racial and ethnic disparities among COVID-19 cases and spread?

How could a sampling network strategy enable decision makers to avoid possible disproportionate impact/burden on underserved communities? For more information on areas of environmental justice (EJ) concern, see EPA EJSCREEN (https://www.epa.gov/ejscreen)1.

• How can data from and lessons learned from the COVID-19 pandemic be used to understand what is needed for future epi/pandemics?

Research Area 3: Develop a strategy to provide actionable wastewater monitoring information to public health officials and utilities to inform efforts to control an epidemic/pandemic.

• How can a wastewater monitoring plan be designed to provide practical approaches and actionable data to public health officials that would inform efforts to control an epidemic? This should include a plan to enhance acceptance and utilization of the information by public health officials and communities.

• How do the objectives of the sampling program affect the design of the program (e.g., university campus vs. community-level monitoring)?

• How can wastewater pathogen measurements be related to community disease prevalence estimates? What models and methods could be used to facilitate this?

• How can populations that rely on septic systems be monitored during epidemics?

Proposed communication structures should consider interactions with public health officials at the national, state, and local level and the existing or potential role of community organizations that work with underserved communities as part of the broader public health framework.

In addition, the research should include a real-world evaluation of the feasibility, implementability and effectiveness of the wastewater monitoring strategy and sampling network design. The evaluation should include at least several communities in different geographical areas, including underserved communities with limited resources, to understand how the strategy could be applied.

Expected Outputs and Outcomes Outputs expected may include demonstrations and analyses of sampling strategies, modeling tools and analyses, peer-reviewed journal articles, workshops and webinars, databases, and communication materials. This may include documents and tools that translate scientific results into easily understandable outreach and education materials for wastewater professionals, public health agencies, and the public. Expected outputs should also include results of the real-world evaluation described above and methods for deploying and maintaining a wastewater monitoring plan and recommended sampling strategies, including in underserved communities. It is expected that outputs will be translational in nature, i.e., applicable to real-world wastewater surveillance systems and their integration with public health decision making.

1 Environmental Justice Web-based Screening Tool – Applicants are encouraged, as appropriate, to include data from EPA’s EJSCREEN tool (or other EJ-focused geospatial mapping tools) as part of their application to help characterize and describe the affected communities/populations and areas and address the environmental justice criterion in Section V. Data from other sources (e.g. studies, census, and third-party reports) should also be included to give a more complete picture of the impacted communities and populations. Instructions, resources, and tutorials on how to use EJSCREEN are included at the hyperlink above.

https://www.epa.gov/ejscreen

The expected outcomes are improvements in science-based approaches for the implementation of wastewater surveillance systems for detection of pathogens in community populations. Such approaches should specifically address the interface of these systems with public health decision making, providing practical structures for the effective use of wastewater surveillance data in infectious disease control. This will facilitate further advancement of wastewater-based pathogen monitoring for public health applications and support the real-world implementation of these systems.

Environmental Justice To the maximum extent practicable, applicants should demonstrate in their application how they will advance environmental justice for underserved communities, as defined in Section I.B. of this solicitation and below. Environmental justice (EJ) is the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation and enforcement of environmental laws, regulations and policies.

Fair treatment means no group of people should bear a disproportionate share of the negative environmental consequences resulting from industrial, governmental and commercial operations or policies. Meaningful involvement means people have an opportunity to participate in decisions about activities that may affect their environment and/or health; the public's contribution can influence the regulatory agency's decision; community concerns will be considered in the decision-making process; and decision makers will seek out and facilitate the involvement of those potentially affected. For purposes of this solicitation and the evaluation of applications, “underserved communities” refers to populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life, including people/communities of color, low-income, tribal and indigenous populations, and other vulnerable populations such as the elderly, children and those who have pre-existing medical conditions.

Underserved communities are often affected by disproportionate impacts. Disproportionate and adverse environmental, human health, climate-related and other cumulative impacts, as well the accompanying economic challenges of such impacts, may result when greater pollution burdens and/or consequences, and the impact of them, are more likely to affect or have affected the underserved communities described in this solicitation. The impacts may result from various factors including but not limited to being a function of historical trends and policy decisions.

Factors that may indicate disproportionate and adverse impacts as referenced above include:

differential proximity and exposure to adverse environmental hazards; greater susceptibility to adverse effects from environmental hazards (due to causes such as age, chronic medical conditions, lack of health care access, or limited access to quality nutrition); unique environmental exposures because of practices linked to cultural background or socioeconomic status (for example, subsistence fishing or farming); cumulative effects from multiple stressors;

reduced ability to effectively participate in decision-making processes (due to causes such as lack of or ineffective language access programs, lack of programs to make processes accessible to persons with disabilities, inability to access traditional communication channels, or limited capacity to access technical and legal resources); and degraded physical infrastructure, such as poor housing, poorly maintained public buildings (e.g., schools), or lack of access to transportation.

In addressing the research areas described above in applications, applicants should demonstrate how their project will address the disproportionate and adverse human health, environmental, climate-related and other cumulative impacts, as well as the accompanying economic challenges of such impacts, resulting from industrial, governmental, commercial and/or other actions that have affected and/or currently affect the underserved communities. Applicants should also demonstrate how the project benefits the underserved communities including those that have experienced a lack of resources or other impediments to addressing the impacts identified above that affect their community and how the project addresses engagement with these communities, especially local residents in these communities who will be affected by the project, to ensure their meaningful participation with respect to the design, project planning, and performance of the project.

Innovation To the maximum 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. Betancourt, W. Q., Schmitz, B. W., Innes, G. K., Prasek, S. M., Brown, K. M. P., Stark, E. R., Foster, A. R., Sprissler R. S., Harris D. T., Sherchan S. P, Gerba C. P., & Pepper, I. L. (2021).

COVID-19 containment on a college campus via wastewater-based epidemiology, targeted clinical testing and an intervention. Science of the Total Environment, 146408.

https://doi.org/10.1016/j.scitotenv.2021.146408

2. Bui, D. P., McCaffrey, K., Friedrichs, M., LaCross, N., Lewis, N. M., Sage, K., Barbeau, B., Vilven, D., Rose, C., Braby, S., Willardson, S., Carter, A., Smoot, C., Winquist, A., & Dunn, A.

(2020). Racial and Ethnic Disparities Among COVID-19 Cases in Workplace Outbreaks by Industry Sector - Utah, March 6-June 5, 2020. MMWR. Morbidity and mortality weekly report, 69(33), 1133–1138. https://doi.org/10.15585/mmwr

3. Bushman, D., Alroy, K. A., Greene, S. K., Keating, P., Wahnich, A., Weiss, D., Pathela, P., Harrison, C., Rakeman, J., Langley, G., Tong, S., Tao, Y., Uehara, A., Queen, K., Paden, C. R., Szymczak, W., Orner, E. P., Nori, P., Lai, P. A., Jacobson, J. L., … Sell, J. (2020). Detection and Genetic Characterization of Community-Based SARS-CoV-2 Infections - New York City, March 2020. MMWR. Morbidity and mortality weekly report, 69(28), 918–922.

https://doi.org/10.15585/mmwr.mm6928a5

4. Centers for Disease Control and Prevention (CDC 2021a). National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. Accessed March 10, 2021.

Developing a Wastewater Surveillance Sampling Strategy. Available at:

https://doi.org/10.1016/j.scitotenv.2021.146408 https://doi.org/10.15585/mmwr https://doi.org/10.15585/mmwr.mm6928a5 https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/wastewater-surveillance/developing-a-wastewater-surveillance-sampling-strategy.html

5. Centers for Disease Control and Prevention (CDC 2021b). National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. Accessed March 10, 2021.

National Wastewater Surveillance System (NWSS). Available at:

www.cdc.gov/coronavirus/2019-ncov/cases-updates/wastewater-surveillance.html

6. Centers for Disease Control and Prevention (CDC 2021c). National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral…