U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Science to Achieve Results (STAR) Program

CLOSED - FOR REFERENCES PURPOSES ONLY

Development and Evaluation of Innovative Approaches for the Quantitative Assessment of Pathogens and Cyanobacteria and Their Toxins in Drinking Water

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2007-STAR-G1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: March 15, 2007
Solicitation Closing Date: July 10, 2007, 4:00 pm Eastern Time

Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Thomas O'Farrell (o'farrell.thomas@epa.gov), PhD; phone: 202-343-9639
Technical Contact: Angela Page (page.angelad@epa.gov), MPH; phone: 202-343-9826

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
C. Other
IV. APPLICATION AND SUBMISSION INFORMATION
A. Internet Address to Request Application Package
B. Content and Form of Application Submission
C. Submission Dates and Times
D. Funding Restrictions
E. Submission Instructions and Other Submission Requirements
V. APPLICATION REVIEW INFORMATION
A. Peer Review
B. Programmatic Review
C. Funding Decisions
VI. AWARD ADMINISTRATION INFORMATION
A. Award Notices
B. Disputes
C. Administrative and National Policy Requirements
VII. AGENCY CONTACTS

Access Standard STAR Forms and Instructions
Research awarded under previous solicitations

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 development and evaluation of innovative approaches to quantitatively detect pathogens or toxigenic cyanobacteria or the identified high priority cyanotoxins: microcystins, anatoxin-a, and cylindrospermopsins, in drinking water. The purpose of this request for applications is to improve the suite of available detection methods for known and emerging microbial drinking water contaminants including freshwater algae or its toxins. Any proposed method should be applicable to source water, treated water, and/or water in the distribution system.

EPA is seeking research proposals that:

  • determine the occurrence of waterborne pathogens, cyanobacteria or high priority cyanotoxins (microcystins, anatoxin-a, and cylindrospermopsins) and enumerate them;
  • present a protocol for preparing and processing water samples for application of the proposed approach; and
  • for those pathogens where it is possible, compare the performance of the new detection method with existing approved EPA methods.

The goal of this Request For Applications (RFA) is the development and evaluation of innovative approaches to quantitatively detect pathogens or toxigenic cyanobacteria or identified cyanotoxins in drinking water.

Award Information:
Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately 6 awards
Anticipated Funding Amount: Approximately $3.6 million total for all awards
Potential Funding per Grant: Up to a total of $600,000, including direct and indirect costs, with a maximum duration of 3 years. Cost-sharing is not required. Proposals with budgets exceeding the total award limits will not be considered.

Eligibility Information:
Public nonprofit institutions/organizations (includes public institutions of higher education and hospitals) and private nonprofit institutions/organizations (includes private institutions of higher education and hospitals) located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. See Section III in the full announcement for more details.

Application Materials:
You may submit either a paper application or an electronic application (but not both) for this announcement. The necessary forms for submitting a STAR application will be found on the National Center for Environmental Research (NCER) web site, https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms. To apply electronically, you must use the application package available at Grants.gov (see "Submission Instructions for Electronic Applications" in Section IV). If your organization is not currently registered with Grants.gov, you need to allow approximately one week to complete the registration process to apply electronically. This registration, and electronic submission of your application, must be performed by an authorized representative of your organization.

Agency Contacts:
Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Thomas O'Farrell (o'farrell.thomas@epa.gov), PhD; phone: 202-343-9639
Technical Contact: Angela Page (page.angelad@epa.gov), MPH; phone: 202-343-9826

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction
Drinking water research is one of the high-priority research areas being addressed by EPA’s Office of Research and Development (ORD). Under the 1996 Amendments to the Safe Drinking Water Act (SDWA), the responsibility for ensuring that public water systems provide safe drinking water is shared among EPA, states, tribal nations, and water systems. Threats to drinking water safety may come from chemical and microbial contaminants, including algae and the toxins they produce. Research is needed to continue to reduce the public health risks from contaminants in public water systems in the United States.

ORD is in the process of revising their Multi-Year Plan for Drinking Water Research which will be publicly available, once completed, at https://www.epa.gov/osp/myp.htm. The Multi-Year Plan will identify drinking water-related research to be conducted by ORD through 2014. The research described will be undertaken by EPA’s intramural program, composed of three national laboratories, and by ORD’s extramural research arm through the Science to Achieve Results (STAR) grants program. EPA currently supports a number of drinking water-related research grants resulting from previous solicitations. Details of these efforts can be found on ORD’s National Center for Environmental Research (NCER) homepage.

B. Background
A major requirement of the 1996 SDWA Amendments [section 1412(b)(1)] requires EPA to publish, every five years, a list of unregulated contaminants known or anticipated to occur in drinking water that may pose a public health risk. This list has subsequently become known as the Contaminant Candidate List (CCL). The first CCL was published in March 1998 [63 Fed. Reg. 10274 (March 2, 1998)] and consisted of 50 chemicals and 10 microbial contaminants/contaminant groups. The second CCL (CCL 2), issued in the Federal Register in February 2005 [70 Fed. Reg. 9071 (February 24, 2005)], repeated the first CCL less the nine contaminants (8 chemicals and 1 microorganism) for which EPA made the determination not to regulate [68 Fed. Reg. 42897 (July 18, 2003)]. There are nine microbial contaminants remaining on the CCL 2 list (Table 1), eight pathogens, and freshwater algae and their toxins.

Table 1: Microbial contaminants on the CCL 2 List.

Adenoviruses
Aeromonas hydrophila
Caliciviruses
Coxsackieviruses
Cyanobacteria (blue-green algae), other freshwater algae, and their toxins
Echoviruses
Helicobacter pylori
Microsporidia (Enterocytozoon and Septata)
Mycobacterium avium intracellulare (MAC)

After publication of CCL 1 in 1998, the Agency recognized the need for a more robust and transparent process for identifying and narrowing the list of potential contaminants for future CCLs and sought advice on how to improve the CCL process from the National Academy of Science (NAS) and the National Drinking Water Advisory Council (NDWAC). The NAS report (NAS, 2001) proposed a broader, more comprehensive, three-step screening process to assist EPA in identifying contaminants on the CCL. The NDWAC supported this approach in the NDWAC report on the CCL classification process (NDWAC (PDF) (188 pp, 651 K), 2004). Based on these recommendations, EPA is currently developing and testing a new, quantitative CCL process for selecting microbial and chemical candidate contaminants. The CCL 3 and other future CCLs will be developed using this approach. EPA anticipates publishing the CCL 3 proposal in late 2007 and the final rule in August 2009.

Pathogens in drinking water are a concern because they are associated with waterborne disease and illness. In the U.S., both the incidence of waterborne disease and the causative agent for a disease outbreak are often uncertain. An analysis of outbreak data from 1991-98 revealed that for 41% of the disease outbreaks, an infectious etiological agent was suspected, but the cause remained undetermined (Craun et al. 2002). Direct culturing, the conventional detection approach frequently considered the “gold standard”, can take several weeks to accurately identify the causative agent of a waterborne illness and has been found to underestimate the densities and diversity of microorganisms in all types of water samples (Amann et al., 1995; Szewzyk et al., 2000). An additional consideration when evaluating microorganisms in drinking water is the need to determine their viability and infectivity (Ford, 1999).

Cyanotoxins are naturally occurring chemicals produced by various genera of freshwater cyanobacteria. Ingestion of surface waters containing high concentrations of toxic cyanobacteria or their toxins may pose adverse health effects. Some cyanotoxins are hepatotoxins, some neurotoxins and still others are thought to produce toxic alkaloids that cause gastrointestinal symptoms or kidney disease in humans. Even among toxin producing species, not all cyanobacteria form toxins so the presence of the viable algae is not an adequate indication of impaired water quality. However, cyanobacterial blooms often contain a mixture of toxins. To date, no approved detection and quantification methods exist for cyanotoxins other than a commercially available Enzyme-Linked ImmunoSorbent Assay (ELISA) method for microcystins. Recently, draft reviews of the toxicity of the high priority cyanotoxins were prepared by EPA’s National Center for Environmental Assessment (U.S. EPA, 2006).

Over the last decade, numerous molecular and genetic-based technologies have been developed and applied to detection of pathogens. These include flow cytometry, magnetic separation techniques, fluorescence in-situ hybridization (FISH), quantitative Polymerase Chain Reaction (qPCR), quantitative reverse transcriptase-PCR (qRT-PCR), and microarrays. While some of these technologies can be applied to cyanobacteria and cyanotoxins, their development lags behind for cyanobacteria and cyanotoxin. The genomic sequences of many microorganisms have been identified and stored in databases around the world (e.g., The Institute for Genomic Research, www.tigr.org; the National Center for Biotechnology Information’s GenBank http://www.ncbi.nlm.nih.gov/Genbank), providing the core information necessary for development of genetic techniques. An essential aspect of many detection approaches is the ability to concentrate microorganisms or toxins in a water sample, prior to their detection by one of the above mentioned technologies. However, microfluidic devices, either alone or coupled with many of these evolving technologies, can potentially create powerful tools for sample processing and microorganism detection. In addition, the rapidly evolving field of nanotechnology may provide its own unique approaches for detecting pathogens, freshwater algae, or algal toxins.

The specific Strategic Goal and Objective from the EPA’s Strategic Plan that relate to this solicitation are: Goal 2: Clean and Safe Water, Objective 2.3: Enhance Science and Research. The EPA’s Strategic Plan can be found at: https://www.epa.gov/ocfo/plan/2006/entire_report.pdf (PDF) (184 pp, 11.56 MB)

C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1, and the Clean Water Act, Section 104, 33 U.S.C. For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102 (2)(F).

D. Specific Research Areas of Interest/Expected Outputs and Outcomes
Note to applicant: The term “output” means an environmental activity or effort, and associated work products, related to a specific environmental goal(s), (e.g., testing a new methodology), that will be produced or developed over a period of time under the agreement. The term “outcome” means the result, effect, or consequence that will occur from the above activit(ies) that is related to an environmental, behavioral, or health-related objective.

Outputs expected from the research funded under this solicitation include:

  • High throughput, sensitive technologies that reduce sample processing times and accurately identify and quantify pathogens, indicators, or toxins such as cyanotoxins occurring at low concentrations in water.
  • Development of rapid analytical approaches that discriminate viable, potentially infective pathogens from non-viable, pathogenic from non-pathogenic or toxigenic cyanobacteria from non-toxic cyanobacteria.

Desired outcomes include:

  • Provide state and local governments and water utilities an improved suite of available detection methods for assessing and managing known and emerging microbial and cyanobacterial drinking water contaminants.
  • Assist risk assessors with “real-time” data regarding the type and quantity of waterborne contaminants in the water.
  • Assist in making informed risk management decisions and/or interventions to reduce human or aquatic exposure to pathogens

The goal of this RFA is to fund projects that develop and evaluate innovative approaches to quantitatively detect pathogenic microorganisms, freshwater cyanobacteria or the identified high priority cyanotoxins: microcystins, anatoxin-a, and cylindrospermopsins. The approach should be for application in source waters for drinking water, treated waters and/or distribution system waters. Microorganisms of concern are those that pose a human health risk via drinking water contamination including, but not limited to, those currently regulated and those currently listed on the CCL. (Microorganisms for which there are National Primary Drinking Water Regulations can be found at: https://www.epa.gov/safewater/contaminants/index.html. The CCL lists are referenced in the Background section of this solicitation.) EPA encourages the use of non-CCL listed microorganisms for this RFA provided these microorganisms potentially present a public health threat in drinking water (e.g., they have caused waterborne disease), or they potentially occur, persist and move in drinking water at concentrations sufficient to cause waterborne disease.

The proposed approaches must: (1) identify and quantify waterborne pathogens or cyanobacteria or high priority cyanotoxins: microcystins, anatoxin-a, and cylindrospermopsins; (2) present a protocol for preparing and processing water samples for application of the proposed approach; and (3) for those pathogens where it is possible, compare the performance of the new detection method with existing approved EPA methods. Those pathogens for which EPA has approved detection methods can be found at: https://www.epa.gov/nerlcwww/index.html.

All proposals must:

  • describe the rationale for selecting the target waterborne pathogen(s) or cyanobacteria or identified cyanotoxin(s).
  • describe how they will evaluate the protocol for preparing and processing water samples, including but not limited to, necessary concentration steps, especially regarding the percent recovery and the precision of the protocol;
  • include testing of actual field samples (both spiked and unspiked with relevant microorganisms or cyanotoxins) following validation of the proposed approach against pure cultures (as appropriate);
  • indicate how they will measure sensitivity, specificity, and positive and negative predictive values (false positive and false negative data) of the proposed method.
  • clearly state how the robustness, feasibility, ease of use, availability, applicability, and limitations of the proposed approach will be addressed.

To the extent possible, proposals for pathogen detection should attempt to:

  1. Be “rapid” or “near real-time,” with results obtainable within minutes or hours, not days.
  2. Determine the viability and/or infectivity of the waterborne pathogens.
  3. Identify and quantify multiple waterborne pathogens.
  4. Identify and quantify pathogens occurring at low concentrations in the water.
  5. Distinguish pathogenic from non-pathogenic strains.
  6. Identify the model system to test for pathogenicity.
  7. Indicate how well proposed specific microbial gene sequences work as diagnostic tools for drinking water quality and how that will be demonstrated.

To the extent possible, proposals for cyanobacteria or cyanotoxins should attempt to:

  1. Provide rapid, field-ready tests.
  2. Identify and quantify types of cyanobacteria and/or cyanotoxin.
  3. Simultaneously identify and quantify multiple types of cyanobacteria or cyanotoxin.
  4. Detect cyanotoxin producing genes.
  5. Identify and quantify cyanobacteria or cyanotoxins occurring at low concentrations in the water.

Any proposals that include a PCR approach are requested to follow the QA/QC guidance provided by EPA document entitled Quality Assurance/Quality Control Guidance for Laboratories Performing PCR Analyses on Environmental Samples. The document can be found at: https://www.epa.gov/nerlcwww/qa_qc_pcr10_04.pdf (PDF) (64 pp, 360 K).

E. References
Amann RI, Ludwig W and Schleifer KH (1995). Phylogenetic identification and in situ detection of individual cell without cultivation. Microbiol. Rev. 59:143-169.

Craun GF, Nwauchuku N, Calderon RL, and Craun MC. (2002). Outbreaks in Drinking-Water Systems, 1991-1998. Journal of Environmental Health 65:16-23.

Ford, TE. 1999. Microbiological safety of drinking water: United States and global perspectives. Environ Health Perspect 107(Suppl 1):191-206.

National Academy of Sciences, National Research Council (2001). Classifying drinking water contaminants for regulatory consideration. National Academy Press, Washington, DC. (http://www.nap.edu/catalog/10080.html#toc

National Drinking Water Advisory Council. (2004). NDWAC Report on the CCL Classification Process to the U.S. EPA. (https://www.epa.gov/safewater/ndwac/pdfs/report_ccl_ndwac_07-06-04.pdf (188 pp, 651 K))

Szewzyk, U, Szewzyk R, Manz W, and Schleifer K-H. (2000). Microbiological safety of drinking water. Annu. Rev. Microbiol. 54: 81-127

US Environmental Protection Agency (USEPA). (1998). Announcement of the drinking water contaminant candidate list: Notice. 63 Fed. Reg. 10273 (March 2, 1998). (https://www.epa.gov/fedrgstr/EPA-WATER/1998/March/Day-02/w5313.htm).

US Environmental Protection Agency (USEPA). (2003). Announcement of Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. 68 Fed. Reg. 42897 (July 18, 2003). (https://www.epa.gov/fedrgstr/EPA-WATER/2003/July/Day-18/w18151.htm).

US Environmental Protection Agency (USEPA). (2003). Drinking Water Research Program Multi-Year Plan.

US Environmental Protection Agency (USEPA). (2004). Quality Assurance/Quality Control Guidance for Laboratories Performing PCR Analyses on Environmental Samples for any proposed PCR-based approaches. (https://www.epa.gov/nerlcwww/qa_qc_pcr10_04.pdf (64 pp, 360 K))

US Environmental Protection Agency (USEPA). (2005). Drinking Water Contaminant Candidate List 2; Final Notice. 70 Fed. Reg. 9071 (February 24,2005). https://www.epa.gov/fedrgstr/EPA-WATER/2005/February/Day-24/w3527.htm).

US Environmental Protection Agency (USEPA). (2006). Draft Toxicological Reviews of Cyanobacterial Toxins: Anatoxin-a, Cylindrospermopsin and Microcystins LR, RR, YR and LA. (https://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=161263).

F. Special Requirements
Agency policy prevents EPA technical staff and managers from providing individual applicants information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, provide technical assistance to applicants preparing applications in response to EPA RFAs, endorse an application or discuss in any manner how the Agency will apply the published evaluation criteria for this competition.

II. AWARD INFORMATION

It is anticipated that a total of approximately $3.6 million will be awarded under this announcement, depending on the availability of funds and quality of applicants received. The EPA anticipates funding approximately 6 grants under this RFA. Requests for amounts in excess of a total of $600,000, 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, consistent with Agency policy and without further competition, to make additional awards under this RFA if additional funding becomes available. Any additional selections for awards will be made no later than four months after the original selection decisions.

EPA intends to fund 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 to achieving the goals of the research under a grant. Interaction that is “incidental” does not involve resource commitments.

III. ELIGIBILITY INFORMATION

A. Eligible Applicants
Public nonprofit institutions/organizations (includes public institutions of higher education and hospitals) and private nonprofit institutions/organizations (includes private institutions of higher education and hospitals) located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. Profit-making firms are not eligible to receive assistance agreements from the EPA under this program.

Eligible nonprofit organizations include any organizations that meet the definition of nonprofit in OMB Circular A-122. However, nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.

National laboratories funded by Federal Agencies (Federally-Funded Research and Development Centers, "FFRDCs") may not apply. FFRDC employees may cooperate or collaborate with eligible applicants within the limits imposed by applicable legislation and regulations. They may participate in planning, conducting, and analyzing the research directed by the applicant, but may not direct projects on behalf of the applicant organization. The institution, organization, or governance receiving the award may provide funds through its assistance agreement from the EPA to an FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research. However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Federal Agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on an assistance agreement, and may not receive salaries or augment their Agency's appropriations in other ways through awards made under this program.

The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere. A written justification for federal involvement must be included in the application. 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 Tom Barnwell (barnwell.thomas@epa.gov) in NCER, phone (202) 343-9862.

B. Cost-Sharing
Institutional cost-sharing is not required.

C. Other
Applications must substantially comply with the application submission instructions and requirements set forth in Section IV of this announcement or they will be rejected. In addition, where a page limitation is expressed in Section IV with respect to parts of the application, pages in excess of the page limit will not be reviewed. Applications must be received by the EPA, or Grants.gov, on or before the solicitation closing date and time in Section IV of this announcement or they will be returned to the sender without further consideration. Also, applications exceeding the funding limits or project period term described herein will be returned without review. Further, applications that fail to demonstrate a public purpose of support or stimulation (e.g., by proposing research which primarily benefits a Federal program or provides a service for a Federal agency) will not be funded.

Applications must address all of the following items or they will not be considered for award:

  • describe the rationale for selecting the target waterborne pathogen(s) or cyanobacteria or identified cyanotoxin(s);
  • describe how they will evaluate the protocol for preparing and processing water samples, including but not limited to, necessary concentration steps, especially regarding the percent recovery and the precision of the protocol;
  • include testing of actual field samples (both spiked and unspiked with relevant microorganisms or cyanotoxins) following validation of the proposed approach against pure cultures (as appropriate);
  • indicate how they will measure sensitivity, specificity, and positive and negative predictive values (false positive and false negative data) of the proposed method;
  • clearly state how the robustness, feasibility, ease of use, availability, applicability, and limitations of the proposed approach will be addressed.

Proposed approaches must:

  • identify and quantify waterborne pathogens or cyanobacteria or high priority cyanotoxins: microcystins, anatoxin-a, and cylindrospermopsins;
  • present a protocol for preparing and processing water samples for application of the proposed approach;
  • for those pathogens where it is possible, compare the performance of the new detection method with existing approved EPA methods. Those pathogens for which EPA has approved detection methods can be found at: https://www.epa.gov/nerlcwww/index.html.

In addition, to be eligible for funding consideration, a project's focus must consist of activities within the statutory terms of EPA's financial assistance authorities; specifically, the statute(s) listed in I.C. 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. These activities should relate to the gathering or transferring of information or advancing the state of knowledge. Proposals should emphasize this "learning" concept, as opposed to "fixing" an environmental problem via a well-established method. Proposals relating to other topics which are sometimes included within the term "environment" such as recreation, conservation, restoration, protection of wildlife habitats, etc., must describe the relationship of these topics to the statutorily required purpose of pollution prevention and/or control.

Applications deemed ineligible for funding consideration will be notified within fifteen calendar days of the ineligibility determination.

IV. APPLICATION AND SUBMISSION INFORMATION

You may submit either a paper application or an electronic application (but not both) for this announcement. Instructions for both types of submission follow. If not otherwise marked, instructions apply to both types of submissions.

A. Internet Address to Request Application Package
For paper applications, forms and instructions can be found on the NCER web site: https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms.

For electronic applications, use the application package available at Grants.gov (see “Submission Instructions for Electronic Applications”). Note: With the exception of the Budget form (available at https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms), all necessary forms are included in the electronic application package.

For both paper and electronic applications, an email will be sent by NCER to the Principal Investigator and the Administrative Contact (see below) to acknowledge receipt of the application and transmit other important information. The email will be sent from receipt.application@epa.gov; emails to this address will not be accepted. If you do not receive an email acknowledgement within 30 days of the submission closing date, immediately inform the Eligibility Contact shown in this solicitation. Failure to do so may result in your application not being reviewed. See “Submission Instructions for Electronic Applications” for additional information regarding acknowledgement of receipt of electronically submitted applications. Please note: Due to often-lengthy delays in delivery, it is especially important that you monitor NCER’s confirmation of receipt of your application when using regular mail.

B. Content and Form of Application Submission
The application is made by submitting the materials described below. It is essential that the application contain all information requested and be submitted in the formats described.

  1. Standard Form 424

    The applicant must complete Standard Form 424. This form will be the first page(s) of the application. Instructions for completion of the SF424 are included with the form. (However, note that EPA requires that the entire requested dollar amount appear on the 424, not simply the proposed first year expenses.) The form must contain the original (or electronic) signature of an authorized representative of the applying institution.

    Applicants are required to provide a "Dun and Bradstreet Data Universal Numbering System" (DUNS) number when applying for federal grants or cooperative agreements. Organizations may receive a DUNS number by calling 1-866-705-5711 or by visiting the web site at http://www.dnb.com.

    Executive Order 12372, "Intergovernmental Review of Federal Programs," applies to most EPA programs and assistance agreements, unless the program or assistance agreement supports tribal, training/fellowships (other than Wastewater and Small Water Systems Operator training programs), and research and development (with some exceptions). The SF424 refers to this Executive Order requirement. National research programs are generally exempt from review unless the proposals (a) require an Environmental Impact Statement (EIS), or (b) do not require an EIS but will be newly initiated at a particular site and require unusual measures to limit the possibility of adverse exposure or hazard to the general public, or (c) have a unique geographic focus and are directly relevant to the governmental responsibilities of a State or local government within that geographic area. To determine whether their state participates in this process, and how to comply, applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html.

  2. Key Contacts

    The applicant must complete the "Key Contacts" form as the second page of the application: a Key Contacts continuation page is also available at https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms. The Key Contacts form should also be completed for major sub-agreements (i.e., primary co-investigators). Please make certain that all contact information is accurate.

  3. Table of Contents

    Provide a list of the major subdivisions of the application indicating the page number on which each section begins.

  4. Abstract (1 page)

    The abstract is a very important document in the review process. Therefore, it is critical that the abstract accurately describes the research being proposed and conveys all the essential elements of the research. Also, the abstracts of applications that receive funding will be posted on the NCER web site.

    The abstract should include the information described below (a-h). Examples of abstracts for current grants may be found on the NCER web site.

    1. Funding Opportunity Title and Number for this proposal.
    2. Project Title: Use the exact title of your project as it appears in the application. The title must be brief yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology. Do not use general phrases such as "research on."
    3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project. Provide a web site URL or an email contact address for additional information.
    4. Institution: In the same order as the list of investigators, list the name, city and state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
    5. Project Period and Location: Show the proposed project beginning and ending dates, and the geographical location(s) where the work will be conducted.
    6. Project Cost: Show the total dollars requested from the EPA (include direct and indirect costs for all years).
    7. Project Summary: Provide three subsections addressing: (1) the objectives of the study (including any hypotheses that will be tested), (2) the experimental approach to be used (a description of the proposed project), and (3) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
    8. Supplemental Keywords: Without duplicating terms already used in the text of the abstract, list keywords to assist database searchers in finding your research. A list of suggested keywords may be found at: https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms.

  5. Research Plan, Quality Assurance Statement and References
    1. Research Plan (15 pages)

      Applications should focus on a limited number of research objectives that adequately and clearly demonstrate that they meet the RFA requirements. Explicitly state the main hypotheses that you will investigate, the data you will create or use, the analytical tools you will use to investigate these hypotheses or analyze these data, and the results you expect to achieve. Research methods must be clearly stated so that reviewers can evaluate the appropriateness of your approach and the tools you intend to use. A statement such as: "we will evaluate the data using the usual statistical methods" is not specific enough for peer reviewers.

      This description must not exceed fifteen (15) consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. While these guidelines establish the minimum type size requirements, applicants are advised that readability is of paramount importance and should take precedence in selection of an appropriate font for use in the proposal.

      The description must provide the following information:

      1. Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important and how it fulfills the requirements of the solicitation. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to expand upon research supported by an existing or former assistance agreement awarded under the STAR program, indicate the number of the agreement and provide a brief report of progress and results achieved under it (one to two pages recommended).
      2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to ten pages recommended).
      3. Expected Results, Benefits, Outputs, and Outcomes: Describe the results you expect to achieve during the project (outputs) and the potential benefits of the results (outcomes). This section should also discuss how the research results will lead to solutions to environmental problems and improve the public's ability to protect the environment and human health. A clear, concise description will help NCER and peer reviewers understand the merits of the research (one to two pages recommended).
      4. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator in each team and describe plans to communicate and share data (one to two pages recommended).
      5. Appendices may be included but must remain within the 15-page limit.

    2. Quality Assurance Statement (1 to 3 pages in addition to the 15-page research plan)

      For projects involving environmental data collection or processing, conducting surveys, modeling, method development, or the development of environmental technology (whether hardware-based or via new techniques), provide a Quality Assurance Statement (QAS) regarding the plans for processes that will be used to ensure that the products of the research satisfy the intended project objectives. Follow the guidelines provided below to ensure that the QAS describes a system that complies with ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. Do not exceed three consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

      Address each section below by including the required information, referencing the specific location of the information in the Research Plan, or explaining why the section does not apply to the proposed research.

      1. Identify the individual who will be responsible for the quality assurance (QA) and quality control (QC) aspects of the research along with a brief description of this person's functions, experience, and authority within the research organization. Describe the organization's general approach for conducting quality research. (QA is a system of management activities to ensure that a process or item is of the type and quality needed for the project. QC is a system of activities that measures the attributes and performance of a process or item against the standards defined in the project documentation to verify that they meet those stated requirements.)
      2. Discuss project objectives, including quality objectives, any hypotheses to be tested, and the quantitative and/or qualitative procedures that will be used to evaluate the success of the project. Include any plans for peer or other reviews of the study design or analytical methods.
      3. Address each of the following project elements as applicable:
        1. Collection of new/primary data:
          (Note: In this case the word "sample" is intended to mean any finite part of a statistical population whose properties are studied to gain information about the whole. If certain attributes listed below do not apply to the type of samples to be used in your research, simply explain why those attributes are not applicable.)
          1. Discuss the plan for sample collection and analysis. As applicable, include sample type(s), frequency, locations, sample sizes, sampling procedures, and the criteria for determining acceptable data quality (e.g., precision, accuracy, representativeness, completeness, comparability, or data quality objectives).
          2. Describe the procedures for the handling and custody of samples including sample collection, identification, preservation, transportation, and storage, and how the accuracy of test measurements will be verified.
          3. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation.
          4. Discuss the procedures for overall data reduction, analysis, and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and/or power, and any statistical software to be used.
        2. Use of existing/secondary data (i.e., data previously collected for other purposes or from other sources):
          1. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation.
          2. Discuss the procedures for overall data reduction, analysis, and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and/or power, and any statistical software to be used.
        3. Method development:
          (Note: The data collected for use in method development or evaluation should be described in the QAS as per the guidance in section 3A and/or 3B above.)

          Describe the scope and application of the method, any tests (and measurements) to be conducted to support the method development, the type of instrumentation that will be used and any required instrument conditions (e.g., calibration frequency), planned QC checks and associated criteria (e.g., spikes, replicates, blanks), and tests to verify the method's performance.

        4. Development or refinement of models:
          (Note: The data collected for use in the development or refinement of models should be described in the QAS as per the guidance in section 3A and/or 3B above.)
          1. Discuss the scope and purpose of the model, key assumptions to be made during development/refinement, requirements for code development, and how the model will be documented.
          2. Discuss verification techniques to ensure the source code implements the model correctly.
          3. Discuss validation techniques to determine that the model (assumptions and algorithms) captures the essential phenomena with adequate fidelity.
          4. Discuss plans for long-term maintenance of the model and associated data.
        5. Development or operation of environmental technology:
          (Note: The data collected for use in the development or evaluation of the technology should be described in the QAS as per the guidance in section 3A and/or 3B above.)
          1. Describe the overall purpose and anticipated impact of the technology.
          2. Describe the technical and quality specifications of each technology component or process that is to be designed, fabricated, constructed, and/or operated.
          3. Discuss the procedure to be used for documenting and controlling design changes.
          4. Discuss the procedure to be used for documenting the acceptability of processes and components, and discuss how the technology will be benchmarked and its effectiveness determined.
          5. Discuss the documentation requirements for operating instructions/guides for maintenance and use of the system(s) and/or process(s).
        6. Conducting surveys:
          (Note: The data to be collected in the survey and any supporting data should be described in the QAS as per the guidance in section 3A and/or 3B above.)

          Discuss the justification for the size of the proposed sample for both the overall project and all subsamples for specific treatments or tests. Identify and explain the rational for the proposed statistical techniques (e.g., evaluation of statistical power).

      4. Discuss data management activities (e.g., record-keeping procedures, data-handling procedures, and the approach used for data storage and retrieval on electronic media). Include any required computer hardware and software and address any specific performance requirements for the hardware/software configuration used.

      Page allowances for the following section(s) are in addition to those allowed for the Research Plan and Quality Assurance Statement.

    3. References: References cited are in addition to the 15-page Research Plan limit.

  6. Budget and Budget Justification

    1. Budget

      Prepare a budget table using the guidance and form found at https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms, and select "All required forms." If a subaward, such as a subagreement with an educational institution, is greater than $25,000 and is included in the application, provide a separate budget and budget justification for the subaward. Include the total amount for the subaward under "Other" in the master budget. Any project containing subawards or subcontracts that constitute more than 40% of the total direct cost of the application will be subject to special review. Additional justification for use of these must be provided, discussing the need for the subaward/subcontract to accomplish the objectives of the research project.

      Please note that institutional cost-sharing is not required. However, if cost-sharing is proposed, a brief statement concerning cost-sharing should be added to the budget justification, and estimated dollar amounts must be included in the appropriate categories in the budget table.

    2. Budget Justification [2 pages in addition to the Section 5 page limitations, not including additions under Nos. (6) and (7) below to support contracts and subawards]

      Describe the basis for calculating the personnel, fringe benefits, travel, equipment, supplies, contractual support, and other costs identified in the itemized budget. The budget justification should not exceed two consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

      Budget information should be supported at the level of detail described below:

      1. Personnel: List all staff positions by title. Give annual salary, percentage of time assigned to the project, and total cost for the budget period.
      2. Fringe Benefits: Identify the percentage used and the basis for its computation.
      3. Travel: Specify the estimated number of trips, locations, and other costs for each type of travel. Explain the need for any travel, paying particular attention to travel outside the United States. Include travel funds for annual STAR program progress reviews (estimate for two days in Washington, D.C.) and a final workshop to report on results.
      4. Equipment: Identify all tangible, non-expendable personal property to be purchased that has an estimated cost of $5,000 or more per unit and a useful life of more than one year. (Personal property items with a unit cost of less than $5,000 are considered supplies.)
      5. Supplies: "Supplies" means tangible property other than "equipment." Identify categories of supplies to be procured (e.g., laboratory supplies or office supplies). Specifically identify computers to be purchased or upgraded.
      6. Contractual: Identify each proposed contract for services/analyses or consultants and specify its purpose and estimated cost. Contracts greater than $25,000 must have a separate itemized budget and budget justification, not to exceed one additional page each, included as part of the application.
      7. Other: List each item in sufficient detail for the EPA to determine the reasonableness of its cost relative to the research to be undertaken. Note that subawards, such as those with other universities for members of the research team, are included in this category. Subawards greater than $25,000 must have a separate itemized budget and budget justification, not to exceed one additional page each, included as part of the application.
      8. Indirect Costs: If indirect costs are included in the budget, indicate the approved rate and base with an explanation of how the indirect costs were calculated.
  7. Resumes

    Provide resumes for each investigator and important co-worker. The resume for each individual must not exceed two consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

  8. Current and Pending Support

    Complete a current and pending support form (provided at https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms) for each investigator and important co-worker. Include all supported research.

  9. Guidelines, Limitations, and Additional Requirements

    1. Letters of Intent/Letters of Support

      Letters of intent to provide resources for the proposed research or to document intended interactions are limited to one brief paragraph committing the availability of a resource (e.g., use of a person's time or equipment) or intended interaction (e.g., sharing of data, as-needed consultation) that is described in the Research Plan. Letters of intent are to be included as an addition to the budget justification documents.

      All letters that do not commit a resource vital to success of the proposal are considered letters of support. Letters of support, and letters of intent that exceed one brief paragraph, are considered part of the Research Plan and are included in the 15-page Research Plan limit.

      Note: Letters of intent or support must be part of the application; letters submitted separately will not be accepted.

    2. Funding Opportunity Number(s) (FON)

      At various places in the application, applicants are asked to identify the FON. The Funding Opportunity Number for this RFA is:

      Development and Evaluation of Innovative Approaches for the Quantitative Assessment of Pathogens and Cyanobacteria and Their Toxins in Drinking Water, EPA-G2007-STAR-G1

    3. Confidentiality

      By submitting an application in response to this solicitation, the applicant grants the EPA permission to make limited disclosures of the application to technical reviewers both w