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DHS-EPA Cooperative Center of Excellence on the Methods and Science to Conduct Microbial Risk Assessment in Support of Homeland Security Objectives
Sorting Code Number: 2004-STAR-P1
Catalog of Federal Domestic Assistance (CFDA) Numbers :
EPA 66.500; DHS 97.061
Solicitation Opening Date: July 14, 2004
Solicitation Closing Date: October 20, 2004
Acceptance receipt deadline date: October 20, 2004, 4:00 p.m. E.S.T.
Thomas Barnwell; Phone: 202-343-9862; Barnwell.Thomas@epa.gov
The U.S. Environmental Protection Agency, as part of its Science to Achieve Results program, in partnership with the Department of Homeland Security’s University Programs, is seeking applications for a Center that will address critical methodological and data gaps that are limiting the Nation’s ability to complete credible microbial risk assessments for bio-threat agents. The focus for this solicitation is on risk assessments for terrorist incidents involving bio-threat agents in indoor and/or outdoor environments. The bio-threat agents of interest include bacteria, viruses, and biotoxins relating to the Category A agents anthrax, smallpox, botulism, plague, viral hemorrhagic fever, and tularemia (http://www.bt.cdc.gov/agent/agentlist-category.asp ). Recognizing that certain Category A agents require containment at biosafety levels that are not readily available (or in the case of smallpox, restricted to the Centers for Disease Control and Prevention), it is therefore understood that validated surrogates will be used to conduct the research in lieu of using the actual agents. However, accessing partners with laboratory containment capabilities is highly encouraged.
Anticipated Type of Award: Grant
Estimated Number of Awards: One
Anticipated Funding Amount: A Maximum $10 million total costs
Cost Sharing: None required
Potential Funding per Grant: Up to $2,000,000/year with a duration of 5 years, including direct and indirect costs. Proposals with budgets exceeding the total award limit of $10 million will not be considered.
Institutions of higher education and not-for-profit institutions located in the U.S. and Tribal, state and local governments, are eligible to apply. See full announcement for more details.
Thomas Barnwell; Phone: 202-343-9862; Barnwell.Thomas@epa.gov
The Environmental Protection Agency’s (EPA) Science to Achieve Results (STAR) Program and the Department of Homeland Security’s (DHS) University Programs (UP) invite proposals for a research Center of Excellence focused on an area of high priority to both Agencies, Microbial Risk Assessment (MRA) for bio-threat agents. The bio-threat agents of interest include bacteria, viruses, and biotoxins relating to the Category A agents anthrax, smallpox, botulism, plague, viral hemorrhagic fever, and tularemia http://www.bt.cdc.gov/agent/agentlist-category.asp . The Centers for Disease Control and Prevention (CDC) define three categories of biologic agents with potential to be used as weapons, based on ease of dissemination or transmission, potential for major public health impact (e. g., high mortality), potential for public panic and social disruption, and requirements for public health preparedness. Agents of highest concerns are in Category A.
The pervasive issue of “How clean is clean?” has previously confronted policy makers but recent national homeland security threats have created new, and more pressing demands. Addressing this issue presents several technological challenges and unique scientific obstacles in the risk assessment arena that require immediate attention. Risk assessors need to be able to provide policy-makers with credible risk information. Armed with this information the policy makers can then set clean-up goals. “How clean is clean?” has important policy, human health and economic implications.
The events of September 11th and the subsequent movement of anthrax-contaminated material through postal facilities, government buildings, media offices, and private residences have highlighted the need for government to be able to quickly assess and communicate real and potential risks. In response to this need, EPA and DHS, through a variety of legislative mandates, are exercising their authority to advance the state of the knowledge for high-priority bio-threat agents and conduct periodic risk assessments through this joint effort. In addition, the Homeland Security Act of 2002 directed DHS ... “to establish a coordinated, university-based system to enhance the Nation’s homeland security.” It is within this spirit that DHS and EPA are partnering to establish a new Center of Excellence focusing on filling the scientific gaps and developing methods and tools for performing bio-threat microbial risk assessments in support of homeland security objectives.
Human health risk assessments for toxic substances have been conducted for decades. The National Research Council’s guidelines, Risk Assessment in the Federal Government: Managing the Process (NRC, 1983), codified the approach for chemical risk assessments. Hazard identification, dose-response assessment, exposure assessment, and risk characterization are the generally accepted components of toxic substance risk assessment. Subsequently, building on this methodology, approaches for microbial risk assessment (MRA) have been developed. One such example is the Revised Framework for Microbial Risk Assessment (ILSI, 2000). This document lays out a generic approach for “identifying scientific information that should be considered in attempts to quantitatively assess the human health risks associated with exposure to infectious agents in water.” The World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations are developing risk-based approaches for the management of public health hazards in food. This activity includes the development of guidelines for conducting microbial risk assessments in food (http://www.who.int/foodsafety/micro/en/ ). However, as a result of 9/11 and the subsequent anthrax attacks, it became clear that there is great need for accelerated development of technological and methodological tools to accomplish both exposure and health effects assessment for biological threat agents.
Currently, consensus-based methodology for evaluating biological threat agents and establishing safe levels for people to return to decontaminated areas does not exist. The progress of MRA is impeded by a lack of rapid and accurate exposure assessment tools, as well as a lack of pathogen-host-medium information for health effects (hazard) assessment. Microbe-specific methods for exposure assessment, dose-response assessment, and risk characterization need to capture the complexity of the dynamic host-pathogen interaction. Approaches and methods are in the developmental stages and remain in flux; few satisfactory assessments of environmental-source pathogens or bioterrorism agents have been published. In order for DHS and EPA to be informed on the appropriate conduct of MRAs for pathogens of interest, as well as to evaluate the quality of assessments performed by others, the scientific validity of the methods used must be critically evaluated and knowledge gaps that impede the process must be resolved. Therefore, it is necessary to acquire and/or develop all relevant information and research related to MRA that may assist in developing methods to assess risk for re-entry into comtaminated sites. To do this, EPA/DHS are soliciting research proposals to fill critical gaps in scientific information with the intent of accelerating formulation of the methods and tools necessary to perform MRAs for homeland security purposes.
The EPA and DHS are looking for creative approaches to bridge critical methodological and data gaps that are limiting the ability to complete credible MRAs. The bio-threat agents of interest include bacteria, viruses, and biotoxins relating to the Category A agents, anthrax, smallpox, botulism toxin, plague, viral hemorrhagic fever, and tularemia. Recognizing that certain Category A agents require containment at biosafety levels that are not readily available (or in the case of smallpox, restricted to the Centers for Disease Control and Prevention), it is therefore understood that validated surrogates will be used to conduct the research in lieu of using the actual agents. However, accessing partners with laboratory containment capabilities is highly encouraged. All appropriate routes of exposure (e.g., inhalation, ingestion, and dermal exposure) should be addressed.
Three major issues regarding adaptability and utility of previous models arise as the establishment of an MRA Cooperative Center of Excellence is considered. These are:
- the appropriateness and adaptability of the structure and methods of the classic chemical risk assessment approach (hazard identification, exposure assessment, dose-response, and risk characterization) to pathogen risk.
- the extent to which the methods and models that have been developed for food- borne or other infectious diseases by other U.S. and international agencies can be utilized or extended upon in assessing homeland security risk. The challenge of MRA lies in integrating, where appropriate, the methodologies and requirements that are established for chemical assessments with the issues that are unique to pathogens.
- the unique characteristics of certain organisms may dictate the need for individualized risk assessments and preclude options for developing or relying upon generalized methodology.
In developing your proposal, remember that the overall objective is to contribute to the development of credible microbial risk assessments for bio-threat agents. What critical gaps in MRA will the Center fill? As part of your proposal, please detail how your Center will address one or more of the bulleted areas below (or others, with appropriate justification) from the perspective of accomplishing the Center’s research objectives. The linkages between the functional and methodological research areas must be clear and justified. Each application must describe the process for identifying, developing, evaluating, and assessing uncertainty. The research program should address, as appropriate, methods for assessing risk of exposure to pathogens in air, water, soil and on hard surfaces for the indoor and/or outdoor environments. The following research areas are provided as starting points for developing the functional (underlying science) and methodological research areas of the Center:
- Devise preliminary risk assessment methodologies by building upon the methods and models that have been developed for food-borne and other infectious diseases by other U.S. and international agencies. Modify existing methodologies as appropriate to address the bio-threat agents of interest.
- Evaluate the limitations and uncertainties characteristic of sampling and detection methods used to measure microbial occurrence in the environment as they apply to determining safe exposure levels for pathogens.
- Review the base of knowledge on the viability and infectivity potential of pathogens in environmental media, identify and prioritize the key gaps, formulate a comprehensive approach for filling those gaps, and undertake those steps possible within the context of this proposal. Integrate this information into exposure assessment methodology using proposed scenarios related to deliberate contamination.
- Develop in vivo and in vitro methods to rapidly screen human populations for signs of exposure to pathogens. Identify and validate biomarkers to substantiate these methods. Our intent is to develop biomarkers to indicate exposure to the organism, not necessarily to be used as a medical diagnostic endpoint. Thus, any physiological or biochemical change indicating presence of the organism is of interest and may not relate to initiation of a stage of the infective process.
- Develop and use probabilistic methods to estimate dose from exposure information. Design approaches and methodologies to integrate epidemiologic data into exposure assessments.
- Assess barriers that limit the establishment of pathogens in human populations. Investigate the relationship of host mobility or immobility to transmissibility and persistence. Design population transmission models incorporating these concepts.
- Discern the appropriate choice of models when dynamic secondary transmission (person-to-person) and/or host persistence play a significant role in exposure.
- Elucidate and, if possible, quantify the relationship between model animal responses to pathogens/infections and human responses to the pathogens/infections. Suggest strategies for addressing the limitations inherent in using animal models to inform human risk assessments and define the uncertainties in making the extrapolation from animals to humans.
National Research Council, 1983. Risk Assessment in the Federal Government: Managing the Process. Washington, D.C. National Academy Press.
- Direct experience with the use, development and application of microbial risk assessment methodology is strongly desired and should be clearly demonstrated in the application.
- The application must demonstrate a strong commitment to educating the next generation of scientists on the science, methodologies and applications of MRA.
- The application must demonstrate a strong commitment to including institutions with high minority student enrollment. Examples of such schools are those that the U.S. Department of Education lists as “Accredited Postsecondary Minority Institutions” on its four web sites listed below, consistent with Executive Orders 13125 (Increasing Participation of Asian Americans and Pacific Islanders), 13230 (Educational Excellence for Hispanic Americans), 13256 (Historically Black Colleges and Universities), and 13270 (Tribal Colleges and Universities), which encourage building of the capacity of minority-serving institutions to provide high quality education.
The authority for this RFA and resulting awards is contained in the following:
EPA: Clean Air Act, Section 103, as amended, Public Law 95-95, 42 U.S.C. 7401 et seq.; Clean Water Act, Section 104, as amended, Public Law 95-217, 33 U.S.C. 1251 et seq.; Safe Drinking Water Act, Section 1442, as amended, Public Law 93- 523.
DHS: Homeland Security Act , Public Law 107-296
It is anticipated that a total of up to $10 million will be awarded, depending on the availability of funds. DHS and EPA anticipate funding one grant under this RFA to be managed by EPA at the National Center for Environmental Research (NCER). The projected award per grant is $1,500,000 to $2,000,000 per year total costs, for up to 5 years. Requests for amounts in excess of a total of $10 million, including direct and indirect costs, will not be considered. The total project period for an application submitted in response to this RFA may not exceed 5 years. Funding in subsequent years will be contingent upon satisfactory progress.
Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state and local governments, are eligible to apply. Profit-making firms are not eligible to receive grants from EPA under this program.
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 principal investigator, but may not direct projects on behalf of the applicant’s organization or principal investigator. The principal investigator’s institution, organization, or governance may provide funds through its grant from EPA/DHS to a 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 a grant, and may not receive salaries or in other ways augment their agency’s appropriations through grants made by this program. However, federal employees may interact with grantees so long as their involvement is not essential to achieving the basic goals of the grant. EPA/DHS encourages interaction between their laboratory scientists and grant principal investigators 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.
An investigator’s 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, along with an assurance from the federal agency involved which commits it to supply the specified service.
Potential applicants who are uncertain of their eligibility should contact Tom Barnwell in NCER, phone 202-343-9862, email: firstname.lastname@example.org
Institutional cost-sharing is not required.
Application forms and other materials can be found on the NCER web site at: http://www.epa.gov/ncer/rfa/forms/.
Information on the content and form of the application submission can be found in Section #2: The Application, and Section #5: Guidelines, Limitations, and Additional Requirements of NCER’s Standard Instructions for Submitting a STAR Application. These instructions can be found on the NCER web site, http://www.epa.gov/ncer/rfa/forms.
- We encourage several institutions to form a consortium to create the Center. Multidisciplinary teams that will result in interdisciplinary research approaches within the Center are strongly encouraged. However, the application must be submitted by a lead institution which is generally responsible for management and administrative liaison with EPA and DHS. A Management plan should be included in the application.
- Each application will consist of a core supporting the direction and administration of the Center plus individual projects that are integrated into the overall goals of the Center based upon the specific research areas of interest presented in this RFA. These cannot be independent, stand-alone projects, but must relate to each other substantively.
- The Center must be led by an overall Director who will provide oversight, coordination, and integration of the Center’s activities. 30% of the Director’s time must be devoted to this task.
- The application must contain a Communication Plan that will define the stakeholders and explain how products, research results, and findings will be disseminated to the stakeholders, as well as how the flow of information among Center investigators will be facilitated.
- The application must contain specific plans for making data and research results available. Research results must be published in the refereed literature.
- The Center will be responsible for organizing an annual joint workshop/review to highlight research and discuss research issues as they arise. The Center’s management will attend annually a joint meeting of the DHS’s Centers of Excellence. Adequate travel funds must be budgeted for these meetings.
- A Quality Assurance narrative is required, as per standard instructions. A Quality Management Plan will be required upon funding.
- Note: the following page limitations supercede those in the Standard Instructions:
|Abstracts||1 page abstract for the Center as a whole and, 1 page abstracts for each proposed project|
|Research Plan||Up to 5 pages for overall Center objectives, approach, and expected benefits. Up to10 pages for administrative core to include management and communication plans. Up to 15 pages for each research project description.|
|Budget||Budget summary pages and project pages should include both annual budgets for each year, one through five, and cumulative totals for the entire five year period; 2 page summary for total Center budget; 2 pages per project; 2 pages per Administrative Core|
|Budget Justification||2 pages per each budget submitted|
The need for a sorting code to be used in the application and for mailing is described in Section #1: Sorting Code area of NCER’s Standard Instructions (http://www.epa.gov/ncer/rfa/forms/). The sorting code for applications submitted in response to this solicitation is 2004-STAR-P1.
Applications must be received by the application receipt date listed in this announcement. If an application is received after that date, it will be returned to the applicant without review.
The following is the schedule for this RFA. It should be noted that this schedule may be changed without notification due to factors that were not anticipated at the time of announcement.
Application Receipt Date: October 20, 2004, 4:00 p.m. E.S.T.
Earliest Anticipated Start Date: April 1, 2005
Research funded under this program may be eligible under E.O. 12372, “Intergovernmental Review of Federal Programs,” if it affects public health or if an environmental impact statement is required. If applicable, an applicant should consult the office or official designated as the single point of contact in his or her State for more information on the process the State requires to be followed in applying for assistance, if the State has selected the program for review.
Requests for funding in excess of a total of $10 million, including direct and indirect costs, will not be considered.
Budgetary requirements will be found in Sections 2-H: Budget and 2-I: Budget Justification of NCER’s Standard Instructions (http://www.epa.gov/ncer/rfa/forms/). The applicant must present a detailed, itemized budget for the entire project. If a sub-agreement, such as a sub-contract, is included in the application, provide a separate budget for the sub-contract in the same format. Include the total amount for the sub-agreement under “Contracts” in the master budget. Any project which contains sub-agreements that constitute more than 40% of the total direct cost of the grant will be subject to special internal review. Additional justification for use of these sub-contracts must be provided, discussing the need for this agreement to accomplish the objectives of the research project.
The original and eight (8) copies of the complete application (9 in all) and one (1) additional copy of the abstract, must be received by NCER no later than 4:00 P.M. Eastern Time on the closing date. Informal, incomplete, or unsigned applications will be returned without review. The original, signed copy of the application must not be bound or stapled in any way.
Because of security concerns, applications cannot be personally delivered. They must be sent through regular mail, express mail, or a major courier.
The following address must be used for regular mail:
U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: 2004-STAR-P1
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460
The following address must be used for express mail and couriers:
U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: 2004-STAR-P1
1025 F. Street, NW (Room 3500)
Washington, DC 20004
Phone: (202) 233-0686
Consideration of an application’s merit is based on the following criteria: (1) the originality and creativity of the proposed research, the appropriateness and adequacy of the research methods proposed and the quality assurance statement; (2) the qualifications of the principal investigator(s) and other key personnel; (3) the Center management structure; (4) the responsiveness of the proposal to the research needs identified for the topic area; (5) the availability and/or adequacy of the facilities and equipment proposed for the project. Although budget information does not indicate an application’s scientific merit, the reviewers are also asked to provide their view on the appropriateness and/or adequacy of the proposed budget. Additional information on review criteria will be found in Section #6: Review and Selection of NCER’s Standard Instructions (http://www.epa.gov/ncer/rfa/forms/).
Review and Selection Process
All grant applications are reviewed by an appropriate technical peer review panel. This review is designed to evaluate each proposal according to its scientific merit. Applications that receive scores of excellent and very good from the peer reviewers are subjected to a programmatic review within the EPA and DHS to assure a balanced research portfolio for the Agencies. The application is selected for an award based on consideration of the scientific quality of proposals and relevance to EPA and DHS program research priorities, program balance, budget and available funds. The applicant recommended for funding will be required to provide additional information and the application will be forwarded to the grants administration office for award in accordance with the EPA’s procedures.
Customarily, applicants are notified about award decisions within six months of the application deadline. A summary statement of the scientific review by the peer panel will be provided to each applicant with the award or declination letter.
Expectations and responsibilities of NCER grantees will be found in Section #8: Expectations and Responsibilities of STAR Grantees of NCER’s Standard Instructions (http://www.epa.gov/ncer/rfa/forms/). Terms and conditions associated with an NCER award can be found at: http://www.epa.gov/ncer/guidance.
Further information, if needed, may be obtained from the EPA and DHS official(s) indicated below. Email inquiries are preferred.
Technical: Barbara Levinson; Phone: 703-347-8036; email: email@example.com
Dawn Myscofski, PhD; email: firstname.lastname@example.org
Eligibility: Thomas Barnwell; Phone: 202-343-9862; email: email@example.com