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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
Biotechnology: Potential Allergenicity of Genetically Engineered Foods
This is the initial announcement of this funding opportunity.
|Development of Methods
for Safety Assessment (EPA-G2006-STAR-E1)
Development of Methods for Safety Assessment and Examination of Underlying Mechanisms & Factors of Susceptibility (EPA-G2006-STAR-E2)
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509
Solicitation Opening Date: December 14, 2005
Solicitation Closing Date: March 21, 2006, 4:00 pm Eastern Time
Eligibility Contact: Tom Barnwell: 202-343-9862; email: email@example.com
Electronic Submissions: Bronda Harrison: 202-564-1790; email: firstname.lastname@example.org
Technical Contact: Susan Laessig; Phone: 202-564-5232; email: email@example.com
Access Standard Application Forms (http://www.epa.gov/ncer/rfa/forms/)
Synopsis of Program
The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing to develop methods to assess the potential allergenicity of genetically engineered foods. The development of these methods will help in identifying substances that induce dietary allergy in humans and lead to improved evaluation of the relative potency of unknown proteins. Currently, the Food and Agriculture Organization of the United Nations and the World Health Organization (FAO/WHO) have proposed a decision tree to be used in assessing the potential allergenicity of novel dietary proteins. However, many of the components recommended in this decision tree have not been sufficiently developed or validated. The STAR program is issuing this request for applications (RFA) for research on appropriate methods, either within or outside the framework of the current decision tree, primarily to assess human allergenicity of proteins in genetically engineered foods and, secondarily, to improve our understanding of the basic mechanisms underlying food allergy and susceptibility to food allergy as it pertains to genetically engineered foods. Ideal methods would improve hazard identification and enhance the ability to estimate the potency of unknown proteins relative to known allergenic and non-allergenic proteins in a logistically feasible and cost effective manner. Development of methods that are further amenable to the investigation of factors that influence susceptibility for sensitization to dietary allergens are also of interest.
Estimated Number of Awards: Approximately 7 awards
Anticipated Funding Amount: Approximately $3 million total for all awards
Potential Funding per Grant and/or Cooperative Agreement: Up to $150,000/year with a duration of 2 or 3 years and no more than a total of $450,000, including direct and indirect costs, for awards for the development of methods for safety assessment only. Requests for amounts in excess of a total of $450,000 for this area, including direct and indirect costs, will not be considered. Alternatively, up to $200,000/year with a duration of 2 or 3 years and no more than a total of $600,000, including direct and indirect costs, for awards for methods for safety assessment and research for an examination of underlying mechanisms and factors of susceptibility. Requests for amounts in excess of a total of $600,000 for both research areas, including direct and indirect costs, will not be considered.
Cost-sharing is not required.
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
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, http://www.epa.gov/ncer/rfa/forms/. To apply electronically, you must use the application package available at https://apply.grants.gov/forms_apps_idx.html (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 appropriate representative of your organization.
Eligibility Contact: Tom Barnwell; phone: 202-343-9862; email: firstname.lastname@example.org
Electronic Submissions Contact: Bronda Harrison; phone: 202-564-1790; email: email@example.com
Technical Contact: Susan Laessig; phone: 202-564-5232; email: firstname.lastname@example.org
Biotechnology is now commonly used to develop new pesticide products for agricultural pest control through the incorporation of genetic material that codes for novel proteins into plants and microorganisms. The pesticidal proteins are often incorporated into plants that are then used for human consumption. However, there is little to no information available regarding the ability of newly introduced proteins to cause allergenicity. Food allergy, an adverse immunologic reaction to food, in Europe and North America currently affects 5-7.5% of children and 1-2% of adults and is believed to have increased in the past decade (see review by Kagen, 2003). The vast majority of allergic reactions to food are caused by only a few dietary items: eggs, peanuts, milk, soy, and wheat in children and shellfish, fish, nuts, and peanuts in adults (Bernstein et al., 2003). Because of the potential for sensitization and allergenicity in people exposed to novel proteins in the diet, the risk of allergenicity of genetically engineered foods should be evaluated. Methods to evaluate the potential allergenicity of foods are limited and research in developing assessment tools is needed in order to investigate factors for allergenic susceptibility and to improve risk assessment for dietary allergy in general.
The EPA, together with the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA), share responsibility for regulating agricultural biotechnology. In accordance with EPA’s mission to minimize risks to human health and to safeguard ecological integrity, EPA is committed to assessing and mitigating risks to human health and the environment from pesticides produced through biotechnology. The EPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS) regulates the use of all pesticides in the U.S., including genetically introduced plant-incorporated protectants (PIPs) and biopesticides. OPPTS has a mandate to establish maximum levels for pesticide residues and evaluate human health and ecological risks under authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) . EPA works closely with USDA and FDA to ensure the safety of the food supply and to identify additional scientific research or data that may be needed for novel proteins including PIPs that may be present as residues in genetically engineered crops.
To date, no adverse health effects attributed to genetically engineered foods have been documented in the human population. However, the majority of soybeans, as well as large proportions of corn, canola, and cotton crops produced worldwide are genetically engineered, mainly for pest resistance. The National Research Council (NRC) (NRC, 2004) has recommended improving the safety assessment of all foods for unintended health effects, including the assessment of genetically engineered crops intended for human consumption. In response, EPA’s Office of Research and Development (ORD) has developed a Biotechnology Research Program (EPA, 2005) that focuses on five key issues of greatest importance one of which is the potential allergenicity of pesticidal proteins introduced into the food supply by genetic engineering.
The Codex Alimentarius Commission’s current guidelines for assessment of possible allergenicity of genetically engineered foods suggest an integrated approach that considers the source of the introduced protein, amino acid sequence similarity to known allergens, and structural properties such as susceptibility to enzymatic degradation, heat stability and/or acid and enzymatic treatment (Codex Alimentarius, 2003). A conceptual and practical framework for risk assessments using a decision-tree analysis was first proposed in 1996 (Metcalfe et al., 1996) and was then revised by the World Health Organization (WHO) and Food and Agriculture Organization of the United Nations (FAO) (FAO/WHO, 2001) The revised decision-tree recommends including information from targeted and specific serum screening assays and validated animal models to assess the risks for allergenicity of genetically engineered foods (Bernstein et al., 2003), but these methods have not been adequately developed, widely applied, or validated. Further research on the development of these methods is needed before they can be used for risk assessment for PIPs and other proteins (Selgrade et al., 2003).
The specific Strategic Goal, Objective and Sub-objective from EPA’s Strategic Plan that relate to this solicitation include:
Goal 4: Healthy Communities and Ecosystems,Objective 4.4: Enhance Science and Research, Sub-objective 4.4.2: Conduct Relevant Research.
The EPA‚s Strategic Plan can be found at http://www.epa.gov/ocfo/plan/2003sp.pdf.
Specific Research Areas of Interest/Expected Outputs and Outcomes
EPA, as part of its Science to Achieve Results (STAR) Program, is seeking applications for research to develop methods to assess the potential allergenicity of pesticidal proteins introduced into the food supply by genetic engineering. The methods should allow testing of the relative allergenic or sensitization potencies of proteins with and without a history of producing food allergy. The primary goal of the research is improved predictability of risk assessments for potential dietary allergenicity of exposure to novel pesticidal proteins in genetically engineered foods.
Development of Methods for Safety Assessment
At present many of the methods proposed for evaluating the allergenicity of novel proteins introduced into the food supply have not been well developed, widely used, or validated. Specific research on safety assessment is of primary interest for this solicitation including:
- Development and evaluation of animal models for safety assessment
- Development of targeted or specific serological assays
- Determination of structure-activity relationships of allergen proteins
The ideal animal model would use a relevant route of exposure in a rodent, without the use of adjuvants, and produce a measurable immunological response comparable to that in humans. This may be difficult to achieve in a single animal model because of the development of oral tolerance (Knippels and Penninks, 2003). Hence, novel approaches to the development of animal models based on a sound rationale are encouraged. The model should assess relevant immune and physiological responses that could be used to compare the relative potency of unknown proteins to proteins with known allergenicity. Careful attention should be paid to the route of exposure and the choice of protein controls for comparison so that a positive control food allergen and negative control non-allergenic dietary protein are included.
Similarly, methods for determining structure-activity relationships and identifying epitopes are impeded by a lack of appropriate databases. Protein structure definition is an important consideration for databases as well as the use of uniform criteria for entering proteins and for the subsequent searches. Methods for using targeted and specific serum screens are also needed and innovative approaches to the problems of the selection of suitable sera and cross-reactivity are encouraged. Development of methods that are further amenable to the investigation of factors that influence susceptibility to sensitization to dietary allergens are desirable. Ideal methods would improve hazard identification and the ability to estimate the potency of unknown proteins relative to known allergenic and non-allergenic proteins in a logistically feasible and cost effective manner.
Examination of Underlying Mechanisms and Factors of Susceptibility
A secondary area of interest is research on basic issues underlying sensitization to food allergens that may be proposed in addition to the development of testing methods. The ability to accurately predict the risk of allergenicity posed by the introduction of a novel protein into the food supply is currently impeded by a lack of understanding of the basic mechanisms underlying the development of food allergy and factors that lead to susceptibility. These basic issues are not limited to allergies developing from genetically engineered food, but have broader implications for the diagnosis, treatment, and prevention of, the sometimes life threatening allergic reactions to food.
Specific research on the following basic issues of allergenicity is of secondary interest:
- Genetic, developmental and other determinants of susceptibility to food allergy
- Mechanisms underlying food allergy including the development of oral tolerance
- Influence of route and duration of exposure on development of dietary allergenic sensitization
The principal output of this RFA will be the development of methods to assess potential allergenicity of novel pesticidal proteins in food. The projected outcome will be an improved ability to assess the potential risks to human health from genetically engineered foods in the diet and an overall improvement in the knowledge of food allergens.
Bernstein, J.A., I.L. Bernstein, L. Bucchini, L.R. Goldman, R.G. Hamilton, S. Lehrer, C. Rubin, and H.A. Sampson (2003). Clinical and laboratory investigation of allergy to genetically modified foods. Environ. Health Perspect. 111(8):1114-1121.
Codex Alimentarius (2003). Assessment of Possible Allergenicity, Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2003).
Food and Agriculture Organization of the United Nations and World Health Organization (2001). Evaluation of Allergenicity of Genetically Modified Foods- Report of a joint FAO/WHO expert consultation on allergenicity of foods derived from biotechnology. FAO: Rome, Italy. Available at: http://www.fao.org/es/ESN/food/pdf/allergygm.pdf
Kagen, R.S. (2003). Food allergy: An overview. Environ. Health Perspect. 111 (2):223-225.
Knippels, L.M.J. and A.H. Penninks (2003). Assessment of the allergic potential of food protein extracts and proteins on oral application using the Brown Norway rat model. Environ. Health Perspect. 111 (2):233-238.
National Research Council (2004). Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. National Academies Press: Washington, DC.
Selgrade, M.J.K., I. Kimber, L. Goldman, and D.R. Germolec (2003). Assessment of allergenic potential of genetically modified foods: An agenda for future research. Environ. Health Perspect. 111 (8):1140-1141.
U.S. Environmental Protection Agency (2005). Biotechnology Research Program, EPA 600/R-03/068. Office of Research and Development, Washington, DC, 2005. Available at: http://www.epa.gov/NHEERL/publications/files/biotechnology_research_program_4_8_05.pdf
Agency policy prevents EPA scientists and engineers from providing individual applicants with information that would provide them with an unfair competitive advantage. Consequently, EPA scientists and engineers will not review, comment, advise, or provide technical assistance to applicants preparing applications in response to EPA RFAs, or discuss in any manner how the Agency will apply the published evaluation criteria for this competition.
Groups of two or more eligible applicants may choose to form a consortium and submit a single application for this assistance agreement. The application must identify which organization will be the recipient of the assistance agreement and which organizations(s) will be subawardees of the recipient.
The application must include a plan (see “Data Plan” in section IV.E.) to make available to the public all data generated from observations, analyses, or model development (primary data) and any secondary (or existing) data used under a grant awarded from this RFA. The data must be available in a format and with documentation such that they may be used by others in the scientific community.
Two levels of funding are available. Applicants may choose to address only the Development of Methods for Safety Assessment or may choose to also address research for the Examination of Underlying Mechanisms and Factors of Susceptibility (see Award Information).
It is anticipated that a total of approximately $3 million will be awarded under this announcement, depending on the availability of funds. The EPA anticipates funding approximately 7 grants under this RFA. The projected award per grant is either $150,000 or $200,000 per year total costs, for up to 3 years, depending on the areas for which the award is for as described below. The level of funding may be up to $150,000/year with a duration of 2 or 3 years and no more than a total of $450,000, including direct and indirect costs, for awards for methods for Development of Methods for Safety Assessment only. Requests for amounts in excess of a total of $450,000 for this area, including direct and indirect costs, will not be considered. Alternatively, individual grants may be funded up to $200,000/year with a duration of 2 or 3 years and no more than a total of $600,000, including direct and indirect costs, for awards for research on Examination of Underlying Mechanisms and Factors of Susceptibility and Development of Methods for Safety Assessment. Requests for amounts in excess of a total of $600,000 for both research areas, 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 3 years. The EPA reserves the right to reject all applications and make no awards under this RFA. The EPA reserves the right to make additional awards under this RFA without further competition if additional funding becomes available. Any additional selections for awards will be made no later than 4 months after the original selection decisions.
EPA will either fund grants or cooperative agreements under this RFA.
Under a grant, EPA scientists and engineers are not permitted to be substantially involved in the execution of 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.
Where appropriate, based on consideration of the nature of the proposed project relative to the EPA’s intramural research program and available resources, the EPA may fund cooperative agreements under this announcement. When addressing a research question/problem of common interest, collaborations between laboratory scientists and grant principal investigators are permitted under a cooperative agreement. These collaborations may include data and information exchange, providing technical input to experimental design and theoretical development, coordinating extramural research with in-house activities, sharing of samples and equipment, and joint authorship of journal articles on these activities. Proposals must not identify EPA cooperators or interactions; specific interactions between EPA’s investigators and those of the prospective recipient for cooperative agreements will be negotiated at the time of award.
Institutions of higher education and not-for-profit institutions located in the U.S., and tribal, state and local governments, are eligible to apply. Universities and educational institutions must be subject to OMB Circular A-21. Profit-making firms are not eligible to receive grants 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 grant 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 a grant, and may not receive salaries or augment their Agency’s appropriations in other ways through grants made by 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 in NCER, phone 202-343-9862, email: email@example.com
Applications that do not substantially comply with the application submission instructions and requirements set forth in Section IV of this announcement will be rejected. In addition, where a page limit is expressed in Section IV with respect to parts of the application, pages in excess of the page limitation will not be reviewed. Applications must be received by the EPA on or before the solicitation closing date published in Section IV of this announcement. Applications received after the published closing date will be returned to the sender without further consideration. Also, applications exceeding the funding limits 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 that primarily benefits a Federal program or provides a service for a Federal agency) will not be funded.
You may submit either a paper application or an electronic application (but not both) for this announcement. Instructions for both forms of submission follow.
Internet Address to Request Application Package
For paper applications, forms and instructions can be found on the NCER web site: http://www.epa.gov/ncer/rfa/forms/.
For electronic applications, use the application package available at https://apply.grants.gov/forms_apps_idx.html (see “Submission Instructions for Electronic Applications”).
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 firstname.lastname@example.org; email to this address will not be accepted. If you do not receive an email acknowledgment within 30 days of the submission closing date, immediately contact the Technical Contact listed under "Agency Contacts" 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 acknowledgment 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.
Content and Form of Application Submission For Phase I Awards
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.
- Standard Form 424
- Key Contacts
- Table of Contents
- Abstract (1 page)
- Research Category and Funding Opportunity Number: The appropriate research areas and associated numbers for this RFA are:
The applicant must complete form SF424. This form will be the first page of the application. Instructions for completion of the SF424 are included with the form. The form must contain the original (or electronic) signature of an authorized representative of the applying institution. Please note that both the Principal Investigator and an administrative contact must be identified in Item 5 of the SF424.
Applicants are required to provide a “Dun and Bradstreet Data Universal Numbering System” (DUNS) number in Item 5 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). Item 16 of the SF424 refers to this requirement. Selection of research proposals is limited to those administered by EPA’s Office of Research and Development which: (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. Otherwise, national research programs are exempt from review. Applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html to determine whether their state participates in this process and how to comply.
The applicant must complete the “Key Contacts” form as the second page of the application; the Key Contacts continuation page is also available http://www.epa.gov/ncer/rfa/forms. The Key Contacts form should also be completed for major sub-agreements (i.e., contacts at the institutions for primary co-investigators). Please make certain that all contact information is accurate.
Provide a list of the major subdivisions of the application indicating the page number on which each section begins. (A Table of Contents is not required for electronic submissions.)
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 indicated in the example format and described below (1-8). Examples of abstracts for current grants may be found on the NCER web site.
- Development of Methods for Safety Assessment, EPA-G2006-STAR-E1
- Development of Methods for Safety Assessment and Examination of Underlying Mechanisms and Factors of Susceptibility, EPA-G2006-STAR-E2
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:
- 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. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to continue research supported by an existing or former grant awarded under the STAR program, indicate the number of the grant and provide a brief report of progress and results achieved under that grant (one to two pages recommended).
- 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).
- Expected Results, Benefits, Outputs, and Outcomes: Describe the results you expect to achieve during the project (outputs) and the 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 understand the merits of the research (one to two pages recommended).
- 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).
- Important Attachments: References cited are in addition to the 15-page Research Plan limit. Appendices may be included but must remain within the 15-page limit.
Quality Assurance Statement (2 pages in addition to the 15-page research plan)
For any project involving data collection or processing, conducting surveys, environmental measurements, modeling, or the development of environmental technology (whether hardware-based or via new techniques), provide a Statement on processes that will be used to assure that results of the research satisfy the intended project objectives. The EPA is particularly interested in the quality controls for data generation and acquisition, and how data validation and usability will be verified. The statement must describe a system that complies with ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, and must not exceed two consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.
For each item below either present the required information, reference the specific location of the information in the Research Plan, or provide a justification of why the item does not apply to the proposed research.
- Identify the individual who will be responsible for the quality assurance and quality control aspects of the research. [Quality assurance (QA) is an integrated system of management activities involving planning, implementation, documentation, assessment, and improvement to ensure that a process or item is of the type and quality needed for the project. Quality control (QC) is the system of technical activities that measures the attributes and performance of a process or item against defined standards to verify that they meet the stated requirements.]
- Discuss the activities to be performed or the hypothesis to be tested and criteria for determining acceptable data quality. Such criteria may be expressed in terms of precision, accuracy, representativeness, completeness, and comparability or in terms of data quality objectives or acceptance and evaluation criteria. These criteria also must be applied to determine the acceptability of existing, or “secondary”, data to be used in the project, and their use discussed. (In this context, secondary data may be defined as data previously collected for other purposes or from other sources.)
- Describe the study design. Include sample type(s) and location requirements, all statistical analyses that were or will be used to estimate the types and numbers of physical samples required, or equivalent information for studies using survey and interview techniques, or describe how new technology will be benchmarked to improve existing processes, such as those used by industry.
- Explain how the effectiveness of any new technology or process will be measured. Describe the procedures that will be used in the calibration and performance evaluation of all analytical instrumentation and all methods of analysis to be used during the project.
- Describe the procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage, or how the accuracy of test measurements will be verified.
- Discuss the procedures for data reduction and reporting, including a description of all statistical methods to make inferences and conclusions, with identification of any statistical software to be used. Discuss any computer models to be designed or utilized and describe the associated verification and validation techniques.
- Describe the quantitative and/or qualitative procedures that will be used to evaluate the success of the project, including any plans for peer or other reviews of the study design or analytical methods prior to data collection.
ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, is available for purchase from the American Society for Quality, phone 1-800-248-1946, item T55. Only in exceptional circumstances should it be necessary to consult this document. An EPA guidance document, Guidance on Satisfying EPA Quality System Requirements for STAR Grants (EPA QA/G-1STAR) is available for potential applicants and addresses in detail how to comply with ANSI/ASQC E4 for STAR grants. This may be found on the Internet at http://www.epa.gov/ncer under “Guidance and FAQs.”
Page allowances for the following sections are in addition to those allowed for the Research Plan and Quality Assurance Statement.
Data Plan (2 pages in addition to the 15-page research plan)
The application must include a plan to make available all data (including primary and secondary/existing data) from observations, analyses, or model development collected or used under an agreement awarded as a result of this RFA in a format and with documentation/metadata such that they may be used by others in the scientific community. Applicants who plan to develop or enhance databases containing proprietary or restricted information must provide a strategy, within the two pages, to make the data widely available, while protecting privacy or property rights.
Prepare a budget table using the guidance and format found at http://www.epa.gov/ncer/rfa/forms/, and select “All required forms”. If a sub-agreement, such as a subcontract, is greater than $25K and is included in the application, provide a separate budget for the sub-agreement. Include the total amount for the sub-agreement under “Contracts” in the master budget. Any project containing sub-agreements that constitute more than 40% of the total direct cost of the grant will be subject to special review. Additional justification for use of such subcontracts must be provided, discussing the need for this agreement 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.
Budget Justification (2 pages in addition to the Section E. page limitations)
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:
- Personnel: List all staff positions by title. Give annual salary, percentage of time assigned to the project, and total cost for the budget period.
- Fringe Benefits: Identify the percentage used and the basis for its computation.
- Travel: Specify the estimated number of trips, locations, and other costs for each type of travel. Explain the need for any travel outside the United States. Include travel funds for annual STAR program progress reviews and a final workshop to report on results.
- 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.)
- Supplies: “Supplies” means tangible property other than “equipment”. Identify categories of supplies to be procured (e.g., laboratory supplies or office supplies) and specifically identify computers to be purchased or upgraded.
- Contractual: Identify each proposed sub-agreement (grant or contract) and specify its purpose and estimated cost. Sub-agreements more than $25K should have a separate itemized budget and budget justification, not to exceed one additional page each, included as part of the application.
- Other: List each item in sufficient detail for the EPA to determine the reasonableness of its cost relative to the research to be undertaken.
- Indirect Costs: If indirect costs are included in the budget, indicate the approved rate and base with an explanation of how indirect costs were calculated.
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.
Current and Pending Support : Identify any current and pending financial resources that are intended to support research related to the proposal or that would consume the Principal Investigator’s time. Provide information on current and pending support in the format provided at http://www.epa.gov/ncer/rfa/forms for each investigator and important co-worker.
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 within and outside the Agency for the express purpose of assisting the Agency with evaluating the application. Information from a pending or unsuccessful application will be kept confidential to the fullest extent allowed under law; information from a successful application may be publicly disclosed to the extent permitted by law.
In accordance with 40 CFR 2.203, applicants may claim all or a portion of the application/proposal as confidential business information (for example, hypotheses or methodologies contained in the research narrative that the applicant wishes to protect from possible public disclosure). EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2. Applicants must clearly mark applications/proposals or portions of applications/proposals they claim as confidential. If no claim of confidentiality is made, the EPA is not required to make an inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure.
Funding Opportunity Number
At various places in the application, applicants are asked to identify the funding opportunity number. The number must be placed at the top of the abstract (location is shown in the abstract format, http://www.epa.gov/ncer/rfa/forms) and in Box 10 of Standard Form 424 for all applications. For paper submissions, the number must also be placed in the address on the package that is sent to the EPA (see below). Each application must be submitted using a single funding opportunity number.
Applicants must select a funding opportunity number corresponding to their proposed research topic area in the solicitation. It is the responsibility of the applicant to identify the proper opportunity number based on the nature of the proposed research. Failure to do so could result in an inappropriate peer review assignment. If your research seems to fit under more than one funding opportunity number, choose the most appropriate one. For electronic submissions, you must use the appropriate electronic application package (see “Submission Instructions for Electronic Applications”) for the chosen funding opportunity number.
Letters of Intent/Letters of Support
Letters of intent to provide resources for the proposed research are limited to one brief paragraph committing the availability of a resource (e.g., use of a person's time or equipment) as described in the Research Plan. Letters of intent are to be included as an addition to the budget justification documents.
Principal investigators may believe that letters of support from local constituencies contribute to the relevance of their proposal. All letters that do not commit a resource vital to success of the proposal are considered letters of support. Letters of intent that exceed one brief paragraph and letters of support are considered part of the Research Plan and included in the 15-page Research Plan limit.
For paper copy submissions, the original and two (2) copies of the complete application (3 in all), and one (1) additional copy of the abstract, must be received by NCER no later than 4:00 pm Eastern Time on the solicitation closing date. Electronic applications must be transferred to grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date. It should be noted that this schedule may be changed without prior notification because of factors that were not anticipated at the time of announcement. In the case of a change in the required application closing date, a new date will be posted on the NCER web site (http://www.epa.gov/ncer/) and a modification posted on www.grants.gov . Applications received after the closing date will be returned to the sender without further consideration.
Solicitation Closing Date Date: March 21, 2006, 4:00 pm Eastern Time
Earliest Anticipated Start Date: October 2006
The funding mechanism for all awards issued under STAR solicitations will consist of assistance agreements from the EPA. All award decisions are subject to the availability of funds. In accordance with the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301 et seq., the primary purpose of a grant is to accomplish a public purpose of support or stimulation authorized by federal statute, rather than acquisition for the direct benefit or use of the Agency. In issuing a grant agreement, the EPA anticipates that there will be no substantial EPA involvement in the design, implementation, or conduct of the research. However, the EPA will monitor research progress through annual reports provided by grantees and other contacts, including site visits, with the Principal Investigator.
If you wish to submit applications for more than one STAR funding opportunity, you must ensure that the research proposed in each application is significantly different from any other that has been submitted to the EPA or from any other grant you are currently receiving from the EPA or other federal government agency.
Collaborative applications involving more than one institution must be submitted as a single administrative package from one of the institutions involved.
Any contracts for services or products funded with EPA financial assistance must be awarded under the competitive procurement procedures of 40 CFR Part 30. Moreover, naming a specific contractor in the application does not relieve the applicant of its obligations to comply with competitive procurement requirements. Also, the regulations contain limitations on consultant compensation.
Submission Instructions for Paper Applications
The application and abstract must be prepared in accordance with these instructions. The original, signed copy of the application must not be permanently bound or stapled in any way. The other two (2) required copies of the application should be secured with paper or binder clips or secure staples.
Because of security concerns, paper 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)
Funding opportunity number: EPA-G2006-STAR-XX (replace the "XX" with the appropriate number)
1200 Pennsylvania Avenue, NW
Washington , DC 20460
The following address must be used for express mail and couriers:
U.S. Environmental Protection Agency
Peer Review Division (8725F)
Funding opportunity number: EPA-G2006-STAR-XX (replace the "XX" with the appropriate number)
1025 F Street, NW (Room 3500)
Washington , DC 20004
Phone: (202) 233-0686
Submission Instructions for Electronic Applications Using Grants.gov
The electronic application package available through the http://www.grants.gov/ web site must be used for electronic submissions. In order to view the application package, download the PureEdge viewer (hyperlink available under "Apply for Grants" then "Apply Step 1"). The application package may be quickly accessed from https://apply.grants.gov/forms_apps_idx.html using either the CFDA number of 66.509 or the funding opportunity number. Be sure to download the electronic application package for the appropriate funding opportunity number or topic. It is recommended that you “Register to Receive Notification” of announcement updates.
The actual submission of an electronic application must be made by an authorized organizational representative (AOR) of the submitting institution who is registered with grants.gov (most individual investigators will not be eligible to submit the application). See http://www.grants.gov/, “Get Started” for further information. The registration process may take a week or longer to complete. Check with your Sponsored Programs or equivalent office to locate your AOR and see if your institution is registered. If your institution is not currently registered, encourage your AOR to begin the process immediately.
The complete application must be transferred to grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date (see “Submission Dates and Times”). An e-mail will be sent by NCER to the Principal Investigator and the Administrative Contact to acknowledge receipt of the application and to transmit other important information. The email will be sent from email@example.com; email to this address will not be accepted. If an email acknowledgment from NCER (not firstname.lastname@example.org) has not been received within 30 days of the submission closing date, immediately contact the Technical Contact listed under “Agency Contacts” in this solicitation. Failure to do so may result in your application not being reviewed.
Documents must be submitted in Adobe Acrobat PDF format to maintain format integrity. Prior to preparing the electronic application package, view files for any PDF conversion errors. Submit the required documents as described below.
On the electronic Grant Application Package page, enter the Principal Investigator’s name, starting with the last name, in the “Application Filing Name” field.
- Application for Federal Assistance (SF-424)
- EPA Key Contacts Form 5700-54
- Complete the form.
- If additional pages are needed, see “E. Other Attachments Form” below.
- Project Narrative Attachment Form
- Compile the Research Plan as described above followed by the Quality Assurance Statement into one document labeled ResearchPlanQA and submit it as the “Add Mandatory Project Narrative File”.
- Prepare a document with your abstract, label it Abstract, and submit it as an “Add Optional Project Narrative File”.
- Prepare one document containing all Resumes followed by Current and Pending Support (see format example located at http://www.epa.gov/ncer/rfa/forms/), label it Resumes, and submit it as an “Add Optional Project Narrative File”.
- Prepare a document containing the Data Plan, label it DataPlan, and submit it as an “Add Optional Narrative File”.
- Budget Narrative Attachment Form
- Where possible, prepare one document for your Budget and Budget Justification (see format example located at http://www.epa.gov/ncer/rfa/forms/), label this document BudgetAndJustification, and submit it as the “Add Mandatory Budget Narrative”.
- If you cannot compile your Budget and Budget Justification into one document, prepare one document for each.
- Label your Budget document Budget and submit it as the “Add Mandatory Budget Narrative”.
- Label the Budget Justification document BudgetJustification and submit it as an “Add Optional Budget Narrative” document.
- When submitting letters of intent, first refer to the “Letters of Intent/Letters of Support” paragraph under Section IV. H. (Guidelines, Limitations and Additional Requirements) for additional information. Letters of intent appropriate for inclusion in the budget justification are to be compiled into one document named LettersofIntent and submitted as an “Add Optional Budget Narrative” document.
- Other Attachments Form
- If Key Contacts Continuation pages are needed for the Key Contacts Form 5700-54, compile them into one document labeled ContactsContinuation and submit the document.
- Other appropriate documents may also be submitted here.
Complete the form. There are no attachments.
Once the application package has been completed, the “Submit” button will become active. Save your completed application package with two different file names before providing it to your AOR to avoid having to re-create the package should submission problems be experienced. Submission of the application package must be completed by your AOR.
Close all other software before attempting to submit the application package. If you experience submission problems, reboot your computer (turning the power off may be necessary) and re-attempt the submission. If submission problems continue, contact grants.gov for assistance (Phone: 1-800-518-4726, Email: email@example.com ). If submission problems are not quickly resolved, contact the NCER electronic submission support person, Bronda Harrison (Phone: 202-564-1790, Email: firstname.lastname@example.org ).
- Research Proposal (criteria “1a” through “1f” are essentially equal):
- The originality and creativity of the proposed research, the appropriateness and adequacy of the proposed research methods, and the Quality Assurance Statement.
- Is the research approach practical and technically defensible, and can the project be performed within the proposed time period?
- Will the research contribute to scientific knowledge in the topic area?
- What are the projected benefits of the proposed activity to society, such as improving the environment or human health?
- Will the results be disseminated broadly to enhance scientific and technological understanding?
- Is the proposal well prepared with supportive information that is self-explanatory or understandable?
- Investigators: The qualifications of the Principal Investigator(s) and other key personnel, including research training, demonstrated knowledge of pertinent literature, experience, and publication records. Will all key personnel make a significant time commitment to the project?
- Responsiveness: The responsiveness of the proposal to the research needs identified for the topic area. Does the proposal adequately address the objectives and special considerations specified by the EPA for this topic area?
- Facilities and equipment: The availability and/or adequacy of the facilities and equipment proposed for the project. Are there any deficiencies that may interfere with the successful completion of the research?
- Budget: Although budget information does not reflect on the application”s scientific merit, the reviewers are asked to provide their view on the appropriateness and/or adequacy of the proposed budget and its implications for the potential success of the proposed research. Input on requested equipment is of particular interest.
Review and Selection Process
All grant applications are reviewed by an appropriate external technical peer review panel using the criteria above. In general, each peer review group is composed of non-EPA scientists, engineers, social scientists, and/or economists who are experts in their respective disciplines and proficient in the technical subjects they are reviewing. Reviewers are asked to assign a summary score of excellent, very good, good, fair, or poor to each application. This review is designed to evaluate each application according to its scientific merit.
Applications receiving scores of excellent or very good as a result of the peer review process will then undergo a programmatic review conducted by technical experts from the EPA, including individuals from the Office of Research and Development (ORD) and program and regional offices involved with the science or engineering proposed. All other applications are automatically declined. The internal programmatic review panel considers:
- the relevance of the proposed science to EPA research priorities,
- the applicant’s past performance and reporting, and
- the applicant’s organizational experience.
The purpose of the programmatic review is to assure an integrated research portfolio for the Agency and help determine which applications to recommend for award. In conducting the programmatic review, the EPA will consider information provided by the applicant and may consider information from other sources including prior/current grantors and agency files.
Final funding decisions are made by the NCER Director based on the results of the peer review and internal programmatic review. In addition, in making the final funding decisions, the NCER Director may also consider program balance, available funds and the Congressionally mandated Experimental Program to Stimulate Competitive Research (EPSCOR) (see http://www.epa.gov/ncer/other/). Applicants selected for funding will be required to provide additional information listed below under “Award Notices.” The application will then be forwarded to EPA’s 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 closing date. A summary statement of the scientific review by the peer panel will be provided to each applicant with an award or declination letter. After selection for award, applicants recommended for funding will be required to submit additional certifications and an electronic version of the revised project abstract. They may also be asked to provide responses to comments or suggestions offered by the peer reviewers, a revised budget, and/or to resubmit their proposal. EPA Project Officers will contact Principal Investigators to obtain these materials. Several topics may be included in the negotiations conducted prior to award including formal identification of key personnel. Where a cooperative agreement is appropriate, the EPA Project Officer will negotiate with applicants to describe the nature of any collaboration with EPA scientists or engineers. The purpose of this negotiation is to ensure all aspects of the collaboration are clearly understood by the affected parties.
Nonprofit applicants recommended for funding under this announcement will be subject to a preaward administrative capability review consistent with sections 8.b, 8.c, and 9.d of EPA Order 5700.8, EPA Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/regulations.htm). The official notification of an award will be made by the Agency”s Grants Administration Division. Applicants are cautioned that only a grants officer can bind the Government to the expenditure of funds; preliminary selection by the NCER Director in the Office of Research and Development does not guarantee an award will be made. Before or after an award, applicants may be required to provide additional quality assurance documentation.
Disputes related to this assistance agreement competition will be resolved in accordance with the dispute resolution procedures set forth in 70 FR 3629, 3630 (January 26, 2005) which can be found at http://www.epa.gov/ogd/competition/resolution.htm. Questions regarding disputes may be referred to the Eligibility Contact identified below.
Administrative and National Policy Requirements
Expectations and responsibilities of NCER grantees are summarized in this section. See http://www.epa.gov/ncer/guidance for the full terms and conditions associated with an award, including which activities require prior approval from the EPA.
- Meetings: Principal Investigators will be expected to budget for, and participate in, All-Investigators Meetings (also known as progress reviews) approximately once per year with EPA scientists and other grantees to report on research activities and discuss issues of mutual interest.
- Approval of Changes after Award: Prior written approval is required from the EPA if there will be significant change from work described in the application. Examples of these changes are contained in 40 C.F.R. 30.25. Note: prior written approval is also required from the EPA for incurring costs more than 90 calendar days prior to award.
- Human Subjects: A grant recipient must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 C.F.R. 26, referred to as the “Common Rule”. No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s Institutional Review Board’s (IRB) approval of the project and the EPA has also provided approval. Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports. Until further notice, applications involving intentional dosing of human subjects will not be considered for award by EPA.
- Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156. The recipient must also agree to abide by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training” (50 Federal Register 20864-20865. May 20,1985).
- Data Access and Information Release: After award, all data (including primary and secondary/existing data) must be made available to the NCER Project Officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and nonspecialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data. If requested, the data products and their metadata must be provided to the NCER Project Officer in a standard exchange format no later than the due date of the grant's final report or the publication of the data product's associated results, whichever comes first.
- Reporting : A grant recipient must agree to provide annual progress reports, with associated summaries for posting on NCER’s web site, and a final report with an executive summary for web posting.
- Acknowledgement of EPA Support: EPA’s full or partial support must be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications. Any documents developed under the agreement for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:
Congress, through OMB, has instructed each federal agency to implement Information Quality Guidelines designed to "provide policy and procedural guidance...for ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by Federal agencies." The EPA's implementation may be found at http://www.epa.gov/quality/informationguidelines/. These procedures may apply to data generated by grant recipients if those data are disseminated as described in the Guidelines.
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with federal funds and (2) cited publicly and officially by a federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If such data are requested by the public, the EPA must ask for it, and the grantee must submit it, in accordance with A-110 and the EPA regulations at 40 C.F.R. 30.36.
A grant recipient must agree to provide copies of any peer reviewed journal article(s) resulting from the research during the project period. In addition, the recipient should notify the EPA Project Officer of any papers published after completion of the grant that are based on research supported by the grant. NCER posts references to all publications resulting from a grant on the NCER web site.
A graphic that can be converted to a slide or used in other ways, such as on a poster, is located at http://www.epa.gov/ncer/guidance/star_images.html. EPA expects recipients to use this graphic in oral and poster presentations.
Further information, if needed, may be obtained from the EPA officials indicated below. Information regarding this RFA obtained from sources other than these Agency Contacts may not be accurate. Email inquiries are preferred.
Eligibility Contact: Tom Barnwell: 202-343-9862; email: email@example.com
Electronic Submissions: Bronda Harrison: 202-564-1790; email: firstname.lastname@example.org
Technical Contact: Susan Laessig; Phone: 202-564-5232; email: email@example.com