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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

Approaches to Assessing Potential Food Allergy from Genetically Engineered Plants

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2009-STAR-H1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: October 2, 2009
Solicitation Closing Date: January 7, 2010, 11:59:59 pm Eastern Time

Eligibility Contact: William Stelz (stelz.william@epa.gov); phone: 703-347-8039
Electronic Submissions: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Technical Contact: Susan Laessig (laessig.susan@epa.gov); phone: 202-564-5232

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 (http://www.epa.gov/ncer/rfa/forms/)
View research awarded under previous solicitations (http://www.epa.gov/ncer/rfa/archive/grants/)

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 issuing this request for applications (RFA) for applied research on innovative or improved methods to predict whether or not a pesticide protein is a food allergen. Research to characterize the key factors that influence human immune responses to dietary proteins is needed in order to better assess potential food allergy from genetically engineered plants. Proposals are requested on the role of dose, route of sensitization, and/or the physicochemical properties of ingested proteins and their influence on the development of immune sensitization, oral tolerance, or the elicitation of allergic symptoms. Also of interest is how the food matrix and gastrointestinal environment in which proteins are ingested may affect these immune responses. The overall aim of the research program is to improve safety assessment for genetically engineered plants by enhancing the ability to estimate the potency of unknown proteins relative to known allergenic and non-allergenic proteins. Because there is no single, definitive test for determining the allergenic potential of novel pesticide proteins in the diet, risk assessment associated with the regulation of foods derived from modern biotechnology currently uses a weight-of-evidence approach. The research will contribute to improved methods for assessing the potential dietary allergenicity of pesticide proteins in genetically engineered plants.

Award Information:

Anticipated Type of Award: Grant    
Estimated Number of Awards: Approximately 4 awards
Anticipated Funding Amount: Approximately $1.7 million total for all awards
Potential Funding per Award: Up to a total of $425,000, 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 full announcement for more details.

Application Materials:
The necessary forms for submitting a STAR application will be found on the National Center for Environmental Research (NCER) web site, http://epa.gov/ncer/rfa/forms/. Electronic submission of your application must be performed by an authorized representative of your organization.

Applicants must submit the full application in PDF format via electronic mail to 2009-Biotech-APPS@epa.gov with the funding opportunity number (FON) in the subject line by the solicitation closing date and time.

If you do not have the technical capability to utilize the electronic mail submission process for this solicitation, call 1-800-490-9194 or send a webmail message to (http://www.epa.gov/ncer/contact_us.html) at least 15 calendar days before the submission deadline to assure timely receipt of alternate submission instructions.  In your message provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available.  Alternate instructions will be e-mailed whenever possible.  Any applications submitted through alternate submission methods must comply with all the provisions of this RFA, including Section IV, and be submitted by the solicitation closing date and time identified above.

Agency Contacts:
Eligibility Contact: William Stelz (stelz.william@epa.gov); phone: 703-347-8039
Electronic Submissions: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Technical Contact: Susan Laessig (laessig.susan@epa.gov); phone: 202-564-5232

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction
Biotechnology is now commonly used to develop new pesticide products for agricultural pest control by incorporating genes that code for pesticidal proteins into plants. The genes for pesticidal proteins are often inserted into plants that are then used for human consumption including the majority of soybeans, as well as large proportions of corn, canola, and cotton crops worldwide. These genetically engineered plants express specific pesticide proteins to kill insects that eat the plant parts or confer tolerance to herbicide application. To date, no adverse health effects attributed to genetically engineered foods have been documented in the human population. As part of the pesticide registration process, EPA assesses the potential of novel pesticide proteins to cause dietary allergy.

In 2004, the EPA Office of Research and Development (ORD) prioritized research on biotechnology, including research on the potential allergenicity of pesticide proteins introduced into the diet by biotechnology. Virtually all known food allergens are proteins and food allergy, an adverse immunologic reaction to food, currently affects 5-7% of children and 1-2% of adults in Europe and North America. Food allergy 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). The scope of this solicitation is applied research on innovative or improved methods to predict whether or not a pesticide protein is a food allergen.

The EPA currently supports a number of biotechnology research grants resulting from previous solicitations. Information regarding current research can be found on ORDs National Center for Environmental Research (NCER) web site at http://epa.gov/ncer/biotechandfood/.

B. Background
Responsibility for regulating agricultural biotechnology is shared between the EPA, the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). EPA is responsible for 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 engineered pesticidal proteins referred to as plant-incorporated protectants (PIPs). OPPTS establishes maximum allowable levels for pesticide residues in food and evaluates 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 the proper human health and ecological assessment of novel proteins including PIPs that may be present as residues in genetically engineered crops. EPAs Biotechnology Research Program (EPA, 2005) has identified the potential allergenicity of pesticidal proteins introduced into the food supply by genetic engineering as one of five key research areas of greatest importance.

The National Research Council (NRC) (NRC, 2004) recommended improving assessment methods of all foods for unintended health effects, including the assessment of genetically engineered crops intended for human consumption. The NRC emphasized the importance of using a combination of approaches to increase the ability to detect or prevent risks to human health and recommended that research priority be given to developing improved methods for identifying potential allergens using endpoints of human immune function and reliable animal models. Because there is no single, definitive test for determining the allergenic potential of novel pesticide proteins in the diet, risk assessment associated with the regulation of foods derived from modern biotechnology currently uses a weight-of-evidence approach.

Current testing methods rely on comparing the amino acid sequence of a novel protein to known protein allergens as well as determining the rate of proteolytic degradation under simulated mammalian conditions of digestion. The international authority on food safety, the Codex Alimentarius, (referred to as Codex) recommends evaluating biotechnology products for potential allergenicity by considering the source of the introduced protein; any significant similarity between the amino acid sequence of the protein and that of known allergens; and its structural properties, including but not limited to, its susceptibility to enzymatic degradation, heat stability and/or, acid and enzymatic treatment. Codex further states: As scientific knowledge and technology evolves, other methods and tools may be considered in assessing the allergenicity potential of newly expressed proteins as part of the assessment strategy. These methods should be scientifically sound and may include targeted serum screening (i.e. the assessment of binding to IgE in sera of individuals with clinically validated allergic responses to broadly-related categories of foods); the development of international serum banks; use of animal models; and examination of newly expressed proteins for T-cell epitopes and structural motifs associated with allergens (Codex, 2003).

The U.S. Environmental Protection Agency (EPA), Health Canada, and industry have recently funded research in an effort to increase the scientific knowledge and technology available to assess the potential allergenicity of transgenic proteins. Significant progress has recently been made toward developing new approaches for assessing potential risk using structure-activity relationships, in vitro screens, and animal models (Selgrade et al., 2009). In 2007, EPA and the National Institute of Allergy and Infectious Disease (NIAID) initiated a joint exploratory research initiative to attract new investigators to study the progression and treatment of food allergy (NIAID, 2007). The research focused on the factors that contribute to the development of food allergies, the relationship between other immune system disorders and food allergies, and the epidemiology and genetics of food allergy, as well as methods for assessing potential allergenicity.

Ongoing challenges for applying existing methods to safety assessment of new pesticide proteins include standardization of test materials, the design and interpretation of results of testing with whole foods versus purified protein, identifying additional sequences of allergenic IgE epitopes, and lack of available sera from allergic patients. Predictive models are needed that can determine the relative allergenicity of a transgenic protein as compared to conventional food proteins (Metcalfe et al., 1996). Specific challenges for animal testing include achieving sensitization and/or elicitation of allergic symptoms at physiologically relevant doses, via the relevant route of exposure in a readily available animal strain. Understanding the development or lack of oral tolerance to food proteins is a continuing issue (Knippels and Penninks, 2003). Since altering digestibility, pH, and/or solubility of the test food extract can change the results obtained from an animal model of oral exposure (Bowman and Selgrade, 2008a,b), further study on the interaction of food in the gastrointestinal system with the immune system and the importance of the food matrix to the development of food allergy is needed to understand the role of the food matrix, predictive ability of pepsin digestibility, and the role of oral tolerance. More work is also needed on identification of appropriate endpoints, particularly those that reflect anaphylactic reactions.

The specific Strategic Goal and Objective from the EPAs Strategic Plan that relate to this solicitation are:

    Goal 4: Healthy Communities and Ecosystems, Objective 4.4: Enhance Science and Research

The EPAs Strategic Plan can be found at: http://www.epa.gov/ocfo/plan/2006/entire_report.pdf (PDF) (184 pp, 9.87 MB, about PDF)

C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r.

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

Applicable regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants). Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220, OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225, OMB Circular A-102 (Grants and Cooperative Agreements With State and Local Governments), OMB Circular A-110 (Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations) relocated to 2 CFR Part 215, and OMB Circular A-122, (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230.

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.

EPA, as part of its Science to Achieve Results (STAR) Program, is seeking applications for applied research on innovative or improved methods to predict whether or not a pesticide protein is a food allergen. Because there is no single, definitive test for determining the allergenic potential of novel pesticide proteins in the diet, risk assessment associated with the regulation of foods derived from modern biotechnology currently uses a weight-of-evidence approach as described above. In order to better assess the human health risk from genetically engineered plants, research is needed to characterize the key factors that influence human immune responses to dietary proteins. The overall aim of the research program is to improve safety assessment for genetically engineered plants by developing innovative or enhancing existing methods to estimate the potency of unknown proteins relative to known allergenic and non-allergenic proteins. The research solicited in this RFA addresses key gaps in the understanding of what makes a protein behave as a dietary allergen in order to improve the risk assessment for pesticide proteins with unknown allergenicity.

Specific research areas of interest for this solicitation include aspects of the mechanisms of development of sensitization, oral tolerance, and the elicitation of allergic symptoms as identified below.

Specific Research Areas of Interest

  • Research on the role of route, dose, and duration of exposure to protein allergens in the development of food allergy that will lead to a better understanding of how the characteristics of exposure may lead to sensitization, oral tolerance, and the elicitation of allergic symptoms in response to pesticide proteins.
  • Research on the influence of physicochemical properties of proteins, such as linear and non-linear protein structure (epitopes), as well as research on how the matrix in which proteins are presented may influence protein structure and subsequent sensitization, oral tolerance, and the elicitation of allergic symptoms in response to pesticide proteins.
  • Research on the importance of the gastrointestinal environment in which proteins are ingested for the development of sensitization, oral tolerance, and the elicitation of allergic symptoms in response to pesticide proteins.
  • Research on how age-related factors associated with food allergy may influence susceptibility to sensitization, oral tolerance, and the elicitation of allergic symptoms in response to pesticide proteins.

These specific research areas target the key unknown factors related to sensitization, oral tolerance, and the elicitation of allergic symptoms that may enable predictions of whether food allergy will develop in individuals exposed to pesticide proteins. Proposals must address one or more of the specific research areas of interest using innovative approaches to develop or improve models that predict dietary protein allergenicity. Interdisciplinary projects and projects that address two or more of these areas are welcomed. The proposed research in these areas should rely on species, routes of exposure, adjuvants, and physiologic and immunological endpoints relevant to human safety assessment. The integration of multiple approaches, such as computational, in vitro, and in vivo approaches, to address these areas is encouraged. Proposals should carefully consider the choice of negative and positive protein controls used to compare food allergens in the model used for the investigation and how the results can be interpreted for proteins with unknown allergenicity. Proposed projects are not required to use or test actual pesticide proteins because they are not commercially available. Research on basic mechanisms of food allergy that does not have a clear application to improving safety assessment of pesticide proteins produced through biotechnology will not be funded.

The expected outputs of this RFA are innovative approaches, test methods, or predictive models and increased knowledge of the mechanisms of dietary sensitization, oral tolerance, and the elicitation of allergic symptoms that may be associated with potential allergenicity of novel pesticide proteins in food. The expected outcomes are an improved ability to accurately predict the risk of dietary allergenicity posed by the introduction of novel genetically engineered pesticide proteins into food as well as improved diagnosis, treatment, and prevention of, the sometimes life threatening allergic reactions to food in general.

E. References

  1. 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.
  2. Bowman, C. C., and Selgrade, M. K. (2008a). Differences in allergenic potential of food extracts following oral exposure in mice reflect differences in digestibility: potential approaches to safety assessment. Toxicol Sci 102, 100-9.
  3. Bowman, C. C., and Selgrade, M. K. (2008b). Failure to induce oral tolerance in mice is predictive of dietary allergenic potency among foods with sensitizing capacity. Toxicol Sci 106, 435-43.
  4. Codex Alimentarius (2003). Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants, Annex: Assessment of Possible Allergenicity (CAC/GL 45-2003).
  5. Kagen, R.S. (2003). Food allergy: An overview. Environ. Health Perspect. 111 (2):223-225.
  6. 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.
  7. Metcalfe, D. D., Astwood, J. D., Townsend, R., Sampson, H. A., Taylor, S. L., and Fuchs, R. L. (1996). Assessment of the allergenic potential of foods derived from genetically engineered crop plants. Crit Rev Food Sci Nutr 36 Suppl, S165-86.
  8. National Institute of Allergy and infectious Diseases. 2007. RFA-AI-07-032: Exploratory Investigations in Food Allergy (R21) (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-07-032.html).
  9. National Research Council (2004). Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. National Academies Press: Washington, DC.
  10. Selgrade MK, Bowman CC, Ladics GS, Privalle L, Laessig SA. (2009). Safety Assessment of Biotechnology Products for Potential Risk of Food Allergy: Implications of New Research. Toxicol Sci. 110(1):31-39.
  11. 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 (52 pp, 6.6 MB)

F. Special Requirements
Agency policy prevents EPA technical staff and managers from providing individual applicants with information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA RFAs, nor will they endorse an application or discuss in any manner how the Agency will apply the published evaluation criteria for this competition.

Multiple Investigator applications may be submitted as: (1) a single Lead Principal Investigator (PI) application with Co-PI(s) or (2) a Multiple PI application (with a single Contact PI). If you choose to submit a Multiple PI application, you must follow the specific instructions provided in Sections IV. and V. of this RFA. For further information, please see the EPA Implementation Plan for Policy on Multiple Principal Investigators (http://rbm.nih.gov/toolkit.htm).

II. AWARD INFORMATION

It is anticipated that a total of approximately $1.7 million will be awarded under this announcement, depending on the availability of funds and quality of applications received. The EPA anticipates funding approximately 4 awards under this RFA. Requests for amounts in excess of a total of $425,000, including direct and indirect costs, will not be considered. The total project period requested in an application submitted for this RFA may not exceed 3 years. The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA. The EPA reserves the right to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made. Any additional selections for awards will be made no later than six months after the original selection decisions.

EPA intends to award only grants under this announcement.

Under a grant, EPA scientists and engineers are not permitted to be substantially involved in the execution of the research. However, EPA encourages interaction between its own laboratory scientists and grant Principal Investigators after the award of an EPA grant for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. This interaction must be incidental 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, located at 2 CFR Part 230. 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 Agencys 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 William Stelz (stelz.william@epa.gov) in NCER, phone (202) 343-9802.

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 submitted to EPA (see Section IV.E. Submission Instructions and Other Submission Requirements for further information) 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.

  • Proposals must address one or more of the specific research areas of interest using innovative approaches to develop or improve models that predict dietary protein allergenicity.
  • Proposed projects are not required to use or test actual pesticide proteins because they are not commercially available.
  • Research on basic mechanisms of food allergy that does not have a clear application to improving safety assessment of pesticide proteins produced through biotechnology will not be funded.

In addition, to be eligible for funding consideration, a projects focus must consist of activities within the statutory terms of EPAs 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 depending on which statute(s) is listed in I.C. above. 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

A. Internet Address to Request Application Package
The full application must be submitted electronically via e-mail to 2009-Biotech-APPS@epa.gov (or through any authorized alternate submission methods described below) by the solicitation closing date and time. All necessary forms are available at http://epa.gov/ncer/rfa/forms/.

An email will be sent by NCER to the Lead/Contact PI 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 acknowledgment 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 Section E. Submission Instructions and Other Submission Requirements for additional information regarding the application receipt acknowledgment.

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

  1. Standard Form 424

    The applicant must complete Standard Form 424. 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 signature of an authorized representative of the applying organization.

    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 exit EPA.

    Executive Order 12372, Intergovernmental Review of Federal Programs, does not apply to the Office of Research and Development's research and training programs unless EPA has determined that the activities that will be carried out under the applicants' proposal (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.

    If EPA determines that Executive Order 12372 applies to an applicant's proposal, the applicant must follow the procedures in 40 CFR Part 29. The applicant must notify their state's single point of contact (SPOC). To determine whether their state participates in this process, and how to comply, applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html. If an applicant is in a State that does not have a SPOC, or the State has not selected research and development grants for intergovernmental review, the applicant must notify directly affected State, area wide, regional and local entities of its proposal.

    EPA will notify the successful applicant(s) if Executive Order 12372 applies to its proposal prior to award.

  2. Key Contacts

    The applicant must complete the Key Contacts form available at http://epa.gov/ncer/rfa/forms/. The form includes an Additional Key Contacts page to be completed for additional investigators. The Key Contacts form should also be completed for major sub-agreements (i.e., primary investigators). Please make certain that all contact information is accurate.

    For Multiple PI applications: The Additional Key Contacts form must be completed (see Section I.F. for further information). Note: The Contact PI must be affiliated with the institution submitting the application. EPA will direct all communications related to scientific, technical, and budgetary aspects of the project to the Contact PI; however, any information regarding an application will be shared with any PI upon request. The Contact PI is to be listed on the Key Contact Form as the Principal Investigator. For additional PIs, complete the Major Co-Investigator fields and identify PI status next to the name (e.g., Name: John Smith, Principal Investigator).

  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: For applications with multiple investigators, state whether this is a single Lead PI (with co-PIs) or Multiple PI application (see Section I.F.). For Lead PI applications, list the Lead PI, then the name(s) of each co-PI who will significantly contribute to the project. For Multiple PI applications, list the Contact PI, then the name(s) of each additional PI. 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: http://epa.gov/ncer/rfa/forms/.
  5. Research Plan, Quality Assurance Statement, Data Plan 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.
      2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above.
      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 publics ability to protect the environment and human health. A clear, concise description will help NCER and peer reviewers understand the merits of the research.
      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.
      5. Appendices may be included but must remain within the 15-page limit.
    2. Quality Assurance Statement (3 pages)

      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.

      NOTE: If selected for award, applicants will be expected to provide additional quality assurance documentation.

      Address each applicable 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. (Not all will apply.)

      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 persons functions, experience, and authority within the research organization. Describe the organizations 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. Identify the types of secondary data needed to satisfy the project objectives. Specify requirements relating to the type of data, the age of data, geographical representation, temporal representation, and technological representation, as applicable.
          2. Specify the source(s) of the secondary data and discuss the rationale for selection.
          3. Establish a plan to identify the sources of the secondary data in all deliverables/products.
          4. Specify quality requirements and discuss the appropriateness for their intended use. Accuracy, precision, representativeness, completeness, and comparability need to be addressed, if applicable.
          5. Describe the procedures for determining the quality of the secondary data.
          6. Describe the plan for data management/integrity.
        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 methods 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.
    3. References: References cited are in addition to other page limits (e.g. research plan, quality assurance statement)
  6. Budget and Budget Justification
    1. Budget

      Prepare a master budget table using SF-424A Budget Information for Non-Construction Programs (aka SF-424A), available at http://epa.gov/ncer/rfa/forms/. Only complete Section B-Budget Categories. Provide the object class budget category (a. - k.) amounts for each budget year under the Grant Program, Function or Activity heading. Each column reflects a separate budget year. For example, Column (1) reflects budget year 1. The total budget will be automatically tabulated in column (5).

      If a subaward, such as a subagreement with an educational institution is included in the application, provide a separate SF-424A and budget justification for the subaward. Include the total amount for the subaward under Other in the master SF-424A. Applicants may not use subagreements to transfer or delegate their responsibility for successful completion of their EPA assistance agreement. Therefore, EPA expects that subawards or subcontracts should not constitute more than 40% of the total direct cost of the total project budget. If a subaward/subcontract constitutes more than 40% of the total direct cost, additional justification may be required before award, 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.

      Please note that when formulating budgets for proposals/applications, applicants must not include management fees or similar charges in excess of the direct costs and indirect costs at the rate approved by the applicants cognizant audit agency, or at the rate provided for by the terms of the agreement negotiated with EPA. The term "management fees or similar charges" refers to expenses added to the direct costs in order to accumulate and reserve funds for ongoing business expenses, unforeseen liabilities, or for other similar costs that are not allowable under EPA assistance agreements. Management fees or similar charges may not be used to improve or expand the project funded under this agreement, except to the extent authorized as a direct cost of carrying out the scope of work.

    2. Budget Justification [2 pages in addition to the Section IV.B.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 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 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 http://epa.gov/ncer/rfa/forms/) for each investigator and important co-worker. Include all current and pending research regardless of source.

  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 the success of the proposal are considered letters of support. Letters of support, and letters of intent that exceed one brief paragraph (excluding letterhead and salutations), 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. Any transactions between the successful applicant and parties providing letters of support or intent financed with EPA grant funds are subject to the funding restrictions described in Section IV. D. Applicants must not submit letters of support from EPA staff.

    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:
      Approaches to Assessing Potential Food Allergy from Genetically Engineered Plants, EPA-G2009-STAR-H1

    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 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 their application/proposal package as confidential business information. EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2. Applicants must clearly mark applications/proposals or portions thereof that they claim as confidential. If no claim of confidentiality is made, EPA is not required to make the inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure. However, competitive proposals/applications are considered confidential and protected from disclosure prior to the completion of the competitive selection process.

C. Submission Dates and Times
Applications must be submitted no later than 11:59:59 pm Eastern Time on the solicitation closing date. Applications submitted after the closing date and time will be returned to the sender without further consideration.

It should be noted that this schedule may be changed without prior notification because of factors not anticipated at the time of announcement. In the case of a change in the solicitation closing date, a new date will be posted on the NCER web site (http://epa.gov/ncer/).

Solicitation Closing Date: January 7, 2010, 11:59:59 pm Eastern Time (applications must be submitted to EPA by this time, see Section IV.E Submission Instructions and Other Submission Requirements for further information).

NOTE: Customarily, applicants are notified about evaluation decisions within six months of the solicitation closing date. Awards are generally made 9-12 months after the solicitation closing date.

D. Funding Restrictions
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 an assistance agreement 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, 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(s).

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 financial assistance 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.

EPA awards funds to one eligible applicant as the recipient even if other eligible applicants are named as partners or co-applicants or members of a coalition or consortium. The recipient is accountable to EPA for the proper expenditure of funds.

Funding may be used to provide subgrants or subawards of financial assistance, which includes using subawards or subgrants to fund partnerships, provided the recipient complies with applicable requirements for subawards or subgrants including those contained in 40 CFR Parts 30 or 31, as appropriate. Applicants must compete contracts for services and products, including consultant contracts, and conduct cost and price analyses to the extent required by the procurement provisions of the regulations at 40 CFR Parts 30 or 31, as appropriate. The regulations also contain limitations on consultant compensation. Applicants are not required to identify subawardees/subgrantees and/or contractors (including consultants) in their proposal/application. However, if they do, the fact that an applicant selected for award has named a specific subawardee/subgrantee, contractor, or consultant in the proposal/application EPA selects for funding does not relieve the applicant of its obligations to comply with subaward/subgrant and/or competitive procurement requirements as appropriate. Please note that applicants may not award sole source contracts to consulting, engineering or other firms assisting applicants with the proposal based solely on the firm's role in preparing the proposal/application.

Successful applicants cannot use subgrants or subawards to avoid requirements in EPA grant regulations for competitive procurement by using these instruments to acquire commercial services or products from for-profit organizations to carry out its assistance agreement. The nature of the transaction between the recipient and the subawardee or subgrantee must be consistent with the standards for distinguishing between vendor transactions and subrecipient assistance under Subpart B Section .210 of OMB Circular A-133, and the definitions of subaward at 40 CFR 30.2(ff) or subgrant at 40 CFR 31.3, as applicable. EPA will not be a party to these transactions. Applicants acquiring commercial goods or services must comply with the competitive procurement standards in 40 CFR Part 30 or 40 CFR Part 31.36 and cannot use a subaward/subgrant as the funding mechanism.

Section V of the announcement describes the evaluation criteria and evaluation process that will be used by EPA to make selections under this announcement. During this evaluation, except for those criteria that relate to the applicant's own qualifications, past performance, and reporting history, the review panel will consider, if appropriate and relevant, the qualifications, expertise, and experience of:

  1. an applicant's named subawardees/subgrantees identified in the proposal/application if the applicant demonstrates in the proposal/application that if it receives an award that the subaward/subgrant will be properly awarded consistent with the applicable regulations in 40 CFR Parts 30 or 31. For example, applicants must not use subawards/subgrants to obtain commercial services or products from for profit firms or individual consultants.
  2. an applicant's named contractor(s), including consultants, identified in the proposal/application if the applicant demonstrates in its proposal/application that the contractor(s) was selected in compliance with the competitive procurement standards in 40 CFR Part 30 or 40 CFR 31.36 as appropriate. For example, an applicant must demonstrate that it selected the contractor(s) competitively or that a proper non-competitive sole-source award consistent with the regulations will be made to the contractor(s), that efforts were made to provide small and disadvantaged businesses with opportunities to compete, and that some form of cost or price analysis was conducted. EPA may not accept sole source justifications for contracts for services or products that are otherwise readily available in the commercial marketplace.

EPA will not consider the qualifications, experience, and expertise of named subawardees/subgrantees and/or named contractor(s) during the proposal/application evaluation process unless the applicant complies with these requirements.

Each proposed project must be able to be completed within the project period and with the initial award of funds. Applicants should request the entire amount of money needed to complete the project. Recipients should not anticipate additional funding beyond the initial award of funds for a specific project.

E. Submission Instructions and Other Submission Requirements
Please read this entire section before attempting an electronic submission.

If you do not have the technical capability to utilize the electronic mail submission process for this solicitation, call 1-800-490-9194 or send a webmail message to (http://www.epa.gov/ncer/contact_us.html) at least 15 calendar days before the submission deadline to assure timely receipt of alternate submission instructions. In your message provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available. Alternate instructions will be e-mailed whenever possible. Any applications submitted through alternate submission methods must comply with all the provisions of this RFA, including Section IV, and be submitted by the solicitation closing date and time identified above.

The applicant must submit the full application package, as described in Section IV.B, in PDF format via electronic mail to 2009-Biotech-APPS@epa.gov with the funding opportunity number (FON) in the subject line.

  1. Preparing for Submission. All required forms can be found at: (http://www.epa.gov/ncer/rfa/forms).

    Note: The electronic submission of your application package must be made by an official representative of your organization who is authorized to sign for Federal assistance. Submission instructions are updated on an as-needed basis. Please provide your authorized representative with a copy of the following instructions to avoid submission delays that may occur from the use of outdated instructions.

  2. Acknowledgement of Receipt. The complete application must be submitted to 2009-Biotech-APPS@epa.gov no later than 11:59:59 pm Eastern Time on the solicitation closing date (see Submission Dates and Times). The only official documentation that the application has been received by NCER is the e-mail acknowledgement sent by NCER to the Lead/Contact PI and the Administrative Contact. This email will be sent from receipt.application@epa.gov; emails to this address will not be accepted. If an email acknowledgment from NCER has not been received within 30 days of the solicitation closing date, immediately inform the Eligibility Contact shown in this solicitation. Failure to do so may result in your application not being reviewed.
  3. Application Package Preparation. The application package consists of a. through c. below.
    1. Application for Federal Assistance (SF 424): Complete the form except for the competition ID field.
    2. EPA Key Contacts Form 5700-54: Complete the form. If additional pages are needed, see (c) below.
    3. Attach a single electronic file labeled Application that contains the items described in Section IV.B.3. through IV.B.9.a (Table of Contents, Abstract, Research Plan, Quality Assurance Statement, References, Budget and Budget Justification, Resumes, Current and Pending Support, and Letters of Intent/Support) of this solicitation. In order to maintain format integrity, this file must be submitted in Adobe Acrobat PDF. Please review the PDF file for conversion errors prior to including it in the electronic application package; requests to rectify conversion errors will not be accepted if made after the solicitation closing date and time. If Key Contacts Continuation pages (see http://www.epa.gov/ncer/rfa/forms) are needed, place them before the Table of Contents (Section IV.B.3.).
  4. Submitting the application. The full application package must be e-mailed to
    2009-Biotech-APPS@epa.gov by an authorized representative of your organization.  Note: Minor problems are uncommon, but may still occur, with electronic mailing of files.
  5. E-mail Transmission Difficulties.

    Please note that if you choose to submit your materials via email, you are accepting all risks attendant to email submission including server delays and transmission difficulties. Email submissions exceeding 15MB will experience delays. For these size submissions, applicants should submit their application materials via hardcopy. Submissions above 70 MB will not be received by the Agency and should be submitted in hardcopy.

    Please do not send compressed files, particularly those with a .zip file extension. The Agencys e-mail server will delete these kinds of file attachments. If necessary, you may choose to divide your application into smaller pieces and e-mail smaller file attachments separately.

    If transmission difficulties that result in a late transmission, no transmission, or rejection of the transmitted application are experienced, send an email to Ron Josephson (Josephson.Ron@epa.gov) with the FON in the subject line within one day after the closing date.  The email should detail the transmission problems experienced and include any error messages. The email should also include information demonstrating that you attempted to submit the application package by the due date in Section IV of the RFA.

    The Agency may decide to review the application if it is clearly demonstrated that transmission difficulties were due solely as a result of problems associated with EPA servers and documentation that these instructions were followed is provided. The decision regarding acceptance of the application for review will be made by the Agency and provided to the applicant within ten calendar days of the request.

V. APPLICATION REVIEW INFORMATION

A. Peer Review
All eligible grant applications are reviewed by an appropriate external technical peer review panel comprised of individual experts using the criteria below. This review is designed to evaluate each application according to its scientific merit. Each peer review panel includes non-EPA scientists, engineers, social scientists, and/or economists who are accomplished in their respective disciplines and proficient in the technical subjects they are reviewing. Reviewers are asked to individually assign a score of excellent, very good, good, fair, or poor to each application. EPA translates the average of these individual scores into the final peer review score.

Individual external peer reviewers consider an applications merit based on the criteria below. Criteria 1-5 are listed in descending order of importance:

  1. Research Proposal (criteria 1a through 1f are essentially equal):
    1. The originality and creativity of the proposed research, the appropriateness and adequacy of the proposed research methods, and the Quality Assurance Statement.
    2. Practical and technically defensible approach that can be performed within the proposed time period.
    3. Research contributes to scientific knowledge in the topic area.
    4. Projected benefits of the proposed activity to society, such as improving the environment or human health.
    5. The results are disseminated broadly to enhance scientific and technological understanding.
    6. The proposal is well prepared with supportive information that is self-explanatory or understandable.
  2. Investigators: The qualifications of the Principal Investigator(s) and other key personnel, including research training, demonstrated knowledge of pertinent literature, experience, and publication records. All key personnel must make a significant time commitment to the project.
  3. Responsiveness: The responsiveness of the proposal to the research needs identified for the research area. The proposal adequately addresses the objectives and special considerations specified by the RFA.
  4. Facilities and equipment: The availability and/or adequacy of the facilities and equipment proposed for the project. Note any deficiencies that may interfere with the successful completion of the research.
  5. Budget: Although budget information does not reflect on the applications 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.

B. Programmatic Review
Applications receiving scores of excellent or very good as a result of the peer review process will then undergo an internal programmatic review, as described below, 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.

After the peer review, those applicants who received scores of excellent or very good as a result of the peer review process will be asked to provide additional information for the programmatic review pertaining to the proposed Lead PIs (in the case of Multiple-PI applications, the Contact PIs) "Past Performance and Reporting History." The applicant must provide the EPA Project Officer with information on the proposed Lead/Contact PI's past performance and reporting history under prior Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) in terms of: (i) the level of success in managing and completing each agreement, and (ii) history of meeting the reporting requirements under those agreements.

This information is required only for the proposed Lead/Contact PI's performance under Federal assistance agreements initiated within the last three years that were similar in size and scope to the proposed project.

The specific information required for each agreement is shown below, and must be provided within three weeks of EPA's request. A maximum of three pages will be permitted for the response; excess pages will not be reviewed. Note: If no prior past performance information and/or reporting history exists, you will be asked to so state.

  1. Name of Granting Agency.
  2. Grant/Cooperative agreement number.
  3. Grant/Cooperative agreement title.
  4. Brief description of the grant/cooperative agreement.
  5. A description of how the agreement is similar in size and scope to the proposed project and whether or not it was successfully managed and completed; if not successfully managed and completed, provide an explanation.
  6. Information relating to the proposed Lead/Contact PI's past performance in reporting on progress towards achieving the expected results (outputs/outcomes) under the agreement. Include the history of submitting timely progress/final technical reports, describe how progress towards achieving the expected results was reported/documented, and if such progress was not being made, provide an explanation of whether, and how, this was reported.
  7. Total (all years) grant/cooperative agreement dollar value.
  8. Project period.
  9. Technical contact (project officer), telephone number, and E-mail address (if available).

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 and current grantors and agency files.

The internal programmatic review panel will assess:

  1. The relevance of the proposed science to EPA research priorities.
  2. The proposed Lead/Contact PI's past performance [under Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) initiated within the last three years that were similar in size and scope to the proposed project] in two areas: First, in successfully managing and completing these prior Federal assistance projects, including whether there is a satisfactory explanation for any lack of success. Second, in reporting progress toward achieving results under these agreements, including the proposed Lead/Contact PI's history of submitting timely progress/final technical reports that adequately describe the progress toward achieving the expected results (outputs/outcomes) under the agreements. Any explanation of why progress toward achieving the results was not made will also be considered. Applicants whose proposed Lead PI/Contact PI has no relevant past performance and/or reporting history, or for whom this information is not available, will be evaluated neither favorably nor unfavorably on these elements.

C. Funding Decisions
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 and available funds. Applicants selected for funding will be required to provide additional information listed below under Award Notices. The application will then be forwarded to EPAs Grants and Interagency Agreement Management Division for award in accordance with the EPAs procedures.

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices
Customarily, applicants are notified about evaluation decisions within six months of the solicitation closing date. A Peer Review Results document summarizing the scientific review will be provided to each applicant with an award or declination letter.

Applicants to be 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 the Lead PI/Contact PI to obtain these materials. Before or after an award, applicants may be required to provide additional quality assurance documentation.

Non-profit applicants that are recommended for funding under this announcement are subject to pre-award administrative capability reviews consistent with Sections 8b., 8c. and 9d. of EPA Order 5700.8 - Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/award/5700_8.pdf (10 pp, 42 K)). In addition, non-profit applicants that qualify for funding may, depending on the size of the award, be required to fill out and submit to the Grants Management Office the Administrative Capabilities Form with supporting documents contained in Appendix A of EPA Order 5700.8.

The official notification of an award will be made by the Agencys Grants and Interagency Agreement Management Division. Applicants are cautioned that only a grants officer is authorized to 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.

B. Disputes
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.

C. Administrative and National Policy Requirements
Expectations and responsibilities of NCER grantees and cooperative agreement holders are summarized in this section, although the terms grant and grantee are used. 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.

  1. 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.
  2. Approval of Changes after Award: Prior written approval is required from the EPA if there will be a significant change from the 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.
  3. Human Subjects: A grant applicant 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 CFR § 26. Studies involving intentional exposure of human subjects who are children or pregnant or nursing women are prohibited by Subpart B of 40 CFR § 26. For observational studies involving children or pregnant women and fetuses please refer to Subparts C & D of 40 CFR § 26. U.S. Department of Health and Human Services regulations at 45 CFR § 46.101(e) have long required "... compliance with pertinent Federal laws or regulations which provide additional protection for human subjects." EPAs regulation 40 CFR § 26 is such a pertinent Federal regulation. Therefore, the applicant's Institutional Review Board (IRB) approval must state that the applicant's study meets the EPA's regulations at 40 CFR § 26. No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicants 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.
  4. 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).
  5. Data Access and Information Release: After award, all data (including primary and secondary or existing data) must be made available to the NCER Project Officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and non-specialists 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.

    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://epa.gov/quality/exmural.html#genreqts. 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 located at 2 CFR Part 215 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.

  6. Reporting: A grant recipient must agree to provide annual progress reports, with associated summaries, and a final report with an executive summary. The summaries will be posted on NCERs website.

    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 were based on research supported by the grant. NCER posts references to all publications resulting from a grant on the NCER web site.

  7. Acknowledgement of EPA Support: EPAs 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 this agreement that are intended for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:
      This publication [article] was made possible by EPA grant number _______. Its contents are solely the responsibility of the grantee and do not necessarily represent the official views of the EPA. Further, the EPA does not endorse the purchase of any commercial products or services mentioned in the publication.

    A graphic that may be converted to a slide or used in other ways, such as on a poster, is located at http://epa.gov/ncer/guidance/star_images.html. EPA expects recipients to use this graphic in oral and poster presentations.

  8. Exchange Network: EPA, states, territories, and tribes are working together to develop the National Environmental Information Exchange Network, a secure, Internet- and standards-based way to support electronic data reporting, sharing, and integration of both regulatory and non-regulatory environmental data. States, tribes and territories exchanging data with each other or with EPA, should make the Exchange Network and the Agency's connection to it, the Central Data Exchange (CDX), the standard way they exchange data and should phase out any legacy methods they have been using. More information on the Exchange Network is available at www.exchangenetwork.net exit EPA.

VII. AGENCY CONTACTS

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: William Stelz (stelz.william@epa.gov); phone: 703-347-8039
Electronic Submissions: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Technical Contact: Susan Laessig (laessig.susan@epa.gov); phone: 202-564-5232

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