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U. S. Environmental Protection Agency
Biotechnology Risk Assessment Research
National Center for Environmental Research
Science to Achieve Results (STAR) Program

Closed - for reference purposes only

Develop Risk Assessment and Data Evaluation Methodologies for the Potential Ecological Impacts of Plant-Incorporated Protectants

Sorting Code Number: 2004-NCER-ZZ
Catalog of Federal Domestic Assistance (CDFA) Number: 66.511

Technical Contact: Bob Frederick; Phone: 703-347-8543; email: frederick.bob@epa.gov
Eligibility Contact: David Kelley; Phone: 703-347-8563; email: kelley.dave@epa.gov

Opening Date: April 19, 2004
Closing Date: June 22, 2004

Table of Contents:
Summary of Program Requirements
Introduction
Background
Specific Areas of Interest
References
Mechanisms of Support/Funding
Eligibility
Cost Sharing
Submitting an Application
Application Processing and Review Information
Contact Points
Authority and Regulations

Access Standard STAR Forms and Instructions
View NCEA Programs

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program:
The United States Environmental Protection Agency’s (EPA) National Center for Environmental Assessment - Washington Division operates under the Office of Research and Development (ORD). NCEA-Washington is issuing this initial announcement of a “Request for Applications” (RFA) for cooperative agreements to provide assistance to Develop Risk Assessment and Data Evaluation Methodologies for the Potential Ecological Impacts of Plant-Incorporated Protectants. The scope of this assistance will be limited to field assessment of Insecticide Resistance Management (IRM) for Plant-Incorporated-Protectants (PIPs) and non-target and ecosystem impacts from crops containing PIPs.

This is the initial announcement for this program.

Award Information:
Anticipated Type of Award: Cooperative Agreement
Estimated Number of Awards: Up to 4 awards
Anticipated Funding Amount: Approximately $700 thousand total costs
Cost Sharing: None Required
Potential Funding per Grant: Up to $100,000/year with a duration of 2 or 3 years and no more than a total of $300,000, including direct and indirect costs. Proposals with budgets exceeding the total award limits will not be considered.

Eligibility Information:
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.

Contact Person:
Technical Contact: Bob Frederick; Phone: 703-347-8543; email: frederick.bob@epa.gov
Eligibility Contact: David Kelley; Phone: 703-347-8563; email: kelley.dave@epa.gov

INTRODUCTION

A major issue for the Agency and more specifically the Office of Prevention, Pesticides and Toxic Substances is to minimize human health and ecological risk from biotechnology derived crops. But these concerns are shared by a much wider community. For all engaged in the development and evaluation of biotechnology products or those who assess their risks, scientific information is primary. The results of the work solicited here may be used by those with an interest in biotechnology such as local stakeholders, the seed industry, and the academic community. EPA anticipates the results will be of interest to a general audience and published in the scientific literature as an incremental addition to research on genetically modified crop varieties and their impact on the environment, or lack thereof, that is now being done at universities and other institutions across the country.

BACKGROUND

EPA’s National Center for Environmental Assessment (NCEA) serves as the national resource center for the overall process of ecological and human health risk assessments; the integration of hazard, dose-response, and exposure data; and models to produce risk characterizations. NCEA’s activities include: 1) the development of methodologies that reduce uncertainties in current risk assessment practices; 2) providing guidance and support to risk assessors; 3) facilitating an exchange of ideas among environmental professionals in the federal, state, industrial, academic, environmental, public interest, and international communities; and 4) characterizing the impacts of environmental receptors whether they result from exposure(s) to single, complex, or multiple physical, chemical, biological or radiological stressors.

Biotechnology presents a wealth of opportunities to improve crop productivity, nutritional value and ability to resist pests and other stresses. However, there are potential risks to human health, natural ecological systems and existing agricultural systems that need to be evaluated so that these products can be properly regulated (Amman et al. 1999; Bartsch and Schuphan 2002; Bartsch and Schmitz 2002; Conner et al. 2003; Dale 1999; Dale et al. 2002; Seidler et al. 1997; Snow, 1997; Watrud 2000; Wolfenbarger and Phifer 2000). Currently, EPA regulates biotechnology products which are pesticides (either produced by plants or by microorganisms) and non-pesticidal substances such as industrial enzymes, biosensors, and bioremediation agents produced using microorganisms.

From an ecological perspective, the regulation of biotechnology products is focused on the following situations where:

  • there is little prior experience with the new trait and host combination;
  • an engineered organism may persist and perhaps replicate in the environment without human intervention;
  • genetic exchange is possible between a transformed organism and unaltered organisms; or
  • the trait confers an advantage to the engineered organism over native species in a given environment (NRC 2000; NRC 2002).

If the target pest becomes resistant to the biotechnology product, that resistance may render related products (e.g., the spores of Bacillus thuringiensis [Bt] sprays used as pesticides) ineffective or it may require increased conventional pesticidal applications, potentially creating additional ecological risk.

Biotechnology research is providing the tools needed to generate information about biotechnology products, generating the knowledge needed to understand the nature and magnitude of potential risks and benefits resulting from the use of biotechnology products in commerce, and providing the means to prevent or control such risks.

The acreage of PIP crops is expected to grow, new and often more sophisticated products are being submitted for registration, and independent research results are being published. Therefore, the opportunity for more robust risk assessment is clear. It is hoped that research resulting from this solicitation will provide valuable data and increased understanding by state and tribal co-regulators, industry, community groups and non-Federal scientists of how to continue to effectively assess PIPs and the potential environmental impacts that may result from large scale planting. This work may lead to the discovery of innovative approaches to data compilation and evaluation leading to more efficient and effective risk assessment and risk management of PIP plants by developers, producers and farmers.

SPECIFIC AREAS OF INTEREST

The following descriptions indicate particular areas of interest for EPA. In designing project proposals, potential applicants should consider the framework within which the information resulting from their projects would be used for risk assessment. Particular attention is called to the Ecological Risk Assessment Guidelines (EPA 1998) published in 1998 and described at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=12460. Proposals should focus on one of the following investigational areas:

Field Assessment of Insecticide Resistance Management (IRM) for Plant-Incorporated-Protectants (PIPs). The goal is to develop field methodologies to assess and monitor the impacts of the high-dose/structured refugia IRM strategy on the long-term susceptibility of target pests to Bt endotoxins.

The development of target pest resistance to the Bt transgene[s] used as plant-incorporated protectants has been identified as a risk both to the sustainability of Bt crops and to the wider utility of environmentally ‘soft’ microbial Bt pesticides (Glaser and Matten 2003; Walker et al. 2003). Resistance management strategies to delay or prevent resistance development have been adopted (Matten et al. 2003) and a recent review reports no increases in the frequency of resistant insects caused by exposure to Bt crops (Tabashnik et al. 2003). However, with growing acceptance of the engineered crops and new varieties being introduced into agricultural production, an evaluation of the resistance management strategies and more research to find sensitive tools for detecting resistance in field pest populations is warranted.

The research being solicited is composed of two parts, each involving the development and refinement of field-based methodologies to assess and manage Bt resistance in the field. Applicants should provide a proposal that covers one or both of these components.

One area of focus may be on field testing and validation of the high-dose/structured refugia strategy for Bt resistance management. Key assumptions of the models upon which this strategy is based need further testing in field populations of the target pests. Additional information regarding pest biology, ecology and population dynamics, particularly with respect to dispersal and use of alternate hosts, is desired. Target pests include key lepidopteran cotton pests, Helicoverpa zea and Pectinophora gossypiella; Helicoverpa zea, a pest of both cotton and corn; and on corn specifically, the lepidopteran pest, Ostrinia nubilalis and two beetle pests, Diabrotica barberi and D. virgifera.

A second research area may focus on developing appropriate tools to identify and measure Bt resistance in field populations of the target pests. These tools should include both functional screens or bioassays, and molecular markers. Of particular interest is exploring the effectiveness of new methods in field populations.

Non-target and ecosystem impacts from Genetically Modified Crops containing Plant- Incorporated Protectants (PIPs). The goal is to develop methodologies for measuring direct impacts and secondary trophic level effects on non-target organisms, and to characterize assessment endpoint(s) and the use of predictive strategies to evaluate potential ecosystem level effects.

The risk of unintended and unexpected adverse impacts on non-target organisms and ecosystems has been identified as a key issue in environmental risk assessment of PIP crop plants (Bartsch and Schuphan 2002, Bartsch and Schmitz 2002; Dale 1999; Dale et al. 2002; Nickson and McKee 2002). While there has been considerable examination of the effects of Bt crops on certain non-target organisms, particularly using species-specific laboratory testing (Mendelsohn et al. 2003), additional empirical work to examine impacts (or lack of impacts) at the field level is desired (NRC 2000; NRC 2002). Existing field censuses documenting species diversity and abundance are useful, but require appropriate baseline studies against which to compare results from agro- and other ecosystems containing PIP crop plants. This project(s) should be structured to answer the questions: 1) What are the potential ecological effects and other impacts on non-target species from the use of biotechnology products? and 2) What are the effective strategies for identifying the key risks of concern and risk management technologies to mitigate these key risks when the monitoring studies indicate unintended adverse consequences?

In the ideal, research to develop standardized and streamlined methodologies for conducting base-line assessments of agricultural and near-field ecosystems non-target species diversity and abundance should be proposed. In addition to broad field censuses, particular plant and animal species may serve as indicators of environmental impacts of PIP crop plant releases. Bio-indicators may be efficient and sensitive tools for predicting adverse impacts during product evaluation as well as measuring long-term impacts of environmental releases. While species presence and/or abundance could offer valuable indicators of non-target effects, potential impacts of PIP crop plants should also be examined in terms of ecosystem functions. Relevant ecosystem functions could include nutrient cycling, predator-prey interactions and the provision of non-target wildlife habitat.

REFERENCES

Ammann, K., Y. Jacot, V. Simonsen, and G. Kjellsson (eds.). 1999. Methods for Risk Assessment of Transgenic Plants. Birkhäuser Verlag, Basel.

Bartsch, D. and I. Schuphan. 2002. Lessons we can learn form ecological biosafety research. Journal of Biotechnology 98: 71-77.

Bartsch, D. and G. Schmitz. 2002. Recent Experience with Biosafety Research and Post-Market Environmental Monitoring in Risk Management of Plant Biotechnology Derived Crops.Chapter 2 in J.A. Thomas and R.L. Fuchs (eds). Biotechnology and Safety Assessment. 3rd Edition, Academic Press, Amsterdam, The Netherlands. Pages 13 - 38.

Conner, A.J., T.R. Glare, and J. Nap. 2003. The release of genetically modified crops into the environment: Part II. Overview of ecological risk assessment. The Plant Journal 33: 19-46.

Dale, P. 1999. Short-term effects, long-term effects and standardization of limits. In Ammann, K., Y. Jacot, V. Simonsen, and G. Kjellsson (eds.), Methods for Risk Assessment of Transgenic Plants. Birkhäuser Verlag, Basel. Pages 57 - 62.

Dale, P.J, B. Clarke and E.M.G. Fontes (2002) Potential for the environmental impact of transgenic crops. Nature Biotechnology 20:567-574.

EPA. 1998. Guidelines for Ecological Risk Assessment. Risk Assessment Forum and Office of Research and Development. Washington, DC. EPA/630/R-95/002F.

Glaser, J.A. and S.R. Matten. 2003. Sustainability of insect resistance management strategies for transgenic Bt corn. Biotechnology Advances 22: 45-69.

Matten, S.M. and A. Reynolds. 2003. Current resistance management requirements for Bt cotton in the United States. Journal of New Seeds 5: 137-178.

Mendelsohn, M., J. Kough, A. Vaituzis and K. Matthews. 2003. Are Bt crops safe? Nature Biotechnology 21: 1003 - 1009.

Nickson, T.E. and M.J. McKee. 2002. Ecological Assessment of Crops Derived through Biotechnology. Chapter 8 in J.A. Thomas and R.L. Fuchs (eds). Biotechnology and Safety Assessment. 3rd Edition, Academic Press, Amsterdam, The Netherlands. Pages 233 - 252

NRC. 2000. Genetically Modified Pest-Protected Plants: Science and Regulation. National Research Council. National Academy Press, Washington, DC.

NRC. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. National Research Council. National Academy Press, Washington, DC.

Sears, M. K., R.L. Hellmich, D.E. Stanley-Horn, K.S. Oberhauser, J.M. Pleasants, H.R. Matilla, B.D. Siegfried, and G.P. Dively. 2001. Impact of Bt corn pollen on monarch butterfly populations: a risk assessment. Proc. Nat. Acad. Sci. USA. 98(21):11937-11942.

Seidler, R., L. Watrud, and S. E. George. 1997. Assessing Risks to Ecosystems and Human Health from Genetically Modified Organisms. In P. Calow (ed.), Handbook of Environmental Risk Assessment and Management. Blackwell Science, Ltd., Oxford. Pages 110-146.

Snow, A. 1997. Commercialization of transgenic plants: ecological risks. Bioscience 47:86-96.

Tabashnik, B.E., Y. Carriere, T.J. Dennehy, S. Morin, M.S. Sisterson, R.T. Roush, A.M. Shelton, and J. Zhao. 2003. Insect resistance to transgenic Bt crops: lessons from the laboratory and field. J. Econ. Entomol. 96(4): 1031-1036.

Walker, K., M. Mendelsohn, S. Matten, M. Alphin and D. Ave. 2003. The role of microbial Bt products in U.S. crop protection. Journal of New Seeds 5: 31-51.

Watrud, L. S. 2000. Genetically Engineered Plants in the Environment–Applications and Issues. In Microbial Interactions in Agriculture and Forestry (vol 2). Subba Rao N. S. and Y.R. Dommergues, eds. Science Publishers, Inc. Enfield, USA and Plymouth, UK. Pages 61-81.

Wolfenbarger, L.L. and P.R. Phifer. 2000. The ecological risks and benefits of genetically engineered plants. Science 290: 2088 - 2093.

MECHANISMS OF SUPPORT/FUNDING

It is anticipated that a total of approximately $700 thousand will be awarded, depending on the availability of funds. Up to 4 awards will be made under this RFA. The projected award per grant is up to $100,000 per year total costs, for up to 3 years. Requests for amounts im excess of a total of $300,000, including direct and indirect costs, will not be considered.

EPA anticipates a collaborative role in any awarded project. The development and research activity under cooperative agreements involves substantial involvement with EPA scientists including: 1) collaboration in the design, measurement, analysis, and interpretation of the research activity; 2) collaboration in publishing articles or reports about the research; and 3) technical assistance in carrying out the work under the agreement.

However, discussions regarding EPA collaborations will not take place until the final negotiations phase of the cooperative agreement; EPA collaboration should not be a part of the initial proposal.

ELIGIBILITY

Institutions of higher education and not-for-profit institutions located in the United States, 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 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 engage in lobbying activities as defined in Section 3 of the Lobbying Disclosure Act of 1995 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 principal investigator, but may not direct projects on behalf of the applicant organization or principal investigator. The principal investigator's institution, organization, or governance may provide funds through its grant from EPA to a FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research. However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Federal agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on a grant, and may not receive salaries or in other ways augment their agency's appropriations through grants made by this program. Nonetheless, federal employees may interact with grantees so long as their involvement is not essential to achieving the basic goals of the grant. EPA encourages interaction between its own laboratory scientists and grant principal investigators for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. This interaction must be incidental to achieving the goals of the research under a grant. Interaction that is “incidental” does not involve resource commitments.

The principal investigator’s institution may enter into an agreement with a federal agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere. A written justification for federal involvement must be included in the application, along with an assurance from the federal agency involved which commits it to supply the specified service.

Potential applicants who are uncertain of their eligibility should contact: David Kelley; Phone: 703-347-8563; email: kelley.dave@epa.gov.

COST-SHARING

Institutional cost-sharing is not required.

SUBMITTING AN APPLICATION

Standard Instructions for Submitting an Application

Although this research is not solicited as part of ORD’s Science to Achieve Results (STAR) program, the peer review will be conducted in the same manner, and, therefore, applicants should use the Standard Instructions for Submitting a STAR Application, including the necessary forms, which can be found on the NCER web site at: http://www.epa.gov/ncer/rfa/forms/

Sorting Code

The need for a sorting code to be used in the application and for mailing is described in the Standard Instructions for Submitting a STAR Application. The sorting code for applications submitted in response to this solicitation is 2004-NCER-ZZ.

APPLICATION PROCESSING AND REVIEW INFORMATION

Applications must be received by the application receipt date listed in this announcement. If an application is received after that date, it will be returned to the applicant without review.
The following is the schedule for this RFA. It should be noted that this schedule may be changed without notification due to factors that were not anticipated at the time of announcement.

Application Receipt Date: June 22, 2004
Earliest Anticipated Start Date: September 30, 2004

The application review process will be found in the Standard Instructions. Consideration of an application’s merit is based on the following criteria: (1) the originality and creativity of the proposed research, the appropriateness and adequacy of the research methods proposed and the quality assurance statement; (2) the qualifications of the principal investigator(s) and other key personnel; (3) the responsiveness of the proposal to the research needs identified for the topic area; (4) the availability and/or adequacy of the facilities and equipment proposed for the project. Although budget information does not indicate an application’s scientific merit, the reviewers are asked to provide their view on the appropriateness and/or adequacy of the proposed budget.

CONTACT POINTS

Further information, if needed, may be obtained for the EPA official(s) indicated below. Email inquiries are preferred.

Bob Frederick; Phone: 703-347-8543; email: frederick.bob@epa.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance at Number 66.511.

The authority for this RFA and resulting awards is contained in the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, as amended; Public Law 92-516; Public Laws 94-140 and 95-396, 7; U.S.C.136 et seq.

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