1. Overview of the USDA Biotechnology Risk Assessment Grants Program Deb Hamernik, PhD National Program Leader, Animal Physiology US Department of Agriculture Cooperative State Research, Education, & Extension Service dhamernik@csrees.usda.gov July 2004

2. USDA Biotechnology Risk Assessment Research Grants Program Program Contacts: Deb Hamernik, PhD; USDA-CSREES John Radin, PhD; USDA-ARS National Program Leader, Plant Physiology & Cotton www.reeusda.gov/crgam/biotechrisk/biotech.htm

3. USDA Biotechnology Risk Assessment Research Grants Program: Competitive grants program Authorized in 1990 Farm Bill All United States public or private research or educational institutions or organizations are eligible. Since 1992, ~$20.97 million awarded through 111 grants

4. USDA Biotechnology Risk Assessment Research Grants Funding: 1990-2002: “…at least 1% withholdings from biotechnology outlays in USDA…” FY2002: ~$1.5 million Limited to “risk assessment” 2002 Farm Bill: “…at least 2% withholdings from biotechnology outlays in USDA…” FY2003: ~$3.37 million Includes “risk management”

5. USDA Biotechnology Risk Assessment Research Grants Program: Purpose: “…to assist Federal regulatory agencies in making science-based decisions about the safety of introducing into the environment genetically modified organisms, including animals, plants, and microorganisms.”

6. FY2004 Research Priorities: (1)Identify and develop appropriate management practices to minimize physical and biological risks associated with genetically engineered animals, plants, and microorganisms

7. FY2004 Research Priorities: (2)Develop methods to monitor the dispersal of genetically engineered animals, plants, and microorganisms

8. FY2004 Research Priorities: (3)To further knowledge of the characteristics, rates and methods of gene transfer that may occur between genetically engineered animals, plants, and microorganisms and related wild and agricultural organisms

9. FY2004 Research Priorities: (4)Environmental assessment research designed to provide analysis which compares the relative impacts of animals, plants, and microorganisms modified through genetic engineering to other types of production systems

10. FY2004 Research Priorities: (5) Other relevant areas of research –Non-target effects –Herbicide resistance management –Effects of genetically engineered plants with “stacked” genes

11. FY2004 Priorities: (6) Conferences designed to bring together scientists, regulators, and other stakeholders to review the science- based data relevant to science-based risk assessment/management of genetically-modified organisms released into the environment

12. USDA Biotechnology Risk Assessment Research Grants Program: Will NOT support: -food safety risk assessment -human/animal health effects -social or economic issues -clinical trials -commercial product development -product marketing strategies

13. Review Criteria: Scientific Merit Relevance to Risk Assessment/Risk Management and Federal Regulation of Agricultural Biotechnology Investigators & Institutional Capabilities

14. Funding Statistics

15. Analysis of the USDA Biotechnology Risk Assessment Research Grants Program: 1992 – 2002: 2003: 2004: Average Award: $179,646 $280,900 $313,670 Average Duration: 32.9 34.1 36.0 (months) Average $$/Year: $65,569 $99,141$104,560 Success Rate: NA 20% 20%

16. Number of Awards & Funding ($M) 1992-2003: #AwardsDollars (M) Transgene Movement 36 7.29 Nontarget Effects 18 3.55 Viral Recombination 20 3.50 Resistant Pests 11 2.34 Whole Organism26 4.29 Total 111 $20.97

17. Number of Awards & Funding ($M) 1992-2003: #AwardsDollars ($M) Microbes51 8.77 Plants 35 7.19 Insects17 3.65 Fish 7 1.09 Mammals & Birds 1 0.27 Total111 $20.97