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 July 2004

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

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

USDA Biotechnology Risk Assessment Research Grants Funding: : “…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”

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.”

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

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

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

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

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

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

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

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

Funding Statistics

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

Number of Awards & Funding ($M) : #AwardsDollars (M) Transgene Movement Nontarget Effects Viral Recombination Resistant Pests Whole Organism Total 111 $20.97

Number of Awards & Funding ($M) : #AwardsDollars ($M) Microbes Plants Insects Fish Mammals & Birds Total111 $20.97