Program Synopsis: USDA Biotechnology Risk Assessment Grants (BRAG) Program
The USDA Biotechnology Risk Assessment Grants (BRAG) program was established in 1992 in response to authority provided in Section 1668 of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5921). From 1992 until 2002, the BRAG program supported risk assessment research regarding the effects of introducing genetically modified organisms into the environment. In 2002, Section 7210 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 7901) amended the authority of the BRAG program to include “research designed to identify and develop appropriate management practices to minimize physical and biological risks associated with genetically engineered animals, plants, and microorganisms”. Currently, the BRAG program supports risk assessment and risk management research regarding the introduction of genetically modified animals, plants, or microorganisms into the environment. The BRAG program also supports conferences that bring together scientists, regulators, and other stakeholders to review the science-based data relevant to science-based risk assessment or risk management of genetically modified organisms released into the environment.
Risk assessment research is defined as the science-based evaluation and interpretation of factual information in which a given hazard, if any, is identified, and the consequences associated with the hazard are explored. Research funded through this program will be relevant to risk assessment and the regulatory process. When evaluating transgenic organisms, Federal regulators must answer the following four general questions: 1) Is there a hazard (potential hazard identification)?; 2) How likely is the hazard to occur (quantifying the probability of occurrence)?; 3) What is the severity and extent of the hazard if it occurs (quantifying the effects)?; 4) Is there an effect above and beyond what might occur with an organism that has similar traits, but was developed using other technologies?
Although Project Directors are not required to perform actual risk assessments as part of the research they propose, they should design studies that will provide information useful to regulators for making science-based decisions in their assessments of genetically modified organisms. Accordingly, applicants are encouraged to address the following questions in their applications: 1) What is the relevance of the proposed research to the evaluation of transgenic organisms?; 2) What information will be provided by this research to help regulators adequately assess transgenic organisms?; and 3) How does this research model approximate studies necessary to identify and/or characterize hazards associated with introducing genetically modified organisms into the environment?
Risk management research is defined to include either: 1) research aimed primarily at reducing effects of specific biotechnology-derived agents; or 2) a policy and decision-making process that uses risk assessment data in deciding how to avoid or mitigate the consequences identified in a risk assessment.
The BRAG program will not support risk assessment or risk management research related to food safety, human or animal health, social or economic issues, methods for seed storage, clinical trials, commercial product development, product marketing strategies, or marketing or trade issues associated with genetically modified organisms.
The BRAG program is supported by a two percent withholding on expenditures for biotechnology research within the U.S. Department of Agriculture. CSREES and the Agricultural Research Service (ARS) of the U.S. Department of Agriculture jointly administer the BRAG program.
In FY 2004, a total of 53 proposals were submitted to the BRAG program requesting a total of $17,294,952. Awards totaling $3,476,141 were made to the highest ranked 11 proposals. The success rate (in terms of number of proposals funded compared to the number of proposals submitted) was 21%. The average award was $313,670 (total costs) for approximately 36 months.
In FY 2003, a total of 60 proposals were submitted to the BRAG program requesting a total of $18,930,068. Awards totaling $3,388,897 were made to the highest ranked 12 proposals. The success rate (in terms of number of proposals funded compared to the number of proposals submitted) was 20%. The average award was $280,900 for approximately 36 months. In FY 2003, one conference award was made for $5,000.
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