The purpose of the Biotechnology Risk Assessment Grants (BRAG) program is to support the generation of new information that will assist Federal regulatory agencies make science-based decisions about the effects of introducing genetically engineered organisms (GE) into the environment.
These organisms include: plants, microorganisms (including fungi, bacteria, and viruses), insects, fish, birds, mammals, and other animals excluding humans. Investigations on the effects of both managed and natural environments are relevant. The BRAG program accomplishes its purpose by providing Federal regulatory agencies with scientific information relevant to regulatory issues.
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 engineered 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 engineered animals, plants, insects, or microorganisms into the environment. The BRAG program also supports conferences and workshops that bring together scientists, regulators, and other stakeholders to review the science-based data relevant to risk assessment or risk management of GE organisms released into the environment. BRAG is co-administered by NIFA and the Agricultural Research Service (ARS). BRAG is also jointly funded by USDA-ARS, USDA-NIFA, and the USDA-Forest Service. These agencies contribute funds to the USDA Biotechnology Risk Assessment Grants program by withholding at least 2 percent from research projects on biotechnology within their respective agencies.
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 the BRAG program will be relevant to risk assessment and the regulatory process. When evaluating genetically engineered organisms, Federal regulators must answer the following four general questions:
- Is there a hazard (potential hazard identification)?
- How likely is the hazard to occur (quantifying the probability of occurrence)?
- What is the severity and extent of the hazard if it occurs (quantifying the effects)?
- 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 engineered organisms. Accordingly, applicants are encouraged to address the following questions in their applications:
- What is the relevance of the proposed research to the evaluation of genetically engineered organisms?
- What information will be provided by this research to help regulators adequately assess genetically engineered organisms?
- How does this research model approximate studies necessary to identify and/or characterize hazards associated with introducing genetically engineered organisms into the environment?
BRAG Program Research Priorities
The BRAG Program supports standard research and conference proposals in the follow areas:
- Management Practices to Minimize Environmental Risk of Genetically Engineered Organisms
- Methods to Monitor and Understand the Dispersal of Genetically Engineered Organisms
- Gene Transfer between Genetically Engineered Animals, Plants, and Microorganisms and Related Wild and Agricultural Organisms
- Environmental Impacts of Genetically Engineered Relative to Non-genetically Engineered Organisms in the Context of Production Systems
- Other Research Topics Designed to Further the Purposes of the BRAG Program
- Environmental Effects of Introducing RNA Interference transgenes
- Assessment of the Effects of Multiple Engineered Insect Resistance Genes (e.g. Bacillus thuringiensis and RNAi) in a Plant on Non-target Arthropod Species and Communities
- Research to Understand How Pests or Diseases Overcome Plant Pest or Disease Resistance Traits Conferred by Genetically Engineered Genes
- Research Addressing Off-target Phenotypic Effects in Genetically Engineered Organisms Developed Using Genome Editing Technologies
- Research Evaluating the Risks of Genetically Engineered Livestock Reared under Commercial Conditions and the Need for Containment
- Research Evaluating the Risks Possible for Genetically Engineered Animals Intended for Release into the Environment (e.g., for pest population control)
- Comparison of the Types and Frequencies of Nucleic Acid Changes Introduced into Important Crop Genomes, via Genetic Engineering Techniques versus Other Plant Breeding Techniques
Please note: 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 engineered organisms.
Please see the BRAG Program Request for Applications (RFA) for more details.
In FY 2020, a total of 32 proposals were submitted to the BRAG program requesting a total of $15,190,054. Awards totaling $5,513,530 were made to 11 research and 1 conference proposals that were highly ranked. The success rate (in terms of number of research proposals funded compared to the total number of research proposals submitted) was approximately 35%. The average research award was $498,527 (total costs).
In FY 2019, a total of 30 proposals were submitted to the BRAG program requesting a total of $12,759,600. Awards totaling $5,238,964 were made to the 11 research and 3 conference proposals that were highly ranked. The success rate (in terms of number of research proposals funded compared to the total number of research proposals submitted) was approximately 41%. The average research award was $469,451 (total costs).
In FY 2018, a total of 37 proposals were submitted to the BRAG program requesting a total of $16,979744. Awards totaling $6,129,457 were made to the 13 research and 1 conference proposals that were highly ranked. The success rate (in terms of number of research proposals funded compared to the total number of research proposals submitted) was approximately 37%. The average research award was $469,599 (total costs).