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# Biotechnology Risk Assessment Research Grants (BRAG) Program

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              -  Biotechnology Programs                   -  Biotechnology Risk Assessment Research Grants (BRAG) Program 
                -  Animal Biotechnology 
                -  Plant Biotechnology 
                -  Microbial Biotechnology 
                -  Insect & Nematode Biotechnology 

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.

**The RFA Technical Assistance Webinar for the FY 2024 BRAG RFA is available for on-demand viewing. ****Watch now.****  **

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                     - Research addressing phenotypic effects associated with on- or off-target errors in GE organisms developed using genome editing technology or other genetic engineering techniques and potential hazards or adverse effects associated with these phenotypic effects to the environment
                    - Research evaluating the potential hazards or adverse effects of GE livestock intended to be reared under commercial conditions on the environment, including the potential need for containment
                    - Research evaluating the potential hazards or adverse effects associated with GE animals intended for release into the environment (e.g., for pest population suppression)
                    - Research evaluating the performance of various technologies to track the effectiveness of limited field release conditions designed to contain genetically engineered animals or microbes
                    - Modeling approaches to understand the impact of genetic engineering for population suppression or alteration (gene drives including for weed control, release of an insect carrying a dominant lethal, etc.) on target populations or non-target species that interact with the targeted species, especially when incorporating biologically realistic parameters (e.g., numbers of individuals released, dispersal, mating behavior, and other life history traits, etc.)
                    - Research evaluating the impact of GE microorganisms used in animal agriculture on the environment (e.g., effect of GE microorganisms on biological diversity of soil microorganisms, fate of GE microorganisms in the environment)
                    - Research focused on the environmental effects of introducing RNA interference transgenes or other gene silencing mechanisms using RNAi, siRNA, or miRNAas 12 replicating in animals, plants, microbes, and/or insects
                    - Assessment of the effects of multiple engineered insects and/or nematode resistance genes (e.g., Bacillus thuringiensis and RNAi) in a plant on non-target arthropod species and communities
                    - Research to understand the frequency and mechanisms by which pests or diseases overcome plant pest or disease resistance traits conferred by engineered genes (including where relevant how this compares to resistance to traditional approaches).  Proposals on pest resistance management are not excluded from the program, but any such proposals submitted should describe clear and significant connection with biotechnology and environmental risk assessment/management
                    - Research evaluating the relative efficacy and potential hazards of various biotechnology and non-biotechnology approaches used alone or in combination for mitigation of pests of quarantine significance (e.g., citrus greening, forest pests and others)
                    - Development and/or evaluation of high-throughput methodologies to assess pathogenicity, biocontrol properties or any other plant pest risk properties of novel strains of GE microorganisms such as but not limited to comparison of bioinformatic vs empirical assessment to determine these properties

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.

#### Funding statistics

In FY 2023, a total of 32 research proposals were submitted to the BRAG program requesting a total of $19,152,977.  Awards totaling $6,370,523 were made to 10 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 31%.  The average research award was $634,552 (total costs).

#### Funded Projects

FY 2023 Projects 

USDA Animal and Plant Health Inspection Service - Biotechnology Regulatory Serv...

U.S. Environmental Protection Agency (EPA), Office of Pesticide Programs (OPP)

U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM)

John E. Erickson

Biotechnology Risk Assessment Research Grants Program

BRAG Project funds new CRISPR methods and associated off-target effects

Plants

Plant Health

Plant Breeding

Crop Production

Pest Management

Animals

Advanced Technologies

Biotechnology

Bioenergy

Nanotechnology