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Biotechnology Risk Assessment Research Grants Program (BRAG)

Grants to USA Educational and Research Institutions to
Study the Environmental Risk of Genetic Engineering

Agency Type:


Funding Source:

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U.S. Department of Agriculture (USDA) - National Institute of Food and Agriculture (NIFA)

LOI Date:


Deadline Date:

02/22/18 5:00 PM ET


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Grants to USA public or private educational or research organizations for environmental assessment research addressing the introduction of genetically engineered organisms to the environment. LOIs are due December 21. Applicants are advised that the online registration may take up to two weeks to complete so it is critical to begin as soon as possible.

Purpose and Priorities:

The Biotechnology Risk Assessment Research Grants (BRAG) Program directly aligns with the Research, Education, and Economics Action Plan and specifically addresses the following goals:

1. Goal 1 – Sustainable Intensification of Agricultural Production, Subgoals 1A, 1B, and 1C (which focus on Crop and Animal Production, Crop and Animal Health, and Crop
and Animal Genetics, Genomics, Genetic Resources, and Biotechnology, respectively); and

2. Goal 2 – Responding to Climate and Energy Needs, Subgoal 2B (which focuses on Bioenergy/Biofuels and Biobased Products).

The BRAG Program is also aligned with the NIFA Strategic Plan, specifically addressing Strategic Goal 1 (Science), Advance Our Nation’s Ability to Fight Hunger and Ensure Global Food Security (Subgoal 1.1).

The purpose of the BRAG Program is to support the generation of new information that will assist Federal regulatory agencies in making science-based decisions about the environmental effects of introducing organisms genetically engineered (GE) by recombinant nucleic acid techniques. Such organisms can include plants, microorganisms (including fungi, bacteria, and viruses), arthropods, fish, birds, mammals, and other animals excluding humans. Investigations of effects on both managed and natural environments are relevant. The BRAG program accomplishes its purpose by providing Federal regulatory agencies with relevant scientific information.

The BRAG Program receives input regarding its program priorities through multiple regulatory agencies that have an interest in the environmental risk related to the introduction of GE organisms. These regulatory agencies include, but are not limited to, USDA’s – Animal and Plant Health Inspection Service - Biotechnology Regulatory Services (APHIS-BRS), Environmental Protection Agency (EPA), and Department of Health and Human Services (DHHS) Food and Drug Administration (FDA).

The BRAG Program supports applied and/or fundamental research relevant to environmental risk assessment, including biological risk, and the Federal regulatory process. When evaluating GE organisms, Federal regulators must answer the following four (4) general questions:

1. Is there a hazard? (Potential hazard identification);
2. How likely is the hazard to occur? (Quantifying the probability of occurrence; identifying likely exposure scenarios);
3. What is the severity and extent of the hazard if it occurs? (Quantifying the effects); and
4. Is there an effect above and beyond what might occur with an unmodified organism or an organism that has similar traits, but was developed using other technologies?

The BRAG Program will also support risk management research, which is defined to include either:
1. Research aimed primarily at reducing negative 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 negative consequences identified in a risk assessment.

Although Project Director(s) (PDs) are not required to perform actual risk assessments as part of the research they propose, they should design studies that will provide useful science-based information for Federal regulators assessing GE organisms or that have been derived via synthetic biology defined as: the ability to generate novel traits or organisms using synthetic genes (synthesized de novo outside the organism of origin).

NIFA is soliciting applications for the BRAG Program under the following areas:
1. Standard Research Proposals
2. Conference Proposals

Program Federal Agency Collaboration:

NIFA and ARS will competitively award research grants to support biotechnology regulation, thereby helping to addressing concerns about the effects genetically engineered (GE) organisms introduced into the environment and helping regulators develop policies regarding such introduction. The BRAG program also encourages proposals seeking partnership with or involvement of international entities where appropriate and domestically beneficial. Research proposals must be of high quality and have merit based upon their relevance to the purpose of the BRAG program. The BRAG program is especially interested in research that is not already in well-developed areas of study. Exploratory research that relates specifically to federal regulatory needs is preferred.

Applications to the BRAG program MUST address one (1) of the following standard research program areas (see below) or seek funding for a conference/workshop. In addition, applicants MUST state in the first sentence of their Project Summary which SINGLE standard research program area aligns best with their proposed project.

Standard Research Proposals:

Standard research proposals address issues related to newly developed GE organisms that are animals, plants, insects, and/or microorganisms. Research proposals can be applied and/or fundamental and must address one (1) of the following five (5) program areas:

1. Management Practices to Minimize Environmental Risk of GE Organisms

Research designed to develop appropriate management practices to minimize physical and biological risks to the environment associated with GE organisms. Potential areas of research include, but are not limited to:

a) Evaluation of management, monitoring, and mitigation methodologies for confinement of field trials of GE organisms;

b) Development of practical management methodologies for reducing the spread and persistence of GE organisms in natural and managed environments;

c) Development or evaluation of effective bio-confinement strategies, including molecular and/or genetic techniques, to limit gene transfer (gene flow) or outcrossing to sexually compatible organisms or transfer of genetic material between viruses or microorganisms;

d) Mitigation measures to limit gene flow when GE organisms are released or escape into the environment, physical containment fails, or biological containment is unavailable;

e) Ecological effects of technologies for reducing the undesired spread of GE organisms;

f) Evaluation of safeguards for controlling the spread of gene drives during research to understand the effect of the desired genetic change on organisms and populations; and/or

g) Explore risk mitigation strategies to ameliorate environmental impacts associated with certain GE organisms.

2. Methods to Monitor and Understand the Dispersal of GE Organisms

Research designed to develop methods to monitor and understand the dispersal and/or population dynamics of GE organisms. Potential areas of research include, but are not limited to:

a) Survivability profile and/or fitness of GE organisms in the wild as compared to appropriate non-GE or previous GE counterparts;

b) Information on dormancy in the seed (e.g. wheat, barley, rice, and canola or other propagules affecting persistence of such propagules), particularly variety x environment effects, to assure confinement of field trials. This would include dormancy of crop, sexually compatible weedy species, and hybrids of the crop and weedy relatives;

c) Strategies for large-scale deployment or field studies of GE organisms, with special reference to those considerations that may not be revealed through contained or small- scale evaluation and tests;

d) Assessing the effects of engineered traits in animal species that may easily spread, such as birds, aquatic species, arthropods and other invertebrates. This area may include: studies on genotype and phenotype stability over multiple generations; comparative mating competence or reproductive studies; comparative behavior and biological studies, including studies addressing whether traits introduced by genetic engineering can alter host range or ecological interactions of organisms such as birds, aquatic species, arthropods and other invertebrates;

e) Understanding and predicting the dynamics of gene drives when released into the environment; especially the identification of the key factors impacting persistence, spread, and frequencies in populations; or

f) Development and/or evaluation of tools for assessing weediness or invasiveness of GE plants relative to unmodified parent organisms.

3. Gene Transfer between Genetically Engineered Animals, Plants and Microorganisms and Related Wild and Agricultural Organisms.

Research designed to further existing knowledge about the characteristics, rates, and mechanisms of gene transfer that may occur between GE organisms, and related wild and agricultural organisms. Gene flow research should be directed to organisms with a high potential for transfer of genetic material (e.g., outcrossing to sexually compatible species or transfer of genetic material between microorganisms or viruses) and to genes that have a high potential for altering the fitness of the recipient organism in its environment. For plants, preference will be given to studies with species that have sexually compatible wild relatives in the United States. For microorganisms, preference will be given to species co- occurring in the same host organism or microenvironment. Potential areas of research include, but are not limited to:

a) Impacts of gene flow from GE plants, particularly perennials (e.g. trees, grasses such as switchgrass), insects, animals, or micro-organisms to related organisms, communities, or ecosystems;

b) Fate and stability (persistence) of engineered genes that have been moved by outcrossing or other means into populations of non-GE organisms, and the degree to which they confer a selective advantage or disadvantage upon the carriers, especially with regard to engineered genes that confer fitness (e.g. enhanced growth or abiotic stress tolerance) in wild populations;

c) Assessing the influence of genetic background on the expression of and phenotypes conferred by introduced genes, to inform understanding of the characteristics and potential outcomes of gene transfer; and/or

d) Data acquisition and modeling of GE organisms or engineered gene escape into the environment, including modeling to identify parameters that influence gene dispersal and its consequences.

4. Environmental Impacts of GE relative to Non-GE Organisms in the Context of Production Systems

Environmental assessment research which compares the relative impacts of animals, plants, and micro-organisms modified through genetic engineering to other types of production systems. Potential areas of research include, but are not limited to:

a) Assessment of the influence of GE as compared to non-GE organisms on agricultural or forest ecosystems (e.g. on community structures of agro- or forest ecosystems). Important focus areas are:
-The presence and function of various types of beneficial organisms;
-Defining the magnitude and types of changes in communities or indicator species that could trigger concerns regarding ecosystem impacts;
-How the biology and ecology of indicator taxa are influenced by geography, seasonal fluctuations, species, etc.); and/or

b) Assessment of how the introduction of GE organisms alters the impact of agriculture on the rural environment, such as altered land use practices or other aspects of human ecology, species displacement, soil erosion, effects on water quality, or other geographically dispersed events. Comparative management techniques and resources for maintenance of non-GE animals versus GE animals (e.g., changes in land use or manure management practices required for GE animals engineered to utilize feed more efficiently);

c) Assessment of how traits introduced by genetic engineering may change aspects of the ecology or behavior of engineered organisms (e.g., mating systems, host range);

d) Comparative assessment of environmental impacts of agricultural production systems using organic and/or conventional methods with those involving plant, animal, or microbial biotechnology. Appropriate parameters or metrics are to include, but are not limited to:
-Soil health, fertilizer, pesticide, and soil amendment inputs;
-Changes in toxicant and pesticide residue levels;
-Prevalence and distribution of weeds, including those with single or multiple
herbicide resistance;
-Prevalence, distribution, and damage from pests and pathogens, including
emergence of resistance;
-Land use related to yield and productivity; and/or

e) Identification and experimental assessment of potential environmental impacts of large-scale growth of GE crops, with emphasis on plants used for bioenergy and/or bio-based products (e.g., sorghum, Camelina, sugarcane, eukaryotic algae, or perennial species such as trees and some grasses), to support the development of a risk assessment framework. For the purposes of this standard area, large-scale refers to cultivation on 100 or more acres. Project must address multiple BRAG topic areas, preferentially chosen from the following:
-Biological and ecological baseline studies associated with GE perennial species that will aid in the development of risk assessment methodologies;
-Strategies for conducting large scale GE field studies with minimal environmental risk;
-Landscape level studies to assess environmental impacts of land use changes and/or ecosystem function and services;
-Assessment and documentation of significant community or ecosystem effects that are not revealed by studies on small plots: such as effects on plant, microbial or animal communities; species displacement; soil health; fertilizer, soil amendment, and pesticide inputs; hydrology; water quality; fire frequency or intensity; toxicant and pesticide residue levels; and/or new plant pests;
-Assessment of the likelihood and impact of gene flow to sexually compatible plants and stable inheritance in related organisms under various management strategies;
-Weediness or invasiveness of the GE organism relative to non-GE parent organism; and/or
-Basic biology and ecology of the unmodified parent organism, including fitness characteristics.

5. Other Research Topics Designed to Further the Purposes of this Program

Other areas of research designed to improve the knowledge of emerging technologies in genomics, genome editing, and/or biotechnology as it relates to the BRAG program. Potential areas of research include, but are not limited to:

a) Research focused on the environmental effects of introducing RNA interference transgenes or other gene silencing mechanisms using RNAi, siRNA, or miRNA as replicating in or heat-killed from animals, plants, microbes, and/or insects. Important areas include, but not limited to:
-Assessment of environmental fate and/or persistence of these small RNA molecules; and/or
-Potential off-target (within the organism), non-target (effects on other organisms), or other unintended effects of these small RNA molecules in animals and plants (including GE and non-GE plants) at the landscape level;

b) 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;

c) Research to understand how pests or diseases overcome plant pest or disease resistance traits conferred by engineered genes; (Proposals on pest resistance management are not excluded from the program, but any such proposals submitted should describe a clear and significant connection with biotechnology and environmental risk assessment/management);

d) Research addressing off-target phenotypic effects in GE organisms developed using genome editing technology and potential risk to the environment associated with the development of analytical methods to differentiate between genome-edited from unedited agriculturally-relevant animals that are intentionally or unintentionally released into the environment;

e) Research evaluating the risks of GE livestock reared under commercial conditions and the need for containment;

f) Research evaluating the risks possible for GE animals intended for release into the environment (e.g., for pest population control); or

g) Comparison of the types and frequencies of nucleic acid changes introduced into important crop genomes, via genetic engineering techniques versus other plant breeding techniques. These studies should support the assessment of potential unintended effects that may occur from genetic engineering compared to other breeding techniques. Proposed projects must be comparative studies designed to analyze and compare statistically relevant data concerning the types and frequencies of genomic sequence changes and associated unintended phenotypic variation resulting from:
-Insertion of DNA with one (1) or more widely used genetic engineering techniques (e.g., particle bombardment, Agrobacterium-mediated transformation), OR off target effects of genome editing technologies (e.g., Zinc finger nucleases, TALENS, and CRISPR-Cas9) compared to:
-One (1) or more other mutation-generating plant breeding techniques (e.g., irradiation or chemical mutagenesis, somatic cell culture and clonal propagation, ploidy alterations, wide interspecies or inter-generic crosses, induced structural changes in chromosomes).

Conference Proposals:

Applicants to the BRAG program may request partial funding to organize a conference or workshop that brings together scientists, regulators, and other stakeholders to review science- based data relevant to gene flow and co-existence, risk assessment, or risk management of GE organisms released into the environment. To be eligible for funding, the steering committee for the proposed conference should include representatives from a variety of relevant and appropriate scientific disciplines.

The goals for the conference should include sharing of scientific information and identification of gaps in knowledge, and/or public education and outreach, among others. Publication of the proceedings is highly encouraged and a copy of any publications should be provided to NIFA.

Grant Types:

The following is a list of available grant types under this RFA.

a) Standard. This is an award instrument by which NIFA agrees to support a specified level of effort for a predetermined project period without the announced intention of providing additional support at a future date.

b) Resubmission. This is a project application that has been submitted for consideration under the same program previously but has not been approved for an award under the program. For competitive programs, this type of application is evaluated in competition with other pending applications in the area to which it is assigned. Resubmissions are reviewed according to the same evaluation as new applications. In addition, applicants must respond to the previous panel review summaries, unless waived by NIFA.

Centers of Excellence:

Pursuant to Section 7214 of the Agricultural Act of 2014 (Pub. L. 113-79), beginning in Fiscal Year 2015, for applicable competitive research and extension programs, NIFA will recognize and provide priority in the receipt of funding to applications from “centers of excellence” that carry out research, extension, and education activities that relate to the food and agricultural sciences. NIFA held listening sessions in July 2014 and accepted written comments from stakeholders to inform NIFA’s implementation of the COE provision. Information from the webinars and a summary of the input are available on NIFA’s website at

A COE is composed of one (1) or more of the following entities that provide financial or in-kind support to the COE.

1. State agricultural experiment stations;
2. Colleges and universities;
3. University research foundations;
4. Other research institutions and organizations;
5. Federal agencies;
6. National laboratories;
7. Private organizations, foundations, or corporations;
8. Individuals; or
9. Any group consisting of two (2) or more of the entities described in (1) through (9).
COE designation is available only to standard grant applicants. Part IV, B., 3. of this RFA contains additional requirements for COE consideration.

GrantWatch ID#:

GrantWatch ID#: 182598

Estimated Total Program Funding:


Estimated Size of Grant:

Standard Research Proposals must not exceed $500,000 total (including indirect costs).

Conference Proposals must not exceed $25,000 total (indirect costs are not allowed on conference grants).

Term of Contract:

Standard Research Proposals may be for project periods of up to four (4) years.

Conferences must occur after July 13, 2018.

Additional Eligibility Criteria:

Applications may only be submitted by United States public or private research or educational institutions or organizations.

The BRAG Program will not support applications for postdoctoral fellowships. In addition, the BRAG Program will not support applications in any of the following areas: food safety risk assessment or risk assessment; health risk assessment or risk assessment of humans or domestic food animals exposed to GE organisms, including clinical trials; methods for seed storage; commercial product development; product marketing strategies; or other research unrelated to environmental risk assessment or risk management.

Pre-Application Information:

The recipient of an award from the BRAG program must provide funds, in-kind contributions, or a combination of both, from sources other than funds provided through such grant in an amount that is at least equal to the amount awarded by NIFA unless one (1) of the exemptions is applicable.

Please review the RFA for more information about entities exempt from the matching funds requirement.

A Letter of Intent (LOI) must be received by 5:00 PM, Eastern Time on December 21, 2017.

Applications must be received by 5:00 PM, Eastern Time on February 22, 2018.

Prior to preparing an application, it is recommended that the Project Director/Principal Investigator (PD/PI) first contact an Authorized Representative (AR, also referred to as Authorized Organizational Representative, or AOR) to determine if the organization is prepared to submit electronic applications through If not (e.g., the institution/organization is new to the electronic grant application process through, then the one-time registration process must be completed PRIOR to submitting an application.

It can take as long as two (2) weeks to complete the registration process so it is critical to begin as soon as possible.

View this opportunity on

Contact Information:

Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.

Primary Programmatic Contact:

Dr. Shing F. Kwok, National Program Leader
U.S. Department of Agriculture
National Institute of Food and Agriculture
Institute of Food Production and Sustainability
800 9th St., SW
Washington, DC 20024
Telephone: (202) 401 – 6060
Fax: (202) 401 – 6071

Additional Programmatic Contacts:

Dr. Lakshmi Matukumalli, National Program Leader
U.S. Department of Agriculture
National Institute of Food and Agriculture
Institute of Food Production and Sustainability
800 9th St., SW
Washington, DC 20024

Dr. Jack Okamuro, National Program Leader
U.S. Department of Agriculture
Agricultural Research Service
George Washington Carver Center
5601 Sunnyside Avenue, Room 4-2220
Beltsville, MD 20705-5139
Telephone: (301) 504- 5912
Mobile: (202) 285 – 9520

Administrative/Business Contact:

Mrs. Rochelle McCrea, Team Leader, Team I
U.S. Department of Agriculture
National Institute of Food and Agriculture
Office of Grants and Financial Management
1400 Independence Ave., SW; STOP 2271
Washington, DC 20250-2271
Telephone: (202) 401-2880
Fax: (202) 401-6271

CFDA Number:


Funding or Pin Number:


URL for Full Text (RFP):

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