Biotechnology Risk Assessment Research

 

The purpose of the BRAG program is to assist Federal regulatory agencies in making science-based decisions about the effects of introducing into the environment genetically engineered organisms, including 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 scientific information relevant to regulatory considerations derived from the risk assessment research that the program funds.

General information about this opportunity
Last Known Status
Active
Program Number
10.219
Federal Agency/Office
Agency: Department of Agriculture
Office: National Institute of Food and Agriculture
Type(s) of Assistance Offered
Project Grants
Program Accomplishments
Fiscal Year 2013: For the FY 2013 award cycle, approximately $ 4,347,545 was available for project grant awards after subtracting administrative costs.

A total of 40 applications requesting a total of $18,367,212 were received in this year’s competition. In June 2013, a 11-member peer review panel evaluated these applications. The peer panel included faculty and administrators from land grant and non-land grant colleges and universities and practitioners from the food and agricultural sciences community.

Funds were available to support a total of 8 awards in the following Project Types (1 conferences: $20,000; 6 standard: $4,259,878; 1 priority: $1,000,000).

The funding success rate for this program in FY13 was 20% for research grants.

Funded projects should address one or more of the following scientific priorities: (1) comparison between transformation-associated genomic variation and genomic variation introduced by non-genetic engineering approaches in plants; (2) development of a risk assessment framework for the environmental impacts of GE crops at the landscape level; (3)
management practices to minimize environmental risk; (4) methods to monitor dispersal of GE organisms; (5) gene transfer to domesticated and wild relatives; (6) environmental impacts of GE relative to non-GE production systems; (7) comparative assessment of the effects of GE plants with either a single transgenic resistance gene vs. multiple transgenic resistance genes or single transgenic resistance gene vs. multiple transgenic genes that confer resistance to insects, diseases, and/or herbicides in order to understand how pest, disease and weedy organisms overcome the resistance conferred; (8) biological and ecological studies associated with GE perennial species; (9) development of environmental risk assessment methodologies for GE organisms when there is little baseline data on the unmodified parent organism (e.g., Panicum virgatum, Miscanthus, Populus spp., Eucalyptus spp., eukaryotic algae); (10) assessment of environmental fate, persistence, and potential for off-target, non-target, or unintended effects of RNA interference transgenes or other gene silencing mechanisms using RNAi, siRNA, or miRNA. Fiscal Year 2014: For the FY 2014 award cycle, approximately $ 3,456,512 was available for project grant awards after subtracting administrative costs.

A total of 45 applications requesting a total of $ 23,600,757 were received in this year’s competition. In June 2014, a 13-member peer review panel evaluated these applications. The peer panel included faculty and administrators from land grant and non-land grant colleges and universities and practitioners from the food and agricultural sciences community.

Funds were available to support a total of 8 awards in the following Project Types (2 conferences: $49,365; 6 standard: $2,988,834)
The funding success rate for this program in FY14 was 17% for research grants.

Funded projects should address one or more of the following scientific priorities: (1) comparison between transformation-associated genomic variation and genomic variation introduced by non-genetic engineering approaches in plants; (2) development of a risk assessment framework for the environmental impacts of GE crops at the landscape level; (3)
management practices to minimize environmental risk of GE organisms; (4) methods to monitor dispersal of GE organisms; (5) gene transfer to domesticated and wild relatives; (6) environmental impacts of GE relative to non-GE organisms in the context of production systems; (7) research focused on the environmental effects of introducing RNA interference transgenes or other gene silencing mechanisms using RNAi, siRNA, or miRNA in animals, plants, microbes, and/or insects; (8) comparative assessment of GE plants with single vs. multiple transgenes that confer resistance to pests or disease, with the goal of understanding how pests or diseases overcome the conferred resistance; (9) biological and ecological studies associated with GE perennial species; (10) development of environmental risk assessment methodologies for GE organisms when there is little baseline data on the unmodified parent organism (e.g., Panicum virgatum, Miscanthus, Populus spp., Eucalyptus spp., eukaryotic algae). Fiscal Year 2015: No data available. Pertinent details will be provided by Program at a future date.
Authorization
Farm Security and Rural Investment Act of 2002, Section 7210 , Public Law 101-171 , 7 U.S.C 5921; Food, Agriculture, Conservation, and Trade Act of 1990, Section 1668 , 7 U.S.C 7901.
Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
Any public or private research or educational institution or organization.
Beneficiary Eligibility
Any public or private research or educational institution or organization.
Credentials/Documentation
No Credentials or documentation are required. OMB Circular No. A-87 applies to this program.
What is the process for applying and being award this assistance?
Pre-Application Procedure
All RFAs are published on the Agency’s website and Grants.gov. Applicants must complete the Grants.gov registration process. Please see the following Grants.gov link for more information: http://www.grants.gov/applicants/get_registered.jsp. An environmental impact statement is required for this program. This program is excluded from coverage under E.O. 12372.
Application Procedure
OMB Circular No. A-102 applies to this program. OMB Circular No. A-110 applies to this program. Applications should be submitted as outlined in the RFA. Applications must follow the instructions provided per Grants.Gov and in the Agency guide to submitting applications via Grants.gov.
Award Procedure
Applications are subjected to a system of peer and merit review in accordance with section 103 of the Agricultural Research, Extension and Education Reform Act of 1998 (7 U.S.C. 1613) by a panel of qualified scientists and other appropriate persons who are specialists in the field covered by the proposal. Within the limit of funds available for such purpose, the NIFA Authorized Departmental Officer (ADO) shall make grants to those responsible, eligible applicants whose applications are judged most meritorious under the procedures set forth in the RFA. Reviewers will be selected based upon training and experience in relevant scientific, extension, or education fields, taking into account the following factors: (a) The level of relevant formal scientific, technical education, or extension experience of the individual, as well as the extent to which an individual is engaged in relevant research, education, or extension activities; (b) the need to include as reviewers experts from various areas of specialization within relevant scientific, education, or extension fields; (c) the need to include as reviewers other experts (e.g., producers, range or forest managers/operators, and consumers) who can assess relevance of the applications to targeted audiences and to program needs; (d) the need to include as reviewers experts from a variety of organizational types (e.g., colleges, universities, industry, state and Federal agencies, private profit and non-profit organizations) and geographic locations; (e) the need to maintain a balanced composition of reviewers with regard to minority and female representation and an equitable age distribution; and (f) the need to include reviewers who can judge the effective usefulness to producers and the general public of each application. Evaluation Criteria will be delineated in the RFA.
Deadlines
Contact the headquarters or regional office, as appropriate, for application deadlines.
Approval/Disapproval Decision Time
Section :094 - Deadlines:
Dates for specific deadlines are announced in the RFA each fiscal year.
Information is also available via our website and may be obtained via the Grants.gov website. Respective links are provided below:
http://www.nifa.usda.gov/
http://www.grants.gov

Section :095 - Range of Approval/Disapproval Time:
From 30 to 180 days.
Appeals
Not Applicable.
Renewals
Specific details are provided in the Request for Applications (RFA) each fiscal year.
How are proposals selected?
Within guidelines established for the program as described in the Request for Application (RFA).
How may assistance be used?
Grant funds must be used for allowable costs necessary to conduct approved research objectives. Funds may not be used for purposes other than those approved in the grant award documents. The use of grant funds to plan, acquire, or construct a building or facility is not allowed under this program. With prior approval, and in accordance with the cost principles set forth in the Office of Management and Budget (OMB) Circular No. A-21, (codified at 2 CFR 220), some grant funds may be used for minor alterations, renovations, or repairs deemed necessary to retrofit existing teaching or research spaces in order to carry out a funded project. However, requests to use grant funds for such purposes must demonstrate that the alterations, renovations, or repairs are essential to achieving the major purpose of the project. Grant funds may not be used for endowment investing.

Section 720 of the Consolidated and Further Continuing Appropriations Act, 2012 (Pub.L. No. 112-55) limits indirect costs to 30 percent of the total Federal funds provided under each award. Therefore, when preparing budgets, applicants should limit their requests for recovery of indirect costs to the lesser of their institution’s official negotiated indirect cost rate or the equivalent of 30 percent of total Federal funds awarded.
.
**Special Note on Indirect Costs as in-kind matching contributions:
Indirect costs may be claimed under the Federal portion of the award budget or, alternatively, indirect costs may be claimed as a matching contribution (if no indirect costs are requested under the Federal portion of the award budget). However, unless explicitly authorized in the RFA, indirect costs may not be claimed on both the Federal portion of the award budget and as a matching contribution, unless the total claimed on both the Federal portion of the award budget and as a matching contribution does not exceed the maximum allowed indirect costs or the institution’s negotiated indirect cost rate, whichever is less. An awardee may split the allocation between the Federal and non-Federal portions of the budget only if the total amount of indirect costs charged to the project does not exceed the maximum allowed indirect costs or the institution’s negotiated indirect cost rate, whichever is less. For example, if an awardees' indirect costs are capped at 30 percent pursuant to FY 2012 appropriated funds, Section 720 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012 (Division A of Pub. L. 112-55), the awardee may request 15 percent of the indirect costs on both the Federal portion of the award and as a matching contribution. Or, the awardee may request any similar percentage that, when combined, does not exceed the maximum indirect cost rate of 30 percent. Fully discretionary.
What are the requirements after being awarded this opportunity?
Reporting
Grantees are to submit initial project information and annual summary reports to NIFA’s electronic, Web-based inventory system that facilitates both grantee submissions of project outcomes and public access to information on Federally-funded projects. The details of the reporting requirements are included in the award terms and conditions. Cash reports are not applicable. Grantees are to submit initial project information and annual summary reports to NIFA’s electronic, Web-based inventory system that facilitates both grantee submissions of project outcomes and public access to information on Federally-funded projects. The details of the reporting requirements are included in the award terms and conditions. A final “Financial Status Report” (SF-269) or “Federal Financial Report” (SF-425) is due within 90 days of the expiration date of the grant and should be submitted to the Awards Management Branch, Office of Extramural Programs at the address listed below, in accordance with instructions contained in 2 CFR 3430.55 (also refer to Section 3015.82 of the Uniform Federal Assistance Regulations).

Awards Management Division (AMD)
Office of Grants and Financial Management (OGFM)
National Institute of Food and Agriculture (NIFA)
U.S. Department of Agriculture (USDA)
STOP 2271
1400 Independence Avenue, SW
Washington, DC 20250-2271
Telephone: (202) 401-4986. Grantees are to submit initial project information and annual summary reports to NIFA’s electronic, Web-based inventory system that facilitates both grantee submissions of project outcomes and public access to information on Federally-funded projects. The details of the reporting requirements are included in the award terms and conditions.
Auditing
In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. This program is also subject to audit by the cognizant Federal audit agency and the USDA Office of Inspector General.
Records
In accordance with the Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and other Non-profit Organizations [2 CFR 215, Subpart C, Section 215.53, (OMB Circular A-110)] grantees shall maintain separate records for each grant to ensure that funds are used for authorized purposes. Grant-related records are subject to inspection during the life of the grant and must be retained at least 3 years. Records must be retained beyond the 3-year period if litigation is pending or audit findings have not been resolved.
Other Assistance Considerations
Formula and Matching Requirements
This program has no statutory formula.
This program has no matching requirements. Funds are awarded competitively. No formula grants are awarded under Subtitle K of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 [7 U.S.C. 3319e].

NIFA does not require matching or cost sharing support for this program.
MOE requirements are not applicable to this program.
Length and Time Phasing of Assistance
The term of a competitive grant under this authority may not exceed five (5) years. Method of awarding/releasing assistance: by letter of credit.
Who do I contact about this opportunity?
Regional or Local Office
None.
Headquarters Office
USDA, NIFA, National Program Leader, Institute of Food Production and Sustainablity, Division of Plant Systems-Production, 1400 Independence Avenue, SW., STOP 2240, Washington , District of Columbia 20250-2240 Phone: (202) 401-4202 Fax: (202) 401-1782
Website Address
http://www.nifa.usda.gov/
Financial Information
Account Identification
12-1500-0-1-352.
Obligations
(Project Grants) FY 13 $2,785,758; FY 14 est $1,901,360; and FY 15 est $1,847,637 - NOTE:
Some of these funds are no year.In terms of availability of appropriations (time), there are no time limits as to when "no-year" funds may be obligated and expended and the funds remain available for their original purposes until expended.
Range and Average of Financial Assistance
If minimum or maximum amounts of funding per competitive project grant or cooperative agreement are established, these will be announced in the annual program announcement or Request for Application (RFA).
Regulations, Guidelines and Literature
7 CFR Part 3430, Competitive and Noncompetitive Non-formula Grant Programs – General Grant Administrative Provisions and Program-Specific Administrative Provisions; 7 CFR Part 3015, USDA Uniform Federal Assistance Regulations; 7 CFR Part 3017, Government wide Debarment and Suspension (Nonprocurement) ; 7 CFR Part 3018, New Restrictions on Lobbying; 7 CFR Part 3019, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-profit Organizations; and 7 CFR Part 3021— USDA implementation of Governmentwide Requirements for Drug-free Workplace (Financial Assistance).
Examples of Funded Projects
Fiscal Year 2013: 1.Assessing the impact of gene replacement and genetic modification methods in a crop species at the whole genome level
2.Monitoring the dispersal of genetically engineered organisms and their byproducts using light transmission spectroscopy
3.Assessing the risk of transgene escape via pollen flow in carrot
4.Switchgrass bioconfinement: delayed flowering, selective male- and seed-sterility, and conditional total bioconfinement
5.Linking pollinator behavior to gene flow to reduce gene flow risk over the landscape
6.Silencing of naturally occurring genes controlling seed dormancy to reduce fitness of transgene-contaminated weedy rice
7.Genome-wide assessment of off-target effect and removal of transgenes associated with TALEN-based gene editing in plant
8.Transgenic animal research conference IX. Fiscal Year 2014: Awards not yet finalized. No data available. Pertinent details will be provided by Program at a future date. Fiscal Year 2015: No data available. Pertinent details will be provided by Program at a future date.