Biotechnology Risk Assessment Grants

(BRAG) Program

Shing Kwok, National Program Leader, NIFALakshmi Matukumalli, National Program Leader, NIFAJack Okamuro, National Program Leader, ARSDesiree Abrams, Program Specialist, NIFA

Program Priorities

Budget: $3.5 - 4.5M

Priority Area• Comparison between Transformation-associated Genomic Variation

and Genomic Variation Introduced by Non-genetic Engineering Approaches in Plants

• Development of a Risk Assessment Framework for the Environmental Impacts of GE crops at the Landscape Level

Program PrioritiesStandard Area• Management Practices to Minimize Environmental Risk of GE Organisms• Methods to Monitor Dispersal of GE Organisms • Gene Transfer to Domesticated and Wild Relatives • Environmental Impacts of GE relative to Non-GE Organisms in the Context of

Production Systems• Others:

• Research focused on the environmental effects of introducing RNA interference transgenes or other gene silencing mechanisms using RNAi, siRNA, or miRNA in animal , plants, microbes, and/or insects

• Assessment of the impacts of genetic engineering on plant-pest interactions

• Assessing the effects of transgene(s) in engineered animal species that may easily spread such as birds, aquatic species, arthropods, and invertebrates

• The effects of multiple transgenic resistance genes on non-target species• Development and/or evaluation of tools for assessing weediness or

invasiveness of GE plant relative to unmodified parent organisms• Non-target effects of genome editing technologies

BRAG Acknowledgement and Impact Statements

• Acknowledgement statement - “This project was supported by Biotechnology Risk Assessment Grant Program competitive grant no. ####-#####-##### from the U.S. Department of Agriculture”

• Notify program staff regarding publications, presentation/talks at conferences, press releases related to BRAG-funded research.

• Impact Statement on REEport should contain:• Information regarding change in knowledge related to biotechnology• New information regarding change in practice to prevention, mitigation, and/or

monitor GE organisms• Information regarding impacts on co-existence and agriculture• Draft impact statements that focus on impacts to researchers, farmers,

commodity groups, federal regulators, congressional leaders, general public• Should not be an extension of your results, should be less technical

BRAG Funding Statistics (FY 2010-2014)

FY2010 FY2011 FY2012 FY2013 FY2014 $-

$1,000,000.00

$2,000,000.00

$3,000,000.00

$4,000,000.00

$5,000,000.00

$6,000,000.00

$7,000,000.00

BRAG Program Funding (FY 2010-2015)

Total - $22,140,795

Conferences(9) 1%

Standard (45) 90%

Priority (2) 9%

Funding by Grant Type

$185,865

$19,962,170

$1,992,760

BRAG Research Project Funding by Science Areas (FY 2010-2014)

Plant Co-existence and Gene Flow

(9) 20%$4,456,385

Bt Crops (10) 20%

$4,486,484

Plant Containment(6) 12%

$2,578,852

Animals(5) 10%

$2,293,000

Plant Vector (4) 7%

$1,546,588

Plant RNAi/Gene Editing(3) 7%

$1,497,128

Genomic Changes due to Transforma-

tion(2) 6%

$1,422,683

Insect/Microbes(2) 4%

$874,122

Other(6) 13%

$2,799,888

Total $21,954,930

2014 Farm Bill and Matching Requirements• 2014 Farm Bill has new matching funds requirements, dollar for dollar and/or in-

kind match (more info: http://nifa.usda.gov/new-matching-requirement-frequently-asked-questions)

• Effective after October 1, 2014

• Exemptions for all USDA sister agencies (ARS, FS, etc.)

• Exemptions from matching requirements for all 1862 (Land-grant), 1890’s (HBCU), and 1994 (Tribal)

• Exemptions to public universities with 4-year degrees offering agricultural sciences degrees

• Exemptions if you “partner” with an exempted institution

• Request for Non-Land Grant College of Agriculture (NLGCA) Status: (http://nifa.usda.gov/webform/request-non-land-grant-college-agriculture-designation)

• Affects most competitive grants programs at NIFA, including BRAG, AFRI FY2015 exemption), etc.

2014 Farm Bill and Centers of Excellence

• The Farm Bill requires that NIFA recognize Centers of Excellence (COE) in research, extension, and education in the food and agricultural sciences. The legislation calls for the agency to give priority in funding to applications from COE in its research and extension competitive grant programs.

• Effective October 1, 2014 (FY 2015 RFAs)

• Eligibility is broad, application must include one of the following: state agricultural experiment stations; colleges and universities; university research foundations; other research institutions and organizations; Federal agencies; national laboratories; private organizations, foundations or corporations; or individuals.

2014 Farm Bill and Centers of Excellence• Programs offering COE in FY 2015:

• Agriculture and Food Research Initiative – Foundational Program and Challenge Areas

• Aquaculture Research• Biomass Research and Development Initiative• Biotechnology Risk Assessment Research Grants Program• Children, Youth, and Families at Risk• Crop Protection/Pest Management• Farm Business Management and Benchmarking• Farm Safety and Youth Farm Safety Education and Certification• Methyl Bromide Transition• Organic Agriculture Research and Extension Initiative• Organic Transition Program• Rural Health and Safety Program• Specialty Crop Research Initiative

• Per RFA instructions, applicants self identify COE in their Project Narrative of their application (same page limit as non COE applicants)

2014 Farm Bill and Centers of Excellence• To be designated as a COE, applicants must justify:

• The ability of the COE to ensure coordination by reducing unnecessarily duplicative efforts regarding research, teaching, and extension.

• The ability of the COE to leverage resources by using public-private partnerships among agricultural industry groups, institutions of higher education, and the federal government.

• The capability of the COE to implement teaching initiatives to increase awareness and effectively disseminate solutions to target audiences through extension activities.

• The ability COE to increase the economic returns to rural communities by identifying, attracting, and directing funds to high priority agricultural issues.

• COE applicants should describe proposed efforts to improve teaching capacity and infrastructure at colleges and universities.

2014 Farm Bill and Centers of Excellence

• Use of COE in panel ranking:

• Priority in funding will be provided after all eligible applicants have been competitively peer reviewed, and ranked in accordance with program’s standard evaluation criteria.

• NIFA will effectively use the COE prioritization as a “tie breaker.”

• More info: • http://nifa.usda.gov/centers-excellence-webinars-and-listening-sessions• http://

nifa.usda.gov/resource/centers-excellence-frequently-asked-questions

2014 Farm Bill and Commodity Board• The Farm Bill requires that NIFA solicit stakeholder input on procedures for federal or

state commodity boards to propose ideas for an Agricultural and Food Research Initiative (AFRI) Request for Application (RFA).

• Effective October 1, 2014 (FY 2015 RFAs)

• NIFA may either accept or reject any proposed RFA idea. Ideas that are accepted will be incorporated into future AFRI RFAs, as appropriate. Grant solicitations under this provision will require the proposing commodity boards to match AFRI awarded funds.

• NIFA is instructed by the 2014 farm Bill to:• Develop priorities for AFRI RFA proposal ideas the commodity boards submit• Develop evaluation criteria for selecting ideas submitted by commodity boards;• Incorporate selected ideas into the larger framework of the AFRI program;• Set limits on commodity board proposals; and• Determine the appropriate mix of ideas from proposals by national and state

commodity boards.

• More info: • http://nifa.usda.gov/commodity-board-afri-rfa-proposal-process

2014 Farm Bill and Commodity Board• The U.S. Department of Agriculture has recognized 22 organizations that meet

the definition of a commodity board:• Beef Board • Blueberry Council• Christmas Tree Board• Cotton Board• Dairy Board• Egg Board• Fluid Milk Board• Hass Avocado Board• Honey Board• Lamb Board• Mango Board

• NIFA has an ongoing process in working with commodity boards

• More info: • http://nifa.usda.gov/commodity-board-afri-rfa-proposal-process

• Mushroom Council• Paper and Paper-Based Packaging• Peanut Board• Popcorn Board• Pork Board• Potato Board• Processed Raspberry Council• Softwood Lumber Board• Sorghum Board• Soybean Board• Watermelon Board

Discussion Questions

1. Absolute containment to prevent gene flow during research trials are severe barriers to field studies. a) Is there, or can there be, regulatory flexibility to allow AP that

might result, at least with familiar markers, gene transfer vectors, and genes (including intra/cisgenics).

b) How can this be moved forward formally?

2. Is EPA seeking to exempt or streamline PIPs (compared to other biopesticides) based on RNAi given their high specificity? a) Or to resurrect its cisgenic/intragenic proposal?

3. Is USDA seeking to close the “loophole” for non-regulated transgenics? That is, biolistic based, non-pathogen sequences?

Discussion Questions

4. Have organisms modified by gene editing technology started to be considered in regards to regulations and risk assessment?

5. Does the USDA plan to regulate new transgenics that don’t use “traditional” recombinant DNA techniques such as Agrobacterium?

6. How do regulators distinguish between results from resistance models that predict different results?

7. If Aquabounty has met all of the FDA requirements, why have their salmon not been approved for sale by FDA? a) What is the delay?

b) How will this affect future applications?

Discussion Questions

8. Would USDA regulate a corn cultivar that had a high level of drought resistance based on engineering that did not involve any plant pest genes?

9. Will USDA regulate a new cultivar that has the same construct (that includes a plant pest gene) as an already deregulated cultivart but with a different insertion event?

AFRI- Foundational Program: Critical Agricultural Research and Extension (CARE)

• Background: Despite prior investments in basic and applied research, critical problems continue to impede the efficient production and protection of agriculturally-important plants and animals. These problems may be local, regional, or national, and may call for work focused on one or more scientific disciplines. However, all need immediate attention to meet producer needs. Finding and implementing solutions to these critical problems require partnership and close coordination among researchers, extension experts, and producers. Funded projects will quickly yield solutions or practices that can be rapidly implemented by producers

• Request for Application (RFA), under Foundational Program in the Agriculture and Food Research Initiative (AFRI) - http://nifa.usda.gov/funding-opportunity/afri-foundational-critical-agricultural-research-and-extension-care, page 35.

• Deadlines: Letters of Intent (LOIs), March 18, 2015; proposals, June 24, 2015

• Budget: $5M, award size : $200K (including indirect cost) for up to three years; Integrated Research and Extension and Research Only

• Contact: Dr. Martin Draper (mdraper@nifa.usda.gov)

AFRI- Foundational Program: Exploratory ResearchBackground: This program area encourages the development of innovative ideas that will position US Agriculture at the global forefront. These developments will lead to quantum leaps in the agricultural fields. They will address the challenges that have never been addressed before or challenges that have been addressed, but where a novel approach with new ideas could promise high potential impact. This program area priority provides support for research projects that develop proof of concept for untested novel ideas that will lead to a significant change in the areas of food security, climate change, environmental quality and natural resources, nutrition, obesity, food safety. Strong families and vibrant communities, and thriving youth.

This program area priority focuses on: • New and emerging innovative ideas that have high potential impact; • Application of new knowledge or approaches to unsolved challenges that have high potential impact; • Tools required to have a paradigm shift in the field; and/or • Rapid response to natural disasters and similar unanticipated events.

• Request for Application (RFA), under Foundational Program in the Agriculture and Food Research Initiative (AFRI) http://www.nifa.usda.gov/funding/rfas/pdfs/14_afri_found_mod_4_4.pdf, page 32.

• Deadlines: Letters of Intent (LOIs), March 1-August 31, 2015; proposals, September 30, 2015 (rolling deadline)

• Budget: $2M, award size : $100K, up to 2 years, Research

• Contact: Ms. Charlotte Kirk Baer(cbaer@nifa.usda.gov)