1. The Specialty Crops Regulatory Initiative EES meeting, Sept 25, 2006 Presenter: Ann Marie Thro CSREES USDA 202 401 6702 athro@csrees.usda.gov

2. Specialty Crops ~ 50% of annual value of US ag production $43B annual sales 26 states >50% ag crop sales 33 states >40% ag crop sales

4. Examples of SAES investment Research investment to produce transgenic plants: Tomato virus resistanceFlorida Citrusvirus resistanceTexas Citrus bacterial resistance Florida Potatoinsect resistant (Bt) Michigan Potatofungus resistant Oregon Grapebacterial resistant Florida

5. Examples of SAES investment Research investment involving gene cloning and eventually transgenic plants: Apple disease resistance Illinois Poplarproduction and qualityOregon Potatoprocessing qualityMinnesota Model spp. abiotic stress tolerance CN, CA, IN,WI

6. Examples of ARD investment Grapebacterial resistant FA&MU Ornamentals fungus resistant TN State U., Fort Valley SU Sweet Potatovarious traitsTuskegee [Small farmer crops various traits Alabama A&M, Alcorn]

7. Specialty Crops High value – but -- low acreage for any one cultivar (variety) Is research on transgenic crops stalling out?

8. US field trials, transgenic fruits & vegetables, 1987 to Oct 2004 (from: Redenbaugh, in Goldner, Thro, and Radin, 2005).

9. SCRI Launched Workshop Nov. 8-9, 2004 Report: www.csrees.usda.gov >home>biotechnology & genomics>biotechnology> partnerships>Specialty Crops Regulatory Initiative identify potential constraints associated with regulatory process how might constraints be addressed? (science-based) are there current activities/programs that might be a model?

10. Consensus from Workshop constraints include costs and uncertainty an entity to assist in guiding biotech- derived products through regulatory process prioritize, public good and societal value simple organization (+ IR-4 model) concept with broad support, public +private develop a concept paper

11. SCRI Evolves Workshop Nov. 21-22, 2005 refined concept consensus on a brief description plans for potential implementation

12. SCRI Goal Create an entity that will contribute to enhancing the potential for U. S. consumers and growers/farmers to realize benefits from biotech-derived specialty crops

13. SCRI Mission Facilitate obtaining regulatory clearance for biotech-derived specialty crops Prioritized cases Initially, products of public good and societal value

14. SCRI Scope will work within existing regulations candidate products should have feasibility to reach farmers and consumers: developer should demonstrate reasonable plans for: right to operate / intellectual property commercialization, stewardship

15. SCRI Structure Stakeholder Liaison Committee Broad participation, all relevant stakeholders Identify and prioritize opportunities; communicate program; resources Program Management Committee Programmatic guidance and oversight, policy, budget Headquarters Staff Science based team with support staff

16. SCRI Status public private support stakeholder support seed funds from OSEC, USDA retained consultant for development

17. SAES and the SCRI SAES are major investors and stakeholders Investment may be lost if current trends continue SCRI will need SAES support Input for development plan and business plan Input to help identify potential priority products Financial support

18. The Specialty Crops Regulatory Initiative End of presentation

19. Appendix 1: Details, SCRI status, Sept 2006 Public-private coalition for moving forward to realize SCRI Planning team represents: Federal and state public research, incl.1862 & 1890 land grants; USDA (CSREES, ARS, APHIS, FAS), private sector research; technology providers; agribusiness; growers Broad support from stakeholders, e.g. American Seed Trade Association American Farm Bureau Federation Seed funding grant from Office of the Secretary, USDA To begin stakeholder consultation process Develop a business plan and implementation plan Consultant hired Summer 2006 Start up meeting with public/private planning team -- Aug 15, 2006

20. Appendix 2: SCRI Steering Committee 2006 Batkin, Ted- Citrus Research Board - Growers/farmers Blalock, June - Agricultural Research Service, USDA - Public sector crop developer Bradford, Kent - U California Davis - Public sector crop developer Dobres, Michael - NovaFlora, Inc. - Private sector crop developer Douches, David - Michigan State University - Public sector crop developer Goldner, Bill - CSREES, USDA- Federal resource person Gutterson, Neal - Mendel Biotechnologies - Private sector crop developer Hood, Elizabeth - Arkansas State University - Public sector crop developer Joshee, Nirmal - Fort Valley SU, GA- Public sector crop developer Kahn, Kathy - Foreign Agricultural Service, USDA - Federal resource person Mascia, Peter - Ceres - Private sector crop developer McCammon, Sally - APHIS, USDA - Federal resource person McHughen, Alan - U. California-Riverside- Public sector crop developer Ortman, Eldon - Purdue University - Public sector crop developer Radin, John - Agricultural Research Service, USDA - Public sector crop developers Redenbaugh, Keith - Seminis Vegetable Seeds - Private sector crop developer Sharma, Govind - Alabama A&M Univ., NSF - Public sector crop developer Swords, Kathy - Simplot - Agri-foods Thro, Ann Marie - CSREES, USDA - Federal resource person Whalen, Stephanie - Hawaii Agric. Res. Center - Farmer-owned research center