The Specialty Crops Regulatory Initiative

EES meeting, Sept 25, 2006

Presenter: Ann Marie ThroCSREES USDA

202 401 6702athro@csrees.usda.gov

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

Examples of SAES investment

Research investment to produce transgenic plants:

Tomato virus resistance Florida Citrus virus resistance TexasCitrus bacterial resistance FloridaPotato insect resistant (Bt) Michigan Potato fungus resistant OregonGrape bacterial resistant Florida

Examples of SAES investment

Research investment involving gene cloning and eventually transgenic plants:

Apple disease resistance IllinoisPoplar production and quality OregonPotato processing quality Minnesota

Model spp. abiotic stress tolerance CN, CA, IN,WI

Examples of ARD investment

Grape bacterial resistant FA&MUOrnamentals fungus resistant TN State U., Fort Valley SU Sweet Potato various traits Tuskegee

[Small farmer crops various traits Alabama A&M, Alcorn]

Specialty Crops

• High value – but -- low acreage for any one cultivar (variety)

• Is research on transgenic crops stalling out?

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

020406080

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Year

# F

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Brassica oleracea

Carrot

Cucumber

Eggplant

Lettuce

Melon

Onion

Pea

Pepper

Squash

Tomato

Watermelon

SCRI LaunchedWorkshop 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?

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 +privatedevelop a concept paper

SCRI EvolvesWorkshop Nov. 21-22, 2005

refined conceptconsensus on a brief descriptionplans for potential implementation

SCRI GoalCreate an entity that will contribute to

enhancing the potential for U. S. consumers and growers/farmers to realize benefits from biotech-derived specialty crops

SCRI MissionFacilitate obtaining regulatory clearance for

biotech-derived specialty cropsPrioritized cases

Initially, products of public good and societal value

SCRI Scopewill 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

SCRI StructureStakeholder Liaison Committee

Broad participation, all relevant stakeholders Identify and prioritize opportunities; communicate

program; resourcesProgram Management Committee

Programmatic guidance and oversight, policy, budget

Headquarters Staff Science based team with support staff

SCRI Status public private supportstakeholder supportseed funds from OSEC, USDAretained consultant for development

SAES and the SCRI SAES are major investors and stakeholdersInvestment may be lost if current trends

continueSCRI will need SAES support

Input for development plan and business plan Input to help identify potential priority products Financial support

The Specialty Crops Regulatory Initiative

End of presentation

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

Appendix 2: SCRI Steering Committee 2006Batkin, Ted- Citrus Research Board - Growers/farmersBlalock, June - Agricultural Research Service, USDA - Public sector crop developerBradford, Kent - U California Davis - Public sector crop developerDobres, Michael - NovaFlora, Inc. - Private sector crop developerDouches, David - Michigan State University - Public sector crop developer Goldner, Bill - CSREES, USDA - Federal resource personGutterson, Neal - Mendel Biotechnologies - Private sector crop developerHood, Elizabeth - Arkansas State University - Public sector crop developerJoshee, Nirmal - Fort Valley SU, GA - Public sector crop developerKahn, Kathy - Foreign Agricultural Service, USDA - Federal resource personMascia, Peter - Ceres - Private sector crop developerMcCammon, Sally - APHIS, USDA - Federal resource personMcHughen, Alan - U. California-Riverside - Public sector crop developerOrtman, Eldon - Purdue University - Public sector crop developerRadin, John - Agricultural Research Service, USDA - Public sector crop developersRedenbaugh, Keith - Seminis Vegetable Seeds - Private sector crop developerSharma, Govind - Alabama A&M Univ., NSF - Public sector crop developerSwords, Kathy - Simplot - Agri-foodsThro, Ann Marie - CSREES, USDA - Federal resource personWhalen, Stephanie - Hawaii Agric. Res. Center - Farmer-owned research center