The Specialty Crops Regulatory Initiative

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The Specialty Crops Regulatory Initiative

• EES meeting, Sept 25, 2006
• Presenter Ann Marie Thro
• CSREES USDA
• 202 401 6702
• athro_at_csrees.usda.gov

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Specialty Crops

• 50 of annual value of US ag production
• 43B annual sales
• 26 states gt50 ag crop sales
• 33 states gt40 ag crop sales

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(No Transcript)
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Examples of SAES investment
Research investment to produce transgenic
plants Tomato virus resistance Florida
Citrus virus resistance Texas Citrus
bacterial resistance Florida Potato insect
resistant (Bt) Michigan Potato fungus resistant
Oregon Grape bacterial resistant Florida

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Examples of SAES investment
Research investment involving gene cloning and
eventually transgenic plants Apple disease
resistance Illinois Poplar production and
quality Oregon Potato processing
quality Minnesota Model spp. abiotic stress
tolerance CN, CA, IN,WI
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Examples of ARD investment
Grape bacterial resistant
FAMU Ornamentals fungus resistant TN
State U., Fort Valley SU Sweet Potato various
traits Tuskegee Small farmer crops various
traits Alabama AM, Alcorn
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Specialty Crops

• High value but -- low acreage for any one
  cultivar (variety)
• Is research on transgenic crops stalling out?

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US field trials, transgenic fruits vegetables,
1987 to Oct 2004 (from Redenbaugh,
in Goldner, Thro, and Radin, 2005).
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SCRI LaunchedWorkshop Nov. 8-9, 2004

• Report www.csrees.usda.gov gthomegtbiotechnology
  genomicsgtbiotechnologygt partnershipsgtSpecialty
  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?

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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

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SCRI EvolvesWorkshop Nov. 21-22, 2005

• refined concept
• consensus on a brief description
• plans for potential implementation

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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

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SCRI Mission

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

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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

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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

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SCRI Status

• public private support
• stakeholder support
• seed funds from OSEC, USDA
• retained consultant for development

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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

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The Specialty Crops Regulatory Initiative

• End of presentation

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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

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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 AM Univ., NSF - Public
  sector crop developer
• Swords, Kathy - Simplot - Agri-foods
• Thro, Ann Marie - CSREES, USDA - Federal
  resource person