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Specialty Crop Regulatory Facilitation Initiative

Specialty Crop Regulatory Facilitation Initiative. Alan McHughen University of California Riverside, Ca alanmc@ucr.edu. Ann Marie Thro John Radin Bill Goldner Ed Kaleikau Ted Batkin Sujatha Sankula Sally McCammon Marvin Burns June Blalock Katherine Kahn. Jeff Wolt Eldon Ortman

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Specialty Crop Regulatory Facilitation Initiative

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  1. Specialty Crop Regulatory Facilitation Initiative Alan McHughen University of California Riverside, Ca alanmc@ucr.edu

  2. Ann Marie Thro John Radin Bill Goldner Ed Kaleikau Ted Batkin Sujatha Sankula Sally McCammon Marvin Burns June Blalock Katherine Kahn Jeff Wolt Eldon Ortman Beth Hood Mike Dobres Neal Gutterson Kanyand Matand Jill Long Thompson Kent Bradford Keith Redenbaugh Kathy Swords Early Builders

  3. SCRI is a Grassroots initiative • US taxpayers have invested $$$ in Agricultural Biotechnology • USDA- ARS, CSREES, • AES and Land grant universities, • 1890 Land grant institutions, • Other public and private universities, • State ag research, • Small ag and biotech companies. • Where’s the return on this investment?

  4. Whither GE specialty crops? • GE soybean: 63 M acres = 87% • GE cotton: 11 M acres = 79% • GE corn: 42 M acres = 52% • GE canola • GE papaya • GE flax • GE squash • GE carnation

  5. R&D since 1983 • Field trials: 10,873 in US since 1987 • Species tested: >100 between 1987- 1997 • Traits: >500 phenotypes field tested • But the benefits of GE crops: • 5 billion additional lbs of food and fiber • $1.9 Billion increase in farm income • 46 million lbs less pesticide • Flow from just Six crops and Three traits

  6. The GMO train… Photo still from In the Heat of the Night, Mirisch Corp, 1967

  7. Obstacles facing GE specialty crops • Intellectual property • Real • Perceived • Regulatory compliance • Real • Perceived

  8. Documents required for new crop variety l: rDNA, r: conventional

  9. Concept document • Need for an organization to guide GE specialty crops through regulatory process • Broad support from all relevant sectors • Prioritization of cases bases on • Public good with broad societal value • Need and opportunity • Structured on a simple but efficient plan.

  10. SCRI Format • Objective: prepare groundwork for Biotech Specialty Crop Regulatory support program, modeled after USDA’s IR-4, FDA’s Orphan-drug program, etc. • New, stand alone program not to compete with IR-4 or other programs. • Work with current regulatory system (!)

  11. Criteria for selection of first cases ? • Technical • Status of product; current database • Legal • FTO or enabling technology license in place? • Socio-economic • Broad public benefits • Utility, competition, international trade, etc. • Supportive market (e.g. lettuce, onion and garlic, citrus) • Ethical/Political • No ethical or politically questionable products • Practical • No allergenic/toxic products • Complexity in regulatory process.

  12. 2006 Status • Private- Public collaboration • Gaining broad support from stakeholders • E.g. AFBF, ASTA • Sought and received seed funds from • Office of the Secretary, USDA • Now recruiting consultant to develop business and implementation plan.

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