Specialty Crop Regulatory Specialty Crop Regulatory Facilitation InitiativeFacilitation Initiative

Alan McHughenAlan McHughenUniversity of CaliforniaUniversity of California

Riverside, CaRiverside, Caalanmc@ucr.edualanmc@ucr.edu

Early BuildersEarly Builders Ann Marie ThroAnn Marie Thro John RadinJohn Radin Bill GoldnerBill Goldner Ed KaleikauEd Kaleikau Ted BatkinTed Batkin Sujatha SankulaSujatha Sankula Sally McCammonSally McCammon Marvin BurnsMarvin Burns June BlalockJune Blalock Katherine KahnKatherine Kahn

Jeff WoltJeff Wolt Eldon OrtmanEldon Ortman Beth HoodBeth Hood Mike DobresMike Dobres Neal GuttersonNeal Gutterson Kanyand MatandKanyand Matand Jill Long ThompsonJill Long Thompson Kent BradfordKent Bradford Keith RedenbaughKeith Redenbaugh Kathy SwordsKathy Swords

SCRI is a SCRI is a GrassrootsGrassroots initiative initiative US taxpayers have invested $$$ in US taxpayers have invested $$$ in

Agricultural Biotechnology Agricultural Biotechnology USDA- ARS, CSREES, USDA- ARS, CSREES, AES and Land grant universities, AES and Land grant universities, 1890 Land grant institutions,1890 Land grant institutions, Other public and private universities,Other public and private universities, State ag research,State ag research, Small ag and biotech companies.Small ag and biotech companies.

Where’s the return on this investment?Where’s the return on this investment?

Whither GE specialty crops?Whither GE specialty crops? GE soybean: 63 M acres = 87%GE soybean: 63 M acres = 87% GE cotton: 11 M acres = 79%GE cotton: 11 M acres = 79% GE corn: 42 M acres = 52%GE corn: 42 M acres = 52% GE canolaGE canola GE papayaGE papaya GE flaxGE flax GE squashGE squash GE carnationGE carnation

R&D since 1983R&D since 1983

Field trials: 10,873 in US since 1987Field trials: 10,873 in US since 1987 Species tested: >100 between 1987- 1997Species tested: >100 between 1987- 1997 Traits: >500 phenotypes field testedTraits: >500 phenotypes field tested But the benefits of GE crops: But the benefits of GE crops:

5 billion additional lbs of food and fiber5 billion additional lbs of food and fiber $1.9 Billion increase in farm income$1.9 Billion increase in farm income 46 million lbs less pesticide46 million lbs less pesticide

Flow from just Six crops and Three traitsFlow from just Six crops and Three traits

The GMO train…The GMO train…

Photo still from Photo still from In the Heat of the NightIn the Heat of the Night, Mirisch Corp, 1967 , Mirisch Corp, 1967

Obstacles facing GE specialty cropsObstacles facing GE specialty crops

Intellectual property Intellectual property RealReal PerceivedPerceived

Regulatory complianceRegulatory compliance RealReal PerceivedPerceived

Documents required for new Documents required for new crop variety crop variety

l: rDNA, r: conventionall: rDNA, r: conventional

Concept documentConcept document

Need for an organization to guide GE Need for an organization to guide GE specialty crops through regulatory processspecialty crops through regulatory process

Broad support from all relevant sectorsBroad support from all relevant sectors Prioritization of cases bases on Prioritization of cases bases on

Public good with broad societal valuePublic good with broad societal value Need and opportunityNeed and opportunity

Structured on a simple but efficient plan.Structured on a simple but efficient plan.

SCRI FormatSCRI Format

Objective: prepare groundwork for Biotech Objective: prepare groundwork for Biotech Specialty Crop Regulatory support Specialty Crop Regulatory support program, modeled after USDA’s IR-4, program, modeled after USDA’s IR-4, FDA’s Orphan-drug program, etc. FDA’s Orphan-drug program, etc.

New, stand alone program not to compete New, stand alone program not to compete with IR-4 or other programs.with IR-4 or other programs.

Work with current regulatory system (!)Work with current regulatory system (!)

Criteria for selection of first cases ?Criteria for selection of first cases ? TechnicalTechnical

Status of product; current databaseStatus of product; current database LegalLegal

FTO or enabling technology license in place?FTO or enabling technology license in place? Socio-economicSocio-economic

Broad public benefitsBroad public benefits Utility, competition, international trade, etc.Utility, competition, international trade, etc. Supportive market (e.g. lettuce, onion and garlic, citrus)Supportive market (e.g. lettuce, onion and garlic, citrus)

Ethical/PoliticalEthical/Political No ethical or politically questionable productsNo ethical or politically questionable products

PracticalPractical No allergenic/toxic productsNo allergenic/toxic products Complexity in regulatory process.Complexity in regulatory process.

2006 Status2006 Status Private- Public collaborationPrivate- Public collaboration Gaining broad support from stakeholdersGaining broad support from stakeholders

E.g. AFBF, ASTAE.g. AFBF, ASTA Sought and received seed funds from Sought and received seed funds from

Office of the Secretary, USDAOffice of the Secretary, USDA Now recruiting consultant to develop Now recruiting consultant to develop

business and implementation plan.business and implementation plan.