1. Regulation of Agbiotech: Science Shows the Way Henry I. Miller, M.S., M.D. The Hoover Institution Stanford University miller@hoover.stanford.edu

2. 2,000 BC 19 th Century 19 th Century Early 20 th Century Early 20 th Century Mid 20 th Century Mid 20 th Century 1930s 1930s 1940s 1940s 1950s 1950s 1970s 1970s (1973) 1983 (1973) 1983 1980s 1980s 1990s 1990s 2000 2000Cultivation Selective Cross Breeding Selective Cross Breeding Wide-Cross Hybridization Wide-Cross Hybridization Mutagensis and Selection Mutagensis and Selection Cell Culture and Somaclonal Variation Cell Culture and Somaclonal Variation Embryo Rescue Embryo Rescue Polyembryogenesis Polyembryogenesis Anther Culture Anther Culture Recombinant DNA Recombinant DNA Marker Assisted Selection Marker Assisted Selection Genomics Genomics Bioinformatics Bioinformatics Genetic Improvement Continuum M. McGloughlin, 2001

3. Genetic modification is not new. – WHO Regional Office for Europe, 1982 Risks can be assessed and managed with current risk assessment strategies and control methods. – WHO Regional Office for Europe, 1982 Consensus on Old vs New Biotech

4. Crops modified by molecular and cellular methods should pose risks no different from those modified by classical genetic methods. – U.S. National Research Council, 1989 As the molecular methods are more specific, users of these methods will be more certain about the traits they introduce into the plants. – U.S. National Research Council, 1989

5. Degree of regulatory scrutiny should be commensurate with risk (“proportionality”) Similar things should be regulated in a similar way Principles of Regulation

6. The product of genetic modification and selection should be the primary focus for making [regulatory] decisions... and not the process by which the products were obtained. – U.S. National Research Council, 1989 If the scope of regulation is unscientific, the entire approach is unscientific Principles of Regulation (cont’d)

7. Principles of Regulation, Ignored Unscientific Process-based Lack of proportionality Endless case by case reviews

8. New versus Old Biotech Source: N. Fedoroff, Pennsylvania State University

9.                     Ultimate Landrace @ @ @@ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ Mutations Recombinations Translocations Deletions Golden IR 64 IR 64 „Natural“ Genome„Genetically Modified“ Genome 

11. Inflated R&D Costs Interminable delays Fewer products in the pipeline Widespread confusion Pseudo-crises Vandalism Intimidation of academics Litigation Malnourishment, illness and death Summary: Consequences of Flawed Regulation

12. Effects of Inflated Regulatory Costs ↓ Agbiotech innovation and product development (Kalaitzandonakes et al, NBT 2007) ↓ Commercialization of already-developed R- DNA-modified horticultural crops (Alston et al, J. Crop Improv. 2006) ↓ Potential for fruits and vegetables, tree fruits and nuts, and nursery and landscape crops (Alston et al, J. Crop Improv. 2006) --

13. Malnourishment, Illness and Death Conway & Toennissen, Science, 2003

14. “Pseudo-crises” Fear-mongering by NGOs Bad Press Over-Regulation Agbiotech’s Problems

15. Risk- and Science-Based Regulation: The “Stanford Model”

16. Distribution of Risk in Field Trials

17. RISK-BASED REGULATION: THE “STANFORD MODEL” Stratification of organisms according to risk Indifferent to technique of genetic alteration Flexible Scientifically defensible Analogous to quarantine regulations

20. You Know the Risk Category: What Next? Example 1:  Category 1: Exempt  Category 2: Notification  Category 3: Prior approval  Category 4: Prior approval

21. You Know the Risk Category: What Next? Example 2:  Category 1: Exempt  Category 2: Prior approval  Category 3: Prior approval  Category 4: Prior approval

22. The Stanford Model Flexible Permits various degrees of risk-aversion Permits discretion -- in a scientific context Exempts field trials that should be exempt; captures field trials that should be reviewed

23. Conclusions No justification for recombinant DNA- specific regulation Effects of recombinant DNA-specific regulation: catastrophic Science shows the way We need more than good intentions

24. Thank you! Q&A