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Regulation of Agbiotech: Science Shows the Way

Regulation of Agbiotech: Science Shows the Way. Henry I. Miller, M.S., M.D. The Hoover Institution Stanford University miller@hoover.stanford.edu. Genetic Improvement Continuum. 2,000 BC 19 th Century Early 20 th Century Mid 20 th Century 1930s

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Regulation of Agbiotech: Science Shows the Way

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

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

  3. Consensus on Old vs New Biotech • 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

  4. Consensus on Old vs New Biotech • 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. Principles of Regulation • Degree of regulatory scrutiny should be commensurate with risk (“proportionality”) • Similar things should be regulated in a similar way

  6. Principles of Regulation (cont’d) • 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

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

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

  11. 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) --

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

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

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

  15. Distribution of Risk in Field Trials

  16. 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

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

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

  19. 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

  20. 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

  21. Thank you! Q&A

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