Regulation of Agbiotech: Science Shows the Way

Henry I. Miller, M.S., M.D.The Hoover InstitutionStanford Universitymiller@hoover.stanford.edu

2,000 BC2,000 BC 1919thth Century Century Early 20Early 20thth Century Century Mid 20Mid 20thth Century Century 1930s1930s

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CultivationCultivation Selective Cross Breeding Selective Cross Breeding Wide-Cross HybridizationWide-Cross Hybridization

Mutagensis and Selection Mutagensis and Selection Cell Culture and Somaclonal Cell Culture and Somaclonal Variation Variation

Embryo Rescue Embryo Rescue Polyembryogenesis Polyembryogenesis Anther Culture Anther Culture

Recombinant DNARecombinant DNA Marker Assisted Marker Assisted

SelectionSelection GenomicsGenomics

BioinformaticsBioinformatics

Genetic Improvement Continuum

M. McGloughlin, M. McGloughlin, 20012001

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

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

Degree of regulatory scrutiny should be commensurate with risk (“proportionality”)

Similar things should be regulated in

a similar way

Principles of Regulation

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)

Principles of Regulation, Ignored Unscientific

Process-based

Lack of proportionality

Endless case by case reviews

New versus Old Biotech

Source: N. Fedoroff, Pennsylvania State University

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IR86 CP SLO 17 SIGADIS

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Mutations

Recombinations Translocations

Deletions

Golden IR 64

IR 64

„Natural“ Genome „Genetically Modified“ Genome

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

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)

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Malnourishment, Illness and Death

Conway & Toennissen, Science, 2003

“Pseudo-crises” Fear-mongering by NGOs Bad Press Over-Regulation

Agbiotech’s Problems

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

Distribution of Risk in Field Distribution of Risk in Field TrialsTrials

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

You Know the Risk Category: What Next?Example 1:

Category 1: Exempt Category 2: Notification Category 3: Prior approval Category 4: Prior approval

You Know the Risk Category: What Next?Example 2:

Category 1: Exempt Category 2: Prior approval Category 3: Prior approval Category 4: Prior approval

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

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

Thank you!

Q&A