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Regulatory Structure for GE Crops

Regulatory Structure for GE Crops. Alan McHughen, D.Phil., University of California Riverside, Ca USA alanmc@ucr.edu. Arguments to ban GMOs…. GMOs are hazardous because… GE breaks the “species barrier”; Nature never allows genes from one species to move to another

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Regulatory Structure for GE Crops

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  1. Regulatory Structure for GE Crops Alan McHughen, D.Phil., University of California Riverside, Ca USA alanmc@ucr.edu

  2. Arguments to ban GMOs… • GMOs are hazardous because… • GE breaks the “species barrier”; Nature never allows genes from one species to move to another • GE involves random insertions into genome • GE crops and foods are untested and unregulated • Once released, GMOs can never be recalled • …or other claims of danger?

  3. USA: Theory of risk assessment • Science based risk analyses • Other factors applied later • Product vs process • rDNA processes are not inherently risky • Any breeding process may result in risky products • Labelling • Product composition, not process

  4. Foreign Genes in Wheat Friebe et al., Crop Science 39:1692-1696 (1999)

  5. Variety release requirements: genetically engineered crops • USDA (APHIS) - environmental issues • HHS (FDA)- food and feed safety • EPA- pesticide usage issues

  6. Variety release requirements: genetically engineered crops • USDA- environmental issues • Plant Protection Act (PPA, 2000); also administers • Plant Patent Act (for asexually propagated plants) • Plant Variety Protection Act (PVPA)

  7. USDA/APHIS procedures • Notification • Simplest means for least hazardous GE plants • Must meet six criteria (non-weedy; stable; known function; non-infectious/toxic/pharmaceutical/industrial; non-virulent; non-human or animal pathogenic source) • Permit (for field testing release) • More complex GE plants, requires greater scrutiny • Petition for nonregulated status (commercialization) • Complete risk analysis

  8. US field trials, 1986-present • 12,000+ • http://nbiap.biochem.vt.edu/cfdocs/fieldtests1.cfm • 47,000 • Environment Maine (PR 8/18/2005) • “…once released, can never be recalled.”

  9. Variety release requirements: genetically engineered crops • FDA- food and feed safety • Federal Food, Drug, and Cosmetic Act (FFDCA) • GRAS (substantially equivalent) • Food Additive

  10. Variety release requirements: genetically engineered crops • EPA- pesticide usage, food safety issues • Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) • Federal Food, Drug, and Cosmetic Act (FFDCA) and • Toxic Substances Control Act (TSCA)

  11. Arguments to ban GMOs… • GMOs are hazardous because… • GE breaks the “species barrier”; Nature never allows genes from one species in another • GE involves random insertions into genome • GE crops and foods are untested and unregulated • Once released, GMOs can never be recalled… • The same “hazards” as other breeding methods.

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