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Regulatory Structure for GE Crops

This document explores the arguments surrounding the regulation and safety of genetically engineered (GE) crops. It addresses concerns about GMOs breaking species barriers, random genome insertions, and the potential hazards associated with their use. Through a review of U.S. regulatory frameworks, including USDA, FDA, and EPA guidelines, it highlights the necessity of risk assessment and labeling based on product composition. It argues that while GE crops are scrutinized, the risks they pose mirror those of conventional breeding practices.

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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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