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Prof. Gregory N. Mandel Albany Law School

Regulating Genetically Modified Food. Prof. Gregory N. Mandel Albany Law School. © 2005 Gregory N. Mandel. Crops Fish Livestock Artificial flavor. Crop products Animal products Insect products. The Food. Genetically Modified Food: . → Coordinated Framework.

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Prof. Gregory N. Mandel Albany Law School

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  1. Regulating Genetically Modified Food Prof. Gregory N. Mandel Albany Law School © 2005 Gregory N. Mandel

  2. Crops Fish Livestock Artificial flavor Crop products Animal products Insect products The Food Genetically Modified Food: → Coordinated Framework

  3. Food and Drug Administration • All food products except meat and poultry • Voluntary review only for GM crops prior to commercialization • No labeling of GM food • Asserted authority over GM fish (tenuous)

  4. Environmental Protection Agency • Authority based on pesticide use or residue in food • Primary authority for GM pest-protected plants • Authorization required for GM pest-protected plants prior to commercialization

  5. Department of Agriculture • Authority based on protection of American agriculture from GM products • Crops: Animal and Plant Health Inspection Service--Approval required before growth (generally through notification process) • Livestock: Food Safety Inspection Service--Authority not yet utilized (no products commercialized yet)

  6. Gaps • Inconsistencies • Inexperience • Overlaps

  7. Regulatory Gaps • Lack of EPA authority for most GM crops, and all GM fish, livestock, and insects • Sufficiency of environmental review by other agencies questionable • No requirement of FDA notification prior to commercialization of GM product • Possible lack of authority over GM fish and other next-generation products

  8. Regulatory Inconsistencies • Agencies define identical regulated products differently • Agencies define identical regulated substances differently • Data and rigor of scientific analysis vary among agencies • Some GM crops require approval before commercialization, others do not

  9. Regulatory Inexperience • Agencies fail to fully grasp potential varied impacts of GM products • StarLink Corn • Agencies regulating outside their areas of expertise due to statutory gaps

  10. Regulatory Overlap • Multiple agencies have authority over identical issues • Agencies conduct overlapping reviews of the impact of certain GM crops • Agencies request identical information and do not share it • Agencies reach differing conclusions on risk presented by the same product

  11. Curing Regulatory Deficiencies • Close statutory and regulatory gaps • EPA authority over environmental risks • Authority over next-generation products • Shift regulatory responsibility based on agency expertise and mandate

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