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

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

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)

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

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)

USESTATUTEAGENCY Food and food additives Meat, poultry, egg products Pesticide residues FFDCA FMIA, PPIA, EPIA FFDCA FDA FSIS EPA Production of pharmaceuticals Human drugs Human biologics Animal drugs Animal biologics FFDCA PHS Act, FFDCA FFDCA AQL, VSTA FDA APHIS Production of pesticidal substances in plants FIFRA PPA EPA APHIS Production of plant herbicide- tolerance Herbicide usage on plants PPA FIFRA APHIS EPA Biocontrol of plantsPPA FIFRA APHIS EPA Biocontrol of plant pestsPPA FIFRA APHIS EPA Biomedical research on animals AWA HREA APHIS NIH Gaps Inconsistencies Inexperience Overlaps

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

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

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

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

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