Transcript Building Confidence Through Teamwork on Regulatory Measures

Regulating Genetically Modified
Food
Prof. Gregory N. Mandel
Albany Law School
© 2005 Gregory N. Mandel
The Food
Genetically Modified Food:
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Crops
Fish
Livestock
Artificial flavor
• Crop products
• Animal products
• Insect products
→ 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 pestprotected 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)
USE
Food and food additives
Meat, poultry, egg
products
Pesticide residues
STATUTE
AGENCY
FFDCA
FMIA, PPIA, EPIA
FDA
FSIS
FFDCA
EPA
Production of pharmaceuticals
Human drugs
Human biologics
Animal drugs
Animal biologics
FFDCA
PHS Act, FFDCA
FFDCA
AQL, VSTA
FDA
FDA
FDA
APHIS
Production of pesticidal
substances in plants
FIFRA
PPA
EPA
APHIS
Production of plant herbicidetolerance
Herbicide usage on plants
PPA
APHIS
FIFRA
EPA
Biocontrol of plants
PPA
FIFRA
APHIS
EPA
Biocontrol of plant pests
PPA
FIFRA
APHIS
EPA
Biomedical research on
animals
AWA
HREA
APHIS
NIH
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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