FDA Regulation of Food from GE...
Transcript of FDA Regulation of Food from GE...
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FDA Regulation of Food from GE Crops
Patrick Cournoyer, Ph.D. U.S. Food and Drug Administration (FDA)
Center for Food Safety and Applied Nutrition Office of Food Additive Safety
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Overview
• Historical perspective: – FDA’s involvement in plant breeding and plant biotechnology
• FDA’s regulatory approach:
– Legal authority related to food from GE plants
• How to consult with us: – The types of data and information FDA evaluates
• Past consultations
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• 1938: The Federal Food Drug & Cosmetic Act – 1958: Food Additive Amendment – Food additives require approval – Exempted: Substances whose uses
are “Generally Recognized as Safe” (GRAS)
• 1970: Regulation on plant breeding
and GRAS – Emerging concerns cited:
• Glycoalkaloids in potatoes • Endogenous defensive compounds • Key vitamins and nutrients
Regulating plant breeding: A historical perspective
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Regulating plant breeding: A historical perspective
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• 1986 Coordinated Framework – USDA – EPA – FDA – Existing legal authorities sufficient
Endogenous Substances
Must not contain substances at levels that are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Including substances added through biotechnology (1984)
Including sufficient levels of key nutrients (1970)
Regulating plant breeding: A historical perspective
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• FDA’s 1992 Statement of Policy: Foods Derived from New Plant Varieties
• FDA views on plant breeding in general • Discussed new methods of biotechnology
• Recommended consultation • Flow charts to help developers determine if important safety
and regulatory concerns exist
Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Labeling Labeling must be truthful and not misleading (misbranding)
Regulating plant breeding: A historical perspective
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Overview
• Historical perspective: – FDA’s involvement in plant breeding and plant biotechnology
• FDA’s regulatory approach:
– Legal authority related to food from GE plants
• How to consult with us: – Data and information FDA evaluates
• Past consultations
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Federal Food Drug & Cosmetic Act (FD&C Act) Core Provisions
FD&C Act Labeling
Labeling must be truthful and not misleading (misbranding)
Safety Food must be safe
(adulteration)
Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
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Federal Food Drug & Cosmetic Act (FD&C Act) Core Provisions
FD&C Act Labeling
Labeling must be truthful and not misleading (misbranding)
Safety Food must be safe
(adulteration)
Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Legal without premarket approval If safety info is publically available
and widely accepted by experts (GRAS)
Premarket review required If safety info is NOT publically available or
NOT widely accepted by experts
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What does GRAS mean?
• GRAS: generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. (FD&C Act, Section 201(s))
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What does “safe” mean?
With respect to added substances: • Safe or safety means that there is a reasonable
certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. (Code of Federal Regulations 170.3(i))
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The FD&C Act applies to food from GE crops
FD&C Act Labeling
Labeling must be truthful and not misleading (misbranding)
Safety Food must be safe
(adulteration)
Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Legal without premarket approval If safety info is publically available
and widely accepted by experts (GRAS)
Premarket review required If safety info is NOT publically available or
NOT widely accepted by experts
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The FD&C Act applies to food from GE crops
Endogenous Substances Must not contain substances at levels that
are harmful
Above 200 milligrams total glycoalkaloid per kilogram of potato
Below 200 milligrams total glycoalkaloid per kilogram of potato
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The FD&C Act applies to food from GE crops
FD&C Act Labeling
Labeling must be truthful and not misleading (misbranding)
Safety Food must be safe
(adulteration)
Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Legal without premarket approval If safety info is publically available
and widely accepted by experts (GRAS)
Premarket review required If safety info is NOT publically available or
NOT widely accepted by experts
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The FD&C Act applies to food from GE crops
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Legal without premarket approval If safety info is publically available
and widely accepted by experts (GRAS)
Premarket review required If safety info is NOT publically available or
NOT widely accepted by experts
Glyphosate tolerant corn with added CP4 EPSPS
protein
CP4 EPSPS
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The FD&C Act applies to food from GE crops
FD&C Act Labeling
Labeling must be truthful and not misleading (misbranding)
Safety Food must be safe
(adulteration)
Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Legal without premarket approval If safety info is publically available
and widely accepted by experts (GRAS)
Premarket review required If safety info is NOT publically available or
NOT widely accepted by experts
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The FD&C Act applies to food from GE crops
Must disclose “material” facts
Common or Usual Name
Labeling Labeling must be truthful and not misleading (misbranding)
25%
75% 72%
0%
20%
40%
60%
80%
GE Soybean with increased levels of
oleic acid Oleic acid content in
oil
New name: “High oleic soybean
oil”
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Overview
• Historical perspective: – FDA’s involvement in plant breeding and plant biotechnology
• FDA’s regulatory approach:
– Legal authority related to food from GE plants
• How to consult with us: – Data and information FDA evaluates
• Past consultations
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Consulting with FDA
FD&C Act Labeling
Labeling must be truthful and not misleading (misbranding)
Safety Food must be safe
(adulteration)
Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Legal without premarket approval If safety info is publically available
and widely accepted by experts (GRAS)
Premarket review required If safety info is NOT publically available or
NOT widely accepted by experts
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Consulting with FDA
Labeling Labeling must be truthful and not misleading (misbranding)
Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Consultation with FDA to resolve safety and regulatory questions before
marketing
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Consulting with FDA
Developer submits
safety and regulatory
assessment
FDA team of experts
evaluates the data and information
FDA requests additional
information as needed
Repeat until safety and regulatory questions
are resolved
FDA summarizes
evaluation in a memo
FDA ends the
consultation by sending a letter to the developer
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Consulting with FDA
Developer submits
safety and regulatory
assessment
FDA team of experts
evaluates the data and information
FDA requests additional
information as needed
Repeat until safety and regulatory questions
are resolved
FDA summarizes
evaluation in a memo
FDA ends the
consultation by sending a letter to the developer
Before sending us a submission for a “final consultation”
Consult with us early! Consult with us often!
Meet with us in person or by teleconference No cost
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Elements of a Submission
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Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Basic Information
• Trait description • Crop uses • Molecular characterization • Trait stability
Labeling Labeling must be truthful and not misleading (misbranding)
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Elements of a Submission
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Basic Information
Characterize insertion(s), copy
number Vector Backbone?
New proteins from alternative
open reading frames?
Stability?
• Trait description • Crop uses • Molecular characterization • Trait stability
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Elements of a Submission
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Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Basic Information
Labeling Labeling must be truthful and not misleading (misbranding)
Compositional assessment:
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Compositional Analysis
Key Nutrients
proximates
fatty acids
amino acids
minerals
vitamins
?
Anti-Nutrients
lectins
raffinose stachyose
phytic acid
protease inhibitors
cyanogenic glycosides
?
Endogenous Toxicants
glycoalkaloids
gossypol
glucosinolates
benzyl isothiocyanate
isoflavones*
?
Endogenous Allergens
soybean
wheat
rice
?
“Good stuff” “Bad stuff”
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Compositional Analysis
Appropriate comparator (Grown concurrently)
To characterize changes
Reference varieties (Grown concurrently)
To characterize existing variation
Published data To characterize existing
variation
New GE variety
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Compositional Analysis
• Field trial design
– Number of locations, years? • Need to represent range of conditions
– Number of replicates?
• Need to control for variables • Need statistical power
• Field trials should be designed to answer
necessary regulatory questions – Case by case
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Elements of a Submission
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Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Basic Information
Labeling Labeling must be truthful and not misleading (misbranding)
Proteins: Toxicity, allergenicity Metabolites
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Evaluating new substances for safety
• What is it? – Prior knowledge – What happens after consumption? (ADME) – What do we know about potential toxicity?
• How much is safe to consume?
– Are feeding studies needed? – NOAEL
• How much is consumed?
– Calculating exposure
• Are expected exposure levels safe? – Margin of exposure
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Elements of a Submission
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Endogenous Substances Must not contain substances at levels that
are harmful
Added Substances Ingredients must meet safety criteria, may
require FDA review and approval
Basic Information
Labeling Labeling must be truthful and not misleading (misbranding)
Common or usual name “Material” differences?
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New Protein Consultations
• Potential unintended presence in food • FDA issued guidance in 2006 to establish
mechanism for FDA to evaluate new proteins before field testing
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Overview
• Historical perspective: – FDA’s involvement in plant breeding and plant biotechnology
• FDA’s regulatory approach:
– Legal authority related to food from GE plants
• How to consult with us: – Data and information FDA evaluates
• Past consultations
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Completed New Protein Consultations
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Completed Consultations Crops (# of events)
Herbicide tolerance
(52)
Corn (45)
Potato (35)
Cotton (25)
Soybean (19)
Canola (18)
Tomato (7) Sugar beet (3)
Alfalfa (3) Radicchio (3)
Other* (14)
* Squash (2), cantaloupe (2), apple (2), rice (2), papaya (2), plum (1), flax (1), wheat (1), creeping bentgrass (1)
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Completed Consultations Traits (# of events)
Insect resistance (Bt)* (71)
Herbicide tolerance (52)
Male sterility (13)
Reduced browning (9)
Insect resistance (RNAi)* (1)
Increased yield (2) Drought tolerance (1)
Processing enzymes (5) Lower acrylamide potential (7)
Altered composition (8) Delayed ripening (8)
Virus resistance (RNAi)* (19)
Disease resistance (R protein)* (1)
Insect resistance (Bt)* (71)
Herbicide tolerance (52)
* Plant-incorporated protectants regulated by EPA
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Thank You • FDA Home Page
– www.fda.gov
• FDA’s Plant Biotechnology Consultation Program – www.fda.gov/GEPlantFoods – Food from GE Plants – How FDA regulates Food from GE Plants – Q&As – Links to guidance and policy documents
• Listing of all completed consultations
– www.fda.gov/bioconinventory – Documents from completed consultations
• Contact
– [email protected] – [email protected] (Biotech program lead) – [email protected] (New Protein Consultation Program lead)