Transcript Safety and Regulation in Agricultural Biotechnology

Safety and Regulation in
Agricultural Biotechnology
MUPGRET Workshop
Comprehensive safety
assessments
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Integrated (coordinated) framework
involves three federal agencies to
ensure biotech product safety.
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USDA: environmental safety
EPA: environmental, food and feed safety
for pest-protected products.
FDA: feed and food safety.
Public participation
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Solicited by USDA, EPA and FDA at
several steps in the process.
Small-scale to commercial testing.
Food and Drug Administration
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Voluntary Labeling
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Indicates whether foods have or have not
been developed using transgenic
technology.
Pre-market notice concerning food
resulting from transgenic technology.
www.access.gpo.gov/su_docs/aces/aces
140.html
Comprehensive international safety
assessments in key export markets
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European Union
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Canada
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Director of EU
Canadian Food Inspection Agency
Japan
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Ministry of Agriculture, Forestry, and
Fisheries; Ministry of Health and Welfare
Safety is a comparison of
Risks and Benefits
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All technologies are evaluated relative to:
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Consequences of their implementation
Consequences of their non-implementation
Comparison to safety of alternative
technologies
Context of current and historical practices
Benefit to human, animal and
environmental health
Minimizing risk
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Comprehensive hazard analysis
Risk identification
Assessment (evaluation)
Risk/benefit consideration
Develop risk management plan
Effective training and communication
Assessing Safety
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Standard is “reasonable certainty that
no harm will result from intended uses
under the anticipated conditions of
consumption”.
Remember
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Food is not inherently safe.
Safety is based on experience.
Relative, not absolute safety.
Substantial Equivalence
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“as safe as”
Compare transgenic products to
conventional products.
Hazard identification
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Toxicity
Allergenecity
Safety of antibiotic resistance markers
Nutritional equivalence
Compositional equivalence
Lack of unintended effects
Safety-Genetic and Protein
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Map of vector and its
components
Position and size of
“novel” DNA
Function of gene in
plant
Source of gene
Inheritance and stability
of trait
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Changes in amino acid
sequence relative to
native protein
Expected expression
Compare to known
toxin/allergens
Test in mice
In vitro digestibility test
Compositional Equivalence
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Fatty acid
Amino acid
Vitamin
Mineral
Anti-nutrient
How does this compare to the variation
present among conventional varieties?
Comparison to toxin/allergens
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Compared in global database against
>100,000 proteins.
“Macro” analysis of entire protein
“Micro” analysis of small stretches of
protein (eg. 600 comparisons for the Bt
protein).
Allergenicity
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1-2% of adults are affected by food allergies.
Eight major allergens:
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Peanut
Milk
Soy
Wheat
Shellfish
Fish
Egg
Tree Nuts
Toxicity Assessment
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Once safety is established, EPA tests for
secondary metabolic activity
These products are labeled because
they have different composition due to
the change in protein.
Testing in Mouse
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Cry1Ac (Cotton, Tomato)
Cry3A (Potato)
Cry1b (Corn)
CP4 EPSPS (Soybean)
4200mg/kg
5200mg/kg
4000mg/kg
572 mg/kg
CROPS
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Coordinated screening and testing
Regulatory review
Other scientific experiments and trials
Performance feedback from growers
Stewardship and monitoring to ensure
responsible use.
www.castscience.org/biotechnology/index.html
Coordinated screening and
testing
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Initial screening
Early field testing
Experimental use permits
Regulatory review
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USDA
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Composition, Germination, Seed longevity,
Growth and Reproduction, Outcrossing,
Fitness Assessment, Herbicial Activity, Field
Observation
EPA
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Plant gene expression, toxicology,
environmental fate
Other scientists
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Land Grant Universities
Private Institutions
Private Foundations
Performance Feedback
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Compare transgenic and conventional in
field setting
Environmental stewardship
New paradigms, ex. Return of beneficial
insects.
Stewardship and Monitoring
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Non-target populations
Risk management plan
Monitor use accordance with
requirements.
Nine chances to say no!
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Biosafety Committee
USDA Greenhouse
Approval
USDA Field Trial
Authorization
USDA Authorization for
transport to field trials
USDA Permit to
Commercialize
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EPA Experimental Use
Permit
EPA Food Tolerance
Determination
EPA Product
Registration
FDA Review
International Agencies
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Food and Agriculture Organization and
World Health Organization say:
“products of plant biotechnology are not
inherently less safe than those
developed by traditional breeding”
“same food safety considerations”
“extensive testing provides equal or
greater assurance of safety”