FDA Regulation of Biotech foods

CFR21
Reserved for rules of the Food and Drug Administration
FDA
Responsible for ensuring safety and proper labeling of all plant derived
foods and feeds, including those developed through genetic engineering
(or cell fusion techniques), except for meat and poultry products
Enforcement responsibilities under the Federal Food, Drug, and
Cosmetics Act
Include seizure and criminal prosecution
Authority for legal action against adulterated (Section 402) or misbranded
food (Section 403)
Adulterated- bears or contains poisonous substance
Misbranded- false or misleading label
Food Additives Amendment of 1958 (Section 409 of FFDCA)
Required pre-market approval for food additives: safety must be
demonstrated.
Additive
Not a normal constituent, or,
Level has been increased by human intervention
Includes preservative, emulsifier, antioxidants, artificial
flavors
Conditions for safe use are specified
FDA and GE foods
Any food additive, introduced by genetic engineering must receive FDA
approval before marketing.
Federal oversight of GE foods ensures public confidence in foods
produced by newer genetic techniques.

Center for Food Safety and Applied Nutrition- CFSAN

CFSAN
Department within FDA primarily responsible for safety of biotech foods.
Also enforces allowable reside levels of pesticides, including biotech
pesticidal substances that appear in food.

FDA Regulation of Biotech Foods

GRAS
Generally Recognized As Safe
Does not require pre-market approval. Marketed despite not being
formally reviewed by FDA.

 Safety had been known based on long history of use in food. Ex: Salt,
vinegar, oil, spices and natural flavors
However, if the producer markets the ingredient as GRAS, and FDA
subsequently concludes the substance is not GRAS, the agency will stop
distribution of product on the ground that such foods contain an unlawful
food additive.
Dietary supplements

FDAs 1986 policy under CFRB

Agency intends to regulate foods produced by rDNA techniques, within the

existing regulatory framework that applies for foods produced by traditional
breeding techniques

FDAs 1992 policy

Statement of Policy: Foods derived from new plant varieties

Recommends that crop developers consult with FDA about bioengineered
foods under development
Identify and discuss safety and nutritional issues
Developer should submit scientific and regulatory issues and FDA
evaluates submission.
Bioengineered foods are regulated similarly to products of traditional
breeding techniques
Regulatory status depends on characteristics and use of food, regardless
of how they were developed: Product, not process
Genetic material is GRAS
Assess unintended occurrences of unsafe levels of toxic components
(=additives) in food as a result of GM because any genetic modification
technique has the potential to alter the composition of food in a manner
relevant to food safety
First consultation was with Calgene for FLAVR SAVR tomatoes
Where expression of a gene involved in ripening was
downregulated
Evaluation process was open to public comment
Possible changes in composition of food that are evaluated by FDA:
Increased production of known plant toxicants due to Rdna
New substances generated- recombinant protein modifies naturally
occurring compounds
Allergens- a previously uncharacterized allergen might be inadvertently
introduced
Change in nutritive levels because of constituents that may affect
absorption or metabolism of nutrients

Identify composition, and nutritional value of modified carbohydrates, or

fats and oils
Guidance for evaluating safety and nutritional aspects of bioengineered foods
3 regulatory endpoints as a result of the assessment:
No concerns
New variety, not acceptable
Consult FDA:
Special label is needed
Food additive petition is needed
Regulatory questions
Testing protocols or scientific issues

1997 Guidance

Need for consultation re-emphasized in 1997 guidance to industry

Submissions are designated as Biotechnology Notification Files (BNF)

1998 Guidance on Antibiotic Resistance Marker Genes in Transgenic

Plants

Make leaf discs

Briefly culture leaf fragments in genetically modified Agrobacter
Transfer to filter paper over nurse cells
Culture 2-3 days
Nurse cells produce growth factors
Transfer to shoot-stimulating medium with antibiotics
Culture 2-4 weeks
Shoots appear
Transfer to root-inducing medium
Roots appear
Transfer to soil after 3 weeks
Regenerated engineered plant
Need to evaluate:
Safety of protein itself that is encoded by the antibiotic R gene, i.e., toxicity
and allergenicity