Potential Rationale for revising FDA’s current GRAS policy governing regulation
of Genetically Engineered Foods
- In 1991, then Vice President Dan Quayle’s Council on Competitiveness called for regulation of Genetically Engineered products based on their performance, not the processes by which they are produced.
- These directives resulted in a system in which the USDA, EPA and FDA regulate GE crops and foods under existing laws, with the responsibility for regulation resulting in USDA’s oversight over plants, EPA over pesticides and FDA over foods.
- The Federal Food, Drug, and Cosmetic Act (FFDCA) grants FDA authority to ensure the safety of all domestic and imported foods.
- FFDCA requires pre-market safety testing of any food additive (defined as a substance intentionally added to food) unless a decision is made that the additive is Generally Recognized as Safe (GRAS). GRAS substances do not require testing of any kind.
- A 1992 Statement of Policy promulgated by FDA argues that genes added to common food substances via genetic engineering are GRAS because the new food is largely the same as its conventional counterpart. (Policy referred to as “Substantial equivalency.”)
- Consequently, the FDA does not require pre-market testing, nor does it impose any obligations on the biotechnology industry.
- The FDA’s own internal files attest that none of these GE foods has been backed by technical evidence of safety as the FFDCA requires.
- The preponderant majority of experts on the FDA’s Biotechnology Task Force has concluded that GE foods pose unusual risks and cannot be presumed safe.
- Federal law requires that material facts about food be disclosed through labeling. However, the FDA claims that the fact a food was produced via genetic engineering is not material because such foods have not been significantly altered and do not pose uncommon risk.
- We as healthcare providers have serious reservations that genetically engineered foods are neither studied nor safe and therefore strongly believe these should not be considered by FDA as GRAS.
- Therefore, we petition that genetically engineered foods be removed from the GRAS list, and be thoroughly studied, and labeled.