US Focus
Risk Assessment and Characterization


Application of Regulations
Risk UK Focus
Risk US Focus

EPA is responsible for assessing ecological risks of plant-expressed pesticidal substances, while USDA is responsible for assessing the plant pest risk posed by plants that express the plant pesticide. As a result, there are issues such as gene flow and its consequences, where the two agencies share regulatory responsibility. Sufficient guidance is lacking on the identification of issues of common concern and the designation of lead and supporting Agency in the assessment of these issues.

Under FDA policy developers of bioengineered foods are expected to consult with the agency before marketing such foods, to ensure that all safety and regulatory questions have been fully addressed. FDAs policy also requires special labeling for a bioengineered food in certain circumstances. For example, a bioengineered food would need to be called by a different or modified name if its composition were significantly different from its conventionally grown counterpart, or if its nutritive value has been significantly altered. Special labeling would be required if consumers need to be informed about a safety issue, such as the possible presence of an allergen that would not normally be found in the conventionally-grown product.

Us focus

In 1986, the US Office of Science and Technology Policy (OSTP) published its Coordinated Framework for the Regulation of Biotechnology (OSTP 1985), which stated that existing statutes were sufficiently broad to regulate biotechnology products. 107 existing laws, regulations and guidelines and determined which acts and agencies would have jurisdiction over genetically engineered products were reviewed and specific responsibilities identified. At the root of the considerations was the initial decision to regulate biotechnology products based on the product and its inherent characteristics as opposed to regulation based on the process used to develop the product. This decision resulted in a division of policies with other countries, many of which based regulation on the process used.

Though initially controversial, the finding that existing laws were adequate to provide oversight of recombinant DNA (rDNA) technology became the basis of regulatory policy in this area in the US. Although there are still those who advocate omnibus legislation regulating GEOs, the US Congress has thus far declined to take such action.

Those federal government agencies with statutory authority for regulating field trials and biotech products were placed in a position to regulate biotechnology products. Thus, the USDA and EPA which have authority over agricultural biotechnology activities were told to share responsibility for agricultural biotechnology products. FDA reviewed its authority under the Food, Drug and Cosmetic Act and found that it could assume its component of the responsibility for assessing the effects of biotechnology products without having to change its regulations. USDA and EPA, on the other hand, elected to develop new guidelines for uncontained applications of GEOs. Final policy statements for these agencies have been published. All three agencies focused primarily on terrestrial products.

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Last Modified: June 19, 2001
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