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.
