Coordinated Framework for the Regulation of Biotechnology

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The Coordinated Framework for the Regulation of Biotechnology ("Coordinated Framework") is the basis for U.S. regulation of agricultural biotechnology. It was originally proposed in the Federal Register in 1986 (51 Fed. Reg. 23, 302, proposed June 26, 1986) and was ultimately finalized in 1992 during the Presidency of George H.W. Bush.

"Since its early iteration in the 1980s, U.S. policy with regard to GMO regulation has been based on three tenets: First, regulation focuses on the characteristics of the end product of the genetic modification; the procedure of genetic modification is not viewed as being significant enough to justify regulatory scrutiny. Second, in contrast with the “precautionary principle” often incorporated in international agreements, the U.S. has taken the view that verifiable “scientific risk” is needed to bar a technology from being introduced and integrated.18 Third, the U.S. has viewed the risks associated with GE food as the same as risks associated with “traditionally” produced foods, such that the existing regulatory oversight is sufficient to safeguard the public.
"This policy developed from the initial regulatory policy regarding the emerging technology of genetic modification in the 1980s and early 1990s. Early in the process of commercialization of biotech products, the Reagan Administration charged the White

House Office of Science and Technology Policy (“OSTP”) with drafting a federal framework for food biotechnology. The OSTP, in its 1984 Coordinated Framework for Regulation of Biotechnology (“Coordinated Framework”), announced a policy that products created by biotechnology were no different than other products, and that existing statutes were sufficient to regulate biotechnology. The Coordinated Framework also generally outlined that biotechnology regulation would be divided among existing federal agencies. The FDA would be responsible for regulating food, feed, food additives, and veterinary drugs, the USDA would be responsible for plant pests, plants, and veterinary biologic, and the EPA for microbial/plant-pesticides, new uses of existing pesticides, novel microorganisms.

"U.S. biotech policy was developed with the goal of promoting the biotech industry. After publication of the Coordinated Framework, the White House initially convened the Biotechnology Science Coordinating Committee (“BSCC”), an inter-agency committee responsible for coordination of science policy. However, when the BSCC was unable to come to agreement, its working materials were forwarded to the President’s Council on Competitiveness, a council formed under the first Bush Administration. The Council on Competitiveness established an Ad Hoc Committee on Scope, which, together with the

OSTP, established the scope of agency jurisdiction over biotechnology.

"During its deliberation process the OSTP proposed draft policy statements that indicated a goal to “minimize regulatory burden while assuring protection of public health and welfare,” and to “accommodate the rapid advances in biotechnology.” These goals were facilitated by the OSTP’s perspective on risk: “Products developed through biotechnology processes do not per se pose risks to human health and the environment; risk depends instead on the characteristics of use of the individual products.”
"The OSTP published its Final Statement of Scope in 1992. The Final Statement of Scope includes five policy principles underlying the Administration’s tenets regarding GE foods:
  • 1. The same physical and biological laws govern the response of organisms modified by modern molecular and cellular methods and those produced by classical methods;
  • 2. Information about the process used to produce a GM organism is... not a useful criterion for determining whether the product requires less or more oversight;
  • 3. No conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques...;
  • 4. Crops modified by molecular and cellular methods should pose risks no different from those modified by classical methods for similar traits...; and
  • 5. In many respects, molecular methods resemble the classical methods for modifying particular strains for microorganisms, but [are even more useful than the classical methods.]"[1]

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