The opinion of the court was delivered by: GESELL
This complaint seeks to have declared illegal and to enjoin operation of a Coordinated Framework for Regulation of Biotechnology ("Framework") issued by the Office of Science and Technology Policy on June 26, 1986, see 51 Fed. Reg. 23,302 (1986). Defendants have moved to dismiss the complaint and plaintiffs have moved for summary judgment. Each motion has been fully briefed and argued in open court. For the reasons set forth below, the complaint must be dismissed for lack of a justiciable case or controversy.
Plaintiff Foundation is a District of Columbia non-profit organization concerned, among other things, with the various implications of certain technological developments involving biochemical and genetic engineering which it sincerely believes may adversely affect the environment and ultimately human and animal health. It envisions release of certain unidentified novel and exotic microorganisms will result in a significant risk of such harm unless more knowledgeable and effective federal controls of new genetic techniques are instituted. The two individual plaintiffs have similar concerns.
The Framework was developed, after opportunity for comment, by an interagency group aided by scientific collaborators. The agencies included the National Science Foundation ("NSF"), Department of Agriculture, Occupational Safety and Health Administration ("OSHA"), Food and Drug Administration ("FDA"), National Institutes of Health ("NIH"), and the Environmental Protection Agency ("EPA"), who through their lead officials are named defendants along with certain other officials involved.
The Framework addresses the regulation of biotechnology research and products by the various defendant federal agencies having statutory authority to address risks potentially raised by introduction of new, genetically modified products into the environment. None of the relevant statutes apparently anticipated fully the introduction of the revolutionary processes of genetic engineering, such as recombinant DNA techniques, allowing direct manipulation of genetic material. Given a lack of specific legislative guidance, there has apparently been some confusion, controversy, indecision and delay in developing a coordinated approach to the regulatory issues that may arise. It was partly in recognition of this situation that an effort was made to create, in aid of communication, research project development and regulatory planning, the elaborate set of biotechnological definitions which is included in the Framework.
Since plaintiffs believe the definitions are incomplete and inexact, and thus will allow potentially dangerous genetically engineered products to be ignored or too casually regulated, they object, contending at the same time that the definitions have serious regulatory significance. Relying on isolated excerpts of the Framework plaintiffs assert that the definitions were injected into already existing regulations and made a mandatory part of subsequent regulations. They urge from this reading of the document that the Framework is defective for lack of notice and hearing, and in any case constitutes irrational agency action. Further, it is suggested the environmental risk posed by the Framework was so substantial that an environmental impact statement was required prior to its implementation.
It is the intention of the Domestic Policy Council Working Group on Biotechnology, the Biotechnology Science Coordinating Committee (BSCC), the Department of Agriculture (USDA), the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the National Science Foundation (NSF), and the Occupational Safety and Health Administration (OSHA) that the policies contained herein be effective immediately.
51 Fed. Reg. 23,302 (1986). And later it states:
Given the statutory differences in the laws that they administer the agencies adopted the principles underlying the definitions in ways consistent with their legislation. EPA, APHIS, and S&E are using the definitions to identify levels of review for microbial products within their jurisdiction. EPA, APHIS, FDA, S&E, and NSF are using the definitions as factors to consider in the review of products or experiments.
These paragraphs, read in the context of the entire document, do not have the effect alleged. The Framework and definitions contained therein are set forth to guide policymaking, not to regulate. While the document is not a model of clarity, its treatment by the agencies involved conclusively establishes it is merely a first effort to aid in formulation of agency policy with respect to control of microorganisms developed by genetic engineering techniques.
Not only is the Framework still being examined, with further comments having been solicited, but its use by the agencies involved varies widely. NSF and NIH have not adopted the definitions as a matter of policy; Agriculture proposed to do so in one respect involving certain pesticides and asked for public comment but later changed its mind; FDA will limit its review only to those products falling within the Framework's definitions; and OSHA is still considering its policy. EPA has decided for the first time to implement review of genetically engineered products under the Toxic Substances Control Act, 15 U.S.C. §§ 2601 to 2629 (1982), by examining certain products falling within the Framework definitions. In its administration of the Federal Insecticide, Fungicide, and ...