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May 16, 1984

FOUNDATION ON ECONOMIC TRENDS, Jeremy Rifkin, Michael W. Fox, Environmental Action, Inc., Environmental Task Force, David Brower, William Turnage, Plaintiffs,
Margaret M. HECKLER, in her official capacity as Secretary of Health and Human Services, James E. Wyngaarden, in his official capacity as Director of the National Institute of Health, Richard M. Krause, in his official capacity as Director, National Institute of Allergy and Infectious Diseases, National Institute of Health, The Regents of the University of California, a corporation, Defendants

The opinion of the court was delivered by: SIRICA

 SIRICA, District Judge.

 This matter is before the Court on plaintiffs' motion for a preliminary injunction and defendants opposition thereto. The plaintiffs have sought injunctive relief on their first and second causes of action which allege violations of the National Environmental Policy Act of 1969, 42 U.S.C. § 4332 (1982) ("NEPA") and the Administrative Procedure Act, 5 U.S.C. § 706 (1982) ("APA"). The plaintiffs ask this Court to enter a preliminary injunction enjoining the defendants from commencing a particular scientific experiment and all similar experimentation until the alleged violations have been corrected. The plaintiffs are three organizations and four individuals who have alleged injury by virtue of the defendants proposed actions. The federal defendants are the three federal officials responsible for the supervision of scientific research conducted at or by the National Institutes of Health (NIH). In addition, the Regents of the University of California have recently been joined as a defendant. All of the parties have submitted lengthy memoranda on the pending motion and, after hearing oral argument, the Court has decided to grant plaintiffs' motion for the reasons recited in this Memorandum.

 Before discussing the reasons for this Court's ruling, a few preliminary comments should be made. First of all, this Court is not, and does not purport to be, competent to address the host of scientific issues associated with the use of the recombinant DNA. See Diamond v. Chakrabarty, 447 U.S. 303, 317, 100 S. Ct. 2204, 2212, 65 L. Ed. 2d 144 (1980). The Court fully joins the comments made by plaintiffs' counsel at oral argument that none of the parties, least of all this Court, is questioning the wisdom or qualifications of the eminent scientists who have labored to insure that this new technology is used in a responsible manner. The issues that this Court must confront are narrow, legal questions. Accordingly, while speculation on the possible benefits and hazards presented by the emerging technology of genetic engineering may intrigue the parties to this litigation, the Court has no desire, authority, or competence to so speculate. This Court's sole task is to review whether the federal defendants should have issued an environmental impact statement under the circumstances of this case.


 A little over a decade ago scientists developed the capability of modifying genetic material in the laboratory. Through a process of splitting and recombining a subcellular unit known as DNA, laboratory scientists could begin to control the natural processes of organism reproduction and growth. The product of this process of altering natural hereditary material is generally known by the name "recombinant DNA." The use of this technique has been limited to small organisms, usually bacteria. More importantly, the production processes wherein these new bacteria are created have been confined, until now, to the laboratory. Stated differently, scientists have not yet deliberately released any of these recombinant DNA organisms into the general environment. In a truly commendable effort, the National Institutes of Health took the initiative during the 1970's to develop responsible limitations on the use and possible misuse of recombinant DNA material. The National Institutes of Health took these early steps largely because its own research, and the research it funded, began to use recombinant DNA with increasing frequency. The Director of NIH assumed responsibility for the supervision of the NIH's efforts to promote recombinant DNA research along uniform standards. To aid the Director and his subordinates in this task an advisory committee was created. This committee, called the Recombinant DNA Advisory Committee (RAC), was, and is, primarily composed of eminent scientists in the field who advise the Director of NIH on numerous questions relating to recombinant DNA research. This lawsuit concerns the decision of the NIH Director, aided by the RAC, to permit the deliberate release of recombinant DNA material into the general environment. The plaintiffs have raised a procedural challenge to the manner in which the federal defendants have authorized deliberate release experimentation to occur. Specifically, the plaintiffs contend that the federal defendants failed to issue appropriate environmental impact statements in conformity with the terms of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. § 4332(2)(C), and in accordance with the regulations of the Council on Environmental Quality. 40 C.F.R. § 1500 et seq.

 The experiment which prompted the plaintiffs to file their motion is currently scheduled to begin on or about May 25, 1984. Although the plaintiffs seek a preliminary injunction to temporarily halt this individual experiment, they are also seeking a broader injunction to halt all such NIH approved deliberate release experiments. Of the three approved experiments, the most imminent experiment will be conducted by scientists from the University of California at Berkeley later this month. As summarized by the University, the California experiment involves the application of a genetically altered bacteria onto a row of potatoes in northern California. See Opposition of the Regents of the University of California, Appendix. The anticipated effect of the application is to make the plants on which the bacteria is placed more frost tolerant and thereby reduce the risk of frost damage. Having completed their laboratory examination of the bacteria, the University of California scientists have sought and obtained approval from NIH to conduct a field test of this organism in northern California. All of the parties agree that this individual experiment was proposed, considered, and approved without the benefit of an environmental impact statement or assessment document.

 The plaintiffs appear before the Court seeking a preliminary injunction against the defendants enjoining not only the first deliberate release experiment, but also all similar experimentation authorized by NIH. The plaintiffs argue that this first experiment should be enjoined until such time as the defendants compile an environmental impact statement. In a more general argument, the plaintiffs assert that when NIH first decided to allow any deliberate release experimentation at all, NIH officials had an obligation to engage in a more comprehensive environmental analysis than that which actually took place. In ruling on the plaintiffs' motion for a preliminary injunction this Court has looked to the four traditional factors which must be present before a court can issue a preliminary injunction. Thus the Court has examined the record to determine whether the plaintiffs have shown: (1) a substantial likelihood that they will succeed on the merits; (2) irreparable injury to plaintiffs' interests if injunctive relief is denied; (3) lack of injury to the defendants if injunctive relief is granted; and, (4) the public interest favors preliminary injunctive relief. Washington Metropolitan Transit Comm'n v. Holiday Tours, 182 U.S. App. D.C. 220, 559 F.2d 841, 844 (D.C.Cir.1977); Virginia Petroleum Jobbers Ass'n v. FPC, 259 F.2d 92l, 925 (D.C.Cir.1958).

 The National Environment Policy Act of 1969 (NEPA), 42 U.S.C. §§ 4321-4347 (1982), was enacted by Congress to insure that the federal government would not undertake major programs or projects without first considering the potential environmental consequences. The Act places an affirmative obligation on the federal government to address potential environmental hazards in a forum open to the public before the government embarks on any particular course of conduct significantly affecting the environment. The Act itself does not dictate any particular accommodation between the frequently conflicting demands of environmental protection and the direction of federal conduct. Instead, NEPA contemplates that responsible federal officials will heed the substantive and procedural requirements set forth in the Act before reaching final decisions about major federal actions. The primary procedural requirement contained in the Act demands that federal decisionmakers compile an Environmental Impact Statement (EIS) prior to final approval of all "major Federal actions significantly affecting the quality of the human environment." 42 U.S.C. § 4332(2)(C).

 The EIS requirement is the principal mechanism chosen by Congress to implement the environmental policies articulated in NEPA. Although the requirement of formulating an EIS accomplishes NEPA's general goal of forcing federal officials to take account of the environment, environmental impact statements perform other valuable functions in keeping with NEPA's purpose. Initially, the actual drafting of the impact statement requires the identification, adoption, and integration of various factual material which the policymaker considers probative as to the assessment of environmental hazards. Second, the drafting process affords the public an opportunity to observe and understand the reasoning of the federal policymaker. Indeed, this informational function of an EIS is particularly important when the federal decision under consideration is a matter of some public controversy and addresses a subject concurrently under extensive investigation by Congress. Finally, after the process of drafting the EIS is complete the final document remains as a testament and record of the investigation, deliberation and resolution of the environmental questions posed by proposed federal action. See generally McGarity, The Courts, the Agencies, and NEPA Threshold Issues, 55 Tex.L.Rev. 801, 805-08 (1977). Of course, Congress did not anticipate nor intend that every federal action should be accompanied by this process. Only "major Federal actions significantly affecting the quality of the human environment" require the compilation of an environmental impact statement. As previously indicated, this litigation centers on whether the challenged federal action falls within this category of federal conduct and, if so, whether the defendants fulfilled their obligation to draft an EIS.

 As the Court interprets the plaintiffs' position, the federal defendants allegedly took at least two separate "actions" which should have been preceded by the preparation of an environmental impact statement. At a minimum, plaintiffs urge, these actions should have prompted the federal defendants to prepare an environmental assessment (EA) as to each action with the requisite finding of no significant environmental impact. See generally Glitzenstein, Project Modification: Illegitimate Circumvention of the EIS Requirement or Desirable Means to Reduce Adverse Environmental Impacts ?, 10 Ecology L.Q. 253-54 (1982) (discussing administrative process of EIS formulation). These two separate "actions" are: the issuance of NIH authorization for the University of California deliberate release experiment and the alteration of the NIH Guidelines to allow NIH authorization of deliberate release experiments at all. As to the latter "action" by NIH, the plaintiffs argue that the federal defendants violated 42 U.S.C. § 4332(2)(C), not only by failing to issue an EIS before the actual modification of the NIH Guidelines but also by failing to issue a broad "programmatic" EIS covering NIH's role and responsibility in the entire area of deliberate release experimentation. The Court will consider each of these alleged "major Federal actions" separately.

 I. The Standard of Review

 Because the plaintiffs must meet their burden of proving a substantial likelihood of success on the merits, the Court has to compare the plaintiffs' showing in support of their motion with that showing which is required for the plaintiffs to prevail on the merits. The decision on whether or not to initiate the formal process of compiling an EIS is largely left to the discretion of the agency contemplating the action. Committee For Auto Responsibility v. Solomon, 195 U.S. App. D.C. 410, 603 F.2d 992 (D.C.Cir. 1979). "An initial agency determination on this matter is judicially vulnerable only when the agency has abused its discretion or has acted arbitrarily." Id. at 1002. In making its determination, the agency must be guided by what has been termed the "rule of reason." Id. at 1003; North Slope Burrough v. Andrus, 206 U.S. App. D.C. 184, 642 F.2d 589, 600 n. 47 (1980). The "rule of reason" also applies to "agency decisions setting limits to the scope of their environmental review." National Wildlife Fed. v. Appalachian Reg. Com'n, 219 U.S. App. D.C. 295, 677 F.2d 883, 889 (D.C.Cir. 1981). In reviewing the merits of the agency's decision this Court must inquire:

(1) whether the agency took a 'hard look' at the problem; (2) whether the agency identified the relevant areas of environmental concern; (3) as to the problems studied and identified, whether the agency made a convincing case that the impact was insignificant; and (4) if there was impact of true significance, whether the agency convincingly established that changes in the project sufficiently reduced it to a minimum.

 Cabinet Mountains Wilderness v. Peterson, 222 U.S. App. D.C. 228, 685 F.2d 678, 682 (D.C.Cir.1982). It is this "hard look" inquiry that the plaintiffs ask the Court to undertake.

 II. A Brief History of the NIH Guidelines

 The National Institutes of Health issued a draft EIS in September of 1976, 41 Fed.Reg. 38425 (1976), and adopted a final EIS for the NIH Guidelines in October of 1977. See National Institutes of Health, Environmental Impact Statement on NIH Guidelines for Research Involving Recombinant DNA Molecules of June 23, 1976 (two parts) (Oct. 1977) (hereinafter referred to as "NIH Guidelines EIS"). In promulgating the NIH Guidelines EIS, the Director of NIH stated for the record that "the issuance of Guidelines establishing conditions and precautions with respect to recombinant DNA experiments is viewed by NIH as within the category of a Federal action that may significantly affect the quality of the human environment." NIH Guidelines EIS, at 2. There is no dispute in this case over whether the EIS for the original Guidelines satisfied the requirements of NEPA. Instead, the dispute concerns a later modification to the Guidelines which removed the absolute prohibition on the deliberate release of recombinant DNA into the environment. Because the original NIH Guidelines barred any experimentation involving the deliberate release of this material into the environment, the environmental impact statement on the original Guidelines did not purport to address the hazards posed by such activity. Thus, the most one can say about the original EIS is that it did not consider the environmental impact of deliberate release experimentation at all. A more ominous conclusion one may draw from the silence of the EIS is that, as late as 1977, the deliberate release of recombinant material was so potentially hazardous as to be beyond prudent consideration. See 41 Fed.Reg. 27907 (July 7, 1976).

 In accordance with NIH's announced intentions, the Guidelines have been the subject of continuous review and reconsideration in light of advances in scientific knowledge. Substantial modification of the NIH Guidelines occurred in 1978, 1982, and 1983. Only one of these three revisions, the 1978 revision, was accompanied by a document purporting to evaluate the environmental consequences of the adopted changes. This document, an EA, 43 Fed.Reg. 60101 (December 22, 1978), concluded that the 1978 revisions to the NIH Guidelines presented no significant impact on the environment. 43 Fed.Reg. 60101. Because the parties have different views on the character of the revisions effected in 1978, 1982 and 1983 as those revisions relate to deliberate release experiments, the Court will briefly describe the revisions in accordance with the plain language of the documents themselves.

 The 1978 revisions to the NIH Guidelines represent the first major effort to recast the Guidelines based on new scientific information obtained since the Guidelines were first issued. Some of the more important features of the 1978 revisions include a general relaxation of the Guidelines' stringency; an offer of NIH's assistance to private industry whereby NIH would evaluate private recombinant research for voluntary compliance with the Guidelines; the extension of NIH sanctions to not only directly funded research but also to other recombinant research at institutions enjoying any amount of NIH recombinant research funding; and, allowing the Director of NIH to make "exceptions" to the blanket prohibitions present in the original Guidelines. This last revision, granting the Director of NIH the authority to grant exceptions to the six absolute prohibitions contained in the Guidelines is the subject of this litigation.

 As previously mentioned, the 1978 revisions to the Guidelines were accompanied by an environmental assessment. In fact, there were two documents described as environmental assessments issued by the NIH Director: one for the revisions as proposed, 43 Fed.Reg. 33096 (July 28, 1978), and one for the revisions as adopted. 43 Fed.Reg. 60101 (December 22, 1978). As the NIH Director remarked in his environmental assessment on the proposed 1978 revisions: "A major proposed revision would give the Director, NIH, authority to grant exceptions to any of the six prohibitions." 43 Fed.Reg. 33107 (July 28, 1978) (emphasis added). Under the proposed changes and in the resulting revision, the Director of NIH could not grant an "exception" unless he had the prior advice of the NIH Recombinant Advisory Committee (RAC). This grant of authority to the NIH Director to waive compliance with the Guideline prohibitions was recommended by the RAC, 43 Fed.Reg. 33051, and supported by commentators, 43 Fed.Reg. 33109. The sole "rationale" given by both the RAC and public commentators for bestowing this authority on the Director was to grant the Director the discretion to authorize otherwise prohibited experiments which were "desirable for some compelling social or scientific reasons -- for example, risk assessment." 43 Fed.Reg. 33107. Accord, 43 Fed.Reg. 33109, 33111. In other words, the only articulated reason given for permitting the Director to waive the Guideline prohibitions was to allow experimentation on assessing the risks of recombinant research.

 When the NIH Director's initial comments on the proposed 1978 revisions, found in his proposal summary, his proposed recommendations, and his environmental assessment of the proposed revisions, are compared with his Final Decision adopting the revisions, it is apparent that some public commentators were very concerned with this change in the prohibitions section of the NIH Guidelines. In particular, the waiver of the Guidelines' ban on experiments involving the deliberate release of recombinant DNA into the environment provoked commentary. 43 Fed.Reg. 60083 (December 22, 1978). When proposing the revisions the NIH Director stated that in the revised Guidelines "the prohibition of deliberate release into the environment of recombinant-DNA-containing organisms can be waived if all the requirements for a waiver (and those of the National Environmental Policy Act) are met." 43 Fed.Reg. 33110 (July 28, 1978) (emphasis added). In his final decision adopting the 1978 revisions, the NIH Director actually acknowledged the lack of "definitive standards" under the revised Guidelines for authorizing deliberate release experiments and referred the question of standards to the RAC "for its consideration." 43 Fed.Reg. 60083 (December 22, 1978). Nevertheless, the Director stated that although "all waiver decisions will include a careful consideration of the potential environmental impact," id., he would determine the necessity of an environmental assessment or full impact statement "on a case-by-case basis." Id. Finally, the Director rejected the suggestions of public commentators that the standard for a waiver decision be "no significant risk and a clear social benefit to be realized," id., and further refused to limit waivers only to risk-assessment experiments. Id. Neither of these decisions were elaborated on in the Directors' short environmental impact assessment on the final version of the 1978 revisions. See 43 Fed.Reg. 60101 (December 22, 1978).

 On the record before the public, by the end of 1978 the Guidelines allowed the NIH Director to grant exceptions to NIH-funded institutions in order to allow the deliberate release of recombinant DNA into the environment. The only previously articulated justification for such experiments was to further research into the risks posed by deliberate release. As interpreted by the Director, however, his authority was not restricted to allowing only risk assessment experiments. Instead, the Director could permit deliberate release experiments, based on standards that the RAC would have to formulate, on a case-by-case determination. In a similar fashion, the Director would determine the need for an environmental impact assessment or statement on a case-by-case basis. In justifying the first conclusion, that he could grant exceptions for as yet unarticulated reasons, the Director stated that the procedural safeguards of RAC review and public participation constituted an adequate "standard" for authorizing deliberate release experimentation. 43 Fed.Reg. 60083 (December 22, 1978). As for the Director's second conclusion, however, the Director did not delegate responsibility for deciding whether to compile an EIS or EA to the RAC for their consideration. Any doubts on the Director's view of the role of the RAC in addressing NEPA have subsequently been answered by the Director's own published remarks: "It is not the function of the RAC to determine what NEPA and the CEQ regulations require. The RAC is not constituted to interpret points of law and the requirements of NEPA. Specifically, it is not a function of RAC to determine when an environmental determination. In a similar fashion, the Director would determine the need for an environmental impact assessment or statement on a ...

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