Foundation on Economic Trends v. Margaret M. Heckler, Secretary of the Department of Health & Human Services, Regents of the University of California, a Corporation, Foundation on Economic Trends v. Margaret M. Heckler, Secretary of the Department of Health & Human Services, Regents of the University of California

Almost 14 years ago, soon after passage of the National Environmental Policy Act (NEPA), 42 U.S.C. Sec. 4321 et seq. (1982), this court faced the challenge of ensuring that the Act's "important legislative purposes, heralded in the halls of Congress, [were] not lost or misdirected in the vast hallways of the federal bureaucracy." Calvert Cliffs' Coordinating Committee v. USAEC, 449 F.2d 1109, 1111 (D.C.Cir.1971). This case poses a no less formidable challenge: to ensure that the bold words and vigorous spirit of NEPA are not similarly lost or misdirected in the brisk frontiers of science.

For this appeal presents an important question at the dawn of the genetic engineering age: what is the appropriate level of environmental review required of the National Institutes of Health (NIH) before it approves the deliberate release of genetically engineered, recombinant-DNA-containing organisms into the open environment? More precisely, in the context of this case, the question is whether to affirm an injunction temporarily enjoining NIH from approving deliberate release experiments without a greater level of environmental concern than the agency has shown thus far.

In September 1983 three environmental groups and two individuals filed suit against the federal officials responsible for genetic engineering decisions.1 Arguing that NIH had not complied with the requirements of NEPA, plaintiffs sought to enjoin a proposed NIH-approved experiment by University of California scientists that would represent the first deliberate release of genetically engineered organisms into the open environment. They also sought to enjoin NIH's approval of any other deliberate release experiments. Plaintiffs later added Regents of the University of California as a defendant. On May 18, 1984 the District Court granted the requested relief and enjoined both the University of California experiment and NIH approval of all other deliberate release experiments.

We emphatically agree with the District Court's conclusion that NIH has not yet displayed the rigorous attention to environmental concerns demanded by law. We therefore affirm the District Court's injunction prohibiting the University of California deliberate release experiment until an appropriate environmental assessment is completed. We also share the District Court's view that NIH should give greater consideration to the broad environmental issues attendant on deliberate release of organisms containing recombinant DNA, and to its own responsibility for approving these deliberate release experiments. We find, however, that the part of the injunction enjoining NIH from approving all other deliberate release experiments is, at this juncture, overly broad, and we therefore vacate the part of the injunction that prohibits NIH approval of those experiments. We wish to emphasize, however, that if NIH fails to give appropriate environmental consideration to any other experiment, as it has failed to do with the University of California experiment, injunctive relief would be clearly proper.

This case arises against a backdrop of the National Environmental Policy Act, the emergence of genetic engineering, and federal attempts to regulate genetic engineering.

On January 1, 1970 the National Environmental Policy Act became law. Recognizing "the profound impact of man's activity on the interrelation of all components of the natural environment," 42 U.S.C. Sec. 4331(a), Congress sought to "fulfill the responsibilities of each generation as trustee of the environment for succeeding generations," id. Sec. 4331(b)(1). The major "action-forcing" provision of NEPA is the requirement that "all agencies of the Federal government" prepare a detailed environmental analysis for "major Federal actions significantly affecting the quality of the human environment." Id. Sec. 4332(C); S.Rep. No. 91-296, 91st Cong., 1st Sess. 19 (1969). Congress mandated that this detailed statement, long known as an Environmental Impact Statement (EIS), include such considerations as "the environmental impact of the proposed action," "any adverse environmental effects which cannot be avoided should the proposal be implemented," and "alternatives to the proposed action." 42 U.S.C. Sec. 4332(C).

Realizing that NEPA would be toothless if agencies could merely issue a conclusory statement that the action did not significantly affect the environment (and that therefore no EIS was required), the Council on Environmental Quality (CEQ), an entity created by NEPA, issued regulations establishing that, unless the major federal action falls within an agency-established "categorical exclusion," 40 C.F.R. Sec. 1508.4 (1983), the agency should support each finding of "no significant impact" with a "concise public document" called an "environmental assessment" (EA). Id. Secs. 1501.4(a)-(b), 1508.9. The environmental assessment must "[b]riefly provide sufficient evidence and analysis for determining whether to prepare an environmental impact statement or a finding of no significant impact." Id. Sec. 1508.9(1). CEQ regulations apply to all federal agencies. Id. Sec. 1501.2; Andrus v. Sierra Club, 442 U.S. 347, 351, 99 S.Ct. 2335, 2338, 60 L.Ed.2d 943 (1979).

Two fundamental principles underlie NEPA's requirements: federal agencies have the responsibility to consider the environmental effects of major actions significantly affecting environment, and the public has the right to review that consideration. Baltimore Gas & Electric Co. v. Natural Resources Defense Council, Inc., 462 U.S. 87, 103 S.Ct. 2246, 76 L.Ed.2d 437 (1983). NEPA's dual mission is thus to generate federal attention to environmental concerns and to reveal that federal consideration for public scrutiny.

In passing NEPA Congress emphasized its particular concern with the role of new technologies and their effect on the environment. The statute explicitly enumerates "new and expanding technological advances" as one of the activities with the potential to threaten the environment. 42 U.S.C. Sec. 4331(a). The legislative history reveals an underlying concern with "[a] growing technological power * * * far outstripping man's capacity to understand and ability to control its impact on the environment." S.Rep. No. 91-296, supra, at 6. One of NEPA's main functions was to bolster this capacity to understand and control the effects of new technology. See Scientists' Institute for Public Information v. AEC, 481 F.2d 1079, 1089-1090 (D.C.Cir.1973).

NEPA thus stands as landmark legislation, requiring federal agencies to consider the environmental effects of major federal actions, empowering the public to scrutinize this consideration, and revealing a special concern about the environmental effects of new technology.

Genetic engineering is an important development at the very cusp of scientific advances. More than a decade ago scientists discovered a method for transplanting deoxyribonucleic acid (DNA), the principal substance of genes. Although exchanges and mutations of DNA occur in nature, genetic engineering provides the ability to control these fundamental processes of life and evolution. DNA segments can be recovered and cloned from one organism and inserted into another. The result is known as "recombinant DNA." See generally 41 Fed.Reg. 27903-27904 (July 7, 1976), Joint Appendix (JA) 231-232; OFFICE OF TECHNOLOGY ASSESSMENT, U.S. CONGRESS, COMMERCIAL BIOTECHNOLOGY: AN INTERNATIONAL ANALYSIS 33-38 (January 1984).

Recombinant DNA technology has been limited primarily to small organisms, usually bacteria. This production of new bacteria through altering genetic material has been confined to the laboratory; organisms with recombinant DNA have never been released into the general environment.

Broad claims are made about both the potential benefits and the potential hazards of genetically engineered organisms. Use of recombinant DNA may lead to welcome advances in such areas as food production and disease control. At the same time, however, the environmental consequences of dispersion of genetically engineered organisms are far from clear. According to a recent report by a House of Representatives subcommittee, "The potential environmental risks associated with the deliberate release of genetically engineered organisms or the translocation of any new organism into an ecosystem are best described as 'low probability, high consequence risk'; that is, while there is only a small possibility that damage could occur, the damage that could occur is great." The Environmental Implications of Genetic Engineering, Report by Subcommittee on Investigations & Oversight to House Committee on Science & Technology, 98th Cong., 2d Sess. 9 (1984) (hereinafter cited as Genetic Engineering Report ), JA 167.

Spurred by scientists involved in genetic research, NIH began efforts to oversee genetic engineering in the mid-1970's. Federal oversight of deliberate release experiments falls into four periods: (1) NIH's 1976 standards, which prohibited deliberate release of organisms containing recombinant DNA; (2) NIH's 1978 revision, which gave the NIH Director power to approve deliberate release experiments; (3) the NIH Director's approval of three such experiments in the early 1980's; and (4) the District Court's injunction prohibiting the University of California experiment and enjoining NIH approval of all other deliberate release experiments.2

1. NIH's 1976 standards: prohibition on deliberate release. In 1976 the NIH Director issued "Guidelines for Research on Recombinant DNA Molecules." 41 Fed.Reg. at 27902, JA 230. The Guidelines were an historic development, representing the first major federal effort to oversee genetic research and the culmination of intense scientific attention to the possible hazards of genetic research.

In 1974 scientists working in genetic research voluntarily called for a moratorium on certain kinds of experiments until an international meeting could be convened to consider the potential hazards of recombinant DNA molecules. Id. On October 7, 1974 NIH established the Recombinant DNA Advisory Committee (RAC) to consider genetic research issues. And in February 1975 NIH, the National Science Foundation, and the National Academy of Sciences sponsored an international conference at the Asilomar Conference Center in Pacific Grove, California to review the questions posed by the possibility of genetic engineering.

Finally, in the summer of 1976 the NIH Director announced the Guidelines that would govern NIH-supported genetic research experiments. In broad terms, the Guidelines permitted certain laboratory experiments to go forward under carefully specified conditions; certain other types of experiments were flatly prohibited. Deliberate release--"[d]eliberate release into the environment of any organism containing a recombinant DNA molecule"--was one of five categories explicitly banned. 41 Fed.Reg. at 27915, JA 243. In announcing the Guidelines the Director noted that deliberate release of organisms with recombinant DNA was not yet feasible and that, if it became feasible, the ban could be reconsidered. Id. at 27907, JA 235. But he stressed that, if such reconsideration occurred, environmental concerns should be paramount: "It is most important that the potential environmental impact of the release be considered." Id.

Significantly, NIH prepared an EIS to accompany its Guidelines, JA 244--the only EIS NIH has ever completed on the subject of genetic engineering. The EIS did not specifically refer to deliberate release experiments; such experiments were banned. The EIS did, however, note that dispersion of organisms with recombinant DNA molecules loomed as a potential environmental hazard from the permitted experiments:

Should organisms containing recombined DNA be dispersed into the environment, they might, depending on their fitness relative to naturally occuring [sic] organisms, find a suitable ecological niche for their own reproduction. A potentially dangerous organism might then multiply and spread. Subsequent cessation of experiments would not stop the diffusion of the hazardous agent.

JA 357.

Thus in 1976 the NIH Guidelines prohibited deliberate release; the Director emphasized the importance of full environmental consideration of any possible future release; and the EIS identified dispersion of organisms with recombinant DNA as a possible environmental hazard.

2. The 1978 revision: permission to waive the prohibition against deliberate release. In 1978 the NIH Director undertook an effort to revise the Guidelines "in light of NIH's experience operating under them and in light of [NIH's] increasing knowledge about the potential risks and benefits of this research technique." 43 Fed.Reg. 33042 (July 28, 1978), JA 433. Proposed in July and adopted in December, the revision changed the Guidelines in several respects. Most importantly for this appeal, the 1978 revision allowed the NIH Director authority to grant exceptions to the five absolute prohibitions in the Guidelines--including the prohibition on deliberate release of organisms containing recombinant DNA into the environment. 43 Fed.Reg. 60108 (December 22, 1978), JA 478.

NIH announced that the standard governing the use of this waiver authority would be the standard generally applicable to the Director's exercise of his duties: "[T]he Director shall weigh each proposed action, through appropriate analysis and consultation, to determine that it complies with the Guidelines and presents no significant risk to health or the environment." Id. at 60126, JA 496. NIH also declared that the Director would exercise his authority "with the advice of the Recombinant DNA Advisory Committee after appropriate notice and opportunity for public comment." Id. at 60108, JA 478. The Director further stated that his "waiver decisions [would] include a careful consideration of the potential environmental impact, and certain decisions may be accompanied by a formal assessment or statement. This must be determined on a case-by-case basis." 43 Fed.Reg. at 33051, JA 442.

On the subject of deliberate release experiments in particular, the Director suggested that clear standards might be necessary to guide his waiver discretion: "Recognizing the need expressed by * * * commentators for more definitive standards [to govern deliberate release waiver decisions], I will refer the matter to the Recombinant Advisory Committee (RAC) for its consideration. * * * [T]he RAC will be asked to address conditions under which exceptions to various prohibited categories of experiments may be granted." 43 Fed.Reg. at 60083, JA 471. Thus the Director perceived a possible need for more definitive standards and suggested that such standards might be forthcoming.

NIH did not prepare an EIS to accompany its 1978 revision. It prepared two Environmental Assessments--one for the revision as proposed, 43 Fed.Reg. at 33111, JA 467, and one for the revision as adopted, 43 Fed.Reg. at 60101, JA 471. The assessments said little about the Director's new waiver authority for deliberate release experiments. The first simply declared, "Waiver decisions will include a careful consideration of potential environmental impact," 43 Fed.Reg. at 33111, JA 466; the second did not mention the waiver authority.

The 1978 revision also extended the coverage of the Guidelines to all experiments at institutions receiving NIH funds for recombinant DNA research, whether or not the particular experiment had received NIH funds. 43 Fed.Reg. at 60123, JA 493.

3. Approval of deliberate release experiments. The 1978 revision was the last significant revision of NIH's guidelines regarding deliberate release experiments. A 1982 revision was largely semantic, 47 Fed.Reg. 17186-17187 (April 21, 1982), JA 503-504; a 1983 revision establishing slightly different procedures for deliberate release involving certain plants, 48 Fed.Reg. 24580 (June 1, 1983), is not part of this appeal. The "more definitive standards" suggested by the Director never emerged.

Although the guidelines have not changed, NIH's role has begun to change dramatically. For, with the maturation of genetic engineering technology, NIH has been faced with applications for approval of deliberate release experiments.

The NIH Director, acting on the advice of RAC, has approved three deliberate release experiments at institutions receiving NIH funds for recombinant DNA research. On August 7, 1981 the Director approved a request by Dr. Ronald Davis of Stanford University to field-test corn plants containing recombinant DNA molecules. 46 Fed.Reg. 40331 (August 7, 1981). The goal was to increase the corn's dietary value by improving its ability to store protein. However, the field tests were never conducted because feasibility problems developed. Genetic Engineering Report at 17, JA 171.

On April 15, 1983 the Director approved a request by Dr. John Sanford of Cornell University to field-test tomato and tobacco plants with recombinant DNA. 48 Fed.Reg. 16459 (April 15, 1983). The goal was to prove that pollen could serve as a "vector" for insertion of recombinant DNA. Again, however, due to feasibility problems, the experiment never went forward. Genetic Engineering Report at 17, JA 171.

On June 1, 1983 the Director gave final approval to the experiment at issue on appeal--the request by Drs. Nickolas Panopoulos and Steven Lindow of the University of California at Berkeley to apply genetically altered bacteria to plots of potatoes, tomatoes, and beans in northern California. 48 Fed.Reg. 24549 (June 1, 1983), JA 522. As discussed in greater detail below, the goal was to increase the crops' frost resistance. Because of the cancellation of the previous two experiments, the Panopoulos-Lindow experiment would be the first NIH-approved deliberate release experiment actually to be conducted.3

In February 1984 a congressional subcommittee report sharply criticized NIH's method of reviewing deliberate release experiments. The report concluded that "the current regulatory framework does not guarantee that adequate consideration will be given to the potential environmental effects of a deliberate release." Genetic Engineering Report at 10, JA 168. In particular, "the RAC's ability to adequately evaluate the environmental hazards posed by deliberate releases is limited by both its expertise and its jurisdiction." Id. The subcommittee report recommended a moratorium on deliberate release approvals until an interagency review panel was established to consider the potential environmental effects of each deliberate release experiment. "Each [deliberate release experiment] could result in major environmental damage or adverse public health effects." Id. at 43-44, JA 176-177.4

4. The injunction. In September 1983 three public interest organizations and two individuals filed suit against the three federal officials ultimately responsible for NIH deliberate release decisions; they later added Regents of the University of California as a defendant. The University of California experiment was scheduled to begin on or about May 25, 1984. On May 18 the District Court issued an injunction enjoining the University of California experiment and NIH approval of other deliberate release experiments. The District Court found that plaintiffs were likely to succeed in showing that NIH should have completed at least a more complete environmental assessment, and perhaps an EIS, before approving the University of California experiment; it also found them likely to succeed in showing that NIH should have completed an Environmental Impact Statement in connection with both its 1978 policy change and its imminent "program" of deliberate release approvals.5

Both the federal defendants and the University of California Regents have filed appeals; the appeals were consolidated and the case heard by this court on an expedited basis.

Two principles guide our analysis of this appeal: the standard for judicial review of an agency decision not to prepare an EIS and the standard for appellate review of a District Court decision to grant an injunction.

A. Review of an Agency Decision Not to Prepare an EIS

That courts must play a cardinal role in the realization of NEPA's mandate is beyond dispute. As the Supreme Court recently emphasized, the critical judicial task is "to ensure that the agency has adequately considered and disclosed the environmental impact of its actions and that its decision is not arbitrary or capricious." Baltimore Gas & Electric, supra, 462 U.S. at 97-98, 103 S.Ct. at 2253. Since NEPA requires the agency to "take a 'hard look' at the environmental consequences before taking a major action," id. (quoting Kleppe v. Sierra Club, 427 U.S. 390, 410 n. 21, 96 S.Ct. 2718, 2730 n. 21, 49 L.Ed.2d 576 (1976) ), the judiciary must see that this legal duty is fulfilled. Although the "agency commencing federal action has the initial and primary responsibility for ascertaining whether an EIS is required," Committee for Auto Responsibility v. Solomon, 603 F.2d 992, 1002 (D.C.Cir.1979), cert. denied, 445 U.S. 915, 100 S.Ct. 1274, 63 L.Ed.2d 599 (1980), the courts must determine that this decision accords with traditional norms of reasoned decisionmaking and that the agency has taken the "hard look" required by NEPA. Sierra Club v. Peterson, 717 F.2d 1409, 1413 (D.C.Cir.1983).

We review the decision to grant an injunction as an exercise of the District Court's discretion. Doran v. Salem Inn, 422 U.S. 922, 932, 95 S.Ct. 2561, 2568, 45 L.Ed.2d 648 (1975); Brown v. Chote, 411 U.S. 452, 457, 93 S.Ct. 1732, 1735, 36 L.Ed.2d 420 (1973). Under this circuit's long-standing test, the District Court should consider (1) the plaintiff's likelihood of prevailing on the merits, (2) the threat of irreparable injury to the plaintiff in the absence of injunctive relief, (3) the possibility of substantial harm to other interested parties from the injunctive relief, and (4) the interests of the public. WMATC v. Holiday Tours, 559 F.2d 841, 842-843 (D.C.Cir.1977); Virginia Petroleum Jobbers Ass'n v. FPC, 259 F.2d 921, 925 (D.C.Cir.1958).

In reviewing this exercise of discretion, we must be conscious of whether we are reviewing findings of fact, conclusions of law, or determinations about the balancing of the injunction factors. In all three we are deferential to the District Court's determination about "what evidence can properly be adduced in the limited time that can be devoted to a preliminary injunction hearing." Friends for All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816, 835 n. 32 (D.C.Cir.1984). We are most deferential to the District Court's balancing of the injunction factors. Id. On questions of fact the usual "clearly erroneous" standard applies, id.; cf. Fed.R.Civ.P. 52(a). We are least deferential on questions of law. "[A] greater amplitude of judicial review is called for when the appeal presents a substantial issue that the action of the trial judge was based on a premise as to the pertinent rule of law that was erroneous. * * * When this can be identified, the appellate court furthers the interest of justice by providing a ruling on the merits to the extent that the matter is ripe, though technically the case is only at the stage of application for preliminary injunction." Natural Resources Defense Council, Inc. v. Morton, 458 F.2d 827, 832 (D.C.Cir.1972); see also Ambach v. Bell, 686 F.2d 974, 979 (D.C.Cir.1982) (per curiam ).

With these principles in mind, we turn to the District Court's injunction as it applies, first, to NIH's approval of the University of California experiment, and, second, to NIH's possible approval of all other deliberate release experiments.

The University Regents raise objections about the District Court's view that the environmental assessment of the University of California experiment was inadequate; they also deploy a barrage of procedural objections. We will address the adequacy of the assessment and the procedural objections in turn. The federal appellants claim not to appeal the part of the injunction that applies to the U.C. experiment, but they continue to insist that the only flaw in NIH's environmental assessment is that NIH did not publish the results of its environmental review in a document titled "Environmental Assessment." Statement of counsel at oral argument; see also brief for federal appellants at 5 n. 3. We will address that contention as well.

1. The proposed experiment. On September 17, 1982 Drs. Lindow and Panopoulos, scientists at Berkeley, submitted a request for NIH approval of an experiment that would involve deliberate release of genetically altered organisms in the open environment. NIH approval was required because the University of California receives NIH funds for recombinant DNA research. Lindow and Panopoulos proposed to apply the genetically altered bacteria to various crops, including potatoes, tomatoes, and beans. By changing the bacteria's genetic composition, Lindow and Panopoulos hoped that the bacteria would change from frost-triggering bacteria to non-frost-triggering bacteria; they further hoped that the engineered non-frost-triggering bacteria would displace the natural frost-triggering bacteria. The ultimate goal was to protect the crops from frost and thus to extend their growing season. Such non-frost-triggering bacteria occur in nature as products of natural mutation, but Lindow and Panopoulos apparently hoped that the genetically engineered organisms would be more stable than the natural mutants. They sought to treat crops at six sites; the workers applying the recombinant-DNA-containing bacteria would wear respirators to reduce the risk of inhalation. Application of Drs. Lindow and Panopoulos, September 17, 1982, JA 728-736.

2. NIH review. NIH announced the Lindow-Panopoulos request for approval, the RAC meeting at which it would be considered, and the opportunity to comment. 47 Fed.Reg. 41925 (September 22, 1982). No comments were received. At the RAC meeting on October 25, 1982 RAC members raised questions about the number of sites, the lack of adequate information, and the possible effects on rainfall. RAC voted to recommend that the Director approve the project; the vote was seven in favor, five opposed, with two abstentions. RAC Minutes, JA 684-686. The Director decided to postpone approval and suggested further consideration.

Lindow and Panopoulos resubmitted their proposal with some modifications, including a reduction of experiment sites from six to one. On April 11, 1983, after some discussion, RAC voted to recommend approving the proposal by a vote of 19-0, with no abstentions. RAC Minutes, JA 713-716. The Director then approved the experiment. 48 Fed.Reg. 24549 (June 1, 1983), JA 523.

3. NEPA compliance. NIH's consideration of the Lindow-Panopoulos experiment falls far short of the NEPA requirements. And, despite the government's apparent belief, the deficiency is not a question of which document contains the environmental analysis. Rather, the deficiency rests in NIH's complete failure to consider the possibility of various environmental effects.

Neither the government nor the University seriously disputes that an environmental assessment is necessary. The government has conceded that the approval is a "major action" and that it does not fall into a categorical exclusion to the EIS requirements, Federal Defendants' Response to Plaintiffs' Second Set of Interrogatories at 17, JA 50; see also Foundation on Economic Trends v. Heckler, 587 F.Supp. 753, 767 (D.D.C.1984). The University's contention here--and the government's contention below, as well as its apparent continuing belief--is that the environmental consideration given by NIH was equivalent to the necessary environmental assessment and that the injunction requires only a document labelled "Environmental Assessment." We thus fear that the University and the government completely misapprehend the District Court's holding and the requirements imposed by NEPA.

The most glaring deficiency in NIH's review of the Lindow-Panopoulos experiment is its treatment of the possibility of dispersion of recombinant-DNA-containing organisms. As noted, NIH's only EIS on genetic engineering specifically identified dispersion as one of the major environmental concerns associated with recombinant DNA research. The consequences of dispersion of genetically altered organisms are uncertain. Some observers believe that such dispersion would affect the environment and the climate in harmful ways. See, e.g., Genetic Engineering Report at 9, JA 167 ("the risk presented by the deliberate release of a genetically engineered organism is that it may cause environmental changes that perturb the ecosystem it encounters and/or that the organism itself may have negative effects if it establishes itself outside of the specific environment for which it was intended").

Thus the problem of dispersion would seem to be one of the major concerns associated with the Lindow-Panopoulos experiment, the first experiment that would actually release genetically engineered organisms in the open environment. Yet in the minutes of the RAC meeting--the only document on appeal that records any NIH consideration of the environmental impact of dispersion--the entirety of the consideration of dispersion is the following statement: according to a RAC evaluator, "Although some movement of bacteria toward sites near treatment locations by insect or aerial transport is possible, the numbers of viable cells transported has been shown to be very small; and these cells are subject to biological and physical processes limiting survival." RAC Minutes (April 11, 1983), JA 715 (emphasis added). In this sentence, which was taken almost verbatim from the Lindow-Panopoulos proposal, the RAC evaluator thus conceded the possibility of aerial or insect transport, but merely commented that the number of viable cells would be small, and that they were subject to processes limiting survival. Remarkably, therefore, RAC completely failed to consider the possible environmental impact from dispersion of genetically altered bacteria, however small the number and however subject to procedures limiting survival.6

In light of this complete failure to address a major environmental concern, NIH's environmental assessment utterly fails to meet the standard of environmental review necessary before an agency decides not to prepare an EIS. The argument that this consideration would be adequate if contained in a document labelled "Environmental Assessment" simply misconceives the clear requirements of NEPA as articulated by the courts, Baltimore Gas & Electric, supra; Kleppe v. Sierra Club, supra, 427 U.S. at 410 n. 21, 96 S.Ct. at 2730 n. 21; Cabinet Mountains Wilderness v. Peterson, 685 F.2d 678, 682 (D.C.Cir.1982), and by the Council on Environmental Quality, 40 C.F.R. Secs. 1501.4, 1508.9. An environmental assessment that fails to address a significant environmental concern can hardly be deemed adequate for a reasoned determination that an EIS is not appropriate. See Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 553, 98 S.Ct. 1197, 1216, 55 L.Ed.2d 460 (1978) ("NEPA places upon an agency the obligation to consider every significant aspect of the environmental impact of a proposed action").

Appellants also contend that the adequacy of the environmental assessment can be divined from the NIH Director's final approval--and his accompanying statement of "no significant risk," 48 Fed.Reg. 24548 (June 1, 1983), JA 522, as required by the 1978 revision. This contention also reveals a fundamental misunderstanding about the adequacy of an environmental assessment. Simple, conclusory statements of "no impact" are not enough to fulfill an agency's duty under NEPA. The only consideration of environmental consequences was apparently the RAC review; as shown, that consideration is inadequate to support the Director's finding. To accept the Director's conclusory statement would violate principles of reasoned decisionmaking, Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168, 83 S.Ct. 239, 245, 9 L.Ed.2d 207 (1962), NEPA's policy of public scrutiny, Baltimore Gas & Electric, supra, and CEQ's own regulations, 40 C.F.R. Secs. 1501.4, 1508.9.

It should be stressed that this inquiry into the adequacy of an environmental assessment is ultimately relevant to the agency's determination that its