Opinion ID: 448992
Heading Depth: 1
Heading Rank: 3

Heading: the university of california experiment

Text: 41 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.
42 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. 43 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. 44 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. 45 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. 46 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. 47 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). 48 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 49 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). 50 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. 51 It should be stressed that this inquiry into the adequacy of an environmental assessment is ultimately relevant to the agency's determination that its proposed federal action will not have a significant impact on the environment--and thus no EIS is required. In that connection, it is notable that NIH never directly addressed the question whether an EIS should be prepared. Such an inquiry is, of course, the ultimate purpose of an environmental assessment. Maryland-Nat'l Capital Park & Planning Comm'n v. U.S. Postal Service, 487 F.2d 1029, 1039-1042 (D.C.Cir.1973). 52 To reiterate, NIH must first complete a far more adequate environmental assessment of the possible environmental impact of the deliberate release experiment than it has yet undertaken. That assessment must provide sufficient evidence and analysis for determining whether to prepare an environmental impact statement or a finding of no significant impact, 40 C.F.R. Sec. 1508.9(a)(1). Ignoring possible environmental consequences will not suffice. Nor will a mere conclusory statement that the number of recombinant-DNA-containing organisms will be small and subject to processes limiting survival. Instead, NIH must attempt to evaluate seriously the risk that emigration of such organisms from the test site will create ecological disruption. Second, until NIH completes such an evaluation the question whether the experiment requires an EIS remains open. The University of California experiment clearly presents the possibility of a problem identified by NIH in its EIS as a potential environmental hazard. This fact weighs heavily in support of the view that an EIS should be completed, unless NIH can demonstrate either that the experiment does not pose the previously identified danger, or that its assessment of the previously identified danger has changed through a process of reasoned decisionmaking. Nor is it sufficient for the agency merely to state that the environmental effects are currently unknown. Indeed, one of the specific criteria for determining whether an EIS is necessary is [t]he degree to which the possible effects on the human environment are highly uncertain or involve unique or unknown risks. 40 C.F.R. Sec. 1508.27(b)(5). 53 Thus we approve the District Court's determination that, as a matter of law, plaintiffs are likely to prevail in showing that NIH's environmental assessment of the University of California experiment--and its discharge of its statutory duty to consider the propriety of an EIS--was wholly inadequate. And, in light of the government's contention, we emphasize as strongly as we can that the problem lay in the adequacy of the assessment itself, not in the document in which the assessment was contained.
54 The University appellant raises four procedural objections to the District Court's injunction against the University of California experiment: (1) the District Court lacked power to issue an injunction against the University; (2) plaintiffs did not exhaust their administrative remedies; (3) the District Court's review of the record was misconceived; and (4) the District Court's balancing of the various factors regarding the injunction was flawed. None of these arguments carries the day. 55 1. Judicial power. The University claims that the District Court had no power to enjoin the University, as a private party, brief for appellant Regents at 49, because NEPA applies only to federal agencies. However, as the University recognizes, it is well established that judicial power to enforce NEPA extends to private parties where non-federal action cannot lawfully begin or continue without the prior approval of a federal agency. Biderman v. Morton, 497 F.2d 1141, 1147 (2d Cir.1974). [W]ere such non-federal entities to act without the necessary federal approval, they obviously would be acting unlawfully and subject to injunction. Id. 56 The University maintains, however, that the Guidelines require only NIH approval as set forth in the NIH Guidelines--and, since the experiment received that approval, the University discharged its responsibilities under the Guidelines, whether or not a court finds the approval invalid under NEPA. This argument is completely meritless. For an NIH approval to be valid under the Guidelines, the approval must comport with NEPA. This requirement is stated explicitly in the NIH Guidelines, 43 Fed.Reg. 33110 (July 28, 1978), JA 465; even if it were not, approvals by NIH--federal actions--would be valid only if the agency discharged its duties under NEPA. Without valid NIH approval under NEPA, the University cannot lawfully go forward with its experiment, and it can thus be enjoined by the court. 7 57 We note also that the justification for NIH's requirement of approval--a requirement that has not been challenged by the University--is that the University receives funds for recombinant DNA research. Federal funding has long been recognized as an appropriate basis to enforce NEPA's requirements on non-federal parties. See Biderman v. Morton, supra, 497 F.2d at 1147; Bradford Township v. Illinois State Highway Authority, 463 F.2d 537, 540 (7th Cir.), cert. denied, 409 U.S. 1047, 93 S.Ct. 518, 34 L.Ed.2d 499 (1972); Named Individual Members of San Antonio Conservation Society v. Texas Highway Dep't, 446 F.2d 1013, 1028 (5th Cir.1971), cert. denied, 406 U.S. 933, 92 S.Ct. 1775, 32 L.Ed.2d 136 (1972). In view of the University's commitment to abide by the binding conditions of the Guidelines, we need not decide whether the funding would itself provide a sufficient basis to support an injunction against the University. 58 2. Exhaustion. The University appellant argues that plaintiffs' objections to the University of California experiment should be barred because plaintiffs failed to raise the objections during the period of NIH consideration. The University appellant points out that NIH announced the experiments and the RAC meetings in the Federal Register and invited public comment. 59 The general rule on exhaustion of administrative remedies is that claims not presented to the agency may not be made for the first time to a reviewing court. Washington Ass'n for Television & Children v. FCC, 712 F.2d 677, 680 (D.C.Cir.1983). However, this well-established exhaustion doctrine is ultimately an exercise of judicial discretion. Action for Children's Television v. FCC, 564 F.2d 458, 469 (D.C.Cir.1977); Great Falls Community TV Cable Co. v. FCC, 416 F.2d 238, 239 (9th Cir.1969); Joseph v. FCC, 404 F.2d 207, 210 (D.C.Cir.1968). In exceptional cases or particular circumstances    where injustice might otherwise result, the reviewing court may consider questions of law which were neither pressed nor passed upon by the    administrative agency below. Hormel v. Helvering, 312 U.S. 552, 557, 61 S.Ct. 719, 721, 85 L.Ed. 1037 (1941). In this case the issue--the appropriate environmental review for the first deliberate release of genetically engineered organisms--is one of great public importance. Indeed, this imminent application of a new technology with unknown environmental consequences is precisely the kind of situation NEPA is intended to address. See Scientists' Institute for Public Information v. AEC, supra, 481 F.2d at 1089. Given the public importance of this issue, we refuse to find that the decision to hear plaintiffs' challenge is an abuse of judicial discretion, particularly in view of NEPA's clear policy favoring public scrutiny of environmental considerations, Baltimore Gas & Electric, supra. 8 60 Additionally, we note that the exhaustion doctrine is premised on a view of fairness to the agency and to the litigants. United States v. L.A. Tucker Truck Lines, Inc., 344 U.S. 33, 37, 73 S.Ct. 67, 69, 97 L.Ed. 54 (1952). The University's claims of unfairness to NIH and to itself are unconvincing. As noted, the possibility of dispersal was not a surprise: NIH explicitly recognized the possibility, but completely failed to consider its possible environmental impact. There was thus no question of unfairness or surprise; there was simply the lack of consideration to the environmental effects of the admitted possibility of dispersion. In these circumstances, a failure to object during the administrative process should not bar plaintiffs. 61 3. The District Court review. The University appellant also attacks the District Court's review of the record on two grounds: it argues that the District Court improperly failed to review the entire administrative record, and that it improperly cast a burden of rebuttal upon the agency. Neither of these contentions is substantial. The District Court did note that NEPA does not require this Court to reconstruct the environmental deliberations of an agency for their adequacy when the agency chooses not to follow the steps outlined in NEPA. 587 F.Supp. at 767. However, in context this comment must be read to mean that the agency's deliberation should be part of the administrative record; the court will not supply reasons that the agency has not revealed in its decisionmaking process. See Motor Vehicle Mfrs Ass'n v. State Farm Mutual Auto. Ins. Co., 463 U.S. 29, ----, 103 S.Ct. 2856, 2865, 77 L.Ed.2d 443 (1983) (hereinafter cited as State Farm to 103 S.Ct. only). Indeed, the District Court emphasized that it had reviewed both the formal and the informal record of the agency decisionmaking process. 587 F.Supp. at 767-768. 9 Similarly, the University seeks to make much of the District Court's use of the word rebutted in its conclusion that plaintiffs have identified several areas of plausible environmental concerns which are not rebutted in the agency record. Id. at 767. It is clear, however, that, far from putting a rebuttal burden on the agency, the District Court was merely referring to whether the agency had considered the problem. Thus both arguments can be dismissed as semantic. 62 4. Balancing of the injunction criteria. The University also argues that, whatever plaintiffs' likelihood of success on the merits, the injunction is not justified under the other three criteria that the court must balance in weighing a request for injunctive relief--the threat of irreparable injury to the plaintiffs, the possibility of injury to other interested parties, and the public interest. 63 The District Court's discretion in balancing these factors is broad. The nature of the discretion peculiar to the preliminary injunction lies in the latitude given to the District Court to engage in a balancing of the traditional factors   . Friends for All Children, Inc. v. Lockheed Aircraft Corp., supra, 746 F.2d at 835 n. 32. The District Court's determinations about the harm to plaintiffs, the harm to other parties, and the public interest were eminently sound, and far from the abuse of discretion that would justify reversal. 64 One point bears further elucidation. The University seeks to minimize the injury that would result if its experiment proceeds without adequate environmental consideration. In doing so the University fundamentally misconceives the nature and significance of NEPA's requirements. The NEPA duty is more than a technicality; it is an extremely important statutory requirement to serve the public and the agency before major federal actions occur. Jones v. D.C. Redevelopment Land Agency, 499 F.2d 502, 513 (D.C.Cir.1974), cert. denied, 423 U.S. 937, 96 S.Ct. 299, 46 L.Ed.2d 271 (1975); Environmental Defense Fund v. TVA, 468 F.2d 1164, 1184 (6th Cir.1972); Scherr v. Volpe, 466 F.2d 1027, 1034 (7th Cir.1972); Calvert Cliffs' Coordinating Committee v. USAEC, supra, 449 F.2d at 1115. If plaintiffs succeed on the merits, then the lack of an adequate environmental consideration looms as a serious, immediate, and irreparable injury. Although the balancing of this harm against other factors is necessarily particularized, State of Alaska v. Andrus, 580 F.2d 465, 485 (D.C.Cir.), vacated in part on other grounds sub nom. Western Oil & Gas Ass'n v. Alaska, 439 U.S. 922, 99 S.Ct. 303, 58 L.Ed.2d 315 (1978), the injury itself is clear. 65 In conclusion, we find that the University's procedural objections are meritless. None of those objections prevents us from reaching our central holding: the District Court's finding that plaintiffs are likely to succeed in showing that NIH failed to give adequate environmental consideration to the University of California experiment was entirely correct, and the resulting injunction completely proper. 66