Foundation on Economic Trends v. Heckler

• Citation: 756 F.2d 143,244 U.S.App.D.C. 122
• Decision Date: 27 February 1985
• Docket Number: 84-5419,Nos. 84-5314,s. 84-5314
• Parties: , 244 U.S.App.D.C. 122, 15 Envtl. L. Rep. 20,248 FOUNDATION ON ECONOMIC TRENDS, et al. v. Margaret M. HECKLER, Secretary of the Department of Health & Human Services, et al., Regents of the University of California, a Corporation, Appellant. FOUNDATION ON ECONOMIC TRENDS, et al. v. Margaret M. HECKLER, Secretary of the Department of Health & Human Services, et al., Appellants, Regents of the University of California.
• Court: United States Courts of Appeals. United States Court of Appeals (District of Columbia)

Page 143

756 F.2d 143

22 ERC 1375, 244 U.S.App.D.C. 122, 15

Envtl. L. Rep. 20,248

FOUNDATION ON ECONOMIC TRENDS, et al. v. Margaret M. HECKLER, Secretary of the Department of Health &

Human Services, et al.,

Regents of the University of California, a Corporation, Appellant.

FOUNDATION ON ECONOMIC TRENDS, et al. v. Margaret M. HECKLER, Secretary of the Department of Health &

Human Services, et al., Appellants,

Regents of the University of California.

Nos. 84-5314, 84-5419.

United States Court of Appeals, District of Columbia Circuit.

Argued Dec. 5, 1984.

Decided Feb. 27, 1985.

J. Carol Williams, Atty., Dept. of Justice, Washington, D.C., with whom Joseph E. diGenova, U.S. Atty., Judith Bartnoff, Asst. U.S. Atty., and Martin W. Matzen, Atty., Dept. of Justice, Washington, D.C., were on brief, for federal appellants.

William A. Anderson, III, Washington, D.C., with whom Darci L. Rock, Washington, D.C., was on brief, for appellant Regents of the University of California.

Edward Lee Rogers, New York City, for appellees Foundation on Economic Trends et al.

Sheldon E. Steinbach, Washington, D.C., was on brief for amici curiae American Council on Education et al., urging reversal.

Before WRIGHT and MIKVA, Circuit Judges, and MacKINNON, Senior Circuit Judge.

Opinion for the court filed by Circuit Judge J. SKELLY WRIGHT.

Concurring opinion filed by Senior Circuit Judge MacKINNON.

J. SKELLY WRIGHT, Circuit Judge:

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.

I. BACKGROUND

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

A. National Environmental Policy Act

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.

B. Genetic Engineering

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 ...