J. Skelly Wright

“ Just as there has been little question of allowing substantive rule-making to intrude on asserted rights to a full hearing before an agency for a determination of a party's rights and liabilities, there has been a similar lack of hesitation in construing broad grants of rule-making power to permit promulgation of rules with the force of law as a means of agency regulation of otherwise private conduct. ”

“ It is believed that the term 'unfair competition' has a legal significance which can be enforced by the commission and the courts, and that it is no more difficult to determine what is unfair competition than it is to determine what is a reasonable rate or what is an unjust discrimination. The committee was of the opinion that it would be better to put in a general provision condemning unfair competition than to attempt to define the numerous unfair practices, such as local price cutting, interlocking directorates, and holding companies intended to restrain substantial competition. ”

“ How else can they act, given a mandate to protect the public health but only a slight or nonexistent data base from which to draw? * * * Sometimes, of course, relatively certain proof of danger or harm from such modifications can readily be found. But, more commonly, "reasonable medical concerns" and theory long precede certainty. Yet the statutes and common sense demand regulatory action to prevent harm, even if the regulator is less than certain that harm is otherwise inevitable. Undoubtedly, certainty is the scientific ideal to the extent that even science can be certain of its truth. ”

“ 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. ”

“ Where there is solid reason, as there plainly is here, to believe that Congress, in fact, has not wholeheartedly accepted the agency's viewpoint and instead enacted legislation out of caution and to eliminate the kind of disputes that invariably attend statutory ambiguity, we believe that relying on the de facto ratification argument is unwise. In such circumstances, we must perform our customary task of coming to an independent judgment as to the statute's meaning, confident that if Congress believes that its creature, the Commission, thus exercises too much power, it will repeal the grant. ”

“ 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. ”

“ We deal here with a radical change in the manner in which our entire nation produces electricity. In many respects, no doubt, this new technique of producing electricity will be less harmful to the environment than present fossil fuel generating plants. But it is evident that the program presents unique and unprecedented environmental hazards. The Commission itself concedes it is expected that by the year 2000 some 600,000 cubic feet of high-level concentrated radioactive wastes will have been generated. ”

“ They are not ultimate; they are not maximum; they are minimal. And, if I may highlight this, testimony on the health question over the last 7 years over and over again has made the point that there is no such thing as a threshold for health effects. Even at the national primary standard level, which is the health standard, there are health effects that are not protected against. ”

“ Appellees argue that since Section 5 mentions only adjudication as the means of enforcing the statutory standard, any supplemental means of putting flesh on that standard, such as rule-making, is contrary to the overt legislative design. But Section 5 (b) does not use limiting language suggesting that adjudication alone is the only proper means of elaborating the statutory standard. It merely makes clear that a Commission decision, after complaint and hearing, followed by a cease and desist order, is the way to force an offender to halt his illegal activities. ”

“ The Senate Committee on Interstate Commerce report endorsing the new version of the commission bill made this point explicitly: "One of the most important provisions of the bill is that which declares unfair competition in commerce to be unlawful, and empowers the commission to prevent corporations from using unfair methods of competition in commerce by orders issued after hearing, restraining, and prohibiting unfair methods of competition, which orders are enforceable in the courts. ”

“ If NIH gives adequate environmental consideration to each deliberate release experiment -- and, as noted, that consideration must be far more complete and rigorous than the consideration NIH has thus far undertaken -- then we cannot, at this point, say that such consideration will obstruct environmental review. We thus reverse the District Court's finding that plaintiffs are likely to succeed in showing, at this point, that the governing law requires NIH to complete a programmatic EIS on deliberate release experiments. ”

“ We thus tread firm ground in holding that NEPA requires impact statements for major federal research programs, such as the Commission's LMFBR program, aimed at development of new technologies which, when applied, will significantly affect the quality of the human environment. ”

“ One of these costs is the toll that these alterations may exact on the environment itself and, in turn, the dangers that this may pose for the public health and welfare. Unfortunately, man's ability to alter the environment often far outstrips his ability to foresee with any degree of certainty what untoward effects these changes may bring. The issues presented by these cases illustrate this sad fact.
Lead's environmental significance is a consequence of both its abundance and its utility. The relative abundance of lead in the earth's crust makes it unique among the toxic heavy metals. ”

“ Moreover, when delay in agency proceedings is minimized by using rules, those violating the statutory standard lose an opportunity to turn litigation into a profitable and lengthy game of postponing the effect of the rule on their current practice. [24] As a result, substantive rules will protect the companies which willingly comply with the law against what amounts to the unfair competition of those who would profit from delayed enforcement as to them. This, too, will minimize useless litigation and is likely to assist the Commission in more effectively allocating its resources. ”

“ We find that the Administrator's decision not to exclude insoluble particles from the lead standards was neither arbitrary nor capricious. The only information in the record on the issue of insolubility that petitioners are able to point to is a two-page discussion in St. Joe's comments on the proposed standards, [104] and even this discussion does not suggest that lead emissions from smelters or other industrial sources are insoluble. The Criteria Document merely states that the exposure of lead miners may "depend to some extent on the solubility of the lead from the ores." ”

“ Any other approach to standing in the context of suits to ensure compliance with NEPA for long-range Government programs not yet resulting in injury to discrete economic, aesthetic or environmental interests would insulate administrative action from judicial review, prevent the public interest from being protected through the judicial process, and frustrate the policies Congress expressed in NEPA, a result clearly inconsistent with the Supreme Court's approach to standing. ”

“ 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. § 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. ”

“ Thus there is little question that the availability of substantive rule-making gives any agency an invaluable resource-saving flexibility in carrying out its task of regulating parties subject to its statutory mandate. More than merely expediting the agency's job, use of substantive rule-making is increasingly felt to yield significant benefits to those the agency regulates. Increasingly, courts are recognizing that use of rule-making to make innovations in agency policy may actually be fairer to regulated parties than total reliance on case-by-case adjudication. ”

“ EPA, supra note 29, 541 F.2d at 24-25, we pointed out: Questions involving the environment are particularly prone to uncertainty. Technological man has altered his world in ways never before experienced or anticipated. The health effects of such alterations are often unknown, sometimes unknowable. While a concerned Congress has passed legislation providing for protection of the public health against gross environmental modifications, the regulators entrusted with the enforcement of such laws have not thereby been endowed with a prescience that removes all doubt from their decisionmaking. ”

“ Development of the technology serves as much to affect the environment as does a Commission decision granting a construction permit for a specific plant. Development of the technology is a necessary precondition of construction of any plants. ”

“ 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.C.t. 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") . ”

“ The argument for judicial deference is not so strong where, as here, the question does not require special agency competence or expertise, requiring the agency, for example, to make a complex judgment involving its areas of expertise, competition and impact of business practices on consumer behavior. Here, the question is simply one of statutory interpretation concerning the procedures and setting in which the Commission may elaborate its statutory standard. ”

“ IV. CONCLUSION At this point it is appropriate that we emphasize the limited nature of the issue under review in this case. By our holding we do not intend in any way to question either the wisdom of the Commission's LMFBR program or the Commission's dedication to protection of the public health and safety. But as one commentator has noted:
"It is obvious that government programs for development of technology do not proceed in callous disregard of the public welfare. ”

“ Secondary air quality standards "specify a level of air quality the attainment and maintenance of which in the judgment of the Administrator, based on such criteria, is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air." ”

“ The pervasiveness of the antitrust laws' coverage, in the sense of affecting business decision-making, needs no elaboration. Suffice it to say that it cuts deeply into and, with limited exceptions, [13] widely across virtually all [p685] of American business. In addition, under its mandate to prevent "unfair or deceptive acts or practices," the Commission has the responsibility to protect the consumer from being misled by governing the conditions under which goods and services are advertised and sold to individual purchasers. ”

“ To be sure, a different question may be presented if it can be shown that an agency decisionmaker has exhibited the type of single-minded commitment to a particular position that makes him or her totally incapable of giving fair consideration to the issues that are presented for decision. This is not, however, such a case. Nothing in the record suggests that Assistant Administrator Hawkins was incapable of considering the issues raised by the lead standards proceedings fairly. ”

“ Not only is the Commission's regulatory power much broader than appellees would have us believe; there is simply no compelling evidence in the Act's legislative history or in the language of the statute itself which would limit the exercise of that power to the prosecutorial function or prevent the Commission from making that function more effective by rule-making. ”

“ The Criteria Document concluded that EP elevation, which begins in children at blood levels of 15-20 ug Pb/dl, is one of the more significant effects of low level lead exposure because it indicates that lead has already begun to affect basic biological functions in the body. We have already examined in some detail the findings that led the Criteria Document to the conclusion that EP elevation is an indication of a physiological impairment which affects human health. ”

“ Storer and its successors are, of course, closely related to the question we face here. For a major component of appellees' complaint is the abridgement of their interest in having the Trade Commission Act's standard of illegality elaborated only in an adjudicatory context. In our view, this argument was adequately answered in Storer, at least to the extent the FTC's rule serves the "purpose of shortening and simplifying the adjudicative process and of clarifying the law in advance," [10] and thus, in Storer' s language, aids the Commission in the "orderly conduct of its business." ”

“ The FTC's charter to prevent unfair methods of competition is tantamount to a power to scrutinize and to control, subject of course to judicial review, the variety of contracting devices and other means of business policy that may contradict the letter or the spirit of the antitrust laws. ”

“ The fact that powers long have been unexercised well may call for close scrutiny as to whether they exist; but if granted, they are not lost by being allowed to lie dormant, any more than nonexistent powers can be prescripted by an unchallenged exercise. We know that unquestioned powers are sometimes unexercised from lack of funds, motives of expediency, or the competition of more immediately important concerns. We find no basis for holding that any power ever granted to the Trade Commission has been forfeited by nonuser [sic ] . ”

“ It is as clear as it is unlimited: "The Commission shall also have power * * * to make rules and regulations for the purpose of carrying out the provisions of [Section 5] ." Ambiguous legislative history cannot change the express legislative intent. The Commission is using rule-making to carry out what the Congress agreed was among its central purposes: expedited administrative enforcement of the national policy against monopolies and unfair business practices. ”

“ We do not find the District Court's reliance on the agency's long-standing practice, until 1962, of not utilizing rule-making or the District Court's reliance on enactment of specific grants of rule-making power in narrow areas sufficiently persuasive to override our view, and the Commission's view, that rule-making is not only consistent with the original framers' broad purposes, but appears to be a particularly apt means of carrying them out. ”

“ Any fears that the agency could successfully use rule making power as a means of oppressive or unreasonable regulation seem exaggerated in view of courts' general practice in reviewing rules to scrutinize their statement of basis and purpose to see whether the major issues of policy pro and con raised in the submissions to the agency were given sufficient consideration. ”

“ All authority of the Commission need not be found in explicit language. Section 16 [the general rule-making provision] demonstrates a realization by Congress that the Commission would be confronted with unforeseen problems of administration in regulating this huge industry and should have a basis for coping with such confrontation. While the action of the Commission must conform with the terms, policies and purposes of the Act, it may use means which are not in all respects spelled out in detail. ”