NEPA's Power to Amend Other Federal Laws: EDF Seeks to Compel the FDA to Consider Environmental Criteria

Two previously unrelated trends, the demise of the returnable glass bottle and the evolution of NEPA into a substantive statute, have recently converged in a suit brought by the Environmental Defense Fund (EDF).¹ EDF is challenging a regulation recently promulgated by the Food and Drug Administration (FDA) that severely restricts the impact of NEPA on the agency's decision-making process.² If upheld, the agency rule will effectively render the FDA powerless to regulate the nationwide use of non-biogradable plastic beer and soft drink bottles on the grounds of their adverse environmental effects.

The regulation in question is general in scope, dealing with all FDA decisions involving NEPA. It acknowledges the agency's responsibility to comply with the procedural requirements of § 102(2)(c) of NEPA, concerning the preparation of environmental impact statements. The agency, however, reads its enabling statute, the Federal Food, Drug and Cosmetic Act (FFDCA),³ as both specifically restricting the criteria for FDA regulatory action to considerations of public health and safety, and requiring approval of any substance or packaging scheme if those criteria are not violated. FDA Commissioner Schmidt declined to read NEPA's declarations of environmental policy as broadening this regulatory mandate by supplementing or amending the agency's enabling act. Unless adverse environmental impacts can be shown to be either directly or indirectly related to a public health or safety hazard within the FDA's traditional areas of concern, the agency maintains that it has no legal authority to take these impacts into consideration.

The implications of the FDA's position became readily apparent in the agency's separate but simultaneous treatment of the plastic bottle issue. The draft environmental impact statement (EIS) concerning the plastic containers was published on the same day as the regulation attacked the EDF. While the statement noted several adverse environmental effects, an immediate application of the new regulation enabled the FDA to refuse to prohibit the plastic containers solely on environmental grounds. The relationship between the bottle issue and the FDA order was underscored by the intervention of the Society of the Plastics Industry, Inc., an organization of major plastics producers, in the EDF action. These developments highlight the importance of the agency's interpretation of both its enabling act and NEPA.

The suit centers on that interpretation by challenging the regulation itself, rather than its specific application to the bottle problem. EDF claims that NEPA gives the FDA the authority to base its decisions on environmental concerns as well as those of health and safety. It is interesting to note that the FDA not only expected to be sued over this restricted interpretation of its NEPA responsibilities, but in fact went so far as to invite a legal challenge. In the regulation, the agency stated that:

This amendment to the regulations constitutes final agency action on this matter. It is the Commissioner's opinion that, since the activities of the Food and Drug Administration directly affect every person in this country, any such person has standing to obtain [5 ELR 10105] judicial review of this regulation in accordance with the provisions of 5 U.S.C. 701 et seq.⁴

Realizing that to ban plastic bottles on environmental grounds would prompt a suit from industry while to refrain from doing so would draw a challenge from environmentalists, the FDA apparently chose to take the latter course. This action generated at least some suspicion that the agency would rather be ordered by a court to undertake such regulation than do so on its own initiative, perhaps in order to avoid the predictable political protests from the plastics industry.

It is by now relatively well settled that NEPA can expand the limited range of authorized areas of concern outlined in the typical agency mandate.⁵ Yet, the precise question of whether or not NEPA can supplement a statute containing not only a finite list of criteria or standards for decision-making, but also a command to refrain from regulation if such criteria are not found to be violated is apparently one of first impression. However, the FFDCA is not unique in its approach to restricting the statutory powers exercised by the agency. The FDA's rationale, if ultimately upheld, could be extended to the enabling statutes of other agencies and provide a convenient means of avoiding substantive compliance with NEPA.

While the case has not yet reached the briefing stage, the FDA's arguments are outlined in its regulation. As noted above, the agency relies on a narrow reading of both its statutory mandate and NEPA. For example, the FDA finds the authority to control such items as plastic beverage bottles in a section of the FFDCA dealing with "food additives."⁶ Additives are to be regulated by the agency according to a safety standard. Upon petition for approval of an additive, the FDA is required to either determine the conditions under which it can be used safely and issue a regulation of that effect, or to declare the additive unsafe and therefore prohibited. The word "safe is defined in the statute as having reference to the "health of man or animal"⁷ The concept of safety under the FFDCA is further refined by requiring the agency to consider "among other relevant factors," the extent to which the additive will be consumed, its "cumulative effect" on man's diet, and the results of experiments on animals.⁸ The act, which dates from 1938, makes no mention of environmental standards. The FDA believes then, that the only factors that it is allowed to consider as "relevant" are those that can lead directly or indirectly to health consequences. The statutory requirement to issue a regulation, or permit, in the absence of such consequences precludes the agency from pursuing regulatory action against a food additive solely on the basis of adverse environmental impacts revealed during the EIS preparation process.

Similarily, the FDA reads NEPA as failing to provide an explicit grant of authority to base its regulatory decisions on environmental criteria. The agency views the requirements of § 102 of NEPA as procedural only. The agency is not, then, free to give substantive weight to any adverse environmental impacts revealed through those procedures unless the environmental problems fall within one of the specific prohibitions in the laws administered by the FDA. Standing alone, grave environmental consequences such as the increases in litter, accelerated use of energy resources, and destruction of scenic beauty can be of no import in a decision to take regulatory action.

This position significantly reduces the potential impact of the policy sections of NEPA.⁹ In recent years several courts have greatly expanded the role of these provisions by initiating substantive review of agency decisions under NEPA.¹⁰ This trend toward finding substantive legal authority in the act is, however, not without its limits. Section 102 of NEPA requires agency compliance "to the fullest extent possible." The FDA maintains that when it defines the environmental impacts and tests them against the standards authorized in the FFDCA, it has gone as far as it possibly can. Any further substantive use of NEPA for regulatory purposes would take the FDA beyond its jurisdiction.

The agency relies in part on the Supreme Court's first opinion in United States v. SCRAP (SCRAP I).¹¹ Known primarily for its rule on standing, the court's discussion of the jurisdictional issue involved in that case resulted in a holding that by itself, NEPA could not revive judicial power explicitly eliminated by Congress.¹² To allow such a resurrection would amount to the repeal by implication of one federal statute by another, a process typically looked upon with disfavor. The FDA feels that the SCRAP I rationale can be extended to cover its challenged regulation. Since NEPA cannot repeal by implication a federal law or portion thereof, it cannot amend the FFDCA.

This line of reasoning is vulnerable on a variety of fronts. First, there would seem to be an important difference between attempting to employ NEPA to repeal an explicit restriction of judicial power, and using the statute to amend or supplement the class of rather broad criteria and standards that an agency must consider in regulatory decision-making.

This distinction is supported by the legislative history [5 ELR 10106] of NEPA. The record demonstrates a congressional intent to liberally construe agency enabling statutes to allow for NEPA considerations. The Senate-House Conference on NEPA addressed this issue not once, but twice. Under the powerful influence of former Congressman Wayne Aspinall, the first conference report left open the suggestion that the phrase "to the fullest extent possible" was indeed a means of escape for agencies not inclined to comply with NEPA duties.¹³ However, a second document attached to the report on the same subject and signed by all the House conferees except Aspinall made it quite clear that the pendulum had swung the other way when it stated:

Thus it is the intent of the conferees that the provision 'to the fullest extent possible' shall not be used by any Federal agency as a means of avoiding compliance with the directives set out in section 102 … no agency shall utilize an excessively narrow construction of its existing statutory authorizations to avoid compliance.¹⁴

Such a strong statement of the congressional will concerning the presence of judicial power was, of course, absent from the history of the statute involved in SCRAP I.

Second, the importance of the factual setting in SCRAP I should not be overlooked. While the court made it clear that NEPA did not repeal by implication any federal law, the refusal to extend NEPA's scope was at least partially based on the subject matter of the case. SCRAP I dealt with railroad rates, an area where the need for uniformity and sensitivity to the financial complexities of the railroad industry serves to discourage judicial involvement. The plurality opinion in SCRAP I relied extensively on these factors to buttress its argument. The factual setting in the EDF suit, however, involves no such considerations.

Finally, the recent history of SCRAP I itself reduces its applicability to the present case. On remand, the question of whether NEPA supplements existing federal laws has fared far better in the hands of Judge J. Skelly Wright than it did in the Supreme Court.¹⁵ Judge Wright read the high court ruling in SCRAP I very narrowly. While accepting the majority holding on NEPA's inability to repeal federal law, he refused to apply that principle unless NEPA requirements ran squarely into an explicit statutory command to the contrary. In SCRAP II then, the three-judge district court was able to assert jurisdiction over a NEPA claim involving general rate orders where its own previously developed judicial doctrines of ripeness and exhaustion of administrative remedies precluded review. Judge Wright found in NEPA special considerations that, in the absence of any specific statutory command to the contrary, such as that found in SCRAP I, allowed jurisdiction over the case.

The Supreme Court will soon announce its decision in SCRAP II. The district court may well be reversed a second time on the jurisdiction issue. In that event, EDF will still be able to fall back on other arguments.

The extremely narrow interpretation of the FFDCA propounded by the FDA is not without its problems. One glaring difficulty is the apparent conflict between the agency's current reading of its statute and the interpretation of the act by the FDA's parent agency, the Department of Health, Education and Welfare (HEW). In 1970, HEW complied with § 103 of NEPA, which requires all agencies to review their statutory authority, determine any inconsistencies in that authority that would prohibit "full compliance" with NEPA, and propose measures that would eliminate those conflicts or deficiencies.¹⁶ This process resulted in a report by HEW that stated, in relevant part:

A review of the authorizing legislation does not reveal any program in which we may not impose appropriate conditions intended to effect compliance with the purpose and provisions of [NEPA] …. The applicable authorizing statutes provide, in varying terms, for the imposition of terms and conditions. This is not construed as prohibiting the implementation of policies and procedures directed at avoiding adverse environmental effects.¹⁷

The report then went beyond this finding of the absence of any express conflict between NEPA and the enabling statutes administered by HEW. It pledged an ongoing review of those statutory mandates in light of the clarification and evolution of the duties and policies outlined in NEPA. Future conflicts, such as the one currently in dispute, were to be avoided by indicating "such measures as may be necessary to insure that the carrying out of the purposes and provisions of [NEPA] to the fullest extent is not thereby impaired."¹⁸ The FDA regulation challenged by EDF, then, not only clashes with previous interpretation of the FFDCA, but seems to thwart the agency policy of eliminating problems in compliance with NEPA instead of creating them.

While the current implications of the 1970 HEW report are not at all clear, it demonstrates at the very least that the FFDCA can be read much more broadly in regard to the inclusion of environmental criteria than the FDA is willing to admit. Those in charge of § 103 review at HEW had the same statutes to evaluate as the FDA has now. The fact that they either missed or dismissed the conflict that the FDA relies on in the present case casts some doubt on the validity of the FDA [5 ELR 10107] interpretation.

The HEW report may have an even larger role in the EDF's suit. A response to § 103 of NEPA that indicates no deficiencies or inconsistencies in statutory authority could be binding on an agency. This was indeed the view of former CEQ chairman Russell Train. It was his position that "these 103 statements are available to the public and may estop agencies from later pleading legal impediments to compliance with the Act."¹⁹

Establishing the exact grounds for an estoppel in this case would be a difficult matter. Yet, even if the FDA is allowed to assert its claim of no legal authority, EDF will still be in a position to rebut that contention through arguments based on NEPA's substantive thrust.

In reviewing agency compliance with NEPA, numerous courts have ruled that the Act requires good faith consideration by an agency of the environmental costs exposed in the accompanying impact statement. A combination of the policy statements contained in § 101 and the "action forcing" procedures of §§ 102-3 of NEPA provides the authority to trigger such substantive judicial review of administrative action. The Council on Environmental Quality (CEQ) believes that this type of review will eventually superimpose environmental standards onto the statutory mandates of all federal agencies. CEQ claims that in the absence of express statutory preclusion, these standards will become binding on any agency, regardless of previous practices or statutory limitations.²⁰ In short, a federal agency cannot excuse itself from taking environmental factors into account by merely pointing out the omission of environmental criteria in its enabling statute. It must go further and point to a specific provision that prevents the consideration of the environmental policies expressed in NEPA.

There is a growing body of case law that indicates support for this position. For example, NEPA has been used to require the AEC to consider environmental criteria even though previous judicial and administrative interpretations of the agency's mandate had limited consideration to radiological health and safety effects.²¹ Similarily, the fifth circuit has held that the Rivers and Harbors Act,²² which had previously been interpretted as allowing only navigational grounds to serve as a basis for the denial of land fill applications, is in part altered by NEPA to permit such denials based on ecological concerns.²³

NEPA itself seems to address this point. Section 105 provides that the "policies and goals set forth in this Act are supplementary to those … in existing authorizations of Federal agencies."²⁴ While rarely cited by courts or commentators, this section reflects the intent of the legislature to modify existing agency statutes whenever possible so as to include environmental factors among the criteria considered in an agency decision-making.

The analysis of CEQ appears, then, to be sound. Central to that position is the concept of specificity. Where Congress, in enabling legislation, has specifically precluded an agency from basing its decisions on the criteria established in NEPA, then Congress must specifically alter that agency's mandate in order to have it consider those criteria. If, on the other hand, the agency's statutory mandate does not explicitly forbid compliance with the substantive requirements of NEPA, then the agency should welcome into its decision-making process the environmental policies outlined in the 1969 law.

Put another way, an agency's criteria for approval or dissapproval and the environmental considerations set forth in NEPA are only mutually exclusive if the agency, in applying NEPA substantively, will have to disregard its established criteria. In the absence of such a situation, NEPA can be said to have amended or supplemented the agency statute. There is a significant distinction between the mere addition of a new consideration in the decision-making process and an attempt to force an agency to take action that it is specifically precluded from taking. NEPA, then, cannot be used to force FDA approval of a misbranded bottle, but it can compel the agency to weigh in good faith the environmental consequences of alternative courses of regulatory action in regard to non-biodegradable plastic bottles.

Both the "explicit prohibition" and the "mutually exclusive" situations noted above would probably prove to be the rare exception rather than the rule. Agency enabling statutes are generally designed to be flexible generic grants of power. Statutory schemes that are constructed to allow administrators a degree of discretion in order to meet the needs of a changing national scene should be able to integrate the additional constraint of environmental concerns imposed by NEPA.

This requirement imposes few costs or hardships on the agency. The FDA has conceded its duty to comply with the EIS preparation procedures outlined in NEPA. These procedures are the costly and time-consuming aspects of NEPA that most agencies would prefer to avoid. By comparison, the consideration of the material developed by procedural compliance with NEPA would require much less of an investment in time and money. Not making use of that material would result in the absurd [5 ELR 10108] and wasteful situation of having the FDA determine adverse environmental costs without even attempting to mitigate them.

On balance then, it would appear that NEPA's policies should indeed be infused into the FDA decision-making process. NEPA is an important general statute designed to impose a new consideration on decision-making in all federal agencies. It does not require the FDA to ignore any of the regulatory criteria the agency employed in the past under the FFDCA. NEPA merely expands the existing agency mandate in order to accomodate an important new national policy. The substantive meaning of that policy has undergone rapid expansion in recent years. To allow agencies to use their enabling statutes to avoid the substantive requirements of NEPA could effectively thwart that expansion. The prospect of hundreds of millions of non-biodegradable plastic bottles littering the American landscape is but the most immediate example of the risks involved in following that course.

1. Environmental Defense Fund, Inc. v. Weinberger, No. 75-1444 (D.C. Cir.) (petition for review filed May 5, 1975).

2. 40 Fed. Reg. 16662 (Apr. 14, 1975).

3. 21 U.S.C. § 301 (1970).

4. 40 Fed. Reg. 16662 (Apr. 14, 1975).

5. Calvert Cliffs Coordinating Committee v. AEC, 449 F.2d 1109, 1 ELR 20346 (D.C. Cir. 1971); Zabel v. Tabb, 430 F2d 199, 1 ELR 20023 (5th Cir. 1970).

6. 21 U.S.C. § 321 (s) (1970).

7. Id., § 342.

8. Id., § 348.

9. 42 U.S.C. §§ 4331, 4332(1) (1970).

10. EDF v. Corps of Engineers, 470 F.2d 289, 2 ELR 20740 (8th Cir. 1972); Conservation Council v. Froehlke, 473 F.2d 664, 3 ELR 20132 (4th Cir. 1973).

11. United States v. Students Challenging Regulatory Agency Procedures (SCRAP) 412 U.S. 669, 3 ELR 20536 (1973).

12. Id. at 20541; for the prohibition itself, see the Interstate Commerce Act, 49 U.S.C. § 15(7) (1970).

13. Dolgin and Guilbert, Federal Environmental Law, 287 (1974).

14. 115 Cong. Rec. (Part 29) at 39702-39703.

15. Students Challenging Regulatory Agency Procedures v. United States, 371 F. Supp. 1291, 4 ELR 20267 (D.D.C. 1974).

16. 42 U.S.C. § 4335 (1970).

17. Committee on Merchant Marine and Fisheries, Administration of the National Environmental Policy Act, Part II, 816, House of Representatives, 91st Congress, 2nd Session, Dec. 1970, Serial No. 91-41.

18. Id.

19. H.R. Rep No. 92-316, 92d Congress, 1st Sess. 27 (1971).

20. Third Annual Report at 225. As the Agency charged with administering NEPA and with evaluating compliance with that statute by federal agencies, determinations by CEQ are entitled to great weight. See Warm Springs Dam Task Force v. Gribble, 4 ELR 20666 (Douglas, Circuit J. 1974).

21. Compare New Hampshire v. AEC, 406 F.2d 170 (1st Cir. 1969), cert. denied, 395 U.S. 962 (1969), with Calvert Cliffs Coordinating Committee v. AEC, 449 F.2d 1109, 1 ELR 20346 (D.C. Cir. 1971).

22. 33 U.S.C. § 403 (1970).

23. Zabel v. Tabb, 430 F.2d 199, 1 ELR 20023 (5th Cir. 1970).

24. 42 U.S.C. § 4335 (1970).