5 ELR 20096 | Environmental Law Reporter | copyright © 1975 | All rights reserved
Ethyl Corporation v. Environmental Protection AgencyNo. 73-2205 (D.C. Cir. January 28, 1975)
The U.S. Court of Appeals for the D.C. Circuit overturns as arbitrary and capricious regulations promulgated by EPA under § 211(c) (1)(A) of the Clean Air Act which provide for the phased reduction of the lead content of motor vehicle gasoline. The statutory provision requires a factually-supported determination by the EPA Administrator that lead emissions from motor vehicles contribute a measurable increment of lead to the human body, and that this measurable increment causes a significant health hazard to a substantial portion of the general population before the use of particular fuels or fuel additives can be prohibited, and the agency has failed to meet this burden. EPA's contention that § 211(c)(1)(A) requires no more direct or certain proof of harm than is required for imposition of emissions standards under other provisions of the Act is in error and fundamentally misconstrues the strict standard of factual proof which that section sets forth. As an alternative ground for its holding, the court also rules that the Administrator made a clear error in judgment in determining that auto emissions contribute significantly to blood lead levels in adults and children, since this conclusion is not adequately supported by evidence in the record. The court notes that EPA is free to issue rules governing lead additives at some point in the future, if evidence sufficient to meet the statutory standard can be developed.
A lengthy dissent by Judge Wright argues that the Administrator may regulate lead in automotive fuel when he determines, based on a consideration of all the information available to him, that lead emissions from automobiles significantly increase the total human exposure to lead so as to cause a significant risk of harm to the public health. The dissent also contends that the majority, by undertaking a critical examination of the evidence upon which the regulations are based, fails to grant the Administrator's determination the deference demanded by the "arbitrary and capricious" standard of review, and in effect simply substitutes its judgment for that of the agency. According to Judge Wright, the evidence provides a rational basis for the Administrator's decision to regulate lead in motor vehicle fuels, and the majority's reversal of that decision is thus unjustified under the "arbitrary and capricious" standard of review.
Counsel for Petitioner Ethyl Corp.
Joseph C. Carter, Jr.
John J. Adams
David F. Peters
Arnold H. Quint
Hunton, Williams, Gay & Gibson
700 East Main Street
Richmond, Va. 23212
Counsel for Petitioners PPG Industries and E.I. Du Pont de Nemours & Co.
Daniel M. Gribbon
Allan J. Topol
Covington & Burling
888 Sixteenth Stret, N.W.
Washington, D.C. 20006
Counsel for NALCO Chemical Co.
Victor P. Kayser
John C. Berghoff, Jr.
Robert E. Nord
Chadwell, Kayser, Ruggles, McGee, Hastings & McKinney
135 South La Salle Street
Chicago, Ill. 60603
William H. Fitz
Pierson, Ball & Dowd
1000 Ring Building
1200 18th Street, N.W.
Washington, D.C. 20036
Counsel for Petitioner National Petroleum Refiners Ass'n.
H. Edward Dunkelberger, Jr.
Theodore C. Garrett
Covington & Burling
888 Sixteenth Street, N.W.
Washington, D.C. 20006
Counsel for Respondent
Wallace H. Johnson Asst. Attorney General
Edward J. Shawaker
Edmund B. Clark
Department of Justice
Washington, D.C. 20530
Leslie A. Carothers
Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
[5 ELR 20096]
WILKEY, Circuit Judge:
We are called upon in these cases, consolidated for purposes of argument and decision, to review regulations promulgated by the Environmental Protection Agency (EPA) pursuant to section 211(c)(1)(A) of the Clean Air Act.1 The regulations provide for the phased reduction of the lead content of motor vehicle gasoline. By 1979 the regulations will permit refiners to manufacture gasoline which has an average lead content of no greater than 0.5 grams of lead per gallon.2
[5 ELR 20097]
In these cases the EPA is acting under authority of section 211(c)(1)(A) of the Clean AirAct which permits EPA's Administrator to prohibit, control, or regulate a fuel or fuel additive if "the emission products of such fuel or fuel additive will endanger the public health or welfare. . . ." The EPA's authority to promulgate these regulations must be distinguished from the EPA's authority and action reviewed in this Court's opinion in Amoco Oil Co. v. Environmental Protection Agency.3 In Amoco we had before us regulations which prohibited use of leaded gasoline in automobiles fitted with the catalytic converter for controlling exhaust emissions and required retail marketing of at least one grade of unleaded gasoline for the use of such automobile.4 Those regulations were issued under the authority of section 211(c)(1)(B) of the Clean Air Act which permits regulation, control, or prohibition of a fuel or fuel additive ". . . if emission products of such fuel or fuel additive will impair to a significant degree the performance of any emission control device or system which is in general use, or which the Administrator finds has been developed to a point where in a reasonable time it would be in general use. . . ."5
The petitioners challenge the regulations on two basic grounds. They contend the Administrator incorrectly interpreted section 211(c)(1)(A) and as a result used an improper legal standard in making the determinations upon which the regulations are based. They also contend that the evidence does not support the EPA's health concern and that the case against auto lead emissions is a speculative and inconclusive one at best.6 We agree with both these contentions and as a result find the issuance of the challenged regulations to be short of statutory right7 and arbitrary and capricious.8
I. THE FACTUAL SETTING
The regulations we are reviewing lessen the use of certain lead compounds, known as lead antiknocks, in motor vehicle gasoline. These compounds control a phenomenon known as knock — the detonation of gasoline in the cylinder prior to maximum compression. Knocking places a limitation on the efficiency and economy of the internal combustion engine because maximum power is only obtained when the explosion in the cylinder occurs at that point when fuel and air are most compressed. Lead antiknock compounds raise a fuel's resistance to knock (known as the octane of the fuel), thus permitting higher compression engines, which in turn are more efficient [5 ELR 20098] and economical in their use of fuel. The refiners claim that to achieve the same antiknock qualities without lead additives would require greater amounts of scarce crude oil. In addition, they claim that lead additives provide them with the flexibility to produce gasoline with differing antiknock qualities (differing octane ratings) with the minimum of refining and processing equipment.
The present section 211 of the Clean Air Act was added to the Act on 31 December 1970.9 Although EPA soon thereafter issued an advance notice of proposed rulemaking,10 it was not until almost three years later that final regulations were promulgated.11 In fact, the decision to issue the regulations was precipitated by an order of this court in Natural Resources Defense Council v. Environmental Protection Agency (No. 72-2233) (29 October 1973) directing the Agency to reach a final decision within thirty days.
The final regulations were accompanied by a detailed health position paper, entitled "EPA's Position on the Health Implications of Airborne Lead" [hereinafter to be referred to as the Third Health Document].12 The document was intended to be an authoritative examination of the ". . . pertinent evidence upon which a decision could be made as to whether or not there is a health justification to regulate lead in gasoline."13 We shall refer extensively to this document in reviewing the evidence in Part IV below.
The preamble to the regulations contains an extended discussion of EPA's health concern. It focuses separately upon adults and children. While conceding that the available evidence does not show that lead in auto emissions alone adversely affects the health of either adults or children, the EPA argues that auto lead emissions make a significant cumulative contribution to human lead exposure. EPA declares that it would be "prudent" to limit this source of lead exposure, because it is a component of overall lead exposure susceptible to human control. Much of the discussion in the preamble to the regulations relates to whether airborne lead from auto emissions actually does get into the human body to a significant degree. (That portion of the preamble that refers to EPA's health concern is reproduced as an appendix to this opinion.) EPA contends that airborne lead is respired by persons in certain occupational groups and contributes to their high blood lead levels. It is also contended that young children ingest dust and dirt containing lead from auto emissions which contributes to excessive blood lead levels among the young. Petitioners take issue with both forks of the EPA's argument, pointing out that the evidence is inconclusive on both issues.
We will examine the evidence later, but first we look at the threshold question whether the Administrator interpreted section 211 correctly.
II. THE LEGAL STANDARD
A. The Statute — Its Interpretation
Section 211(c)(1) of the Clean Air Act authorizes the EPA Administrator to
control of prohibit the manufacture, introduction into commerce, offering for sale, or sale of any fuel or fuel additive for use in a motor vehicle or motor vehicle engine (A) if any emission products of such fuel or fuel additive will endanger the public health or welfare. . . .14
The initial question presented is whether the Administrator properly interpreted this legal standard when he made the factual determinations upon which these regulations must be predicated.
The petitioners contend that the "will endanger" stand are requires a determination that lead motor vehicle emissions, in and of themselves, pose a direct and provable health hazard to significant portions of the general public. By contrast, if it can only be demonstrated that lead emissions contribute to a health hazard, the Administrator is limited to acting under section 202,15 which deals with emission standards imposed on new car manufacturers, and sections 107 through 110 of the Clean Art Act,16 which deal with ambient air quality standards.
The Administrator stated his interpretation of the statutory language when he issued the regulations:
It is the Administrator's view that the statutory language quoted above does not require a determination that automobile emissions alone create the endangerment on which controls may be based. Rather, the Administrator believes that in providing this authority the Congress was aware that the public's exposure to harmful substances results from a number of sources which may have varying degrees of subceptibility to control.17
The EPA argues that the "will endanger" standard requires no more direct or certain proof of harm than is required for the imposition of emission standards under other provisions of the Act.18 The EPA believes ultimately that it has broad discretion to reach a "reasoned judgment on a border area of scientific knowledge and policy choice."19
We regard section 211 as part of an overall scheme in the Clean Air Act to control various air pollutants, not as an isolated sole power of EPA to deal with lead or other fuel additives or fuels. Even if we focus upon the lead additive alone, as the EPA wrote in its preamble to the regulations, "before prescribing regulations based on public health consideration, the Administrator must consider 'other technological and economically feasible means of achieving emission standards under section 202.'" We emphasize this overall scheme of regulation further when we compare section 211 with section 108 and 202 infra.
Our reading of the language of the Act, its legislative [5 ELR 20099] history, and the administrative record lead us to the view that section 211(c)(1)(A) requires the Administrator to conclude "after consideration of all relevant medical and scientific evidence available to him" that a fuel or fuel additive causes an emission which causes a significant health hazard to a substantial portion of the general population before he can control or prohibit the use of particular fuels or fuel additives. Logically, only if the Administrator can say that a fuel additive causes a significant health hazard can he say that controlling or prohibiting such fuel additive would reduce significantly such health hazard. Whether we term the Administrator's decision one of "assessment of risks," as our dissenting colleague urges, or whether we emphasize that such decision must be based on "facts," the causal connection between lead emissions and the harm must be established by relevant scientific and medical evidence.
When we refer to the necessity under the statute of showing that a fuel additive causes a health hazard, we do not mean that the statute requires a showing that the fuel additive (lead) causes a health hazard without consideration of other sources of lead in the human body having their determined effect also. To interpret the statute in this manner would be preposterous on its face, for as we shall discuss later in Part IV, on the EPA's data most of the lead in the human body comes from dietary sources, food and drink. We think that the statute does require that, before the Administrator can prescribe the regulations involved here, he must find that the lead from auto emissions by itself or alone contributes a measurable increment of lead to the human body, and that this measurable increment causes a significant health hazard.
To repeat, only if the Administrator can say that an identifiable measurable increment of lead in the human body is derived from auto fuel additives and that this measurable increment of lead itself (taking into consideration all other sources of lead) causes a significant health hazard, can the Administrator claim that controlling or prohibiting lead would reduce significantly such health hazard.
To us all analysis leads inescapably to this conclusion, yet the dissent endeavors to avoid this by resorting to two obfuscating dichotomies (perhaps the same distinction expressed in two ways). First, the dissent attempts to separate actual from potentialharm, and, second, to separate risk from fact. "[T]he majority . . . requirement that lead emissions cause actual harm, not merely the threat of harm, . . . And, having transformed the required showing from one of risk to one of fact, . . ." (P. 9) We submit no such separation occurs in the real world, and if the Administrator proceeded on any such fanciful theory, it is another instance of his failure to discern the intent of Congress manifested by the words "will endanger."
As to the first distinction, the dissent later states, ". . . the inescapable thrust of the majority opinion is that actual, not potential, harm must be found before regulation is justified under Section 211(c)(1)(A)." (P. 12) There is no distinction possible here between actual and potential, between past and future harm. The Administrator is dealing with a continuing situation. If there can be found potential harm from lead in exhaust emissions, the best (and only convincing) proof of such potential harm is what has occurred in the past, from which the Administrator can logically deduce that the same factors will produce the same harm in the future. For the dissent to argue that the Administrator can dispense with proof of actual harm, i.e., what has occurred in the past, and can nevertheless somehow determine potential harm, is to grant the plainest license for the wildest speculation. We have always thought scientific conclusions, above all, demanded proof by events recorded and observed.20
The dissent's second asserted dichotomy, risks versus facts, is equally indefensible in logic. All true risk assessment is based on facts and nothing else.21 Those professional risk-assessors, the professional sports gambling fraternity, would smile at any other theory. To the extent that hunch and intuition enter into any final decision, these are separate factors outside of any scientific risk calculation. It is precisely a devotion to facts, not hunches, that distinguishes the professionals from the amateurs in assessing risks; we deem the Administrator to have been intended by Congress to be a "professional."
We need not discuss in any great detail the precise meaning of "the public health" because of our disposition of these cases on the salient errors of the Administrator's interpretation of the "will endanger" clause, and his failure to support his ultimate conclusion with a logical rationale. It should be noted, however, that Congress was considering both the Clean Air Act and the Occupational Safety and Health Act (OSHA) at the same time. It is possible that Congress may have had in mind that a health hazard which affected only one or a few occupational groups should be dealt with as an occupational health hazard, without subjecting the entire 213 million of the American general public to regulations when only a small percentage needed protection, and that protection could be afforded by actions less widespread in their effect. It will be time enough to consider the impact of this and other facts on the meaning of the admittedly vague phrase, "the public health and welfare," if these regulations are repromulgated.
B. Threshold Factual Determination Required
The EPA, relying upon our recent opinions in Amoco, supra, and Industrial Union Department, AFL-CIO v. Hodgson,22 argues:
In the present case, as in Hodgson, the EPA must determine what amount of lead it should permit to be used as additives to gasoline. Here, too, "reliable [5 ELR 20100] data is not currently available with respect to the precisely predictable health effects of various levels" of lead which the EPA could permit to be used. The Agency's decision to require a gradual diminution in the permissible amount of lead is, in the last analysis, a policy judgment "concerning the relative risks of underprotection as compared to overprotection."
* * *
The regulations here reflect reasoned judgment on a border area of scientific knowledge and a policy choice in favor of protecting people exposed to automobile exhausts and particularly urban children. This judgment should be upheld.23
In essence, it is argued that the "will endanger the public health . . ." standard is a delegation of quasi-legislative power to the Administrator and not a requirement that he reach a reasoned determination purely on the scientific and medical data.
It is manifest that Congress wished the Administrator's threshold determination under section 211(c)(1)(A) to be a reasoned factual determination based solely on the medical and scientific evidence. This is made quite clear by subsection 211(c)(2)(A) which emphasizes that "[n]o fuel, class of fuels, or fuel additive may be controlled or prohibited by the Administrator pursuant to clause (A) of paragraph (1) except after consideration of all relevant medical and scientific evidence available to him. . . ." By directing the Administrator to consider "all relevant, medical and scientific evidence" before deciding to institute controls, the Congress must have intended that such evidence act as the basis for his determination.
If the intention had been to permit him to make "an essentially legislative policy judgment, rather than a factual determination . . .,"24 some indication of this should have appeared in the statute. Other sections of the Clean Air Act closely related to section 211 do contain some indication that a broad discretionary power is being vested in the Administrator. Section 108 authorizes the Administrator to set air quality criteria for each air pollutant "which in his judgment has an adverse effect on public health or welfare . . . ."25 Section 202 authorizes the Administrator to set standards for each automobile emission "which in his judgment causes or contributes to, or is likely to cause or to contribute to, air pollution which endangers the public health or welfare."26
By the same token, neither section 108 nor section 202 requires the Administrator in his threshold determination to consider either scientific or medical evidence. Section 108 air quality criteria are required however to "reflect the latest scientific knowledge useful in indicating the kind and extent of all identificable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air, in varying quantities."27 Section 108 therefore requires a factual determination based on "the latest scientific knowledge" in establishing criteria, while permitting wider discretion in making the original threshold determination as to which pollutants to list.
Turning again to section 211, although the legislative history on this point is sparse, the floor debate in the House on the somewhat different House bill28 lends support to our view. Representative Staggers of West Virginia, the Chairman of the Interstate and Foreign Commerce Committee, which committee produced the bill, had in mind a factual determination in the following colloquy:
Mr. Waggoner: If the Secretary feels that he already has sufficient information, can he now say, "you cannot manufacture gasoline and market it any longer that has lead in it"?
Mr. Staggers: No, he cannot. If the gentleman is talking about present law, as it is now constituted, he cannot.
Mr. Waggoner: I am talking about the law as it will be by these amendments.
Mr. Staggers: He will have that authority.
Mr. Waggoner: And he could do that tomorrow?
Mr. Staggers: If he has the facts, and he has proven this by facts, that they are a danger and poisonous — I am trying to find it in the bill so I can cite it to the gentleman.
Mr. Waggoner: We are getting into some dangerous groups ground, because we are talking about something we have not thought through.
Mr. Staggers: It says in this clause under section 8:
(g)(1) Any standards pursuant to clause (A) of subsection (f)(1) [later 211(c)(1)] shall be established by the Secretary on the basis of specific findings derived from relevant medical and scientific evidence. . . .29
Representative Rogers of Florida, a member of the subcommittee that produced the bill, was of the same view:
What we are saying is we want the Secretary to have the authority wherever the facts show that a particular component or an additive of gasoline — a particular item — affects adversely the public health or prevents emission standards from being met, then the Secretary can say that this item should be reduced or eliminated. It is put on that basis and the findings are made.30
A careful analysis of the nature of the issues presented for review in Amoco compared with those here will be illuminating. In that case the oil refiners argued [5 ELR 20101] that the Administrator was required to make specific "findings" on the threshold determinations listed in sections 211(c) (2) (B) and (C) and also with respect to the implementation decisions by which he determined the means to be used by the EPA to prevent lead additives from impairing the platinum catalytic converter. Judge Wright, speaking for the court, rejected both prongs of the refiner's broad construction of the "findings" requirement of sections 211(c) (2) (B) and (C). Initially, the court rejected the requirement of specific "findings," "'specific' in the sense of being detailed or voluminous,"31 for the threshold determinations listed in the two subsections. This result was dictated by Congress' preference for "simplicity and workability" and "the imperative need for administrative flexibility and expedition" derived by anology from the APA.32 The court then went on to reject "distinct 'findings' with respect to every significant decision and determination made in the course of regulating fuels . . . ." This holding was based on a thorough analysis of the nature of agency rulemaking. As the court pointed out "[t]he process is quasi-legislative in character . . . one will search in vain for those intermediate 'findings' of fact which mark the midway point in an adjudicator's linear march from raw evidence to single, ultimate conclusion."33 Correct though such analysis may be for those relatively minor implementing decisions, the court rejected the analysis as to those "particular factual determinations . . . concerning the threshold necessity of embarking upon fuel regulation."34
For the portion of the statute, 211(c) (1) (A), we are construing, the most relevant part of the Amoco court's analysis is that dealing with the required threshold determinations.
. . . Section 211(c) (2) (C) calls on EPA to answer a particular factual question, while Section 211(c) (2) (B) requires that particular factual determinations be made concerning the threshold necessity of embarking upon fuel regulation. Because these findings requirements are reasonably precise and comprehensible, they are compatible with the mechanics of rulemaking and with the exigencies of judicial review.35
In the present case section 211(c) (1) (A) requires a factual threshold determination as to whether fuel additives should be regulated or prohibited. Again, as the Amoco court put it:
Section 211(c) (2) (B) is centrally concerned with EPA's threshold determination whether or not to regulate a particular fuel additive. . . . The findings are to show why regulation, as opposed to no regulation, is necessary or otherwise advisable.36
While it may be pointed out that 211(c) (1) (A) carries no language calling for the publication of "findings," as do 211(c) (2) (B) and (C), yet this in no way alters the fact that there is a threshold determination by the Administrator required under each of the subsections, and that each such threshold determination must have a factual basis. In Amoco the court did not reason that there was a factual threshold determination to be made because the word "findings" was used in the statute. The Court reasoned from the other language of the subsections that there were threshold and implementing determinations to be made, and that the type of "findings" to be published were likewise derived logically from the overall responsibilities given the Administrator by the subsections.
In this regard it is significant that neither the requirement of published findings nor a public hearing (under (B)) removed the Administrator's action under 211(c) (2) (B) and (C) from the category of rulemaking into that of adjudication, and neither adjudication procedures under sections 7 and 8 of the APA nor the test of substantial evidence was thought proper in Amoco.37 Further, the Amoco opinion takes pains to point out, that inasmuch as rulemaking under the APA is involved, the "published findings" language of subsections (B) and (C) adds nothing to what "would be required in any case by sections 4 and 10 of the APA."
The "basis and purpose" statement required by Section 4(c) of the APA must be sufficiently detailed and informative to allow a searching judicial scrutiny . . . . In particular, the statement must advert to administrative determinations of a factual sort to the extent required for a reviewing court to satisfy itself that none of the regulatory provisions were framed in an "arbitrary" or "capricious" manner.38
"In light of this jurisprudence, which has developed without the aid of a statutory requirement for 'findings,' . . ." nothing is added by 211(c) (2) (B) and (C)'s reference to "findings" beyond that already required of an agency and court by well established rulemaking procedures under the APA. And, of course, in the present case involving section 211(c) (1) (A) of the same Act, we are likewise reviewing rulemaking under Section 4 of the APA.
The dissent contends that we have failed to take adequate account of the fact that the Senate bill and not the House bill, which was more restrictive on EPA's freedom of regulation, was adopted by the conference committee and ultimately enacted into law.39 Quite the contrary, we are giving full weight to the court's analysis in Amoco of the conference committee's decision. However, that conference committee decision was, as Amoco makes clear, basically one concerning the written form of decision.
Completely apart from the Amoco opinion, we take it to be the dissenting position that we failed to give adequate substantive weight to the fact that the House bill dropped by the conference committee required "specific findings" for each determination to be made under (what became) section 211(c)(1)(A) (the subsection relevant to these cases) and section 211(c)(1)(B) and (C) (the [5 ELR 20102] subsections relevant to the Amoco cases).40 As a preliminary matter, two comments are in order. First, it should be emphasized that we regard the actual language of a statute as the best indication of the intent of Congress. Legislative history, although useful at times, is clearly secondary evidence of intent. This is not solely because the legislative history is not "enacted" by the Congress, but also because it rarely speaks with a single, clarion voice. It is for this reason that we have placed principal reliance upon the language of section 211 and a comparison of section 211 with sections 202 and 108. Second, in this particular case the crucial conference committee report does not even speak with many voices. The House managers' entire discussion of section 211 is reproduced in the margin and it gives no indiciation of what Congress was attempting to do when it substituted the Senate bill for the House bill.41
With this in mind, we venture some discussion, made through the prism of Amoco of the legislative history of section 211(c) (1) (A). Assuming some substantive weight to the substitution, its effect would be reflected to a greater degree in the implementing decisions of the Administrator as opposed to the threshold determination. The initial portion of section 211(c), which in the House version was section 210(f), read as follows:
(f)(1) The Secretary may, on the basis of specific findings made in accordance with subsection (g), establish standards respecting the composition or the chemical or physical properties of any fuel or fuel additive by specifying limitations on (or providing for elimination of) ingredients (including additives) or on the physical or chemical characteristics of any fuel or class of fuels (A) if any emission products of such fuel or fuel additive will endanger the public health or welfare . . . .42
Section 210(g) of the House version provided:
(g)(1) Any standards pursuant to clause (A) of subsection (f)(1) shall be established by the Secretary on the basis of specific findings derived from relevant medical and scientific evidence, including (in the case of a standard with respect to a motor vehicle fuel or fuel additive) a finding thatt it is not otherwise technologically or economically feasible to achieve the emission standards established pursuant to section 202 of this Act.
(2) Any standards pursuant to clause (B) of subsection (f)(1) shall be established by the Secretary on the basis of specific findings derived from scientific evidence, including a cost-benefit analysis comparing emission control devices or systems which are or will be in general use and require the proposed standard with emission control devices or systems which are or will be in general use and do not require the proposed standard.43
By emphasizing the fact that it is "standards" which must be based on specific findings, the House bill was focusing on implementation and not on the threshold determination. Thus, the dropping of "specific findings," if we are to assume it was meant to have substantive effect at all, would have had a greater effect on implementing determinations.44 Indeed, we find it of some [5 ELR 20103] relevance that Amoco holds that the phrases just after subsection 211(c) (1) (A) must be parsed in such a way that the initial threshold determination "turn[s] crucially on factual issues" while the implementing decisions "turn on choices of policy, on assessment of risks."45
In conclusion, we hold that the threshold determination whether an emission "will endanger the public health . . ." does turn and was intended by Congress to "turn crucially on factual issues" and not upon "choices of policy."
C. A Substantial Causal Connection Required
The "will endanger" standard requires a substantial quantum of evidence. As we have indicated, the Administrator must not only establish that lead from auto emissions alone contributes a measurable increment of lead to the human body but he must also establish that this measurable increment directly results in a health hazard which is itself significant. We believe that at least such a showing is implicit in the rigorous "will endanger" standard as a matter of plain English meaning
In addition, a comparison of section 211 with sections 202 and 108 shows that in section 211 Congress wanted the clearest and most exacting showing by the Administrator before he could act. Our dissenting colleague makes clear the rationale of Congress:
When EPA acts under § 211(c) (1) (A) it is essentially telling manufacturers how to make their fuels, a task Congress felt the agency should enter upon only with trepidation. . . . On the other hand, when the Agency acts under § 202, it is only mandating an end product — regulated emissions. The method for achieving the required result is entirely in the hands of the manufacturers.46
Similarly, section 108 empowers the Administrator to do no more than establish "criteria" for air pollutants.47 We now turn to a more detailed comparison of the various sections of the Clean Air Act.
Section 202 permits the Administrator to impose emission standards on new car manufactors if "in his judgment [an air pollutant] causes or contributes to or is likely to cause or contribute to, air pollution which endangers the public health or welfare." (Emphasis added.) The difference of the language is striking. Not only does section 202 permit regulation if a pollutant merely contributes to air pollution which endangers public health, but also the Administrator only need be able to conclude that a pollutant is likely to contribute to a health hazard.
When by section 202 the Administrator is given power to establish standards in regard to air pollutant emissions from automobiles, observe the lenient standard for the Administrator in so doing — "in his judgment . . . likely to cause or contribute to." But in meeting this lenient standard, the Administrator is not given power to ban absolutely emissions from an automobile; he can set standards, recognizing that such emissions of one kind or another must be tolerable. In contrast, under section 211 the Administrator may "control or prohibit . . . any fuel or fuel additive . . . (A) if any emission products of such fuel or fuel additive will endanger the public health or welfare." Here the power of the Administrator is to ban absolutely a fuel or fuel additive, but to do so he must meet a higher standard of proof, i.e., "will endanger the public health or welfare," not merely "likely to cause or contribute to air pollution which endangers the public health or welfare," the more lenient standard of section 202.
The more lenient standard of section 202 is matched by the less power in the hands of the Administrator. The more rigorous standard of section 211 is matched by the greater power to ban absolutely in the hands of the Administrator. Likewise, the impact on the economy from actions taken by the Administrator is proportional. To prescribe standards for auto emissions will not drastically upset either the manufacture or use of automobiles or the manufacture or use of fuels. At the time of legislation the device of the catalytic converter, admittedly an added cost and perhaps bothersome, was a foreseen solution, and there were others. On the other hand, it is strenuously urged by the petitioners in the case at bar that the economic impact of the regulations on fuel additives will upset the entire refining industry, add to costs to the consumer, and increase the national consumption of petroleum at a time of dangerous dependence on foreign imports, because the fuel additives unquestionably permit the more efficient use of the same given amount of fuel.
By the same token, section 108 provides for an even less rigorous standard of proof than either section 202 or section 211. As has been noted earlier, section 108 authorizes the Administrator to set national primary and secondary air quality standards for each air pollutant "which in his judgment has an adverse effect on public health or welfare . . . ."48 The statutory scheme created by section 108-110 grants the Administrator little power to implement these standards. The States are granted primary responsibility for implementing national primary and secondary ambient air quality standards. The Administrator merely retains a residual power to implement the standards in default of state submission of a proper plan.
The statutory standard of "has an adverse effect" is clearly less rigorous than the "will endanger" standard in at least two respects. First, an adverse effect can be any result which is contrary, opposed, or conflicting with the public health.49 Such a result need not be as substantial as one which will endanger the public health. Second, the adverse effect need not have as proximate or substantial a relation to the air pollutant as is denoted by "will endanger." This interpretation is supported by a comparison with the proposed Senate bill which in addition to the above quoted language also provided:
. . . [T]he Secretary shall publish proposed national ambient air quality goals the attainment and maintenance of which are necessary to protect the public health and welfare from any known or anticipated adverse effects associated with the presence of such air pollution agent or combination of such agents in [5 ELR 20104] the ambient air, including, but not limited to, adverse effects on soils, water, vegetation, man-made materials, animals, wildlife, weather, visibility, and climate, as well as effects on economic values.50
The point is driven home by the Senate Report on the proposed legislation:
In setting such air quality standards the Secretary should consider and incorporate not only the results of research summarized in air quality criteria documents, but also the need for margins of safety. Margins of safety are essential to any health-related environmental standards if a reasonable degree of protection is to be provided against hazards which research has not yet identified.
* * *
. . . However, the Committee emphasizes that included among those persons whose health should be protected by the ambient standard are particularly sensitive citizens such as bronchial asthmatics and emphysematics who in the normal course of daily activity are exposed to the ambient environment. In establishing an ambient standard necessary to protect the health of these persons, reference should be made to a representative sample of persons comprising the sensitive group rather than to a single person in such a group.
Ambient air quality is sufficient to protect the health of such persons whenever there is an absence of adverse effect on the health of a statistically related sample of persons in sensitive groups from exposure to the ambient air. An ambient air quality standard, therefore, should be the maximum permissible ambient air level of an air pollution agent or class of such agents (related to a period of time) which will protect the health of any group of the population.
For purposes of this description, a statistically related sample is the number of persons necessary to test in order to detect a deviation in the health of any person within such sensitive group which is attributable to the condition of the ambient air.51
Compare this to the same Senate Committee's comments on the "will endanger the public health . . ." standard in, what became, section 211:
There are two basic reasons to regulate the sale of a fuel. First, the combustion or evaporation of such fuel from any engine may produce an emission that is a direct endangerment to the public health. Second, the fuel may have an adverse effect on the general welfare or on an emission control system or device.
In matters related to public health and welfare the Committee's concern is with the effect of the actual emissions from the tailpipe, not with the composition of the fuel. The combustion of the fuel in its intended environment — inside an engine with proper emission controls — would be the proper criterion for the Secretary to use in judging the health and welfare effects of that fuel.
The Committee believes that an endangerment to health would be of such importance that the Secretary might prohibit or control the sale of such fuel. Adverse environmental effects would fall in the category of general welfare. Since the nature of the general welfare is less well-defined than the public health, the Committee believes it essential that the Secretary hold a public hearing on any proposed prohibition or control relating to public welfare.52
Although the latter discussion is sparse, there is emphasis on the directness of the endangerment and there is an absence of any discussion of "particularly sensitive citizens." There is also a clear statement relating the importance of the "endangerment to health" to, and as a justification for, the vigorous action authorized, i.e., absolute prohibition or control, a point we found significant in contrasting sections 211 with section 202 above.
In conclusion, we hold that the "will endanger" standard is a rigorous one which requires a substantial quantum of proof. As a result we are convinced that the EPA is incorrect in asserting that section 211 requires no more certain proof of harm than "the imposition of emission standards under other provisions of the act."53
D. Agency Action on the Regulations under Section 211
We also take note of the extended gestation period of these regulations. Implicit in the administrative record generated by this three-year delay in promulgating these regulations is the recognition by EPA that available scientific data did not provide a clear and certain basis for reaching the statutorily mandated conclusion. The advance notice of proposed rulemaking was filed within a month of the enactment of the Clean Air Act amendments.54 Over a year later in February 1972 the Administrator issued a notice of proposed rulemaking under section 211(c) (1) (A).55 In the notice the Administrator stated the following conclusion: "that airborne lead levels exceeded two milligrams per cubic meter, averaged over a period of three months or longer, are associated with a sufficient risk of adverse physiologic effects to constitute endangerment of public health."56 EPA's first health document, entitled "Health Hazards of Lead," was issued contemporaneously. Subsequently, an additional paper entitled "Atmospheric Lead and Public Health" was issued by the EPA further to bolster the EPA's conclusion.57
[5 ELR 20105]
In the ensuing year EPA received a great deal of adverse comment as to its health position, including critical comment from every other department of the Government asked to comment thereon. We regard this of considerable significance, as each of these departments has its own independent scientific staff, and presumably is in that group of "independent" experts to which EPA itself stated (rightly or wrongly) that it would give more credence than to either industry scientists or environmental crusaders. Dr. Edward E. Davis, Jr., Director of the White House Office of Science and Technology, wrote:
. . . OST has reviewed the medical evidence that supposedly supports the EPA Administrator's desire to reduce lead content of gasoline. OST finds the Administrator's position in this regard unsupported by the evidence.
* * *
With respect to the medical evidence there is no correlation between airborne lead and lead levels in blood for the range of airborne lead levels encountered in rural or urban communities. . . .58
In "Airborne Lead in Prospective," the National Academy of Science (NAS) made a thorough study of the scientific literature as to lead in the air and its biological effects. After preliminary comparison of this NAS report and the EPA's health grounds, the Under Secretary of the Interior, M.J. Pecora, gave his evaluation:
After examining the National Research Council report and that of the background information of EPA, it seems that EPA's conclusions are strongly oriented toward a one-sided view of the report's findings. In general, the Research Council indicates there is no basis for restriction of lead in gasoline from a health standpoint.59
The Department of Commerce commented:
It therefore appears that EPA's position that any amount of airborne lead constitutes an endangerment of public health is largely conjectural and not adequately premised on available scientific or medical information.60
Perhaps the most biting comment came in a letter from Dr. Merlin K. DuVal, Assistant Secretary for Health, Department of Health, Education and Welfare:
The decision having been made on grounds other than those having to do with hazard to the public health, your staff now wish to explore with us the question of whether or not hazard to the public health could be invoked as a reason for accelerating the implementation date of the primary decision. It was our firm view that there is no firm evidence, at this time, that lead poisoning in humans could be traced per se to the presence of lead in gasoline, indeed, if there were, this would have constituted justification for the elimination of lead as an additive in the first instance.61
As a result the EPA was forced back to basics, asking for public comment on virtually every conclusion it had reached as to lead in the air and its relation to man.62
[5 ELR 20106]
On 4 January 1973 a new notice of proposed rulemaking was issued, in which the EPA repudiated its earlier conclusions and reached the following weakened appraisal:
Though none of the above findings viewed individually and in the context of possible experimental error can be taken as conclusive evidence that airborne lead is contributing to excessive total lead exposures among the general urban population. In light of this evidence, the Administrator has concluded that it would be prudent to reduce preventable lead exposures from automobile emitted "airborne" lead to the fullest extent possible.63
This latest EPA position was supported by a Second Health Document.64
Despite these changes in EPA's position, criticism from other governmental agencies continued. For example, Dr. Charles H. Powell, Assistant Director of the National Institute for Occupational Safety and Health of the United States Public Health Service, evaluated the reproposed regulations and the Second Health Document, as follows:
We have not been persuaded, however, that reduction in environmental lead by its reduction in gasoline will result in a significant improvement in the health of the public. This statement is based on our review of the problem and discussions with responsible scientists in the Health Services and Mental Health Administration (NIOSH and BCEM) and the Food and Drug Administration.
This position has been reconsidered by a review of the report on health effects of airborne lead submitted with your letter. The report is often speculative and is based in significant part on unpublished informaion, which we have not been able to review. We have been able to review some of the abstracts of the October 1972 meeting in Amsterdam, but this has not been sufficient to allow evaluation of the content of the papers.
A specific point that has been commented on in previous drafts of this paper is the description of lead absorption in greater than normal amounts, as reflected by higher than normal blood lead levels, as asymptomatic lead poisoning. In the present version, this description is attributed to unnamed clinicians and health departments, whose knowledge, reputation, and expertise cannot be evaluated. It invites unfavorable inferences.65
Acting Secretary of the Interior John C. Whitaker stated, "After reviewing the reproposed regulations, we see no reason to change from our position as detailed in our enclosed analysis. . . ."66
Secretary Elliot L. Richardson of Health, Education, and Welfare (HEW), in a letter to Senator Tunney, took issue with EPA's revised hearlth justification for the regulations: regulations:
Our view is:
(a) there is no firm evidence at this time that lead derived from combusted gasoline is harmful to the health of the general public, though it may, under certain circumstances, contribute to the total body burden of lead and may, as a consequence, reduce somewhat the physiologic reserve against lead poisoning from other sources . . . .67
On 28 November 1973 the final regulations here under review were promulgated after an order of this court directed the Administrator to reach a final decision on the matter within thirty days.68 These final regulations were accompanied by the Third Health Document, which had never been subjected to public — or other government official — comments. The unease of the Administrator with the "will endanger" standard helps explain not only this three-year delay but also his reluctance to couch his ultimate finding in the language of the statute itself and the previously noted apologetic for a less rigorous standard.69
In sometimes caustic tones, the dissent refers to "the majority's attempts at scientific analysis"70 "in its self appointed role as scientist-statistician,"71 and concludes that "the court is simply substituting its judgment for that of the EPA."72 We are not doing so, but it is readily apparent from the recital of the other government agency comments that we would have plenty of company in our judgment if we did. For the collective scientific judgment in every department or agency of the government commenting on the first two EPA Health Documents and proposed regulations is dead against the Administrator's conclusion — and he did not risk this same [5 ELR 20107] fate with the Third Document. If, as the dissent says, ". . . it is precisely the function of 'arbitrary and capricious' review to define the bounds to permissible agency reasoning and to hold the agency to some rudimentary form of rationality in both weighing the evidence and reaching its conclusions,"73 then our analysis of the flaws in the Administrator's logic finds powerful support in the unanimity of conclusion of the independent scientific minds concerned throughout the government outside of EPA itself. To the appropriate standard of our review we now turn.
III. SCOPE OF REVIEW
The EPA in promulgating these regulations followed the informal rulemaking procedure outlined in the Administrative Procedure Act, 5 U.S.C. § 553.74 Since the Clean Air Act neither provides for review "on the record of an agency hearing" nor provides specifically the standard of judicial review, our scope of review of these regulations is limited to a determination of whether "agency action, findings . . . [or] conclusions . . . [are] arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . ." or "in excess of statutory jurisdiction, authority, or limitations, or short of statutory right."75
It is well recognized that in reviewing the record we are not to substitute our judgment for that of the Administrator.76 Thus, we are required to affirm agency determination with which we disagree. However, we are also under an obligation not to act as a rubber stamp of agency rulemaking action. As a result, in reviewing agency rulemaking under section 553, we are obligated to engage in a "substantial inquiry," and "inquiry into the facts is to be searching and careful . . . ."77 As the Supreme Court has indicated, we "must consider whether the decision [of the administrative agency] was based on a consideration of the relevant factors and whether there has been a clear error of judgment."78
Certainly a determination made in the absence of any evidence in the record to support it would lead a reviewing court to conclude that a "clear error of judgment" had occurred. However, a reviewing court could reach a similar conclusion in the presence of some evidence supporting the agency determination.79 Since a court must review "the entire record," it may well be that the evidence detracting from the agency's conclusion is so overwhelming or so persuasive, or the agency's approach so one-sided, or the decision-making process so flawed, that a reviewing court must conclude that the agency erred in the exercise of its rulemaking power.80 Or, if there is [5 ELR 20108] an essential point or element missing in the logical progression toward the conclusion that the agency reaches, then the agency's action likewise may be arbitrary or capricious, because it is not supported by a logical thought process.
In these consolidated environmental protection cases the thought process by which an agency reaches its conclusion on informal rulemaking resembles a chain. If there is a link missing, then the agency, to reach the conclusion that it did, was required to take an arbitrary jump in its logic to reach that conclusion. To illustrate, we have the admitted fact that there is lead in gasoline which goes into the automobile tank. At the other end of the thought progression there is the scientific conclusion that too much lead in the human blood level is harmful — although there seems to be no agreed conclusion as to exactly what that blood level is (for this case, we assume the EPA level correct). Logically, as we view the scientific evidence, the chain of transmittal of the lead in the auto tank to the lead in the bloodstream is vital on the issue before us — whetherthere is valid reasoning based on evidence to sustain a finding thatt lead additives will endanger public health. The standard of "will endanger" makes the existence or nonexistence of a scientifically demonstrated chain of transmittal, not mere guesswork, decisive. For if no such scientifically proved chain exists, the Administrator's decision can only be arbitrary and capricious.
The recent First Circuit case, South Terminal Corporation v. EPA,81 supports our application of the "clearerror of judgment" standard of review to the Administrator's determination in this case. In that case, the court was called upon to review the Metropolitan Boston Air Quality Transportation Control Plan promulgated by the Administrator under section 11082 after the Commonwealth of Massachusetts had failed to submit an acceptable plan to implement the previously discussed83 national primary and secondary ambient air quality standards. We quote, at length, the First Circuit's discussion of the standard of review:
Under § 706, we must determine whether EPA followed lawful procedures in evolving its plan; whether it acted within its statutory authority; and whether the plan is constitutional. If so, we must set aside the plan only if it is found to be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706 (2) (A).
In the following parts of this opinion we deal first with the procedural objections to the plan and later with the constitutional ones. In between we consider statutory objections and, most difficult of all, those objections addressed to the merits of the plan. The last objections, it is clear, are outside our province unless they show that EPA's decision was not based on consideration of relevant factors or else included a "clear error of judgment". Overton Park, supra, 401 U.S. at 416, 91 S. Ct. 814. We are not empowered to substitute our judgment for that of the agency.5
The questions about the plan on review are of two types: the rationality of EPA's technical decisions (such as its determinations of local photochemical oxidant and carbon monoxide levels and the amount of reductions required to meet national standards), and the rationality of EPA's "control strategy", that is, the measures adopted to reduce emissions. The former present peculiar difficulties for nonexperts to evaluate. Yet "[our] inquiry into the facts is to be searching and careful", id., and we must assure ourselves as best we can that the Agency's technical conclusions no less than others are founded on supportable data and methodology and meet minimal standards of rationality. See Section III. infra.
Assuming EPA's technical determinations are reasonably based, we must decide whether the selected controls are arbitrary or capricious. In so doing, we must bear in mind that Congress lodged with EPA, not the courts, the discretion to choose among alternative strategies.6 Unless demonstrably capricious — such as much less costly but equally effective alternatives were rejected or the requisite technology is unavailable — the Administrator's choices may not be overturned. . . .
Appropriately enough, Part III of the opinion is entitled, Whether EPA Committed a Clear Error of Judgment in Computing the Need for Emission Reductions. The First Circuit's emphasis on adequate data and appropriate methodology is fully in accord with our interpretation of the "arbitrary and capricious" standard.
In the case at hand, we have concluded that at certain points in assessing the scientific and medical data the Administrator made "clear error[s] of judgment." This conclusion is based upon a "searching and careful" inquiry into the facts underlying the determination that airborne lead will endanger the public health. At several points in the Administrator's reasoning we have found little or no evidence to support his conclusions, and at several points we have noted clear errors of a substantial nature in the Administrator's analytical and evaluative methodology and the EPA's decision-making process. Several vital links in the chain are unsupported; [5 ELR 20109] for the Administrator to leap to the conclusion he did can only be termed arbitrary and capricious. We conclude that "a clear error of judgment" has occurred.
IV. THE EVIDENCE
A. The Contribution of Auto Lead Emissions to Blood Lead in Adults
In order to speed the administrative process, as an alternative ground of decision we will undertake an examination of the evidentiary support for the various determinations made by the Administrator. We will assume throughout our discussion of the evidence that lead levels in the blood are an appropriate index of total lead body burdens.85 We will assume that blood levels of 40 micrograms of lead per 100 grams of blood (hereinafter all blood levels will be per 100 grams of blood) represent the lower boundary of lead levels which are associated with subclinical changes having significant metabolic effects.86 In order to place this figure in perspective, it should be noted that classic lead poisoning is said to occur at levels above 80 micrograms.87 On the other hand, the general population has head levels of 10 to 30 micrograms, which levels are within normal tolerances.88
When the Administrator promulgated the regulations, he stated the basic factual issue in the following way: "Is there a correlation between air lead levels and blood lead levels?" (Emphasis in original.) He answered this question in the affirmative, and thus felt justified in reaching the ultimate conclusion that auto lead emissions contributed significantly to blood lead levels in adults. We hold that the Administrator made a clear error in judgment in answering this basic factual question in the affirmative;89 whatever were his other shortcomings in reasoning and methodology along the way, he had no firm platform from which to make the logical jump to his ultimate conclusion.
In its preamble to the regulations EPA relies on four studies to support the conclusion that there is a correlation between air lead levels and blood lead levels: the pilot lead isotope study, a study made in japan, the Chamber study, and the Daines study conducted in New Jersey. A fifth study, cited in the preamble and Third Health Document, permits inferences both for and against the Administrator's conclusion. Several other studies are discussed by EPA in its Third Health Document; however, their data and conclusions do not support EPA and were not cited in the preamble to the regulations.90
The pilot lead isotope study91 was based upon observations of a single subject who was fed a low lead content diet, containing lead of a specific lead isotope, while he lived in a metabolic unit. While in the unit the subject was exposed to airborne lead in a concentration of two micrograms per cubic meter. The purpose of the study appears to have been to determine whether the technique was a workable approach for determining the relative contribution of airborne lead to total lead absorption in man. It was incident to this purpose that the study produced data as to relative contribution in the one subject studied. Realistically, it is impossible to say that any definite scientific or medical conclusions can be drawn from the observations of one or two subjects. Yet the Administrator in promulgating these regulations leads off his discussion of the evidence supporting a correlation between air lead levels and blood lead levels with the preliminary data produced by the study of one subject.92 The study technique and the data produced are doubly suspect because the study came to light a mere month before EPA promulgated the regulationsand thus had never been subjected to formal public comment.
The Administrator relies next on "[a]n unpublished study in Japan," the data of which, in the Administrator's own words, "has not yet been completely analyzed."93 This study came to light so late it did not even get analyzed by the EPA in the Third Health Document.94 If it had been, perhaps it would not have been included, because the authors of the Japanese study themselves concluded that "[w]ith the present level of blood concentrations in the air it is difficult to establish any direct relationship between lead levels in the air and such [5 ELR 20110] levels in blood and urine,"95 a conclusion somewhat devastating to EPA's conclusion here.
The dissent finds support for the Administrator in the following two statements found in the Japanese study: "No doubt an increased respiratory exposure will contribute to an increased intake of lead into the body."96 "[T]here is a significant, positive correlation between ambient level and blood level for workers by area."97 Read in context neither of these statements lend support to the Administrator.
Just before the first sentences quoted above, the study states quite clearly that:
. . . [e]ven though the air lead concentrations may range from 0.1 mg/m3 in rural areas to 1-3 mg/m3 in cities, without monitoring personal exposure, the urban-rural differential in blood lead may not be considered to reflect the differential in air lead concentration. The urban people may have distinctly different life style in alimentary intake of lead from the rural people or their blood composition can be different by the degree of urbanization as observed in the current study.98
The second sentence loses its purported significance when read in the context of the following discussion which follows two paragraphs after:
Indeed, the urban-rural difference in blood lead level is statistically significant, but the magnitude of such difference is rather small; in the current report the level ranges from 17.0 ug/100g in the Pacific Hachijo Island to 18.4 ug/100gm in the center-city. Out of 11 communities in the "Seven-Cities Studies" the maximum difference observed was 3.7 ug/100gm for Chicago urban-suburban persons. There can be differences in smoking habit or food habit between the urban-rural living pattern. It is, in fact, found that males present significantly higher lead concentrations in blood than the female even if both sexes live in the same area. It is conceivable that their respiratory exposure to lead differs. But it may be also argued that the sex difference is due to the differential alimentary and other intake of lead by sex, and due the difference of Ht value. In any case, it should be reminded that the "exposure variables" explain only minute portion of the total variations of PbB and PbU as shown in the regression analysis. From areal correlations, we have seen that there are negative correlations between the hematologic measurements and air lead concentrations. This observation is not related to lead exposure, because ALA did not show any correlations with air lead concentrations. It rather may come from comples [sic] milieu of urbanizing process. So might the level of blood lead.99
The fact that the Japanese study was not analyzed by EPA's own scientists before it was used in the preface to the final regulations raises serious questions as to the decision-making processes followed by EPA. Since there was no time for EPA to evaluate the Japanese study, it goes without saying that no one outside the agency had an opportunity to make an evaluation.The record thus indicates that no formal evaluation of the Japanese study was made prior to promulgation.
The next study referred to by the Administrator was the Chamber study.100 The data in this study was derived from subjects who had been exposed for as long as eighteen weeks to particulate lead in a specially modified room. The lead particles used in this experiment differed in size and chemical composition from the lead particles found in ambient air. The Third Health Document minimizes these differences in a phrase: "these differences were sufficiently small so that inferences can be made regarding effects of airborne lead among the general population."101 EPA's scientists give no reason for their conclusion. This fact is particularly disturbing since previously in their report they made a point of noting that "[r]espiratory absorption of lead is dependent upon the size, shape, and density of the inhaled particle. . . ."102 In addition, the authors of the Chamber study in their final report, state:
It is tempting to compare the measured blood lead levels with those which can be predicted by other investigations but certain precautionary points should be borne in mind. Although the present study was designed to simulate certain features of environmental exposure to lead, there were some differences which could bear on the results we obtained. Inorganic lead emitted in the exhaust of automobiles is in the form of various compounds including halides, mixed oxides, carbonates, and other products. It is also associated with other particulate matter found in the atmosphere. In contrast, we exposed the men to a less complex particulate. This, and the fact that the ambient air has a relatively greater proportion of larger sized particles, could mean that under the same conditions of total airborne lead content, the portion of lead absorbed the lung [sic] due to our experimental state may differ from the portion absorbed due to exposure of men to ambient air.103
At the least, these differences require EPA to justify its conclusion that the composition and size differences were too minor to matter before any reliance can be placed on the conclusions reached.The authors' own proviso certainly undercuts any reliance by a reviewing court on this study.
Finally, EPA relies on a study by Daines, et al., of blood lead levels among females who resided at various distances from a heavily traveled highway.104 The study was in two parts. In one part, blood samples were taken from black females living 3.7, 38.1 and 121.9 meters north of "a major one-way, westbound, three-lane road carrying an average of 33,000 cars a day." Air samples [5 ELR 20111] were also taken on the front porch and in a front room, "which served as a bedroom by night and the family and TV room by day." The area is described as "economically depressed." In the other part of the study, blood samples were taken from twenty white females living in an upper middle-class neighborhood. They resided either 33.5 or 457 meters north of a section of the New Jersey Turnpike carrying 60,000 cars daily. Inside and outside air samples were also taken.
The results of part one of the study showed only a weak correlation between distance from the highway and blood lead levels. The women living 3.7 meters (12 feet) from the edge of the highway averaged 23.1 micrograms of lead while those living 38.1 meters (125 feet) and 121.9 meters (400 feet) averaged 17.4 and 17.6 micrograms, respectively.105 These figures must be compared with the air samples which showed front-porch readings of 4.60 micrograms of lead per cubic meter of air at 3.7 meters, 2.41 micrograms at 38.1 meters, and 2.24 micrograms at 121.9 meters.106
The report gives very few figures on the second part of the study; however, it does conclude that "there was no significant differences in the lead content of the blood taken from donors in the two locations."107 This is not quite the whole story. Since the report indicates air lead content was lower at the greater distance (we are not told how much) and yet the blood readings averaged 16.1 at the greater distance and 15.7 at the closer distance, it is likely that a statistically significant inverse correlation between air and blood levels would have been uncovered. In other words, since blood lead levels were higher at the further distance even though the lead level had decreased, a relation precisely opposite to that sought by the Administrator might have been uncovered.
Taking both parts of the study into account, the data represents at best a weak correlation between air lead levels and blood level levels. It is also very important to note that the average blood level levels among the women who spent their entire day twelve feet from the edge of a highway was a very normal 23.1 micrograms. In addition, 96.4% of the women in this group had lead readings below 35 micrograms as compared to 98.4% of the women living 400 feet from the highway.108
Though the usefulness of the Daines study is limited, it could have constituted some evidence of a correlation between air and blood lead levels, the only such reliable evidence in the record. However, the Administrator clearly misunderstood what the study attempted to do and what it ultimately showed. We quote the Administrator:
Differences in the blood lead levels between urban and suburban residents in the same geographic area have been found. When comparable groups with similar lead intakes from other sources besides air were studied, blood leads were consistently higher in urban areas and near highways where air lead concentrations were greatest. Thus while correlations between blood leads and air lead at lower exposure levels are not always good, the evidence indicates that air lead does contribute to general population lead exposure.109
The errors of the Administrator are obvious. Nothing in the Daines study mentions the lead intake from sources other than the air. If variables such as dietary intake had been controlled, the value of the study would have been much greater. In addition, no comparisons between urban and suburban areas were made in the study. Indeed, the Japanese study, which did explore possible differences between urban and rural blood levels concluded that "the magnitude of such differences is rather small . . . [and the differences] may not be considered to reflect the differential in air lead concentration . . ." but, rather, may be accounted for by such factors as "distinctly different life style in alimentary intake of lead . . . ."110 It is thus clear that the Daines study was misunderstood and not used for whatever limited value it might have had.
A comment about the dissent's approach to these studies might help clarify our relative positions. In reference to the pilot lead study the dissent states: "EPA is not drawing its conclusions from these observations of two subjects; these data are simply supportive of the total body of evidence on which the Agency relied."111 The results of the Daines study "on their face . . . seem fully consistent with EPA's conclusions about lead absorption."112 As regards the Chamber studies our dissenting colleague concludes: "[The Administrator] is finding in the results support for his conclusions that lead emissions are in fact absorbed from the ambient air, a conclusion the authors' statement fully supports, and he is using the results in a qualitative way to confirm independent calculations, based on Kehoe's data, of possible absorption."113 When one looks to the dissent's discussion of the regression calculations derived from the Kehoe experiments, one finds the following statement: "[T]hese calculations . . . are supported by the chamber studies described above. . . . I would hold that these calculations, buttressed as they are by the chamber study findings, provide substantial support for the Administrator's conclusion."114
Obviously, the dissent recognizes the defects of each of these studies and is thus reluctant to say that the Administrator was justified in relying on them in support of his conclusions. According to the dissent, study after study tends to confirm some independent conclusion made by the Administrator. Our problem is that, in the first place, nothing directly supported the Administrator. He appears to have reached a conclusion as an independent deduction, but without any chain of scientific facts or [5 ELR 20112] reasoning leading him ineluctably to this conclusion and once there, cast about for whatever studies (all inconclusive) were available which were consistent with his conclusion. After careful examination of the entire record115 we conclude that the Administrator has made a clear error of judgment in finding a significant correlation between air and blood lead levels. As a result, there is no basis for the ultimate finding thatt auto emissions contribute significantly to blood lead levels in adults.
B. The Contribution of Auto Lead Emissions to Blood Levels in Children
1. Failure to Make a Firm Determination
As a second major reason for adopting these regulations, EPA contends that contamination of dust and dirt by lead from automotive emissions is a significant source of lead exposure to children. This conclusion is based on the following chain of reasoning:
a. High lead concentrations in dust and dirt are prevalent in urban areas.
b. In most circumstances, lead from exhausts and not lead paint or lead from stationary sources is the primary source of lead in urban dust and dirt.
c. Children, especially those between the ages of one and three, eat non-food objects, including dust and dirt. This phenomenon is known as pica.
d. As a result of ingesting leaded dust and dirt, children "can be expected to absorb some of the lead into their bodies."
An alternative argument is also made that excessive lead levels are found among children who do not come from areas where peeling paint is common and therefore their lead levels must be accounted for by auto lead emissions.116
Neither the Administrator in promulgating these regulations nor EPA's scientists in the Third Health Document have explicitly stated that auto lead emissions are a significant source of lead to children. In fact the Administrator states: "Ingestion of peeling paint has long been recognized as the primary cause of clinical lead poisioning in children."117 The Administrator has quite frankly stated that the chain of reasoning outlined above is a hypothesis not yet completely proved:
Currently, the contention that lead contamination of dust and dirt by automotive emissions is a significant source of lead exposure is a hypothesis consistent with information provided by a variety of studies. However, at this time, not all links in the argument have been established beyond dispute and no single study has collectively inter-related all steps in the exposure process to conclusively inter-related [sic] all steps in the exposure process to conclusively prove or disprove the hypothesis. Despite the existing uncertainties, comments received from the majority of scientists not affiliated with industrial or environmental groups support the contention that dust is an important source of exposure.118
The conclusion drawn by EPA's scientists, after reviewing all the evidence submitted in the proceedings, is even more tentative.
In conclusion, clinical experience indicates that leaded paint is primarily responsible for the great majority of overt clinical lead toxicity in children. There is, however, sufficient data to strongly suggest that sources of lead other than paint play an important role in childhood lead exposure. These other sources may be especially significant at levels of exposure below overt clinical poisoning.
Lead in the air, and particularly lead in dust, are ubiquitous sources of lead which may well be important contributing factors to the problem. Exposure to dirt and dust sufficiently contaminated by lead could reduce significantly the quantity of additional lead exposure required to produce clinical poisoning in a child whith other sources of exposure. Though exposure to lead contaminated dirt and dust from automobile exhaust, alone, has not been shown to be responsible for cases of overt lead poisoning, automotive lead has been related to undue lead absorption in children. At this time, it would be prudent to decrease the potential air and dust lead exposure. It should be recognized that further studies are necessary to better quantitate the sources of lead contamination in dust and dirt and the magnitude of the contribution that leaded dust and dirt make to both subclinical and clinical lead overexposure.119
The Administrator has implied that the large incidence of excessive lead exposure among children "known to not reside in homes where peeling lead based paint can be found . . . indicate[s] that in some circumstances dust lead is an important factor and at times may be the primary factor contributing to excessive lead exposure associated with subclinical if not clinical effects."120 There is literally nothing in the record which accounts for these high lead levels among children who live outside of "the central city environment." Assuming that lead based paint was not the explanation, neither EPA's scientists nor the studies they evaluated could offer an alternative explanation, much less tie the excessive exposure to auto emissions. The Third Health Document identified "lead in food, water, pottery, toys, pencils, solder, etc." as possible explanations for excessive lead exposure in those cases where lead paint was not a problem.121 It also noted that "[f]urther information is required to arrive at a definitive assessment of the significance of . . . [lead contaminated dust and dirt as a] source of lead contamination."122
[5 ELR 20113]
Probably the best overall conclusion on EPA's dust and dirt hypothesis was made in one of EPA's own internal memorandums by two members of the Office of Planning and Evaluation to Dr. Kenneth Bridbord of the Office of Research and Monitoring:
The reaction of this Office to the balance of Section VI, The Mechanism of Dustfall Lead Exposure, is an ambivalent one. We basically have no objections to the content of this Section; that is, we feel that it meets satisfactory standards of objectivity and quality as a scientific report in itself. On the other hand, if the purpose of this section is to establish a direct line between lead-contaminated dust and dirt from automotive exhausts and cases of lead poisoning and to thereby support the proposed lead regulations, then we find it lacking.
The report's conclusion concerning the bio-avail-ability of lead from ingested contaminated dust and dirt is not at issue here. However, we should like to emphasize that none of the studies cited directly implicated lead from automotive exhausts as being responsible for the harming of any human being.123
2. The Administrator's Faulty Analysis and Procedure
Since the EPA has failed to make any firm determination linking auto emissions and excessive lead levels in children, we could stop at this point. However, we will examine the evidence in order to highlight a few of the more serious analytical and methodological deficiencies in the record.
Implicit in EPA's position is the premise that lead from auto emissions falls to the ground and mixes with the dust and the dirt at those places where children are likely to play or be. Petitioners concede that lead from auto emissions does fall to the ground, e.g., the center of a six-lane highway. However, they contend it does not fall in those places where significant numbers of children usually spend their time.124 They contend that lead paint and, in some circumstances, emissions of stationary sources account for lead in the dust and the dirt that children are likely to eat. They emphasize that lead paint is the culprit pointed to by the available evidence.
The principal support in the record for the Administrator's "hypothesis" is a study conducted in Newark, New Jersey. This study made a retrospective statistical comparison between blood lead levels in children and their residential location.125 The study related to more than 5,000 children from poorer sections of Newark, and it was found that of those children residing within 100 feet of a major roadway, 49.3% were found to have blood lead levels between 40 and 59 micrograms and 8.1% had levels of 60 micrograms and over. The blood lead levels of children residing 100 to 200 feet and more than 200 feet from a major roadway did not differ significantly from each other; approximately 25% of the blood levels in both groups were between 40 and 59 micrograms and 3% to 5% were 60 micrograms or higher.126
Analytically, the Newark study has this very fundamental defect: It provides no support for the EPA's dust and dirt hypothesis. The study is purely a statistical correlation127 between blood levels and residence and does not provide any evidence as to the causal connection between the two.128
Petitioners strongly attack the Newark study. They point out that in May 1973 "the investigators found no [5 ELR 20114] statistically significant correlation between blood lead levels and proximity to traffic or traffic density . . . ."129 Yet in November 1973, by "increasing the amount of data in the study through the inclusion of another group of children with blood lead levels less than 40," the investigators were able to reach a conclusion opposite from that reached in May.130 The EPA concedes that an opposite conclusion was reached; however, they argue that "[p]etitioners make no argument why this additional data may not legitimately be included."131
The answer to this argument is that petitioners have had no opportunity so to argue. The Newark study falls into that uncomfortably large body of evidence, relied upon by EPA to support these regulations, which came into their possession just days before final promulgation. Thus, interested parties had no reasonable opportunity to question the methodology of the Newark investigators and EPA counsel can point to the absence of rebuttal evidence and imply that all was well in the later study.
We are fully cognizant of the fact that EPA was under compulsion by an order of this court to reach a final decision on this matter within thirty days, Natural Resources Defense Council, Inc. v. EPA,132 and thus was not able to receive additional comment prior to final promulgation. However, in light of the fact that EPA had been gathering evidence on airborne lead for three years, and that after each of the previous public comments EPA had been forced to reconsider its health position, the fact that so many of the studies that EPA uses to support its position were reported to EPA in the two months prior to promulgation of the regulations, must necessarily give pause to this court.
The absence of any public comment must be taken into account by the reviewing court. The Administrative Procedure Act, 5 U.S.C. §§ 706 and 553,133 contemplates review of agency determinations after, at a minimum, an opportunity for public and governmental agency comment on all the evidence in the record. When this court mandated a decision within 30 days on a matter the Administrator had had under consideration for three years, there was no suggestion that the Administrator go to totally new, untested and uncommented upon, data as a basis for his decision. The rationale behind such an order could only have been that the court believed the Administrator already not only had the necessary data in hand, but also had afforded the opportunity for informed public and other governmental department comment required in valid agency rulemaking pursuant to section 553. If the Administrator believed that the data in the First and Second Health Documents, with the searching criticisms received appended thereto, would not support the decision he was about to make, then he could not lawfully make that decision. Nor could he make it on the basis of new and untested data in the Third Health Document.134
On two separate and alternative grounds we find the regulations on fuel additives promulgated by the Environmental Protection Administrator to be invalid: the Administrator incorrectly interpreted section 211(c) (1) (A) of the Clean Air Act; accepting the Administrator's faulty statutory standard, his analysis reflected a clear error of judgment upon the available evidence. Under the standards of review in 5 U.S.C. §§ 706(a) (C) and (A), the regulations must be set aside.135
First, the statutory test of "will endanger the public health or welfare" clearly sets forth a strict standard of factual proof. That this was the Congressional intention is shown by comparison of the "will endanger" test of section 211 with the more lenient tests of sections 202 and 108. Both sections are part of the overall control scheme of the Clean Air Act and must be interpreted to set different standards and confer different authority on the Administrator.
Second, even assuming the incorrect statutory standard employed by the agency, EPA falters on both prongs of its argument in regard to the impact of lead emissions on the general public health and on children particularly. We find no plausible showing that lead in the air makes a "significant contribution to elevated blood lead levels" in either the general population or among children. The preamble to these regulations itself states, "It is generally agreed that food is the major source of lead to the general population." This is backed up by the conclusion of Dr. Carl Shy of EPA, that on the besis of the Seven Cities Study136 only three percent of the differential in blood lead levels between those who lived in urban areas and those who lived in the suburbs can be accounted for by the "air lead gradient" between the two areas.137 As for children, the preamble [5 ELR 20115] states, "Ingestion of peeling has long been recognized as the primary cause of clinical lead poisoning in children." As we pointed out at the outset,138 only if auto lead emissions can be shown to contribute significantly to blood lead levels can it logically follow that a reduction or elimination of auto lead emissions would contribute significantly to solving the problem of lead in the human body.
The frailty of support for the Administrator's conclusion, the resulting arbitrary and capricious nature of that conclusion and the clear error of judgment inherent therein, is perhaps best demonstrated by the second study relied upon in the preamble, the unpublished study in Japan. As our discussion makes clear,139 the study provides no support for EPA's position. It does give some measure of the Agency's desperation in grasping for support. The study carries on the title page, as reproduced in the record, "Draft/Do Not Cite or Quote."
This court may be, as the dissent reminds us, "without scientific background or access to expertise,"140 but we think this brand of administrative agency action should be readily apparent — and equally abhorrent — to any appellate judge. To detect and set aside agency action based on such shoddy foundations, not to engage in rival scientific calculations or substitute judgment, is the function of a reviewing court.
We appreciate the quandry in which the Administrator found himself after three years of pondering this question. Beset on all sides by those urging the Administrator to take action, to ban or limit drastically the use of lead in gasoline, confronted by the arguments of those who asserted that such action was completely unjustified, attempting in the First Health Document and in the Second Health Document to postulate a scientific basis for the action he had tentatively decided to take, only to have the scientific bases of his action riddled by the analysis of scientists in all departments of the same government commenting thereon, and confronted finally by an order of this court that he act one way or another in a period of 30 days, the Administrator found himself with the question "whether . . . to take arms against a sea of troubles, and by opposing end them."141 So the Administrator acted, in reliance primarily on data only partially analyzed by his own staff and not commented on by any outside party.142 The result was, Hamlet-like, a blind stab through a curtain of ignorance, inflicting anguish, but in our judgment not rationally solving any problem.
It should be understood that our action today does not prohibit EPA from regulating lead additives under section 211(c) (1) (A) at some point in the future, should evidence sufficient to meet the statutory standard be developed and should action appear appropriate. On the present record we cannot agree that the EPA has properly decided that lead additives in gasoline will cause emissions which "will endanger the public health"; therefore, we set aside the regulations.143
[5 ELR 20116]
Title 40 — Protection of Environment
Chapter I — Environmental Protection Agency
Part 80 — Regulation of Fuels and Fuel Additives
Control of Lead Additives in Gasoline
* * *
Health implications of airborne lead — Introduction. The issue concerning the contribution of automobile lead exhausts to the country's lead exposure problem is complex and controversial. In order to complete a fair assessment of this problem, EPA has made a concentrated effort to obtain and review all the medical and scientific evidence. The Agency has repeatedly requested information and comments from the medical and scientific communities as well as the general public. Since the reproposal of the regulations, information gathered through the comment period on the reproposed regulations, earlier comment periods on the originally proposed regulations, and surveys of relevant studies by EPA personnel have been thoroughly reviewed and evaluated by a task force of EPA medical experts and scientists. A paper entitled "EPA's Position on the Health Implications of Airborne Lead" sets forth in detail the Agency's evaluation that there is a health basis for reducing the use of lead in gasoline. A copy of this paper is available from the Publications Section, Environmental Protection Agency, 401 M Street SW, Room 238W, Washington, D.C. 20460.
General summary of health issue. Environmental lead exposure is a major health problem in this country. A small but significant portion of the urban adult population and up to 25 percent of children in urban areas are over-exposed to lead. The lead exposure problem is caused by a combination of sources including food, water, air, leaded paint, and dust. The aggregate contribution of lead from all these sources poses a significant threat to health. However, it is extremely difficult to determine what percentage of the problem each separate environmental factor contributes. Since these are additive sources whose importance varies considerably among individuals it is likewise difficult to determine what impact would be achieved by partial or total reduction of lead from any source. Should the lead in all sources be reduced, however, it seems clear that the situation would be substantially improved. Leaded gasoline is a source of air and dust lead which can be readily and significantly reduced in comparison to these other sources. It is also one of the few lead sources not yet subject to any controls other than EPA's lead-free gasoline regulations.
Lead from gasoline accounts for approximately 90 percent of airborne lead, total lead additive usage being well over 200,000 tons a year. Lead from stationary sources and deteriorating leaded paint from buildings, combined with lead from gasoline cause high lead levels in dirt and dust. Of these sources, lead from gasoline is the most ubiquitous source of lead found in both the air and the dirt and dust in urban areas. Human exposure to this lead takes place by inhalation and by ingestion of dirt and dust contaminated by air lead fallout. Since exposure to lead among the general population is widespread, it is reasonable that efforts be made to reduce preventable sources of lead exposure including lead emissions resulting from lead in gasoline.
Many of those disagreeing with the reproposed regulations based their comments on EPA's failure to show sufficient evidence of adverse health effects specifically caused by the use of lead additives in gasoline. While most agree that the combustion of leaded gasoline causes an increase in the amount of lead in the environment, they do not believe that lead in gasoline represents a sufficient endangerment to health or a sufficient risk to the environment to warrant promulgation of controls. The arguments against the position set forth in EPA's reproposed regulations include the following: (1) EPA has failed to show a clear correlation between lead levels in the air and those in the blood of exposed individuals; (2) lead from dust and dirt does not represent a significant threat to body burden of lead; (3) leaded paint is the primary cause of childhood lead poisoning and lead in gasoline does not play an important role in lead poisoning or excessive lead exposure; (4) lead in food and water and not airborne lead are the principal sources of lead to the general population.
A discussion of the four major areas of criticism and a summary of the significant new information received since the regulations were reproposed are provided below.
I. Is there a correlation between air lead levels and blood lead levels? A portion of the comments received were critical of EPA's reproposed regulation on the basis that consistently strong correlations have not been found between air lead and blood lead levels. The conclusion expressed by many comments is that except for persons whose occupations bring them in close contact with environmental lead, exposure to airborne lead does not contribute to increased blood lead levels and does not pose a significant threat to health.
These comments cite several studies which did not demonstrate a strong correlation between air lead and blood lead levels. For example, The Seven Cities Study did not show a close correlation between increase in blood lead levels and simultaneous increases in air lead exposures. Blood lead levels were lower among the New York City residents studies than the Philadelphia residents, despite the fact that air lead exposures among the New York residents were actually greater than those in Philadelphia. Also cited as evidence against EPA's position is the observation that despite significant increases in the use of lead in gasoline in recent years there have been no discernible increases in blood lead levels of populations so exposed.
Residential differences in blood leads levels have also not always corresponded to differences in air lead exposures. For example, studies of primitive populations, as well as studies of rural U.S. populations, have shown that the blood lead levels in some of these groups are as high or higher than those of persons living in industrial areas, even though the air lead levels in those rural areas should have been much lower. A comparison between London day and night taxi drivers has also shown no significant differences in blood lead levels but did find differences in exposure to carbon monoxide suggesting that despite the possibility that air lead exposure in the day may have been higher than at night, this was not reflected in blood lead increases. However, differences in smoking intensity, as well as actual differences in air lead exposure between groups, could explain these results and neither were measured.
In summary, a number of comments have criticized [5 ELR 20117] EPA's position on the basis that there is not a good correlation between air lead exposure and blood lead levels.
The Agency has weighed against these criticisms studies which have shown that airborne lead does contribute significantly to lead exposure in the general population. For example, using a pilot lead isotope approach, preliminary data show that airborne lead at 2 mu g/m3 can contribute as much as 1/3 to total lead exposure in man. This result is consistent with data concerning the deposition of lead particles in the pulmonary tact and the absorption of such particules into the blood stream.
An unpublished study in Japan similar to the Seven Cities Study, but which has not yet been completely analyzed, has preliminarily demonstrated that airborne lead exposures below 2 mu g/m3 affect blood lead levels.
Chamber studies in carefully controlled environments, have shown significant increases in blood lead of men exposed to air lead slightly greater than 3 mu g/m3.
Differences in the blood lead levels between urban and suburban residents in the same geographic area have been found. When comparable groups with similar lead intakes from other sources besides air were studied, blood leads were consistently higher in urban areas and near highways where air lead concentrations were greatest. Thus while correlations between blood leads and air leads at lower exposure levels are not always good, the evidence indicates that air lead does contribute to general population lead exposure.
Failure to find consistent correlations does not in the Administrator's judgment invalidate the above conclusions Studies which have come to contrary conclusions have generally failed to take into account the influence of other sources of lead on blood lead levels in people being studied. In the Seven Cities Study, for example, these other sources of lead influencing blood lead levels were not adequately considered in the blood lead-air lead comparisons. EPA has re-analyzed the Seven Cities Study and has found that air lead was a significant, though not the most influential factor affecting blood lead levels. Further, in the Seven Cities Study, urban-suburban differences in blood leads between comparable groups were consistently found which at least in part reflect differences in air lead exposure.
In summary, absorption of air lead does contribute to total lead exposure and when added to lead from other sources such as food and water results in total exposure that is excessive. Thus, the partial removal of lead from the air will help to reduce the degree of excess lead exposure which currently exists among adults and children in the United States.
II. Does dust lead contribute to lead poisoning in children? Many comments received by the Agency express the viewpoint that the primary cause of lead poisoning in children is ingestion of lead-based peeling paint. Investigations of cases of clinical lead poisoning in children have repeatedly demonstrated peeling leaded paint as the major source of exposure.Since peeling leaded paint has consistently been observed in the environment of lead poisoned children, many commentors thought it unlikely that lead in dust and dirt could make a significant contribution to this problem. They also point out that lead in dust could be cuased by peeling or erosion of leaded paint in or near a home.
One commentor cites X-ray studies of the abdomen among children with lead-poisoning as showing paint chips inthe majority of instances. Another argues that differences in blood lead levels between Black and Puerto Rican children could not be explained by exposure to different quantities of lead in dust. Further, studies have shown that animals do not absorb lead from dust as readily as they absorb lead from paint.
Commentors have criticized the Agency for considering that the El Paso Study supports the dustfall hypothesis related to lead in gasoline. In the El Paso Study, children living near a leadsmelter were examined for blood lead levels and for sources of lead in their environment. These results showed that children living nearest the smelter had the highest blood lead levels and that dust lead was a probable major cause. Many commentators, however, considered the El Paso Study applicable only to stationary lead sources and not to lead in gasoline which is different in particle size and chemical composition from smelter-emitted lead.
EPA recognizes the importance of leaded paint as a source of lead exposure for children and that it is the primary cause of clinical lead poisoning. However, based on the evidence available to it, EPA does not believe that leaded paint is the only significant source of lead contributing to excessive lead exposures in children. The Agency's position is that numerous sources contribute to childhood exposure including lead in food, water, air, dust, and dirt as well as paint. Among these sources, contaminated dust and dirt from motor vehicles exhausts are believed to be important exposure routes.
Currently, the contention that lead contamination of dust and dirt by automotive emissions is a significant source of lead exposure is a hypothesis consistent with information provided by a variety of studies. However, at this time, not all links in the argument have been established beyond dispute and no single study has collectively inter-relate all steps in the exposure process to conclusively inter-related all steps in the exposure process to conclusively prove or disprove the hypothesis. Despite the existing uncertainties, comments received from the majority of scientists not affiliated with industrial or environmental groups support the contention that dust is an important source of exposure. This is based on the following evidence:
A. Environmental sampling in a number of cities has demonstrated the ubiquitous presence of lead contaminated dust in urban areas. These measurements were taken inside and outside of buildings including homes and schools. Dust lead measurements outside homes commonly ranged from 0.1 to 0.5 percent lead by weight. Measurements well in excess of 0.5 percent have also been recorded. Inside homes, samples were found to contain lead contents ranging from 0.05 to 0.2 percent and in some instances as high as 0.5 percent. Current Federal regulations have already established that lead concentrations in paint in excess of 0.5 percent represent a definite hazard to children and serious consideration is being given to reducing the allowable level to 0.06 percent. In testimony before the United States Senate, Dr. Merlin DuVal, at the time Assistant Secretary for Health and Scientific Affairs at HEW, commented on an appropriate safe level for lead in paint:
Based on information now available to us, we are [5 ELR 20118] satisfied that it is technologically feasible, and desirable from a health viewpoint to move toward the .06 percent standard recommended by the American Academy of Pediatrics.
B. As was stated above, high lead concentrations in dust are prevalent in urban areas. It is not clear in all instances, which sources are contributing most to this contamination. Comments received by the agency point out that high lead levels in some cases may be caused by the chipping or peeling of leaded paint from interior and exterior surfaces. EPA agrees that this is true. In other cases, the lead dust content is clearly the result of lead emission from stationary sources such as smelters. However, EPA believes an important and the most ubiquitous source of lead in dust is the exhaust of automobiles using leaded gasoline. Annually, over 200,000 tons of lead are used as additives in gasoline. The vast majority of this lead is emitted into the environment. Although significant amounts of lead remain airborne for extended periods of time, evidence indicates that a large quantity of the exhaust lead rapidly settles to the ground within several hundred feet of the source. Measurements of lead in dust and soil further indicate that lead content decreases with increased distance from the roadway. It has also been found that dust lead levels in homes near heavily traveled roadways are significantly higher than in comparable homes located along side streets. It should be noted that the majority of studies reporting high levels of lead in dust and dirt did not associate sources of peeling leaded paint or stationary lead sources with the lead dust measurements. Accordingly, the Agency believes that in most circumstances lead from automobile exhaust is the primary source of lead in dust and soil in urban areas.
C. The general environment of urban children commonly includes dirt and dust contaminated with lead. A large percentage of children, especially between the ages of one and three years, are known to ingest non-food objects in their mouths. It has been demonstrated that children living in high dust lead environments have greater quantities of lead on their hands than children living in less contaminated environments. The existence of leaded dust on the hands of urban children has been highlighted by the common occurrance of inadvertent lead contamination of finger prick blood lead specimens taken from these children.
D. Children who ingest leaded dust and dirt can be expected to absorb some of the lead into their bodies. Though it is difficult to determine the precise amount of lead that would be absorbed, animal experiments suggest that appreciable quantities of this lead, whether from smelters, paint or gasoline exhaust, are absorbed. Further, it has also been shown that at least some children residing in environments heavily contaminated by leaded dust and dirt absorb enough to suffer from subclinical and even clinical effects of lead overexposure. This was particularly true in the case of El Paso, mentioned above. Though the lead source was a smelter, animal studies indicate that lead in dust due to leaded gasoline would be absorbed in quantities comparable to that emitted by the smelter. Another study from Charleston, South Carolina indicates that children residing in homes near high soil lead concentrations had a greater frequency of lead poisoning than children residing in less contaminated areas. This study suggests that lead from soil was absorbed, although it is not clear what sources were primarily responsible for those high soil lead levels. It should be further noted that instances such as those above, coupled with known high levels of lead in dirt and dust, indicate that children could easily ingest enough lead by this route to be significant.
E. Various studies indicate that cases of lead poisoning and significant over-exposure are not always associated with urban home environments in which sources of peeling or chipping leaded paint were observed. These studies include children residing primarily in inner city areas. Admittedly children may be exposed to peeling or chipping leaded paint in environments away from their own homes. However, since several recent studies indicate that up to 60 percent of children with excessive lead exposure are known to not reside in homes where peeling lead based paint can be found, it is unlikely that peeling paint exposure away from the homes accounts totally for this difference. Furthermore, extension of blood lead screening programs outside of slum areas indicates that the lead exposure problem is found in children residing in higher income areas where peeling paint is not frequent and exposure to this source away from the home is less likely. In conjunction with these findings, residence near roadways have been found to contain higher quantities of lead than those measured away from the road. Findings such as these indicate that in some circumstances dust lead is an important factor and at times may be the primary factor contributing to excessive lead exposure associated with subclinical if not clinical effects.
F. Clinical symptoms resulting from very high lead exposure in children are known to be associated with permanent neurologic damage. It has also long been suspected, but not proven beyond doubt that lead exposures below those sufficient to cause clinical symptoms in children are also harmful. In particular it has been observed that physiologically signficant biochemical changes occur in children with excessive exposures below clinical toxicity and it has been proposed that these changes are reflective of subclinical changes that precede overt disease. Recently available scientific information, though far from completely resolving this issue, supports the view that adverse effects due to lead in children are not confined only to situations in which overt clinical symptoms of lead poisoning occur. Included in these findings are increased subtle neurological impairments among children more highly exposed to lead below levels known to cause clinical disease.
III. Will a reduction of lead in gasoline reduce the incidence of clinical lead poisoning in children? Ingestion of peeling paint has long been recognized as the primary cause of clinical lead poisoning in children. This position has been expressed in many comments received by the in the field of lead poisoning. For this reason, numerous in the field of lead poisoning. For this reason, numerous comments have questioned the need to reduce lead in gasoline on the basis that this action would have little if any impact on reducing the incidence of clinical lead poisoning in children.
While EPA recognizes the importance of leaded paint as a source of lead for children and has supported governmental efforts to reduce this risk, the findings of several studies suggest that lead poisoning can develop in the absence of significant sources of leaded paint. Though this possibility does not affirm that reducing lead in gasoline will reduce the incidence of lead poisoning in children [5 ELR 20119] it indicates that lead in gasoline may, in conjunction with other nonpaint sources, contribute to the development of lead poisoning. Whatever the impact this reduction may have upon clinical lead poisoning, the action will significantly reduce lead exposure among children.
EPA is also concerned about the probability that children exposed to lead at levels below those associated with clinical poisoning are also being adversely affected. Several effects identified as subclinical lead effects include impairment of fine motor functions, and altered behavior.
It is noteworthy that in a significantly large percentage of excessive lead exposure cases (up to 50 percent in some instances) peeling lead based paint in the home cannot be identified as a source of the exposure. Thus, while leaded paint is recognized as the major cause of childhood lead poisoning, it is not clear that leaded paint is singly responsible for the large degree of excess childhood lead exposure in this country.
IV. Excess lead exposure among the general population could result from a combination of lead sources, not one of which by itself is sufficient to be a problem. Under these circumstances, would it not be preferable to formulate a control strategy based upon reducing lead levels among those sources that contribute the most to this total exposure? It is generally agreed that food is the major source of lead to the general population. A World Health Organization expert committee reports that according to the results of total diet studies in the industrialized countries, the total intake of lead from food generally ranges from 200-300 ug per person per day. WHO further states that based upon available data, these levels are similar to those found in the past 30-40 years and that no upward trend in lead levels in food is evident.
This information suggests that the level of lead in food has remained relatively constant in recent times. Though lead in food would certainly contribute to total lead exposure for the general population, lead in food is probably not the source that is most readily reduced in the event that total exposure to lead is excessive. According to WHO, "Any increase in the amount of lead derived from drinking water or inhaled from the atmosphere will reduce the amount that can be tolerated in food. The lead in air is probably the contribution that is most accessible to action for reducing the total body burden of lead, especially where this fraction is large compared with that absorbed from food."
V. What new information has become available since reproposals of the regulation and as a result of the additional comment period? The majority of comments addressed the evidence presented by EPA in support of its proposed regulation and did not introduce new evidence. The number of comments received were approximately evenly divided between those in favor and those against. The bulk of comments critical of EPA's health position was submitted by industry or industry affiliated scientists. Independent scientists who commented, not affiliated directly with the industry or environmental groups, were in favor of the regulation by approximately 2/1. Most favorable comments, though often from scientists knowledgeable in the field of lead, provided testimonial support rather than new evidence. Most new data that either was presented in comments or which subsequently became available to EPA does support the need to reduce lead emissions from automobiles. Among these latest data are the following:
(1) Studies of subclinical lead effects in children continue to suggest that fine motor function and behaviorare affected. Though this issue is not completely resolved, the new data emphasize the potential subclinical risk.
(2) It has been reaffirmed that high dust lead levels, up to 1% lead content, have been found in children's play areas, inside schools and in homes.
(3) New evidence reaffirms that high dust lead levels can be caused by leaded gasoline. A recent study in Rochester, New York, demonstrates that high dust lead levels in homes are not always associated with peeling paint and that house dust lead levels are higher in urban than suburban homes. A study in Vermont has shown that higher concentrations of lead in house dust are found in homes located near busy roads compared to homes on sidestreets. This latter point is consistent with the previously known fact that air lead fallout decreases with increased distance from roadways. A study by EPA in New York City indicates that higher household dust and soil lead levels are found in areas with greater dust lead fallout from the air as compared to areas with little lead fallout.
(4) Young children living in homes with high dust lead contents have been found to have more lead on their hands than children in homes with low dust lead content. This finding provides an important link in the dust fall lead hypothesis. The finding is consistent with observations that finger prick blood-lead specimen taken from children are routinely contaminated by lead that is present on the fingers.
(5) Studies continue to indicate that a high degree of exposure to environmental lead is not confined to inner city areas. Cases of over-exposure continue to be reported from areas in which leaded paint would not be expected to be the predominant factor.
(6) Studies from Newark, New Jersey, observed that the frequency of lead poisoning and undue lead exposure is doubled among children living close to major roadways compared to children living farther away.
* * *
38 FED. REG. 33734-33737 (6 December 1973); App. 2-5.
1. 42 U.S.C. § 1857f — 60(c)(1)(A) (1970).
2. The regulations are as follows:
Part 80 of Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:
1. In § 80.1, the second sentence is revised to read as follows:
§ 80.1 Scope.
* * * These regulations are based upon a determination by the Administrator that the emission product of a fuel or additive will endanger the public health, or will impair to a significant degree the performance of a motor vehicle emission control device in general use or which the Administrator finds has been developed to a point where in a reasonable time it would be in general use were such regulations promulgated; and certain other findings specified by the Act.
2. In § 80.2, a new paragraph (m) is added as follows:
§ 80.2 Definitions.
* * * *
(m) "Lead additive manufacturer" means any person who produces a lead additive or sells a lead additive under his own name.
3. A new § 80.20 is added as follows:
§ 80.20 Controls applicable to gasoline refiners.
(a)(1) In the manufacture of gasoline at any refinery no gasoline refiner shall exceed the average lead content per gallon specified below for each 3-month period (Januuary through March, April through June, July through September, October through December):
(i) 1.7 grams of lead per gallon, after January 1, 1975;
(ii) 1.4 grams of lead per gallon, after January 1, 1976;
(iii) 1.0 grams of lead per gallon, after January 1, 1977;
(iv) 0.8 grams of lead per gallon, after January 1, 1978;
(v) 0.5 grams of lead per gallon, after January 1, 1979.
(2) For each 3-month period (January through March, April through June, July through September, October through December); the average lead content per gallon shall be computed by dividing total grams of lead used at a refinery in the manufacture of gasoline by total gallons of gasoline manufactured at such refinery.
(3) For each 3-month period (January through March, April through June, July through September, October through December) commencing with the period January 1, 1975 through March 31, 1975, each refiner shall submit to the Administrator a report showing for each refinery (i) the total grams of lead in lead additive inventory on the first day of the period, (ii) the total grams of lead received during the period, (iii) the total grams of lead in lead additive inventory on the last day of the period, (iv) the total gallons of gasoline produced by such refinery during the period, and (v) the average lead content in each gallon of gasoline produced during the period. Reports shall be submitted within 15 days after the close of the reporting period, on forms supplied by the Administrator upon request.
(b) The provisions of paragraph (a)(1)(i) and (ii) of this section shall not be applicable to any refiner which does not have more than 30,000 barrels per day crude oil bona fide feed stock capacity from owned or leased facilities or from facilities made available to such refiner under an arrangement such as, but not limited to, an exchange agreement (except one on a refined product for refined product basis), or a throughput or other form of processing agreement, with the same effects as though such facilities had been leased.
4. A new § 80.25 is added as follows:
§ 80.25 Controls applicable to lead additive manufacturers.
For each 3-month period (January through March, April through June, July through September, October through December) commencing with the period January 1, 1975, through March 31, 1975, each lead additive manufacturer shall submit to the Administrator a report showing the total grams of lead shipped to each refinery by such lead additive manufacturer during the period. Reports shall be submitted within 15 days after the close of the reporting period, on forms supplied by the Administrator upon request. 5. A new § 80.26 is added as follows:
§ 80.26 Confidentiality of information.
Information obtained by the Administrator or his representatives pursuant to this part shall be treated, in so far as its confidentiality is concerned, in accordance with the provisions of 40 CFR Part 2.
38 FED REG. 33734, 33741 (6 December 1973); Appendix to the Briefs [hereinafter App.] at 9.
The EPA adopted in the final regulations a total pool computation method. This method of calculation permits a refiner to produce some gasoline having a lead content in excess of the prevailing average maximum, as long as sufficient gasoline is also produced at the refining facility below the average so as to compensate for the overage. Some of the petitioners attack the total pool computation method. In light of the disposition of this case, we do not feel compelled to reach this subsidiary issue.
3. Amoco Oil Company, et al. v. Environmental Protection Agency, U.S. App. D.C. , 501 F.2d 722 (1974). In the Amoco catalytic converter case we were dealing entirely with unleaded gasoline and the necessity for unleaded gasoline to be used to prevent destruction of the platinum catalytic converter. The Congress and EPA directed unleaded gasoline to be used, not because it had found that leaded gasoline in any quantity was dangerous to human health, but because it had been scientifically established that leaded gasoline would destroy essential elements of the catalytic converter in a very few thousand miles of use. Now this court is concerned with the possible impact of leaded gasoline on human health. This is a matter decided by neither EPA nor this court in Amoco, nor was it decided by Congress when it enacted the legislation.
Unlike the basic facts in Amoco, we have here a situation in which leaded gasoline must necessarily be used in all pre-1975 cars and leaded gasoline may very well be used in many new cars manufactured without the platinum catalytic converter. Some of the parties before us have argued strenuously that the universality of use of the catalytic converter is by no means as certain today as when EPA promulgated its regulation. Other engineering devices to avoid the air pollution of the hydrocarbons, i.e., PNA carcinogenic poisons, may come on the market, and the number of new cars using leaded gasoline increase. Be that as it may, the catalytic converter is a device to take out the PNA carcinogenic elements from gasoline; it is not in any way a device to take out lead.
4. Those regulations appear in 38 FED. REG. 1254 (10 January 1973) and are reproduced in full as an Appendix to the Amoco opinion.
5. 42 U.S.C. § 1857f — 6c(c)(1)(B) (1970).
6. Petitioners also raise other objections to the regulations which we do not need to reach at the present time. See note 135, infra.
7. 5 U.S.C. § 706(2)(C) (1970).
8. 5 U.S.C. § 706(2)(A) (1970).
9. Clean Air Act Amendments of 1970, § 9(a), Pub. L. 91-604, 31 Dec. 1970.
10. 36 FED. REG. 1486 (30 January 1971).
11. In Part II of the opinion, pp. 31-40, we discuss in some detail the events occurring during this three-year period.
12. App. 27 (28 November 1973).
13. Id. at 30.
14. 42 U.S.C. § 1857f — 6(c)(1) (1970).
15. 42 U.S.C. § 1857f-1 (1970).
16. 42 U.S.C. § 1857c-2 through 42 U.S.C. § 1857c-5 (1970).
17. FED. REG. 33734; App. 2.
18. Respondent's Brief in Nos. 73-2205, 73-2270, 74-1021 [hereinafter R. Br.] at 42.
19. R. Br. at 45.
20. Poets and politicians concur: "All our past acclaims our future" (Swinburne); "I know no way of judging of the future but by the past" (Patrick Henry).
21. In all games of chance in which theoretically the factor of human control is not present, e.g., roulette, dice, the fall of cards, the risk of a given event occurring or not occurring can be calculated with mathematical certainty. In those games in which human or animal skill is presumed to predominate, e.g., football, basketball, horse racing, the facts as to the physical conditions and mental attitude of the contestants are avidly sought by the professional risk-assessors; it is on the basis of known facts that the initial odds are fixed.
22. U.S. App. D.C. , 499 F.2d 467 (1974).
23. R. Br. at 44-45.
24. Industrial Union Department, AFL-CIO v. Hodgson, U.S. App. D.C. , , 499 F.2d 467, 475 (1974).
25. 42 U.S.C. § 1857c — 3(a)(1)(A) (1970) (emphasis added).
26. 42 U.S.C. § 1857f — 5a(2)(1) (1970) (emphasis added).
27. 42 U.S.C. § 1857c — 3(a)(2) (1970) (emphasis added).
28. See p. 26 infra, for the text of the House bill.
29. 116 CONG. REC. (Part 14) 19229-30 (10 June 1970) (emphasis added). While the Congressional debates refer to the Secretary of HEW as the responsible official contemplated under the Act, Reorganization Plan No. 3 of 1970, § 2(a)(3), effective 2 December 1970, 35 FED. REG. 15623, 84 Stat. 2086, transfered to the Administrator of the Environmental Protection Agency virtually all the functions relating to air pollution previously vested by law in the Secretary of Health, Education, and Welfare or in the Department of Health, Education, and Welfare.
30. Id. at 19231 (emphasis added).
31. Amoco Oil Co. v. EPA, U.S. App. D.C. , , 501 F.2d 722, 734 (1974).
32. Id. at , 501 F.2d at 733, 734.
33. Id. at , 501 F.2d at 735.
35. Id. at , 501 F.2d at 735 (emphasis added).
36. Id. at , 501 F.2d at 736.
37. Id. at , 501 F.2d at 732 n. 25.
38. Id. at , 501 F.2d at 739.
39. Judge Wright's dissenting opinion, p. 25-30.
41. SECTION 211. REGULATION OF FUELS
Existing law (sec. 210 of the Clean Air Act) provides for registration of fuels and fuel additives delivered for introduction into commerce. The House bill amended this section to authorize the Administrator to establish standards respecting the physical or chemical properties of any fuel or fuel additive by specifying limitations on (or providing for elimination of) ingredients (including additives) or on the physical or chemical characteristics of any fuel or class of fuels if either (1) emission products from the fuel or fuel additive endanger public health or welfare, or (2) the fuel or fuel additive will significantly impair performance of an emission control device or system in general use (or likely to be in general use) on a significant number of motor vehicles or motor vehicle engines. Such standards must be based on specific medical, scientific, economic, and technological findings specified in the House bill.
The Administrator's authority under the House bill was applicable to all types of fuels, whether used in stationary sources or in motor vehicles, except that it did nto apply to aviation fuel or additives thereto.
The Senate amendment amended the fuel registration provisions to expand the Administration's authority in this area, and in addition authorized him to control or prohibit the introduction into commerce of any fuel for use in vehicle engines if the combustion or evaporation of such fuel produces emissions which endanger the public health or welfare, or if such emissions prevent operation of effective systems for the control of emissions from any vehicle or vehicle engine which the Administrator finds would otherwise conform to applicable emission standards. The Administrator was required to hold public hearings and make certain findings before establishing a control or prohibition under this provision. Regulation of motor vehicle fuels by Statrs and political subdivisions for purposes of emission control was preempted by the Senate amendment.
Under the conference substitute the Administrator may control or prohibit manufacture or sale of any motor vehicle fuel or fuel additive if any emissions therefrom will endanger the public health or welfare, or if emission products of such fuel or additive will impair to a significant degree the performance of any emission control device or ssytem which is or will be in general use. Existing provisions of law relating to registration of fuels and fuel additives are retained with some revisions.
Before controlling or prohibiting manufacture or sale, the Administrator is required to consider specific technical and cost factors. Automobile manufacturers are required to furnish to the Administrator any information developed concerning emissions from motor vehicles resulting from the use of any fuel or fuel additive or the effect of such use on the performance of any emission control device or system.
No State may prescribe or enforce controls or prohibitions respecting any fuel or additive unless they are identical to those prescribed by the Federal Government or unless a State implementation plan under sec. 110 includes provision for fuel or additive control and such plan is approved by the Administrator as being necessary for achievement of national air quality standards. These restrictions will nto apply to California.
A civil penalty of $10,000 per day is provided for violation of the provisions relating to fuels and additives.
Conference Report on Clean Air Amendments of 1970 H.R. Rep. No. 91-1783, 91st Cong., 2d Sess. 52-53 (17 December 1970). Interestingly, paragraph four of the conference report makes no mention of the fact that §§ 211(c) (1) (B) and (C) require "findings" and that § 211(c) (1) (A) does not.
42. H.R. 17255, 91st Cong., 2d Sess. § 210(f) (1970) (emphasis added).
43. H.R. 17255, 91st Cong., 2d Sess. § 210(g) (1970) (emphasis added).
44. It should be remembered that an identical dichotomy is made in section 108. See pp. 17-18 supra.
45. Amoco Oil Co. v. EPA, U.S. App. D.C. , , 501 F.2d 722, 740-41 (1974).
46. See Judge Wright's dissenting opinion, p. 7, note 9.
47. 42 U.S.C. § 1857c — 5(a)(2) (1970).
48. 42 U.S.C. § 1857c — 3(a)(1)(A) (1970) (emphasis added).
49. The principal definition of "adverse" in Webster's International Dictionary (1931) is as follows: "Acting against, or in a contrary direction; opposed; contrary; conflicting . . . ."
50. S. 4358, 91st Cong., 2d Sess. § 110(b) (1970). Under the Senate bill an "air pollution agent or combination of such agents" was itself defined in § 109(a)(1) as follows:
Sec. 109.(a)(1) The Secretary shall, within thirty days after enactment of this section and from time to time thereafter, publish in the Federal Register a list of air pollution agents or combination of such agents —
(A) which have, or may be expected to have, an adverse effect on public health or welfare;
(B) the presence of which in the ambient air results from numerous and diverse mobile or stationary sources; and
(C) for which air quality criteria requisite for the protection of public health and welfare are planned.
The Secretary shall, after consultation with appropriate advisory committees and Federal departments and agencies and within twelve months after such publication, develop and issue to the States such criteria.
51. Report on S. 4358, National Air Quality Standards Act of 1970, S. REP. No. 91-1196, 91st Cong., 2d Sess. 9-10 (1970).
52. Id. at 33-34 (emphaisis added).
53. R. Br. at 42.
54. 36 FED. REG. 1486 (30 January 1971); App. 26.
55. 37 FED. REG. 3882 (23 February 1972); App. 23.
57. App. 276 (11 April 1972).
58. Memorandum from Dr. Edward E. David, Jr., Office of Science and Technology, to Donald E. Crabill, Chief, Natural Resources Programs Division, Office of Management and Budget, 1 November 1972, p. 2, App. 2471.
59. Letter from M.J. Pecora, Under Secretary of the Interior, to George P. Schultz, Director, Office of Management and Budget, 14 February 1972, p. 1, App. 2501.
In the preface to its report the NAS panel stated that it had "decided to consider biologic effects of lead not necessarily attributable directly to atmospheric sources and not necessarily at levels of exposure as low or as prolonged as those related to general ambient air. Such consideration was necessary because lead attributable to emission and dispersion into general ambient air has no known harmful effects." NAS, 1972, App. 314.
60. Letter from W.N. Letson, General Counsel, Department of Commerce, to Casper W. Weinberger, Director, Office of Management and Budget, 2 November 1972, p. 15, App. 2464.
61. Letter from Merlin K. DuVal, M.D., Assistant Secretary of Health (HEW), 17 November 1972; App. 2481.
62. The Environmental Protection Agency is attempting to gather additional health effects information by asking various members of the medical and scientific community to respond to the following questions. All other interested parties are also invited to address these questions:
(1) In the light of any criticisms you may have of the Goldsmith-Hexter approach and the Environmental Protection Agency's use of a regression equation based upon it (see Figure 3-3 of "Airborne Lead in Perspective." National Academy of Sciences, 1972, and Table 7 of the "Health Hazards of Lead," Environmental Protection Agency, revised April 11, 1972, which was corrected in "Corrections and Additions to Health Hazards of Lead," April 27, 1972), what are the permissible uses and limitations in its application for obtaining reasonable estimates of blood lead levels as a function of air lead exposures?
(2) How accurate a reflection is blood lead of lead body burden? What is the effect of elevated blood leads upon lead body burden? Can small increments in blood lead be expected to result in a significant lead body burden elevation? From a public health point of view, is it permissible to allow slight increases in lead body burdens among the general population when this increment can be prevented? Can the pool of body lead stored in the bone be viewed as totally "physiologically inert"? It is known that chelation therapy of children with elevated blood leads can result in acute clinical symptoms of lead poisoning as a result of mobilizing lead from bone. Is there any evidence that subtle metabolic changes could also mobilize this lead pool under other conditions?
(3) The Environmental Protection Agency has relied upon the National Academy of Sciences (NAS) Report (Appendix C, p. 249, footnote "a") for estimates of daily respired air by an average adult in its own calculations in Table 7 of the "Health Hazards" raper. How accurate are these estimates of pulmonary physiology (a) that an adult male breathes 23 cubic meters of air per day, (b) that 30 percent of respired lead particles will be retained, and (c) that nearly 100 percent of retained lead particles will be absorbed? Is there additional evidence available in this area besides that which is cited in the NAS Report?
(4) What is an appropriate safety factor for extrapolating industrial threshold limit values (TLV) to the general population? Should such an extrapolation to the general population even be permitted? The proposed TLV for lead is due to be revised to 150 mu g./m.3 for a 40-hour week. On a weekly basis, this corresponds to breathing air continually at between 35-40 mu g./m.3 of lead. If TLV's can be extrapolated to the general population, what would be an appropriate safety factor for this purpose so that all groups, including those most suscepible to lead will be protected?
(5) In regard to the dustfall lead theory (p. 139 of the NAS Report): How much of a hazard is dustfall lead to children prone to pica? The Environmental Protection Agency's calculations indicate that continued ingestion of even small amounts of lead contaminated dusts and dirt containing as much as 0.25-0.35 percent lead could theoretically result in dangerously elevated blood leads among children, or could contribute significantly to additional unnecessary lead burdens in children with other known lead exposures (such as lead paint). Will the Environmental Protection Agency's proposed 60-65 percent of reduction of leaded auto emissions significantly reduce the risk of this potential contamination?
(6) Although lead paint has traditionally been considered the prime causal factor in childhood lead poisoning, how effective would reductions in other known environmental sources of lead exposure (such as dustfall) be in helping to reduce the risk of undue lead exposure among children also exposed to peeling lead paint? How clear is it that all lead poisoning in children is, in fact, caused only by lead paint? Since many years are required to solve the lead paint problem, would the risk of undue lead absorption and possible lead poisoning not be reduced by also decreasing airborne lead and consequently lead in dust?
(7) What is the consequence upon the environment in general of allowing large quantities of lead to be expelled into the atmosphere from motor vehicle exhausts? Does this environmental contamination pose any direct or indirect threat to man?
37 FED. REG. 11786, 11787 (14 June 1972); App. 21.
63. 38 FED. REG. 1258, 1259 (10 January 1973); App. 16.
64. App. 158.
65. Letter from Dr. Charles H. Powell to Dr. Kenneth Bridbord, Acting Chief, Health Effects Branch, Office to Research and Monitoring, EPA, 2 March 1973; App. 2477.
66. Letter from Acting Secretary John C. Whitaker to Hon. William D. Ruckelshaus, Administrator of EPA, 26 February 1973; App. 2494.
67. Letter from Elliot L. Richardson, Secretary of Health, Education, and Welfare to Senator John V. Tunney, 29 January 1973; App. 2479.
68. Natural Resources Defense Council v. EPA, D.C. Cir. No. 72-2233 (29 October 1973).
69. See note 17, supra, and accompanying text.
70. Judge Wright's dissenting opinion, pp. 66.
71. Id. at p. 83.
72. Id. at p. 60.
73. Id. at p. 53.
74. Section 553(c) provides:
After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation. After consideration of the relevant matter presented, the agency shall incorporate in the rules adopted a concise general statement of their basis and purpose. When rules are required by statute to be made on the record after opportunity for an agency hearing, sections 556 and 557 of this title apply instead of this subsection.
75. U.S.C. §§ 706(2) (A) and (C) (1970).
76. Calcutta East Coast of India and East Pakistan/U.S.A. Conference v. FMC, 130 U.S. App. D.C. 261, 264, 399 F.2d 994, 997 (1968).
77. Citizens to Preserve Overton Park, Inc. v. Volpe, Secretary of Transportation, 401 U.S. 402, 415, 416 (1971).
78. Ibid. (emphasis added). This statement of the scope of review was reaffirmed very recently by a unanimous Supreme Court in Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., 43 U.S.L.W. 4091, 4092-93 (23 December 1974). See also Portland Cement Assoc. v. Ruckleshaus, 158 U.S. App. D.C. 308, 335, 486 F.2d 375, 402 (1973): "We cannot substitute our judgment for that of the agency, but it is our duty to consider whether 'the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment.' Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416, 91 S. Ct. 841, 824, 28 L. Ed. 2d 136 (1971). Ultimately, we believe, [sic] that the cause of a clean environment is best served by reasoned decision-making."
79. The Supreme Court made this quite clear in Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., 43 U.S.L.W. 4091, 4092 (23 December 1974):
The District Court properly concluded that, though an agency's finding may be supported by substantial evidence, based on the definition in Universal Camera Corp. v. NLRB, 340 U.S. 474, it may nonetheless reflect arbitrary and capricious action. There seems, however, to be agreement that the findings and conclusions of the Commission are supported by substantial evidence. The question remains whether, as the District Court held, the Commission's action was "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" as provided in § 10(e) (B). (Footnotes omitted.)
* * *
Under the "arbitrary and capricious" standard the scope of review is a narrow one. A reviewing court must "consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment. . . . Although this inquiry into the facts is to be searching and careful, the ultimate standard of review is a narrow one. The court is not empowered to substitute its judgment for that of the agency." Citizens to Preserve Overton Park v. Volpe, supra, at 416. The agency must articulate a "rational connection between the facts found and the choice made."
The lack of a connection between facts found and choices made is the Agency failure we find here.
80. The following exchange during the debate on the Clean Air Act typifies the Congressional understanding that this court should review for clear errors of judgment:
Mr. ROGERS of Florida. . . . We have said that if there is a component part of the gasoline or if there is an additive which the facts show will affect the public health, and medical and scientific facts show this, or will prevent the emission standards from being met, the Secretary may act as to the component part or that additive.
Mr. WAGGONNER. What appeals are made available to the manufacturer of an engine or the producer of a fuel, if they take issue with the findings of the Secretary of Health, Education, and Welfare?
Mr. ROGERS of Florida. They have the Administrative Procedure Act.
Mr. WAGGONNER. And only the Administrative Procedure Act?
Mr. ROGERS of Florida. And an appeal to the court, from the Administrative Procedure Act.
* * *
Mr. WAGGONNER. Not in all cases do people have the right of appeal to the court under the Administrative Procedure Act. In some instances under the Administrative Procedure Act the decisions are final, when they render a decision.
Mr. ROGERS of Florida. I believe they would in this instance.
* * *
Mr. STAGGERS. I think the gentleman from Louisiana was worried about the fact that this would be a hard ruling made in the courts. Of course, these matters come up under the Administrative Procedure Act, and then they have recourse to the courts. If they feel, after all of the hearings have been laid before them, that these were not the facts and that the ruling was wrong, the court will have the final decision.
116 CONG. REC. (Part 14) at 19230-31 (House) (10 June 1970) (emphasis added).
81. 504 F.2d 646 (1st Cir. 1974).
82. 42 U.S.C. § 1857c — 5(c) (1970).
83. See pp. 29-30, supra.
5. The wisdom of the plan in the ordinary sense is outside our province. "We inquire into the soundness of the reasoning by which the [Agency] reaches its conclusions only to ascertain that the latter are rationally supported." United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742, 749, 92 S. Ct. 1941, 1946, 32 L. Ed. 2d 453 (1972).
6. "Looking to the future, and commanded by Congress to make policy, a rule-making agency necessarily deals less with 'evidentiary' disputes than with normative conflicts, projections from imperfect data, experiments and simulations, educated predictions, differing assessments of possible risks, and the like. The process is quasilegislative in character, and one will search it in vain for those intermediate 'findings' of fact which mark the midway point in an adjudicator's linear march from raw evidence to single, ultimate conclusion." Amoco Oil Co. v. EPA, 501 F.2d 722, at 734-35 (D.C. Cir. 1974).
85. See, e.g., Third Health Document, IV-1 - IV-2; App. 69-70.
86. Id. at IV-3; App. 71.
87. Id. at III-2; App. 55.
89. Structurally, our discussion of the evidence should be considered an alternative holding. In holding that the Administrator failed in his analysis of and reliance on inconclusive facts, we do not rely in any way on the conclusion reached in Part II above that he also erred on the law.
90. At best the EPA is attempting to draw positive inferences from the data underlying these other studies, inferences which the scientists making the study refused to draw. In general, the Administrator in his analysis of all of the studies has assumed his conclusion that there is a causal relation between air lead levels and blood lead levels. Particularly disturbing to us is the Administrator's mention of studies conducted in communities having lead smelters. Any conclusions based upon such studies must necessarily assume that the routes and amounts of lead exposure in such communities are fundamentally similar to those of non-smelter communities. No discussion of this assumption or even mention that comparability may be a problem is made in the Third Health Document.
91. Rabinowitz, M., et al., "Lead Metabolism in the Normal Human: Stable Isotope Studies," 182 SCIENCE 725 (November 1973); App. 704. Preliminary data on a second subject was presented at an EPA-NIEHS Conference on Low Level Lead Toxicity in Raleigh, N.C., on 1-2 October 1973, App. 678.
92. The Agency has weighed against these criticisms studies which have shown that airborne lead does contribute significantly to lead exposure in the general population. For example, using a pilot lead isotope approach, preliminary data show that airborne lead at 2 mu g/m3 can contribute as much as 1/3 to total lead exposure in man. This result is consistent with data concerning the deposition of lead particles in the pulmonary tract and the absorption of such particles into the blood stream.
38 FED. REG. 33735 (6 December 1973); App. 3.
The dissent chides us for our criticism of the EPA's excessive reliance on a one subject experiment, citing the brillant work of Pasteur and Jenner. If we are seeking a comparison of quick scientific deduction (although there is nothing as inevitable as gravity about the Administrator's conclusions here), a more apt parallel might have been found in Sir Isaac Newton's observation of the falling apple. In all three ultimate scientific triumphs, a great deal of work remained to be done, particularly if nationwide regulation was to be premised on scientific conclusions.
93. 38 FED. REG. 33735 (6 December 1973): App. 3.
94. Tsuchiya, K., et al., "Study of Lead Concentrations in Atmosphere and Population in Japan," draft, undated; App. 1092.
95. Id. at 40; App. 1131.
96. Id. at 33; App. 1124; See Judge Wright's dissenting opinion, p. 69.
97. Id. at 32; App. 1123; See Judge Wright's dissenting opinion, p. 69.
98. Id. at 33; App. 1124.
99. Id. at 34-35; App. 1125-26 (emphasis supplied).
100. Knelson, J.H., et al., "Kinetics of Respiratory Lead Uptake in Humans," Proceedings of the International Symposium on Environmental Health Aspects of Lead, Amsterdam (2-6 October 1972); App. 596.
101. Third Health Document, V-7 - V-8; App. 87-88.
102. Id. at V-3; App. 83.
103. Quoted in ILZRO/LIA Critique of "EPA's Position on the Health Effects of Airborne Lead," International Lead Zinc Research Organization, Inc. (9 March 1973), p. 16; App. 2377.
104. Daines, R.H., et al., "Air Levels of Lead Inside and Outside of Homes," 41 INDUSTRIAL MEDICINE 26 (October 1972); App. 465.
105. Id. at 27; App. 466, Table 1.
106. Id. at 28; App. 467, Table 2.
107. Id. at 28; App. 467.
108. Id. at 28; App. 467, Table 3.
109. 38 FED. REG. 33735 (6 December 1973); App. 3. Although the Daines study is not identified by name in the preamble, the substance of the quoted reference as well as the process of elimination make clear the fact that this was thestudy being discussed.
The dissent appears to quibble with this conclusion and contends that the Administrator was also referring to the Seven Cities Study. Even if this were the case, the fact remains that the Administrator stated that groups being compared in the Daines study had "similar lead intakes from other sources", a statement unsupported by the study.
110. Tsuchiya, K., et al., op. cit., pp. 33-34; App. 1124-25.
111. Judge Wright's dissenting opinion, p. 67.
112. Id. at p. 71.
113. Id. at p. 70.
114. Id. at p. 73-74.
115. In the interest of space we will not discuss those studies which do not support the Administrator's conclusions. The following are the three principal studies cited by Petitioners and discussed in the Third Health Document:
Tepper, L.B., and Levin, L.S., "A Survey of Air and Population Lead Levels in Selected American Communities" (The Seven Cities Study), Dept. of Environmental Health, College of Medicine, U. Cincinnati, Ohio (EPA Contract PN 22-68-28) (December 1972) (App. 840); Azar, A., et al., "Relationship of Community Levels of Air Lead and Indices of Lead Absorption." pp. 581-594, Proceedings of International Symposium on Environmental Health Aspects of Lead, Amsterdam (26 October 1972) (App. 387); Jones, R.D., et al., "Blood Lead and Carboxyhaemoglobin Levels In London Taxi Drivers," 2 THE LANCET 302-303 (12 August 1972) (App. 498).
116. 38 FED. REG. 33736 (6 December 1973); App. 4.
118. Id. at 33735-36; App. 3-4.
119. Third Health Document, VI-21 - VI-22; App. 131-32.
120. 38 FED. REG. 33736 (6 December 1973); App. 4.
121. Third Health Document, VI-13; App. 123.
123. App. at 1057 (3 August 1973) (emphasis added).
124. Reply Brief for Petitioners in Nos. 73-2268 and 73-2269, p. 17.
125. Margulis, H.L., et. al., "Residential Location, Ambient Air Lead Pollution and Childhood Lead Poisoning," ARCH. ENV. HLTH. [in press at time record was assembled]; App. 626.
126. Id. at App. 639, Table 2; Third Health Document, VI-16 - VI-18; App. 126-28.
127. The dissent is astonished that we question a causal connection based on pure statistical correlation and argues that criminal convictions occur every day based upon "correlations, whether statistical or otherwise." Judge Wright's dissenting opinion, p. 83. We doubt the contention that a criminal conviction could be based upon purely statistical correlations. For a discussion of the dangers posed by the utilization of mathematical methods at trial, see Tribe, Trial by Mathematics: Precision and Ritual in the Legal Process, 84 HARV. L. REV. 1329 (1971). In any event, pure statistical correlations prove little the moment alternative variables are introduced to explain theseeming correlations. For example, the movement of the sun through the daytime sky was at one time equally consistent with a heliocentric and a geocentric theory of the universe. The fact that both theories were entirely consistent with the available astronomical data obligated the scientist to look beyond pure statistical correlations to causal theories that related the sun's movement to more universal phenomenon and experience.
128. In contrast to the Newark study, we found the Detroit study conducted by Ter Haar and Aronow to be apparently probative on EPA's dust and dirt hypothesis. Ter Haar, G., and Aronow, R., "New Information on Lead in Dirt and Dust as Related to the Childhood Lead Problem," paper presented at EPA-NIEHS Conference on Low Level Lead Toxicity in Raleigh, N.C., on 1-2 October 1973, App. 917; Discussed in Third Health Document, pp. VI-1 - VI-2 and VI-10 - VI-12; App. 111-12, 120-22. The study was based on the fact that Lead 210, a rare isotope of lead, is found in low concentrations in lead paint and in higher concentrations in fallout dust. "Eight children suspected of having elevated lead body burdens were compared to ten children living in good housing where lead poisoning was not a problem." Third Health Document, VI-10; App. 120. Fecal excretion of both stable lead and Lead 210 were determined and compared. The six children who had elevated lead body burdens (thus excluding two children whose levels were normal) had stable lead isotope concentrations 4 to 400 times higher than those of the normal children. However, there was no difference in Lead 210 fecal excretion between the groups and thus the report concluded that children suspected of elevated lead body burdens did not ingest dust. Id. at VI-10 - VI-11; App. 120-21. Although this study ultimately did not support EPA's dust and dirt hypothesis, this was the type of research which EPA should have relied upon in its attempt to link excessive blood lead levels in children to auto lead emissions. This is not to say that the Detroit study is not also open to criticism. Groups of six to ten children are too small a sample upon which to base any firm conclusions. In addition, the Third Health Document pointed out that Lead 210 intake from the diet and the air could have affected the results, and that "no firm conclusions were warranted regarding non-dietary sources of lead-210" unless intake was known to be equivalent in each group. Id. at VI-11; App. 121.
(Without intending to down play this criticism of the Detroit study, we find it worthy of mention that the Third Health Document makes no similar criticism of the Daines study. See notes 104-109 and accompanying text. In both studies adequate controls on dietary intake would have made the studies more valuable. Yet, the EPA's scientists raise this criticism against a study unsupportive of their hypothesis, but say nothing when the study is supportive.)
129. Brief for Petitioners in Nos. 73-2268 and 73-2269, p. 34.
130. Id. at 35.
131. Brief for Respondent in Nos. 73-2268 and 73-2269, p. 32.
132. No. 73-2233 (29 October 1973).
133. Sections 10e and 4 of the Administrative Procedure Act, respectively.
134. It is significant that the First Circuit in South Terminal Corporation v. EPA, 504 F.2d 646 (1st Cir. 1974), while quoting on page 659 the same portion of International Harvester as does the dissent re the effect of comments on rulemaking, yet in evaluating the degree of reliance the EPA was entitled to place on an ambient air report, stated, "Moreover, it was published after the plan was announced and interested parties have not had an opportunity to criticize the findings." 504 F.2d at 664. And later, in discussing the whold broad issue of the adequacy of EPA air measurements, the First Circuit said, "[T]he record as now constituted, made without specific consideration of the mentioned objection, leaves us in doubt as to whether or not there is a rational basis for EPA's estimate . . . ." 504 F.2d at 666.
135. Petitioners have raised other objections to these regulations which we do not reach:
(1) Did the EPA properly consider other technologically or economically feasible means of achieving emission standards under section 202 of the Clean Air Act?
(2) Did EPA adequately consider such alternative means of regulation as air quality criteria and state plans pursuant to sections 107 through 110?
(3) Was the EPA required to file an environmental impact statement or its functional equivalent?
(4) Has the EPA given adequate consideration to the adverse health consequences of lead reduction as required by section 211?
(5) Is the lead reduction schedule provided for in the regulations arbitrary and capricious?
136. Tepper, L.B. and Lenin, L.S., "A Survey of Air and Population Lead Levels in Selected American Communities," Department of Environmental Health, College of Medicine, University of Cincinnati (O.) (December 1972); App. 840.
137. Transcript of Lead Portion of Meeting of EPA Hazardous Materials Advisory Committee, Washington, D.C., 26 February 1973; App. 987, 991-92. Petitioners asserted at oral argument that 98% of all lead in the blood comes from food, but we are unable to find in the record data which cuts the portion contributed by other sources by this one third.
138. See p. 13.
139. See pp. 52-54, supra.
140. Judge Wright's dissenting opinion, p. 96.
141. Hamlet, Act III, scene 1, line 57 et seq.
142. It is the EPA's position that the petitioners had notice of the data and studies upon which it was relying in the Third Health Document because of a previous Freedom of Information Act suit. In addition, EPA indicates that it had accepted comments on these studies (despite the fact that the 60-day comment period had expired) up to the date of promulgation. We are persuaded by petitioners' claim that due process and the APA require that the EPA give them notice of the specific data it intends to rely upon in the final regulations, at least where an agency is receiving large numbers of studies and the burden of responding to every one would be clearly unreasonable. The EPA could have avoided this whole problem by complying with 5 U.S.C. § 553(b) (B). The subsection is an exception to the notice and comment provisions of § 553 and provides:
Except when notice or hearing is required by statute, this subsection does nto apply —
(A) To interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or
(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.
143. On 27 January 1975 the EPA released a tentative study which casts a grave shadow over the continued use of the catalytic converter to control emissions of hydrocarbons and carbon monoxide from automobiles. The fear now is that the catalytic converter causes emissions of sulfates and sulfuric acid at such a high level that they would present a nation-wide health problem within four years of such proportions as to outweigh any other benefits of the device.
Before the Administrator can act under section 211 (c)(1)(A) to regulate or prohibit lead fuel additives he must make the findings required by section 211 (c)(2)(C):
(C) No fuel or fuel additive may be prohibited by the Administrator under paragraph (1) unless he finds, and publishes such finding, that in his judgment such prohibition will not cause the use of any other fuel or fuel additive which will produce emissions which will endanger the public health or welfare to the same or greater degree than the use of the fuel or fuel additive proposed to be prohibited.
In promulgating the lead regulations, the Administrator found that the increased use of polynuclear aromatic hydrocarbons (PNA), a known carcinogen, as a substitute for lead tetraethyl presented a lesser relative endangerment to health. This finding was explicitly based upon the assumption that 1976 federal emission standards, implemented as they must be by the catalytic converter, would result "in an approximately 78 percent decrease in polynuclear aromatic emissions from current levels of automobile emissions." 38 Fed. Reg. 33734, 33738 (6 December 1973). Based on this assumption the Administrator could conclude that, "[i]mplementation of the lead regulations will slow the rate of emission decrease by about 2 percent." Ibid.
In light of the newly discovered dangers of the catalytic converter, the Administrator may well be forced to reconsider the finding he made about the relative endangerment of PNA and lead emissions. Discontinuing the catalytic converter, should that prove necessary, might result in an increase in PNA, a condition which would be exacerbated by these regulations. Therefore, it is more necessary than ever to remand these regulations to EPA so that priorities can be reassessed and steps taken to control the known dangers of PNA and sulfates.
[5 ELR 20119]
WRIGHT, Circuit Judge, dissenting:
Nine months ago, this court approved regulations issued by the Environmental mental Protection Agency (EPA) requiring the nation's oil companies to market at least one grade of lead-free gasoline. Amoco Oil Co. v. EPA, U.S.App.D.C. , 501 F.2d 722 (1974). Since leaded gasoline fouled the catalytic converter emission control systems developed by the major automobile companies to meet the air pollutant emission standards set by Congress in Section 202 of the Clean Air Act,1 general availability of a leadfree gasoline for the new cars that would bear the catalytic converter was necessary for implementation of the statutory scheme.
The regulations in Amoco were promulgated under Section 211(c)(1)(B) of the Act,2 which gives EPA authority to regulate gasoline additives whose emission products "will impair to a significant degree the performance [5 ELR 20120] of any emission control device or system which is in general use * * *." Id. Now we must review regulations3 that would reduce, in step-wise fashion, the lead in all remaining leaded gasolines, used primarily by pre-1975 automobiles. These regulations are based on parallel Section 211(c)(1)(A), which empowers the Administrator to regulate gasoline additives whose emission products "will endanger the public health or welfare * * *." The Administrator has found the emission products of lead in gasoline to endanger the public health. The majority today finds that the Administrator has misinterpreted the requirements of the statute and that in any event his decision is not supported by the evidence and is arbitrary and capricious. Because I believe it is the majority that has misinterpreted the requirements of the statute and has employed a standard of review that distracts from our judicial task and transforms us instead into a super-agency, I cannot join in the court's opinion. And because I believe that under the appropriate standard of review the Administrator properly interpreted the statute and rationally applied it, I respectfully dissent.
I. THE STATUTE, THE PROCEEDINGS AND THE REGULATIONS
Hard on the introduction of the first gasoline-powered automobiles came the discovery that lead "antiknock" compounds, when added to gasoline, dramatically increase the fuel's octane rating. Increased octane allows for higher compression engines, which operate with greater efficiency. Since 1923 antiknocks have been regularly added to gasoline, and a large industry has developed to supply those compounds. For almost as long, however, scientists have questioned whether addition of lead to gasoline, and its consequent diffusion into the atmosphere from the automobile emission, poses a danger to the public health.4 As use of automobiles, and emission of lead particulates, has accelerated in the last quarter century, this concern has mounted. The reasons for concern are obvious (and essentially undisputed by petitioners): (1) Lead in high concentrations in the body is toxic; (2) lead can be absorbed into the body from the ambient air; (3) lead particulate emissions from gasoline engines account for approximately 90 per cent of the lead in our air. While the lead antiknock industry has refused for years to accept the evidence that lead automobile emissions are a danger to public health, Congress, in the Clean Air Act Amendments of 1970, Pub. L. 91-604, December 31, 1970, 84 STAT. 1698-1700, finally set up a legal mechanism by which that evidence could be weighed in a more objective tribunal.It gave the newly-created EPA authority to control or prohibit the sale or manufacture of any fuel additive whose emission products "will endanger the public health or welfare * * *." 42 U.S.C. § 1857f-6c(c)(1)(A) (1970). It is beyond question that the fuel additive Congress had in mind was lead.5 Given this mandate, EPA published on January 31, 1971 advance notice of proposed rule-making. The Administrator announced he was considering possible controls on lead additives in gasolines, both because of their possible danger to health and because of their incompatibility with the catalytic converter emission control system.6 36 FED. REG. 1486 (1971). Proposed regulations were issued a year later, February 23, 1972, supported by a document, Health Hazards of Lead,7 prepared by the EPA scientific staff. Comments were invited for a 90-day period, later reopened for an additional 30 days. 37 FED. REG. 11786-11787 (1972). At the same timepublic hearings were held in Washington, D.C., Dallas, and Los Angeles.
On January 10, 1973 the Administrator, while issuing final regulations requiring availability of lead-free gasoline to allow implementation of the catalytic converter system, 38 FED. REG. 1254, reproposed the health-based regulations now at issue. 38 FED. REG. 1258. The reproposal was supported by a second health document, EPA's Position on the Health Effects of Airborne Lead, Joint Appendix (JA) at 158, and was necessitated by a modification of EPA's analysis of the health effects of lead emissions. The Agency concluded, after considering the comments received, that when considered in isolation it was virtually impossible to identify the precise amount of airborne lead which will endanger public health. Instead, the control strategy would concentrate on evaluating the cumulative effect of airborne lead on total human lead exposure. 38 FED. REG. 1258. The reproposed regulations themselves were similar to the original proposal, requiring a phased cutback to 1.25 grams of lead per gallon of leaded gasoline, but, in recognition of the industry's lead-time problems, the timetable for reduction was pushed back one year.The Agency again invited public comment, this time for a 60-day period.
On October 28, 1973, as a result of a petition for review in Natural Resources Defense Council, Inc. v. EPA, D.C. Cir. No. 72-2233, this court ordered EPA to reach within 30 days a final decision on whether lead additives should be regulated for health reasons. EPA published its final health document, entitled EPA's Position on the Health Implications of Airborne Lead, on November 28, 1973. JA at 27. The document (hereinafter the Third Health Document) extensively details and reviews the state of knowledge of the health effects of airborne lead. It candidly [5 ELR 20121] discusses the various scientific studies, both pro and con, underlying this information, and ultimately concludes that lead from automobile emissions will endanger the public health. The same day, based largely on the conclusions of the Third Health Document, EPA promulgated its final regulations, accompanied by a through discussion of its health conclusions, the impact of the regulations, and the alternative courses of action considered and rejected. 38 FED. REG. 33734. The final regulations require the same step-wise reduction of lead additives but, in response to the comments of various manufacturers, calculate the reduction in a slightly different manner. Whereas the original and reproposed regulations set standards for lead content on the basis of grams of lead per gallon of leaded gasoline (leaded pool averaging), the final regulations base the standards on grams of lead per gallon of all gasoline (total pool averaging). The quantkty of lead emitted into the atmosphere is the same under both systems; EPA simply converted its leaded pool figures into total pool figures. Under the final regulations, lead in all gasoline would be reduced over a five-year period to 0.5 grams per gallon.8
These regulations are challenged by petitioners on a variety of grounds, all of which will be addressed below. Their primary claims, and the ones on which the majority bases its reversal, are that the Administrator misinterpreted the statutory standard of "will endanger" and that his application of that standard is without support in the evidence and arbitrary and capricious.
II. THE STATUTORY REQUIREMENTS
Under Section 211(c)(1)(A) EPA may, on the basis of all the information available to it, promulgate regulations that
control or prohibit the manufacture, introduction into commerce, offering for sale, or sale of any fuel or fuel additive for use in a motor vehicle or motor vehicle engine (A) if any emission products of such fuel or fuel additive will endanger the public health or welfare * * *.
42 U.S.C. § 1857f-6c(a)(1)(A). The Administrator cannot act under Section 211(c)(1)(A), however, until after "consideration of all relevant medical and scientific evidence available to him, including consideration of other technologically or economically feasible means of achieving emission standards under [Section 202]." Section 211(c)(2)(A), 42 U.S.C. § 1857f-6c(c)(2)(A). Section 202 of the Act, 42 U.S.C. § 1857f-1, allows the Administrator to set standards for emission of pollutants from automobiles (as opposed to standards for composition of the gasoline that produces the emission), and is thus the preferred — although not the mandatory — alternative under the statutory scheme, presumably because it minimizes Agency interference with manufacturer prerogatives.9
The Administrator is also required, before prohibiting a fuel or fuel additive under Section 211(c)(1)(A), to find, and publish the finding, that in his judgment any fuel or fuel additive likely to replace the prohibited one will not "endanger the public health or welfare to the same or greater degree * * *." Section 211(c)(2)(C), 42 U.S.C. § 1857f-6c(c)(2)(C). It is significant that this is the only conclusion the Administrator is expressly required to "find" before regulating a fuel or fuel additive for health reasons.
A. The Threshold Determination
In making his threshold determination that lead particulate emissions from motor vehicles "will endanger the public health or welfare," the Administrator provided his interpretation of the statutory language by couching his conclusion in these words: such emissions "present a significant risk of harm to the health of urban populations, particularly to the health of city children." 38 FED. REG. 33734. By way of further interpretation, he added that it was his view
that the statutory language * * * does not require a determination that automobile emissions alone create the endangerment on which controls may be based. Rather, the Administrator believes that in providing this authority, the Congress was aware that the public's exposure to harmful substances results from a number of sources which may have varying degrees of susceptibility to control.
Id. It is the majority's first ground of decision that the Administrator has erroneously interpreted Section 211(c)(1)(A) by not sufficiently appreciating the rigor demanded by Congress in estabishing the "will endanger" standard and that, therefore, the Administrator's action is "short of statutory right," in violation of Section 10(e)(2)(C) of the Administrative Procedure Act (APA), 5 U.S.C. § 706(2)(C) (1970).
The majority's points of difference with the Administrator do not appear on a first reading of its interpretation of the "will endanger" standard. The court accepts the Administrator's contention that he may consider the cumulative impact of airborne lead in addition to all other human exposure to the substance. Majority opinion at 12-13.Moreover, its restatement of the requirements for action under Section 211(c)(1)(A) seems little different from the Administrator's reading of the statute:
[S]ection 211(c)(1)(A) requires the Administrator to conclude "after consideration of all relevant medical and scientific evidence available to him" that a fuel or fuel additive causes an emission which causes a significant health hazard to a substantial portion of the general population * * *.
[5 ELR 20122]
Id. at 12, quoting Section 211(c)(2)(A) (footnote omitted; emphasis in original). But while "endanger[ing] the public health" (the statutory language), "present[ing] a significant risk of harm to the health of urban populations" (the Administrator's interpretation), and "caus[ing] a significant health hazard to a substantial portion of the general population" (the majority's interpretation) may seem essentially synonymous to a reader who is merely well-versed in plain English, the majority proceeds to distort its reading of the statutory standard into a requirement that lead emissions cause actual harm, not merely the threat of harm, before the public health is endangered within the meaning of Section 211(c)(1)(A). And, having transformed the required showing from one of risk to one of fact, the majority takes the next logical step and forbids the Administrator from assessing risks in making his determination.10
I believe the Administrator properly interpreted the statute, and that the majority's interpretation would make it virtually imopssible for the Administrator ever to regulate lead additives under Section 211(c)(1)(A), a result that would certainly surprise the congressmen who labored so long to authorize such regulation. In presenting what I believe to be the proper construction of the statute, I shall consider, the majority's redenfinition in some detail, along with the interpretations offered by the various petitioners.
1. The Meaning of "Will Endanger." Even in this age of disrepute of the "plain meaning" school of statutory interpretation,11 the majority cannot quite bring itself to address frontally the transiguration it imposes on the plain meaning of "will endanger." Thus it works its magic indirectly. The meaning of "endanger" is, I hope, beyond dispute. Case law and dictionary definition agree that endanger means something less than actual harm.12 When one is endangered, harm is threatened; no actual injury need ever occur. Thus, for example, a town may be "endangered" by a threatening plague or hurricane, and yet emerge from the danger completely unscathed. A statute allowing for regulation in the face of danger is, necessarily, a precautionary statute. Regulatory action may be taken before the threatened harm occurs; indeed, the very existence of such precautionary legislation would seem to demand that regulatory action precede, and, optimally, prevent, the perceived harm. As should be apparent, the "will endanger" language of Section 211(c)(1)(A) makes it such a precautionary statute.
The Administrator interpreted this "will endanger" language to mean "presents a significant risk of harm." 33 FED. REG. 33734. By breaking the statutory language into its component parts "risk of harm," he recognized that the standard necessarily raises two questions: (1) How much risk? (2) How much harm? These questions, which inhere in every precautionary statute, are distinct in that any combination of risk and harm may be legislated. In discussing the meaning of "will endanger," however, the majority muddles these two concepts and treats them as one. Because of this confusion, the inescapable thrust of the majority opinion is that actual, not potential, harm must be found before regulation is justified under Section 211(c)(1)(A). Before exposing the error of the majority's approach I shall explore in some detail what I believe to be the proper interpretation of the two parts of the "will endanger" standard.
(a) how Much Risk? The majority bases its determination that actual harm must be found before action is permitted under Section 211(c)(1)(A) on a comparison of that section with two other provisions of the Clean Air Act, Sections 108 and 202, that allow for regulation of air pollutants for health reasons. Since Congress seemed to assume that the meaning of the threshold determinations required by the various sections of the Clean Air Act would be self-evident, there is a complete absence of helpful legislative history. Thus I think the majority's approach an appropriate method to discern the legislative intent, and I shall utilize it as well.
[5 ELR 20123]
Section 108 authorizes the Administrator to set national primary and secondary ambient air quality standards for each pollutant "which in his judgment has an adverse effect on public health or welfare * * *." Section 108(a)(1)(A), 42 U.S.C. § 1857c-3(a)(1)(A) (emphasis added). Section 202 authorizes the Administrator to set standards for each automobile emission "which in his judgment causes or contributes to, or is likely to cause or contribute to, air pollution which endangers the public health or welfare." Section 202(a)(1), 42 U.S.C. § 1857f-1(a)(1) (emphasis added).
Comparison of the risk to health necessary before regulation under each of these sections with that required under Section 211 is particularly rewarding because the sections are so diverse. I think it readily apparent that, as for extent of risk, Section 108 demands the most rigorous showing. While Section 202 and 211 both speak only of "danger" to health, Section 108 requires an actual "adverse effect" on health to be found before regulation is justified; actual harm must result. As the majority notes, an adverse effect is one "which is contrary, opposed, conflicting with the public health." Majority opinion at 30 (footnote omitted). Thus Section 108 is at the most rigorous end of the risk spectrum and, in fact, is not a precautionary statute at all. Agency action is justified only after the fact.
Section 202, on the other hand, plainly is the most wide-ranging of the three sections in this regard, allowing regulation of emissions that have the most remote effects on public health. "Likely to * * * endanger" certainly embraces consequences farther removed from actual harm than "willendanger," whatever risk the latter term connotes. While "likely" does suggest some degree of probability, it need not be significant degree, and the probability is only of endangerment, itself a risk.13
These two sections provide useful guidance in assessing the degree of risk necessary before action under the "will endanger" standard of Section 211. Since endanger, by definition, means no more than the risk of harm, it is apparent that the standard is not as strict as that of Section 108; contrary to the majority's implication, a showing of actual harm cannot be a requirement for Section 211(c)(1)(A) regulation. On the other hand, while only a risk need be shown, the section does not include consequences as remote as the "likely" risk allowed by Section 202. The Administrator found that the risk must be "significant," 38 FED. REG. 33734, and I think his definition is sufficient. A "significant risk" is essentially in accord with the dictionary definition of endanger, which speaks of "probable" harm or peril. WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY 748 (1961); see note 12 supra. Moreover, the term is virtually synonymous with the definition first offered, and then ignored, by the majority: a "significant * * * hazard." I see no reason to find the Administrator's assessment of risk to health to be in error.14
(b) How Much Harm? Having ascertained that lead automobile emissions must present a "significant risk" of harm to the public health in order to justify regulation under Section 211(c)(1)(A), we are not yet quite ready to apply the "will endanger" standard. The section also necessarily prescribes a level of harm to the public health that must be threatened before regulation is proper, and the parameters of that level must be sketched at least to the extent necessary to ensure that the Administrator's action falls within them. Comparison with Sections 108 and 202 is not particularly helpful here. All of these sections are concerned with harm to the "public health," a broad and uncertain term. See pages 44-46 infra. Section 202 contemplates the same level of threatened damage as Section 211; both ultimately allow regulation only of pollution that "endangers the public health."15 Whatever harm that term embraces, it is the same for both sections. While the majority asserts that the "adverse effects" language of Section 108 allows proof of harm less substantial and more attenuated than Section 211, I find its argument unconvincing, and, in any case, not productive of useful parameters of "will endanger."16
[5 ELR 20124]
Another section of the Clean Air Act, however, does provide a useful comparison. Section 112 empowers the Administrator to identify, and regulate, "hazardous air pollutants," which, in terms of severity, are defined as those which "in the judgment of the Administrator may cause, or contribute to, an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness." Section 112(a)(1), 42 U.S.C. § 1857c-7(a)(1) (emphasis added). This suggests to me that when Congress intended regulation to proceed only upon the threat of the most severe consequences it was quite capable of making its intent clear. Since I think a danger to the "public health" need not be as great as the threat of death or incapacitation necessary under Section 112, I think it safe to assume that the "will endanger" standard embraces a broader range of threatened harm than Section 112.17
Further than this, it is not necessary to go. The regulations at issue are premised on the danger of lead poisoning, a deadly disease and near universal threat, see pages 38-43 infra. Such harm surely fits within any definition of harm necessary to meet the "will endanger" standard, probably even within the severe harm necessary under Section 112. Thus, while the Administrator did not expressly interpret the severity of harm necessary for action under Section 211(c)(1)(A), I think interpretation was unnecessary, and would hold that the threat of widespread lead poisoning meets the severity of harm standard of the statute.
(c) The Majority Approach. The court begins its discussion of the "will endanger" standard innocuously enough. Its initial statement — that endanger means "causes a * * * hazard" — is unobjectionable, "hazard" meaning no more than "danger" or "peril." WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY 1041 (1961). It is only when the majority begins discussing what it means by "causes" that its true meaning emerges.18 In [5 ELR 20125] seeking to illuminate the "rigor" of the "will endanger" standard by comparing it with Sections 108 and 202, the majority insists on arranging the sections in linear fashion, treating them as though risk of harm were but one concept. Since, as indicated above, the sections necessarily embody two concepts, the majority's arrangement distorts their meaning and enables the court to insert its insistence upon actual harm as a prerequisite to action under Section 211.
First the majority compares the degree of risk required for action under Sections 202 and 211. Properly enough it concludes that Section 202 is the more lenient provision. The problem of the majority approach is already apparent, however, for it evidences no understanding that it has only compared the levels of risk required by the two sections, and nothing else. Cf. page 15 supra. The majority promptly compounds its problems by assessing Section 108 only in terms of the severity of harm necessary for action under that section, which it asserts is less demanding than that required by the "will endanger" standard. Whether that is true or not, we have seen that the result of such a comparison is irrelevant for assessing whether the "will endanger" standard was properly applied in this case. See pages 15-16 supra. The majority's comparison has nothing to say about the relative risks necessary for action under the two sections. Nonetheless, having shown that the far-ranging risks encompassed by Section 202 make that section "less rigorous" than Section 211, and that, in its view, the allegedly less substantial harm encompassed by Section 108 makes that section "less rigorous" than Section 211, the majority turns the statute on its head by comparing these two unrelated findings to assess the relative "rigor" of the three sections. While this court, in a panel opinion joined by Judge Wilkey, recently approved the distinction between probability and severity of harm, and held, contrary to the majority's present approach, that neither severity nor probability alone, but only a combination of the two, can be used to assess danger, Carolina Environmental Study Group v. United States,__ U.S. App. D.C. __ , __, __ F.2d __, __ (No. 73—1869, decided January 21, 1975) (slip op. at 6), the majority is not dissuaded from its course. Its study, the majority says, shows that Section 108 "provides for an even less rigorous standard of proof than either section 202 or 211."19 Majority opinion at 29. But each section does not provide for a standard of proof; rather, each contains two separate distinct standards of proof. The majority is comparing apples and oranges, and attempting to rank them. The effect of this comparison, in the one-dimensional world in which the majority is operating, is that, since the "will endanger" standard is more "rigorous" than the "adverse effect" standard, the former standard necessarily requires proof of more than an actual adverse effect on the public health. Thus the majority holds that the public health is not endangered until it is actually harmed.
The majority has succeeded only in confusing a very important issue. Its action is particularly unfortunate in that it was unnecessary. The Administrator presented an interpretation of the statute for the majority to consider. But the majority, in vacating the regulations in this case because of the Administrator's "misinterpretation" of the statutory standard, does not even bother to quote his interpretation, let alone discuss it. I think that, to the degree it was necessary for him to construe the meaning of "will endanger," the Administrator committed no error. A "significant" risk to health is a risk that is sufficiently likely to occur to meet Section 211's standard of risk; and the harm caused by lead poisoning is sufficiently debilitating to meet the section's standard of harm.20 Rather than ignoring the Administrator's determination, the majority should have accorded it considerable deference. The deference ordinarily owed to the interpretation of a statute by the officer charged with its administration, see Zuber v. Allen, 396 U.S. 168, 192 (1969); Udall v. Tallman, 380 U.S. 1, 16 (1965); United States v. American Trucking Assns, 310 U.S. 534, 549 (1940), is heightened when, as here, the interpretation is of a new statute by its implementing agency.21 See Power Reactor Development Co. v. International Union of Electricians, 367 U.S. 396, 408 (1961); United States v. Zucca, 351 U.S. 91, 96 (1956); United States v. American Trucking Assns, supra; Norwegian Nitrogen Products Co. v. United States, 288 U.S. 294, [5 ELR 20126] 315 (1933). The majority's linear comparison of Sections 108, 202 and 211 distorts the statutory scheme and transforms the carefully drafted precautionary language of Section 211 into a requirement that the Administrator sit idly by as the storm approaches, consigned to wait until its damage is felt before taking then largely superfluous preventive action. Since I do not believe that is what Congress intended or the statute requires, I reject the majority's construction, and would defer to the Administrator's
2. Assessment of Risks Permitted. The majority demands that the Administrator make a "threshold factual determination" that automobile lead emissions "will endanger" the public health,22 majority opinion at 16-17, and rejects his claim that he may make "an essentially legislative policy judgment, rather than a factual determination, concerning the relative risks of underprotection as compared to overprotection." Industrial Union Department, AFL-CIO v. Hodgson, U.S.App.D.C. , , 499 F.2d 467, 475 (1974). The majority position flows inexorably from its transformation of the "will endanger" determination from one of risk into one of fact. Indeed, the majority's willingness to disregard the plain meaning of "endanger" may be explained by its desire to make its "factual" argument. But Section 211 does not call upon the Administrator for a factual judgment. Determination of endangerment involves the assessment of risks. The threshold question posed for the Administrator is whether lead emissions "present a significant risk of harm." 38 FED. REG. 33734. How can the Administrator determine whether lead emissions are a significant risk to public health if he cannot assess risks?And how can he assess risks if he cannot make policy judgments? Surely reliance on "facts" as contemplated by the majority will provide little guidance. Fortunately, sole reliance on facts was not demanded by Congress.23
Originally, it is true, it appeared that Congress would severely restrict the Administrator's ability to assess risks and make policy judgments to protect public health. The bill sent to the floor of the House, and eventually passed by the House, would have allowed EPA to control fuels or fuel additives only it the determination that their emission products would endanger the public health was established
on the basis of specific findings derived from relevant medical and scientific evidence, including * * * a finding that it is not otherwise technologically or economically feasible to achieve the emission standards established pursuant to section 202 of this Act.
H.R. 17255, 91st Cong., 2d Sess., § 210(g)(1) (1970) (emphasis added). The specific findings requirement had more than procedural significance.24 It limited the scope of evidence on which the Administrator could proceed, made alternative action under Section 202 mandatory if possible, and was widely interpreted in the House, as the extracts of debate quoted by the majority show, majority opinion at 18-19, as requiring that any EPA action be based solely on facts.25 See also H.R. Rep. No. 91-1146, 91st Cong., 2d Sess., at 13 (1970).
But the House bill did not become law. The Senate's preference for less restriction of EPA freedom in regulating [5 ELR 20127] fuel additives for health reasons26 was adopted by the conference committee and ultimately enacted into law.27 As Section 211 now reads, the only "finding" the Administrator is required to make is that any fuel additive that might replace one that is prohibited does not cause emissions that will pose the same or greater danger to the public health.28 The substantive impact of the change is clear. All of the requirements for specific findings quoted above are replaced by requirements that the Administrator "consider" the specified evidence. The mandatory deference to Section 202 is removed. And the Administrator may act based on all information available to him.29 As we recognized in Amoco, the conference committee's decision "was a deliberated one and was meant to have significance."30 Amoco Oil Co. v. EPA, supra, U.S.App.D.C. at , 501 F.2d at 733.
In this case the decision has even more significance than it did in Amoco, for under Section 211(c)(1)(B), at issue in Amoco, the Administrator was still required to make "findings." All the conferees dropped was the adjective "specific." For regulation under Section 211(c)(1)(A), at issue here, however, the entire requirement was dropped, and no greater restriction was placed on the Administrator than that required by the "basis and purpose" statement of Section 4(b) of the APA, 5 U.S.C. § 553(c). We interpreted the meaning of the limited findings requirement for acting under Section 211(c)(1)(B) in Amoco:
[W]e read Section 211(c)(2)(B) as incorporating the commonsense approach which the courts have developed in applying Section 4(b)31 of the APA. Where EPA's regulations turn crucially on factual issues, we will demand sufficient attention to these in the statement to allow the fundamental rationality of the regulations to be ascertained. Where, by contrast, the regulations turn on choices of policy, on an assessment of risks, or on predictions dealing with matters on the frontiers of scientific knowledge, we will demand adequate reasons and explanations, but not "findings" of the sort familiar from the world of adjudication.
Amoco Oil Co. v. EPA, supra, U.S.App.D.C. at - , 501 F.2d at 740-741. Thus the Amoco court read the limited findings necessary for action under Section 211(c)(1)(B) as a flexible requirement that demanded actual findings for questions of fact and something less — "adequate reasons and explanations" — for questions of policy.
As the majority correctly points out, the Amoco court applied this approach by holding that the threshold determination whether to regulate at all under Section 211(c)(1)(B) was essentially a question of fact, for which a factual finding must be offered. In holding [5 ELR 20128] that such a finding is necessary for action under Section 211(c)(1)(A) as well, however, the majority ascribes no significance to the complete deletion of the findings requirement for that section. By so glossing over the language of the statute (after lecturing us that "the actual language of a statute [is] the best indication of the intent of Congress," majority opinion at 23), the majority misses a vital difference between the threshold determinations under Sections 211(c)(1)(A) and (B). Recall what the Administrator must find in order to act under Section 211(c)(1)(B): that the emission products of the fuel or additive to be regulated
will impair to a significant degree the performance of any emission control device or system which is in general use, or which the Administrtor finds has been developed to a point where in a reasonable time it would be in general use were such regulation to be promulgated.
42 U.S.C. § 1857f-6c(c)(1)(B). At its core, this is a peculiarly factual finding. Will the emission impair the performance of a control device? Is the device in general use, or has it the potential to be? It was these questions, highly suitable to factual proof, that the Amoco court construed. Contrary to the majority's implication, the court did not hold that any threshold determination to regulate must be based on factual proof, but that this threshold determination must be factually based. The Section 211(c)(1)(A) threshold determination, however, is inherently unlike that of its sister section. "Endanger," as I have suggested above, is not a standard prone to factual proof alone. Danger is a risk, and so can only be decided by assessment of risks.
Thus a reason emerges for deletion of the findings requirement for action under the "will endanger" standard. The Amoco court held the findings requirement of Section 211(c)(1)(B) no more than reiterated the minimal demands of the basis and purpose statement of the APA. Amoco Oil Co. v. EPA, supra, U.S.App.D.C. at , 501 F.2d at 739. What Congress was doing, then, was using the findings requirement to indicate which section demanded a factual threshold determination and which section did not. While inclusion of the phrase was unnecessary in that the APA would have demanded a factual threshold determination under Section 211(c)(1)(B) in any case, the selective use of the findings requirement served to emphasize to the Administrator the demands of the APA and the intent of the Congress. Thus I interpret deletion of the findings requirement for action under Section 211(c)(1)(A) as a recognition by Congress that a determination of endangerment to public health is necessarily a question of policy that is to be based on an assessment of risks and that should not be bound by either the procedural of the substantive rigor proper for questions of fact. Unitl the majority deals with the deletion, it has not considered the "actual language" of the statute, and its opinion remains, to my mind, unpersuasive.
All this is not to say that Congress left the Administrator free to set policy on his own terms. To the contrary, the policy guidelines are largely prescribed, both in the statutory term "will endanger" and in the relationship of that term with other sections of the Clean Air Act. Thus, as has been discussed extensively above, see pages 10-19 supra, "will endanger" contemplates regulation of emissions "present[ing] a significant risk of harm." The parameters of that term are fleshed out by its juxtaposition with more and less rigorous language in Sections 108, 112 and 202. But while Congress has made the basic policy decision, the Administrator is left, in his judgment, to interpret and apply it. That is, the Administrator's delegated duty under Section 211(c)(1)(A) is to assess the risks to the public health posed by automotive emissions of lead particulates.
Of course risks are not assessed in thin air. Assessment of risk, beyond all doubt, is based on fact.The point the majority cannot quite grasp, however, is that it is not based on fact alone.32 Rather, a risk may be assessed from suspected, but not completely substantiated, relationships between facts, from trends among facts, from theoretical projections from imperfect data, or from probative preliminary data not yet certifiable as "fact." See Amoco Oil Co. v. EPA, supra, U.S.App.D.C. at - , 501 F.2d at 740-741; Industrial Union Department, AFL-CIO v. Hodgson, supra, U.S.App.D.C. at , 499 F.2d at 475. By allowing regulation in the absence of proof of actual harm, Congress has made a policy judgment in favor of overprotection rather than underprotection. See Industrial Union Department, AFL-CIO v. Hodgson, supra, U.S.App.D.C. at - , 499 F.2d at 474-475. Such a cautious policy can be implemented Only if the Administrator is empowered to assess risks. Of course, this power does not permit him to act on hunches or wild guesses; Amoco makes it quite clear that his conclusions must be rationally justified. But the command of Congress is that the Administrator act to prevent harm. He cannot wait, as the majority would have him, until he can point, with factually indisputable precision, to the poisoning effect of lead automobile emissions in the past. Majority opinion at 14. I, Probably more than the majority, agree that Congress wanted the Administrator to act as a professional, for I think Congress gave him the power to make tough professional decisions, and not merely the power to implement foregone conclusions. Congress did not make the Administrator a functionary. His duty is to be our environmental watchdog, to warn us and to protect us when, inter alia, lead particle emissions from automobiles threaten our health. I am confident Congress did not assign this high duty without giving the Administrator, in Section 211(c)(1)(A), the power to do the job.
[5 ELR 20129]
In sum, the task of the Administrator in making the threshould "will endanger" determination is to consider all the information available to him, including, but not limited to, the evidence he is expressly required to "consider" by Section 211(c)(2)(A). Some of the information will be factual, but much of it will be more speculative — scientific estimates and "guesstimates" of probable harm, hypotheses based on still-developing data, etc. The final determination is, of course, for the Administrator. Operating within the policy guidelines inherent in the "will endanger" standard, he must act, in part on "factual issues," but largely "on choices of policy, on an assessment of risks, [and] on predictions dealing with matters on the frontiers of scientific knowledge * * *." Amoco Oil Co. v. EPA, supra, U.S.App.D.C. at , 501 F.2d at 741. A standard of danger — fear of uncertain or unknown harm — contemplates no more.
3. Propriety of the Cumulative Impact Approach. In addition to demanding that the Administrator act solely on facts, petitioner Ethyl Corporation (Ethyl) insists that those facts convince him that the emission to be regulated, "in and of itself," i.e. considered in isolation, endangers health. Ethyl brief at 14-18. The majority approves the Administrator's contention that the impact of the emission is properly considered together with all other human exposure to the chemical in question. I agree with the majority since I think the nature of human exposure to lead, which was the fuel additive Congress had in mind in enacting Section 211(c)(1)(A), necessitates the Administrator's construction of the statute, and I believe his cumulative impact approach is what Congress intended. Indeed, the arguments cited by Ethyl only prove that the "in and of itself" test was never considered, let alone mandated, by Congress. Since the majority does not fully explain its rejection of Ethyl's argument, I shall elaborate somewhat.
First, Ethyl points to the language of Section 202 allowing regulation of any automobile emission that "causes or contributes to, or is likely to cause or contribute to, air pollution which endangers the public health or welfare." Section 202(a)(1), 42 U.S.C. § 1857f-1(a)(1) (emphasis Ethyl's in its brief at 18). This is contrasted with the language of Section 211 allowing regulation of fuels or fuel additives whose "emission products * * * will endanger the public health or welfare." By italicizing the "contribute to" language of Section 202 Ethyl presumably suggests that the more lenient Section 202 allows use of the cumulative impact theory while Section 211 does not. I cannot, however, read Section 202 to be any more or less assertive of the cumulative impact theory than Section 211, and so I reject Ethyl's argument. While it is possible that Section 202's inclusion of emissions that "cause or contribute to air pollution" is more encompassing than Section 211's term "emission products," it is clear that whatever leniency Section 202 suggests only concerns the makeup of air pollution. This is largely irrelevant to the cumulative impact theory. However they differ, both Section 202 and Section 211 allow regulation of lead additives only on a determination that the resultant polluted air, however composed, endangers the public health.33 Both provisions leave open the question whether emissions or air pollution can be found to endanger the public health when that endangerment is not caused by that pollution alone.34
While Ethyl's comparison suggests no answer, the question is directly raised here. The Administrator found endangerment, but recognized that the national lead exposure problem is caused, not by automobile lead emissions alone, but by an aggregate of sources, including food, water, air, leaded paint, and dust.He believed that regulation was justified because the aggregate was dangerous, and because leaded gasoline was a significant source that was particularly suited to ready reduction. 38 FED. REG. 33734. To the question whether the Administrator was correct in his belief, comparison with the "contribute to" language of Section 202 provides no guidance.
The only other evidence relied upon by Ethyl for its "in and of itself" theory is a quotation, taken out of context, from Senator Baker. When the context of Ethyl's partial quotation is revealed, the irrelevance of his statement to Ethyl's theory becomes clear. Senator Baker reviewed the Committee bill for the Senate:
The [Administrator] is authorized to either control or prohibit the sale of any given fuel when he finds one of two things:
First. That the combustion or evaporation of such fuel produces emissions that, in and of themselves, endanger the public health or welfare; or
Second. That such emissions prevent the operation of a system that is necessary to reduce automobile emissions to the levels required by standards issued by the [Administrator] under section 202 of the act.
116 CONG. REC. 32920 (1970) (emphasis added). Ethyl relies on the Senator's subsequent repetition of the words "in and of themselves," italicized above. Ethyl brief at 16. But the second paragraph makes clear that Senator Baker's meaning is contrary to Ethyl's implication. He is simply emphasizing the different nature of the two provisions and thus uses the words "in and of themselves" to show that under Section 211(c)(1)(A) the Administrator may act only because of the direct effects of lead additives on a legislative goal, protection of health, while under Section 211(c)(1)(B) he may act because of their indirect effects on another goal, implementation of emission control systems.35
[5 ELR 20130]
Beyond these two points, Ethyl has nothing more to offer in support of its "in and of itself" reading. Thus it has made out no case at all, particularly in light of the realities of human exposure to lead and what Congress knew about those realities. Such consideration demonstrates both that, under Ethyl's approach, EPA regulation of lead on health grounds would be impossible and that Congress could not possibly have intended the restrictive "by itself" reading.
Lead is an ubiqutious element. It is found in the land, in the sea, in plants, in animals, and, ultimately, in humans. Traces of lead ranging from 10 to 30 micrograms per 100 grams of blood (10-30 ug/100g)36 are found in everyone, including those living in environments with almost no atmospheric lead. Third Health Document at III-2, JA at 55; NATIONAL ACADEMY OF SCIENCES COMMITTEE ON BIOLOGIC EFFECTS TO ATMOSPHERIC POLLUTANTS, AIRBORNE LEAD IN PERSPECTIVE 47 (1972) (hereinafter NAS Report). Despite its universal presence, however, lead serves no known purpose in the human body, and it is undisputed that at higher concentrations lead is toxic, causing anemia, severe intestinal cramps, paralysis of nerves, fatigue, and even death. Clinical symptoms of lead poisoning appear at blood lead levels of 80-100 ug or higher, and symptomatic lead poisoning may appear at levels of 50-60 ug, particularly in the presence of anemia. Third Health Document at III-1, 2, JA at 54-55. EPA established 40 ug as a prudent level at which to assume an undue exposure to lead. Id. at III-11, JA at 64. Thus lead is present in everyone, and it is only when lead concentrations climb above the normal 10-30 ug level to 40 ug and above that danger to health is indicated.
Where does human body lead come from? In most people, the largest source is the diet. EPA estimates daily dietary lead intake for adults to average 200-300 ug per day, with a range of from 100-500 ug a day. Third Health Document at V-2, JA at 82. Absorption of dietary lead into the bloodstream is estimated at about 10 per cent, although in children absorption may be as high as 50 per cent. Thus the average adult adds 20-30 ug of lead to his bloodstream daily from his diet alone. This daily intake, which may be highly variable depending on individual diets, NAS Report at 50, is generally regarded as, for all practical purposes, uncontrollable.37 Certainly petitioners have not suggested that the Government could more profitably proceed against lead through food regulation.
A second major source of the body's lead burden, at least among urban children, is reported as controllable, although effective control may be both difficult and expensive to achieve. Ingestion of lead paint by children with pica (the abnormal ingestion of non-food substances, a relatively common trait in pre-school children, particularly below age three) is generally regarded as "the principal environmental source in cases of severe acute lead poisoning in young children." NAS Report at 140. Lead-based paint was widely used in pre-1940 housing, for both interiors and exteriors, so children living in older housing, particularly in urban ghettos, where such paint is both present and peeling are most susceptible to this form of lead poisoning. Limited control has been achieved in that lead paints are now rarely used, and are frequently banned by statute, for interior surfaces. But while some local laws require removal of existing peeling lead paints, and there is federal legislation to aid states and municipalities in such efforts, Lead-Based Paint Poisoning Prevention Act, 42 U.S.C. §§ 4801 et seq., (1970), there is no concentrated national effort at removal, and the danger to children living in dilapidated housing will remain for some time.38
The last remaining major source of lead exposure for humans is the ambient air. This source is easily the most controllable, since at least 90 per cent of lead in the air comes from automobile emissions.39 While the extent to which such lead actually enters the body is vigorously contested by petitioners, all parties agree that, at least in theory, airborne lead can be absorbed through the lungs as a person breathes lead-contaminated air and that it can be eaten by children with pica after larger lead particles fall to the ground and mix with dust. Respiratory absorption of lead is significantly higher than gastrointestinal absorption (most ingested lead is ultimately excreted). Approximately 30 per cent of the lead that enters the lungs is retained by the body, and eventually enters the bloodstream.40 Based on this figure, EPA calculates that an average man, who breathes a total of 20 cubic meters of air in one day, can absorb as much lead from the air as from his food if the lead concentration in the ambient air is 5 ug/m n3, a concentration that can be found today in parts of some of our larger cities. Third Health Document at V-7 & Table V-4, JA at 87 & 103. According to EPA, ingestion of lead dustfall can supplement the toxic effect of ingestion of lead-based paint peelings. Indeed, lead dustfall alone may be almost as dangerous as lead paint peelings. As the NAS Panel concluded: "The concentration of lead in street dust and surface soil of large cities is extremely high." NAS Report at 30 (emphasis added). Other than lead contamination near certain industrial sites, virtually all of the lead in dust comes from the fallout [5 ELR 20131] of automobile emissions. The NAS Panel found average concentrations in residential and commercial sites to be 1,636 ug/g and 2,413 ug/g respectively. Even in city parks high concentrations were found, ranging from 194 to 3,357 ug/g. Id. Ingestion of a small quantity of such dust by a child could account for eight to ten times as much lead absorption as he receives from his daily diet.
In summary form, then, lead enters the human body from food and water, from the air, from lead paints, and from dust. It is important to note that once within the body the source of the lead becomes irrelevant; all lead in the bloodstream, from whatever source, is essentially fungible.Thus, so long as there are multiple sources of lead exposure, it is impossible to isolate one source and determine its particular effect on the body. The effect of any one source is meaningful only in cumulative terms. If, for example, airborne lead were the only source of the lead body burden, and it caused, by itself, a blood lead level of 30 ug, there would be no danger to the public health. But if that hypothetical 30 ug is added to a possible 30 ug attributable to dietary ingestion, the blood lead level would be 60 ug, a definite threat to health. Under Ethyl's approach, despite obvious endangerment such a cumulative finding is insufficient to justify regulation. Airborne lead, in and of itself, may not be a threat. But the realities of human lead exposure show that no one source in and of itself (except possibly leaded paint) is a threat. Thus under Ethyl's tunnel-like reasoning, even if parallel legislation permitted regulation of other sources of lead exposure, which it does not, no regulation could be justified. Ethyl would bid the public to suffer patiently the gradual debilitation of lead poisoning, while it sends the responsible federal agency on an endless hunt for an impossible finding.
Such cannot be the case.Congress understood that the body lead burden is caused by multiple sources. It understood that determining the effect of lead automobile emissions, by themselves, on human health is of no more practical value than finding the incremental effect on health of the fifteenth sleeping pill swallowed by a would-be suicide.41 It did not mean for "endanger" to be measured only in incremental terms.42 This the Administrator also understood. He determined that absorption of lead automobile emissions, when added to all other human exposure to lead, raises the body lead burden to a level that will endanger health. He realized that lead automobile emissions were, far and away, the most readily reduced significant source of environmental lead. And he determined that the statute authorized him to reduce those emissions on such a finding. I agree with the majority that there was no error in the Administrator's use of the cumulative impact approach.43
4. The Meaning of "Public Health." The majority refrains from attempting to define the statutory term "public health," a restraint which I applaud. Since the question of the statutory meaning of "public health" is not raised in this case, I think it is neither necessary nor appropriate to provide one. The term "public health" is peculiarly ill-suited to precise generalized definition,44 particularly in the absence of a concrete controversy.45
The majority does, however, imply, based solely on a cursory comparison with a largely unrelated bill that happened to be contemporaneously working its way through the Congress,46 that, as a matter of law, these [5 ELR 20132] lead regulations deal only with limited occupational groups and that national regulation may therefore be unjustified. I reject that implication. In this case the Administrator has regulated based on perceived danger to "the health of urban populations, particularly to the health of city children." 38 FED. REG. 33734. I think it is sufficient to note that urban populations account for some three quarters of the total populations.47 I think it beyond question that concern about the danger of lead poisoning of such a group can justify regulations under a "public health" standard no matter how the term is defined. See, e.g., Bunting v. Oregon, 243 U.S. 426 (1917); State v. Cleveland, 47 N.M. 230, , 141 P.2d 192, 197 (1943). Accordingly, I would hold, as a matter of law, that the Administrator's concern about possible lead poisoning of our urban populations justifies his regulation under Section 211(c)(1)(A),48 and leave any further refinements of the "public health" standard for future cases.49
5. Summary of the "Will Endanger" Determination. In sum, I disagree extensively with the majority's reading of the "will endanger" standard. The majority has, I believe, imposed a cramped and unrealistic interpretation on Section 211(c)(1)(A), one that renders it largely useless as a basis for health-related regulation of lead emissions. The majority's action contradicts the plain meaning of the statute and the Administrator's interpretation of it, the legislative history, the implications that can be drawn from other sections of the same statute, and the well-known maxim that health-related legislation is to be liberally construed to achieve its purpose.50
I believe the Administrator may regulate lead automobile emissions under Section 211(c)(1)(A) when he determines, based on his assessment of the risks as developed by consideration of all the information available to him, including but not limited to relevant scientific and medical evidence,51 and as guided by the policy judgment inherent in the statute, that lead automobile emissions significantly increase the total human exposure to lead so as to cause a significant risk of harm to the public health. Such an interpretation would not allow baseless or purposeless regulation,but it would grant the Administrator the flexibility needed to confront realistically the public health problem presented by massive diffusion of lead emissions from automobiles. In my judgment, this is what Congress intended. Despite the majority's invitation to the Administrator to repromulgate new lead regulations under Section 211(c)(1)(A), majority opinion at 73, its opinion effectively forecloses that possibility.I fear the majority leaves the Administrator to chase "the fatal futility of Fact." H. JAMES, THE SPOILS OF POYNTON (Doubleday ed. 1971), when the real question posed here is one of judgment.
B. Comparison with Substitute Additives
Even when the Administrator has determined that a fuel or fuel additive causes emissions which endanger the public health, he is not yet free to prohibit the substance under Section 211. He must first find, and publish his finding,
that in his judgment such prohibition will not cause the use of any other fuel or fuel additive which will produce emissions which will endanger the public health or welfare to the same or greater degree than the use of the fuel of fuel additives proposed to be prohibited.
Section 211(c)(2)(C), 42 U.S.C. § 1857f-6c(c)(2)(C). While the majority in reversing does not find it necessary to construe this section, I must briefly comment on its requirements, since I would affirm the Administrator's determination.
Preliminarily it must be noted that the section requires a finding only before the Administrator "prohibits" a fuel or fuel additive under Section 211. Since the proposed regulations only "control" lead additives, the findings requirement, on its face, does nto apply to the EPA action.52 If the requirement were read to apply, [5 ELR 20133] however, I suggest it demands no more than the findings requirement of Section 211(c)(2)(B), as construed in Amoco, see page 29 supra. This conclusion is compelled, to my mind, by the identical genesis of the two provisions, plus the fact that the Section 211 (c)(2)(C) finding is judgmental by its own terms. Thus where the judgment turns "on factual issues" I believe we should "demand sufficient attention to these in the statement to allow the fundamental rationality * * * to be ascertained." Amoco Oil Co. v. EPA, supra, __ U.S.App.D.C. at __-__, 501 F.2d at 740-741. By contrast, where the judgment is necessarily more speculative, we should "demand adequate reasons and explanations, but not 'findings' of the sort familiar from the world of adjudication." Id., __ U.S.App.D.C. at __, 501 F.2d at 741.
After making the "will endanger" determination, and where necessary the "substitute additives" finding, EPA had complied with the statutory mandate and is free to regulate the fuel or fuel additive under Section 211.
III. THE STANDARD OF REVIEW
Nothing causes appellate judges more difficulty than finding and applying the proper standard of review in agency cases. Although the majority would reverse the Administrator for improperly interpreting Section 211, it plunges on to review the evidence under his interpretation and, in doing so, misapplies the proper standard of review. The majority recognizes, as it must, that EPA's proceedings under Section 211 constitute informal rule-making and must be reviewed, since the statute does not indicate otherwise,53 under Section 10(e)(2)(A)-(D) of the APA, 5 U.S.C. § 706(2)(A)-(D).54 The majority's evidentiary review is governed by Section 10(e)(2) (A), which requires the reviewing court to strike "agency action, findings, and conclusions" that it finds are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law * * *."55 5 U.S.C. § 706(2) (A). But while the majority purports to apply this test, its excessive reliance on a phrase torn from the context of a leading Supreme Court case, Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971), effectively transforms its review into the substantial evidence test appropriate only for formal rule-making and adjudication.
This transformation is a common phenomonem. It may be that courts are so willing to abandon the statutorily mandated "arbitrary and capricious" standard because the standard is so singularly undemanding. The extreme deference the statute demands of the reviewing court cuts against the grain of judges who have been taught that their generalist backgrounds equip them to provide dispassionate and comprehensive answers to any sort of problem. While ofter such judicial intervention is important — nay, essential — to preservation of our government of laws and achievement of our societal goals,56 Congress recognized that review of agency informal rulemaking was not a proper occasion for such activism. Thus Congress mandated the most limited scope of review. And, like it or not, the courts must live with what Congress constitutionally ordered.
Perhaps the most useful way to appreciate the limited scope of "arbitrary and capricious" review is to compare it with "substantial evidence" review. Substantial evidence review is expressly reserved for adjudication and for rule-making required to be "on the record." 5 U.S.C. § 706(2)(E); "arbitrary and capricious" review is obviously something less. Cf. Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 414-416. What that something less might be is suggested by the extreme deference to agency findings demanded by substantial evidence review itself. Under that test a court may not reverse agency proceedings merely because it considers them "clearly erroneous." n57Instead the court must apply [5 ELR 20134] the familiar definition of Chief Justice Hughes:
Substantial evidence is more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.
Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). See also Universal Camera Corp. v. NLRB, 340 U.S. 474, 477 (1951). Hard though it is for courts to accept, evidence that meets the "arbitrary and capricious" standard is not quite that. It may include evidence that at least some reasonable minds might not accept as adequate to support a conclusion. Put another way, under the "arbitrary and capricious" standard it is not the court's task to weigh evidence and pronounce it "adequate."
This is not to say there is no requirement of rationality for agency rule-making. To the contrary, it is precisely the function of "arbitrary and capricious" review to define the bounds of permissible agency reasoning and to hold the agency to some rudimentary form of rationality in both weighing the evidence and reaching its conclusions.58 The tension between the court's scrutiny of the evidence and its limited role in evaluating it has been recognized by the Supreme Court, which left the issue in careful balance. It has recently held that, while the "inquiry into the facts is to be searching and careful, the ultimate standard of review is a narrow one." Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 416. Significantly, the Court then added, "The court is not empowered to substitute its judgment for that of the agency." Id. This addition, the most recent High Court affirmance of the basic principle of the narrow "arbitrary and capricious" standard of review,59 reasserts that in making its "searching and careful" inquiry, a reviewing court is not to test de novo the adequacy of the evidence that supports agency's conclusions, but rather is simply to assure itself that the decisionmaker has given actual, good faith, and serious consideration to all the relevant evidence.60 If he has, then it matters little what weight he has assigned to particular pieces of evidence in making his final judgment.
Of course, the Supreme Court is not demanding mere procedural review.61 Indeed, the seriousness and good faith of the agency proceedings can be tested only by assessing the rationality with which the decision-maker addresses critical comments and weaves a path through the evidence to the final rule. Thus, beyond doubt, the "arbitrary and capricious" standard demands the court assure itself that the agency has acted rationally and not through whimsy or caprice. But, also beyond doubt, it demands no more; and the standard of rationality is relatively undemanding.
The majority has correctly stated the standards for "arbitrary and capricious" review, but it then takes one phrase from Overton Park and applies it completely out of context. In the course of its definitive treatment of "arbitrary and capricious" review the Court in Overton Park indicated that part of the judicial review function was to consider whether there has been "a clear error of judgment."62 Id. at 416.The Court's use of the phrase, carefully bracketed by traditional statements of the restraint [5 ELR 20135] of "arbitrary and capricious" review, did not work any change in existing law. The majority, however, takes the "clear error of judgment" standard and uses it, in isolation, as the test for "arbitrary and capricious" review. This is a dangerous course, for the phrase, standing alone, has considerable potential to distort the proper standard of review. The danger derives, of course, from the phrase's similarity to the "clearly erroneous" standard used to assess a trial judge's findings of fact and abuses of discretion.63 "Clearly erroneous" review is highly probing and, indeed, permits the reviewing court to substitute its judgment for that of the trial court and upset findings that are not unreasonable.64 This Overton Park expressly forbade, so it is clear that the phrase was used in a far more limited context. The majority, however, by taking from Overton Park only the "clear error of judgment" language, and leaving the other trappings of "arbitrary and capricious" review behind, has granted itself a scope of review that the APA does not allow: The power to invade the Administrator's judgment and reverse it because the court disagrees with his conclusions. I fear that this is what has occurred.
The proper course for reviewing informal agency action is to use the statutory language itself. The court must inquire whether the action is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law * * *." Section 10(e)(2)(A), 5 U.S.C. § 706 (2)(A). This is the approach consistently taken by the Supreme Court in applying the "arbitrary and capricious" standard, and it is, of course, the approach demanded by the APA. In utilizing this standard, the Court has most recently reversed a three-judge District Court that inquired too intrusively into an order of the Interstate Commerce Commission and therefore thought it proper to invalidate the order as "arbitrary and capricious." The unanimous Court, after expicitly reaffirming Overton Park's statement of the bounds of "arbitrary and capricious" review, dramatically emphasized the extreme deference to agency decisions demanded by that standard:
The Commission's treatment of the evidence of the applicant's performance on other routes is not a paragon of clarity. Had the Commission responded in a more considered manner to the evidence appellees presented, review would have been greatly facilitated, and review by this Court perhaps avoided entirely. But we can discern in the Commission's opinion a rational basis for its treatment of the evidence, and the "arbitrary and capricious" test does not require more.
Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., U.S. , , 43 U.S. L. WEEK 4091, 4094 (Dec. 23, 1974) (emphasis added). The Court is saying agency action is presumed valid unless, after diligent search, no rational basis for the action can be perceived. By searching through the record seeking "clear errors of judgment," and by failing entirely to attempt to "discern * * * a rational basis for [the Administrator's] treatment of the evidence," the majority has misapplied the "arbitrary and capricious" test and transformed it into an unduly rigorous standard.65 While criticizing the Administrator's purported "unease * * * with the 'will endanger' standard,"66 majority opinion at 41, the majority's own unease with the "arbitrary and capricious" standard deprives the Administrator of the deference to which he is due.
With Congress' mandate that informal rule-making be tested by the "arbitrary and capricious" standard firmly in mind,67 I now turn to the evidence supporting the instant regulations.
[5 ELR 20136]
IV. THE EVIDENCE
The majority would reverse the Administrator because it finds that he has misconstrued the statutory requirements of the "will endanger" standard. Nonetheless, it proceeds to consider the evidence adduced, and the Administrator's conclusions drawn therefrom, purportedly under the standard it now holds erroneous. Majority opinion at 69 & note 89. Despite this tacit concession of the dubiety of its reading of Section 211(c)(1)(A), the majority does not actually do what it promises. In supposedly considering the evidence under the standard as construed by EPA, the court neglects to concede that the "will endanger" standard is one of risk or that the Administrator has any power to assess risks. Thus the court's evidentiary review continues its ill-starred hunt for fact in this highly judgmental area. This is not an alternative ground of decision, but merely a reemphasis of the initial ground. Moreover, not only does the court deny the Administrator the deference implicit in the "will endanger" language itself, it fails as well to grant the deference demanded by the "arbitrary and capricious" standard of review. The court takes the evidence relied on by EPA, criticizes its substance if it can, criticizes EPA procedures if it cannot, and reaches its own conclusions.65 The court is nto applying the "arbitrary and capricious" test. In purporting to look for "clear errors of judgment," the court is simply substituting its judgment for that of the EPA.69
In minor detail, some of the majority's criticisms may have merit. One would expect no less in a critique of an evidentiary record of over 10,000 pages. But if a criminal defendant, the most carefully protected party in our entire judicial system, cannot properly expect a perfect trial, but only a fair one, Lutwak v. United States, 344 U.S. 604, 619 (1953), surely petitioners cannot expect a perfect agency proceeding. The task of the reviewing court, as I have stressed above, is not to seek perfection. Rather we must merely apply the undemanding "arbitrary and capricious" standard to the Administrator's undemanding threshold determination that lead emission products "will endanger" the public health. O my mind, it is impossible to do that in this case and conclude the Administrator has erred.
While petitioners launch multitudinous assaults on the evidence, some things appear to be uncontested. Thus petitioners seem to concede the following: that lead serves no useful purpose in the human body; that lead in sufficiently high quantity is destructive to the body, causing anemia, severe intestinal cramps, paralysis, neurologic damage, and, in sufficient dosage, death, Third Health Document at III-1, 2, JA at 54-55; that more than 250,000 tons of lead per year are used in production of lead additives, accounting for 90 per cent of all airborne lead, id. at Table II-1, JA at 46; and that blood lead levels are a reasonable indication of the body's lead burden. Stripped of their generalized, and largely unsubstantiated, claims of "bias" and "distortion of the evidence," petitioners principally challenge three EPA conclusions: (1) that, based on a preliminary determination that blood lead levels of 40 ug are indicative of danger to health, elevated blood lead levels "exist to a small but significant extent in the general adult population, and to a very great extent among children," Third Health Document at VII-3, JA at 144; (2) that airborne lead is directly absorbed in the body through respiration to a degree that constitutes a risk to public health; and (3) that airborne lead falls to the ground where it mixes with dust and poses a significant health risk to urban children.
A. Blood Lead Levels are Elevated Among the General Public
1. Blood lead levels of 40 ug are indicative of danger to health. While the majority assumes, for the sake of argument, the Administrator to be correct in this determination, majority opinion at 49, petitioners contest that conclusion, so it is necessary for me to consider the validity of their claims. Much of petitioners' argument adds up to nothing more than that petitioners are unhappy the Administrator chose to exercise his judgment, and think the statute does not permit such discretion. They cite medical studies that show, not that a blood lead level of 40 ug is unrelated to danger, but that scientists are simply uncertain about the effect of such blood levels. Ethyl brief at 37-38; brief for petitioners PPG Industries and E.I. duPont be Nemours & Commpany (hereinafter PPG brief) at 11-12; brief of petitioner Nalco Chemical Company (hereinafter Nalco brief) at 14. But, as we have seen, exercise of reasoned discretion based on the facts is not only permitted, but mandated, by Section 211(c)(1)(A). The Administrator recognized from the outset that the health effects of varying human blood lead levels were uncertain and that continuing research was necessary.70 His determination of the 40 ug level is, on its face, an assessment of risks based on the facts then known and not improper as such.
In addition to their generalized attack on the Administrator's power, petitioners challenge the sufficiency of the enidence to support his determination. In applying the "will endanger" standard, however, I find the evidentiary basis for the Administrator's determination to be more than adequate. I note that petitioners do not contest the recommendation of the United States Public Health [5 ELR 20137] Service that 80 ug be taken as the standard of unequivocal lead poisoning, or the Service's recommendation that blood lead levels of 50-79 ug justify immediate evaluation for possible lead poisoning. Medical Aspects of Childhood Lead Poisoning, HSMHA Health Reports, 86(2), 140-143 (1971), cited in Third Health Document at IV-3, JA at 71. What draws petitioners' fire is only the last of the Service's recommendations, adopted by EPA, that for older children and adults "a blood lead concentration of 40 ug or more per 100 ml of whole blood * * * be considered evidence suggestive of undue absorption of lead, either past or present." Id. While the reasonableness of establishing as a danger point a lead exposure level somewhat lower than that at which actual damage may occur seems to me both logically unassailable and well within the intent of the "will endanger" standard, the Administrator went beyond that sufficient conclusion. He recognized, and warned of, possible dangers, particularly to children, from lead at the 40-60 ug level, and even below, thereby suggesting that the Public Health Service's recommended danger level, designed for adults, may be set too high. Because this latter evidence was only suggestive, however, the Administrator conservatively settled on the 40 ug standard. Third Health Document III-5, 6, 7, 8, JA at 58-61. Although recognizing that 40 ug "does not represent a sharp demarcation between health and disease," he found it "prudent to regard blood lead levels over 40 ug/100 g as indicators of lead intake that should be prevented." Third Health Document at III-11, JA at 64. Such a determination is well within the Administrator's discretion under the "will endanger" standard. I have examined the evidence relied upon carefully and, while it is not necessary to summarize it here,71 I find that it supports the Administrator's "prudent" determination under any proper standard of review.
2. Blood lead levels are elevated among a significant number of adults and a considerable number of children. Again, petitioners challenge the Administrator's determination as unsupported by the evidence. The problem here is one of choosing among the items of evidence. Petitioners rely heavily on the results of the so-called Seven Cities Study,72 which found a very small percentage of adults with elevated (in excess of 40 ug) blood levels.73 PPG brief at 12-15; Nalco brief at 16. The Administrator, on the other hand, finds serious methodological flaws in the Seven Cities Study that limit its usefulness, EPA brief at 21-22, and relies instead on studies which concededly support his conclusion, Third Health Document at Tables VII-1, 2 & 3, JA at 145-147, but which petitioners score as representative only of certain occupational groups. PPG brief at 15; Nalco brief at 15-16.
Having analyzed this evidence and the arguments of the parties, I would again defer to the Administrator's judgment. First I note that, while contesting the source of lead exposure, petitioners do not challenge at all the Agency's conclusion that blood lead levels are elevated in a large number of children, including a possible 25 per cent of all urban children. Third Health Document at Table VII-3, JA at 147.Next, while the studies relied on by the Administrator are largely of various occupational groups, they are frequently occupations whose only exposure to lead is through the ambient air in which their practitioners — policemen, service station employees, parking attendants, and the like — are forced to work. Some studies are of such "specialized" groups as "Drivers of Cars," "Male Commuters," and "Urban" residents. Id. at Tables VII-1 & 2, JA at 145-146. I think these data are a sufficient basis for the Administrator's conclusion that elevated blood leads exist "to a small but significant extent in the general adult population, and to a very great extent among children." Id. at VII-3, JA at 144.
B. Automobile Lead Emission Products are Directly Absorbed in the Body to a Significant Extent
While the majority assumes the validity of the above discussion, it finds the Administrator has committed reversible error in finding a correlation between ambient air lead levels and the lead body burden, and in relying on the lead dustfall theory. While I believe the majority's attempts at scientific analysis are out of place in reviewing agency action under the "arbitrary and capricious" standard, I shall, with some trepidation, try my hand at this task in order to meet the majority on its own ground.74
[5 ELR 20138]
The majority discusses in some detail four studies relied on by the Administrator in finding a correlation between air lead levels and body lead levels. It then announces that "in the interest of space" it will not discuss those studies not supportive of the Administrator's conclusion, majority opinion at note 115, leaving the impression that its critique of the four studies discussed has left the Administrator without support. To the contrary, the majority has simply chosen to ignore at least six other sources of evidence supportive of the EPA position. See majority opinion at note 90. After considering the majority's analysis I shall briefly discuss this additional supportive evidence.
The majority first takes on the pilot lead isotope study75 which, by carefully controlling the lead intake of two experimental subjects while maintaining a relatively low air lead concentration of 2 ug/m3, indicated that ambient air can contribute, at that concentration, up to one third of the total lead body burden. The majority does not dispute this conclusion in any way; rather, it disposes of the study by commenting: "Realistically, it is impossible to say that any definite scientific or medical conclusions can be drawn from the observations of one or two subjects." Majority opinion at 51. The majority has slain a horrible of its own making. EPA is not drawing its conclusions from these observations of two subjects; these data are simply supportive of the total body of evidence on which the Agency relied. Moreover, remembering how Pasteur developed the cure for rabies, and Jenner the smallpox vaccination,76 I cannot say with any certainty that the evidence of even one human subject is insufficient for health-related regulation, at least within the precautionary "will endanger" standard.
The majority next criticizes a Japanese study, similar to the Seven Cities Study, that demonstrated to the Administrator "that airborne lead exposures below 2 ug/m3 affect blood lead levels." 33 FED. REG. at 33735. The majority contends that the study's conclusion that "[w]ith the present level of lead concentration in the air it is difficult to establish any direct relationship between lead levels in the air and such levels in blood and urine," K. Tsuchiya et al., "Study of Lead Concentrations in Atmosphere and Population in Japan," at 40 (undated draft), JA at 1131 (emphasis added), is "devastating," majority opinion at 52, to the Administrator's reliance. But that conclusion is not at all contrary to the Administrator's position. The study carefully notes that in Japan "[t]he overall mean atmospheric lead concentration was 0.65 ug/m3 and it is far less than those observed in the U.S. cities." Id. at 39, JA at 1130 (emphasis added). And even at that significantly lower air lead concentration, the study was able to find "a significant positive correlation between ambient [lead] level and blood level for workers by area," id. at 32, JA at 1123, and to conclude, "No doubt an increased respiratory exposure will contribute to an increased intake of lead into the body." Id. at 33, JA at 1124. See also id. at 27, 31-32, JA at 1118, 1122-1123. The increase of blood levels with urbanization "was statistically significant." Id. at 30, JA at 1130. The conclusion quoted by the majority recognizes that, although statistically significant differences were found, they were of relatively small magnitude because of the overall relatively low lead concentrations in Japan. The lengthy quotations presented by the majority do no more than reflect the limitations on the data caused by these low air lead levels. These limitations confine the reach of the important relationships found, but do not undercut in any way the Administrator's limited reliance on this study.
The chamber studies, J. Kuelson et al., "Kinetics of Respiratory Lead Uptake in Humans," Proceedings of the International Symposium on Environmental Health Aspects of Lead, Amsterdam (October 2-6, 1972), JA at 596, which found marked increases in blood lead concentrations among men kept in a controlled environment and exposed to precise air lead concentrations, are attacked by themajority on the basis of differences in size and chemical composition between the lead particles used in the experiment and those found in the ambient air. The Administrator found "these differences [to be] sufficiently small so that inferences can be made regarding effects of airborne lead among the general population." Third Health Document at V-7, 8, JA at 87-88. The majority, however, has located a statement from the authors of the studies warning that because of the cited differences "the portion of lead absorbed the lung [sic] due to our experimental state may differ from the portion absorbed due to exposure of men to ambient air." Quoted in ILZRO/LIA Critique of "EPA's Position on the Health Effects of Airborne Lead," International Lead Zinc Research Organization, Inc. at 16 (March 9, 1973), JA at 2377 (emphasis added), cited in majority opinion at 55. The majority is drawing absolute conclusions from the most circumspect of statements and ignoring the use to which the Administrator puts the chamber studies. All [5 ELR 20139] the quoted statement says is that the study results might not exactly predict the amount of lead absorbed by man from the ambient air. But the Administrator is not using the results for that purpose. He is finding in the results support for his conclusion that lead emissions are in fact absorbed from the ambient air, a conclusion the authors' statement fully supports, and he is using the results in a qualitative way to confirm independent calculations, based on Kehoe's data, of possible absorption. See Third Health Department Document at V-7, 8, 9, JA at 87-89. See pages 73-74 infra. Nothing the majority says indicates that such reliance is improper.
Lastly, the majority addresses the persuasive Daines study, Daines et al., Air Levels of Lead Inside and Outside of Homes, 41 INDUSTRIAL MEDICINE 26 (October 1972), JA at 465, and attempts to criticize it by offering its own statistical analysis. The study tested blood lead levels of black females living 3.7, 38.1, and 121.9 meters from a major highway; air lead levels at these locations were 4.60, 2.41, and 2.24 ug/m3 respectively. The results showed the women living 3.7 meters from the highway's edge averaged lead concentractions of 23.1 ug, while those at the greater distances averaged 17.4 and 17.6 ug. The majority takes special note of a parallel, although less extensive, study of white women living 33.5 and 457 meters from another major highway in air lead concentrations of 1.95 and 1.73 ug/m3; these women showed blood lead levels of 16.1 and 15.7 ug respectively. The majority's analysis is totally conclusory. The first study, it announces, shows "only a weak correlation" between air lead levels and blood lead levels. Majority opinion at 56. The second study, on the other hand, probably presents "a statistically significant inverse correlation * * *." Id. at 57 (emphasis in original).
I wish the majority had explained its conclusions, for they are contrary to those of the scientist-authors of the report and to those of the Administrator. Professor Daines tells us the first study showed, not a "weak correlation," but "a significantly higher lead level" in the blood of occupants of the houses at 3.7 meters. Daines et al., supra, at 26, JA at 465. And, on their face, the results seem fully consistent with EPA's conclusions about lead absorption. Women at 3.7 meters had blood lead levels approximately 32 per cent higher than those living at the greater distances; the air lead concentration at 3.7 meters was approximately 60 per cent higher than at the other locations. Assuming that approximately half of the subjects' blood lead level was derived from dietary intake, the correlation of air lead concentration and blood lead concentration becomes near perfect.77 The Daines study fully supports the Administrator's conclusion.
As for the second study, which the majority finds so significant, all readings were taken beyond the point of the most dramatic changes in air lead concentration and beyond the point at which the statistically significant results of the first study were found. Thus the absence of significant findings is hardly surprising. Moreover, although the air lead concentrations at the two locations were found to differ significantly, the differences were small and comparable to the differences found at like distances in the first study.To my layman's mind, the difference found in the blood lead levels in this study, a negative difference of 0.4 ug (16.1 - 15.7), is hardly different from that found in the first study at those remote distances, a positive difference of 0.2 ug (17.6 - 17.4). I see no reason why these figures are not to be attributed to experimental error, and I certainly see no basis for the majority's attributing any sort of statistical significance to them. Thus the Administrator's reliance on the results of the Daines study is not only proper, but highly enlightening.78
Besides these four sources, which I believe are fully supportive of the Administrator's conclusion, the Third Health Document refers to further supportive material which the majority does not address. Most significantly, the majority ignores the Agency's calculations, based on Kehoe's classic experiments with human absorption of lead, of the ambient air lead concentration necessary to bring an average man's blood lead level to the 40 ug danger point. These calculations are based on a regression line derived from Kehoe's data, and present variable projections based on daily dietary lead absorption of 20 and 30 ug, daily respiration of 15 and 20 m3, and absorption of 17, 30, and 37 per cent of the lead in the respired air. For a standard man, who absorbs 30 ug of dietary lead daily, breathes 20 m3 of air, and absorbs 30 per cent of the respired lead, the Agency calculates that exposure to air lead concentrations of 5.0 ug/m3 would increase daily lead absorption by 30 ug and produce a 40 ug blood lead level within a year. Third Health Document at V-4, 5, 6, 7, Figures V-1 & V-2 & Tables V-1, 2, 3, 4, JA at 84-87, 89-103. Petitioners do not seriously contest the validity of these calculations,79 which are [5 ELR 20140] supported by the chamber studies described above. Third Health Document at V-7, 8, 9, JA at 87-89. I see nothing wrong with considering such predictions from imprecise data when acting under the "will endanger" standard, Cf. Industrial Union Department, AFL-CIO v. Hodgson, supra, U.S.App.D.C. at , 499 F.2d at 475, and I would hold that these calculations, buttressed as they are by the chamber study findings, provide substantial support for the Administrator's conclusion.
In addition to this important theoretical extrapolation, the majority has ignored several positive inferences EPA has drawn even from studies relied on by petitioners. Thus the Agency noted that the Seven Cities Study found urban dwellers had consistently higher blood lead levels that their suburban neighbors. Since other sources of human lead exposure are likely to be relatively constant within the same metropolitan area, greater airborne lead concentrations in the inner city is the presumptive culprit.80 Third Health Document at V-9, JA at 89. Likewise, the majority has overlooked the Administrator's inference that the data produced by the Azar study, Azar et al., "Relationship of Community Levels of Air Lead and Indices of Lead Absorption," Proceedings of an International Symposium on Environmental Health Aspects of Lead, CEC, CID, Luxembourg, at 581 (May 1973), JA at 387, show a positive correlation between average blood leads and increasing air lead levels. Third Health Document at V-12, JA at 92. Moreover, studies of lead smelter communities fully supportive of the Administrator are dismissed by the majority in a footnote. Majority opinion at note 90. One such study showed positive, although qualitative, differences between children living in smelter and non-smelter communities,81 and another quantified decreasing blood lead levels corresponding with increasing distance from the smelter.82
Lastly, in its quickness to criticize based on the qualifications placed on their data by the researchers and on often picayune statistical differences in the evidence, the majority shows that it has also not considered the Administrator's candid discussion of the inherent limitations in all the data before him, whether presented by industry or Agency scientists. Third Health Document at V-13, 14, 15, 16, JA at 93-96. His point is, basically, that in this area of developing scientific knowledge there will be some limitations on every scientific study conducted and that, therefore, the Administrator's job is to search knowledgeably among the limited data for information that is nonetheless probative. The greatest source of uncertainty in the data, the Administrator explains, is dietary intake. Since daily lead dietary intake may vary from 100 to 500 ug, fixed air lead levels may have widely divergent results on individuals with variable dietary intake. This is the principal flaw with the Seven Cities Study, which made no attempt to control this variable. It is for this reason the Administrator has wisely chosen to rely heavily on the pilot lead isotope study and the chamber studies, which are virtually the only attempts to evaluate air lead intake in a controlled diet situation.
The uncertainty of the data is not limited to diet, however. Most of the calculations are for a "standard" man, while much of the data is for women. While there are substantial reasons for this,83 this fact makes comparisons of raw data with theoretical calculations difficult.84 Moreover, little is known about the propensity of children to absorb atmospheric lead and direct comparison with adults is impossible.85 It is probable, however, that any threat airborne lead poses for adults will be even greater for children.86
[5 ELR 20141]
The Administrator well understood the limitations of the data with which he was dealing. He understood, too, the flexibility of the "will endanger" standard. Thus he was able to conclude, after careful consideration of the best evidence, that enough is known to support his determination that airborne lead is absorbed into the human body in sufficient quantity measurably to increase the blood lead level and, ultimately, to endanger public health. My review of the evidence, both that relied on by the Administrator and that suggested by petitioners as contrary, convinces me that the Administrator has committed no error. Far from finding any "clear error of judgment," I am readily able to "discern * * * a rational basis for [the Administrator's] treatment of the evidence * * *." Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra, __ U.S.__ at __, 43 U.S. L. WEEK at 4049. Thus I think the majority's reversal is unjustified under the "arbitrary and capricious" standard of review."87
C. Lead Exposure from Dustfall Threatens the Health of Children
The Administrator's hypothesis, based on considerable circumstantial evidence, that lead from the ambient air falls to the ground where it mixes with dirt and dust which may be ingested by children with pica has generated virulent responses from petitioners88 and a lengthy eritique from the majority. Both, however, constantly confuse the issue by ignoring what the "will endanger" standard allows the Administrator to consider, and by attempting to refute him with evidence that he both understands and has accounted for. Thus it is helpful first to set these matters straight.
First, I must repeat that the "will endanger" standard allows the Administrator to evaluate risks. See pages 23-34 supra. A risk, like a fact, may be ascertained from circumstantial evidence as well as from direct evidence, cf. 1 J. WIGMORE, EVIDENCE § 26 (3d ed. 1940), and, if shown to be sufficiently hazardous, will, of course, meet the "will endanger" standard. The majority's lengthy attack, majority opinion at 61-63, on the Administrator for failing to conclude that "auto lead emissions are a significant source of lead to children," id. at 61 (emphasis in original), is, therefore, no more than a rehash of its first ground of decision — that the Administrator must proceed only on proved facts — now expanded to criticize his proper use of circumstantial evidence. See id. at 16-27.
Second, although it seems too obvious to mention, the Administrator understood and expressly recognized that leaded paint "is the primary cause of clinical lead poisoning" in children. 38 FED. REG. at 33735. Although petitioners repeatedly try to rebut EPA conclusions by stating this fact, the Administrator was well aware of it and his estimates of possible danger invariably accounted for it.
With this settled, I now turn to the evidence supporting the Administrator's determination. The majority has laid out the logical steps to the Administrator's conclusion:
a. High lead concentrations in dust and dirt are prevalent in urban areas.
b. In most circumstances, lead from exhausts and not lead paint or lead from stationary sources is the primary source of lead in urban dust and dirt.
c. Children, especially those between the ages of one and three, eat non-food objects, including dust and dirt. This phenomenon is known as pica.
d. As a result of ingesting leaded dust and dirt, children "can be expected to absorb some of the lead into their bodies."
Majority opinion at 60-61, quoting 38 FED. REG. at 33736. The majority holds that such a chain of reasoning does not produce a conclusion firm enough to support regulations under Section 211(c)(1)(A), a holding with which I fundamentally disagree. Beyond that, however, the majority, and petitioners, do not really contest any of the first three steps in the chain or the evidence supporting them. All that is challenged is the ultimate conclusion, embodied in step "d," that children absorb lead through dustfall, and its underlying evidence. I have examined the evidence supporting the Administrator's predicate conclusions and have found it firm and convincing. In the interest of space, I shall not detail it here.89 Given that logical predicate, I find the Administrator's ultimate conclusion eminently reasonable on its face. And having considered its evidentiary basis, I find it fully supported.
The majority continues its technique of selective consideration of the evidence by ignoring several supportive studies and considering only the Newark study, Margulis et al., "Residential Location, Ambient Air Lead Pollution [5 ELR 20142] and Childhood Lead Poisoning." — ARCH. ENV. HEALTH — (in press at time record was assembled), JA at 626, which it recognizes as the "principal support in the record for the Administrator's 'hypothesis.'" Majority opinion at 64. The majority is correct in concentrating its energy on discrediting this study for its data reveal more vividly than any other the hazard airborne lead poses for the city children of this nation. Blood lead data for over 5,000 Newark children routinely tested for lead poisoning were correlated with their residential addresses. Of the children living within 100 feet of major highways, 49.3 per cent had blood lead levels of 40-49 us and 8.1 per cent had levels of 60 ug or more; of children living between 100 and 200 feet from the highways, the respective percentages were 24.2 and 3.7; and of those living further than 200 feet from the highways, the figures were 20.9 and 4.7. Id. at Table 2, JA at 639. Children living within 100 feet of major highways were more than twice as likely to have elevated blood lead levels. The implication that these figures are causally related to proximity to major arteries, and the lead automobile emissions emanating therefrom, was dramatically confirmed by further refinement of these data. Taking only children living within 200 feet of the major highways, the researchers created two groups, one of children living near highways bearing an average weekday traffic density of less than 24,000 vehicles, the other of children living near highways bearing greater than 24,000 vehicles daily. Of the former group, a high 36.6 per cent had blood lead levels of 40-59 ug, and 5.1 per cent had levels greater than 60 ug; in the latter group, however, the respective percentages were enormous: 51.3 and 10.8. Id. at Table 4, JA at 640. Children living within 200 feet of very heavily travelled highways were one and a half times as likely to have elevated blood leads as those living within 200 feet of less heavily travelled major roads. The researchers calculated that, as the size of the sample would suggest, the results of both studies were significant. Id. at 8-9, JA at 633-634. Given that lead emissions fall to the ground most heavily near their source, and that pica is common among young children, the Administrator took this evidence as firm support for his conclusion that ingestion of automobile lead emissions poses a threat to the health of children.90
Somewhat astonishingly, the majority, in its self-appointed role of scientist-statistician, announces that the Newark study provides "no support" for the dustfall theory because it "is purely a statistical correlation between blood levels and residence and does not provide any evidence as to the causal connection between the two." Majority opinion at 65-66 (footnotes omitted). This argument parallels that of the tobacco industry, which for years rejected evidence of the high incidence of lung cancer in cigarette smokers compared to non-smokers. The rules of science aside, however, the rules of law indicate otherwise. Every day in our criminal and civil courts mere "correlations," whether statistical or otherwise, are used to prove causal connections. The defendant owned the murder weapon; it is covered with his fingerprints; one bullet has been discharged. Did he kill the victim? Juries have found, time after time, that he did beyond a reasonable doubt. No such heavy standard is applicable here, yet I think the Administrator has proved a "causal connection" just as surely. When the courts, after centuries of balking, have finally realized that circumstantial evidence can have probative value as great as that of direct evidence, 1 J. WIGMORE, supra, § 26, can the majority really be suggesting an opposite rule for scientific evidence? I think, to the contrary, that when the threshold determination is as undemanding as the "will endanger" standard, the regulations aimed at protection of the public health, and direct evidence extremely difficult to obtain, regulatory action may be completely premised on convincing circumstantial evidence, including statistical correlations.91 I find the results of the Newark study ample support for the Administrator's hypothesis that automotive lead in dust is eaten by children.92
The Newark study was not, however, the only study relied on by the Administrator in reaching his conclusion, and I shall briefly indicate the substance of some of the others. First, the Administrator points to several studies of industrial communities showing with some certainty that, where ground lead levels are high, children likewise have high blood lead levels.93 These suggest [5 ELR 20143] that children may ingest lead through dust. Other work demonstrates higher lead levels in urban than in suburban household dust. Moreover, since only 58 per cent of the urban households had lead-based paint, lead paint chips were discounted as the sole source of elevated lead levels.94 Another study found a small, but significant, number of children living in good housing with no apparent exposure to lead paint to have, nonetheless, high lead levels, again suggesting another source.95 This parallels the consistent finding thatt in a fraction of children with overt lead poisoning no prior exposure to leaded paint can be found.96 Again an alternative source is indicated. Results from New York City bolster the Newark study's suggestion that the major alternative source is lead automobile emissions. Use of lead automobile additives was sharply controlled in New York City as of November 1971. Since that date the New York City Bureau of Lead Poisoning Control reports an appreciable drop in its case load.97
The evidence that lead-based paint is not the sole cause of lead poisoning in children, the evidence linking lead automobile emissions to childhood lead poisoning, the known facts concerning the massive emissions of lead additives, their subsequent contamination of the adjacent ground, and the propensity of children to eat dust and dirt,98 all lend support to the Administrator's hypothesis. So does the report of the NAS Panel which, while recognizing that lead-based paint is the primary source of childhood lead poisoning, concluded:
Airborne lead wastes from such sources as automotive emissions and the weathering and demolition of old buildings can be expected to have a significant additive effect on the total intake. This would be sufficient to evoke compensatory metabolic responses that are now considered subclinical (such as increased urinary ALA), at the very least. It may be estimated that dustfall from airborne lead, if swallowed, can make a significant contribution to a small child's total lead intake and thereby contribute to the occurrence of lead poisoning, especially in urban areas.
NAS Report at 140. Thus the Administrator's hypothesis is well grounded in the evidence. Not any hypothesis, of course, would qualify under the "will endanger" standard. But the risks suggested by the cited evidence and by the Administrator's analysis, when added to the risk of lead-based paint, would significantly increase the risk of actual harm to the health of urban children. Such a determination, whether termed a "hypothesis" or a "conclusion," is all that Section 211(c)(1)(A) demands.
In sum, then, in determining the health effects of airborne lead the Administrator faced an extraordinarily complicated problem, one which he handled with great care and candor. The evidence did not necessarily always point in one direction and frequently, until EPA authorized research, there was no evidence at all. Confusion in the evidence is typical, however, of any decisionmaking "on the frontiers of scientific knowledge." Industrial Union Department, AFL-CLO v. Hodgson, supra, U.S.App.D.C. at , 499 F.2d at 474. After hearings spread over many months and consideration of thousands of pages of documents, the Administrator concluded that "lead particle emissions from motor vehicles present a significant risk of harm to the health of urban populations, particularly to the health of city children." 38 FED. REG. 33734. I have examined the massive record in this case with care — far more care than I think the [5 ELR 20144] "arbitrary and capricious" standard demands — and I conclude that the evidence before the Administrator fully supports his determination under the "will endanger" standard.
V. EPA PROCEDURES
The majority finds EPA's decision-making process to be "arbitrary and capricious," majority opinion at 48-49, and thus a ground for invalidating the regulations. It does not launch a straightforward attack on EPA procedures, but rather merges its discussion with its critique of the evidence. Majority opinion at 49-68. I have rebutted its attacks on the Administrator's analytical methodology in discussing the evidence above, and so only one procedural objection remains. After allowing comment periods on the First and Second Health Documents, the Administrator, under order of this court to reach a decision, did not allow a formal comment period on the Third (and final) Health Document. Petitioners claim this deprived them of administrative due process in contravention of the demands of Section 4 of the APA, 5 U.S.C. § 553, see Ethyl brief at 50; PPG brief at 43; Nalco brief at 64; NPRA brief at 44, and the majority lends credence to this claim by complaining about the lack of a final comment period whenever it cannot rebut the Administrator's evidence on substantive grounds. See majority opinion at 51-53, 54, 67-69. I find the argument to be groundless.
Section 4 requires that prior to final promulgation of a rule the agency must make public "either the terms or substance of the proposed rule or a description of the subjects and issues involved." 5 U.S.C. § 553(b)(3). The courts have added useful flesh to this statutory language. The notice should be sufficiently descriptive of the "subjects and issues involved" so that interested parties may offer informed criticism and comments. See, e.g., Portland Cement Assn v. Ruckelshaus, 158 U.S. App. D.C. 308, 325-327, 486 F.2d 375, 392-394 (1973), cert. denied, 417 U.S. 921 (1974); Mobil Oil Corp. v. FPC, 157 U.S.AppD.C. 235, 248 n.39, 483 F.2d 1238, 1251 n.39 (1973). But the notice need not contain "every precise proposal which [the agency] may ultimately adopt as a rule." California Citizens Band Assn v. United States, 9 Cir., 375 F.2d 43, 48, cert. denied, 389 U.S. 844 (1967). This last qualification is extremely important since the notice invites comments and the comments will frequently prompt changes in the ultimate regulations.
There is nothing in Section 4 that requires new notice whenever the agency responsibly adopts the suggestions of interested parties. Nonetheless, in this case the Administrator did just that. When criticism of the regulations originally proposed prompted him to alter somewhat the theories on which he was acting, he did not simply promulgate final rules based on these new theories. Rather, he reproposed the regulations and opened them up for additional comment. It is only when the final regulations were issued, under order of this court, that the Administrator omitted a new comment round. There was no reason for further comment. The Agency theories underlying the final regulations were identical with those of the Second Health Document and reproposed regulations. The Third Health Document differs from the Second only in that it responds to the comments and incorporates new information received since the reproposal.
It should go without saying that the Administrator can respond to comments offered, and even alter his position somewhat because of those comments, without having to issue new notice and accept further commentary.99 Petitioners' claim to the contrary would "lead to the absurdity that in rulemaking under the APA the Agency can learn from the comments on its proposals only at the peril of starting a new procedural round of commentary."100 International Harvester Co. v. Ruckelshaus, 155 U.S. App. D.C. 411, 428, 478 F.2d 615, 632 (1973). Likewise, the Administrator can properly consider newly available information from any appropriate source without having to begin the rule-making process all over again. The statute requires him to consider "all relevant medical and scientific evidence available to him." Section 211(c)(2)(A), 42 U.S.C. § 1857f-6c(c)(2)(A) (emphasis added). Moreover, it is absurd to suggest that in a rapidly developing scientific area regulating agencies must proceed on information no more current than their last public notice. When new information comes to light, whether pro or con, it is irresponsible, and probably ground for reversal, for an agency purposely to ignore it. It is equally absurd to suggest that the proper agency response to newly available information is "to start the proceedings all over again. If such were the rule the proceedings might never be terminated." Logansport Broadcasting Corp. v. United States, 93 U.S. App. D.C. 342, 346, 210 F.2d 24, 28 1954). See also Owensboro on the Air, Inc. v. United States, 104 U.S. App. D.C. 391, 397, 262 F.2d 702, 708 (1958), cert. denied, 360 U.S. 911 (1959).101
Thus the Administrator fully complied with the notice and comment demands of Section 4. In any case, petitioners cannot claim any prejudice from lack of an official final comment period. All health-related documents were made public upon receipt,102 and comments on the documents were accepted up until the date of [5 ELR 20145] final promulgation.103 On this record, I cannot find that petitioners were deprived of administrative due process by EPA procedures.104
And so, almost four years after he first proposed health-based regulation of lead additives, the Administrator now finds his efforts to have been in vain. The majority has so construed Section 211(c)(1)(A) that it is virtually impossible to find that emission products endanger the public health. Rather than sending him back to consider further evidence, the majority is advising the Administrator to spend his time on other tasks.
That is not all. The majority is also telling the Administrator that, even if he could convince us that he has properly construed the language of Section 211(c)(1)(A), he need not bother analyzing evidence any more. Just pack it up and send it over here, the majority says, and we will analyze it for you. Thus the majority analyzes the evidence in this case and says it won't wash. That the Administrator thought the contrary just does not matter.
But all this cannot be. Congress did not enact Section 211(c)(1)(A) in order that it not be used. And Congress did not vest the Administrator with authority to act in order for this court to ignore his determinations and substitute our own. I have analyzed the voluminous record before us and the relevant precedents and I reach a conclusion dramatically opposed to that of the majority. I think the "will endanger" standard of Section 211(c)(1)(A) is a precautionary standard that leaves the Administrator ample discretion to act. And I think the "arbitrary and capricious" standard of review is an undemanding one that mandates great tolerance in reviewing the Administrator's exercise of discretion. In applying this undemanding standard to the Administrator's undemanding threshold determination, I find that the evidence now presented — and not some future unknown evidence envisioned by the majority — is fully sufficient to support these regulations.
[5 ELR 20146]
I must suspect that the rigor of the majority's review, and its hostility to these regulations, are related to the energy crisis and a reluctance to "waste" a single gallon of gasoline for reasons of health when extra gallons might prove to be in short supply. I sympathize with the majority's impulse, but it is not for the courts to respond to this crisis by emasculating health-related legislation fully considered and enacted into law by the Congress. Cf. Greene County Planning Board v. FPC, 2 Cir., 455 F.2d 412, 422-423 (1971), cert. denied, 409 U.S. 849 (1972). That, needless to say, is a chore for the Congress, if indeed the crisis demands it. For the time being, however, the legislation must be applied as written, and this, I believe, the majority has failed to do.
The majority tells us that the Administrator, the environmental expert installed and staffed by Congress, has, Hamlet-like, stabbed blindly "through a curtain of ignorance, inflicting anguish, but in our judgment not rationally solving any problem." Majority opinion at 73. I suggest, to the contrary, that it is the majority that, without scientific background or access to expertise, is stabbing blindly through the curtain of ignorance. And, with due deference to the "anguish" the Administrator has inflicted on the suppliers of lead for the petroleum industry, it is the anguish of the children and urban adults who must continue to breathe our lead-polluted air that moves me.105
I respectfully dissent.
1. 42 U.S.C. § 1857f-1 (1970). This requirement was set by the Clean Air Amendments of 1970, Pub. L. 91-604, Dec. 31, 1970, 84 STAT. 1698-1700.
2. 42 U.S.C. § 1857f-6c (1970).
3. The new regulations would amend 40 C.F.R. § 80 (1973). They are set out at 38 FED. REG. 33741 (1973).
4. The principal studies and symposia over the years on the subject have included Sayers et al., "Experimental Studies on the Effect of Ethyl Gasoline and Its Combustion Products," Bureau of Mines, 1927; HEW, "Public Health Aspects of Increasing Tetraethyl Lead Content in Motor Fuel," Public Health Service Pub. No. 712, 1959; Kehoe, "The Metabolism of Lead in Man in Health and Disease," The Harben Lectures, 1960, JA at 500-579; HEW, "Survey of Lead in the Atmosphere of Three Urban Communities," JA at 789-839; HEW, "Symposium on Environmental Lead Contamination," Public Health Service Pub. No. 1440, 1966, JA at 975-984; Tepper & Levin, "A Survey of Air and Population Lead Levels in Selected American Communities," 1972, JA at 840-916; National Academy of Sciences, "Airborne Lead in Perspective," 1972, JA at 309-362; EPA and Commission of European Communities, Proceedings of International Symposium, "Environmental Health Aspects of Lead," Luxembourg, 1973, JA at 676-677; EPA and National Institute of Environmental Health Services, Conference on "Low-Level Lead Toxicity," Raleigh, N.C., 1973.
5. See, e.g., 166 CONG. REC. 19207 (1970) (remarks of Rep. Skubitz) ("The Government can require that the oil companies get the lead out"); id. at 19228-19230 (colloquy between Reps. Waggoner & Staggers); id. at 19234 (remarks of Rep. Williams); id. at 19239 (remarks of Rep. Sebelius).
6. Regulations promulgated for the latter reason were approved in Amoco Oil Co. v. EPA, U.S.App.D.C. , 501 F.2d 722 (1974).
7. JA 292. This document was subsequently revised by Health Hazards of Lead (rev. April 11, 1972), JA 254; Atmospheric Lead and Public Health, (April 11, 1972), JA 276; and Corrections and Additions to Health Hazards of Lead (rev. April 11, 1972), JA 272.
8. The reduction would proceed in the following steps:
1.7 g/gal. after Jan. 1, 1975
1.4 g/gal. after Jan. 1, 1976
1.0 g/gal. after Jan. 1, 1977
0.8 g/gal. after Jan. 1, 1978
0.5 g/gal. after Jan. 1, 1979
40 C.F.R. § 80.20. Since an ever larger percentage of cars on the road would be equipped with the lead-sensitive catalytic converter during those years, an ever increasing amount of substantially lead-free gasoline would be manufactured. This gasoline is included in the total pool, so that an overall lead content of 5 grams per gallon means that leaded gasoline would contain, according to EPA estimates, approximately 1.25 grams of lead per gallon, the same as under the original regulations. See 38 FED. REG. at 33739 (1973).
9. When EPA acts under § 211(c)(1)(A) it is essentially telling manufacturers how to make their fuels, a task Congress felt the Agency should enter upon only with trepidation.See, e.g., 116 CONG. REC. 32920 (1970) (remarks of Senator Baker); id. at 19229 (remarks of Reps. Rogers & Waggoner). On the other hand, when the Agency acts under § 202, it is only mandating an end product — regulated emissions. The method for achieving the required result is entirely in the hands of the manufacturers.
10. The majority finds two other flaws in the Administrator's interpretation of the statute, but they are of so little merit that the majority no more than implies its disapproval. First, the majority seems to think there is something wrong with the Administrator's failure "to couch his ultimate finding in the language of the statute itself * * *." Majority op. at 41. The majority is in an uncomfortable position for throwing stones, for it demonstrates a considerable ability to avoid statutory language itself. See pp. 55-59 infra. Nonetheless, it is well established that ultimate findings not only do not have to be expressed in the language of the statute, they do not have to be expressed at all. Rather, absent compelling countervailing considerations, an ultimate finding will be implied from the action taken. Pacific States Box & Basket Co. v. White, 296 U.S. 176, 186 (1935); Martin v. Mott, 25 U.S. (12 Wheat.) 19, 32-33 (1827) (Story, J.). Cf. Joseph v. FCC, 131 U.S. App. D.C. 207, 211-212, 404 F.2d 207, 211-212 (1968). The law is fully developed in 2 K. DAVIS, ADMINISTRATIVE LAW TREATISE § 16.07 at 455-459 (1958).
Second, the majority recounts in some detail the proceedings in this case and concludes, "The unease of the Administrator with the 'will endanger' standard helps explain * * * this three year delay * * *." Majority op. at 41. Since no "unease" is shown, the majority's point, I take it, is the opposite: the three-year delay and the proceedings therein somehow reflect on the Administrator's interpretation of the statute. This is absurd. The majority's recitation shows that the Administrator issued a notice of proposed rule-making in Jan. 1971, 36 FED. REG. 1486 (1971), and proposed regulations in Feb. 1972, 37 FED. REG. 3882 (1972). Of that delay, fully explainable by the start-up of a new agency, the majority has no criticism. In response to written comments and public hearings, EPA reformulated its proposed regulations, which were issued for further comment in Jan. 1973, 38 FED. REG. 1259 (1973). Final regulations followed 11 months later. 38 FED. REG. 33734 (1973). In this record I find only evidence of an agency responsibly responding to criticism it had gone out of its way to seek. And when contrasted with, e.g., the 11 years it took the Food & Drug Administration to determine the proper peanut content for peanut butter, EPA's proceedings seem, on the snail-like scale by which agencies proceed, almost hurried. See Merrill & Collier, "Like Mother Used to Make": An Analysis of FDA Food Standards of Identity, 74 COLUM. L. REV. 561 (1974). I do not mean to imply, of course, that I approve of such delay in agency proceedings, only that no reasonable implication about the validity of the Administrator's construction of § 211(c)(1)(A) can be taken from this delay.
11. See, e.g., Schwegmann Brothers v. Calvert Distillers Corp., 341 U.S. 384 (1951); United States v. American Trucking Assns, 310 U.S. 534 (1940).
12. See, e.g., State v. Fine, 324 Mo. 194, , 23 S.W.2d 7, 9 (1929). See also cases cited in note 14 infra. Webster defines "endanger" as "to bring into danger or peril of probable harm or loss." WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY 748 (1961). The use of the future tense, "will endanger," rather than the present tense, "endangers," adds to the construction of Section 211(c)(1)(A) asa precautionary, preventive statute.
13. Section 202 can be read to require the same level of risk as § 211. Literally, the words "likely to" determine the probability that the emission at issue contributes to air pollution which, in turn, endangers public health. Whether the indicated air pollution endangers public health demands a showing of the same risk as whether, under § 211, the emission product endangers public health. In this reading, "likely to" only addresses the rigor of proof necessary to show the emission at issue contributes to the pollution, and is irrelevant to the risk of harm posed by the resultant pollution. Cf. pp. 35-36 infra. Since resolution of this issue is irrelevant to my determination of this case, and to minimize nonessential disagreement with the majority opinion, I go no further, except to note that this is not a case involving § 202, so its terms are by no means being construed here with finality.
14. While "risk" and "harm" are separate concepts that cannot be compared and ranked, as the majority attempts to do, I should observe that because § 211 presents those concepts in the single term "endanger," there is a reciprocal relationship between them, and they may not really be assessed in isolation. Thus the public health might simultaneously be endangered, within the statutory meaning, by a greater risk of a lesser harm and a lesser risk of a greater harm. The "significance" of the risk, therefore, can only be ascertained through knowledge of the threatened harm, and it is the total "risk of harm" that must be sufficient to endanger the public health. This relationship does not, however, invalidate the separate analysis above, for the parameters of each term must be identified before their interaction can be studied. If anything, the grave harm of lead poisoning lessens the level of risk neecssary to be shown under § 211.
There is little case law interpreting "risk" within the statutory term "endanger." All of it recognizes that actual harm need not occur, see note 12 supra, but the likelihood that it will has been variously interpreted. Where grounds for divorce are few, for instance, courts have interpreted laws allowing divorce because of inhuman treatment that "endangers the life" to require a very low probability of actual loss of life. Indeed, action that merely endangers health has been held to endanger life on the theory that the former cannot be endangered without threatening the latter. See Cole v. Cole, 23 Iowa 433, 438 (1867); Beebe v. Beebe, 10 Iowa 133, 139 (1859). In one of the latest of these cases, mistreatment that deprived a spouse of needed rest and peace of mind was held to "endanger" life. Smith v. Smith, 258 Iowa 557, , 139 N.W.2d 453, 456 (1966). I find the inclusion in § 202 of terms expressly setting the requisite probability for action under that section at low levels persuasive that the "will endanger" standard of § 211 requires more than remote possibilities.
15. Thus while Congress preferred regulation under § 202 to fuel content regulation under § 211, see note 9 supra, there is no reason to assume that in situations where § 211 regulation is proper, the Administrator must find greater potential harm before acting.
16. In support of its argument that harm within the meaning of the "adverse effect" standard can be less substantial than that within the "will endanger" standard, the majority offers nothing more than a definition of "adverse." The definition proves nothing at all. Certainly an adverse effect under § 108 is one that is "contrary, opposed, or conflicting" with the public health. Majority op. at 30. To my mind, however, that is also a definition of harm to the public health. See WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY 1034 (1961). Since endanger means no more than the threat of harm, the majority's definition has only proved that, in terms of the severity of harm required, the two standards are remarkably similar.
The majority next argues, at great length, that an adverse effect under § 108 "need not have as proximate or substantial a relation to the air pollutant as is denoted by 'will endanger.'" Majority op. at 30. The argument is made by extensive quotations from original drafts of the statute and committee reports. Unfortunately these quotations reveal only how extensively the majority has misunderstood this statute. First the majority quotes an early version of § 108 that explains the adverse effects to be considered include those on "soils, water, vegetation, man-made materials, animals, wildlife, weather, visibility, and climate, as well as effects on economic values." S. 4358, 91st Cong., 2d Sess. § 110(b) (1970). Presumably this language is designed to show how "attenuated" effects can be and still justify regulation of pollutants under § 108. The language does no such thing. Section 108, like § 211, allows for regulation to protect the "public health or welfare." The quoted language does no more than flesh out the scope of permissible "welfare"-based regulation. The scope of the "welfare" clause in § 211 is no less broad. As language later quoted by the majority itself explains, under § 211, "[a]dverse environmental effects would fall in the category of general welfare," S. Rep. No. 91-1196, 91st Cong., 2d Sess. 34 (1970), quoted in majority op. at 33. Thus the early draft of § 108 proves nothing.
The majority then contrasts lengthy quotations from the Senate Report on the two proposed provisions. The quotation about § 108 mainly makes explicit that although actual harm must be proved to meet the § 108 standard, it need not be universal harm; rather, adverse effects on the health of "particularly sensitive citizens" would suffice. Id. at 10, quoted in majority op. at 31. Such clarification is helpful. If the Administrator cannot regulate until he finds actual harm to the public health, it is desirable for Congress to specify how widespread that harm must be before he can act.
This language is contrasted with an excerpt from the Report about § 211 that adds little to the meaning of endanger other than what the statute plainly indicates; namely, that if an endangerment to health from automobile emissions were found it "would be of such importance that the [Administrator] might prohibit or control the sale of such fuel." Id. at 34, quoted in majority op. at 32-33. If an adverse effect were found under § 108 the Administrator might do the same thing via his standard-setting power; italicizing the quoted language, as the majority does, does not make the test under § 211 any stiffer. The language in the excerpt speaking of "direct" endangerment, also italicized by the majority, does not imply that the endangerment need be any more direct than an adverse effect. Rather the committee is simply contrasting the direct purpose of regulation under § 211(c)(1)(A) with the indirect purpose of regulation under § 211(c)(1)(B). The majority knows this well, since it has presumably placed just this neutral construction on similar language when it regjected petitioners' attack on the Administrator's cumulative impact theory. See p. 37 infra. Lastly, the fact that the Committee does not expressly mention harm to small groups as a basis for regulation under § 211 implies nothing. Surely the majority is not suggesting that because of the absence of that discussion regulation under the "will endanger' standard would be inappropriate if lead automobile emissions were found to pose a serious threat for "particullarly sensitive citizens such as bronchial asthmatics and emphysematics who in the normal course of daily activity are exposed to the ambient environment." Id. at 10, quoted in majority op. at 31. Of course regulation would be proper, at least if the group were of sufficient size and could be protected in no other way. Regulation to protect the "public health" is almost never designed to protect every member of the public; protection of "particularly sensitive citizens" is the norm, not the exception. See pp. 44-46 infra. Since Congress defined the broad scope of "public health" within the meaning of § 108, there was no need for redundancy in explaining its scope in § 211.
In sum, the entire discussion by the majority proves only that, in terms of severity of harm contemplated as a prerequisite for action, §§ 108 and 211 are quite similar. In fact, the sections differ in only one regard with respect to the proximity or substantiality of relationship between air pollutant and effect. The difference, of course, is that the "will endanger" standard allows health-based regulation of pollutants whose effects are less proximately related to proved harm than the "adverse effects" standard, which we know demands actual, not probable, harm.
17. I think, however, that "will endanger" does not encompass de minimis harm. The harm must be sufficiently significant to justify health-based regulation of national impact. Nonetheless, Congress made clear that "significant" harm means neither universal nor crippling harm. See note 16 supra. The precise scope of the standard will be developed by future cases.
18. A hint of the majority's meaning appears earlier, immediately after its definition of the "will endanger" language, when it explains that, under its reading of the statute, the causal connection "between lead emissions and the harm must be established by relevant scientific and medical evidence." Majority op. at 12 (emphasis added). Of course, the statute demands no more than a causal connection between lead emissions and the danger of harm to the public health.
19. The majority attempts to bolster its argument that §§ 108 and 202 are less demanding than § 211 by suggesting that the Administrator is given less power to act under the former sections, and that this proves that those sections require less rigorous proof. The argument is premised on the fact that the Administrator, when acting under § 211, may "control or prohibit" fuels or fuel additives, but, when acting under §§ 108 and 202, may "only" set standards for air pollutants. Majority op. at 28-30. The suggested comparison is without merit. No reason is offered why a "standard" of zero air pollutants may not be set under § 108 or 202, and, indeed, such a standard seems fully within the Administrator's delegated powers under those sections. The majority's cramped reading of "standards" rivals the restrictive construction of "control or prohibit" offered by petitioners in Amoco. Such linguistic obstructionsim was scored there, and is inappropriate here as well. See Amoco Oil Co. v. EPA, supra note 6, U.S.App.D.C. at - , 501 F.2d at 744-745.
Moreover, any suggestion of congressional intent to tie rigor of finding to delegated power is shattered when § 112 is added to the equation. That section's requirement that the Administrator act only when he finds that an air pollutant "may cause, or contribute to, an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness," 42 U.S.C. § 1857c-7(a)(1), surely demands the most rigorous finding of threatened harm of any of the sections under discussion. Yet, after this most rigorous determination, the Administrator is given only the same "slight" power of §§ 108 and 202, the power to set "standards." Under the majority's interpretation, the emission of even the most deadly air pollutant could never be prohibited under a standard-setting power. But this is nonsense. Congress' delegation of no more than standard-setting power in § 112, tied to a most rigorous determination of harm, makes it clear that it did not intend the majority's narrow construction of that power.
20. Whether the evidence is sufficient to support these determinations is discussed below at pp. 59-88 infra.
21. For just these reasons, this court has recently deferred to the interpretation placed by the EPA Administrator on another section of this same statute. Natural Resources Defense Counsel, Inc. v. Train, __ U.S. App. D.C. __, __, __ F.2d __, __ (No. 74-1433, decided Dec. 5, 1974) (slip op. at 26-27). See also Gulf Oil Corp. v. Hickel, 140 U.S. App. D.C. 368, 435 F.2d 440 (1970); Lindberg v. Brenner, 130 U.S. App. D.C. 257, 399 F.2d 990 (1968); Bamberger v. Clark, 129 U.S. App. D.C. 70, 390 F.2d 485 (1968); City of Los Angeles v. FMC, 128 U.S. App. D.C. 156, 385 F.2d 678 (1967); Brhd of R. R. Trainmen v. Akron & Barberton Belt R. Co., 128 U.S. App. D.C. 59, 385 F.2d 581 (1967), cert. denied, 390 U.S. 923 (1968).
22. Besides relying on legislative history of dubious relevance, see note 25 Infra and accompanying text, and a misguided interpretation of the Amoco decision, see pp. 30-32 infra, the majority bases much of its case on the absence in § 211 of a phrase expressly allowing the Administrator to use his "judgment," in contrast with the presence of such a phrase in §§ 108 and 202. Majority op. at 17-18; see p. 12 supra, quoting the relevant language. The majority's argument has been foreclosed, however, by Amoco. Section 211(c)(1)(B), at issue in that case, also does not include the phrase "in his judgment," yet the court recognized, nonetheless, that the Administrator has power to assess risks and make policy decisions when the determinations called for are judgmental. Amoco Oil Co. v. EPA, supra note 6, U.S.App.D.C. at - , 501 F.2d at 740-741, quoted in text at pp. 29-30 infra. Whether or not the court agrees that the "will endanger" standard is judgmental it cannot "prove" that it is not by pointing to the absence of the "in his judgment" phrase when the Amoco court, in finding judgmental powers under parallel § 211(c)(1)(B), ignored a like omission.
Moreover, there is no reason why significance should be ascribed to the omission of the phrase. Section 112 of the Act, as indicated above, see pp. 17-18 supra, requires proof of greater impending harm than § 211(c)(1)(A). Yet, it expressly includes a judgmental phrase: a "hazardous air pollutant" is one which "in the judgment of the Administrator may cause, or contribute to, an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness." Section 112(a)(1), 42 U.S.C. § 1857c-7(a)(1) (emphasis added). Likewise, § 108 requires proof of greater risk to health than § 211(c)(1)(A), yet it expressly allows the Administrator to use his "judgment" to find an adverse effect. 42 U.S.C. § 1857c-3(a)(1)(A), quoted in text at p. 12 supra.
Lastly, the majority's observation that the Administrator, when acting under § 108 or 202, is not required to "consider" scientific or medical evidence proves nothing at all. Of course, the majority is not implying that, when acting under those sections, the Administrator should not consider such evidence. It is only saying that he is allowed to consider other evidence as well. But, since this is plainly true for action under § 211 also, the observation is meaningless. See note 29 infra.
23. At least one of the petitioners concedes the Administrator's power to assess risks in making the "will endanger" determination. Reply brief of petitioner National Petroleum Refiners Association at 4 (hereinafter NRPA reply brief). Another does not seem to address the issue at all. Reply brief of petitioners PPG Industries & E. I. duPont de Nemours & Co. 3-4, 24 (hereinafter PPG reply brief). But see reply brief of petitioner Ethyl Corporation 7-9 (hereinafter Ethyl reply brief); reply brief of petitioner Nalco Chemical Co. 1-8 (hereinafter Nalco reply brief).
24. See note 30 Infra.
25. The majority suggests that if the "specific findings" requirement, and its subsequent deletion, are to have substantive effect, it would have "greater effect on implementing determinations" than on the threshold "will endanger" determination. Majority op. at 27. This is because a literal reading of proposed § 210(g)(1) suggests that regulatory standards, and not the initial regulatory decision, are to be made on the basis of the specified findings. The inconsequentiality of this argument is apparent on the face of the majority opinion. The majority itself quotes a lengthy colloquy between Reps. Waggoner and Staggers in order to show that the threshold determination is to be a factual one. Majority op. at 18-19. In that discussion Rep. Staggers proves that a factual threshold determination is intended by quoting the very language the majority now says applies largely to subsequent implementing decisions. The majority cannot have it both ways. I think it clear, as did Rep. Staggers, chairman of the committee that drafted the House bill, that the specific findings language of proposed § 210(g)(1) required a factual threshold determination. If deletion of the specific findings requirement had substantive significance, which I shall show it had, see pp. 27-29 and note 30 infra, then the majority must confront the effect of the deletion on the original requirement of a factual threshold determination.
26. The original Senate version of the bill provided:
The Secretary may from time to time on the basis of information obtained under subsection (b) of this section [which required fuel manufacturers to furnish various information to the Secretary] or other information available to him, by regulation control or prohibit the introduction into commerce of any fuel or fuels for use in vehicle engines if the combustion or evaporation of such fuel produces emissions which endanger the public health or welfare * * *
S. 4358, § 212(c)(1), 91st Cong., 2d Sess. (1970). The Senate bill drew a distinction between regulation on public health and public welfare grounds and required that regulation for the latter reason be preceded by public hearings. Id. § 212(c)(2). With minor verbal changes and deletion of the health-welfare dichotomy the Senate version became § 211(c)(1).
27. For this reason, statements made in the House about the bill should be used only with great care in any attempt to assess legislative intent. House discussion centered on a significantly more rigorous bill, and statements such as those offered by the majority at pp. 18-19 prove only the effect of the ultimate deletion of the "specific findings" requirement. Rep. Staggers' statement, for instance, directly relating the need for a factual threshold determination to the "specific findings" requirement is, in fact, strong support for the conclusion that deletion of the requirement was intended to do away with such a rigorous threshold requirement. See note 25 supra.
28. Section 211(c)(2)(C), 42 U.S.C. § 1857f-6c(c)(2)(C), quoted in text at p. 48 infra.
29. The House bill required the Administrator to act only on the basis of the required specific findings. The Senate and final bill allows him to act on the basis of information obtained under § 211(b), which requires fuel and fuel additive mamufacturers to furnish the Administrator with information about their products' content and, at his request, to conduct various tests on the compounds and furnish him with descriptions of testing techniques. The Administrator is also free to act on the basis of any "other information available to him," § 211(c)(1) (emphasis added), thus making the basis for action under § 211(c)(1)(A) unlimited.
While I suspect the threshold determination will typically be made largely, it not solely, on the basis of relevant scientific and medical evidence, the majority's suggestion that the Administrator is limited to considering such evidence is meritless. The majority claims the statutory requirement that relevant scientific and medical evidence be "considered" prior to regulation, § 211(c)(2)(A), 42 U.S.C. § 1857f-6c(c)(2)(A), mandates that only such evidence may be considered. Majority op. at 16-17. Besides being liguistically unjustified, the majority position is completely without support. Sen. Muskie made the validity of consideration of broader evidence clear when he introduced the Conference Committee's version of § 211 to the Senate:
[T]he conference committee wishes to call the attention of the Administrator to the broad environmental, esthetic and health considerations underlying the Enactment of this legislation which should be kept in mind in making these determinations [to prohibit or control fuels or fuel additives].
116 CONG. REC. 42386 (1970). See Amoco Oil Co. v. EPA, supra note 6, U.S.App.D.C. at - , 501 F.2d at 733-734.
In any case, even if the Administrator could consider nothing other than scientific and medical evidence, it is a large step, and one that the majority again takes without support, to translate such a requirement into a requirement that regulation may be premised only on factual determinations gleaned from such evidence. Majority op. at 16.
30. On its face, the change was not "basically one concerning the written form of decision," majority op. at 23, and Amoco does not suggest otherwise. All the changes discussed in text above are substantive changes, and all were directly accomplished by deletion of the "specific findings" requirement. We recognized in Amoco that "[a]dvocates of the House version had viewed the specificity requirement as a major limitation on EPA's regulatory power over fuels," Amoco Oil Co. v. EPA, supra note 6, U.S.App.D.C. at , 501 F.2d at 733 (footnote omitted; emphasis added). Deletion of the requirement increased EPA power, and did not merely liberalize its procedures.
31. The opinion refers to § 4(c), but § 4(b), which requires the agency to "incorporate in the rules adopted a concise statement of their basis and purpose," was obviously intended. See § 4 of the APA, 60 STAT. 239 (1946), 5 U.S.C. § 553.
32. Contrary to the majority's suggestion that "[a]ll true risk assessment is based on facts and nothing else," majority op. at 14, one must recognize that, at least in a methaphysical sense, all facts are themselves nothing more than risks, or statistical probabilities. See, e.g., D. HUME, A TREATISE OF HUMAN NATURE, bk I, pt. III, § 6, at 87 (L. A. Selby-Bigge ed. 1958). This is certainly true in a legal sense as well. For an event to be proved as "fact" before a civil jury, for instance, the probability of its occurrence need only be 51% certain. As the fact-risk distinction has evolved in this quite technical branch of the case law, however, "fact" refers to that which is scientifically proved (although, again, science only "proves" to within a statistical — and not a factual — certainty), and "assessment of risk" refers to all other permissible inferences that may be drawn from the proved facts and other data.See Amoco Oil Co. v. EPA, supra note 6, U.S.App.D.C. at - , 501 F.2d at 740-741; Industrial Union Department, AFL-CIO v. Hodgson, U.S.App.D.C. , - , 499 F.2d 467, 474-475 (1974). We must remember, however, that since an administrative agency's fact-finding powers are, at the least, as broad as those of a jury, see note 57 infra, reliance on less certain proof than contemplated by the majority is always proper in agency rule-making — and adjudications — unless the statute in clearest terms demands a stricter finding. Thus what is herein termed "assessment of risks" is but a form of fact-finding. It is the rule and not the exception in agency proceedings, and not the "fanciful theory" the majority terms it.
33. As far as the cumulative impact theory is concerned, the relevant portions of the two provisions are as follows:
The Administrator may regulate any automobile emission that "causes or contributes to, or is likely to cause or contribute to, air pollution which endangers the public health or welfare."
Section 202(a)(1), 42 U.S.C. § 1857f-1(a)(1) (emphasis added).
The Administrator may regulate a fuel or fuel additive "if any emission products of such fuel or fuel additive will endanger the public health or welfare * * *."
Section 211(c)(1)(A), 42 U.S.C. §-1857f-6c(c)(1)(A) (emphasis added).
34. Since all parties agree that automobile emissions generate approximately 90% of all airborne lead, see note 39 infra and accompanying text, the danger posed by lead polluted air is virtually identical to that posed by lead automobile emissions. As the text suggests, the non-automotive sources of lead with which the cumulative impact theory is concerned are not airborne.
35. Ethyl actually quotes Sen. Baker's second use of the phrase, a few sentences after the one quoted in the text, see 116 CONG. REC. 32920 (1970).It, however, is in the same context of contrasting permissible EPA action under §§ 211(c)(1)(A) and (B), andthus provides no more support for Ethyl's position. The implausibility of Ethyl's reading of Sen. Baker's words is heightened by the fact that the Senator himself realized the important contribution of dietary lead to the total body lead burden and so informed the Senate only sentences before the quoted language. Id.
36. Some of the data discussed herein speak of micrograms of lead per 100 grams of blood, while other data report micrograms per 100 mililiters of blood. Since the density of blood is close to 1.0, these figures are directly comparable. Therefore, lead concentrations, unless otherwise indicated, will hereafter simply be given in micrograms.
37. Lead in food and water ultimately can be traced to lead in soil and this, of course, is uncontrollable. The NAS Report concluded that "[t]here is no evidence that the amount of lead in the diets of people has changed substantially since 1940." NAS Report at 206.
38. A list of local laws regarding control and/or removal of lead-based paints can be found in NAS Report at 77.
39. this is the EPA's figure, Third Health Document at II-4, JA at 37, but it is not contested by petitioners. It was determined by discounting the NAS Panel's conclusion that "about 98% of the airborne lead that can be traced to its source comes from combustion of gasoline." NAS Report at 31. see also id. at 12-13.
40. Thirty per cent is the commonly accepted figure. Other estimates range from 17% to 37%. Third Health Document at V-3, JA at 83.
41. While the incremental effect of lead emissions on the total body lead burden is of no practical value in determining whether health is endangered, it is of value, of course, in deciding whether the lead exposure problem can fruitfully be attacked through emission control. Moreover, even under the cumulative impact theory emissions must make more than a minimal contribution to total exposure in order to justify regulation under § 211(c)(1)(A). I accept the Administrator's determination that the contribution must be "significant" before regulation is proper. See 38 FED. REG. 33734; cf. note 17 supra.
42. Congress had before it a complete explanation of the multiple sources of human lead exposure. It understood that lead is ubiquitious in nature, that trace elements of lead are present in everyone, and that only when lead concentration reaches higher levels would the public be endangered. It could not have thought that lead automobile emissions could, by themselves, endanger the public, although it clearly did think they could be regulated only if they provided a significant increment to the total human lead burden. See, e.g., Hearings on S. 3229, S. 2466 & S. 3546 before the Subcommittee on Air & Water Pollution of the Senate Committee on Public Works, 91st Cong., 2d Sess., pt. 1, at 433-434 (1970) (answers to Sen. Muskie's questions, supplied by the Dept. of Health, Education & Welfare); id., pt. 3, at 1177; 116 CONG. REC. 32920 (1970) (remarks of Sen. Baker).
43. The majority appears to retreat from its wholehearted embrace of the cumulative impact theory when it summarizes the theory as demanding a finding thatt lead from automobile emissions "by itself or alone contributes a measurable increment of lead to the human body, * * * and that this measurable increment of lead itself (taking into consideration all other sources of lead) causes a significant health hazard * * *." Majority op. at 13 (emphasis in original). While I agree that lead emissions must cause at least a measurable contribution to the body lead burden, see note 41 supra, I am not quite sure what the majority means by its apparent non sequitur that the increment itself, considering all other lead sources, causes the hazard. I would fear this to be no more than the rebirth of the "in and of itself" theory, were the majority not so vehement in seeming to reject that theory. Of course, as I have made clear, no one source can fairly be said to, by itself, cause any danger when, as here, the cumulative impact is dangerous and not properly assignable to individual sources. Since I think the majority realizes this, I would read its language to make, somewhat obscurely, the point that the increment, besides being measurable, must make a significant contribution to the body lead burden before regulation under § 211(c)(1)(A) is justified. See note 41 supra; cf. note 17 supra.
44. Thus, for example, the United States Code has an entire title entitled "The Public Health and Welfare" that offers no definition of the term anywhere in its over 4500 sections. 42 U.S.C. §§ 1 et seq. (1970). For useful discussions of the broad scope of the term, see 15 ENCYCLOPEDIA BRITANICA 202 (1974); 13 INTERNATIONAL ENCYCLOPEDIA OF THE SOCIAL SCIENCES 164-170 (1968); 12 ENCYCLOPEDIA OF SOCIAL SCIENCES 646-657 (1934).
45. See, e.g., State ex rel. Anderson v. Fadely, 180 Kan. 652, , 308 P.2d 537, 548 (1957): "The term 'public health' is not susceptible to accurate definition since it takes on new definitions when new conditions arise * * *."
Thus determining the suitable public for "public health" regulation depends not simply on defining a proper number, but, at a minimum, also includes evaluating the dispersal of the threatened public, the presence or absence of alternative means of control, and, particularly, the severity and nature of the perceived threat. All of these factors vary from case to case, even in the application of a single statute.
46. While the Occupational Safety & Health Act (OSHA), 29 U.S.C. § 651 et seq. (1970), does allow the Secretary of Labor to set standards to protect employees from exposure to harmful chemicals, the threshold determination for such regulation is significantly more rigorous than the "will endanger" standard: the chemical must cause "material impairment of health or functional capacity * * *." Id. § 655(b)(5). Moreover, there is absolutely no reason to suppose that Congress intended the Administrator, acting under the Clean Air Amendments, and the Secretary, acting under OSHA, to coordinate their efforts.
47. According to the 1970 Census, there are approximately 149 million Americans living in urban environments and approximately 54 million in rural environments. THE 1973 WORLD ALMANAC 145 (1972).
48. The reason for the majority's statement may be that it is making a disguised attack on the evidence supporting the Administrator's decision, although it does not return to this question when it does discuss the evidence. It is true that the effects of lead emissions are more serious for some occupational groups than for others, but those particularly hard hit are largely so affected because their jobs force them to spend a significant part of their working hours on heavily travelled streets breathing the polluted air — policemen, service station attendants, and the like. Third Health Document at Table VII-1, JA at 145. Such exposure is ill-suited to occupational health regulations and, in any case, these workers suffer only to an accentuated degree the exposure to lead emissions common to all who use the city streets. Thus I think the Administrator committed no error in defining the affected public as "urban populations." See pp. 64-65 infra.
49. Fundamentally, I do not think the meaning of "public health" will ever pose a problem under § 211(c)(1)(A). The section was expressly designed to "get the lead out," see note 5 supra and accompanying text, and it is unlikely to find other application. Lead's potential to harm all whom it touches makes its regulation inevitably for the "public health."
50. See, e.g., Parke v. Bradley, 204 Ala. 455, 86 So. 28 (1920); Forbes v. Board of Health, 28 Fla. 26, 9 So. 862 (1891); People ex rel. Barmore v. Robertson, 302 Ill. 422, 134 N.E. 815, 22 A.L.R. 835 (1922); Blue v. Beach, 155 Ind. 121, 56 N.E. 89 (1900); Walker v. Sears, 245 Iowa 262, 61 N.W.ed 729 (1953); State ex rel. Anderson v. Fadely, Supra note 45; Board of Health v. Kollman, 156 Ky. 351 160 S.W. 1052 (1913); Rock v. Carney, 216 Mich. 280, 185 N.W. 798, 22 A.L.R. 1178 (1921); State ex rel. Freeman v. Zimmerman, 86 Minn. 358, 90 N.W. 783 (1902); Crayton v. Larabee, 220 N.Y. 493, 116 N.E. 355 (1917); Salt Lake City v. Howe, 37 Utah 170, 106 P. 705 (1910).
51. "Consideration" of the relevant scientific and medical evidence, including the possibility of regulation under § 202, is required by the statute, § 211(c)(2)(A), 42 U.S.C. § 1857 f-6c(c)(2)(A). That means, of course, no more than it says: actual good faith consideration of the specified evidence, as reflected in the basis and purpose statement required by § 4(b) of the APA, 5 U.S.C. § 553(c). Petitioners have not persuaded me that this good faith standard was not met. See note 54 infra.
52. This distinction is not unduly technical, since § 211(c)(1) expressly allows the Administrator to "control or prohibit" while § 211(c)(2)(C), drafted contemporaneously, repeatedly indicates that a finding is required only before a fuel or fuel additive is "prohibited." Paralled §§ 211(c)(2)(A) and (B), on the other hand, also expressly apply before a fuel or fuel additive may be "controlled or prohibited."
Nonetheless, the purpose behind § 211(c)(2)(C) — avoidance of counterproductive results and protection of the public health — suggests that a finding is of equal import whether the fuel or fuel additive is to be controlled or prohibited, so I do not conclude definitely that no such finding is required for control under § 211. Since the Administrator has furnished a finding such as is required by § 211(c)(2)(C), 38 FED. REG. 33737-33739 (1973), and I think that finding is adequate under the Amoco standards suggested below, I do not find it necessary to determine whether the finding was required in this case.
53. All the Clean Air Act says about judicial review of EPA action under § 211 is that it shall be available exclusively in this court. 42 U.S.C. § 1857h-5(b)(1). n54 The hybrid procedures that placed the EPA action somewhere between informal rule-making and adjudication and that caused such extended inquiry by the Amoco court are largely absent from this case. In Amoco, in addition to the "findings" requirement of § 211(c)(2)(B), the court had to deal with the same section's requirement of a public hearing. The resultant standard of review was, nonetheless, not significantly different from traditional "arbitrary and capricious" review. See Amoco Oil Co. v. EPA, supra note 6, U.S.App.D.C. at - , 501 F.2d at 731-741. In this case there is no public hearing requirement and the only "findings" requirement is that of § 211(c)(2)(C), which I have construed at pp. 48-49 supra.
The requirement that the Administrator "consider" various evidence before acting under § 211(c)(1)(A) guides the direction, but does not affect the rigor, of "arbitrary and capricious" review. Such guidelines are typical as a prerequisite for agency action, see, e.g., § 1002(e) (the Rule of Ratemaking) of the Federal Aviation Act of 1958, 49 U.S.C. § 1482(e) (1970), and assurance of agency compliance is simply one part of "arbitrary and capricious" review. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971) (court must determine "whether the decision was based on a consideration of the relevant factors"). n55 The majority's review of the Administrator's construction of the statute is justified under § 10(e)(2)(C), 5 U.S.C. § 706(2)(C), which allows the court to set aside "agency action, findings, and conclusions" it finds to be "in excess of statutory jurisdiction, authority, or limitations, or short of statutory right * * *." (Emphasis added.) Such review involves straightforward and well-established principles of judicial construction and usually presents no problem of application to a reviewing court. While I believe the majority has erred in its construction, I do not suggest that it has exceeded the proper bounds of an appellate court in making that construction, except insofar as it failed to accord proper deference to the Administrator's interpretation of the statute. See pp. 22-23 supra.
56. I have myself favored judicial activism in the proper circumstances. See Wright, Professor Bickel, the Scholarly Tradition, and the Supreme Court, 84 HARV. L. REV. 769 (1971); Wright, The Role of the Supreme Court in a Democratic Society — Judicial Activism or Restraint, 54 CORNELL L. REV. 1 (1968).
57. The "clearly erroneous" standard is that used to review the findings of a trial court sitting without a jury. Rule 52 (a), FED. R. CIV. P. Such findings may be fairly readily reversed. The "substantial evidence" test, on the other hand, is that traditionally used to review the findings of a jury, and it is well established that this test is significantly more deferential. District of Columbia v. Pace, 320 U.S. 698, 702 (1944). The "substantial evidence" test of the APA is directly borrowed from this latter test, as is well-documented in 4 K. DAVIS, supra note 10, § 29.02, at 118-126 (1958).
In recognizing the APA's debt to the standard of review of jury findings, Judge Frank once observed:
A wag might say that a verdict is entitled to high respect because the jurors are inexperienced in finding facts, an administrative finding is given high respect because the administrative officers are specialists (guided by experts) in finding a particular class of facts, but, paradoxically, a trial judge's finding has far less respect because he is blessed neither with jurors' inexperience nor administrative officers' expertness.
Orvis v. Higgins, 2 Cir., 180 F.2d 537, 540, cert. denied, 340 U.S. 810 (1950). And, of course, when agency expertness is applied in informal rule-making it is entitled to even more respect than a jury finding, although the wag might have difficulty mocking that distinction. An agency engaged in informal rule-making is acting most nearly like the quasi-legislative body it is in schizophrenic part. Its rules are highly dependent on agency expertise and judgment, and the courts have neither the expertise nor the time to second-guess the agency.
58. As the Supreme Court put it recently, under "arbitrary and capricious" review a court must affirm an agency's determination if it "can discern in the [agency's] opinion a rational basis for its treatment of the evidence * * *." Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., U.S. , , 43 U.S. L. WEEK 4091, 4094 (Dec. 23, 1974) (emphasis added). See p. 56 infra. "A" rational basis is not, of course, one that the court itself would necesarily adopt, and when such a basis can only be "discerned" its rationality is obviously of the most rudimentary sort. See pp. 55-57 infra. n59 See also Unimed, Inc. v. Richardson, 147 U.S. App. D.C. 368, 370, 458 F.2d 787, 789 (1972); M. Steinthal & Co. v. Seamans, 147 U.S.App.D.C.221, 230-231, 455 F.2d 1289, 1298-1299 (1971). n60 As Overton Park puts it, the reviewing court "must consider whether the decision was based on a consideration of the relevant factors * * *." Citizens to Preserve Overton Park v. Volpe, supra note 54, 401 U.S. at 416.
61. While it may be tempting in this "new era" of administrative law, Environmental Defense Fund, Inc. v. Ruckelshaus, 142 U.S. App. D.C. 74, 87, 439 F.2d 584, 597 (1971), to read the "arbitrary and capricious" standard to require no more than strict review of agency procedures, see International Harvester Co. v. Ruckelshaus, 155 U.S. App. D.C. 411, 446-449, 478 F.2d 615, 650-653 (1973) (Bazelon, C.J., concurring), it cannot be doubted that substantive review is mandated. Mere procedural review under the "arbitrary and capricious" standard would make a redundancy of § 10(e) (2)(D), which already requires such review. 5 U.S.C. § 706 (2)(D).
Nonetheless, substantive review under the "arbitrary and capricious" standard is entirely dependent upon agency compliance with the procedural requirements of § 4 of the APA, 5 U.S.C. § 553. Compliance with the notice requirement of § 4(a), 5 U.S.C. § 553(b), will produce the initial agency proposal, tentative empirical findings and expert advice, and a description of critical methodological and experimental techniques on which the agency intends to rely. The comment period required by § 4(b), 5 U.S.C. § 553(c), will generate the criticism and concerns of interested parties. And the mandatory "basis and purpose" statement accompanying the final rule will supply the agency's explanation of the rule, its justification for it, and a description of the technique by which the rule was derived. Id. This administrative "record" provides an ample basis both for assuring procedural regularity and for testing the rationality of the final rule.
62. The Court's complete discussion is as follows: Section 706(2)(A) requires a finding thatt the actual choice made was not "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A) (1964 ed., Supp. V). To make this finding the court must consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment. [L. JAFFE, JUDICIAL CONTROL OF ADMINISTRATIVE ACTION] at 182 [(1965)]. See McBee v. Bomar, 296 F.2d 235, 237 (CA 6 1961); In re Josephson, 218 F.2d 174, 182 (CA 1 1954); Western Addition Community Organization v. Weaver, 294 F. Supp. 433 (ND Cal. 1968). See also Wong Wing Hang v. Immigration and Naturalization Serv., 360 F.2d 715, 719 (CA 2 1966). Although this inquiry into the facts is to be searching and careful, the ultimate standard of review is a narrow one. The court is not empowered to substitute its judgment for that of the agency.
Citizens to Preserve Overton Park v. Volpe, supra note 54, 401 U.S. at 416. n63 See note 57 supra. The Court's use of the "clear error of judgment" phrase is to some extent troubling since the sources to which it refers largely involve application of the "clearly erroneous" standard. See sources cited by the Court in note 62 supra. The Court may have used the phrase because both the "clearly erroneous" and the "arbitrary and capricious" standards allow for review of "abuse of discretion." See In re Josephson, 1 Cir., 218 F.2d 174, 182 (1954); 5 U.S.C. § 706 (2)(A). Cf. Rule 52(a), FED. R, CIV. P. While the term "abuse of discretion" remains constant, however, the standards of review are highly divergent. Wong Wing Hang v. I&NS, 2 Cir., 360 F.2d 715, 718-719 (1966) (Friendly, J.). The court obviously did not intend vastly to revamp the "arbitrary and capricious" standard of review, see Bowman Transportation, Inc. v. Arkansis-Best Freight System, Inc., supra note 58, but its use of a phrase familiar to judges in another, and significantly more intrusive, context makes the possibility of judicial misapplication of the "arbitrary and capricious" standard much more likely. Indeed, that is what has happened in this case. n64 See 4 K. DAVIS, supra note 10, at 121-122.
65. The majority virtually admits that it is substituting its judgment for that of the Administrator. In attempting to deny this charge, the majority proclaims:
We are not doing so, but if we did, it is readily apparent from the recital of the other government agency comments that we would have plenty of company in our judgment if we did.
Majority op. at 41. This concludes a lengthy summary of criticism of the EPA action from other federal agencies, which the majority apparently thinks is of some aid in interpreting the demands of the "will endanger" standard. (Since the criticism is all addressed to the evidence before the Administrator, I cannot understand how its quotation helps the majority interpret § 211(c)(1)(A) and so I have not commented on it.) The majority is plainly more comfortable in the company of these other agencies, none of which is charged with enforcement of the Clean Air Act. In betraying its general disregard of the considered and expert judgment of the Administrator as against the comments of other agencies, the majority clearly shows that it is not according the Administrator's determination the statutorily mandated deference, and that it is quite willing to invalidate his judgment simply because it and the commenting agencies disagree with it. n66 As I have pointed out at note 10 supra, this criticism is groundless.
67. The interpretation of the "arbitrary and capricious" standard expressed herein is further elaborated in Wright, The Courts and the Rulemaking Process: The Limits of Judicial Review, 59 CORNELL L. REV. 375 (1974).
68. The confusion between procedural and substantive objections in the majority opinion makes it impossible to determine just what is the basis for the majority's decision. Thus I shall treat each objection as though it alone were ground for reversal. I should note, however, that if the real objection were procedural, the proper response would, of course, have been to remand this case to the Administrator for further explanation and, possibly, new proceedings. See South Terminal Corp. v. EPA, 1 Cir., 504 F.2d 646 (1974); International Harvester Co. v. Ruckelshaus, supra note 61.
69. See note 65 supra.
70. Indeed, at the conclusion of Section IV of the Third Health Document, "Can an Acceptable Lead Body Burden be Defined?," the Agency suggested seven important areas for future inquiry. Third Health Document at IV-7, 8, JA at 75-76. Ethyl claims these questions only demonstrate "that EPA is unable at this time to support its blood lead level theories with pertinent data * * *." Ethyl brief at 38. To the contrary, the questions only show the candor with which the Agency has approached this important issue. Sufficient data exists for the Administrator to assess risks and make a judgment within the "will endanger" standard. That further data would enable the Agency to deal more precisely with the problem does not undercut the Administrator's judgment. It is the nature of scientific inquiry that further data will always permit such refinement. See note 87 infra.
71. A few examples indicate the kind of evidence before the Administrator:
A study by David et al. associating increased frequency of hyperactivity among children with blood lead levels of 25-55 ug. Cited in Third Health Document at III-6, 7, JA at 59-60.
A study by Piomelli et al. which found that 55% of children tested with blood lead levels of 40-59 ug and 100% of those tested with blood lead levels in excess of 60 ug had demonstrable evidence of metabolic interference with heme synthesis in the bone marrow. Cited in Third Health Document at IV-3, 4, 5, JA at 71-73.
A study by Tola et al, finding mild anemia in lead workers with blood lead levels in the 40-60 ug range. Cited in Third Health Document at III-6, JA at 59.
A study by Pueschel et al. suggesting that in children lead body burdens below those usually associated with clinical lead poisoning may contribute to renal as well as neurological damage. Cited in Third Health Document at III-5, JA at 58.
72. Tepper & Levin, "A Survey of Air and Population Lead Levels in Selected American Communities," Dept. of Environmental Health, College of Medicine, U. Cincinnati, Ohio (EPA Contract PN 22-68-28) (Dec. 1972), JA at 840 (hereinafter Seven Cities Study).
73. Ethyl also once again attacks the mere fact that the Administrator exercised his judgment. See Ethyl brief at 47.
74. I am, nonetheless, in full sympathy with Judge Bazelon's comment in another highly technical case:
Socrates said that wisdom is the recognition of how much one does not know. I may be wise if that is wisdom, because I recognize that I do not know enough about dynamometer extrapolations, deterioration factor adjustments, and the like to decide whether or not the government's approach to these matters was statistically valid.
International Harvester Co. v. Ruckelshaus, supra note 61, 155 U.S. App. D.C. at 446-447, 478 F.2d at 650-651 (Bazelon, C.J., concurring in result) (footnote omitted).
While believing the majority's attempts at scientific analysis and criticism are out of place, I do agree that a reviewing court must immerse itself in technical and scientific matters sufficiently to ascertain that the agency has exercised a "reasoned discretion." See Portland Cement Assn v. Ruckelshaus, 158 U.S. App. D.C. 308, 335, 486 F.2d 375, 402 (1973), cert. denied, 417 U.S. 921 (1974); International Harvester Co. v. Ruckelshaus, supra note 61, 155 U.S. App. D.C. at 444, 478 F.2d at 648; Essex Chemical Corp. v. Ruckelshaus, 158 U.S. App. D.C. 360, 367, 486 F.2d 427, 434 (1973), cert. denied, 416 U.S. 969 (1974). That does not mean, however, that the court should view itself as the equivalent of a combined Ph.D. in chemistry, biology, and statistics.
75. Rabinowitz et al., "Study of human lead metabolism using stable isotope tracers," paper presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C., Oct. 1-2, 1973, JA at 678; Rabinowitz et al., "Lead Metabolism in the Normal Human: Stable Isotope Studies," 182 SCIENCE 725 (Nov. 1973), JA at 704. See Third Health Document at V-3, JA at 83. See also 38 FED. REG. at 33735.
76. The stories are well-known. Pasteur developed what he hoped would be a preventive treatment for rabies by animal experimentation and sheer speculation. Finally he applied the technique to man and on July 6, 1885 saved the lief of a nine-year-old boy who had been bitten by a rabid dog. Jenner, a century before, had observed that those stricken by the relatively mild cowpox never contracted smallpox. Based only on this observation, in the spring of 1796 he drew matter from a dairymaid stricken with cowpox and innoculated an eight-year-old boy. A month and a half later he innoculated the boy with smallpox matter. No disease developed and the cure was found.
While Pasteur received immediate recognition for his discovery, Jenner's results, based on this single case, were rejected for publication by the Royal Society. It was some years before the procedure became widely accepted. See J. NICOLLE, LOUIS PASTEUR: THE STORY OF HISMAJOR DISCOVERIES (1961); F. DREWITT, THE LIFE OF EDWARD JENNER, M.D., F.R.S. (2d ed. 1933). While I do not necessarily advocate implementation of widespread regulation based on such scant evidence, I am loath to score it and think there may be circumstances when regulatory reaction might be justified.
Sir Isaac Newton's observation of the falling apple, while inducing prompt deduction, was, unlike the work of Jenner and Pasteur, not based on observation of one or two human subjects.
Thus, while I appreciate the majority's suggestion, it does not aid my point. See majority op. at note 92. I fear, however, the majority has ignored my real point; namely, that reliance on the lead isotope study as supportive of other evidence cannot be dismissed out of hand merely because it involved only two subjects. See note 87 infra.
77. If this is not obvious, my calculations follow. The women at 38.1 meters have average blood lead levels of 17.4 ug. If half is derived from diet, then 8.7 ug are attributable to airborne lead. A 60% increase in lead levels would increase that 8.7 ug share by 60% as well, to 13.9 ug. But the other 8.7 ug attributable to dietary intake would remain constant. Thus the total blood lead level would rise to 22.6 ug, only a 30% rise, and approximately that found by Daines at the nearer location. Of course, this calculation proceeds on the roughest of assumptions and I do not mean it to be taken as more than an indication of support for the Administrator's finding.
78. The majority further attempts to discredit the Administrator's reliance on the Daines report by suggesting that he "clearly misunderstood what the study attempted to do and what it ultimately showed." Majority op. at 57. The majority supports this view by citing a portion of the preamble to the regulations which it claims displays the Administrator's lack of understanding. In a footnote the majority significantly notes:
Although the Daines study is not identified by name in the preamble, the substance of the quopted reference as well as the process of elimination make clear the fact that this was the study being discussed.
Id. at note 83. It is the majority, I think, which has "clearly misunderstood." The Administrator in the quoted material is discussing both the Daines study and the Seven Cities Study, as his subsequent explicit use of the latter study makes clear. See Third Health Document at V-9, JA at 89. This is not "quibbling," majority op. at note 109, since all of the Administrator's language cited by the majority is fully supported by one or the other of these studies, or by reasonable inferences drawn therefrom. Cf. note 80 infra.
79. Only Ethyl attempts any challenge to these conclusions. It argues that EPA uses a simple straight-line calculation from Kehoe's data in contravention of its own warning that "[a]s exposure increases, blood lead levels rise, although slowly and in a nonlinear fashion, because excretion of lead also rises with increasing exposure." Third Health Document at IV-1, JA at 69; Ethyl brief at 38. EPA realized this danger, however, and counterated it. The Agency did not use the regression equation to predict blood lead levels beyond a concentration of 40 ug, which represents the point at which the curve may level off. Third Health Document at V-5, JA at 85.
80. The authors of the Seven Cities Study concluded:
In a given metropolitan area, urban-suburban comparisons tend to minimize the influence of diet and climate. That airborne lead contributes to the relatively higher blood lead concentrations in center-city populations would seem to be the most probable interpretation of this consistent observation.
Seven Cities Study, supra note 72, at 49, JA at 892.
81. Hammer, et al., "Trace Metals in Human Hair as a Simple Epidemiologic Monitor of Environmental Exposure," TRACE SUBSTANCES IN ENVIRONMENTAL HEALTH V: A SYMPOSIUM 25 (D. Hemphill, ed. 1972).
82. Nordman, Blood Lead Levels and Erythrocyte Delta-Aminolevulinic Acid Dehydratase Activity in People Living Around a Secondary Lead Smelter, 10 WORK — ENVIRONMENT — HEALTH 19 (1973).
83. Respiration and absorption data are more complete for men than for women, so calculations are made for the "standard man." Third Health Document at V-15, 16, JA at 95-96. On the other hand, women move around less during the day, often staying at home, so they form a more reliable data base to test the effect of airborne lead concentrations in specified locations. Thus the Daines and Seven Cities Studies are of women only. Note, however, that the important controlled environment pilot lead isotope study and chamber studies were of men.
84. Nonetheless, the Administrator observed:
While the total dietary intake and total daily respiration of women are generally less than those of men, women generally are smaller with proportionally lower caloric and oxygen requirements. Thus the relative relationships with respect to lead absorption from the gastrointestinal and respiratory tracts should be rather similar to those for men.
Third Health Document at V-16, JA at 96.
85. The Administrator explained:
It is even more difficult to extrapolate such calculations to children because they are in a phase of rapid growth and the parameters of interest change in a non-linear fashion. For example, a one year old child has only about 1/7 the body weight of an adult, yet has about 1/3 to 1/4 the total daily air intake (6m3) and about 40-60% of an adult's total dietary lead intake (130 ug) * * *. Hence, a child takes in less lead on a total basis, but proportionately more lead on a body weight basis than an adult.At present, the ultimate effect of these differences upon lead intake and absorption in children when compared to adults is not fully known.
Third Health Document at V-16, JA at 96.
86. Besides the proportionally greater lead intake in children noted by the Administrator, see note 85 supra, children are likely to be exposed to greater air lead concentrations than their taller parents:
Lead concentration in ambient air varies inversely with altitude, and devices used in measuring air lead concentration are rarely, if ever, placed at the height at which young children breathe. This fact is seldom given consideration in calculations of the respiratory intake of lead among young children. One study indicated that lead concentration at 20 meters above the ground is only half the amount obtained at 1.5 meters.
Lin-Fu, Vulnerability of Children to Lead Exposure and Toxicity, 289 NEW ENGLAND J. MEDICINE 1229 (Dec. 6, 1973), JA at 619. See also Third Health Document at VI-7, JA at 117.
87. Besides misapplying the "arbitrary andcapricious" standard of review, the majority displays a remarkable misunder-standing of the sort of evidence that would support scientific conclusions like those made by the Administrator. The majority sees some error in my repeated observations that study after study "supports" or "confirms" the Administrator's conclusion: "Obviously, the dissent recognizes the defects of each of these studies and is thus reluctant to say that the Administrator was justified in relying on them in support of his conclusions." Majority op. at 59. Let me be explicit: I believe the Administrator was justified in relying on each of these studies in support of his conclusions. In one way or another, each study supports the conclusion. The majority, however, seems to think something more is required of useful scientific evidence, that studies that are in themselves "inconclusive" cannot form the basis of a conclusion. The majority is in grave error. Scientific evidence is by its nature cumulative: the more supporting evidence available, the more likely the accuracy of the conclusion. If one single study or bit of evidence were sufficient independently to mandate a conclusion, there would, of course, be no need for any other studies. But science does not usually work that way. Studies continue for years — in the case of lead automobile emissions for almost 50 years, see note 4 supra — and eventually the cumulative effect of the research is sufficient to mandate the conclusion. Such is the case here. I do not assert that any single study would by itself demand regulation of lead automobile emissions. Nor does the Administrator so claim. After analyzing the various studies, including those supporting the lead dustfall theory, see pp. 79-88 infra, he found what he thought sufficient scientic support to justify regulation. I think his decision that regulation was appropriate was a reasoned one, fully supported by the totality of available evidence. Science can offer no more.
88. See, e.g., Ethyl brief at 41 ("the ultimate 'lead herring'"); Nalco brief at 29 ("a diverting influence to the vital task of eradicating leaded paint from the walls of housing in this country").
89. Some of this evidence is suggested, however, at pp. 40-41 supra.
90. While drawing the causal connection suggested in text, the Administrator did caution that "[t]hese results could conceivably be confounded by existence of poorer quality housing nearest roadways and by racial and social class differences among residents near major roadways." Third Health Document at VI-17, JA at 127. Because no significant differences were found between children living 100 to 200 feet from the major roads and those living beyond 200 feet, the Administrator concluded that auto emissions were the dominant, if not the sole, cause of the differences and "that these other factors were likely not major confounding variables." Id.
Undoubtedly, respiration of airborne lead emissions contributed to the elevated blood lead levels, but the fact that a far greater percentage of these children had elevated blood leads than comparable adults, see the Daines study, discussed at pp. 70-72 supra, suggests that ingestion of lead dustfall significantly supplemented any respiratory intake.
91. Health-based regulations based only on such correlations have often proceeded over the vehement objections of the regulated industries that no direct evidence of causation had been produced. Familiar examples are mandatory pasteurization of milk and regulation of cigarette advertising. A classic case is the story of the Broad Street Pump. When a cholera epidemic broke out in a London neighborhood in 1849, John Snow observed that most of the victims drank from the pump, known for its fine water. Without further evidence of causation and based on what the majority would denigrate as merely a statistical correlation, authorities closed the pump and thereby ended the epidemic. J. SNOW, ON THE MODE OF COMMUNICATION OF CHOLERA (1849).
While the majority is correct that the import of a statistical correlation can be significantly diminished when a persuasive alternative correlation is introduced, majority op. at note 127, in the absence of such an alternative, as in this case, there is nothing wrong with following an unambiguous correlation to its obvious conclusion.
92. Petitioners, and the majority, suggest that something is wrong with these data because preliminary results did not reach the same conclusion. Nalco brief at 22-23; PPG brief at 34-35; majority op. at 57-58. Preliminary calculations on data points only above 40 ug lead concentration did not produce significant results, so the data field was expanded to include all the evidence, whereby these results were obtained. I see nothing wrong with such refinement of experimental data.
93. The El Paso study of children living near a lead smelter is most convincing. Within one mile of the smelter, 35.2% of the children tested had blood lead levels of 40 ug or greater; beyond that the percentage dropped to around 10. Epidemiologic Studies of Human and Environmental Lead Pollution: El Paso, Texas (unpublished 1972), JA at 468, Table 2. The chairman of the NAS Panel concluded that
the Smeltertown [El Paso] study alone lends a high degree of credibility to the hypothesis that very young children will, in fact, ingest toxicologically significant amounts of dust and dirt when it contains lead at the level of 0.1 percent and up.
Letter from Dr. Paul B. Hammond to Dr. Kenneth Bridbord, EPA, March 9, 1973, JA at 2417.
A Charleston, S.C. study is also of some support. It found that the yards of houses where pediatric lead poisoning had occurred contained large amounts of lead, more than the yards of randomly selected homes. Moreover, "most cases of pediatric Pb [lead] poisoning occur in an area of high soil Pb values." Fairey & Gray, Soil Lead and Pediatric Lead Poisoning in Charleston, S.C., J. S.C. MED. ASSN 79 (March 1970), JA at 482, 485.
Ethyl argues that the Charleston and El Paso data are rebutted by contradictory data from England showing inconsequential increases in children's blood lead levels despite significant changes in soil lead levels. Ethyl brief at 42, citing Barltrop & Strehlow, "The Significance of High Soil Lead Concentrations for Childhood Lead Burdens," presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C. (Oct. 1-2, 1973), JA at 415. The Administrator thinks the American data outweigh this contrary finding, and I would defer to his judgment. Third Health Document at VI-5, JA at 115.
94. Sayre et al., House and Hand Dust as a Potential Source of Childhood Lead Exposure, AM. J. DIS. CHILD (1973) (in press at time of insertion in record), JA at 720; Vostal et al., "Lead Analysis of the House Dust: A Method for the Detection of Another Source of Lead Exposure in Inner City Children," presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C. (Cot. 1-2, 1974), JA at 738.
95. Needleman & Shapiro, "Dentine Lead Levels in Asymptomatic Philadelphia School Children: Subclinical Exposure in High and Low Risk Groups," presented at EPA-NIEHS Conference on Low Level Toxicity, Raleigh, N.C. (Oct. 1-2, 1973), JA at 662. While, as Nalco points out, Nalco brief at 23, this study did not directly implicate automobile emissions as the source of high lead exposure, it does support EPA's contention that lead in dust can contribute to childhood lead exposure.
96. See, e.g., NYC Bureau of Lead Poisoning Control, data submitted to EPA Aug. 31, 1972 & Sept. 12, 1972, cited in Second Health Document at V-10, JA at 188 (20% of children with elevated blood lead levels come from homes without identifiable peeling lead paint); Lepow, testimony before Subcommittee on the Environment, Senate Committee on Commerce, May 8, 1972, cited in Second Health Document at A-20, 21, JA at 233-234 (40% or rural children with excessive blood lead levels do not have accessible lead paint surface).
97. Letter from Fred C. Hart, Commissioner, to William J. Ruckelshaus, EPA, March 20, 1973, JA at 2620, 2628.
98. PPG and duPont do challenge, unpersuasively, EPA's determination that lead automobile emissions fall to the ground where they may be eaten by children. Conceding that the lead particulates fall to the ground, these petitioners argue that "the lead fallout along busy highways stays along those highways and does not migrate to areas in which children play." PPG reply brief at 17. Evidence in the record contradicts this argument. The Daines study and the Newark study both suggest a sharp drop-off in lead concentration and consequent fallout, but not so sharp that the fallout does not reach residential areas where children play (remember that the homes analyzed by Daines were only 3.7 meters from the roadway). More important, however, is the fact that urban children frequently play in the city streets themselves, where even petitioners agree lead fallout can be found.
99. The majority suggests the Administrator could have avoided his purported conflict with the APA by expressly finding thatt notice and comment were "impracticable, unnecessary, or contrary to the public interest," under the procedures of Section 4, 5 U.S.C. § 553(b). Majority op. at note 142. The suggestion is unnecessary for, as the majority fails to acknowledge, the Administrator already had given full notice and allowed comment in complete compliance with Section 4.
100. For this reason, the Agency's switch in the final regulations from leaded pool averaging to total pool averaging was proper. The reproposed regulations made clear that the two alternatives were under consideration and presented the Agency's reasons for favoring the former. 38 FED. REG. 1260 (1973). When the majority of industry comments favored use of the latter method, 38 FED. REG. 33739 (1973), the Administrator shifted his position. I see no effor in the Administrator's final adoption of that scheme.
101. I see no basis at all for the majority's suggestion that this court's order of Oct. 28, 1973 that the Administrator decide within 30 days whether to regulate under § 211(c)(1)(A) can somehow be construed as a judicial instruction that the Administrator consider the evidentiary record to be frozen as of Jan. 10, 1973, the date of the reproposed regulations. Majority op. at 66-67. Such an instruction would be no more than an invitation to lawless rule-making. Cf. International Harvester Co. v. Ruckelshaus, supra note 61, 155 U.S. App. D.C. at 428, 478 F.2d at 632.
102. Indeed, petitioner Ethyl was directly furnished with all such documents as a result of a Freedom of Information Act, 5 U.S.C. § 552 (1970), suit. EPA brief at 71.
103. The record reflects a flurry of comment to the Administrator immediately following this court's 30-day order. See, e.g., letter from P.N. Gammelgard, American Petroleum Institute, to Russell E. Train, EPA, Nov. 20, 1973, JA at 2613; cablegram from J.H. Barksdale to Bryce N. Harlow, Counselor to the President, Nov. 23, 1973, JA at 2617; cablegram from J.D. Harnett, Standard Oil Co. (Ohio), to Russell E. Train, EPA, Nov. 26, 1973, JA at 2635; letter from Claude S. Brinegar, Secretary of Transportation, to Russell E. Train, EPA, Nov. 26, 1973, JA at 2651.
Moreover, although there was no formal final comment period, the Administrator's step-wise regulations would be subject to continuing scrutiny and refinement. The Administrator announced:
EPA will review progress under the regulations as well as additional studies every three years, beginning in 1977. This review will afford a firmer basis for a decision on whether further action is necessary to regulate lead in gasoline to protect public health and welfare.
38 FED. REG. 33740. Thus petitioners would have further opportunity to comment on the most recent evidence. Where evidence is fast developing, an agency can offer no more fair procedure if it is ever to regulate at all in the face of a continuing onslaught of new material.
104. Beyond their attacks on the evidence, the Administrator's interpretation of the statutory language, and the EPA procedures, petitioners raise a host of other objections to the final EPA regulations. Claims relating to the Administrator's application of the various prerequisites to regulation under § 211 were considered when those requirements were discussed. See notes 51-52 supra. I shall briefly address petitioners' remaining contentions.
Ethyl claims a right to cross-examine agency witnesses. Ethyl brief at 55. Not only does the Clean Air Act not require any hearings at all, but even if hearings were required cross-examination is not mandated in § 4-type proceedings, 5 U.S.C. § 553. United States v. Florida East Coast R. Co., 410 U.S. 224, 240 (1973). Petitioners were afforded a meaningful opportunity to be heard and to controvert the evidence. Fairness demands no more. See International Harvester Co. v. Ruckelshaus, supra note 61, 155 U.S. App. D.C. at 427, 478 F.2d at 631.
PPG and duPont claim the Administrator was required to set ambient air standards for lead under § 108, 42 U.S.C. § 1857e-3, before acting under § 211, and his failure to do so warrants reversal. PPG brief at 45. The finding of risk to health from lead pollution necessary for action under § 108 is stiffer than that required under § 211, see pp. 12-13 supra, so it is inconceivable that regulation under § 108 was intended to be a prerequisite to action under § 211. This is supported by the fact that while § 211 itself requires consideration of action under § 202, it makes no mention of § 108. Moreover, it is worth noting that the Administrator claims, with some statutory support, that action under § 108 is discretionary with him. 38 FED. REG. 33740 (1973).
Nalco, PPG and duPont all claim that the Administrator did not give sufficient consideration to the adverse economic effects of his decision to regulate lead additives. Nalco brief at 42; PPG brief at 40. Even if the Administrator is allowed to consider at all the economic effects of regulations issued under § 211(c)(1)(A), a question I do not address, he has plainly both well understood and considered the consequences of these regulations and found them to be minimal. 38 FED. REG. 33739 (1973).
NPRA objects to the Administrator's switch from leaded pool averaging to total pool averaging. Brief of petitioner National Petroleum Refiners Association at 42 (hereinafter NPRA brief). EPA switched in response to the comments of a majority of refiners, including NPRA itself. JA at 2179. I find nothing wrong with use of that system. I discuss at note 100 supra the propriety of the Agency's announcing this change when promulgating its final regulations.
Lastly, Ethyl, PPG, duPont and NPRA claim that EPA was required to file an environmental impact statement under § 102(2)(C) of the National Environmental Policy Act, 42 U.S.C. § 4332(2)(C) (1970), or the functional equivalent of one. Ethyl brief at 57; PPG brief at 46; NPRA brief at 53. So far as EPA regulation under § 211 is concerned, we answered this question in Amoco, and recent legislation has made the point doubly clear. An environmental impact statement from EPA does not appear necessary; a "functional equivalent" suffices. The Amoco court held that when the Administrator has considered the evidence and alternative courses of action required before action under § 211 is permitted, he has necessarily furnished the "functional equivalent" of an impact statement. Amoco Oil Co. v. EPA, supra note 6, U.S.App.D.C. at - , 501 F.2d at 749-750. Since I believe the Administrator has complied with all the demands of § 211 in this case, I believe he has likewise complied with NEPA.
Any lingering doubt in this regard has been removed by recent congressional action. The Energy Supply and Environmental Coordination Act of 1974, Pub.L. No. 93-319 (June 22, 1974), provides, "No action taken under the Clean Air Act shall be deemed a major Federal action significantly affecting the quality of the human environment within the meaning of the National Environmental Policy Act of 1969." Id. § 7(c)(1). Thus Congress has expressly exempted EPA action under the Clean Air Act from NEPA's environmental impact statement requirement.
105. The majority notes EPA's recent announcement of possible dangerous emissions from the catalytic converter, the device developed by the automobile companies to meet the emission requirements set by Congress in § 202 of the Act. Majority op. at note 143. The possibility of this problem was noted in Amoco. See Amoco Oil Co. v. EPA, supra note 6, U.S. App. D.C. at n.32, 501 F.2d at 736 n.32. Such emissions were not, however, an issue in that case, see id., and they are not an issue in this one. Whether the converter must eventually be withdrawn or not, the automobile manufacturers must still meet the PNA emission standards of the Act. Since the Administrator's calculations are based on those standards, and not on use of the catalytic converter, they are still accurate. See 38 Fed. Reg. 33738. It is only an indication of the majority's desperation in grasping for theories to support its conclusion that it suggests reversal of this case is further justified by this most recent irrelevant development. Surely it is unprecedented for a reversal to be grounded, even in part, on highly speculative projections from an agency announcement of tentative findings, stamped "DRAFT: DO NOT QUOTE OR CITE," and not even submitted to the court, let alone fully considered by the agency, briefed by the parties, or entered into the record. The majority's action is particularly ill-advised since there is not the slightest indication that the agency will not itself responsibly conform its pertinent regulations to ongoing research, if that is necessary, without this court's premature intervention. To say this issue is not ripe for review is to understate the obvious. Proper methods for assessing any health hazards presented by the catalytic converter are suggested in Amoco. Id.
5 ELR 20096 | Environmental Law Reporter | copyright © 1975 | All rights reserved