Argued En Banc May 30, 1975.
Certiorari Denied June 14, 1976. See 96 S.Ct. 2662, 2663.
Opinion for the court, in which Chief Judge BAZELON and Circuit Judges McGOWAN, LEVENTHAL, and SPOTTSWOOD W. ROBINSON, III, concur, filed by Circuit Judge J. SKELLY WRIGHT.
Concurring opinion, in which Circuit Judge McGOWAN joins, filed by Chief Judge BAZELON.
Concurring statement filed by Circuit Judge LEVENTHAL.
Dissenting opinion filed by Circuit Judge MacKINNON.
Dissenting opinion, in which Circuit Judges TAMM and ROBB join, filed by Circuit Judge WILKEY.
J. SKELLY WRIGHT, Circuit Judge:
Man's ability to alter his environment has developed far more rapidly than his ability to foresee with certainty the effects of his alterations. It is only recently that we have begun to appreciate the danger posed by unregulated modification of the world around us, and have created watchdog agencies whose task it is to warn us, and protect us, when technological "advances" present dangers unappreciated—or unrevealed—by their supporters. Such agencies, unequipped with crystal balls and unable to read the future, are nonetheless charged with evaluating the effects of unprecedented environmental modifications, often made on a massive scale. Necessarily, they must deal with predictions and uncertainty, with developing evidence, with conflicting evidence, and, sometimes, with little or no evidence at all. Today we address the
Section 211(c)(1)(A) of the Clean Air Act
I. THE FACTS, 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. Today, approximately 90 percent of motor gasoline manufactured in the United States contains lead additives, even though most 1975 and 1976 model automobiles are equipped with catalytic converters, which require lead-free gasoline. From the beginning, however, scientists have questioned whether the addition of lead to gasoline, and its consequent diffusion into the atmosphere from the automobile emission, poses a danger to the public health.
Lead is an ubiquitous 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 40 micrograms per 100 grams of blood (10-40 ug/100g)
Human body lead comes from three major sources. 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 100-500 ug a day. Third Health Document at V-2, JA 82. Absorption of dietary lead into the bloodstream is estimated at about 10 percent, although in children absorption may be as high as 50 percent. 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.
A second major source of the body's lead burden, at least among urban children, is regarded 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, particular ages 1-3) 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
The last remaining major source of lead exposure for humans is the ambient air. This source is easily the most controllable, since approximately 90 percent of lead in the air comes from automobile emissions,
The multiple sources of human exposure to lead explain in part why it has been difficult to pinpoint automobile lead emissions as a danger to public health. Obviously, any danger is caused only by the additive effect of lead emissions on the other, largely uncontrollable, sources of lead. For years the lead antiknock industry has refused to accept the developing evidence that lead emissions contribute significantly to the total human lead body burden. In the Clean Air Act Amendments of 1970, Pub.L. 91-604, December 31, 1970, 84 Stat. 1698-1700, however, Congress 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.
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 newly-developed catalytic converter emission control system.
On January 10, 1973 the Administrator, while issuing final regulations requiring availability of some lead-free gasoline to allow implementation of the catalytic converter system, 38 Fed.Reg. 1254; approved in Amoco Oil Co. v. EPA, 163 U.S.App.D.C. 162, 501 F.2d 722 (1974), 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 (hereinafter Second Health Document), JA 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 it was virtually impossible to identify the precise amount of airborne lead that will endanger public health. Instead, the control strategy would concentrate on evaluating the cumulative effect of airborne lead on total human lead exposure and the significance of that contribution. 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, pushing the timetable for reduction 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 motion filed 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 27. This document, the Third Health Document, extensively details and reviews the state of knowledge of the health effects of airborne lead. It candidly 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 thorough 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 a majority of refiners, calculate the reduction in a slightly different manner. Whereas the original and reproposed regulations set standards for permissible lead use by each refiner on the basis of grams of lead per gallon of leaded gasoline produced (leaded pool averaging), the final regulations base the standards on grams of lead per gallon of all gasoline produced (total pool averaging). The quantity 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 an average of 0.5 grams per gallon.
Petitioners, various manufacturers of lead additives and refiners of gasoline, appealed the promulgation of low-lead regulations to this court under Section 307 of the Clean Air Act, 42 U.S.C. § 1857h-5. The
The 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 division majority based 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) the Administrator may, on the basis of all the information available to him, promulgate regulations that
42 U.S.C. § 1857f-6c(c)(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 the composition of the gasoline that produces the emissions), and is thus the preferred—although not the mandatory—alternative under the statutory scheme, presumably because it minimizes Agency interference with manufacturer prerogatives.
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
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
Id. It is petitioners' first claim of error that the Administrator has erroneously interpreted Section 211(c)(1)(A) by not sufficiently appreciating the rigor demanded by Congress in establishing the "will endanger" standard. Therefore, petitioners argue, 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).
Petitioners argue that the "will endanger" standard requires a high quantum of factual proof, proof of actual harm rather than of a "significant risk of harm." See supplemental brief of petitioner Ethyl Corporation (hereinafter Ethyl Supp.Br.) at 20. Since, according to petitioners, regulation under Section 211(c)(1)(A) must be premised upon factual proof of actual harm, the Administrator has, in their view, no power to assess risks or make policy judgments in deciding to regulate lead additives. Moreover, petitioners argue, regulation must be based on the danger presented by lead additives "in and of themselves," so it is improper to consider, as the Administrator did, the cumulative impact of lead additives on all other sources of human exposure to lead. We have considered these arguments with care and find them to be without merit.
The Administrator read it as such, interpreting "will endanger" to mean "presents a significant risk of harm." 38 Fed.Reg. 33734. We agree with the Administrator's interpretation. This conclusion is reached not only by reference to the plain meaning of the statute, but by juxtaposition of Section 211(c)(1)(A) with other sections of the Clean Air Act and by analysis of pertinent precedent.
Petitioners support their view of the rigorous nature of the "will endanger" standard by relying on two other sections of the Clean Air Act that also allow for regulation of air pollutants for health reasons. Ethyl
Petitioners suggest that the threshold decision to regulate under both Section 108 and Section 202 can be based on less evidence than required under Section 211 and that, therefore, the proof necessary for action under Section 211 must be particularly firm. Petitioners misread both sections. Section 108 requires an actual "adverse effect" on health before an air pollutant may be listed for regulation; actual harm must result.
Thus, before ordering this extensive chain of action to begin, Congress demanded a threshold determination that the pollutant causes actual harm.
Petitioners also rely on Section 202 to support their strict reading of Section 211. Ethyl suggests that Section 202 is more lenient than Section 211 in that it allows regulation of "likely" dangers. Ethyl Supp.Br. at 18-19. See also Nalco Supp.Br. at 20-21; NPRA Supp.Br. at 31-36. Section 202 provides that the Administrator may regulate
42 U.S.C. § 1857f-1(a)(1) (emphasis added). While this language may be unnecessarily opaque, we think a fair reading disproves petitioners' suggestion. The italicized language upon which petitioners rely refers not to the causal relationship between air pollution and health, but to the relationship between automobile emissions and air pollution.
Thus the two sections of the Clean Air Act presented by petitioners in support of their stringent reading of the threshold requirement for action under Section 211 turn out, upon analysis, to be of no support at all. Section 108 only bolsters our reading of Section 211 as a precautionary statute while Section 202 includes the same standard as Section 211 and thus is of no guidance one way or the other. While petitioners have little more to offer to prove that the "will endanger" standard demands proof of actual harm and is not precautionary in nature, we may turn, in support of our interpretation, to the relevant case law. While cases interpreting the meaning of "endanger" are few in number,
In Reserve Mining Co. v. EPA, 514 F.2d 492 (8th Cir. 1975) (en banc), the Eighth Circuit addressed, among other issues, the meaning of the phrase "endangering the health or welfare of persons" under Section 112 of the Federal Water Pollution Control Act of 1970 (FWPCA), 33 U.S.C. § 1160. FWPCA and the Clean Air Act together constitute the bulk of this nation's substantive environmental protection legislation.
Id. at 528.
In sum, based on the plain meaning of the statute, the juxtaposition of Section 211 with Sections 108 and 202, and the Reserve Mining precedent, we conclude that the "will endanger" standard is precautionary in nature and does not require proof of actual harm before regulation is appropriate.
Perhaps because it realized that the above interpretation was the only possible reading of the statutory language, petitioner Ethyl addresses this interpretation and argues that even if actual harm is not required
In Reserve Mining the issue was whether asbestiform wastes flushed into Lake Superior by the Reserve Mining Company endangered health.
514 F.2d at 529 (footnote omitted; emphasis added). The court thus allowed regulation of the effluent on only a "reasonable" or "potential" showing of danger, hardly the "probable" finding urged by Ethyl as the proper reading of the "endanger" language in Section 211. The reason this relatively slight showing of probability of risk justified regulation is clear: the harm to be avoided, cancer, was particularly great. However, because the risk was somewhat remote, the court did not order the immediate cessation of asbestiform dumping, but rather ordered such cessation within "a reasonable time." Id. at 538.
Reserve Mining convincingly demonstrates that the magnitude of risk sufficient to justify regulation is inversely proportional to the harm to be avoided. Cf. Carolina Environmental Study Group v. United States, supra. It would be a bizarre exercise in balancing horrors to determine whether cancer or lead poisoning is a greater harm to be avoided,
2. The Administrator's Power to Assess Risks. Petitioners argue that Section 211 requires the Administrator to make a "threshold factual determination" that automobile emissions "will endanger" the public health, Nalco Supp.Br. at 15-20; Ethyl Supp.Br. at 24-26, and dispute EPA's claim that the Administrator 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, 162 U.S.App.D.C. 331, 339, 499 F.2d 467, 475 (1974). We must reject petitioners' argument, since the power to assess risks, without relying solely on facts, flows inexorably from the nature of the "will danger" standard. We have already found that Section 211 allows the Administrator to regulate fuel content when he finds that emissions cause a significant risk of harm to the public health. Yet, how can the Administrator determine that a risk is a significant risk if he cannot assess risks? And how can he assess risks if he cannot make policy judgments? Surely reliance on "facts" as contemplated by petitioners will provide little guidance. However, sole reliance on facts was not demanded by Congress.
H.R. 17255, 91st Cong., 2d Sess. § 210(g)(1) (1970) (emphasis added). The specific findings requirement had more than procedural significance. 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 relied upon by petitioners show, Ethyl Supp.Br. at 24; NPRA Supp.Br. at 30; Nalco Supp.Br. at 15, as requiring that any EPA action be based solely on facts.
But the House bill did not become law. The Senate's preference for less restriction of EPA freedom in regulating fuel additives for health reasons
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 :
Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 180-181, 501 F.2d at 740-741 (emphasis added). 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 petitioners correctly point 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 suggesting that such a finding is necessary for action under Section 211(c)(1)(A) as well, however, petitioners completely ignore the fact that a finding is required for action under Section 211(c)(1)(B) and is not required under Section 211(c)(1)(A). By so glossing over the language of the statute, petitioners miss 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
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? These were the questions, highly suitable to factual proof, that the Amoco court construed. Contrary to petitioners' 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 we have suggested above, is not a standard prone to factual proof alone. Danger is a risk, and so must be decided by assessment of risks as well as by proof of facts.
Thus a reason emerges for the 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, 163 U.S.App.D.C. at 179, 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. While Congress did not discuss the extent of the Administrator's power under the "will endanger" standard, its actions—the statute it enacted and the one it rejected—make the legislative intent clear. We find that deletion of the findings requirement for action under Section 211(c)(1)(A) was 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 or the substantive rigor proper for questions of fact.
This conclusion follows not only from the language of Section 211(c)(1)(A) and its legislative history, but from the nature of the Administrator's charge: to protect the public from danger. Regulators such as the Administrator must be accorded flexibility, a flexibility that recognizes the special judicial interest in favor of protection of the health and welfare of people, even in areas where certainty does not exist. Environmental Defense Fund, Inc. v. Ruckelshaus, 142 U.S.App.D.C. 74, 88, 439 F.2d 584, 598 (1971).
Questions involving the environment are particularly prone to uncertainty. Technological man has altered his world in ways never before experienced or anticipated. The health effects of such alterations are often unknown, sometimes unknowable. While a concerned Congress has passed legislation providing for protection of the public health against gross environmental modifications,
Undoubtedly, certainty is the scientific ideal—to the extent that even science can be certain of its truth.
The problems faced by EPA in deciding whether lead automotive emissions pose a threat to the public health highlight the limitations of awaiting certainty. First, lead concentrations are, even to date, essentially low-level, so that the feared adverse effects would not materialize until after a lifetime of exposure. Contrary to petitioners' suggestion, however, we have not yet suffered a lifetime of exposure to lead emissions. At best, emissions at present levels have been with us for no more than 15-20 years.
The scientific techniques for attempting to overcome these limitations are several: toxicology can study the distribution and effect of lead in animals; epidemiological techniques can analyze the effects of lead emissions on entire populations; clinical studies can reproduce in laboratories atmospheric conditions and measure under controlled circumstances the effects on humans. All of these studies are of limited usefulness, however. Dr. J. H. Knelson, Director of EPA's Human Studies Laboratory, has described, in the context of setting ambient air standards, the limitations of these various investigative tools:
JA 582-583. The best biomedical evidence will be derived from relating all three research approaches. This EPA did. That petitioners, and their scientists, find a basis to disagree is hardly surprising, since the results are still uncertain, and will be for some time. But if the statute accords the regulator flexibility to assess risks and make essentially legislative policy judgments, as we believe it does, preventive regulation based on conflicting and inconclusive evidence may be sustained. Recent cases have recognized this flexibility in similar situations.
In Industrial Union Department, AFL-CIO v. Hodgson, supra, this court considered the Secretary of Labor's delegated power under the Occupational Safety and Health Act (OSHA), 29 U.S.C. § 651 et seq., to protect the health of industrial workers by setting standards for exposure to industrial pollutants. Under review was a standard for exposure to asbestos dust, thought to be carcinogenic. Judge McGowan, writing for the division, laid down the rule:
162 U.S.App.D.C. at 338, 499 F.2d at 474.
This rule was likewise applied in Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir.), cert. denied, 421 U.S. 992, 95 S.Ct. 1998, 44 L.Ed.2d 482 (1975), where the Second Circuit reviewed regulations limiting industrial exposure to vinyl chloride, also considered a carcinogen:
Id. at 1308. And in Reserve Mining the Eighth Circuit agreed. Although reviewing the determination of a District Court, not an expert Administrator, the court recognized that it must nonetheless apply the test of the preventive statute before it:
514 F.2d at 507 n.20. See also id. at 529.
These cases, recognizing as they do the developing nature of environmental medicine, fortify our analysis of the "will endanger" language of Section 211.
3. Propriety of the Cumulative Impact Approach. In addition to demanding that the Administrator act solely on facts, petitioner Ethyl insists that those facts convince him that the emission product of the additive to be regulated "in and of itself," i. e., considered in isolation, endangers health. The Administrator contends that the impact of lead emissions is properly considered together with all other human exposure to lead. See page ___ of 176 U.S.App.D.C., page 12 of 541 F.2d supra. We agree.
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 to 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 Section 211's language 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 Section 202 is more lenient, allowing use of the cumulative impact theory while Section 211 does not. This argument is but a variant on Ethyl's already rejected claim that Section 202 allows for regulation of "likely" dangers while Section 211 does not. As with the earlier argument, this reading of Section 202 must be rejected. 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 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.
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 air pollution alone, but by an aggregate of sources, including food, water, leaded paint, and dust.
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:
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.
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. As has been discussed more extensively above, see pages ___ - ___ of 176 U.S.App.D.C., pages 8-9 of 541 F.2d supra, lead enters the human body from multiple sources, so that 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 ever be justified.
Such cannot be the case. Congress understood that the body lead burden is caused by multiple sources. It understood
4. Summary of the "Will Endanger" Determination. In sum, we must reject petitioners' cramped and unrealistic interpretation of Section 211(c)(1)(A). Their reading would render the statute largely useless as a basis for health-related regulation of lead emissions. Petitioners' arguments are rebuffed by the plain meaning of the statute and the Administrator's interpretation of it,
We believe the Administrator may regulate lead additives under Section 211(c)(1)(A) when he determines, based on his assessment of the risks as developed by
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,
Section 211(c)(2)(C), 42 U.S.C. § 1857f-6c(c)(2)(C).
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 not apply to the EPA action.
After making the "will endanger" determination and the "substitute additives" finding, EPA has complied with the statutory mandate and is free to regulate the fuel or fuel additive under Section 211.
III. THE EVIDENCE
A. The Standard of Review
In promulgating the low-lead regulations under Section 211, EPA engaged in informal rule-making. As such, since the statute does not indicate otherwise, its procedures are conducted pursuant to Section 4 of the APA,
This is not to say, however, that we must rubber-stamp the agency decision as correct. To do so would render the appellate process a superfluous (although time-consuming) ritual. Rather, the reviewing court must assure itself that the agency decision was "based on a consideration of the relevant factors * * *."
Greater Boston Television Corp. v. FCC, 143 U.S.App.D.C. 383, 392, 444 F.2d 841, 850 (1970), cert. denied, 403 U.S. 923, 91 S.Ct. 2229, 2233, 29 L.Ed.2d 701 (1971). See also 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, 94 S.Ct. 1991, 40 L.Ed.2d 558 (1974); 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, 94 S.Ct. 2628, 41 L.Ed.2d 226 (1974); International Harvester Co. v. Ruckelshaus, 155 U.S.App.D.C. 411, 444, 478 F.2d 615, 648 (1971).
There is no inconsistency between the deferential standard of review and the requirement that the reviewing court involve itself in even the most complex evidentiary matters; rather, the two indicia of arbitrary and capricious review stand in careful balance. The close scrutiny of the evidence is intended to educate the court. It must understand enough about the problem confronting the agency to comprehend the meaning of the evidence relied upon and the evidence discarded; the questions addressed by the agency and those bypassed; the choices open to the agency and those made. The more technical the case, the more intensive must be the court's effort to understand the evidence, for without an appropriate understanding of the case before it the court cannot properly perform its appellate function. But that function must be performed with conscientious awareness of its limited nature. The enforced education into the intricacies of the problem before the agency is not designed to enable the court to become a superagency that can supplant the agency's expert decision-maker. To the contrary, the court must give due deference to the agency's ability to rely on its own developed expertise. Market Street Railway v. Railroad Commission, 324 U.S. 548, 559-561, 65 S.Ct. 770, 776-777, 89 L.Ed. 1171, 1180-1182 (1945). The immersion in the evidence is designed solely to enable the court to determine whether the agency decision was rational and based on consideration of the relevant factors. Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 416, 91 S.Ct. at 823, 28 L.Ed.2d at 153; Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra, 419 U.S. at 285, 290, 95 S.Ct. at 441, 444, 42 L.Ed.2d at 455, 458. It is settled that we must affirm decisions with which we disagree so long as this test is met.
Thus, after our careful study of the record, we must take a step back from the agency decision. We must look at the decision not as the chemist, biologist or statistician that we are qualified neither by training nor experience to be, but as a reviewing court exercising our narrowly defined duty of holding agencies to certain minimal standards of rationality.
With the "arbitrary and capricious" standard firmly in mind, we now turn to the evidence supporting the regulations before us.
B. Overview of the Evidence
Petitioners vigorously attack both the sufficiency and the validity of the many scientific studies relied upon by the Administrator, while advancing for consideration various studies allegedly supportive of their position. The record in this case is massive—over 10,000 pages. Not surprisingly, evidence may be isolated that supports virtually any inference one might care to draw. Thus we might well have sustained a determination by the Administrator not to regulate lead additives on health grounds. That does not mean, however, that we cannot sustain his determination to so regulate. As we have indicated above, we need not decide whether his decision is supported by the preponderance of the evidence, nor, for that matter, whether it is supported by substantial evidence.
A word about our approach to the evidence may be in order. Contrary to the apparent suggestion of some of the petitioners, we need not seek a single dispositive study that fully supports the Administrator's determination. Science does not work that way; nor, for that matter, does adjudicatory fact-finding. Rather, the Administrator's decision may be fully supportable if it is based, as it is, on the inconclusive
While we have studied the record with great care, we do not discuss it all here; to do so would make this already lengthy opinion completely unwieldy. Instead, we shall briefly review the bases for the Administrator's conclusions that petitioners have singled out for special attack.
1. Blood Lead Levels are Elevated Among the General Public
a. Blood lead levels of 40 ug are indicative of danger to health. Although recognizing that a blood lead level of 40 ug "does not represent a sharp demarcation between health and disease," the Administrator found it "prudent to regard blood lead levels over 40 ug/100g as indicators of lead intake that should be prevented." Third Health Document at III-11, JA 64. Petitioners contest this determination. Much of their argument, however, adds up to nothing more than that they are unhappy the Administrator chose to exercise his judgment and think the statute does not permit such discretion. Petitioners cite medical studies that show not that a blood lead level
In addition to their generalized attack on the Administrator's power, petitioners challenge the sufficiency of the evidence to support his determination. Under the "will endanger" standard, however, we find the evidentiary basis for the Administrator's determination to be more than adequate. Petitioners do not contest the recommendation of the United States Public Health 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 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 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.
b. Blood lead levels are elevated among a small, but 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,
Having analyzed this evidence and the arguments of the parties, we would again defer to the Administrator's judgment. First we 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 percent of all preschool children living in substandard housing.
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 workers—policemen, mailmen, service station employees, parking lot attendants, and the like—are forced to spend their working hours.
Petitioners argue that the negative conclusions of the Seven Cities Study and several other studies should outweigh the positive indications of the studies described above. PPG/duPont Supp.Br. at 16-23; NPRA Supp.Br. at 5-8. The Administrator disagreed, and we cannot fault his conclusion. Because of the many uncontrolled variables in epidemiological studies, valid conclusions may be obscured. But, while the possibility of false negative conclusions is a real one, the possibility of false positive findings is considerably less likely. Clark & MacMahon, supra, at 100. Thus the Administrator credited the occupational and other studies reporting a small, but significant, portion of the general population with elevated blood lead levels and discounted the negative studies on which petitioners rely. Third Health Document at VII-3, JA 144. We cannot say his conclusion was arbitrary or capricious.
2. Automobile Lead Emission Products are Directly Absorbed in the Body to a Significant Extent
Since it is apparent from the face of his decision and the Third Health Document that the Administrator considered all the evidence before him, the only issue is whether he treated that evidence in a rational manner. Petitioners have now conceded that lead emissions are directly absorbed in the body from the ambient air, and they challenge only whether the extent of absorption is significant enough to justify these regulations. Nalco Supp.Br. at 37; PPG/duPont Supp.Br. at 23. The Administrator's
The Administrator relied on three types of evidence: theoretical, epidemiological, and clinical studies. The theoretical evidence consisted of a set of calculations designed to estimate the amount of lead in the air which, when added to an average dietary intake, would suffice to bring the blood lead burden of a "standard man" up to 40 ug.
The second type of evidence relied upon by the Administrator in reaching his conclusion that airborne lead contributes significantly to the human lead body burden consisted of epidemiological research. Epidemiologists study the effects of various phenomena on humans under uncontrolled or "natural" conditions. These effects are correlated with other observed facts in an attempt to develop significant relationships among the data. The science is limited, however, in that inferences may be drawn, but relationships cannot be proved by the correlations alone. JA 583. The studies before the Administrator were of large groups of people; correlations were sought between blood lead level and exposure to lead in the ambient air. The studies were confounded, however, by the multiple sources of lead. Since diet accounts for a major portion of the body lead burden, an individual's blood lead level varies not only according to his exposure to lead in the ambient air, but according to his daily dietary intake of lead. Wide variations in dietary lead intake, which are common, can completely mask the effects of air lead absorption. Nonetheless, none of the epidemiological studies could control or measure dietary lead intake. This uncertainty in the data severely limited the usefulness of the broadly conceived epidemiological studies and led the Administrator to rely instead on data limited to situations in which dietary exposure could roughly be termed constant.
Following this rationale, the Administrator focused on the consistent relationship found between air and blood lead levels within particular metropolitan areas, rather than on the lack of such a relationship between areas.
The conclusions the Administrator drew from theoretical calculations and the epidemiological studies are significantly bolstered by two important clinical studies. Clinical studies are laboratory experiments on humans in which variables can be controlled and causal relationships demonstrated. Clinicians attempt to reproduce atmospheric conditions in the laboratory and measure the response to pollution of small numbers of humans chosen to represent the population at large. JA 583. Because of its necessarily significant intrusion on the subjects' lives, clinical research is limited in the number of subjects it can study. Nonetheless, the two clinical studies are especially valuable since they are the only attempts to control or account for dietary lead intake. Thus they sought to measure the contribution of respiratory absorption of lead unmasked by variations in dietary lead. Both studies found that airborne lead provided a significant portion of the lead in the blood of the experiments' subjects. Moreover, the amount of lead actually absorbed from the air during these studies corresponded closely with the amount EPA's theoretical calculations predicted would be absorbed. See pages ___ to ___ of 176 U.S.App.D.C., pages 61 to 63 of 541 F.2d infra.
While we must consider petitioners' arguments carefully, the necessary existence of limitations and inconsistencies in the data remind us to observe carefully our limited appellate function. It does not matter whether or not we agree with the Administrator's determination. Nor does it matter whether the evidence might support a conclusion contrary to that reached by the Administrator. All that is of concern to us is that there be a rational basis in the evidence for the conclusion reached. We cannot say there is not. The bulk of the evidence cited supports the Administrator. See Appendix A to this opinion. The Administrator treated all the evidence in a consistent and rational manner. This treatment disposed of most of the studies relied upon by petitioners, leaving the plain conclusion that lead emissions form a significant part of the human body burden. Particularly in light of the precautionary nature of the "will endanger" standard, we cannot find the Administrator's conclusion to be arbitrary or capricious. Accordingly, we must uphold his determination.
3. Lead Exposure from Dustfall Threatens the Health of Children
While we would have no difficulty in sustaining the low-lead regulations solely on the basis of the evidence and conclusions discussed above, the Administrator based his decision to regulate on other evidence as well. He presented a hypothesis, which he found consistent with known information, that urban children are particularly threatened by lead additives in that they are prone to ingest lead emissions that have fallen to the ground and mixed with dust. While the hypothesis is admittedly not proved as fact, we need not decide whether it would be sufficient by itself to support the low-lead regulations, for it is offered only in support of the evidence already presented. Petitioners vigorously attack the hypothesis nonetheless, but constantly confuse the issue by ignoring the flexibility
First, as we have demonstrated above, see pages ___ - ___ of 176 U.S.App.D.C., pages 12-20 of 541 F.2d supra, the "will endanger" standard is a precautionary standard that embraces a wide range of permissible proof. It is therefore no objection to the dustfall hypothesis that it is merely a hypothesis. A supportable and reasonable hypothesis may well form the basis for regulations under Section 211(c)(1)(A). Indeed, the totality of evidence relied upon in the Reserve Mining case constituted no more than such a hypothesis. See pages ___ - ___ of 176 U.S.App.D.C., pages 45-46 of 541 F.2d infra.
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. 33735. Although petitioners repeatedly try to rebut EPA conclusions by stating this fact, the Administrator was well aware of it and his evaluation of the data before him invariably accounted for it. We do not believe the importance of lead paint to the lead poisoning problem in children invalidates the Administrator's reliance on the dustfall theory. The Administrator justified his hypothesis as a basis for regulation on grounds that dustfall may be regulated far more readily than leaded paint, that dustfall contributes significantly to the threat from leaded paint by raising blood lead levels so as to make lead poisoning easier to contract, and that even when acute lead poisoning does not develop absorption of lead dustfall may cause undesirable and avoidable subclinical effects. 38 Fed.Reg. 33736-33737.
With these preliminaries settled, we turn to the evidence supporting the Administrator's determination. Since the hypothesis is only a secondary basis for the regulations, and since the evidence cited goes considerably beyond that necessary to establish the hypothesis as reasonable, we shall address only the thrust of petitioners' objections and the Administrator's responses. The logical steps to the Administrator's conclusion are these:
38 Fed.Reg. 33736. If the intermediate steps are supported by the evidence, the validity of the Administrator's conclusion as a reasonable hypothesis is unassailable. Our study of the underlying evidence convinces us that it is firm and convincing, and certainly sufficient to support the Administrator's hypothesis as reasonable.
Petitioners concede that lead concentrations are high in the dust near highways and adjacent to homes with lead paint. They contest, however, that high lead concentrations
Where does this high dust lead content come from? The Administrator concluded that since 90 percent of the lead in the ambient air is from automotive exhausts and since, as petitioners concede, PPG/duPont Reply Br. at 17, the lead eventually settles to the ground, most of the lead in dust is a product of automobile lead emissions. Petitioners do not seriously contest this; indeed their own studies suggest this by showing that lead content in soil decreases with distance from highways.
Petitioners do not contest that pica is a common phenomenon among preschool children, although they note that it "is a psychological disorder; it is not characteristic of all children * * *." PPG/duPont Supp.Br. at 37 n. 86. While this is certainly true, pica is characteristic of a significant number of children. Petitioners do not challenge the conclusion of the NAS Panel that pica occurs in at least 50 percent of both middle- and lower-class children. NAS Report at 133.
On the basis of this evidence alone it is reasonable to hypothesize that children with pica will ingest dust and dirt containing lead dustfall from automobiles. Indeed, on such limited evidence the NAS Panel accepted the dustfall hypothesis as credible:
NAS Report at 140 (emphasis added). Again petitioners focus on the last sentence and emphasize the danger from leaded paints. Since the Administrator is in agreement with them on the point, however, their arguments are superfluous.
Petitioners' primary claims are not addressed to the evidence that establishes the dustfall hypothesis as tenable. Rather, they argue that there is no evidence that lead dustfall from automobiles is in fact swallowed by children with pica. While such proof is not necessary to establish the Administrator's hypothesis as reasonable, see pages ___ - ___ of 176 U.S.App.D.C.,
In any case, all the evidence suggesting that the children with pica tend to eat dust contaminated with lead fallout from automobiles takes the Administrator's theory far beyond the hypothesis stage. He offered only a tentative result, "a hypothesis consistent with information provided by a variety of studies." 38 Fed.Reg. 33736. Undoubtedly, he has shown that. Indeed, as reasonable medical hypotheses go, this one is particularly solid. This is vividly demonstrated by recalling the kind of evidence relied upon to justify similar precautionary relief in Reserve Mining.
The question in that case was the validity of the hypothesis that ingestion of asbestos fibers was dangerous to health. The reason for concern was that epidemiological studies had associated inhalation of asbestos with cancer. The evidence supporting the hypothesis was of three kinds: (1) a court-sponsored study to determine whether asbestos fibers were present in residents who drank the polluted water; (2) animal studies designed to measure whether asbestos fibers can be absorbed into the body from the stomach; and (3) epidemiological studies associating inhalation of asbestos fibers with gastrointestinal cancer and the theory that this may be due to ingestion of asbestos fibers initially inhaled. Reserve Mining Co. v. EPA, supra, 514 F.2d at 514. Upon review of the evidence the court concluded (1) asbestos fibers were not present in long-time residents; (2) the animal studies were ambiguous on whether asbestos fibers could be absorbed if ingested; and (3) the theory that asbestos workers ingested asbestos fibers as well as inhaled them was no more than a theory, id. at 514-516. Nonetheless, solely on the basis of this evidence, the court concluded that "the theory that excess cancers may be attributed to the ingestion of asbestos fibers rests on a tenable medical hypothesis," id. at 516. On the basis of this tenable hypothesis, the court accepted the further hypothesis that asbestos could be ingested from the drinking water and that, therefore, there was a "reasonable medical concern" for the public health which justified abatement of the asbestos discharge under the "endangering" language of the FWPCA. Id. at 520.
None of these uncertainties cloud the Administrator's dustfall hypothesis. Lead is present in children, and in elevated amounts. Children do ingest dust, and dust is heavily laden with lead. Animal studies prove that ingested lead dust is absorbed into the bloodstream. And epidemiological studies associate high lead concentrations in children with high lead concentrations in dirt and dust, and with proximity to automobiles. Since the automobile is the predominant source of lead in dust, the Administrator's hypothesis stands firm as reasonable, undoubtedly with more support in studies already made than the hypothesis that justified regulation in Reserve Mining. Indeed, the primary difference between this case and Reserve Mining is that the Eighth Circuit justified ordering abatement of asbestos discharges into the water solely on the basis of a hypothesis,
C. Summary of the Evidence
From a vast mass of evidence the Administrator has concluded that the emission products of lead additives will endanger the public health. He has handled an extraordinarily complicated problem 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.
In tracking his path through the evidence we, in our appellate role, have also considered separately each study and the objections petitioners make thereto. In no case have we found the Administrator's use of the evidence to be arbitrary or capricious. Having rejected the individual objections, we also reject the overall claim of error. We find the Administrator's analysis of the evidence and assessment of the risks to be well within the flexibility allowed by the "will endanger" standard. Accordingly, we affirm his determination that lead emissions "present a significant risk of harm to the health of urban populations, particularly
IV. EPA PROCEDURES
Petitioners' last major objection to the low-lead regulations is the claim that they are procedurally defective in that, after allowing a total of three formal comment periods, the Administrator did not allow a fourth prior to issuing the regulations.
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, 94 S.Ct. 2628, 41 L.Ed.2d 226 (1974); Mobil Oil Corp. v. FPC, 157 U.S.App.D.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, 375 F.2d 43, 48 (9th Cir.), cert. denied, 389 U.S. 844, 88 S.Ct. 96, 19 L.Ed.2d 112 (1967). This last qualification is 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, after two comment rounds, 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 as amended and opened them up for a third comment round. It was only when the final regulations were issued that the Administrator omitted a fourth comment period. 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 incorporates new information received since the reproposal and responds to the comments. The only change in the regulations as issued was the switch, supported by comments from a majority of refiners, from
All significant new information developed during the rule-making in this area on the frontiers of scientific knowledge was made available to petitioners and the public for comment well in advance of issuance of the final regulations on November 28, 1973.
1. The Pilot Lead Isotope Study. The pilot lead isotope study consists of two separately reported experiments which produced similar results.
2. The Unpublished Japanese Study. The dissent places great stress on the fact that this unpublished and undated draft
3. The Chamber Study. The dissent attempts to build an argument from the fact that the Second Health Document cites the chamber study
4. The Seven Cities Study. The dissent criticizes only the Administrator's reliance on an EPA reanalysis of the data on which this study was based, since it is conceded that the study itself
5. The Newark, Rochester, Philadelphia, and Chicago Studies. The only clear references to these studies,
Moreover, as the Administrator's placement of the discussion of these studies makes clear, the studies are not needed or used to support the conclusion that the dustfall hypothesis is reasonable. That conclusion is a sufficient basis for regulation under the statute. See pages ___ _ ___, ___ of 176 U.S.App.D.C., pages 11-20, 44 of 541 F.2d supra. These additional studies, which are corroborative of the dustfall hypothesis, see pages ___ _ ___ of 176 U.S.App.D.C., pages 44-46 of 541 F.2d supra and Appendix B to this opinion, play no role in the Administrator's decision to regulate.
Finally, petitioners and the dissent suggest that even if all the new studies were made available to the public for comment well before the Administrator reached his decision, Section 4 of the APA requires still another procedural step: that the Administrator, before arriving at his decision, publicly identify the recently received studies and comments on which he intended to rely so that the public might have yet another opportunity to comment on that material. If this new round of comments provided any significant information, the Administrator would presumably be able to use that information only if he formally stated his intent to do so and allowed still another round of comments. For obvious reasons, there is no support for this novel suggestion in the Act or in the jurisprudence.
The complex scientific questions presented by this rule-making proceeding were "resolved in the crucible of debate through the clash of informed but opposing scientific and technological viewpoints." International Harvester Co. v. Ruckelshaus, 155 U.S.App.D.C. 411, 448, 478 F.2d 615, 652 (1973) (concurring opinion of Chief Judge Bazelon). On January 31, 1971 the EPA began the debate by publishing advance notice of proposed rule-making concerning possible controls on lead additives in gasolines because of their possible danger to health. On February 23, 1972 it published the proposed regulations supported by a document, Health Hazards of Lead (First Health Document), prepared by the EPA scientific staff. It invited comment from the lead industry, the scientific community, and the concerned public. The EPA held public hearings in Washington, D.C., Dallas, and Los Angeles to give people across the country an opportunity to join the debate.
On January 10, 1973 the EPA reproposed the regulations in slightly changed form, supported by a Second Health Document which reflected the scientific comments on the first and brought the scientific information on the subject up to date. Scientific studies, pro and con, which had become available since the proposed regulations were first published were included. Again the EPA invited the parties, the scientific community, and the concerned public to comment. Finally, on November 28, 1973,
Because of the importance of the issues raised, we have accorded this case the most careful and exhaustive consideration. We find that in this rule-making proceeding the EPA has complied with all the statutory procedural requirements and that its reasons as stated in its opinion provide a rational basis for its action. Since we reject all of petitioners' claims of error the Agency may enforce its low-lead regulations.
1. Experimental Calculations. The Administrator leads off his discussion of the relationship between airborne and blood lead levels with a set of calculations based on the experimental work of Kehoe and designed to provide a rough estimate of the dangers posed by exposure to various ambient air lead concentrations. Third Health Document, V-2 to V-9, JA 82-89. Kehoe, in his classic Harben Lectures,
These calculations start with the absorption figures for ingested lead. Commonly accepted data for daily dietary intake for adults are on the order of 200-300 ug/day, with ranges of 100 to 500 ug/day. Of this amount, 10 percent is thought to be absorbed into the blood; the remainder is excreted. Thus the 600 ug daily intake of subject S.W. caused a daily absorption of 60 ug into the blood. If daily dietary lead intake averages 200-300 ug, for a daily absorption of 20-30 ug, what air lead exposure level, asked EPA, could result in an increased absorption of 30-40 ug daily, so that total absorption remained 60 ug? Third Health Document at V-6, JA 86.
Absorption of respiratory lead is dependent on three factors: air lead concentration, volume of air inhaled daily, and percent of inhaled lead absorbed. EPA based its calculations on daily respiration of 15 and 20 cubic meters (m
These calculations suggest that the danger from lead emissions in the atmosphere is a real one. If substantiated, they warn that air lead concentrations can make a significant contribution to blood lead levels. Two clinical studies, which will be discussed in detail below, have recently provided important empirical support for this theoretical
Petitioners' attack on the Administrator's analysis is so misguided that it is questionable whether they have even attempted to understand the purpose of these calculations. Instead, they fight again a battle they won over two years ago. Petitioners vigorously attack the Administrator's calculations as a revitalization of the so-called Goldsmith-Hexter regression equation. Nalco Supp.Br. at 39-40; PPG/duPont Supp.Br. at 32-33. As they rightly observe, EPA abandoned this approach at the time of the Second Health Document. See Second Health Document, Appendix A, JA 214-218. Petitioners do not recognize, however, that the mere fact the Administrator is once again engaged in theoretical calculations does not necessarily mean he has returned to the discredited Goldsmith-Hexter approach.
The Goldsmith-Hexter regression equation was an attempt by EPA to predict a person's blood lead level as a direct function of the air lead concentration to which he was exposed. This equation would then be used to find a "safe" air lead concentration to avoid elevated blood lead levels. First Health Document at 3-5 & Table 7, JA 294-296, 305. The approach simply made too many assumptions. In particular, it did not recognize the wide variability of dietary lead intake and thus was of no predictive value. After considering petitioners' critiques, EPA abandoned its attempt to quantify a safe level of exposure and settled on its current, more qualitative, approach to the evidence. JA 214-218.
The current analysis is much more modest in scope and does not rely at all on the Goldsmith-Hexter data or equation. Well established work has shown that blood lead levels will reach the 40 ug mark if a daily absorption of 60 ug is maintained over time. EPA simply calculates, for various specified situations, the air lead concentrations necessary to produce that daily 60 ug absorption figure. Since petitioners' objections are not addressed to this use of the Kehoe data, they can hardly be credited.
2. Epidemiological Studies. The intercity correlations produced by the major epidemiological study, the Seven Cities Study, were negative. The Study was an attempt to correlate atmospheric and body lead levels in seven cities in the United States. No statistically significant correlation was found between the atmospheric lead in a city and the blood lead level of its inhabitants. As the Administrator noted in promulgating the low-lead regulations, residents of New York City had lower average blood lead levels than residents of Philadelphia, despite the fact that somewhat higher airborne lead levels were measured in New York. 38 Fed.Reg. 33735.
Petitioners rely heavily on the negative conclusion of the Seven Cities Study. PPG/duPont Supp.Br. at 24-25; Nalco Supp.Br. at 34-35; NPRA Supp.Br. at 11-12; Ethyl Supp.Br. at 45-46. The Administrator, however, discounted the significance of the Study's overall conclusion because of the intercity differences in lead intake from sources other than the air, 38 Fed.Reg. 33735, and instead relied on data in the study relating to individual metropolitan areas. In such areas climate was constant
JA 892. Upon reanalysis of the underlying data, the Administrator concluded that while air lead was not the most influential factor affecting urban-suburban blood lead levels, it was a significant factor. 38 Fed.Reg. 33735; Third Health Document at V-9, JA 89. Petitioners do not so much attack the Administrator's reliance on this data as they argue that the intercity comparisons of the Study should be accepted. In this context, we cannot say that the Administrator's statement of reasons for crediting the suburban-urban data while discounting the intercity data was irrational.
For reasons similar to those advanced for discounting the intercity results of the Seven Cities Study, the Administrator also
JA 398-399. See Third Health Document at V-11, 12, JA 91-92.
While not according significant weight to the study for these reasons, the Administrator did observe a generally positive relationship between average blood lead values and increasing airborne lead exposure. Third Health Document at V-12, JA 92. See JA 396 (Fig. 3). This relationship is especially striking in the data for Los Angeles, the only city in the study in which two groups were evaluated. Taxi drivers exposed to air lead concentrations of 6 ug showed blood lead concentrations some 25 percent higher than office workers exposed to air lead concentrations of 3 ug. JA 392 (Table 1). This finding, again assuming some rough dietary comparability, is consistent with the urban-suburban differences of the Seven Cities Study.
The inferences the Administrator drew from the Seven Cities Study and the Azar study were bolstered by the preliminary results of a Japanese study
Nonetheless, once again the urban-suburban gradient clearly emerged. 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. 1123, and to conclude that the increase of blood levels with urbanization "was statistically significant," although of small magnitude. Id. 1130. See also id. 1119, 1122-1123. Given the low levels of air lead concentration throughout Japan, the small magnitude is hardly surprising; what is surprising is that the difference is significant at all. It is for this finding that the Administrator cited the study.
Petitioners are quick to point out that the authors observe:
JA 1124. See Nalco Supp.Br. at 36; Ethyl Supp.Br. at 47. In context, however, the statement does not have the significance petitioners ascribe to it. The authors have just observed that although air lead concentrations are generally lower in rural areas than in the cities, pockets of high and low air lead concentrations may exist in both areas. JA 1123. Thus they simply caution that without firm proof of individual exposure to air lead it is improper to conclude with certainty that the urban-suburban gradient necessarily reflects air lead differentials. JA 1124. As has been observed above, however, inability to prove conclusively cause and effect relationships is an inherent limitation of epidemiological research. The authors' warning is proper and does not detract at all from a study of this nature. It is significant, however, that immediately after this warning, the authors suggest the proper inference to be drawn from the data, "No doubt an increased respiratory exposure will contribute to an increased intake of lead into the body," id. 1124, and conclude, "A positive correlation between the lead levels in air and blood was strongly suggested * * *." Id. 1131. We think petitioners have failed to show that the Administrator's reliance on this study was improper.
Beyond the Azar and Seven Cities Studies, the only study affirmatively offered by petitioners to disprove the Administrator's conclusion is the London taxicab study, an epidemiological study of a much smaller group than any of the work discussed above. The study, conducted by Jones et al.,
The Seven Cities, Azar, and Japanese studies all were broadly based epidemiological work. Nonetheless, the Administrator found supportive evidence in all of them when he analyzed the data according to regions so that the effects of diet and climate could be, to the extent possible, minimized. Perhaps the most important epidemiological study before him, however, was the Daines study,
Petitioners attempt to discredit the Daines study by pointing to the results of the second neighborhood studied. There the researchers studied, for a three-month period, white women living 33.5 and 457 meters from another major highway in air lead concentrations of 1.95 and 1.73 ug/m
We cannot fault the Administrator's analysis. The suggested inverse relationship is nonexistent. The slight difference between 15.7 and 16.1 ug was analyzed by Daines and found to be insignificant. JA 467. We have been shown no reason to believe his analysis was in any way improper. Meanwhile, the data correspond closely to those found in the first neighborhood at distances beyond 100 feet (approximately 30 meters). Since the study found the air lead levels decreased by over 60 percent after the first 100 feet, JA 465, it is not surprising that no significant differences were found in either of the two neighborhoods beyond that distance.
The Administrator also drew some support from several studies conducted in communities housing lead smelters which, like automobiles, emit lead particulates into the atmosphere. One such study showed positive differences between children living in smelter and nonsmelter communities
These constitute the primary epidemiological studies before the Administrator. None of them attempted to control the important variable of dietary intake; such control would be impossible in a pure epidemiological study since controls destroy the "real life" nature of the experiment. Recognizing that diet is nonetheless a major factor in human lead intake, the Administrator sought data in which dietary lead could be assumed relatively constant among all subjects.
3. Clinical Studies. In the Albany chamber study
Petitioners argue that these results show little since exposure to even this high air lead level (twice that found in even the most polluted urban areas) did not cause the subjects' blood lead levels to pass the 40 ug warning point. PPG/duPont Supp.Br. at 30-31; Nalco Supp.Br. at 38. This argument misses the point. These subjects were exposed to high air lead concentrations for only 18 weeks; the Administrator, however, is concerned about the effects of exposure over a lifetime. The rapid rise of blood lead among the experimental subjects in this short period shows that air lead is a significant factor in the body lead burden and that the Administrator's concern may well be warranted. Petitioners' argument boils down to an objection that the study is flawed because it did not continue until the subjects were poisoned. We can hardly credit such a complaint.
Petitioners also argue that the study is suspect because the lead particulates to which the subjects were exposed were not identical to those emitted from automobiles. PPG/duPont Supp.Br. at 30; Nalco Supp.Br. at 38. It is true that the particles differed somewhat from those found in automobile exhausts. This was an inherent
The second clinical study, the pilot lead isotope study,
Certainly the project proceeds on some rough assumptions and presents data on only two subjects, as petitioners quickly point out, Nalco Supp.Br. at 38-39; PPG/duPont Supp.Br. at 27-28, and as the researchers freely conceded. JA 683, 684, 686, 688. The limited number of subjects would seem a necessary consequence of the intrusive, as well as confining and time-consuming, nature of the study. And the very magnitude of the air-blood correlation found, and the limited purpose to which the results were put—to support the independent theoretical calculations, Third Health Document at V-3, JA 83—convince us that the Administrator's reliance was not improper.
Petitioners also argue that the result is so inconsistent with the other evidence that it must be rejected. PPG/duPont Supp.Br. at 28; NPRA Supp.Br. at 12. To the contrary, the results are remarkably consistent with the evidence the Administrator credited—the Seven Cities and Japanese urban-suburban data, the Azar intracity data, the Daines study, the chamber study. All of these findings indicate a significant contribution of air lead to the body lead burden; a finding of a 28 percent contribution is consistent with that conclusion. The finding
The two clinical studies, then, provide important support for the Administrator's conclusion. They show that exposure to high airborne lead concentrations can lead to rapid increases in blood lead levels, and that respiratory absorption of lead accounts for a significant amount of the body lead burden. These findings are consistent with the theoretical calculations and support the clear inference of the many epidemiological studies.
To support his conclusion that children with pica swallow dust contaminated by lead from automobile emissions, the Administrator relied on studies showing that a persistent fraction of children with lead poisoning had no contact with leaded paint, thereby implicating another source.
Petitioners attack these studies for various reasons. Primarily, they argue that too many variables were uncontrolled and that the Administrator cannot properly extrapolate data from lead smelter communities to urban areas in general. We have examined these objections and find them to be without merit. The variables that were uncontrolled were uncontrollable and/or were adequately accounted for by the Administrator.
We likewise reject the evidence affirmatively presented by petitioners to disprove the dustfall theory. Most of it only proves that leaded paint is the primary cause of lead poisoning in children, something the Administrator had repeatedly acknowledged.
Because of this, the authors concluded that the children suspected of elevated lead body burdens did not ingest dust.
The Administrator criticized the study for failing to measure the children's exposure to lead-210 in their diet or in the air; exposure by either of these routes could have confounded the results. Third Health Document at VI-11, 12, JA 121-122. Moreover, while positive results would have shown conclusively that some children ingested lead through dust, these negative results show only that the six children who tested positive had not eaten lead dustfall. Without some reason to believe their exposure to dustfall was typical of all children, extrapolation of the results beyond the sample studied is unwarranted—and is not suggested by the authors.
I concur in Judge Wright's opinion for the court,
I agree with the court's construction of the statute that the Administrator is called upon to make "essentially legislative policy judgments" in assessing risks to public health.
This record provides vivid demonstration of the dangers implicit in the contrary view, ably espoused by Judge Leventhal, which would have judges "steeping" themselves "in technical matters to determine whether the agency `has exercised a reasoned discretion'".
Because substantive review of mathematical and scientific evidence by technically illiterate judges is dangerously unreliable, I continue to believe we will do more to improve administrative decision-making by concentrating our efforts on strengthening administrative procedures:
It does not follow that courts may never properly find that an administrative decision in a scientific area is irrational. But I do believe that in highly technical areas, where our understanding of the import of the evidence is attenuated, our readiness to review evidentiary support for decisions must be correspondingly restrained.
As I read the court's opinion, it severely limits judicial weighing of the evidence by construing the Administrator's decision to be a matter of "legislative policy," and consequently not subject to review with the "substantive rigor proper for questions of fact."
* * * * * *
An additional matter which emerges from this record deserves comment: namely, the failure of the record to clearly disclose the procedural steps followed by EPA. As a result, an onerous, time-consuming burden was cast upon the court to reconstruct these steps by inference and surmise. It is not enough for an agency to prepare a record compiling all the evidence it relied upon for its action; it must also organize and digest it, so that a reviewing court is not forced to scour the four corners of the record to find that evidence for itself.
It is regrettable that EPA did not give the same care to clearly setting forth procedural matters for the record as it gave to substantive matters. It may well be that this court's 30-day order interfered with the opportunity to do so. Based on that possibility, and the court's own reconstruction of the procedural record (albeit at the expense of much judicial time and effort), I am persuaded that the petitioner's rights were not prejudiced. Ordinarily, however, I think a record which so burdens judicial review would require a remand for clarification.
Statement of Circuit Judge LEVENTHAL:
I concur without reservation in the excellent opinion for the court.
I write an additional word only because of observations in the concurring opinion authored by Chief Judge Bazelon. I would not have thought they required airing today, since they in no way relate, so far as I can see, to the court's en banc opinion. But since they have been floated I propose to bring them to earth, though I can here present only the highlights of analysis.
What does and should a reviewing court do when it considers a challenge to technical administrative decision-making? In my view, the panel opinion in this case overstepped the bounds of proper judicial supervision in its willingness to substitute its own scientific judgments for that of the EPA. In an effort to refute that approach convincingly the panel dissent may have over-reacted and responded too much in kind. In a kind of sur-rebuttal against such overzealousness, Judge Bazelon has also over-reacted. His opinion—if I read it right—advocates engaging in no substantive review at all, whenever the substantive issues at stake involve technical matters that the judges involved consider beyond their individual technical competence.
If he is not saying that, if he agrees there must be some substantive review, then I am at a loss to discern its significance. Certainly it does not help those seeking enlightenment to recognize when the difference in degree of substantive review becomes a difference in kind.
Taking the opinion in its fair implication, as a signal to judges to abstain from any substantive review, it is my view that while giving up is the easier course, it is not legitimately open to us at present. In the case of legislative enactments, the sole responsibility of the courts is constitutional due process review. In the case of agency decision-making the courts have an additional responsibility set by Congress. Congress has been willing to delegate its legislative powers broadly—and courts have upheld such delegation
Our present system of review assumes judges will acquire whatever technical knowledge is necessary as background for decision of the legal questions. It may be that some judges are not initially equipped for this role, just as they may not be technically equipped initially to decide issues of obviousness and infringement in patent cases. If technical difficulties loom large, Congress may push to establish specialized courts. Thus far, it has proceeded on the
The aim of the judges is not to exercise expertise or decide technical questions, but simply to gain sufficient background orientation. Our obligation is not to be jettisoned because our initial technical understanding may be meagre when compared to our initial grasp of FCC or freedom of speech questions. When called upon to make de novo decisions, individual judges have had to acquire the learning pertinent to complex technical questions in such fields as economics, science, technology and psychology. Our role is not as demanding when we are engaged in review of agency decisions, where we exercise restraint, and affirm even if we would have decided otherwise so long as the agency's decisionmaking is not irrational or discriminatory.
The substantive review of administrative action is modest, but it cannot be carried out in a vacuum of understanding. Better no judicial review at all than a charade that gives the imprimatur without the substance of judicial confirmation that the agency is not acting unreasonably. Once the presumption of regularity in agency action
Mistakes may mar the exercise of any judicial function. While in this case the panel made such a mistake, it did not stem from judicial incompetence to deal with technical issues, but from confusion about the proper stance for substantive review of agency action in an area where the state of current knowledge does not generate customary definitiveness and certainty. In other cases the court has dealt ably with these problems, without either abandoning substantive review or ousting the agency's action for lack of factual underpinning.
On issues of substantive review, on conformance to statutory standards and requirements of rationality, the judges must act with restraint. Restraint, yes, abdication, no.
MacKINNON, Circuit Judge (dissenting):
This complex and lengthy lawsuit was foreordained when, on October 29, 1973, a panel of this court directed the Administrator of the Environmental Protection Agency to reach a final decision within 30 days
I therefore join in Part I of the dissent. Unlike Judge Wilkey, however, I would specifically remand this record back to the EPA with instructions to reconsider the regulations in light of whatever criticism is received after a suitable notice-and-comment period. The agency should be cautioned to proceed to a decision as soon as possible under the circumstances, and this court would retain jurisdiction to order further expedition of the matter on petition if a decision was not reached by the agency within a reasonable period. I would set no specific deadline for agency action, however.
If the case were to be remanded to the EPA for compliance with the Administrative Procedure Act, the Administrator should also be directed to review the evidentiary support and the rationale for his decision. I agree that section 211(c)(1)(A) of the Clean Air Act
WILKEY, Circuit Judge, with whom joined TAMM and ROBB, Circuit Judges (dissenting):
We are called upon in these cases, consolidated for purposes of argument and decision,
In these cases EPA is acting under authority of section 211(c)(1)(A) of the Clean Air Act which permits EPA's Administrator to prohibit, control, or regulate a fuel or fuel additive if "any emission products of such fuel or fuel additive will endanger the public health or welfare . . . ." EPA's authority to promulgate these regulations must be distinguished from EPA's authority and action reviewed in this court's opinion in Amoco Oil Co. v. EPA.
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. More importantly, they also contend that the evidence in no way supports EPA's conclusion that the public health is or will be endangered, and that the case against auto lead emissions is a speculative and inconclusive one at best.
I. THE THREE-YEAR HISTORY OF EPA'S EFFORTS TO DEVISE ACCEPTABLE REGULATIONS
A. The Regulations and Supporting Health Documents
The regulations we are reviewing lessen the use of certain lead compounds, known as lead antiknocks, in motor vehicle gasoline.
The final regulations were accompanied by a detailed health position paper, entitled "EPA's Position on the Health Implications
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, 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 EPA's argument, pointing out that the evidence is inconclusive on both issues.
B. Adverse Nature of Government Expert Scientific Comment
The present section 211 was added to the Clean Air Act on 31 December 1970.
Within a month of the enactment of the Clean Air Act EPA issued an advance notice of proposed rulemaking.
Almost three years passed before the final regulations were promulgated. This extended gestation period has significance in itself. Implicit in the administrative record generated by this three-year delay is the recognition by EPA that available scientific data did not provide a clear and certain basis for reaching the statutorily mandated conclusion, i. e., that a "fuel additive will endanger the public health or welfare."
What the gestation period of these regulations would have been without the intervention of this court, we will never know, for the decision to issue the regulations was precipitated by the third in a series of orders of this court in Natural Resources Defense Council v. EPA
In February 1972, over a year after the prompt advance notice, the Administrator
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.
In "Airborne Lead in Perspective," the National Academy of Science (NAS) made a thorough study of the scientific literature as to lead in the air and its biological effects [hereinafter referred to as the NAS Report]. After preliminary comparison of the NAS Report and EPA's health grounds, the Under Secretary of the Interior, M. J. Pecora, gave his evaluation:
The Department of Commerce commented:
Perhaps the most biting comment came in a letter from Dr. Merlin K. DuVal, Assistant Secretary for Health, Department of Health, Education and Welfare:
As a result 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.
This latest EPA position was supported by a Second Health Document.
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:
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. . . ."
Secretary Elliot L. Richardson of Health, Education, and Welfare (HEW), in a letter to Senator Tunney, took issue with EPA's revised health justification for the regulations:
At this point it is perhaps appropriate to point out that we are not substituting our judgment for that of the Administrator; as members of a reviewing court we are saying that his procedural process was faulty, and that on the data he had available to him any conclusion could be only speculative. We are not disputing a supposed expert's conclusions on his own ground, 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. 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. 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 conclusions—and he did not risk the same fate with the Third Health Document.
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
C. The Opportunity for Informed Public Comment on the Third Health Document
The Administrative Procedure Act (APA) provides that the notice of rulemaking shall include "either the terms or substance of the proposed rule or a description of the subjects and issues involved."
Pertinently, the APA also provides in section 553(c):
Pursuant to this statutory provision, ample opportunity was given interested private parties and government agencies to comment on the original proposed regulations, the regulations reproposed with slight modifications, and the first two Health Documents. The last formal period of comment, on the Second Health Document and the reproposed regulations, closed 11 March 1973. It is for the subsequent period that the question arises as to whether the agency gave "interested persons an opportunity to participate in the rulemaking through the submission of written data, views, or arguments . . ."; more precisely, whether an opportunity was afforded to submit written data, views, or arguments specifically directed to the Third Health Document and the new studies EPA was preparing to embrace therein.
Three matters seem beyond dispute:
(1) The Third Health Document was issued simultaneously with the final regulations on 28 November 1973.
(2) No formal period of comment was announced on the Third Health Document, although a "draft Third Health Document" was apparently given at least a limited circulation on 19 October 1973.
(3) The independent scientific minds in the other government agencies, whose devastating critical comments on the first two Health Documents have been discussed above, made no comment on the Third Health Document.
It is highly significant that nowhere in the fourteen-page detailed discussion of the EPA procedures at the close of their opinion do our colleagues maintain that such independent government agency scientific comment was received by EPA, although our colleagues go to great lengths to establish notice in fact and comment by some of the private industry petitioners upon portions of the scientific studies which eventually made up the Third Health Document.
Two matters appear very much in dispute:
(1) The extent to which the Administrator relied upon new scientific data, appearing as EPA sponsored for the first time in the Third Health Document, as the basis for the final regulations.
(2) The extent to which interested private parties, some of whom are petitioners here,
(b) were given notice as to which studies were to be relied upon by the Administrator in the Third Health Document, and
(c) commented thereon prior to the issuance of the Third Health Document itself.
We set forth the record facts on these two issues as briefly as is consistent with clarity and accuracy:
1. The extent to which the Administrator relied upon new scientific data, appearing as EPA sponsored for the first time in the Third Health Document, as the basis for the final regulations.
The Preamble to the Regulations (attached to this opinion) makes clear that when the Administrator decided, he relied materially upon studies which had not before been subjected to public criticism. In the Administrator's own words, "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."
The Preamble then launches into a discussion of six studies relating to lead as a hazard to the general public—two pilot isotope studies, "[a]n unpublished study in Japan," the chamber studies, the Seven Cities study, and the Daines study. These were followed by several studies relied on for the Administrator's conclusions concerning children in urban areas—the Newark studies (two parts), and the Chicago, Philadelphia, and Rochester (N.Y.) studies.
(a) Pilot Lead Isotope Studies—In the Third Health Document EPA relies on two pilot lead isotope studies by the same authors —Rabinowitz, Wetherill, and Kopple. The first of these studies is an unpublished paper presented to a scientific conference at Raleigh, North Carolina, on 1-2 October 1973.
The second pilot lead isotope study was published in the November 1973 issue of Science magazine.
(b) Unpublished Study in Japan—Significantly, the cover page of this study bears the following inscription: "Draft/Do Not Cite or Quote."
(c) The Chamber Studies—The chamber studies
(d) The Seven Cities Study—The Preamble's discussion of blood lead levels of urban and suburban residents and between cities probably refers to both the Seven Cities study and the Daines study. The Preamble earlier had referred directly to the Seven Cities study as an example of previous EPA data which had been cited by other experts as contrary to EPA's own conclusions:
Both the Preamble and the Third Health Document state that "EPA has reanalyzed the Seven Cities study and has found that air lead was a significant, though not the most influential factor affecting blood lead levels."
The majority opinion asserts that EPA made the reanalysis public at an EPA committee meeting on 26 February 1973—thirteen days before, instead of four days after, the close of the formal comment period on the Second Health Document (11 March 1973).
(e) The Daines Study—The Daines study had been published in Industrial Medicine in October 1972. It and the chamber studies represent the only studies mentioned in the Preamble to appear in equivalent form in both the Second and Third Health Documents.
(f) The Newark Studies—This study was done in two parts by the same investigators. After studying blood levels of children in various areas of Newark, the first paper of May 1973 was unable to relate elevated blood levels to traffic or traffic density, or to any other variable source. The investigators were with EPA in spirit, though, even if not with the facts, for they wistfully reported, "We only wish our results were more positive."
Petitioners strongly attack the Newark study. They point out that in May 1973 "the investigators found no statistically significant correlation between blood lead levels and proximity to traffic or traffic density . . . ."
(g) The Chicago, Philadelphia, and Rochester Studies—In both the Preamble and in the Third Health Document itself heavy reliance is placed on the studies from Chicago, Philadelphia, and Rochester (N.Y.), as well as the studies from Newark.
According to the Third Health Document, "studies from Philadelphia, Chicago, and Newark discussed above provide persuasive
These studies were absolutely crucial to the Third Health Document and to the Administrator's entire conclusions in regard to the lead danger to urban children. Each of these studies—Newark, Philadelphia, Chicago, and Rochester—came to EPA in October-November 1973 after the orders of this court and shortly before promulgation of the regulations on 28 November 1973.
2. The extent to which interested private parties, some of whom are petitioners here, were given or acquired actual notice of the existence of the scientific studies, were given notice as to which studies were to be relied upon by the Administrator in the Third Health Document, and commented thereon prior to the issuance of the Third Health Document itself.
The Administrator argues, and our colleagues confidently assert, "There is nothing in Section 4 [5 U.S.C. § 553] that requires new notice whenever the agency responsibly adopts the suggestions of interested parties."
More importantly, by October-November 1973 he was largely shifting his ground from the discredited scientific data of the First and Second Health Documents to the new data embraced in the Third Health Document. This is the crucial time at which informed comment from the best scientific minds in other government agencies and elsewhere should have been sought—unless EPA was irrevocably resolved to promulgate the restrictive regulations on lead which it had originally proposed years before, in spite of the barrage of unanimous critical comment from other government scientific minds, as well as interested outsiders.
With relation to the precise dates on which the scientific information later incorporated in the Third Health Document could possibly have become available to anyone, we summarize what the record shows—or fails to show.
(a) Pilot Lead Isotope Studies and
(b) Unpublished Study in Japan—Since the formal period for comment expired 11 March 1973, and since the final regulations accompanied by the Third Health Document were promulgated on 28 November 1973, the dates when the two pilot lead isotope studies and the unpublished study in Japan were first placed in EPA's "public file" and transmitted to Ethyl under a FOIA agreement—4 October 1973, 6 August 1973, and 22 July 1973, respectively—indicate the limited opportunity available for effective comment to be received by EPA. Moreover, even these late dates do not fully reveal the inadequacy of EPA's compliance with section 553 since (1) filing papers under
(c) The Chamber Studies—This study was available in preprint form at the time of the Second Health Document. However, since public access to preprints is generally quite limited, the study probably was not available to the public in a meaningful sense until it was published in May 1973.
(d) The Seven Cities Study—The critical feature here, of course, is the "Additional Analyses of the Seven City Lead Study" of 15 March 1973. Besides the one EPA committee meeting,
We conclude that the reanalysis marked a dramatic shift in the EPA's appraisal of the Seven Cities study—not, as the majority suggests, a mere reconfirmation of the validity of earlier data or a determination "that comments received during a preceding comment period [did] not undermine the validity of a particular piece of evidence."
(e) The Daines Study—Adequate opportunity for comment was afforded because this study was in the same form in both the Second and Third Health Documents.
(f) The Newark Studies—The first part gave no support to the Administrator's conclusions, but in the second paper new and additional data was brought in. The second part was in press in November 1973 and had not even been published when the regulations were issued. It is indisputable that no opportunity for comment by anyone on this important second study was afforded.
Our colleagues attempt to minimize the importance of the Newark, Chicago, Philadelphia, and Rochester studies as a basis for the Administrator's conclusions, through a reading of the Administrator's Preamble designed to escape the fact that the Administrator was relying materially on these new, uncommented upon studies. The court's opinion suggests that "[t]he only clear references to these studies, which bear on the validity of the dustfall hypothesis, occur in a portion of the Administrator's decision that addresses the question, `What new information has become available since reproposal of the regulation and as a result of the additional comment period?'"
That may be the "only clear reference" to our colleagues, but open eyes can read more. These studies were not just listed in the "new information" sections; they were discussed in the reliance portion, too. A comparison of the two critical sections of the Preamble reveals that the Administrator's language describing the evidence he is relying upon (found in subsection E of section II—entitled "Does dust lead contribute to lead poisoning in children?") is repeated virtually verbatim in section V's description of "[w]hat new information has become available since reproposal of the regulation . . . ?"
We are as well aware as are our colleagues that practical administrative procedure requires that at some point the responsible agency emerge from the decisionmaking process, and act. By act we mean that the agency should take such action as is supported by the evidence in hand, whether that action is to change drastically the petroleum refining industry and ultimately the type automotive engine manufactured in this country, or simply to let this portion of the economy remain unchanged until and if further evidence calls for changes.
We do not contend, as our colleagues suggest, that new information brought to the agency's attention too late to be made available during the formal comment period must be ignored or that an additional formal comment period is required whenever a review of recently developed information identifies new studies the Administrator finds supportive of his conclusions.
Indeed, there appears to be little, if any, difference in our position on EPA's responsibilities under the APA and our colleagues' position on this subject. We are not attempting to develop a novel procedural theory or "to transmute the three-step process established by § 4 [APA § 553] into a potentially unending and fruitless series of notices, comments, and notices of intent to rely on comments."
It is important to understand that we fault EPA not because all evidence "was not specifically delivered to or called to the attention of petitioners when it arrived at EPA,"
Our position does not conflict with the following, previously stated position of this court:
In fact, one page earlier in the opinion containing this quotation Judge Leventhal states, "It is not consonant with the purpose of a rule-making proceeding to promulgate rules on the basis of inadequate data, or on data that, critical degree [sic], is known only to the agency."
When this court issued its order on 29 October 1973 for EPA to act within thirty days on the question of regulating lead additives in gasoline, we did not hint in what manner the Administrator should act, but presumably we intended that the Administrator should act on tested data he had been accumulating for some three years. Bearing in mind the fate EPA's previous data had suffered at the hands of the knowledgeable scientific community, it was not a responsible choice for the Administrator to resort to the most recently acquired, mostly never previously revealed, and never commented on data as the principal basis for his action.
Similarly, in an adjudicatory proceeding the Supreme Court has commented,
Much of the data described in the Preamble and the Third Health Document was data which had been shielded from adverse comment by the factor of time of acquisition. The fate of previous submissions to public scrutiny is an indication of the type comment this new data might likely have received. While agreeing that at some point the Administrator must cease deciding and act, no valid administrative procedure would countenance launching an enterprise drastically affecting a substantial portion
The interested private parties had some fear that just this might occur. On 19 October 1973, following the conference in early October at which several of the studies later relied on by EPA first were revealed, EPA "circulated" a "draft Third Health Document."
Our colleagues assert that such a request was an effort to evade the mandate of this court that regulations issue within thirty days. We think that petitioner Du Pont recognized the same point that we make here, that if indeed the Administrator had discovered a new basis for the regulations, then responsible, practical administrative procedure demanded that the interested parties be given the same opportunity to
The court's opinion also asserts that "[t]he early October preparation and circulation of a draft decision and a draft Third Health Document, both in obviously near final form, belie[s] [any] contention that this court's 30-day order . . . forced EPA to rush into a decision it was not yet ready to make."
It is instructive to see the result of EPA's action in circulating in some quarters a draft Health Document containing new data in late October, but affording no formal comment period. According to the certified index to the record, precisely twenty persons, corporations, or entities made twenty-four written submissions to EPA during the sixty-day period up to and including 28 November 1973, the date upon
The content of these twenty-four submissions is equally illuminating. After carefully examining each of these submissions, we found only one, Nalco's review of EPA's health position dated 19 November 1973,
The court's opinion strives strenuously to prove that three of the five petitioners received notice in fact of the Third Health Document, or at least portions thereof. They assert that "petitioner Ethyl was directly furnished with all such documents as a result of a Freedom of Information Act . . . suit."
Furthermore, of course, as shown by the dates of many critical documents relied upon by the Administrator (including, inter alia, one which was not even included in the Third Health Document;
In their attempts to demonstrate that "comments [on the Third Health Document] were received",
Strangely, our colleagues seem to feel that EPA "went far beyond the measures it was required to take" by placing new information in the so-called "public file" and thereby making it "available for comment and criticism."
In summary, we find the conclusion undeniable that no effective comment on EPA's revised health position took place—nor could it have taken place—in the brief period just prior to promulgation, as the court's opinion would have us believe. The absence of any comment on EPA's new health data
As indicated by the heading of this opinion subsection, it is not enough under the Administrative Procedure Act merely to make the scientific data "available" to the public and all interested parties. First, the claimed "availability" here boils down to a compelled furnishing of data to one interested party under the Freedom of Information Act and the placing of hundreds of miscellaneous documents—scientific studies, papers, published articles, etc.—in a poorly indexed
Since Nalco was able to prepare and submit a substantive critique of the draft Third Health Document on 19 November 1973, obviously Nalco somehow received actual notice of the existence of the draft Third Health Document and the new evidence therein. (Perhaps Nalco's representatives were luckier or more adept than the representatives of other interested parties when it came to sifting through poorly indexed documents.) The record, however, does not indicate that any other interested party received notice of the existence of this new evidence, and clearly, no interested party, including Nalco, received any notice that EPA intended to rely on these new studies. As we mentioned earlier, on its cover page, the 19 October draft bore the following notation:
Accordingly, Nalco wrote in the introduction to its substantive comments, "It is understood that these documents [the draft Health Document and the draft regulations] are preliminary drafts and have not been formally released by the agency and should not be construed to represent Agency policy."
To emphasize the gross procedural irregularities approved by the majority of this court, in the following chart we capsulize what the record reveals—or fails to reveal:
NEW EVIDENCE Unpublished Newark, Chicago Pilot Lead Pilot Lead Study in Seven Cities Philadelphia and Isotope Study Isotope Study Japan Reanalsis Rochester Studies #1 #2 ___________________________________________________________________________________________________________________________________________ Notice of | | | | | | | | | | | | (a) the evidence's | Ethyl (4 Oct. 1973) | Ethyl (6 Aug. 1973) | Ethyl (22 July 1973)| Ethyl (25 Feb. 1973) | Nalco (19 Oct. 1973) | existence | Nalco (19 Oct. 1973) | Nalco (19 Oct. 1973) | Other interested | Nalco (19 Oct. 1973) | Other interested | | Other interested | Other interested | parties (none) | Other interested | parties (none) | | parties (none) | parties (none) | | parties (none) | | (b) EPA's intent | | | | | | to rely on |_______________________|________________________|_____________________|______________________|_______________________| this evidence | none | none | none | none | none | |_______________________|________________________|_____________________|______________________|_______________________| | | | | | | Time Available | | | | | | for Comment After | | | | | | Notice of | | | | | | | | | | | | (c) the evidence's | Ethyl (55 days) | Ethyl (114 days) | Ethyl (129 days) | Ethyl (9 mos.) | Nalco (39 days | existence | Nalco (39 days) | Nalco (39 days) | Other interested | Nalco (39 days) | Other interested | | Other interested | Other interested | parties (none) | Other interested | parties (none) | | parties (none) | parties (none) | | parties (none) | | (d) EPA's intent |_______________________|________________________|_____________________|______________________|_______________________| to rely on | none | none | none | none | none | this evidence | | | | | | |_______________________|________________________|_____________________|______________________|_______________________|
II. THE LEGAL STANDARD
A. The Statute—Its Interpretation
Section 211(c)(1) of the Clean Air Act authorizes the EPA Administrator to
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" standard 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,
The Administrator stated his interpretation of the statutory language when he issued the regulations:
As far as this statement goes, we deem it correct. To recognize lead in the ambient air as but one possible source of lead in the human body is merely to recognize undisputed fact. But to argue that, because there are multiple sources of lead, a chain of causation from lead in the air produced by auto emissions to a level of lead in the blood high enough to be dangerous to health need not be established is totally fallacious. We are not clear that the Administrator really argues this, but it is certain that our colleagues, in order to bolster the agency's position, have throughout their opinion embraced this fallacy.
Our reading of the language of the Act, its legislative history, and the administrative record lead us to the view that section 211(c)(2)(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 colleagues urge, or whether we emphasize that such decision must be based on "facts," the causal
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 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 court's opinion endeavors to avoid this by resorting to two obfuscating dichotomies (perhaps the same distinction expressed in two ways). First, the opinion attempts to separate actual from potential harm, and, second, to separate risk from fact. "[T]he `will endanger' standard is precautionary in nature and does not require proof of actual harm before regulation is appropriate."
As to the first distinction, 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 (either in 50 years of practical usage or in laboratory experimentation), from which the Administrator can logically deduce that the same factors will produce the same harm in the future. For the court's opinion to hold 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.
The court's second asserted dichotomy, risks versus facts, is equally indefensible in logic. All true risk assessment is based on facts and nothing else.
Our colleagues apparently find it necessary to legitimatize the Administrator playing hunches. They assert, "Danger is a risk, and so must be decided by assessment of risks as well as by proof of facts."
B. Threshold Factual Determination Required
EPA, relying upon our recent opinions in Amoco, supra, and Industrial Union Department, AFL-CIO v. Hodgson,
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 . . . ,"
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 which EPA ultimately promulgated are required, however, to "reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air, in varying quantities."
In conclusion, we believe 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."
III. SCOPE OF REVIEW
EPA in promulgating these regulations followed the informal rulemaking procedure outlined in the Administrative Procedure Act, 5 U.S.C. § 553.
It is well recognized that in reviewing the record we are not to substitute our judgment for that of the Administrator.
Certainly a determination made in the absence of any evidence in the record to
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
The recent First Circuit case, South Terminal Corporation v. EPA,
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 [28 L.Ed.2d 136]. We are not empowered to substitute our judgment for that of the agency.
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
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, it seems obvious that 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 EPA's decision-making process. Several vital links in the chain are unsupported; for the Administrator to leap to the conclusion he did can only be termed arbitrary and capricious. We submit that "a clear error of judgment" has occurred,
IV. THE EVIDENCE
A. This Court's Task
It is of crucial importance to recognize that this court's task on review of agency rulemaking is twofold. One of these tasks is universally acknowledged. We must explore the evidentiary record to determine whether the statements and conclusions of facts have an adequate basis in the underlying evidence. However, an equally important role is our review of agency analysis in order to determine whether it is principled and reasonable. Properly understood, our role is not to review directly the evidence, but to review the agency's treatment and analysis of the evidence. Of course, in so doing we will defer to the agency's expertise and experience in the subject matter of the decision.
In our view, the court's treatment of the evidence neglects this second, equally important function of a reviewing court. Our colleagues' extended review of the evidence (in some respects much more extensive than EPA's own Third Health Document) at several points supplies reasons, distinctions, or modes of analysis that are otherwise absent from the Administrator's discussion. Just as agency counsel cannot supply a post hoc rationalization for agency determinations, neither can a reviewing court.
B. "A small but significant portion of the urban adult population . . . [is] over-exposed to lead."
1. The 40 ug Demarcation
The Administrator introduces his analysis of the evidence with the following statement:
Although the Preamble does not define what is meant by "overexposed to lead," Chapter Three (and to a lesser extent Chapter Four) of the Third Health Document explores the issue. The Document notes that blood lead levels, measured usually in terms of ug/100 g of blood (micrograms per hundred grams), are generally considered an appropriate index by which to assess the total lead body burden. The general population carries blood lead levels of between 10 and 30 ug/100 g.
The bulk of the discussion in Chapter Three relates to those studies which have attempted to identify the health effects associated with blood lead levels below those associated with lead poisoning. On the basis of those studies, EPA's staff tentatively concluded that "subclinical changes" may be associated with blood lead levels in the 40 to 60 ug/100 g range. The document is careful to emphasize that a 40 ug/100 g blood level "does not represent a sharp demarcation between health and disease." It rather represents a level above which it would be "prudent" to prevent further lead exposure.
The court's opinion states that petitioners are contesting the setting of 40 ug/100 g as
2. Over-Exposure in the General Adult Population
Again we must turn directly to the Third Health Document, since the Preamble does not further amplify the basis for concluding that lead levels are indeed elevated in a significant portion of the population. As regards adults, the Health Document discusses the issue in the equivalent of one page of text and in two charts.
Given the limitations on the underlying data, EPA's staff was still willing to conclude that certain groups, principally ones "occupationally exposed to automobile exhaust," "frequently or characteristically" have elevated blood lead levels.
In addition, petitioners point to the study of Azar, et al.,
Second, petitioners attack the Administrator's reliance upon data derived from occupational categories exposed to unusual quantities of automotive exhaust, such as those working in parking structures, traffic tunnels, and closed garages, as well as those exposed to lead from sources other than the air, such as service station attendants and garage mechanics.
We agree in substantial measure with petitioner's position. EPA has presented no evidentiary basis for concluding that a significant portion of the general urban adult population has elevated blood lead levels. Table VII-1 in the Third Health Document amply demonstrates this fact.
Unexplained is the absence from Table VII-1 of the results of the Seven Cities study—1,935 persons tested and at most three with elevated blood levels. The court's opinion declares that "[p]etitioners rely heavily on the results of the so-called Seven Cities Study, which found a very small percentage of adults with elevated (in excess of 40 ug) blood levels. . . . The Administrator, on the other hand, finds serious methodological flaws in the Seven Cities Study that limit its usefulness, 38 Fed.Reg. 33735 . . . ."
Thus, the court concludes that "[t]he problem here is one of choosing among the items of evidence."
The court, however, again steps into the breach to offer its analysis of the studies:
This rationalization of the Administrator's decision is purely post hoc. There is no basis for it in the Third Health Document.
The above is illustrative of the amazing lengths this court will go to to produce a decision for some uncertain, ill-defined, supposed environmental benefit. This court not only commands the Administrator to produce a decision by a certain date, but rewrites his decision to fill in the gaps when his logic falters.
The court, in addition, attempts to draw support from the fact that in the Reserve Mining case some of the evidence indicating the possibility of absorption of asbestos particles by the general public came from studies of asbestos workers. This reliance is entirely misplaced. We do not here suggest that the Administrator cannot seek to reach a conclusion about the general public on the basis of studies of occupationally exposed individuals. Rather, we believe, that, if he has so concluded, he has not adequately explained how he did it. By contrast, the Eight Circuit undertook an extensive discussion of asbestos fiber exposure, relating occupational exposure to exposure by the general public through the ambient air. There is considered analysis on this precise issue in both the Eighth Circuit's opinion and the district court's opinion.
A crucial aspect of the Administrator's decision is deficient both because of its analysis and because of the absence of an evidentiary basis. On the record before us, we fail to see how the Administrator found an endangerment to a significant portion of the general urban adult population.
C. "[A]bsorption of air lead does contribute to total lead exposure and when added to lead from other sources . . results in total exposure that is excessive."
In promulgating the regulations, the Administrator stated the basic factual question to be resolved as follows: "Is there a correlation between air lead levels and blood lead levels?"
In the Preamble the Administrator explicitly relies upon the following studies to support the conclusion that there is a correlation between air lead levels and blood lead levels: the pilot lead isotope studies,
This is no minor slip on the Administrator's part. His entire argument in reply to criticism about the way in which he picked and chose among the various studies is that "[s]tudies which have come to contrary conclusions have generally failed to take into account the influences of other sources of lead on blood lead levels in people being studied."
The court's opinion, however, well recognizes the gravity of the Administrator's error and as a result offers for our edification a meatier, amplified version of this explanation as to why the Administrator embraces favorable studies possessing the same deficiency as the studies he rejects:
No matter whether the court or the Administrator himself first came up with this explanation for EPA's inconsistent and selective approach to the evidence, it passes our understanding how anyone can find dietary control a problem in a comparison between greater Philadelphia and greater New York (thus justifying rejection of that data), but of no importance in a comparison between Scarsdale and Harlem (thus justifying reliance on urban-suburban data from greater New York). The art of reconciling total inconsistencies has soared to new heights when this court can seriously conclude (1) that "dietary lead [can] be assumed relatively constant"
D. The Contribution of Auto Lead Emissions to Blood Levels in Children—The Speculative Nature of EPA's Determination
As a second subsidiary 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:
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.
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 poisoning in children."
The conclusion drawn by EPA's scientists, after reviewing all the evidence submitted in the proceedings, is even more tentative:
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."
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:
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.
Recognizing the weakness of their position, our colleagues attempt to discount the importance of the Administrator's dustfall hypothesis,
Since we, unlike our colleagues, would not sustain the low-lead regulations on the basis of "the evidence already presented" (i. e., the evidence discussed in sections IV. B. and C. supra), we cannot avoid deciding whether the Administrator's dustfall hypothesis is sufficient by itself to support the regulations. Based on the three common-sensical assumptions stated above, we conclude that it is not even more likely than not that lead dustfall from automobile emissions is swallowed by preschool children with pica. Until, and if, the Administrator can at least establish this causal connection, we should reject his dustfall hypothesis.
Based in part upon EPA's own assessment of the evidentiary record, it is undeniable that the dust and dirt hypothesis continues to be a speculative explanation of high blood lead levels among certain children.
The regulations on fuel additives promulgated by the Environmental Protection Administrator should be held invalid: assuming the correctness of the Administrator's interpretation of section 211(c)(1)(A) of the Clean Air Act, his analysis reflected a clear error of judgment upon the available evidence. Under the standards of review in 5 U.S.C. § 706(2)(A),(C), and (D), the regulations should be set aside.
There is an uncomfortably large body of evidence, relied upon by EPA to support these regulations, which came into its possession just days before final promulgation. Further, EPA's practice of accumulating a mass of scientific documents of all types in its "public information" file, without designating on which information it would rely until the promulgation of the Third Health Document simultaneous with the regulations, is by no means the "notice" required by the Administrative Procedure Act. Thus, interested parties had no reasonable opportunity to question the methodology of the investigators; EPA counsel can thus point to the absence of rebuttal evidence and imply that all was well in the later studies. 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 comment periods 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 the Agency less than sixty days prior to promulgation of the regulations, must necessarily give pause to this court.
The Administrative Procedure Act (5 U.S.C. §§ 706 and 553)
Turning from the procedure to the substantive basis of the decision, the supporting evidence, and the analytical rationale applied 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. 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 by the conclusion of Dr. Carl Shy of EPA, that on the basis of the Seven Cities study
We judges may be, as we are sometimes reminded, without scientific background or access to expertise, 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 analyses of scientists in all other departments of the Government commenting thereon, and confronted finally by an order of this court that he act one way or another in a period of thirty days, the Administrator found himself with the question "whether . . . to take arms against a sea of troubles, and by opposing end them."
It should be understood that our view would not prohibit EPA from regulating lead additives under section 211(c)(1)(A) at some point in the future, should evidence
* * * * * *
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 there 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
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 lead 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 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 ug/m
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 ug/m
Chamber studies in carefully controlled environments, have shown significant increases in blood lead of men exposed to air lead slightly greater than 3ug/m
Differences in the blood lead levels between urban and suburban residents in the
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 caused 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 in the 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
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 of Health and Scientific Affairs at HEW, commented on an appropriate safe level for lead in paint:
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 high-lighted by the common occurrence 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
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 significant 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 Agency including those from several noted authorities 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
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 behavior are 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.
(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.
On March 5, 1975, the Administrator suspended the 1977 statutory standards for automobile emissions of hydrocarbons and carbon monoxide, establishing interim standards for that model year equal to those now in effect. 40 Fed.Reg. 11900. This action was taken to slow the emission reduction schedule and thereby minimize a potential health hazard posed by the gradual increase in sulfuric acid emissions produced by the catalytic converter. So far as this decision is relevant to this case, it bears noting that the lead-free gasoline regulations will continue in effect and automobiles will continue to be equipped with catalytic converters for the foreseeable future. See note 68 infra.
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, 197940 C.F.R. § 80.20 (1975). According to EPA calculations, when the overall lead content of both leaded and unleaded gasoline averages 0.5 grams per gallon, leaded gasoline would contain an average of 1.25 grams of lead per gallon, the same as under the original regulations. See 38 Fed.Reg. at 33739 (1973).
Nonetheless, deference to regulation under § 202 is not mandatory. The Administrator is only required to "consider" the possibility of regulating under that section instead of under § 211. This language is in sharp contrast to the version of § 211 that was passed by the House. The House version would have allowed regulation under § 211 only after the Administrator made a specific 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). This mandatory deference to § 202 regulation was removed in conference and the present more flexible language was substituted. See pages ___ - ___ of 176 U.S.App.D.C., pages 22-23 of 541 F.2d infra.
Id. at 33741. See 40 C.F.R. § 80.1 (1974).
In any case, however, the issue is spurious. It is well established that ultimate findings do not have to be expressed at all, let alone be expressed in the language of the statute. 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, 56 S.Ct. 159, 163, 80 L.Ed. 138, 146 (1935); Martin v. Mott, 25 U.S. (12 Wheat.) 19, 32-33, 6 L.Ed. 537, 30-32 (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 455-59 (1958).
Train v. Natural Resources Defense Council, Inc., 421 U.S. 60, 75, 95 S.Ct. 1470, 1479, 43 L.Ed.2d 731, 743 (1975). See also id. at 87, 95 S.Ct. at 1485, 43 L.Ed.2d at 750.
Not all courts have agreed that "probability" of harm is the proper determinant of danger. Where grounds for divorce are few, for instance, courts have interpreted laws allowing divorce because of inhuman treatment that "endangers the life" to require only the slightest possibility of actual loss of life. Thus action that 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, 561, 138 N.W.2d 453, 456 (1966). We need not decide here how remote the possibility of actual harm could be under the "will endanger" standard since we accept the Administrator's determination in this case that a "significant" risk to health falls within the statutory language. See pages ___ - ___ of 176 U.S.App.D.C., pages 17-20 of 541 F.2d infra.
Ethyl Supp.Br. at 11 (footnote omitted). We may preliminarily observe that the absorption of lead does cause lead poisoning, a known fact that may be evaluated by the public and the EPA. However, in so far as Ethyl is complaining that the mechanism by which plagues and storms cause damage is well known while the question of the relation between lead automobile emissions and the absorption of lead is less certain, Ethyl's observation only supports the reading of § 211(c)(1)(A) as a precautionary statute. The massive diffusion of airborne lead is a gross environmental modification never before experienced. Of course, there are no past disasters of the kind anticipated by the Administrator on which the community's experience may be based. This, however, is inherent in such a threat and does not imply that no danger is posed by it. We believe the precautionary language of the Act indicates quite plainly Congress' intent that regulation should precede any threatened, albeit unprecedented, disaster. Ethyl is correct that we have not had the opportunity to learn from the consequences of an environmental overdose of lead emissions; Congress, however, sought to spare us that communal experience by enacting § 211(c)(1)(A).
Nalco points to the "margin of safety" language of § 109 as proof of a "lower standard" under § 108, Nalco Supp.Br. at 22, without recognizing that the margin of safety refers only to the implementing requirement of formulating standards and not to the threshold decision to regulate. NPRA likewise confuses this point by suggesting that the listing requirement of § 108 is like the reporting requirements of § 211(a), so that the "margin of safety" language is comparable to § 211(c)(1)(A), only more generous. NPRA Supp.Br. at 42-43. This ignores the fact that once a pollutant is listed under § 108 the decision to regulate is made; standards under § 109 must follow. On the other hand, additives reported under § 211(a) are not necessarily regulated; regulations are premised only on a § 211(c)(1)(A) finding of endangerment. Thus, as suggested in text, the threshold determination under § 108 is properly compared to the threshold determination under § 211(c)(1)(A).
Ethyl argues that an "adverse effect" does not have as severe a connotation as "endangerment." Ethyl Supp.Br. at 19 n.27. Even if true, however, this argument has nothing to do with whether the threshold determination to regulate is, or is not, precautionary. Even if § 108 allowed regulation of less severe effects than does § 211, regulations could still be premised only on a finding of an actual effect, while § 211 regulations could still be premised on a precautionary finding of threatened, albeit more severe, harm.
Quite obviously, this is not what Congress said.
Nalco takes issue with the dismissal of this question and asks sarcastically, "If causation is irrelevant to the regulation of fuel additives, why is EPA concerned about meeting any standard at all in these regulations." Nalco Supp.Br. at 20-21. Nalco is confusing two separate causation issues. There is undoubtedly a causation issue about whether lead emissions cause a danger to public health. On the other hand, however, there is no causation issue about whether lead emissions contribute to lead air pollution. There is no such issue, first, because § 211, unlike § 202, does not demand such a finding and, second, because in any case petitioners could not, and do not, contest the validity of that assertion. It is only this issue of causation, to which the "likely" language of § 202 relates, that EPA argues, and we agree, is irrelevant to this case. See EPA Supp.Br. at 17-18.
Id. at 32 (emphasis in original). Since under this reading, NPRA argues, the Administrator would always reach a positive conclusion, this reading must be incorrect. We agree that this reading is of little value, but we do not think it is the proper result of our analysis above. Rather, we think that to regulate under § 202 the Administrator must find that emission of the air pollutant is likely to cause or contribute to dangerous air pollution. This addition is important, for not all air pollutants contribute to dangerous air pollution and, more importantly, not all dangerous air pollution is caused by air pollutants that are, themselves, dangerous. Thus hydrocarbons, whose emission is regulated by § 202, are not themselves always dangerous, but are properly regulated because they react in sunlight to form smog, which is dangerous. See S.Rep. 89-192, 89th Cong., 1st Sess. 5-6 (1965); EPA Supp.Br. at 18 n.15. Thus, far from stating a tautology, § 202 allows for the regulation of such apparently innocent pollutants, which indirectly cause dangerous pollution.
Id. at 360, 465 F.2d at 540 (emphasis added).
In another case interpreting the standards for cancellation of a pesticide under the same statute, we held, per Judge Wilkey, that a showing of "potentially great dangers from DDT" sufficed as a basis for cancellation. Environmental Defense Fund, Inc. v. EPA (Coahoma), 160 U.S.App.D.C. 123, 128, 489 F.2d 1247, 1252 (1973).
514 F.2d at 507. The Eighth Circuit is not drawing a sharp line between "danger" and "risk," but is only contrasting degrees of danger. Nalco fails to note that the "legally cognizable" risk ultimately found was that Reserve's discharges were "endangering" the public health within the meaning of the Federal Water Pollution Control Act. See page ___ of 176 U.S.App.D.C., page 19 of 541 F.2d infra. Necessarily, "risk" is an element of "danger," and the Reserve Mining court explicitly recognized that fact. 514 F.2d at 520.
The Power Reactor case is likewise of no support to Nalco. There the Supreme Court simply recognized that when regulations juxtaposed, and ordered, findings of "undue risk" and "endanger," an "undue risk" was not intended to mean "endanger," The Court did not say that risk was not an element of danger, only that in the regulations before it an "undue" risk was not necessarily a sufficient risk to constitute a "danger."
Id. at 536 (emphasis added). Thus the court only ordered cessation of dumping within a "reasonable time." Id. at 538.
In any case, however, even if cancer is considered more serious than lead poisoning, the Administrator acted based on an assessment that the risk of lead poisoning from automobile emissions was considerably greater than the cancer risk that motivated the Reserve Mining court. Thus this greater risk of an arguably lesser harm still constitutes endangerment.
Whether the evidence relied upon by the Administrator is sufficient to support his finding of a "significant risk of harm" is discussed below at pp. ___ - ___ of 176 U.S.App.D.C., at pp. 33-48 of 541 F.2d infra.
The irrelevancy of the omission is shown by the Amoco decision, where the court construed § 211(c)(1)(B), which, like its sister section at issue here, does not contain the phrase "in his judgment." Nonetheless, the court recognized the Administrator must, necessarily, have the power to assess risks and make policy decisions under that section whenever the determinations called for are judgmental. Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 180-181, 501 F.2d at 740-741, quoted in text at pp. ___ - ___ of 176 U.S.App.D.C., at p. 23 of 541 F.2d infra.
This conclusion is bolstered by § 211(c)(1)(B) and its interpretation by the Amoco court. Section 211(c)(1)(B), unlike § 211(c)(1)(A), retains the finding requirement and the requirement is phrased as ambiguously as the specific findings requirement in the House version of § 211(c)(1)(A). The Amoco court recognized that a literal reading of this findings requirement (which it termed "awkwardly drafted," Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 179, 501 F.2d at 739), would produce an anomalous result, just as the literal reading now urged by Nalco of the deleted findings requirement would produce an anomalous result. "Thus in a literal sense the provision requires `findings with respect to' the actual items of data which the Administrator must `consider.'" Id., 163 U.S.App.D.C. at 176, 501 F.2d at 736 (emphasis in original). The court rejected this literal, nonsensical, reading and instead read the statute to require a threshold factual finding that regulation was necessary under § 211(c)(1)(B). Id., 163 U.S.App.D.C. at 176-178, 501 F.2d at 736-738.
Based on the legislative history of the House proposed § 210(g) and the Amoco precedent relating to the parallel section, it is clear that had the proposed specific findings requirement been enacted into law, it would have been interpreted, as suggested in text, as requiring a specific factual finding for the threshold decision to regulate, and not necessarily specific findings for all the subsequent implementing decisions.
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).
Petitioners argue that the Senate as well as the House contemplated a factual threshold determination. Nalco Supp.Br. at 15-16; Ethyl Supp.Br. at 24-26; NPRA Supp.Br. at 30. Their arguments are without merit. While the House debate contains several references to the need for such a determination, always coupled with discussion of the "specific findings" requirement, see notes 38 supra and 40 infra, petitioners can point to no express reference in the Senate proceedings to the need for a factual threshold finding. Instead they identify discussions of danger and suggest that these somehow imply that the assessment of danger be factually based. The implication is nonsensical; the cited discussions do no more than reiterate the language of the statute, which does not in terms require a factual finding. See S.Rep. No. 91-1196, 91st Cong., 2d Sess. 117 (1970) ("if the combustion or evaporation of such fuel produces emissions which endanger the public health or welfare"); id. at 33-34 ("emission that is a direct endangerment to the public health") (see notes 25 & 36 supra ); 116 Cong.Rec. 32921 (1970) (statement of Sen. Baker) ("emissions that, in and of themselves, endanger the public health or welfare") (see page ___ of 176 U.S.App.D.C., pages 29-30 of 541 F.2d infra). When compared with the explicit House discussion of the need for a factual finding, these statements only show that the Senate intended no such thing. Ethyl also cites this excerpt from the Senate Report:
Ethyl Supp.Br. at 25 (emphasis in original). Since the Senate bill explicitly deleted the finding requirement for action under § 211(c)(1)(A), this language can hardly be taken as supporting its sub silentio inclusion. If anything, the language, which uses "finds" in its colloquial, not legal, sense, only demonstrates the judgmental nature of the Administrator's decision. See note 37 supra.
116 Cong.Rec. 42386 (1970). See Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 173-174, 501 F.2d at 733-734. In the absence of legislative history discussing the change, we must rely on the language of the present law and its contrast to the rejected House version.
The uncertainty of scientific fact parallels the uncertainty of all fact. In a metaphysical sense, at least, facts are themselves nothing more than risks, or statistical probabilities. See D. Hume, A Treatise of Human Nature, bk. I, pt. III, § 6, at 87 (L.A. Selby-Bigge ed. 1958).
Environmental Defense Fund, Inc. v. EPA (Coahoma), supra note 28, 160 U.S.App.D.C. at 128, 489 F.2d at 1252 (emphasis added).
Nalco asserts that the cases are distinguishable in that Industrial Union and Society of the Plastics Industry involve the manner in which standards are set under OSHA, rather than the Secretary's power to set standards at all. Nalco Supp.Br. at 12. This purported distinction is no more than a factual difference between the cases. Flexibility is necessary under OSHA only in the manner of setting standards, since the command to set standards is clear. Under the Clean Air Act, on the other hand, flexibility is necessary both in standard-setting and in deciding whether to regulate. The teaching of the cases is nonetheless applicable.
Reserve Mining shows the spurious nature of both asserted distinctions. In that case, as here, there was no command to regulate, only a statutory term of a precautionary nature—"endangering"—to justify flexible decision-making (in Reserve Mining by a court rather than by an agency). Likewise, that case involved not only the manner of standard-setting, but the threshold decision to regulate as well. Nonetheless, Reserve Mining is fully consistent with Industrial Union and Society of the Plastics Industry, and all three cases support our conclusion here.
Such certainty has never characterized the judicial or the administrative process. It may be that the "beyond a reasonable doubt" standard of criminal law demands 95% certainty. Cf. McGill v. United States, 121 U.S.App.D.C. 179, 185 n.6, 348 F.2d 791, 797 n.6 (1965). But the standard of ordinary civil litigation, a preponderance of the evidence, demands only 51% certainty. A jury may weigh conflicting evidence and certify as adjudicative (although not scientific) fact that which it believes is more likely than not. Since Reserve Mining was adjudicated in court, this standard applied to the court's fact-finding. Inherently, such a standard is flexible; inherently, it allows the fact-finder to assess risks, to measure probabilities, to make subjective judgments. Nonetheless, the ultimate finding will be treated, at law, as fact and will be affirmed if based on substantial evidence, or, if made by a judge, not clearly erroneous.
The standard before administrative agencies is no less flexible. Agencies are not limited to scientific fact, to 95% certainties. Rather, they have at least the same fact-finding powers as a jury, particularly when, as here, they are engaged in rule-making.
Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 175, 501 F.2d at 735. An agency's finding of fact differs from that of a jury or trial judge primarily in that it is accorded more deference by a reviewing court. See note 74 infra. Thus, as a matter of administrative law, the Administrator found as fact that lead emissions "will endanger" the public health. That in so doing he did not have to rely solely on proved scientific fact is inherent in the requirements of legal fact-finding. Petitioners' assertions of the need to rely on "fact" confuse the two terminologies. We must deal with the terminology of law, not science. At law, unless the administrative or judicial task is peculiarly factual in nature, or Congress expressly commands a more rigorous finding, see 21 U.S.C. § 355(d); cf. pages ___ - ___ of 176 U.S.App.D.C., pages 23-24 of 541 F.2d supra, assessment of risks as herein described typifies both the administrative and the judicial fact-finding function, and is not the novel or unprecedented theory that petitioners contend.
Section 202(a)(1), 42 U.S.C. § 1857f-1(a)(1) (emphasis added).
Section 211(c)(1)(A), 42 U.S.C. § 1857f-6c(c)(1)(A) (emphasis added).
NPRA, joined by Nalco, further argues that EPA's consideration of § 202 regulation was arbitrary and capricious because the agency rejected reliance on lead traps as a means of emission control. NPRA Supp.Br. at 35-37; Nalco Supp.Br. at 57-58. EPA did reject lead traps, but that rejection was not arbitrary and capricious. Rather, they were rejected because § 202 authorizes EPA to order emission controls only on new vehicles, which would largely be using lead-free gasoline anyway because of the catalytic converter. On new vehicles there would be no lead emissions to trap. See note 2 supra. The regulations before us seek to reduce lead emissions from in-use vehicles; for such a purpose § 202 is of no use. 38 Fed.Reg. 33737.
We find that EPA's consideration of the evidence presented and of the alternatives to regulation under § 211 meets the good faith test suggested above. See Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416, 91 S.Ct. 814, 823, 28 L.Ed.2d 136, 153 (1971). See also note 68 infra.
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 we 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 we think that finding is adequate under the Amoco standards suggested below, we do not find it necessary to determine whether the finding was required in this case. See note 68 infra.
In any case, however, Nalco's claim is without merit. Undoubtedly high octane aromatic hydrocarbons will be used to compensate for the reduction in lead caused by the regulations and the average aromatic content of gasoline will rise from 22% to 29% (this increase includes that attributable to the lead-free regulations at issue in Amoco). Aromatics can result in emissions of polynuclear aromatic (PNA) hydrocarbons, some of which are carcinogenic.
Nonetheless, the Administrator determined that substitution of PNA emissions for lead emissions would be less dangerous to the public health because: (1) PNA emissions from automobiles, together with emissions from refineries that produce gasoline, account for only approximately 2% of PNA emissions in the ambient air; (2) PNA emissions are being reduced from automobiles by the applicable hydrocarbon standards; and (3) PNA automobile emissions will continue to decrease overall, even while the hydrocarbon content of gasoline increases, as uncontrolled automobiles are retired and replaced by those with emission control systems. 38 Fed.Reg. 33738. Thus the Administrator concluded that replacement of lead additives by increased hydrocarbons would result only in a slight slowing of the rate of decrease of PNA emissions from automobiles. We think this is a sufficient finding under § 211(c)(2)(C).
Nalco's charge that suspension of emission standards changes this calculation is untrue. Even under the suspended standards, hydrocarbons will be significantly controlled and PNA emissions will continue to decrease. EPA calculated the effect of an increase in hydrocarbon content of gasoline under several anticipated circumstances, including the assumption that the interim standards would remain in effect through 1980. In that circumstance, which may turn out to be the correct forecast, PNA emissions would still decrease 69% over 1973 levels by 1980. Without the low-lead regulations they would decrease 72%, only a 3% better rate. JA 1428-1431; see also id. 1489-1490. Thus EPA anticipated the possibility of suspended emission standards, calculated the effects of that suspension on PNA emissions, and found them to be minimal. We cannot find this substitute additive finding to be insufficient.
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, 91 S.Ct. 814, 823, 28 L.Ed.2d 136, 153 (1971) (court must determine "whether the decision was based on a consideration of the relevant factors").
Since Overton Park expressly forbade such intrusive review, 401 U.S. at 416, 91 S.Ct. at 823, 28 L.Ed.2d at 153, it plainly did not intend to use the "clear error of judgment" phrase to replace sub silentio "arbitrary and capricious" review with "clearly erroneous" review. Nonetheless, more than linguistic echoes of "clearly erroneous" review accompany the Court's turn of phrase. To the extent the cases relied upon by the Court support consideration of "clear errors of judgment," they all involve review of trial courts', and not agencies', abuses of discretion. See cases cited supra, and compare L. Jaffe, supra, at 182 with id. at 615-616. Such review is intrusive and essentially identical with "clearly erroneous" review. See McBee v. Bomar, supra; In re Josephson, supra. On the other hand, the Court also cited a case in which Judge Friendly recognized that an agency's abuse of discretion, unlike a court's, is reviewed under the "arbitrary and capricious" standard, 5 U.S.C. § 706(2)(A), and that review in such cases should be much more deferential than under the "clearly erroneous" standard. Wong Wing Hang v. INS, supra, 360 F.2d at 718-719.
All of this makes the Court's intent in Overton Park somewhat difficult to plumb and its standard even more uncertain of application. We do not think the Court's use of the "clear error of judgment" phrase was an attempt vastly to revamp traditional "arbitrary and capricious" review. See infra. Nonetheless, we fear its use of this phrase so familiar to judges in another, and significantly more intrusive, context may unintentionally prompt judicial distortion of the "arbitrary and capricious" standard. Already at least one court has expressly indicated that it is prepared to read the Court's use of the phrase as approval of intrusive "clearly erroneous" review of agency action. Raitport v. National Bureau of Standards, 385 F.Supp. 1221, 1225 (E.D.Pa.1974). Meanwhile, other courts use the "clear error of judgment" phrase as a shorthand summary of "arbitrary and capricious" review, see, e. g., Union Electric Co. v. EPA, 515 F.2d 206, 216 (8th Cir.), cert. granted, 423 U.S. 821, 96 S.Ct. 35, 46 L.Ed.2d 38, 44 U.S.L. Week 3200 (1975); Conservation Council of North Carolina v. Froehlke, 473 F.2d 664, 665 (4th Cir. 1973); Schicke v. United States, 346 F.Supp. 417, 420, 422-423 (D.Conn.1972), while others loosely treat the phrase as synonymous with "clearly erroneous." Duke City Lumber Co. v. Butz, 382 F.Supp. 362, 374 (D.D.C.1974) ("whether the agency's threshold decision was arbitrary, capricious or otherwise clearly erroneous"); Daly v. Volpe, 350 F.Supp. 252, 255 (W.D.Wash.1972) ("it was not clearly erroneous, and therefore it was not arbitrary and capricious").
Post-Overton Park decisions, as well as the internal evidence in Overton Park itself, see supra, have made clear that the Court does not intend the "clear error of judgment" phrase to sanction review more intrusive than traditional "arbitrary and capricious" review; rather, the Court has reaffirmed that the reviewing court must defer if the agency has a rational basis for its decision. Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra note 73, 419 U.S. at 290, 95 S.Ct. at 444, 42 L.Ed.2d at 458; United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742, 749, 92 S.Ct. 1941, 1946, 32 L.Ed.2d 453, 460 (1972). See note 79 infra. Thus it is important that courts not think themselves licensed to embark upon wide-ranging searches for "clear errors of judgment." Such searches can only distort the established appellate role in reviewing informal agency action. Rather, we think Overton Park's troublesome phrase is best read as no more than an affirmation of the traditional standard of review. Accordingly, in the context of "arbitrary and capricious" review, we shall reverse for a "clear error of judgment" only if the error is so clear as to deprive the agency's decision of a rational basis.
Environmental Defense Fund, Inc. v. EPA (Coahoma), supra note 28, 160 U.S.App.D.C. at 128, 489 F.2d at 1252 (emphasis in original). See also note 53 supra.
United States v. Allegheny-Ludlum Steel Corp., supra note 74, 406 U.S. at 749, 92 S.Ct. at 1946, 32 L.Ed.2d at 460.
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 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 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 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 58.
Ethyl argues that these children have high blood lead levels primarily because of exposure to lead-based paint. Ethyl Supp.Br. at 40-41. The Administrator does not disagree. 38 Fed.Reg. 33735. What is important for his purpose is that blood lead levels are elevated in the general public; under the cumulative impact theory the source of the elevation is irrelevant in determining whether the public health is endangered by exposure to lead. See pages ___ - ___ of 176 U.S.App.D.C., pages 29-31 of 541 F.2d supra. The source becomes relevant only when deciding whether the emission products of lead additives make a significant contribution to that exposure, thereby justifying regulation under § 211(c)(1)(A).
Hearings on S. 3229, S. 3455, S. 3546 before the Subcomm. on Air and Water Pollution of the Senate Comm. on Public Works, 91st Cong., 2d Sess, at 74 (1970). No less than with "particularly sensitive citizens such as bronchial asthmatics and emphysematics" who receive the special attention of the Clean Air Act, S.Rep.No.91-1196, 91st Cong., 2d Sess. 10 (1970), citizens who are occupationally exposed outdoors to otherwise uncontrollable lead concentrations in the ambient air are among "the most vulnerable in our population" and deserve to be considered when regulations under § 211(c)(1)(A) are at issue.
Despite its origins in the Seven Cities Study itself, the dissent rejects this explanation for the Administrator's approach to the evidence as totally irrational. The dissent argues that it is illogical to maintain that intrametropolitan dietary lead can be assumed to be relatively constant despite the income differences in a large metropolitan area. This argument, which has no foundation in any material before this court, illustrates the danger of "plausible-sounding, but simplistic, judgments of the relative weight to be afforded various pieces of technical data." Concurring op. of Chief Judge Bazelon at ___ of 176 U.S.App.D.C., at 66 of 541 F.2d. Without ourselves attempting to assume a scientific role, we note that since the main source of dietary lead is the soil, see note 5 supra, the geographical origin of foodstuffs may be a more important determinant of their lead content than is price. In any event, whatever the underlying basis for this approach might be, the important point is that we have no reason to fault the Administrator's decision to rely on the scientific expertise of the authors of the epidemiological studies before him.
Second, the dissent's equation of the views of other Government agencies with the views of the independent scientific community is itself fallacious. Without in the least impugning their motivation, it may be assumed that agencies such as the Department of the Interior and the Department of Commerce, see dissent at ___, ___ of 176 U.S.App.D.C., at 74, 76-77 of 541 F.2d respond to and represent interests other than those concerned with the environment and the public health. The very existence of EPA is evidence that Congress believed the other agencies of the Government could not adequately appraise and act against environmental threats. Truly independent scientific opinion, represented by comments from those with no association with environmental groups or industry, favored the regulations by a margin of approximately two to one. JA 5.
We also note that the California Air Resources Board has recently adopted regulations imposing a more stringent lead reduction schedule than is imposed by the regulations before us. See N.Y. Times, Feb. 20, 1976, at 12 col. 3.
NPRA claims that placing the new studies in the public file did not satisfy EPA's obligations because "EPA did not notify the public of the availability of these documents or that it intended to rely upon them in promulgating the final regulations." NPRA Reply Br. at 17. This statement is not accurate, since EPA's public notice of the proposed low-lead rule-making, supra, stated that all new information received concerning the proposed regulations would be made available for public inspection at its Office of Public Affairs. 38 Fed.Reg. at 1260, JA 17. Moreover, NPRA's own submissions refer to documents contained in the EPA public file. See JA 1962; Doc. 1259. See also Doc. 1089 (letter from Ethyl, dated Oct. 12, 1973, requesting that certain documents not yet in the public file be placed there). Since the statute requires the Administrator to consider all evidence available to him, the complaint that petitioners could not know the Administrator would make use of the material in the public file is unimpressive.
The dissent attempts to avoid this fact by repeatedly lamenting that EPA's public file was "poorly indexed" (and dusty). Dissent at ___ n.34 ___, ___ - ___ of 176 U.S.App.D.C., at 79 n.34, 82, 90-91 of 541 F.2d. On examination this entire attack turns out to be based on the excuse offered by EPA's attorney for a slight delay in providing a document to this court. See id., at ___ n.34, of 176 U.S.App.D.C., at 79 n.34, of 541 F.2d. Had petitioners complained that they were not able to use the public file, we would of course have treated that complaint as a serious matter. But petitioners made no such allegation, nor did they suggest that EPA's public file procedures were in any way less adequate than the procedures customarily followed by administrative agencies. It may well be that the public reference procedures of this still relatively new agency can be improved. But we see no basis for a hypothesis, really a speculation, that persons affected are so unable to use the public file that minimal fairness is lacking. In any event that complaint was not made by able and experienced counsel for petitioners.
The dissent finds it strange that we consider this transcript a substantive comment on the studies discussed at the meeting. Dissent at ___, ___ of 176 U.S.App.D.C., at 89, 90-91 of 541 F.2d. In response, we simply note that the only possible interpretation of Ethyl's action in preparing and submitting the transcript was that the company wished to have the critical comments of its scientists and some others who attended the meeting brought to EPA's attention as substantive critiques of the studies. A covering letter from Ethyl's counsel which accompanied the company's submission of the transcripts of a Feb. 26 and a March 15 meeting explicitly states this purpose. See JA 986.
Id. at 307.
Typically, scientists refuse to certify an observed relationship as "significant" unless they are 95% certain that the data could not have been generated randomly. See note 58 supra. Thus the authors of the Seven Cities Study found the relationship between air and blood lead levels between cities "[n]ot significantly different from 0 at the 5% level," JA 902, meaning that they could not be certain that if there were no genuine relationship in the real world, the relationship that was observed in this study would be found in at most five out of every 100 randomly drawn data samples. On reanalyzing the data using more refined techniques, EPA's scientists determined that the observed relationship could be expected to be produced by chance less than one time out of 1,000. See Doc. 228 at Table 3. Similarly, the authors of the Seven Cities Study themselves recognized the implication of their "consistent observation" that blood lead levels were higher in a given metropolitan area's urban region than in its suburbs. See p. ___ of 176 U.S.App. D.C., p. 42 of 541 F.2d, & note 92 supra. The reanalysis simply demonstrated that this "consistent observation" has less than a one in 1,000 likelihood of being the product of chance. See Doc. 228 at Table 3.
There is, of course, no reason why the Administrator cannot rely on observed relationships among data which he is less than 95% certain reflect a true underlying relationship between the phenomena that the data measure. See note 58 supra. The dissent's assertion that only the reanalysis provides support for the Administrator's decision assumes that the Administrator must be 95% certain before he credits any evidence.
Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra note 73, quoted, dissent at ___ of 176 U.S.App.D.C., at 86 of 541 F.2d also offers no support for the proposition that the APA requires notice of what material received and made public after publication of a proposed rule will be relied on to support the final regulation. In the first place, Bowman was an adjudicatory proceeding, not a notice-and-comment rule-making. More importantly, in the sentence immediately following the language quoted by the dissent the Supreme Court noted that a party's right "to be apprised of the factual material on which the agency relies for decision" does "not preclude a factfinder from observing strengths and weaknesses in the evidence that no party identified." 419 U.S. at 288 n.4, 95 S.Ct. at 443 n.4, 42 L.Ed.2d at 457 n.4. The Administrator's treatment of the Seven Cities Study, as well as of the Japanese study submitted by lead industry opponents of the proposed regulation, fits squarely within this observation. Moreover, the Bowman Court also noted that the petitioners there "are not in a position to claim unfair surprise" because the Commission had offered the same rationale for its interpretation of evidence in a case decided at the time the hearings in Bowman were beginning. Id. at 289 n.4, 95 S.Ct. at 443 n.4, 42 L.Ed.2d at 457 n.4. That rationale, it should be noted, was potentially rebuttable. In the face of this conclusion, the assertion that petitioners were not on notice that the agency might rely on information in the public record of this rule-making proceeding appears frivolous.
Finally, we note that nothing in Wright, The Courts and the Rulemaking Process: The Limits of Judicial Review, 59 Cornell L.Rev. 375 (1974), supports the dissent's attempt to transmute the three-step process established by § 4 into a potentially unending and fruitless series of notices, comments, and notices of intent to rely on comments.
The early October preparation and circulation of a draft decision and a draft Third Health Document, both in obviously near final form, belie the dissents' contention that this court's 30-day order, see p. ___ of 176 U.S.App.D.C., p. 10 of 541 F.2d supra, forced EPA to rush into a decision it was not yet ready to make.
Ethyl claims a right to cross-examine agency witnesses. Ethyl Br. 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, 93 S.Ct. 810, 818, 35 L.Ed.2d 223, 236 (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, 155 U.S.App.D.C. 411, 427, 478 F.2d 615, 631 (1973).
PPG, duPont and NPRA claim the Administrator was required to set ambient air standards for lead under § 108, 42 U.S.C. § 1857c-3, before acting under § 211, and his failure to do so warrants reversal. PPG/duPont Br. at 45; NPRA Supp.Br. at 37-47. There is no basis in the statute for this claim. While § 211 expressly mentions consideration of regulation under § 202, it makes no mention at all of § 108. Moreover, the Administrator claims, with some statutory support, that action under § 108 is discretionary with him. 38 Fed.Reg. 33740 (1973). Cf. note 21 supra.
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 Br. at 42; PPG Br. 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 we 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). We cannot say his judgment was irrational.
NPRA objects to the Administrator's switch from leaded pool averaging to total pool averaging. NPRA Supp.Br. at 47-48. EPA switched in response to the comments of a majority of refiners. 38 Fed.Reg. 33739. We find nothing wrong with the use of that system. We discussed 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 Br. at 57; PPG Br. at 46; NPRA Br. 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 2, 163 U.S.App.D.C. at 189-190, 501 F.2d at 749-750. Since we believe the Administrator has complied with all the demands of § 211 in this case, we 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, 88 Stat. 246 (1974) (codified at 15 U.S.C. § 791 et seq. (Supp. IV 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), 15 U.S.C. § 793(c)(1). Thus Congress has expressly exempted EPA action under the Clean Air Act from NEPA's environmental impact statement requirement.
JA 85, cited in Nalco Supp.Br. at 39. The EPA calculations, however, make just the adjustment suggested (which is hardly surprising since the suggestion appears in the Third Health Document). EPA calculates only the air lead levels necessary, under various circumstances, to bring blood leads to 40 ug—and no higher. Whether or not blood lead increases plateau thereafter is of no consequence for these calculations.
Since only 58% of the inner-city households had lead-based paint, lead paint chips were discounted as the sole source of elevated lead levels. The study made no attempt to determine "whether the lead comes from airborne sources, chalking of paint, or from paint chips shed from walls and perhaps pulverized underfoot." JA 732.
Neither pesticides nor automobile exhausts account for the high Pb [lead] levels in Charleston, though undoubtedly they add to the contamination.
Petitioners attempt to rebut the Charleston findings, and those of the El Paso study, see note 5 infra and accompanying text, by relying on apparently contradictory data from England showing inconsequential increases in children's blood lead levels despite significant changes in soil lead levels. PPG/duPont Supp.Br. at 43-44; Ethyl Br. 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 415. But see EPA Supp.Br. at 57 n.51. The Administrator pointed to various possible differences between American and English data that might account for the inconsistency. Third Health Document at VI-5, JA 115. We shall defer to his judgment that the American data are preferable.
Letter from Dr. Paul B. Hammond to Dr. Kenneth Bridbord, EPA, March 9, 1973, JA 2417. While petitioners cited an apparently contradictory statement from Dr. Hammond, JA 2611, he has not repudiated the observation quoted above.
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 lead than comparable adults, see the Daines study discussed at pp. ___ to ___ of 176 U.S.App.D.C., pp. 59-60 of 541 F.2d supra, suggests that ingestion of lead dustfall significantly supplemented any respiratory intake.
Petitioners also argue the El Paso data is useless since blood lead levels were elevated in adults as well, so that the high lead body burdens may have been due to inhalation rather than ingestion. Nalco Supp.Br. at 41-42. While this suggestion may undercut petitioners' argument that inhalation of airborne lead does not significantly affect the lead body burden, it does not undercut the Administrator's use of the study. While adult blood leads were indeed elevated, the Administrator noted that the frequency of elevated blood leads among young children was much higher, thus suggesting "a special exposure route for young children," i. e., ingestion. Third Health Document at VI-7, JA 117. (Petitioners overstate by at least a factor of 10 the air lead concentrations in El Paso, compare Nalco Supp.Br. at 41 with JA 117, 469, 2344.)
The Greater Boston TV case, from which Judge Leventhal draws this language, involved FCC non-renewal of a license in part because it was held by parties controlling a major newspaper in the area. As indicated in the text, such issues are much more amenable to judicial comprehension than the scientific judgments in a case such as the present.
While acknowledging that the general rules of administrative law might be modified, rather than imported wholesale, into scientific and technical areas, Judge Leventhal apparently concludes that encouraging judges to parse the evidence themselves is necessary if courts are to remain "fully vigilant to exercise rather than abdicate their supervisory role" in areas such as environmental law which touch fundamental interests in life and health. See Leventhal, Environmental Decisionmaking and the Role of the Courts, 122 U.Pa.L.Rev. 509, 511-12 (1974).
Similarly, Judge Wilkey, in his original panel opinion, discounts the value of a particular study with the observation: "Realistically, it is impossible to say that any definite scientific or medical conclusion can be drawn from the observation of one or two subjects." Panel op. at 51.
I do not know whether or not these observations are valid, although it was my impression that techniques had been devised which minimized these problems in certain cases. Be that as it may, these overt examples of homespun scientific aphorisms indicate that on more subtle, and less visible, matters of scientific judgment we judges are well beyond our institutional competency.
This construction of the proper scope of review makes unnecessary Judge Wright's exhaustive analysis of the scientific evidence, which is evidently undertaken to answer those who believe we must judge the technical data for ourselves.
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.
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 Report, Doc. 14, App. at 314.
37 Fed.Reg. 11786, 11787 (14 June 1972), App. at 21.
Letter dated 7 Aug. 1973, App. at 2507 (emphasis in original). We do, not however, read Secretary Weinberger's comments as a repudiation of HEW's "final Departmental position" (emphasis added). Indeed, Secretary Weinberger appears to be quoting from Secretary Richardson's earlier letter when he uses the phrase "may contribute to the body burden of lead." (emphasis in original.) Additionally, Weinberger's other rationale for lead removal—that lead "provides no known direct benefit to human health"—clearly is not a sufficient basis for EPA's low lead regulations. Thus, we conclude that Weinberger's letter to NRDC did not alter HEW's prior conclusion that "there is no firm evidence at this time that lead derived from combusted gasoline is harmful to the health of the general public."
In the instant case, as members of a reviewing court we are saying that the Administrator's process was faulty, that the logic of his conclusion has great gaps in the chain, and that the evidence to support his conclusion is totally insufficient. "The agency must articulate a `rational connection between the facts found and the choice made.'" Bowman Transp. Inc. v. Arkansas-Best Freight Sys., Inc., 419 U.S. 281, 285, 95 S.Ct. 438, 442, 42 L.Ed.2d 447, 456 (1974). The agency's choice here is only a guess, not an expert judgment drawn from conflicting evidence. We are thus dealing here with procedure, logic, and substantiality of evidence, not attempting to dispute a supposed expert's conclusions from a mass of evidence.
Doc. 875. See generally EPA letter of 2 Oct. 1975.
Court's opinion at ___ & n.121 of 176 U.S.App.D.C., at 53 & n.121 of 541 F.2d. Rather than quibble over the degree of similarity or dissimilarity between the draft and final document, we will simply describe with more specificity what the court refers to as "a few additional inconsequential paragraphs and references." Significantly, the three sections with the more extensive revisions bear these far from inconsequential titles: III. "Health Aspects of Lead Exposure"; IV. "Can an Acceptable Lead Body Burden be Defined?"; and VI. "Lead Exposure from Dustfall." The following chart roughly indicates the amount of revision performed on each of these sections:
There is nothing in the Administrator's decision (i. e., the Preamble) or the Third Health Document that indicates that EPA would have made the same decision without the new supportive evidence indicated above. Unless the Administrator makes it clear that he considered this additional evidence "inconsequential," we cannot excuse his failure to make it available for public comment. An agency may not keep secret evidence on which it intends to rely to support its decision.
Compare the action of the EPA here with its action in Environmental Defense Fund, Inc. v. EPA (Coahoma), 160 U.S.App.D.C. at 128, 489 F.2d at 1252. See note 28 supra. There the Administrator accumulated a mass of data, much of it conflicting, pondered it, and drew his conclusion. Here the Administrator advanced proposed regulations, saw his supporting data riddled by other scientific minds, shifted twice the supporting rationale, and three years later came out with virtually the identical regulations he had advanced three years earlier. This court respected the Administrator's decision in Coahoma, but here the Administrator's action calls logically for a different result.
House, Lost in a Smog Bank, Wall Street Journal, 16 Jan. 1976, at 4, col. 3.
He mentioned the health problem only to query: "With future gasoline usage now likely to fall significantly, . . . is it not necessary to re-calculate future total lead emissions and their possible health hazards?" Doc. 1269, App. at 2651.
Id. at ___ of 176 U.S.App.D.C., at 53 of 541 F.2d (footnotes omitted).
85 Yale L.J. 38, 70 (1975). These unwieldy and disorganized records plague not only the interested parties, but also the courts.
The lack of a connection between facts found and choices made is the Agency failure we find here.
116 Cong.Rec. (Part 14) at 19230-31 (House) (10 June 1970) (emphasis added).
150 U.S.App.D.C. 348, 359, 465 F.2d 528, 539 (1972) (emphasis added). Here, too, the interests at stake are too important to permit EPA's decision to be sustained on the basis of speculative inference as to why the Administrator might have embraced certain studies and rejected others. "[T]he necessary articulation of reasons must appear in the preamble to the promulgated rule or in some other document of equally formal standing." 85 Yale L.J. 38, 71 (1975), citing Associated Indus. of N.Y. State, Inc. v. United States, 487 F.2d 342, 353 (2d Cir. 1973); Dry Color Mfrs. Ass'n v. United States Dep't of Labor, 486 F.2d 98, 105-07 (3d Cir. 1973); Kennecott Copper Corp. v. EPA, 149 U.S.App.D.C. 231, 234, 462 F.2d 846, 849 (1972).
App. at 89.
NAS Report at 133 (footnotes omitted and emphasis added).
(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?