Appendix — E. I. du Pont de Nemours & Co. v. Environmental Protection Agency

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IN THE

Supreme Court of the United States

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JOLIT APPENDIX TO

PETITIONS FOR WRIT OF CERTIORARI

re ee,

Notice: This opinion is subject to formal revision before publication

in the Federal Reporter or U.S. App. D.C. Reports. Users are requested

to notify the Clerk of any formal errors in order that corrections may be

made before the bound volumes go to press.

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

No. 73-2205

ETHYL CORPORATION, PETITIONER

v.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 73-2268

PPG INDUSTRIES, INC., PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 73-2269

KE. I. DUPONT DE NEMouURS & COMPANY, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

2

No. 73-2270

NALCO CHEMICAL COMPANY, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 74-1021

NATIONAL PETROLEUM REFINERS ASSOCIATION, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

Petitions for Review of an Order of the

Environmental Protection Agenc,

On Rehearing En Bane

Argued En Bane May 30, 1975

Decided March 19, 1976

SYLLABUS

Section 211(c) (1) (A) of the Clean Air Act authorizes

the Administrator of the Environmental Protection Agency

to regulate gasoline additives whose emission products

“will endanger the public health or welfare ‘i ;

42 U.S.C. §$ 1857f-6e(c) (1) (A) (1970). Acting pur-

3

suant to that power in rule-making proceedings, the Ad-

ministrator determined that leaded gasoline automotive

emissions present “a significant risk of harm” to the

public health, thereby endangering it within the con-

templation of the statute. Based on this finding, the

Administrator issued regulations requiring annual re-

ductions in the lead content of leaded gasoline. Held:

1. The Administrator’s interpretation of the statutory

“will endanger” standard is entitled to great deference.

Train Vv. Natural Resources Defense Council, Ine., 421

U.S. 60, 75 (1975). We find no basis in the language

of the statute or in its legislative history to fault his

interpretation. In applying the “will endanger” stand-

ard, the Administrator is authorized to assess risks of

harm and, where the risk is found to be significant, to

act to prevent the harm from happening. Thus the regu-

latory action under this precautionary statute should pre-

cede, and hopefully prevent, the perceived harm. Pp. 17-

66.

a. Some of the questions involved in promulga-

tion of environmental regulations “are on the fron-

tiers of scientific knowledge, and consequently as to

them insufficient data is presently available to make

a fully informed factual determination. Decision

making must in that circumstance depend to a

greater extent upon policy judgments and less upon

purely factual analyses.” Industrial Union Depart-

ment, AFL-CIO v. Hodgson, 162 U.S.App.D.C. 331,

338, 499 F.2d 467. 474 (1974). Pp. 45-56.

b. In making his policy judgment by assessing

risks the Administrator is not required to limit his

consideration to the danger presented by lead ad-

ditives “in and of themselves.” He may consider

the cumulative impact of lead additives with other

sources of human exposure to lead. Pp. 56-61.

4

2. The Administrator’s determination that lead emis-

sions “present a significant risk of harm to the health

of urban populations, particularly to the health of city

children,” is not “arbitrary, capricious, an abuse of dis-

cretion, or otherwise not in accordance with law * * *.”

5 U.S.C. § 706(2)(A) (1970). His determination has

a rational basis in the evidence. Pp. 66-97.

a. We must look at the Administrator’s 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 agency action to certain

minimal standards of rationality. Pp. 66-74.

b. We need not seek a single dispositive scientific

study that fully supports the Administrator’s de-

termination. Science does not work that way; nor

does agency fact-finding. Rather, the Administratcr’s

decision may be fully supportable if it is based, as

it is here, on the inconclusive but suggestive results

of numerous studies. By its nature, scientific evi-

dence is often cumulative; the more supporting,

albeit inconclusive, evidence available, the more

likely the accuracy of the conclusion. Pp. 75-76.

ce. The vast bulk of the evidence before the Ad-

ministrator provides inferences, no one of which

is dispositive, which support the Administrator’s

findings. Particularly in light of the precautionary

nature of the “will endanger” standard, we can-

not find the Administrator’s conclusion that lead

automotive emissions present a significant risk of

harm to the public health arbitrary or capricious.

Pp. 77-97.

The order of the Environmeniai rirctection Agency

is

Affirmed.

~

v

Joseph C. Carter, Jr., with whom John J. Adams and

David F. Peters were on the brief, for petitioner in

No. 73-2205. Arnold H. Quint also entered an appear-

ance for petitioner in No. 73-2205.

Daniel M. Gribbon, with whom Allan J. Topol and

Charles Lister were on the brief, for petitioners in Nos.

73-2268 and 73-2269.

Victor P. Kayser, with whom John C. Berghoff, Jr.,

Robert E. Nord, David Machanic, and William H. Fitz

were on the brief, for petitioner in No. 73-2270.

H. Edward Dunkelberger, Jr., with whom Theodore

L. Garrett was on the brief, for petitioner in No. 74-

1021.

Robert V. Zener, General Counsel, Environmental Pro-

tection Agency, and Leslie A. Carothers, Attorney, En-

vironmental Protection Agency, with whom Wallace H.

Johnson, Assistant Attorney General, and Edmund B.

Clark, Martin Green, and Fdward J. Shawaker, Attor-

neys, Department sf Justice, were on the brief, for re-

spondent. Ri wnd N. Zagone, Attorney, Department

of Justice, also entered an appearance for respondent in

No. 73-2268.

David Schoenbrod filed a brief on behalf of Natural

Resources Defense Council, Inc. et al. as amici curiae

urging affirmance.

Before BAZELON, Chief Judge, and WRIGHT, MCGOWAN,

TAMM, LEVENTHAL, ROBINSON, MACKINNON, Ropp, and

WILKEY, Circuit Judges, sitting en bance.

Opinion for the court, in which Chief Judge BAZELON

and Circuit Judges MCGOWAN, LEVENTHAL, and RoBIN-

SON concur, filed by Circuit Judge WRIGHT.

Concurring opinion, in which Circuit Judge MCGOWAN

joins, filed by Chief Judge BAZELON.

Concurring statement filed by Circuit Judge LEVEN-

THAL.

6

Dissenting opinion filed by Cireuit Judge MACKINNON.

Dissenting opinion, in which Cirevit Judges TAMM

and Ross join, filed by Circuit Judge WILKEY.

Wricut, 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 altera-

tions. It is only recently that we have begun to ap-

preciate 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 unap-

preciated—or unrevealed—by their supporters. Such

agencies, unequipped with crystal balls and unable to

read the future, are nonetheless charged with evaluat-

ing the effects of unprecedented environmental modifica-

tions, often made on a massive scale. Necessarily, they

must deal with predictions and uncertainty, with de-

veloping evidence, with conflicting evidence, and, some-

times, with little or no evidence at all. Today we ad-

dress the scope of the power delegated one such watch-

dog, the Environmental Protection Agency (EPA). We

must determine the certainty required by the Clean Air

Act before EPA may act to protect the health of our

populace from the lead particulate emissions of auto-

mobiles.

Section 211/c)(1)(A) of the Clean Air Act' autho-

rizes the Administrator of EPA to regulate gasoline ad-

ditives whose emission products “will endanger the pub-

lic health or welfare * * *.” 42 U.S.C. § 1857f-6e(¢) (1)

(A). Acting pursuant to that power, the Administrator,

after notice and comment, determined that the automo-

tive emissions caused by leaded gasoline present “a signi-

' All sections of the Act pertinent to this case vere added

by the Clean Air Amendments of 1970, Pub. L. 91-604, Dec.

31, 1970, 84 Stat. 1698-1700.

7

ficant risk of harm” to the public health. A cordingly,

he promulgated regulations that reduce, in step-wise

fashion, the lead content of leaded gasoline. We must

decide whether the Administrator properly interpreted

the meaning of Section 21l(c)(1)(A) and the scope of

his power thereunder, and, if so, whether the evidence

adduced at the rule-making proceeding supports his final

determination. Finding in favor of the Administrator

on both grounds, and on all other grounds raised by

petitioners, we affirm his determination.

* The new regulations, together with regulations requiring

all gasoline refiners to market at least one line of lead-

free gasoline, are set out in 40 C.F.R. § 80 (1975). The lead-

free regulations serve a different purpose than the low-lead

regulations now before us. Leaded gasoline fouls the cata-

lytic converter emission control system developed by the major

automobile companies to meet the air pollutant emission

standards set by Congress in § 202 of the Clean Air

Act. 42 U.S.C. § 1857f-1. So as to allow implementation of

the catalytic converter, the Administrator ordered the market-

ing of lead-free gasoline pursuant to his authority under

§ 211(c) (1) (B), the sister section to §211(c)(1)(A) at

issue here. Section 211(c)(1)(B) gives EPA authority to

regulate gasoline additives whose emission products “will

impair to a significant degree the performance of any emis-

sion control device or system which is in general use * * *.”

42 U.S.C. § 1857f-6ce(c) (1) (B). The lead-free regulations

were approved by this court in Amoco Oil Co. v. EPA, 163

U.S.App.D.C. 162, 501 F.2d 722 (1974).

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 Fep. REG. 11900.

This action was taken to slow the emission reduction sched-

ule 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 regu-

lations will continue in effect and automobiles will continue

to be equipped with catalytic converters for the foreseeable

future. See note 68 infra.

8

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 con-

tains lead additives, even though most 1975 and 1976

model automobiles are equipped with catalytic conver-

ters, which require lead-free gasoline. From the be-

ginning, 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. As use of automobiles,

* The principal studies and symposia over the years on the

subject have included Sayers et al., “Experimental Studies

on the Effect of Ethyl Gasoline and Its Combustion Prod-

ucts,” Bureau of Mines, 1927; HEW, “Public Health Aspects

of Increasing Tetraethyl Lead Content in Motor Fuel,” Pub-

lic Health Service Pub. No. 712, 1959; Kehoe, “The Metabo-

lism of Lead in Man in Health and Disease,” The Harben

Lectures, 1960, JA 500-579; HEW, “Survey of Lead in the

Atmosphere of Three Urban Communities,” JA 789-839;

HEW, “Symposium on Environmental Lead Contamination,”

Public Health Service Pub. No. 1440, 1966, JA 975-984;

Tepper & Levin, “A Survey of Air and Population Lead

Levels in Selected American Communities,” 1972, JA 840-

916; National Academy of Sciences, “Airborne Lead in Per-

spective,” 1972, JA 309-362; EPA and Commission of

European Communities, Proceedings of International Sym-

posium, “Environme: tal Health Aspects of Lead,” Luxem-

bourg, 1973, JA 676-677; EPA and National Institute of

Environmental Health Services, Conference on “Low-Level

Lead Toxicity,” Raleigh, N.C., 1973.

9

and emission of lead particulates, has accelerated in the

last quarter century, this concern has mounted. The rea-

sons for concern are obvious (and essentially undisputed

by petitioners): (1) lead in high concentrations in the

body is toxic; (2) lead can be absorbed into the body

from the ambient air; and (3) lead particulate emis-

sions from gasoline engines account for approximately

90 percent of the lead in our air. Despite these apparent

reasons for concern, hard proof of any danger caused

by lead automotive emissions has been hard to come by.

Part of the reason for this lies in the multiple sources

of human exposure to lead.

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 micro-

grams per 100 grams of blood (10-40 ug/100g)* are

found in everyone, including those living in environments

with almost no atmospheric lead. NATIONAL ACADEMY OF

SCIENCES COMMITTEE ON BIOLOGIC EFFECTS OF ATMOS-

PHERIC POLLUTANTS, AIRBORNE LEAD IN PERSPECTIVE 118

(1972) (hereinafter NAS Report). Despite its uni-

versal presence, however, lead serves no known purpose

in the human body, and at higher concentrations is

toxic, causing anemia, severe intestinal cramps, paral-

ysis of nerves, fatigue, and even death. Clinical symp-

toms of lead poisoning appear at blood lead levels of

80-100 ug or higher, and symptomatic lead poisoning

may appear at levels of 50-60 ug, particularly in the

* Some of the data discussed herein speak of micrograms of

lead per 100 grams of blood, while other data report micro-

grams per 100 milliliters of blood. Since the density of blood

is close to 1.0, these figures are directly comparable. There-

fore, lead concentrations, unless otherwise indicated, will

hereafter simply be given in micrograms. See NATIONAL

ACADEMY OF SCIENCES COMMITTEE ON BIOLOGIC EFFECTS OF

ATMOSPHERIC POLLUTANTS, AIRBORNE LEAD IN PERSPECTIVE

61 n. * (1972) (hereinafter NAS Report).

10

presence of anemia. EPA’s POSITION ON THE HEALTH

IMPLICATIONS OF AIRBORNE LEAD (hereinafter Third

Health Document) at III-1, Joint Appendix (hereinafter

JA) 54-55.

Human body lead comes from three major sources. In

most people, the largest source is the diet. EPA esti-

mates 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 depend-

ing 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 ex-

pensive 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, particu-

larly ages 1-3) is generally regarded as “the principal

environmental source in cases of severe acute lead poi-

soning in young children.” NAS Report at 140. Lead-

based paint was widely used in pre-1940 housing, for

both interiors and exteriors, so children living in older

housing, particularly in urban ghettos where such paint

is both present and peeling, are most susceptible to this

form of lead poisoning. Limited control has _ been

achieved in that lead paints are now rarely used, and

° Lead in food and water ultimately can be traced to lead in

soil and this, of course, is uncontrollable. The NAS Report

concluded that “[t]here is no evidence that the amount of

lead in the diets of people has changed substantially since

1940.” NAS Report at 206.

ll EEE OOOO

11

are frequently banned by statute, for interior surfaces.

But while some local laws require removal of existing

peeling lead paints, and there is federal legislation to

aid states and municipalities in such efforts, Lead-Based

Paint Poisoning Prevention Act, 42 U.S.C. §§ 4801 et

seq., (1970), there is no concentrated national effort at

removal, and the danger to children living in dilapidated

housing will remain for some time.*

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,’ and can be

simply eliminated by removing lead from gasoline.* While

the extent to which such lead actually enters the body

is vigorously contested by petitioners and lies at the heart

of this appeal, all parties agree that, to some extent at

least, airborne lead can be absorbed through the lungs

as a person breathes lead-contaminated air and that it

can be eaten by children with pica after larger lead

particles fall to the ground and mix with dust. Once

the lead is in the body, however, its source becomes irre-

levant; all lead in the bloodstream, from whatever source,

is essentially fungible. Thus so long as there are multi-

* A list of local laws regarding control and/or removal of

lead-based paints can be found in NAS Report at 77.

’ This is EPA’s figure, Third Health Document at II-4, JA

37, and Ethy! Corporation (hereinafter Ethyl), alone among

the petitioners, contests it. Supplemental brief of petitioner

Ethyl Corporation (hereinafter Ethyl Supp. Br.) at 40. We

cannot say that EPA’s estimate is unreasonable. It was de-

termined by discounting the NAS Panel’s conclusion that

“about 98° of the airborne lead that can be traced to its

source comes from combustion of gasoline.” NAS Report at

31. See also id. at 12-13.

* An alternative «pproach, considered and rejected by EPA,

is to trap and remove lead emissions from the exhausts of

automobiles using leaded gasoline. See note 66 infra.

12

ple sources of lead exposure it is virtually impossible to

isolate one source and determine its particular effect on

the body. The effect of any one source is meaningful

only in cumulative terms.

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 re-

fused to accept the developing evidence that lead emis-

sions 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 newiy-created EPA authority to

control or prohibit the sale or manufacture of any fuel

additive whose emission products “will endanger the pub-

lic health or welfare * * *.” 42 U.S.C. §$ 1857f-6e(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 Ad-

ministrator announced he was considering possible con-

trols on lead additives in gasolines, both because of their

possible danger to health and because of their incom-

patibility with the newly-ceveloped catalytic converter

emission control system.” 36 FED. REG. 1486 (1971).

* See, e.g., 116 CoNnG. Rec. 19207 (1970) (remarks of Rep.

Skubitz) (“the Government can require that the oil com-

panies get the lead out’); id. at 19228-19230 (colloquy be-

tween Reps. Waggoner & Staggers); id. at 19234 (remarks

of Rep. Williams); id. at 19239 (remarks of Rep. Sebelius).

‘e Regulations promulgated for the latter reason were ap-

proved in Amoco Oil Co. Vv. EPA, supra note 2. See note 2

supra.

es ee pe

13

Proposed regulations were issued a year later, Febru-

ary 23, 1972, supported by a document Health Hazards

of Lead" (hereinafter First Health Document), pre-

pared by the EPA scientific staff. Comments were in-

vited for a 90-day period, later reopened for an additional

30 days. 37 Fep. Rec. 11786-11787 (1972). At the

same time public hearings were held in Washington,

D. C., Dallas, and Los Angeles.

On January 10, 1973 the Administrator, while issuing

final regulations requiring availability of some lead-free

gasoline to allow implementation of the catalytic con-

verter system, 38 Fep. 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 Fep. Rec. 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 sig-

nificance 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.

"JA 292. This document was subsequently revised by

HEALTH HAZARDS OF LEAD (rev. April 11, 1972), JA 254;

ATMOSPHERIC LEAD AND PUBLIC HEALTH, (April 11, 1972),

JA 276; and CORRECTIONS AND A. “"\ONS TO HEALTH HAZARDS

OF LEAD (April 27, 1972), +A 272

14

On October 28, 1973, as a result of a motion filed in

Natural Resources Defense Council, Ine. 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, ex-

tensively 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, underly-

ing this informatien, and ultimately concludes that lead

from automobile emissions will endanger the public health.

The same day, based largely en 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 re-

jected. 38 FrEp. ReG. 33734. The final regulations re-

quire 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

standard: 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.’

** The reduction would proceed in the following steps:

1.7 g/gal. after Jan. 1, 1975

1.4 g/gal. after Jan. 1, 1976

[continued]

15

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 appeal was

heard by a division of the court on September 9, 1974.

On December 20, 1974, the division, one judge dissent-

ing, ordered the regulations set aside. The majority and

dissenting opinions were published on January 28, 1975."

Because of the importance of the issues presented, we

granted EPA’s petition for rehearing en banc on March

17, 1975, vacating the judgment and opinions of the

division and setting the case for reargument on May 30,

1975. All parties were invited to submit supplementary

briefs addressing the issues raised by the division

opinions.

The regulations are challenged by petitioners on a vari-

ety of grounds, all of which will be addressed below.

Their primary claims, and the ones on which the division

1.0 g/gal. after Jan. 1, 1977

0.8 ¢/gal. after Jan. 1, 1978

0.5 g/gal. after Jan. 1, 1979

40 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).

18 Commentators have been uniformly critical of the ma-

jority opinion. See Gardner, Federal Courts and Agencies:

An Audit of the Partnership Books, 75 CoLuM. L. REv. 800,

801 & n.77 (1975); Note, Judicial Review of the Facts in In-

formal Rulemaking: A Proposed Standard, 84 YALE L.J. 1750,

1767-68 & nn. 81-82 (1975); Note, Reserve Mining—The

Standard of Proof Required to Enjoin an Environmental

Hazard to the Public Health, 58 MINN. L. REV. 893, 918-19

n.116 (1975). See also Reserve Mining Co. Vv. EPA, 514 F.2d

492, 519-520 (8th Cir. 1975) (en banc).

16

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 ma.

on the basis of all the information available to him,

promulgate regulations that

control or prohibit the manufacture, introduction

into commerce, offering for sale, or sale of any fuel

or fuel additive for use in a motor vehicle or motor

vehicle engine (A) if any emission products of such

fuel or fuel additive will endanger the public health

or welfare * * *.

42 U.S.C. §$ 1857-6e(a) (1) (A). The Administrator can-

not 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].” Sec-

tion 211(e) (2) (A), 42 U.S.C. § 1857f-6e(c) (2) (A). See-

tion 202 of the Act, 42 U.S.C. § 1857f-1, allows the Ad-

ministrator to set standards for emission of pollutants

from automobiles (as opposed to standards for the com-

position of the gasoline that produces the emissions), and

is thus the preferred—although not the mandatory—

alternative under the statutory scheme, presumably be-

cause it minimizes Agency interference with manufac-

turer prerogatives."

* When EPA acts under § 211(c) (1) (A) it is essentially

telling manufacturers how to make their fuels, a task Con-

gress felt the Agency should enter upon only with trepidation.

See, e.g., 116 Conc. REc. 32920 (1970) (remarks of Sen.

Baker) ; id. at 19229 (remarks of Reps. Rogers & Waggoner).

[continued ]

17

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. § i857f-6e(¢c) (2)(C). It is significant that this

is the only conclusion the Administrator is expressly re-

quired to “find” before regulating a fuel or fuel additive

for health reasons. ;

A. The Threshold Determination

In making his threshold determination that lead par-

ticulate emissions from motor vehicles “‘wiil endanger the

public health or welfare,” the Administrator provided

his inierpretation of the statutory language by couch-

ing his conclusion in these words: such emissions “pre-

sent a significant risk of harm to the health of urban

populations, particularly to the health of city children.”

38 FrED. REG. 33734. By way of further interpretation,

he added that it was his view

On the other hand, when the Agency acts under § 202, it is

only mandating an end product—regulated emissions. The

method for achieving the required result is entirely in the

hands of the manufacturers.

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 un-

der § 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 Ad-

ministrator 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 con-

ference and the present more flexible language was substi-

tuted. See pages 40-43 infra.

18

that the statutory language * * * does not require

a determination that automobile emissions alone cre-

ate the endangerment on which controls may be

based. Rather, the Administrator believes that in

providing this authority, the Congress was aware

that the public’s exposure to harmful substances re-

sults from a number of sources which may have

varying degrees of susceptibility to control.

Id. It is petitioners’ first claim of error that the Admin-

istrator has erroneously interpreted Section 211(c) (1)

(A) by not sufficiently appreciating the rigor demanded

by Congress in establishing the “will endanger” stand-

ard. Therefore, petitioners argue, the Administrator’s

action is “short of statutory right,’ in violation of Sec-

tion 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 ac-

tual 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 Ad-

ministrator 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 addi-

tives on all other sources of human exposure to lead.

We have considered these arguments with care and find

them to be without merit.’’ It is our view that the

** At oral argument, petitioners claimed the regulations

were void because the Administrator had failed to couch his

ultimate finding in the language of the statute itself. See also

Supplemental brief of petitioner National Petroleum Refiners

19

Administrator’s interpretation of the standard is the cor-

rect one."

1. The Precautionary Nature of “Will Endanger.”

Simply as a matter of plain meaning, we have difficulty

crediting petitioners’ reading of the “will endanger”

Association (hereinafter NPRA Supp. Br.) at 5. The short

answer to the argument is that petitioners’ view of the facts

is erroneous. While interpreting the “will endanger” standard

to mean “presents a significant risk of harm,” 33 FED. REG.

33734, the Administrator ultimately did make his finding in

the language of the statute:

These regulations are based upon a determination by the

Administrator that the emission product of a fuel or

additive will endanger the public health * * *.

Id. at 33741. See 40 C.F.R. § 80.1 (1974).

In any case, however, the issue is spurious. It is well estab-

lished 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. Pa-

cific States Box & Basket Co. Vv. White, 296 U.S. 176, 186

(1935); Martin v. Mott, 25 U.S. (12 Wheat.) 19, 32-33 (1827)

(Story, J.). Cf. Joseph v. FCC, 131 U.S.App.D.C. 207, 211-

212, 404 F.2d 207, 211-212 (1968). The law is fully developed

in 2 K. DAVIS, ADMINISTRATIVE LAW TREATISE § 16.07 at 455-

59 (1958).

1° We note that even if we did not agree fully with the

Administrator’s interpretation of the Act, we would be obliged

to accord it considerable deference. As the Supreme Court

recently held in approving, despite the contrary views of

several circuits, the Administrator’s reading of another sec-

tion of the Clean Air Act:

Without going so far as to hold that the Agency’s con-

struction of the Act was the only one it permissibly

could have adopted, we conclude that it was at the very

least sufficiently reasonable that it should have been

accepted by the reviewing courts.

Train V. Natural Resources Defense Council, Inc., 421 U.S.

60, 75 (1975). See also id. at 87.

20

standard. The meaning of “endanger” is not disputed.

Case law and dictionary definition agree that endanger

means something less than actual harm.'*' When one is

endangered, harm is threatened; no actual injury need

ever occur. Thus, for example, a town may be “endan-

gered” by a threatening plague or hurricane and yet

emerge from the danger completely unscathed.’* A stat-

‘ It is linguistically clear, of course, that one can be “en-

dangered” without actually being harmed. Nonetheless, some

risk of harm is necessary. State v. Fine, 324 Mo. 194, 23

S.W.2d 7, 9 (1929). Webster defines “endanger” as “to bring

into danger or peril of probable harm or loss.”’ WEBSTER’S

THIRD NEW INTERNATIONAL DICTIONARY 748 (1961) (empha-

sis added).

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 en-

dangered 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, .

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 31-36 infra.

's Petitioner Ethyl suggests that while these may indeed be

examples of endangerment they differ from the threat from

automotive lead emissions in that

plagues do cause death and illness; violent storms do

cause damage—known facts that may be experienced by

the threatened community.

Ethyl Supp. Br. at 11 (footnote omitted). We may prelimi-

narily observe that the absorption of lead does cause lead

poisoning, a known fact that may be evaluated by the public

ee

21

ute allowing for regulation in the face of danger is, nec-

essarily, a precautionary statute. Regulatory action may

be taken before the threatened harm occurs; indeed, the

very existence of such precautionary legislation would

seem to demand that regulatory action precede, and,

optimally, prevent, the perceived threat. As should be

apparent, the “will endanger” language of Section 211

(c) (1) (A) makes it such a precautionary statute.

The Administrator read it as such, interpreting “will

endanger” to mean “presents a significant risk of harm.”

38 Fep. 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 sec-

tions of the Clean Air Act and by analysis of pertinent

precedent."

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 be-

tween 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 modi-

fication 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 lan-

guage of the Act indicates quite plainly Congress’ intent that

regulation should precede any threatened, albeit unprecedent-

ed, disaster. Ethyl is correct that we have not had the oppor-

tunity 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).

1 Since Congress seemed to assume that the meaning of

the threshold determination required by § 211(c) (1) (A)

would be self-evident, there is a complete absence of

22

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 regula-

tion of air pollutants for health reasons. Ethyl Supp.

Br. at 18-23; supplemental brief of petitioner Nalco

Chemical Company (hereinafter Nalco Supp. Br.) at

20-25; NPRA Supp. Br. at 31-46. However, we find in the

same sections relied upon by petitioners firm support for

our view of the precautionary nature of Section 211(c)

(1) (A). The provisions identified by petitioners are Sec-

tions 108 and 202 of the Act. Section 108 directs the Ad-

ministrator to list, for the purpose of establishing national

primary and secondary ambient air quality standards

pursuant to Section 109, each air pollutant “which in

his judgment has an adverse effect on public health or

welfare * * *.” Section 108(c) (1) (A), 42 U.S.C. § 1857

e-3(a) (1) (A). Section 202 authorizes the Administrator

to set standards for each automobile emission “which

in his judgment causes or contributes to, or is likely to

cause or contribute to, air pollution which endangers

the public health or welfare.” Section 202(a) (1), 42

U.S.C. § 1857f-1(a) (1).

Petitioners suggest that the threshold decision to reg-

ulate 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 mis-

read both sections. Section 108 requires an actual “ad-

verse effect” on health before an air pollutant may be

listed for regulation; actual harm must result.”’ This

helpful legislative history. What little there is of relevance

is discussed at pages 38-43 infra. See also note 89 infra.

7 Should there be any doubt about this conclusion, it is

quickly resolved by reference to §109. There Congress

ee re

23

firm threshold finding is reasonable in light of the con-

siderable disruption caused by action under Sections 108-

110. After a pollutant is listed under Section 108, the

Administrator must issue national ambient air quality

standards under Section 109 within a year. Promulga-

tion of standards begins the implementation plan process

of Section 110 under which the states must control, on

a mandatory timetable, the listed pollutants to the ex-

tent necessary to achieve the federal standards. Sec-

tion 110, 42 U.S.C. §1857c-5. Sections 108-110 are

“technology forcing” provisions; the attainment of the

primary, health-based standards takes precedence over

the cost and present technological feasibility of achieving

the requisite control. Union Electric Co. v. EPA, 515

F.2d 206, 215-16 (8th Cir.), cert. granted, —— US.

— , 44 U.S. L. WEEK 3200 (Oct. 6, 1975). Cf. Train

v. Natural Resources Defense Council, 421 U.S. 60, 90-

91 (1975). See also S. Rep. No. 91-1196, 91st Cong.,

2d Sess. 1-3 (1970).

Thus, before ordering this extensive chain of action

to begin, Congress demanded a threshold determination

that the pollutant causes actual harm.*' In this sense

made it quite clear how it would refer to anything other than

actual harm. Section 109(b) (2) provides that national second-

ary ambient air quality standards for pollutants listed under

§ 108 be prescribed with a margin of safety; they should

be sufficient to protect against “any known or anticipated

adverse effects associated with the presence of such air

pollutant in the ambient air.” 42 U.S.C. § 1857c-4(b) (2)

(emphasis added). When Congress uses the phrase in § 108

without the modifier “known or anticipated” it plainly

embraces only the usual meaning of adverse effects, i.e., known

adverse effects or actual harm.

21 The Administrator appears to have a measure of discre-

tion in determining whether to list a pollutant under § 108,

which, by its terms, speaks of the exercise of his “judg-

ment.” See 38 FED. REG. 33740 (1973). Amicus Natural Re-

sources Defense Council (NRDC) has argued that listing of

24

Section 108 is not a precautionary statute at all, and so

differs sharply from Section 211. However, the effects

of such after-the-fact regulation are somewhat amelio-

rated by the Act; Congress did provide a precautionary

element in standard-setting under Sections 108-110. See-

tion 109 expressly requires that the ambient air stand-

ards ultimately issued provide for “an adequate margin

of safety.” 42 U.S.C. § 1857c-4(b) (1). Thus, while the

threshold decision to regulate under Sections 108-110

is not precautionary but rather requires proof of demon-

strable harm caused by the suspect pollutant, once the

decision is made the standards promulgated must be

preventive in nature. Congress’ choice of this scheme

is in direct contrast to the procedures it established

under Section 211. Under that section the decision to

regulate is based on perceived danger. Unless we are

to assume Congress chose its language carelessly, regula-

tion in the face of “danger” rather than in the face of

“adverse effects” must mean that the threshold decision

to regulate under Section 211 is precautionary.*? The

contrast between the standards of Sections 108-110 and

of Section 211 supports our view of the precautionary

nature of the “will endanger” standard.”

air pollutants under §108 is mandatory. Its petition for

review of these regulations raising that issue was dis-

missed by the division for want of jurisdiction, Natural Re-

sources Defense Council, Inc. V. “PA, No. 74-1023 (D.C. Cir.

September 11, 1974), and NRDC has since brought a success-

ful citizen’s suit under § 304 of the Act, 42 U.S.C. § 1857h-2, to

compel issuance of national ambient air standards for lead.

Natural Resources Defense Council, Inc. Vv. Train, No. 74-

Civ-4617 (S.D.N.Y. decided March 1, 1976).

** Thus we must reject amicus NRDC’s suggestion that the

standards for action under §§ 108 and 211 are the same.

** Petitioners’ arguments that the threshold determination

under the “adverse effect” standard is less rigorous than un-

der the “will endanger” standard are either spurious or mis-

=<

25

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 Naleo Supp. Br. at 20-21; NPRA Supp. Br.

directed. Naleo Chemical Company (Nalco) and Ethyl argue

that the presence of the phrase “in his judgment” in § 108,

and its absence in § 211, means the Administrator has greater

discretionary power under the former section. Ethyl Supp. Br.

at 21; Nalco Supp. Br. at 22. As we shall explain below, see

note 37 infra, the Administrator retains the same (if not

greater, see note 21 supra) discretionary power under § 211.

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 stand-

ards and not to the threshold decision to regulate. NPRA

likewise confuses this point by suggesting that the listing re-

quirement of §108 is like the reporting requirements of

§ 211(a), so that the “margin of safety” language is com-

parable to § 211(c) (1) (A), only more generous. NPRA Supp.

Br. at 42-48. 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 re-

ported under § 211(a) are not necessarily regulated; regula-

tions are premised only on a § 211(c) (1) (A) finding of en-

dangerment. Thus, as suggested in the 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, prevautionary. Even if § 108 allowed regu-

lation 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 pre-

cautionary finding of threatened, albeit more severe, harm.

26

at 31-36. Section 202 provides that the Administrator

may regulate

the emission of any air pollutant {from any new

motor vehicle] which in his judgment causes or con-

tributes to, or is likely to cause or contribute to,

air pollution which endangers the public health or

welfare.

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 itali-

cized language upon which petitioners rely refers not

to the causal relationship between air pollution and

health, but to the relationship between automobile emis-

sions and air pollution.** Thus regulation may not be

premised on a threshold determination of likely danger;

rather regulation must be premised on a determination

of danger, a finding that “air pollution which endangers

the public health” is the end product of the emission to

be regulated. This is essentially the same finding of

endangerment as under Section 211. “Likely’”’ enters

the equation only in determining whether the emitted

air pollutant, which would be regulated, contributes to

the air pollution which is found dangerous. Here the

statute allows for a somewhat attenuated chain of causa-

tion. Regulation may be premised on a determination

that an air pollutant emitted from a new automobile is

likely to contribute to air pollution which endangers the

public health. In establishing this chain of causation

**In essence, petitioners are suggesting § 202 is more

properly read to provide for regulation of any automotive

emission

which in his judgment causes or contributes to, or is

likely to cause or contribute to, air pollution which causes

or contributes to, or is likely to cause or contribute to,

the endangerment of the public health or welfare.

Quite obviously, this is not what Congress said.

—

27

Section 202 is more lenient than Section 211,” but in

making the threshold determination of danger both sec-

tions are the same:* air pollution must endanger the

public health before regulation is justified.*’

** Section 211 simply skips this chain of causation and re-

quires instead that the emission products of the fuel additive

to be regulated endanger the public health. This omission of

a step does not support petitioners’ “in and of itself” theory,

see pages 56-61 infra, but rather is responsive to the different

intendments of §§ 101 and 211. See note 27 infra. In any

case, it is plain that for regulation under § 211 the emission

products must directly (although not necessarily by them-

selves) endanger the public he:|lth; whether they contribute

to air pollution that in turn endangers the public health, as

required by § 202, is irrelevant. Since the Administrator

found that lead emissions directly endanger the public health,

whatever leniency § 202 provides is irrelevant to this case.

Nalco takes issue with the dismissal of this question and

asks sarcastically, “If causation is irrelevant to the regula-

tion 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.

“Thus while Congress preferred emission regulation un-

der § 202 to fuel content regulation under § 211, see note 14

supra, there is no reason to assume, as NPRA argues, NPRA

Supp. Br. at 31-35, that in situations where § 211 regulation

is proper, the Administrator must find greater potential harm

before acting. Cf. note 23 supra.

** NPRA recognizes that a literal reading of § 202 pro-

duces the result suggested above. Thus it argues that this

28

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. Sec-

tion 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

result is “meaningless, or at best tautological,”” NPRA Supp.

Br. at 32, so that its “likely” danger theory emerges as an

acceptable, although linguistically incorrect, alternative. Jd.

at 33. NPRA argues that the above reading would require

the Administrator to determine whether “the emission

of any air pollutant ... is likely to cause or to contribute

to, air pollution ....”

Id. at 32 (emphasis in original). Since under this reading,

NPRA argues, the Administrator would always reach a posi-

tive 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 danger-

ous. See S. Rep. 89-192, 89th Cong., Ist Sess. 5-6 (1965);

IcPA 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.

en)

re, ee

29

meaning of “endanger” are few in number,” at least one

recent case is directly on point and fully in accord

with our view.

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 “endanger-

ing the health or welfare of persons” under Section 1160

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.** As

** See note 17 supra. See also Environmental Defense

Fund, Inc. v. EPA, 150 U.S.App.D.C. 348, 465 F.2d 528

(1972), where in interpreting the more rigorous statutory

language “imminent hazard” which must be found before the

registration for a pesticide may be suspended pending the

conclusion of cancellation proceedings, 7 U.S.C. § 136d(c)

(Supp. II 1972), we concluded, per Judge Leventhal:

It is enough if there is substantial likelihood that seri-

ous harm will be experienced during the year or two

required in any realistic projection of the administrative

process.

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 De-

fense Fund, Inc. Vv. EPA (Coahoma), 160 U.S.App.D.C. 123,

128, 489 F.2d 1247, 1252 (1973).

“Cf. Environmental Education Act, 20 U.S.C. § 1531 et

seq.; Environmental Quality Improvement Act of 1970, 42

U.S.C. § 4371 et seq.; National Environmental Policy Act of

1969 (NEPA), 42 U.S.C. § 4321 et seq. While initially the

procedural requirements of NEPA consumed judicial en-

ergies most conspiciously, see, e.g., Natural Resources Defense

Council V. Morton, 148 U.S.App.D.C. 5, 458 F.2d 827 (1972);

Calvert Cliffs’ Coordinating Committee, Inc. v. AEC, 146

U.S.App.D.C. 33, 449 F.2d 1109 (1971), courts are increas-

30

such, and because of their contemporaneous enactment,

interpretations of provisions of one Act have frequently

been applied to comparable provisions of the other. See,

e.g., Natural Resources Defense Council, Inc. v. Train,

166 U.S.App.D.C. 312, 321-322, 510 F.2d 692, 701-702

(1975). Thus Reserve Mining’s interpretation of “en-

dangering” is relevant to the meaning of the term “en-

danger” in the Clean Air Act. Indeed, it is particularly

relevant because in construing the language before it the

Kighth Circuit borrowed extensively from the interpre-

tation of the “will endanger” language of Section 211

expressed in the dissent from the division opinion in this

case, the same interpretation we adopt here. See Re-

serve Mining Co. v. EPA, supra, 514 F.2d at 528-529.

After analysis of the plain meaning of the FWPCA

provision, comparison with other sections of that Act,

and reference to our division’s dissent, the Eighth

Circuit’s unanimous conclusion fully supports our view

of the “will endanger” standard:

In the context of this environmental legislation, we

believe that Congress used the term “endangering”

in a precautionary or preventive sense, and, there-

fore, evidence of potential harm as well as actual

harm comes within the purview of that term.

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

ingly according substantive weight to the NEPA language.

See Sierra Club v. Morton, U.S.App.D.C. , -

& n.25, 514 F.2d 856, 873-875 & n.25 (1975), and cases

cited therein, cert. granted, sub nom. Kleppe v. Sierra Club,

—- U.S. , 44 U.S. L. WEEK 3397 (Jan. 12, 1976).

has

31

does not require proof of actual harm before regulation

is appropriate.”

Perhaps because it realized that the above interpreta-

tion was the only possible reading of the statutory

language, petitioner Ethyl addresses this interpretation

and argues that even if actual harm is not required for

action under Section 211(c) (1) (A), the occurrence of

the threatened harm must be “probable” before regula-

tion is justified. Ethyl Supp. Br. 12. While the diction-

ary admittedly settles on “probable” as its measure of

danger,’ we believe a more sophisticated case-by-case

analysis is appropriate. See note 17 supra. Danger, the

Administrator recognized, is set not by a fixed probability

of harm, but rather is composed of reciprocal elements

of risk and harm, or probability and severity. Cf.

Carolina Environmental Study Group v. United States,

166 U.S.App.D.C. 416, 419, 510 F.2d 796, 799 (1975) ;

Reserve Mining Co. v. EPA, supra, 514 F.2d at 519-520.

That is to say, the public health may properly be found

endangered both by a lesser risk of a greater harm and

by a greater risk of a lesser harm. Danger depends

% See Green, The Risk-Benefit Calculus in Safety Deter-

minations, 43 GEO. WASH. L. REv. 791 (1975); Handler, A

Rebuttal: The Need for a Sufficient Scientific Base for Gov-

ernment Regulation, id. at 808. Both authors agree that

government safety determinations should be preventive and

based on assessment of risks. Dr. Handler differs from Pro-

fessor Green in arguing that risks should be quantified be-

fore regulatory decisions are made. Professor Green believes

that quantification is not always necessary or possible, and

that the public health is better served by the making of value

judgments, however inexact.

1 See note 17 supra.

* This proposition must be confined to reasonable limits,

however. In Carolina Environmental Study Group v. United

States, 166 U.S.App.D.C. 416, 510 F.2d 796 (1975), a division

of this court found the possibility of a Class 9 nuclear reactor

32

upon the relation between the risk and harm presented

by each case, and cannot legitimately be pegged to “prob-

able” harm, regardless of whether that harm be great

or small. As the Eighth Circuit found in Reserve Min-

ing, these concepts “necessarily must apply in a de-

termination of whether any relief should be given in

eases of this kind in which proof with certainty is im-

possible.” ** 514 F.2d at 520.

disaster, a disaster of ultimate severity and horrible conse-

quences, to be so low that the Atomic Energy Commission’s

minimal consideration of the effects of such a disaster in an

environmental impact statement prepared for a new reactor

was sufficient. Likewise, even the absolute certainty of de

minimis harm might not justify government action. Under

§ 211 the threatened harm must be sufficiently significant

to justify health-based regulation of national impact. Ulti-

mately, of course, whether a particular combination of slight

risk and great harm, or great risk and slight harm, consti-

tutes a danger must depend on the facts of each case.

*3 Nalco devotes several pages of its brief to arguing that

there is a distinction between “risk” and “danger” that EPA

fails to recognize. Nalco Supp. Br. at 9-11, citing Reserve

Mining Co. v. EPA, supra note 13, and Power Reactor Devel-

opment Co. Vv. International Union of Electricians, 367 U.S.

396 (1961). To the extent Nalco argues that risk and danger

are not synonymous, Nalco battles with a straw man. EPA

recognizes that a risk to public health is not necessarily a

danger to public health; it only argues that a significant risk

of widespread lead poisoning constitutes such a danger. To

the extent Nalco argues there is no element of risk in danger,

it is plainly wrong, as the cases it cites demonstrate. In sup-

port of its position, Nalco quotes the following language from

Reserve Mining, in which the en bane court compares its

present opinion with the “stay” opinion of a division of the

court, Reserve Mining Co. v. United States, 498 F.2d 1073

(8th Cir. 1974), in which the division stayed the District

Court’s injunction ordering the immediate closing of the Re-

serve Mining plant:

As will be evident from the discussion that follows, we

adhere to our preliminary assessment that the evidence

i

i

:

*

33

In Reserve Mining the issue was whether asbestiform

wastes flushed into Lake Superior by the Reserve Min-

ing Company. endangered health.** The polluted lake

is insufficient to support the kind of demonstrable dan-

ger to the public health that would justify the immediate

closing of Reserve’s operations. We now address the

basic question of whether the discharges pose any risk

to the public health, and, if so, whether the risk is one

that is legally cognizable.

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 cog-

nizable” risk ultimately found was that Reserve’s discharges

were “endan: ering” the public health within the meaning of

the Federal Water Pollution Control Act. See page 34

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 regu-

lations juxtaposed, and ordered, findings of ‘undue risk” and

“endanger,” an “undue risk” was not intended to mean “en-

danger.” 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 “dan-

ger.”

** Reserve Mining involved issues not only under FWPCA,

but under § 407 of the Rivers and Harbors Act of 1899, 33

U.S.C. § 401 et seq., the federal common law of public nui-

sance, and various Minnesota air and water pollution laws,

Minn. Stat. Ann. § 116.081(1); id. § 115.07(1); id. § 105.41.

Finding the evidence of danger posed by Reserve Mining’s

waste emissions into the air more compelling than that of

the danger posed by the water emissions (since a correlation

between inhalation, but not ingestion, of asbestos fibers and

cancer could be found), the Eighth Circuit found the con-

tinued air emissions to be in violation of various Minnesota

regulations and ordered Reserve to “promptly take all steps

necessary to comply” with the law. Reserve Mining Co. V.

EPA, supra note 138, 514 F.2d at 538. With respect to the

34

waters formed the drinking supply of several surround-

ing communities, while a medical theory, bolstered only

by inconclusive evidence, suggested that ingestion of the

wastes caused cancer. See pages 93-94 infra. Applying

the “endangering the health or welfare of persons” stand-

ard of the FWPCA, the court found the wastes to be a

danger cognizable under the Act. The court did not

find that the danger was probable; rather it found the

wastes to pe “potentially harmful,” 514 F.2d at 528, and

potential harm to be embraced by the “endangering”

standard, id. See page 30 supra. The court concluded:

The record shows that Reserve is discharging a

substance into Lake Superior waters which under

an acceptable but unproved medical theory may be

considered as carcinogenic. As previously discussed,

this discharge gives rise to a reasonable medical

concern over the public health. We sustain the dis-

trict court’s determination that Reserve’s discharge

into Lake Superior constitutes pollution of waters

“endangering the health or welfare of persons”

within the terms of $$ 1160(c) (5) and (g) (1) of

the Federal Water Pollution Control Act and is

subject to abatement.

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.

water pollution, as described in the text, the court found the

probabilities of danger to be

low for they do not rest on a history of past health

harm attributable to ingestion but on a medical theory

implicating the ingestion of asbestos fibers as a causa-

tive factor in increasing the rates of gastrointestinal

cancer among asbestos workers.

Id. at 536 (emphasis added). Thus the court only ordered

cessation of dumping within a “reasonable time.” Jd. at 538.

en

35

The reason this relatively slight showing of probability

of risk justified regulation is clear: the harm to be

avoided, cancer, was particularly great. However, be-

cause 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.” Jd. at 538.

Reserve Mining convincingly demonstrates that the

magnitude of risk sufficient to justify regulation is in-

versely 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,** but fortunately such

balancing is unnecessary in this case. Undoubtedly, the

harm caused by lead poisoning is severe; nonetheless,

the Administrator does not rely on a “potential” risk

or a “reasonable medical concern” to justify the regula-

** Petitioners properly point out that, unlike lead, there is

no known safe human exposure level for carcinogens. Nalco

Supp. Br. at 9; Ethy] Supp. Br. at 29. See The Society of the

Plastic Industry, Inc. v. OSHA, 509 F.2d 1301, 1307 (2d Cir.),

cert. denied, 421 U.S. 992 (1975); Industrial Union Depart-

ment, AFL-CIO v. Hodgson, 162 U.S.App.D.C. 331, 499 F.2d

467 (1974). This does not, however, imply that the harm

caused by lead poisoning is less significant than that caused

by cancer, only that safe human exposure levels to the causes

of the two diseases may differ. This the Administrator recog-

nized. Unlike the actions of the Secretary of Labor in the

above cited cases, he did not order the lead content of gaso-

line reduced to the lowest detectable levels, but rather directed

a phased cutback to what he deemed a safe level.

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.

36

tions before us. Instead, he finds a “significant’’ risk

of harm to health. While this finding may be less than

the “probable” standard urged by Ethyl, it is con-

siderably more certain than the risk that justified regu-

lation in Reserve Mining of a comparably “fright-laden”

harm. Cf. Environmental Defense Fund, Inc. v. EPA,

150 U.S.App.D.C. 348, 358, 465 F.2d 528, 538 (1972).

Moreover, like the Reserve Mining court, in the face of

this still less than certain risk the Administrator did not

_ order the cessation of use of lead additives, but rather

directed a phased step-down to a plateau level. Thus we

conclude that however far the parameters of risk and

harm inherent in the “will endanger” standard might

reach in an appropriate case, they certainly present a

“danger” that can be regulated when the harm to be

avoided is widespread lead poisoning and the risk of that

occurrence is “significant.”

** This conclusion that a “significant risk of harm” states

a sufficient probability of occurrence to fall within the “will

endanger” standard is bolstered by the fact that Congress

did not employ various modifiers frequently used (in the

Clean Air Act and elsewhere) to mandate more certain en-

dangerment. Thus Congress did not require that the lead

emissions “clearly endanger” the public health, cf. 21 U.S.C.

§ 454(c); id. § 661(c); 50 U.S.C. § 1517, or that the emis-

sions pose an “imminent and substantial endangerment” to

the public health, cf. 33 U.S.C. § 1364 (Supp. 1974); 42

U.S.C. §$300i(a); id. § 1851c-10(b); id. § 1857c-7(c) (1).

See Reserve Mining Co. Vv. EPA, supra note 13, 514 F.2d at

528. We find these omissions more significant than the use

of the modifier “will,” which Ethyl argues adds “a particular

degree of certainty to the probability that must be shown.”

Ethyl Supp. Br. at 12. To the contrary, “will” only makes

it clear that the standard is one of danger and nothing less,

a conclusion with which we agree.

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. 66-97 infra.

The als seat

uve

Bibb io Nake! Sea NOTES Reva Cw. tote

37

2. The Administrator’s Power to Assess Risks. Pe-

titioners argue that Section 211 requires the Adminis-

trator 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” stand-

ard. 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 deter-

mine that a risk is a significant risk if he cannot

assess risks? And how can he assess risks if he can-

not make policy judgments? Surely reliance on “facts”

as contemplated by petitioners will provide little guid-

ance. However, sole reliance on facts was not demanded

by Congress.”

87 Besides the arguments discussed below, petitioners sup-

port their claim that a “factual” not judgmental decision is

required by pointing to the absence in § 211 of a phrase ex-

pressly allowing the Administrator to use his “judgment,” in

contrast to the presence of such a phrase in §§ 108 and 202.

Nalco Supp. Br. at 21-22; Ethyl Supp. Br. at 21-22. The argu-

ment ignores an important difference between the cited sec-

tions and § 211. Sections 108 and 202 are mandatory in their

terms; under both sections the Administrator “shall” regu-

late if “in his judgment” the pollutants warrant regulation.

Because of the mandatory nature of the provisions, express

provision for administrative discretion via the “judgment”

phrase is necessary. By contrast, §211 is permissive; the

Administrator “may” regulate if emissions “will endanger”

38

Originally, it is true, it appeared that Congress would

severely restrict the Administrator’s ability to assess

risks and make policy judgments to protect public health.

The bill sent to the floor of the House, and eventually

passed by the House, would have allowed EPA to con-

trol fuels or fuel additives only if the determination that

their emission products would endanger the public health

were established

on the basis of specific findings derived from rele-

vant medical and scientific evidence, including * * *

a finding that it is not otherwise technologically or

economically feasible to achieve the emission stand-

ards established pursuant to section 202 of this Act.

H.R. 17255, 91st Cong., 2d Sess. § 210(g)(1) (1970)

(emphasis added). The specific findings requirement had

more than procedural! significance. 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

the public health. Since discretion is provided in the directive

to the Administrator, the safety valve of a “judgment” phrase

is unnecessary. On the other hand, since we find the exercise

of judgment to be implicit in a determination of “danger,”

there is no need for an express statement of that power and

no reason to ascribe significance to the omission of the phrase.

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 Ad-

ministrator 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. 43-44 infra.

39

based solely on facts.** See also H.R. Rep. No. 91-1146,

91st Cong., 2d Sess., at 13 (1970).

“* Petitioner Nalco argues that if the specific requirement,

and its subsequent deletion, have substantive effect at all,

that effect relates not to the threshold decision to regulate,

but to the subsequent implementing decisions about how to

regulate. Nalco Supp. Br. at 17-20. It is true that a literal

reading of the House version, proposed § 210(g) (1), sug-

gests that specific findings are required in setting “stand-

ards” for fuel additives rather than for the threshold deci-

sion to regulate. Nonetheless, it is doubtful that the language

was intended to exempt the threshold decision to regulate

from the specific findings requirement, and equally doubtful

that a court would ever have so interpreted it. First, as a

practical matter it is questionable whether specific findings

on “standard” setting could be made without a specific find-

ing as to danger. The threshold finding would seem to be a

prerequisite to any subsequent specific findings. Second, the

legislative history makes it clear that the House intended the

specific findings requirement to apply to the threshold regu-

latory decision. In presenting the proposed bill to that cham-

ber Rep. Staggers, chairman of the committee that drafted

the bill, was confronted with questions about the basis on

which the Administrator could regulate fuel additives. Rep.

Staggers responded that the Administrator could regulate

only “[i]f he has the facts, and he has proven this by facts,

that they are a danger and poisonous * * *.” 116 CoNG. REC.

19229 (1970). To confirm that regulation could proceed only

upon a threshold factual determination of danger, Rep. Stag-

gers then quoted the specific findings provision that Nalco

now argues is inapplicable to this question. Jd. at 19230.

Likewise, Rep. Rogers, a member of Rep. Staggers’ commit-

tee, made clear that the threshold determination—that the

gasoline additive endangers health—must be made on the

basis of facts and findings. /d. at 19231. These are the only

specific comments on proposed § 210(g¢)(1), and as they

are made by knowledgeable committee members the legisla-

tive history is clear that specific findings were intended for

the threshold decision to regulate.

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

40

But the House bill did not become law. The Senate’s

preference for less restriction of EPA freedom in regu-

lating fuel additives for health reasons** was adopted

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 ‘find-

ings with respect to’ the actual items of data which the Ad-

ministrator must ‘consider.’” Jd., 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). Jd., 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 re-

quirement been enacted into law, it would have been inter-

preted, as suggested in the text, as requiring a specific fac-

tual finding for the threshold decision to regulate, and not

necessarily specific findings for all the subsequent implement-

ing decisions.

8° The original Senate version of the bill provided:

The Secretary may from time to time on the basis of in-

formation obtained under subsection (b) of this section

[which required fuel manufacturers to furnish various

information to the Secretary] or other information avail-

able to him, by regulation control or prohibit the intro-

duction into commerce of any fuel or fuels for use in

vehicle engines if the combustion or evaporation of such

fuel produces emissions which endanger the public

health or welfare * * *.

S. 4358, § 212(c) (1), 91st Cong., 2d Sess. (1970). The Sen-

ate 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. Jd. § 212

(c) (2). With minor verbal changes and deletion of the

41

by the conference committee and ultimately enacted into

law.*° Although the legislative history does not expressly

health-welfare dichotomy the Senate version became § 211

(c) (1).

Petitioners argue that the Senate as well as the House con-

templated 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 de-

termination, always coupled with discussion of the “specific

findings” requirement, see notes 38 supra and 40 infra, peti-

tioners can point to no express reference in the Senate pro-

ceedings 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 factuaily

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 en-

danger the public health or welfare’); id. at 33-34 (“emis-

sion 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 them-

selves, endanger the public health or welfare’) (see page 58

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. Ethy] also cites this

excerpt from the Senate Report:

“The [Administrator] may prohibit the use of any fuel

in commerce which may provide emissions that, he finds,

would endanger the public health.” Sen. Rep. No. 91-

1196, 91st Cong., 2d Sess. 64 (1970).

Ethyl Supp. Br. at 25 (emphasis in original). Since the Senate

bill explicitly deleted the finding requirement for action un-

der § 211(c) (1) (A), this language can hardly be taken as

supporting its sub silentio inclusion. If anything, the lan-

guage, which uses “finds” in its colloquial, not legal, sense,

only demonstrates the judgmental nature of the Administra-

tor’s decision. See note 37 supra.

* For this reason, statements made in the House about the

bill should be used only with great care in any attempt to

42

discuss the reasons for the change,*' the contrast in lan-

guage is stark. As Section 211 now reads, the only

“finding” the Administrator is required to make is that

any fuel additive that might replace one that is pro-

hibited does not cause emissions that will pose the same

or greater danger to the public health.** The substantive

assess legislative intent. House discussion centered on a

significantly more rigorous bill, and statements such as those

offered by petitioners from the House debate prove only the

effect of the ultimate deletion of the “specific findings’ re-

quirement. See Ethyl Supp. Br. at 24; Nalco Supp. Br. at

15; NPRA Supp. Br. at 30. Rep. Staggers’ statement, for

instance, directly relates the need for a factual threshold

determination to the “specific findings” requirement. As

such, it is strong support for the conclusion that deletion of

the requirement was intended to do away with such a rigor-

ous threshold requirement. See note 38 supra.

‘1 Neither the House managers’ conference report nor the

summary of the conference agreement prepared for the Sen-

ate address directly the effect of the changes here at issue.

See Conference Agreement on the Clean Air Amendments of

1970, H.R. Rep. No. 91-1783, 91st Cong., 2d Sess. 52-53

(1970) ; Summary of the Provisions of Conference Agreement

on the Clean Air Amendments of 1970, 116 CoNG. REc. 42384,

42385-42386 (1970). The most relevant discussion, which is

only oblique, is in the Senate conference report, where the

need for flexibility in applying § 211 is made clear:

[T]he conference committee wishes to call the attention

of the Administrator to the broad environmental, esthe-

tic and health considerations underlying the enactment

of this legislation which should be kept in mind in mak-

ing these determinations [to control or prohibit a fuel

or fuel additive].

116 Conc. 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.

* Section 211(c) (2)(C), 42 U.S.C. § 1857f-6e(c) (2) (C),

quoted in text at p. 64 infra.

43

impact of the change is clear. All of the requirements

for specific findings quoted above are replaced by re-

quirements that the Administrator “consider” the speci-

fied evidence. The mandatory deference to Section 202

is removed.** And the Administrator may act based on

all information available to him.** As we recognized in

Amoco, construing a similar change in parallel Section

211(c) (1) (B), the conference committee’s decision “was

a deliberated one and was meant to have significance.”

Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 173,

501 F.2d at 733.

In this case the decision has even more significance

than it did in Amoco, for under Section 211(c) (1) (B),

at issue in Amoco, the Administrator was still required

to make “findings.” All the conferees dropped was the

adjective “specific.” For regulation under Section 211

(c) (1) (A), at issue here, however, the entire require-

ment 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:

[We read Section 211(c)(2)(B) as incorporating

the commonsense approach which the courts have

*® See note 14 supra.

“The House bill required the Administrator to act only

on the basis of the required specific findings. The Senate «nd

final bill allows him to act on the basis of information ob-

tained under § 211(b), which requires fuel and fuel additive

manufacturers to furnish the Administrator with information

about their products’ content and, at his request, to conduct

various tests on the compounds and furnish him with descrip-

tions of testing techniques. The Administrator is also free

to act on the basis of any “other information available to

him,” § 211(c) (1) (emphasis added), thus making the basis

for action under § 211(c) (1) (A) unlimited.

44

developed in applying Section 4(b)'**! of the APA.

Where EPA’s regulations turn crucially on factual

issues, we will demand sufficient attention to these

in the statement to allow the fundamental ration-

ality of the regulations to be ascertained. Where,

by contrast, the regulations turn on choices of pol-

icy, on an assessment of risks, or on predictions

dealing with matters on the frontiers of scientific

knowledge, we will demand adequate reasons and

explanations, but not “findings” of the sort familiar

from the world of adjudication.

Amoco Oil Co. v. EPA, supra, 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 ac-

tion under Section 211(c)(1)(B) as a flexible require-

ment 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 Sec-

tion 211(c)(1)(A) as well, however, petitioners com-

pletely 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 differ-

ence between the threshold determinations under Sec-

tions 211(c)(1)(A) and (B). Recall what the Ad-

ministrator must find in order to act under Section 211

** The opinion refers to § 4(c), but § 4(b), which requires

the agency to “incorporate in the rules adopted a concise

statement of their basis and purpose,” was obviously intended.

See § 4 of the APA, 60 Star. 239 (1946), 5 U.S.C. § 553.

ne mati handed Mee Aa attests

45

(c)(1)(B): that the emission products of the fuel or

additive to be regulated

will impair to a significant degree the performance

of any emission control device or system which is

in general use, or which the Administrator finds

has been developed to a point where in a reasonable

time it would be in general use were such regula-

tion to be promulgated.

42 U.S.C. § 1857f-6e(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 fac

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” stand-

ard. The Amoco court held the findings requirement of

Section 211(c) (1) (B) no more than reiterated the mini-

mal demands of the basis and purpose staternent 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 determina-

tion and which section did not. While inclusion of the

phrase was unnecessary in that the APA would have

demanded a factual threshold determination under Sec-

tion 211(c)(1)(B) in any case, the selective use of the

46

findings requirement served to emphasize to the Ad-

ministrator 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 Con-

gress 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 flexi-

bility 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. Environ-

mental Defense Fund, Inc. v. Ruckelshaus, 142 USS.

App.D.C. 74, 88, 439 F.2d 584, 598 (1971).

Questions involving the environment are particularly

prone to une?>rtainty. Technological man has altered

his world in ways never before experienced or antici-

pated. 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 modifi-

cations,“ the regulators entrusted with the enforcement

*©Clean Air Act, 42 U.S.C. § 1857 et seq.; Federal Water

Pollution Contro! Act, 33 U.S.C. § 1151 et seq.; Federal In-

secticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 135

et seq.

fe eiletihe tai ees de ae tidal - tee

47

of such laws have not thereby been endowed with a

prescience that removes all doubt from their decision-

making. Rather, speculation, conflicts in evidence, and

theoretical extrapolation typify their every action. How

else can they act, given a mandate to protect the public

health but only a slight or nonexistent data base upon

which to draw? Never before have massive quantities

of asbestiform tailings been spewed into the water we

drink.’ Never before have our industrial workers been

occupationally exposed to vinyl chloride ** or to asbestos

dust.*” Never before has the food we eat been permeated

with DDT” or the pesticides aldrin and dieldrin."* And

never before have hundreds of thousands of tons of

lead emissions been disgorged annually into the air we

breathe. Sometimes, of course, relatively certain proof

of danger or harm from such modifications can be

readily found. But, more commonly, “reasonable medi-

eal concerns” and theory long precede certainty. Yet the

statutes—and common sense—demand regulatory action

to prevent harm, even if the regulator is less than

certain that harm is otherwise inevitable.

Undoubtedly, certainty is the scientific ideal—to the

extent that even science can be certain of its truth.”

But certainty in the complexities of environmental medi-

cine may be achievable only after the fact, when scientists

47 Reserve Mining Co. v. EPA, supra note 13.

*s The Society of the Plastics Industry, Inc. v. OSHA, su-

pra note 35.

* Industrial Union Department, AFL-CIO v. Hodgson,

supra note 35.

° Environmental Defense Fund, Inc. v. EPA (Coahoma),

supra note 28.

" Environmental Defense Fund, Inc. v. EPA (Shell), 167

U.S.App.D.C. 71, 510 F.2d 1292 (1975).

°? Even scientific “facts” are not certain, but only theories

with high probabilities of validity. Scientists typically speak

not of certainty, but of probability; they are trained to act

48

have the opportunity for leisurely and isolated scrutiny

of an entire mechanism. Awaiting certainty will often

allow for only reaccive, not preventive, regulation.” Pe-

titioners suggest that anything less than certainty, that

any speculation, is irresponsible. But when statutes seek

to avoid environmental catastrophe, can preventive, albeit

uncertain, decisions legitimately be so labeled?

The problems faced by EPA in deciding whether lead

automotive emissions pose a threat to the public health

on probabilities that statistically constitute “certainties.” See

generally T. KUHN, THE STRUCTURE OF SCIENTIFIC REVOLU-

TIONS. While awaiting such statistical certainty may consti-

tute the typical mode of scientific behavior, its appropriate-

ness is questionable in environmental medicine, where regu-

lators seek to prevent harm that often cannot be labeled “‘cer-

tain” until after it occurs. See note 58 infra.

The uncertainty of scientific fact parallels the uncertainty

of all fact. In a metaphysical sense, at least, facts are them-

selves 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. 195%).

°° Thus this court, per Judge Wilkey, affirmed EPA’s gen-

eral ban on the use of DDT even though the evidence was

considerably less than certain:

[T]here is a great mass of often inconsistent evidence

which was developed at the hearing; this evidence is

substantial enough to support the conclusions of the Ad-

ministrator, although it possibly might support contrary

conclusions as well. Considering the evidence as a whole,

we cannot say that the Administrator’s decision was not

based on substantial evidence, even if the hazardous

nature of DDT has not been proved beyond a reasonable

doubt. Sufficient evidence has been adduced to show

potentially great dangers from DDT, and the Adminis-

trator’s decision to cancel the DDT registration is well

within his statutory authority.

Environmental Defense Fund, Inc. v. EPA (Coahoma), su-

pra note 28, 160 U.S.App.D.C. at 128, 489 F.2d at 1252 (em-

phasis added).

ee ee rN re

3

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ers . er

49

highlight the limitations of awaiting certainty. First,

lead concentrations are, even to date, essentially low-

level, so that the feared adverse effects would not ma-

terialize until after a lifetime of exposure. Contrary

to petitioners’ suggestion, however, we have not yet suf-

fered a lifetime of exposure to lead emissions. At best,

emissions at present levels have been with us for ne

more than 15-20 years. Second, lead exposure from

the ambient air is pervasive, so that valid control groups

cannot be found against which the effects of lead on

our population can be measured. Third, the sources

of human exposure to lead are multiple, so that it is

difficult to isolate the effect of automobile emissions.

Lastly, significant exposure to lead is toxic, so that con-

siderations of decency and morality limit the flexibility

of experiments on humans that would otherwise acccle-

rate lead exposure from years to months, and measure

those results.*° Cf. Environmental Defense Fund, Inc.

Vv. EPA (Shell), 167 U.S.App.D.C. 71, 78, 510 F.2d 1292,

1299 (1975).

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 populacions; clinical studies can reproduce in

** According to the NAS Panel, present air lead concentra-

tions, which over the largest American cities are 2,000 times

greater than air lead concentrations over the mid-Pacific

Ocean, have existed for 15 years. NAS Report at 205, JA 356.

The Panel attributed these high concentrations primarily to

automotive emissions. /d.

°° It is for these reasons that, although lead additives have

been used for over 50 years, the danger posed by lead emis-

sions is still a question “on the frontiers of scientific knowl-

edge.’ Industrial Union Department, AFL-CIO v. Hodgson,

supra note 49, 162 U.S.App.D.C. at 338, 499 F.2d at 474.

See note 97 infra.

50

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 Lab-

oratory, has described, in the context of setting ambient

air standards, the limitations of these various investiga-

tive tools:

Each of these investigative approaches—classic

toxicology, epidemiology, and clinical research has

its advantages and disadvantages. The toxicologist

can control the dose and use invasive or destructive

techniques in measuring response in the animal, but

is always faced with the problem of extrapolating

results to humans. Epidemiology is most relevant

because it studies phenomena actually occurring in

humans under “natural” conditions, but can only

draw inference from observed correlations rather

than prove cause and effect relationships. Clinical

research can provide the most accurate dose-

response relationships in the species of interest.

Precisely because the study subjects are humans,

however, many experimental design problems are

encountered in assuring their safety. Although the

dose of an atmospheric pollutant can be carefully

controlled and measured in the clinical laboratory,

qualitative comparability to the multiplex variable

of atmospheric pollution cannot always be assured.

The best scientific criteria for establishing air

quality standards result from interactions between

these disciplines. Clinical studies must be preceded

by exhaustive toxicological assessment in other

species; observations from population studies should

play an important role in the experimental design

of clinical research. Biomedical data from all these

sources, taken in their entirety, should be used for

the prudent definition of air pollution control needs.

JA 582-583. The best biomedical evidence will be de-

rived from relating all three research approaches. This

EPA did. That petitioners, and their scientists, find a

Ae ee + OUTS i et

WB Ge wteere. Be WES lee ee

bt Meee tle? Has werden. <2

51

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 conflict-

ing and inconclusive evidence may be sustained. Recent

cases have recognized this flexibility in similar situations.

In Industrial Union Department, AFL-CIO v. Hodg-

son, 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:

From extensive and often conflicting evidence, the

Secretary in this case made numerous factual de-

terminations. With respect to some of those ques-

tions, the evidence was such that the task consisted

primarily of evaluating the data and drawing con-

clusions from it. The court can review that data in

the record and determine whether it reflects sub-

stantial support for the Secretary’s findings. But

some of the questions involved in the promulgation

of these standards are on the frontiers of scientific

knowledge, and consequently as to them insufficient

data is presently available to make a fully informed

factual determination. Decision making must in

that circumstance depend to a greater extent upon

policy judgments and less upon purely factual analy-

sis.'*

18 Where existing methodology or research in a new era

of regulations is deficient, the agency necessarily enjoys

broad discretion to attempt to formulate a solution to

the best of its ability on the basis of available informa-

tion, Permian Basin Area Rate Cases, 390 U.S. 747, 811,

88 S.Ct. 1344, 20 L.Ed.2d 312 (1968).

162 U.S.App.D.C. at 338, 499 F.2d at 474.

52

This rule was likewise applied in The Society of the

Plastics Industry, Ine. v. OSHA, 509 F.2d 1301 (2d

Cir.), cert. denied, 421 U.S. 992 (1975), where the

Second Circuit reviewed regulations limiting industrial

exposure to vinyl chloride, also considered a carcinogen:

As in Industrial Union Department, AFL-CIO v.

Hodgson, supra, the ultimate facts here in dispute

are “on the frontiers of scientific knowledge,” and,

though the factual finger points, it does not con-

clude. Under the command of OSHA, it remains

the duty of the Secretary to act to protect the work-

ingman, and to act even in circumstances where

existing methodology or research is deficient. The

Secretary, in extrapolating the MCA study’s finding

from mouse to man, has chosen to reduce the per-

missible level to the lowest detectable one. We find

no error in this respect.

Id. at 1308. And in Reserve Mining the Eighth Cir-

cuit 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:

|Wje note that many of the issues in this case do

not involve “historical” facts subject to the ordinary

means of judicial resolution. Indeed, a number of

the disputes involve conflicting theories and experi-

mental results, about which it would be judicially

presumptuous to offer conclusive findings [quoting

Amoco Oil Co, v. EPA, 163 U.S.App.D.C. 181, 501

F.2d at 741, which relied on Jndustrial Union]. In

such circumstances, the finder of fact must accept

certain areas of uncertainty, and the findings them-

selves cannot extend further than atten.pting to as-

sess or characterize the strengths and weaknesses

of the opposing arguments.

514 F.2d at 507 n.20. See also id. at 529.

53

These cases, recognizing as they do the developing

nature of environmental medicine, fortify our analysis

of the “will endanger” language of Section 211.°° Where

a statute is precautionary in nature,” the evidence dif-

* Ethyl argues that Industrial Union and Society of the

Plastics Industry are distinguishable from this case in that

under OSHA the Secretary is directed to set standards for in-

dustrial exposure to toxic substances, 29 U.S.C. § 655(b) (5),

while action under § 211 is discretionary with the Adminis-

trator. Ethyl Supp. Br. at 28-30. Ethyl has merely identified

the source of the flexibility granted the Secretary, while

failing to set the cited cases apart from this one. Under the

Clean Air Act the Administrator’s flexibility is derived

not from a command to act, but from a precautionary statute

that necessarily includes risk assessment if its preventive

purpose is to be achieved. Since there is reason to accord

flexibility to the regulator under both acts, the cited cases

are good support for the way in which that flexibility is to

be exercised.

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 distinciion 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 flexibile decision-making (in Re-

serve Mining by a court rather than by an agency). Like-

wise, that case involved not only the manner of standard-

setting, but the threshold decision to regulate as well. None-

theless, Reserve Mining is fully consistent with J/ndustrial

Union and Society of the Plastics Industry, and all three

cases support our conclusion here.

* Or, as with OSHA, mandatory in its command to act.

See note 56 supra.

54

ficult to come by, uncertain, or conflicting because it is

on the frontiers of scientific knowledge, the regulations

designed to protect the public health, and the decision

that of an expert administrator, we will not demand

rigorous step-by-step proof of cause and effect. Such

proof may be impossible to obtain if the precautionary

purpose of the statute is to be served. Of course, we

are not suggesting that the Administrator has the power

to act on hunches or wild guesses. Amoco makes it quite

clear that his conclusions must be rationally justified.

Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 180-

181, 501 F.2d at 740-741. However, we do hold that in

such cases the Administrator may assess risks. He must

take account of available facts, of course, but his in-

quiry does not end there. The Administrator may apply

his expertise to draw conclusions from suspected, but

not completely substantiated, relationships between facts,

from trends among facts, from theoretical projections

from imperfect data, from probative preliminary data

not yet certifiable as “fact,” and the like. We believe

that a conclusion so drawn—a risk assessment—may,

if rational, form the basis for health-related regulations

under the “will endanger” language of Section 211.”

°* It bears emphasis that what is herein described as “‘assess-

ment of risk” is neither unprecedented nor unique to this area

of law. To the contrary, assessment of risk is a normal part

of judicial and administrative fact-finding. Thus EPA is not

attempting to expand its powers; rather, petitioners seek to

constrict the usual flexibility of the fact-finding process.

Petitioners argue that the Administrator must decide that

lead emissions “will endanger” the public health solely on

“facts,” or, in the words of the division majority, by a “chain

of scientific facts or reasoning leading [the Administrator]

ineluctably to this conclusion * * *.” Division op. at 59. Peti-

tioners demand sole reliance on scientific facts, on evidence

that reputable scientific techniques certify as certain. Typi-

cally, a scientist will not so certify evidence unless the prob-

ee ere ae See ee OS ae

55

All of this is not to say that Congress left the Ad-

ministrator free to set policy on his own terms. To the

contrary, the policy guidelines are largely set, both in

the statutory term “will endanger” and in the relation-

ability of error, by standard statistical measurement, is less

than 5%. That is, scientific fact is at least 95% certain.

Such certainty has never characterized the judicial or the

administrative process. It may be that the “beyond a reason-

able doubt” standard of criminal law demands 95% cer-

tainty. 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, de-

mands 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. None-

theless, 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.

Looking to the future, and commanded by Congress to

make policy, a rule-making agency necessarily deals less

with “evidentiary” disputes than with normative con-

flicts, projections from imperfect data, experiments and

simulations, educated predictions, differing assessments

of possible risks, and the like.

Amoco Oil Co. Vv. 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

56

ship of that term to other sections of the Clean Air Act.

These prescriptions direct the Administrator’s actions.

Operating within the prescribed guidelines, he must con-

sider all the information available to him. Some of the

information will be factual, but much of it will be more

speculative—scientific estimates and “guesstimates” of

probable harm, hypotheses based on still-developing data,

ete. Ultimately he must act, in part on “factual issues,”

but largely “on choices of policy, on an assessment of

risks, [and] on predictions dealing with matters on the

frontiers of scientific knowledge * * *.” Amoco Oil Co.

v. EPA, supra, 163 U.S.App.D.C. at 181, 501 F.2d at

741. A standard of danger—fear of uncertain or wun-

known harm—contemplates no more.

3. Propriety of the Cumulative Impact Approach. In

addition to demanding that the Administrator act solely

on facts, petitioner Ethyl insists that those facts con-

vince 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 18

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 con-

scientific fact is inherent in the requirements of legal fact-

finding. Pet’tioners’ assertions of the need to rely on “fact”

confuse the two terminologies. We must deal with the termi-

nology of law, not science. At law, unless the administrative

or judicial task is peeultiarly factual in nature, or Congress

expressly commands a more rigorous finding, see 21 U.S.C.

§ 355 (d); cf. pages 43-45 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.

‘

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57

tribute to, air pollution which endangers the public

health or welfare.” Section 202(a) (1), 42 U.S.C. § 1857

f-1(a)(1) (emphasis Ethyl’s in its brief at 18). This

is contrasted with Section 211’s language allowing regu-

lation of fuels or fuel additives whose “emission prod-

ucts * * * will endanger the public health or welfare.”

Py 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 Sec-

tion 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 encom-

passing than Secticn 211’s term “emission products,”

it is clear that whatever leniency Section 202 suggests

only concerns the makeup of air pollution. This is irrele-

vant 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 re-

sultant polluted air, however composed, endangers the

public health.” Both provisions leave open the question

°° As far as the cumulative impact theory is concerned, the

relevant portions of the two provisions are as follows:

[The Administrator may regulate any automobile emis-

sion that] causes or contributes to, or is likely*to cause or

contribute to, air pollution which endangers the public

health or welfare.

Section 202(a)(1), 42 U.S.C. § 1857f-1(a)(1) (emphasis

added).

[The Administrator may regulate a fuel or fuel additive]

if any emission products of such fuel or fuel additive

will endanger the public health or welfare * * *.

Section 211(c) (1) (A), 42 U.S.C. § 1857f-6c(c) (1) (A) (em-

phasis added).

58

whether emissions or air pollution can be found to en-

danger the public health when the endangerment is not

caused by that pollution alone.”

While Ethyl’s comparison suggests no answer, the ques-

tion 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. He believed that regulation was

justified because the aggregate was dangerous, and be-

cause leaded gasoline was a significant source that was

particularly suited to ready reduction. 38 FED. REG.

33734. To the question whether the Administrator was

correct in his belief, comparison with the “contribute

to” language of Section 202 provides no guidance.

The only other evidence relied upon by Ethyl for its

“in and of itself’ theory is a quotation, taken out of

context, from Senator Baker. When the context of Ethyl’s

partial quotation is revealed the irrelevance of his state-

ment to Ethyl’s theory becomes clear. Senator Baker

reviewed the Committee bill for the Senate:

The |Administrator] is authorized to either control

or prohibit the sale of any given fuel when he finds

one of two things:

First. That the combustion or evaporation of

such fuel produces emissions that, in and of them-

selves, endanger the public health or welfare; or

Second. That such emissions prevent the opera-

tion of a system that is necessary to reduce automo-

** Since automobile emissions generate approximately 90%

of all airborne lead, see note 7 supra and accompanying

text, the danger posed by lead-polluted air is virtually

identical to that posed by lead automobile emissions. As the

text suggests, the non-automotive sources of lead with which

the cumulative impact theory is concerned are not airborne.

a = —

59

bile emissions to the levels required by standards

issued by the [Administrator] under section 202 of

the act.

116 Conc. 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 them-

selves” 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, partieularly in light of

the realities of human exposure to lead and what Con-

gress knew about those realities. Such consideration dem-

onstrates both that, under Ethyl’s approach, EPA regula-

tion of lead on health grounds would be impossible and

that Congress could not possibly have intended the re-

strictive “by itself” reading. As has been discussed more

extensively above, see pages 10-12 supra, lead enters the

human body from multiple sources, so that the effect

*1 Ethyl actually quotes Sen. Baker’s second use of the

phrase, a few sentences after the one quoted in the text, see

116 Conc. REc. 32920 (1970). It, however, is in the same

context of contrasting permissible EPA action under

§§ 211(c) (1) (A) and (B), and thus provide; 1:0 more sup-

port for Ethyl’s position. The implausibility of i‘thyl’s read-

ing of Sen. Baker’s words is heightened by the ‘act that the

Senator himself realized the important contributivn of dietary

lead to the total body lead burden ai i so informed the Senate

only sentences before the quoted language. Jd.

60

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 en-

dangerment 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 reg-

ulation 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 un-

derstood that determining the effect of lead automobile

emissions, by themselves, on human health is of no more

practical value than finding the incremental effect on

health of the fifteenth sleeping pill swallowed by a

would-be suicide.’ It did not mean for “endanger” to

be measured only in incremental terms.’’ This the Ad-

** While the incremental effect of lead emissions on the total

body lead burden is of no practical value in determining

whether health is endangered, it is of value, of course, in

deciding whether the lead exposure problem can fruitfully be

attacked through control of lead additives. Moreover, even

under the cumulative impact theory emissions must make

more than a minimal contribution to total exposure in order

to justify regulation under § 211(c) (1) (A). We accept the

Administrator’s determination that the contribution must be

— before regulation is proper. See 38 Frp. Rec.

4,

* Congress had before it a complete explanation of the

multiple sources of human lead exposure. It understood that

i a oe

61

ministrator also understood. He determined that absorp-

tion of lead automobile emissions, when added to all other

human exposure to lead, raises the body lead burden to a

level that will endanger health. He realized that lead

automobile emissions were, far and away, the most

readily reduced significant source of environmental lead.

And he determined that the statute authorized him to

reduce those emissions on such a finding. We find no

error in the Administrator’s use of the cumulative im-

pact approach,

4. Summary of the “Will Endanger” Determination.

In sum, we must reject petitioners’ cramped and unreal-

istic interpretation of Section 211(¢c) (1) (A). Their read-

ing would render the statute largely useless as a basis

for health-related regulation of lead emissions. Peti-

tioners’ arguments are rebuffed by the plain meaning

of the statute and the Administrator’s interpretation

of it,’ by the legislative history and the implications

lead is ubiquitous in nature, that trace elements of lead are

present in everyone, and that only when lead concentration

reaches higher levels would the public be endangered. It could

not have thought that lead automobile emissions could, by

themselves, endanger the public, although it clearly did think

they could be regulated only if they provided a significant

increment to the total human lead burden. See, e.g., Hearings

on S, 3229, S. 2466 & S. 3546 before the Subcommittee on Air

& Water Pollution of the Senate Committee on Public Works,

Sist Cong., 2d Sess., pt. 1, at 433-484 (1970) (answers to

Sen. Muskie’s questions, supplied by the Dept. of Health,

Education & Welfare); id., pt. 3, at 1177; 116 CoNna. Rec.

$2920 (1970) (remarks of Sen. Baker).

‘Considerable deference is owed to the interpretation of

a statute by the officer charged with its administration. Train

v. Natural Resources Defense Council, Inc., 421 U.S. 60, 87

(1975) (Clean Air Act); Zuber v. Allen, 396 U.S. 168, 192

(1969); Udall v. Tallman, 880 U.S. 1, 16 (1965); United

States Vv. American Trucking Assns, 310 U.S. 534, 549 (1940).

This deference is heightened when, as here, the interprete

that can be drawn from other sections of the same

statute, by the relevant precedents, and by the estab-

lished maxim that health-related legisiation is liberally

construed to achieve its purpose.”

We believe the Administrator may regulate lead ad-

ditives under Section 211(¢c)(1)(A) when he deter-

mines, based on his assessment of the risks as developed

by consideration of all the information available to him,

and as guided by the policy judgment inherent in the

statute, that lead automobile emissions significantly in-

crease the total human exposure to lead so as to cause

a significant risk of harm to the public health. Before

so regulating, he must consider the possibility of regula-

tion under Section 202." This interpretation of Section

tion is of a new statute by its implementing agency. Power

Reactor Development Co. Vv. International Union of Elec-

tricians, 367 U.S. 396, 408 (1961); United States v. Zucca,

351 U.S. 91, 96 (1956); United States v. American Trucking

Assns, supra; Norwegian Nitrogen Products Co, v. United

States, 288 U.S. 294, 315 (1933); Natural Resources Defense

Council, Inc. Vv. Train, 166 U.S.App.D.C, 312, 326, 510 F.2d

692, 706 (1975) (Clean Air Act). See note 16 supra.

** See, e.g., Parke Vv. Bradley, 204 Ala, 455, 86 So, 28 (1920);

Forbes Vv. Board of Health, 28 Fla. 26, 9 So, 862 (1891);

People ex rel. Barmore V. Robertson, 302 Ill, 422, 184 N.E,

815, 22 A.L.R. 885 (1922); Blue v. Beach, 155 Ind. 121, 56

N.E. 89 (1900); Walker v. Sears, 245 lowa 262, 61 N.W.2d

729 (1953); State ex rel. Freeman v. Fadeley, 180 Kan, 652,

308 P.2d 587, 548 (1957); Board of Health v. Kollman, 156

Ky. 351, 160 S.W. 1052 (1913); Rock v. Carney, 216 Mich.

280, 185 N.W. 798, 22 A.L.R. 1178 (1921); State ex rel. Free-

man V. Zimmerman, 86 Minn. 358, 90 N.W. 783 (1902);

Crayton Vv. Larabee, 220 N.Y. 498, 116 N.E. 355 (1917);

Salt Lake City Vv. Howe, 87 Utah 170, 106 P. 705 (1910).

" The statute demands “consideration” not only of the rele-

vant scientific and medical evidence, but also of the possi-

bility of regulation under § 202. Section 211(c) (2) (A), 42

U.S.C, § 1857f-6e(c) (2) (A). That means, of course, no more

than it says: actual good faith consideration of the specified

211 does not allow for baseless or purposeless regulation,

but does grant the Administrator the flexibility needed

to confront realistically the public health problem pre-

sented by massive diffusion of lead emissions from

automob les.

B. Comparison with Substitute Additives

Even when the Administrator has determined that a

fuel or fuel additive causes emissions which endanger

evidence and options, as reflected in the basis and purpose

statement required by § 4(b) of the APA, 5 U.S.C, § 553(c).

NPRA argues that the statute demands mandatory deference

to the possibility of regulation under § 202 rather than mere

consideration of such a possibility. NPRA Supp. Br. at 33-35.

We reject the argument. NPRA ignores the deletion of the

specific findings requirement from the original bill. As pointed

out above, see pages 38-43 & note 14 supra, one effect of the

deletion was to eliminate mandatory deference to § 202 and

substitute instead “consideration” of § 202 regulation. While

Congress thus indicated its preference for regulation under

$ 202, it left the Administrator with full discretion to im-

plement that preference or not, See note 14 supra,

NPRA, joined by Nalco, further argues that EPA’s consid-

eration of § 202 regulation was arbitrary and capricious be-

cause 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 be-

cause § 202 authorizes EPA to order emission controls only

on new vehicles, which would largely be using lead-free gaso-

line anyway because of the catalytic converter. On new ve-

hicles 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 Feo. Rea. 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 (1971). See also

note 68 infra.

64

the public health, he is not yet free to prohibit the sub-

stance under Section 211. He must first find, and pub-

lish his finding,

that in his judgment such prohibition will not cause

the use of any other fuel or fuel additive which

will produce emissions which will endanger the pub-

lic health or welfare to the same or greater degree

than the use of the fuel or fuel additive proposed

to be prohibited.

Section 211(c)(2)(C), 42 U.S.C, § 1857f-6e(¢e) (2) (C).

Preliminarily it must be noted that the section re-

quires a finding only before the Administrator “pro-

hibits” 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.” If the requirement is read to apply,

however, it plainly demands no more than the findings

requirement of Section 211(c) (2)(B), as construed in

Amoco, see pages 43-44 supra. This conclusion is compelled

*' This distinction is not unduly technical, since § 211 (c) (1)

expressly allows the Administrator to “control or prohibit”

while § 211(c) (2) (C), drafted contemporaneously, repeatedly

indicates that a finding is required only before a fuel or fuel

additive is “prohibited.” Parallel §§ 211(c) (2) (A) and (B),

on the other hand, also expressly apply before a fuel or fuel

additive may be “controlled or prohibited.”

Nonetheless, the purpose behind § 211(c) (2) (C)—avoid-

ance 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 furn-

ished a finding such as is required by § 211(c) (2)(C), 38

Fep. 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.

wh aie a a eR

65

by the identical genesis of the two provisions, plus the

fact that the Section 211(¢) (2) (C) finding is judgmental

by its own terms. Thus where the judgment turns “on

factual issues’ we will “demand sufficient attention to

these in the statement to allow the fundamental ra-

tionality * * * to be ascertained.” Amoco Oil Co. v. EPA,

supra, 163 U.S.App.D.C. at 180-181, 501 F.2d at 740-

741. By contrast, where the judgment is necessarily

more speculative, we will “demand adequate reasons and

explanations, but not ‘findings’ of the sort familiar from

the world of adjudication.” /d., 163 U.S.App.D.C. at 181,

501 F.2d at 741.”

"“Naleo argues that the Administrator’s recent decision to

suspend the 1977 statutory emission standards for hydro-

carbons and carbonmonoxide, 40 FED. REG. 11900, see note 2

supra, invalidates his assessment of the impact of the substi-

tute additive, aromatic | ydrocarbons, Nalco Supp. Br. at 45-

50. Cf. NPRA Supp. Br, at 48-49. This argument appears to

be a challenge to the regulations based on new information,

Such challenges are cognizable under § 307 of the Clean Air

Act, 42 U.S.C, § 1857h-5(b) (1), but may be brought to this

court only after a preliminary presentment of the new infor-

mation and a request for action to the agency, Oljato wena

ter of Navajo Tribe Vv. Train, ——~ U.S.App.D.C., »

————«, 515 F.2d 654, 666-667 (1975). Since Naleo has not com-

plied with the rule of Oljato Chapter, this new information

claim does not appear to be properly before us.

In any case, however, Nalco’s claim is without merit, Un-

doubtedly high octane aromatic hydrocarbons will be used to

compensate for the reduction in lead caused by the regula-

tions 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) hydro-

carbons, 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 auto-

mobiles, together with emissions from refineries that produce

gasoline, account for only approximately 2% of PNA emis-

66

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.

Ill. Tue 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 proce-

sions in the ambient air; (2) PNA emissions are being re-

duced from automobiles by the applicable hydrocarbon stand-

ards; and (3) PNA automobile emissions will continue to

decrease overall, even while the hydrocarbon content of gaso-

line jnereases, as uncontrolled automobiles are retired and

replaced by those with emission control systems, 38 FED.

Reo, 33738, Thus the Administrator concluded that replace-

ment of lead additives by increased hydrocarbons would re-

sult only in a slight slowing of the rate of decrease of PNA

emissions from automobiles. We think this is a sufficient find-

ing 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 as-

sumption that the interim standards would remain in effect

through 1980. In that circums*ince, which may turn out to

be the correct forecast, PNA e.aissions would still decrease

69°) over 1973 levels by 1980. Without the low-lead regula-

tions 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.

67

dures are conducted pursuant to Section 4 of the APA,"

5 U.S.C. $553, and must be reviewed under Section 10

of the Act,” 5 U.S.C. § 706(2)(A)-(D). Our review of

the evidence is governed by Section 10/e) (2) (A), which

requires us to strike “agency action, findings, and con-

clusions” that we find to be “arbitrary, capricious, an

abuse of discretion, or otherwise not in accordance with

law * * *.”" 5 U.S.C. § 706(2)(A). This standard of

** The hybrid procedures that placed the EPA action some-

where between informal rule-making and adiudication and

that caused such extended inquiry by the Amoco court are

largely absent from this case. In Amoco, in addition to the

“findings” requirement of § 211(c) (2) (B), the court had to

deal with the same section’s requirement of a public hearing.

The resultant standard of review was, nonetheless, not sig-

nificantly different from traditional “arbitrary and capri-

cious” review. See Amoco Oil Co. v. EPA, supra note 2, 163

U.S.App.D.C. at 171-181, 501 F.2d at 731-741. In this case

there is no public hearing requirement and the only “find-

ings” requirement is that of § 211(c) (2) (C), which we have

construed at pp. 63-66 supra.

The requirement that the Administrator “consider” vari-

ous evidence before acting under § 211(¢)(1)(A) guides

the direction, but does not affect the rigor, of “arbitrary and

capricious” review. Such guidelines are typical as a prerequi-

site for agency action, s:, e.g., § 1002(e) (the Rule of Rate-

making) of the Federal Aviation Act of 1958, 49 U.S.C.

§ 1482(e) (1970), and assurance of agency compliance is sim-

ply one part of “arbitrary and capricious” review. Citizens

to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971)

(court must determine “whether the decision was based on a

consideration of the relevant factors’’).

* All the Clean Air Act says about judicial review of EPA

action under § 211 is that it shall be available exclusively in

this court. 42 U.S.C. § 1857h-5(b) (1).

"Our review of the Administrator’s construction of the

statute, see pages 16-66 supra, is authorized by § 10(e) (2)

(C), 5 U.S.C. § 706(2) (C), which allows the reviewing court

to set aside agency action it finds to be “in excess of statutory

jurisdiction, authority, or limitations, or short of statutory

68

review is a highly deferential one. It presumes agency

action to be valid. Citizens to Preserve Overton Park

v. Volpe, 401 U.S. 402, 415 (1971); Pacific States Box

& Basket Co. v. White, 296 U.S. 176, 185-186 (1935) ;

United States v. Chemical Foundation, 272 U.S. 1, 14-

15 (1926).°%* Moreover, it forbids the court’s substi-

tuting its judgment for that of the agency, Citizens

to Preserve Overton Park v. Volpe, supra, 401 USS.

at 416, and requires affirmance if a rational basis exists

for the agency’s decision."* Bowman Transportation, Inc.

v. Arkansas-Best Freight System, Inc., 419 U.S. 281,

290 (1974). Cf. United States v. Allegheny-Ludlum Steel

Corp., 406 U.S. 742, 749 (1972).

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

right * * *.” Our review of EPA procedures, see pages 97-

111 infra, is pursuant to § 10(e) (2) (D), 5 U.S.C. § 706(2)

(D), which authorizes reversal of agency action taken “with-

out observance of procedure required by law.”

7? NPRA seeks to attach meaning to the fact that an ex-

press presumption of validity was included in the Senate ver-

sion of the Clean Air Act, and then deleted by the conference

committee. NPRA Supp. Br. at 21-24. See S. Rep. No. 91-

1196, 91st Cong., 2d Sess. at 41, 125 (1970). As the above

cited cases make clear, however, a general presumption of

validity attaches to any regulation within an agency’s dele-

gated powers. Thus the deletion is of no consequence.

"Of course, that basis must be expressed by the agency

itself and not supplied by the court. SEC v. Chenery Corp.,

332 U.S. 194, 196 (1947). Nonetheless, a decision of “less

than ideal clarity” will be upheld if the agency’s rationale

“may reasonably be discerned.” Bowman Transportation,

Ine. V. Arkansas-Best Freight System, Inc., 419 U.S. 281,

286 (1974). See also Colorado Interstate Gas Co. v. FPC,

324 U.S. 581, 595 (1945).

69

consideration of the relevant factors * * *.”™ More-

"Overton Park also requires the reviewing court to con-

sider “whether there has been a clear error of judgment.”

Citizens to Preserve Overton Park v. Volpe, supra note 69,

401 U.S. at 416, citing L. JAFFE, JUDICIAL CONTROL OF AD-

MINISTRATIVE ACTION 182 (1965) ; McBee v. Bomar, 296 F.2d

235, 237 (6th Cir. 1961); In re Josephson, 218 F.2d 174, 182

(1st Cir. 1954); Western Addition Community Organization

Vv. Weaver, 294 F.Supp. 433 (N.D. Cal. 1968); Wong Wing

Hang V. INS, 360 F.2d 715, 719, (2d Cir. 1966). While as

used, carefully bracketed by traditional statements of the

restraint of “arbitrary and capricious” review, the phrase

works no change in the law, the Court’s choice of language is

troublesome. The phrase sounds much like the “clearly er-

roneous” standard used to review the factual findings of a

trial court sitting without a jury. Rule 52(a), “ED. R. Civ. P.

Unlike an agency determination or a jury verdict, such find-

ings may be fairly readily reversed. District of Columbia v.

Pace, 320 U.S. 698, 702 (1944); 4 K. DAVIs, supra note 15,

§ 29.02, at 118-126; L. JAFFE, supra, at 615-616. See espe-

cially Orvis Vv. Higgins, 180 F.2d 537, 540 (2d Cir.) (Frank,

J.), cert. denied, 340 U.S. 810 (1950). Indeed, under “clearly

erroneous” review a court may substitute its judgment for

that of the trial court and upset findings that are not unrea-

sonable. See 4 K. DAVIS, supra note 15, at 121-122.

Since Overton Park expressly forbade such intrusive re-

view, 401 U.S. at 416, it plainly did not intent 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 consid-

eration of “clear errors of judgment,” they a!l 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 iden-

tical 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

70

over, it must engage in a “substantial inquiry” into the

facts, one that is “searching and careful.” Citizens to

Preserve Overton Park v. Volpe, supra, 401 U.S. at 415,

move deferential than under the “clearly erroneous” stand-

ard. Wong Wing Hang Vv. INS, supra, 360 F.2d at 718-719.

All of this makes the Court’s intent in Overton Park some-

what 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 irfra.

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 “arbi-

trary and capricious” standard. Already at least one court

has expressly indicated that it is prepared to read the Court’s

use of the phrase 2s approval of intrusive “clearly erroneous”

review of agency action. Raitport v. National Bureau of

Standards, 385 F.Supp. 1221, 1225 (E.D. Pa. 1974). Mean-

while, other courts use the “clear error of judgment” phrase

as a shorthand summary of “arbitrary and capricious” re-

view, see, e.g., Union Electric Co. Vv. EPA, 515 F.2d 206, 216

(8th Cir.), cert. granted, U.S. , 44 U.S. L. WEEK

3200 (Oct. 6, 1975); Conservation Council of North Carolina

Vv. Froehlke, 473 F.2d 664, 665 (4th Cir. 1973); Schicke Vv.

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. Vv. Butz, 382

F.Supp. 362, 374 (D.D.C. 1974) (“whether the xagency’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 there-

fore it was not arbitrary and capricious’).

Post-Overton Park decisions, as well as the internal evi-

dence 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,

Ince. V. Arkansas-Bist Freight System, Inc., supra note 73,

419 U.S. at 290; United States v. Allegheny-Ludlum Steel

Corp., 406 U.S. 742, 749 (1972). See note 79 infra. Thus it

71

416. This is particularly true in highly technical cases

such as this one.

A court does not depart from its proper function

when it undertakes a study of the record, hopefully

perceptive, even as to evidence on technical and spe-

cialized matters, for this enables the court to pene-

trate to the underlying decisions of the agency, to

satisfy itself that the agency has exercised a rea-

soned discretion, with reasons that do not deviate

from or ignore the ascertainable legislative intent.

Greater Boston Television Corp. v. FCC, 143 U.S.App.

D.C. 383, 392, 444 F.2d 841, 850 (1970), cert. denied,

493 U.S. 923 (1971). See also Essex Chemical Corp.

Vv. Ruckelshaus, 158 U.S.App.D.C. 360, 367, 486 F.2d

427, 404 (1973), cert. denied, 416 U.S. 969 (1974);

Portland Cement Assn Vv. Ruckelshaus, 158 U.S.App.

D.C. 308, 335, 486 F.2d 375, 402 (1973), cert. denied,

417 U.S. 921 (1974); International Harvester Co. v.

Ruckelshaus, 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 review-

is important that courts not think themselves licensed to em-

bark upon wide-ranging searches for “clear errors of judg-

ment.” Such searches can only distort the established appel-

late 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 re-

view. Accordingly, in the context of “arbitrary and capri-

cious” review, we shall reverse for a “clear error of judg-

ment” only if the error is so clear as to deprive the agency’s

decision of a rational basis.

** While 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 (1971), was a substantial evidence case, its

statement of the proper scope of a reviewing court’s inquiry

into the evidence has been adopted by the informal rule-

making cases cited above.

72

ing court involve itself in even the most complex evi-

dentiary 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 enabie the court to become a super-

agency that can supplait the agency’s expert decision

maker. To the contrary, the court must give due defer-

ence to the agency’s ability to rely on its own developed

expertise. Market Street Railway v. Railroad Commis-

sion, 324 U.S. 548, 559-561 (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; Bowman Transportation, Inc. v. Arkansas-Best

Freight System, Inc., supra, 419 U.S. at 285, 290. It

is settled that we must affirm decisions with which we

disagree so long as this test is met.” Bowman Trans-

°° This rule has been most directly stated in cases involving

substantial evidence review, see, e.g., Consolo v. Federal

Maritime Commission, 383 U.S. 607, 620 (1966); Universal

Camera Corp. V. NLRB, 340 U.S. 474, 488 (1951) ; Environ-

mental Defense Fund, Inc. Vv. EPA (Coahoma), supra note 28,

160 U.S.App.D.C. at 130, 489 F.2d at 1254, but it is none-

theless applicable here as well. The requirement of affirm-

“a

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73

portation, Inc. v. Arkansas-Best Freight System, Inc.,

supra, 419 U.S. at 290; United States v. Allegheny-

Ludlum Steel Corp., supra, 406 U.S. at 749.

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 statis-

ticiar. that we are qualified neither by training nor ex-

perience to be, but as a reviewing court exercising our

narrowly defined duty of holding agencies to certain

minimal standards of rationality.” “Although [our] in-

quiry into the facts is to be searching and careful, the

ultimate standard of review is a narrow one.” Citizens

to Preserve Overton Park v. Volpe, supra, 401 U.S. at

ing decisions with which we disagree is inherent in Overton

Park’s command that “[t]he court is not empowered to sub-

stitute its judgment for that of the agency.” Citizens to Pre-

serve Overton Park v. Volpe, supra note 69, 401 U.S. at 416.

“In a substantial evidence case Judge Wilkey has well

delineated our limited role:

In the case at bar our task is made somewhat simpler

than the agency’s by adhering conscientiously to the

proper scope of judicial review of administrative action,

1.€., we as a court are confronted with a problem in ad-

ministrative law, not in chemistry, biology, medicine, or

ecology. It is the administrative agency which has been

called upon to hear and evaluate testimony in all scien-

tific fields relevant to its ultimate question of permission

or prohibition of the sale and use of DDT. The EPA

Administrator had an opportunity to make a careful

study of the record of seven months of public hearings

and the summaries of evidence prepared for him, heard

oral argument, and now has arrived at a decision to ban

most uses of DDT. It is his decision which we must re-

view; we are not to make the same decision ourselves.

Environmental Defense Fund, Inc. v. EPA (Coahoma), su-

pra note 28, 160 U.S.App.D.C. at 128, 489 F.2d at 1252 (em-

phasis in original). See also note 53 supra.

74

416. We must affirm unless the agency decision is ar-

bitrary or capricious."

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 can-

not 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 evi-

dence, nor, for that matter, whether it is supported by

substantial evidence.” To the contrary, we must sustain

In stating the scope of review of informal rule-making

by the Interstate Commerce Commission, the Supreme Court

succinctly summarized these principles:

We do not weigh the evidence introduced before the

Commission; we do not inquire into the wisdom of the

regulations that the Commission promulgates, and we

inquire into the soundness of the reasoning by which

the Commission reaches its conclusions only to ascertain

that the latter are rationally supported.

United States Vv. Allegheny-Ludlum Steel Corp., supra note

74, 406 U.S, at 749.

Review for substantial evidence is mandated only for

agency adjudications and formal rule-making proceedings.

5 U.S.C, § 706(2) (E). Since “arbitrary and capricious” re-

75

if it has a rational basis in the evidence. Keeping in

mind the precautionary “will endanger” standard under

which the Administrator acted, we have no difficulty in

terming his decision rational.

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 determina-

tion, Science does not work that way; nor, for that

matter, does adjudicatory fact-finding. Rather, the Ad-

ministrator’s decision may be fully supportable if it is

based, as it is, on the inconclusive but suggestive re-

sults of numerous studies. By its nature, scientific evi-

dence is cumulative: the more supporting, albeit incon-

clusive, evidence available, the more likely the accuracy

of the conclusion.’ If, as petitioners suggest, one single

view does not involve determining whether the agency deci-

sion is supported by substantial evidence, it is considered the

more lenient form of review, Nonetheless, some have noted

that in reviewing the evidence relied upon in ageney pro-

ceedings, the two standards often seem to merge. Associated

Industries of New York State, Ine. v. U.S. Department of

Labor, 487 F.2d 342, 349-350 (2d Cir, 1973) (Friendly, J.).

The primary difference between the two in such cases would

seem to be that “substantial evidence” review is limited to

evidence developed in formal hearings, while “arbitrary and

capricious” review of an agency engaged in informal rule-

making is not so limited, but rather may consider the agency's

developed expertise and any evidence referenced by the

agency or otherwise placed in the record. Marlet St. Ry. V.

Railroad Comm'n, 824 U.S. 548, 559-561 (1945); City of

Chicago Vv. FPC, 147 U.S.App.D.C. 312, 822-326, 458 F.2d

731, 741-745 (1971), cert. denied, 405 U.S. 1074 (1972).

“ As Chief Justice Shaw observed over a century ago, “in-

ferences drawn from independent sources, different from

each other, but tending to the same conclusion, not only sup-

port each other, but do so with an increased weight.”’ Com-

monwealth V. Webster, 59 Mass. (5 Cush.) 295, 817 (1850).

76

study or bit of evidence were sufficient independently

to mandate a conclusion, there would, of course, be no

need for any other studies. Only rarely, however, is

such limited study sufficient. Thus, after considering

the inferences that can be drawn from the studies sup-

porting the Administrator, and those opposing him, we

must decide whether the cumulative effect of all this

evidence, and not the effect of any single bit of it,

presents a rational basis for the low-lead regulations.

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."' Before we turn to those issues, however, we

should note that some things appear to be uncontested.

Thus petitioners seem to concede the following: that

lead serves no known purpose in the human body; that

lead in sufficiently high quantity is destructive to the

body, causing anemia, severe intestinal cramps, paralysis,

neurologic damage, and, in sufficient dosage, death, Third

Health Document at III-1, 2, JA 54-55; that more than

250,000 tons of lead per year are used in production

of lead additives, accounting, according to EPA, for ap-

proximately 90 percent of all airborne lead,’ id. at

Table II-1, JA 46; that lead concentrations in the air

over our largest cities are 2,000 times greater than lead

concentrations in the air over the mid-Pacific, NAS

Report at 205; that lead in the ambient air contributes

to body blood lead levels, Nalco Supp. Br. at 37; supple-

mental brief of petitioners PPG Industries and E.I.

“' Both petitioners and the Wilkey dissent (hereinafter dis-

sent) engage in a detailed attack on the evidentiary basis for

the Administrator’s decision. Their arguments are considered

in corresponding detail in the appendices to this opinion,

“ Sce note 60 supra.

——

77

duPont de Nemours & Company (hereinafter PPG/du-

Pont Supp. Br.) at 23; and that blood lead levels are

a reasonable indication of the body’s lead burden. Strip-

ped of their generalized and largely unsubstantiated

claims of “bias” and “distortion of the evidence,” pe-

titioners principally challenge three EPA conclusions:

(1) that, based on a preliminary determination that

blood lead levels of 40 ug are indicative of danger to

health, elevated blood lead levels “exist to a small but

significant extent in the general adult population, and

to a very great extent among children,” Third Health

Document at VII-3, JA at 144; (2) that airborne lead

is directly absorbed in the body through respiration to

a degree that constitutes a significant risk to public

health; and (8) that airborne lead falls to the ground

where it mixes with dust and poses a significant risk

to the health of urban children.

1. Blood Lead Levels are Elevated Among the General

Publie

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 be-

tween health and disease,” the Administrator found

it “prudent to regard blood lead levels over 40 ug/100

g as indicators of lead intake that should be prevented.”

Third Health Document at III-11, JA 64. Petitioners

contest this determination. Much of their argument, how-

ever, adds up to nothing more than that they are un-

happy the Administrator chose to exercise his judg-

ment and think the statute does not permit such dis-

cretion. Petitioners cite medical studies that show not

that a blood lead level of 40 ug is unrelated to danger,

but that scientists are simply uncertain about the effect

of such blood levels. Ethyl brief at 37-38 and Supp.

Br. at 41-42; PPG/duPont brief at 11-12; Naleo brief

78

at 14. But, as we have seen, exercise of reasoned dis-

cretion based on the evidence is not only permitted, but

mandated, by Section 211(¢c)(1)(A). The Administra-

tor recognized from the outset that the health effects

of varying human blood lead levels were uncertain and

that continuing research was necessary.’ His determina-

tion of the 40 ug level is, on its face, an assessment

of risks based on the known facts and not improper as

such.

In addition to their generalized attack on the Ad-

ministrator’s power, petitioners challenge the sufficiency

of the evidence to support his determination, Under

the “will endanger” standard, however, we find the evi-

dentiary basis for the Administrator’s determination to

be more than adequate. Petitioners do not contest the

recommendation of the United States Public Health Serv-

ice 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 evalua-

tion for possible lead poisoning. Medical Aspects of

Childhood Lead Poisoning, HSMHA Health Reports, 86

(2), 140-148 (1971), cited in Third Health Document

at IV-3, JA 71. What draws petitioners’ fire is only

‘Indeed, at the conclusion of Section IV of the Third

Health Document, “Can an Acceptable Lead Body Burden

be Defined?,” the Agency suggested seven important areas

for future inquiry. Third Health Document at IV-7, 8, JA

75-76. Ethyl claims these questions only demonstrate “that

EPA is unable at this time to support its blood lead level

theories with pertinent data * * *.” Ethyl brief at 38, To

the contrary, the questions only show the candor with which

the Agency has approached this important issue,

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