Petition for Writ of Certiorari — E. I. du Pont de Nemours & Co. v. Environmental Protection Agency

Supreme Court brief1976

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IN THE

Supreme Court of the Cited States

OCTOBER TERM, 1975.

- 75-1613

NALCO CHEMICAL COMPANY,

Petitioner,

VS.

ENVIRONMENTAL PROTECTION AGENCY,

Respondent.

PETITION FOR WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE DISTRICT OF COLUMBIA CIRCUIT.

Victor P. KAYSER,

JOHN C. BERGHOFF, Jr.,

135 South LaSalle Street,

Chicago, Illinois 60603,

DaviD MACHANIC,

WILLIAM H. FITZ,

1200 18th Street, N. W.,

Washington, D. C. 20036,

Attorneys for Petitioner.

Of Counsel:

CHADWELL, KAYSER, RUGGLES,

McGEE & HASTINGs,

135 South LaSalle Street,

Chicago, Illinois 60603,

(312) 726-2545,

PIERSON, BALL & Down,

1200 18th Street, N. W.,

Washington, D. C. 20036,

(202) 331-8566.

Gunthorp-Warren Printing Company, Chicago e Financial 6-6565

Sietat eta ol

TABLE OF CONTENTS.

PAGE

I Cc Vicna lee tai Coe ete eS 1

MI ies x Vids FL ewes Cae Oa ee hc eae oe 2

SINE oy yao doen eduh cs ewdcyiee nus 2

Statutes and Regulations Involved .................. 3

UN GE TE. iwi Dh ehh aay cdacesaadeuks 3

Chronology of the Regulations ................. 3

I Se ce iN wads dene Owe ews 5

Reasons for Granting the Writ ....... 2... ...002000. 7

I. The Lower Court Unjustifiably Attributed Inherent

Discretion in the EPA to Regulate, Despite a

Limited Congressional Grant of Authority ......

A. Threshold Determination ................

B. Lepeistive Mistery .........0.sencseca 10

C. Comparison with Other Sections .......... 11

D. Generalized Attribution of Discretion ...... 12

Il. The Lower Court Unjustifiably Limited the Scope

of Its Review Because This Case Involved Environ-

IT SE ee a at cance eas 15

A. The Conflict Within the Lower Court as to

PU Se NE 5. vce bonne euaicies 15

B. The Record Does Not Support the Regulation

and Its Promulgation Constitutes a Clear Error

AP I hf ses be ee fase oes ee 19

If]. The Regulation Should Be Set Aside or Remanded

to the EPA Because of Failure to Provide Mean-

ingful Opportunity for Comment .............. 22

AE oo 6 ha. k be wee ee wea cee a Ae ee ee 30

Ce ee eee eer ee err ee eek nt Al

ND koh veka oo ccs eRe eae ee ewer Bl

DHAMnRD COHOPRPY

TABLE OF AUTHORITIES.

Cases.

Amoco Oil Co. v. EPA, 501 F. 2d 722 (D. C. Cir. 1974)

SE NaIE Sadi tactnas excita Sacer lice Seas aati GAG as enn sala: 4,9, 10

Austin v. Jackson, 353 F. 2d 910 (Sth Cir. 1965) ...... 23

Bowman Transportation v. Arkansas-Best Freight System,

We 20

Burlington Truck Lines, Inc. v. United States, 371 U. S.

ih eee eae ti ep oa 6 iad ode 17

Camp v. Pitts, 411 U.S. 138 (1973) ............00-. 28

Citizens to Preserve Overton Park v. Volpe, 401 U. S.

} I eee ceieg reer a ln Gay os vce dees 17,19

: Environmental Defense Fund, Inc. v. EPA, 465 F. 2d

i ee exo ce a adc mews pnuw es 13, 19, 23

/ Environmental Defense Fund, Inc. v. EPA, 510 F. 2d 1292

a I ea are seer kh noms two wes eww 8 13

3 Environmental Defense Fund, Inc. v. Ruckelshaus, 439

: F. 2d 584 (D.C. Cir. 1971) ............005. 16, 17, 20

Great Lakes Screw Corp. v. NLRB, 409 F. 2d 375 (7th

: ee ee ack i ww kleié nadine 23

: Greater Boston Television Corp. v. FCC, 444 F. 2d 841

(D. C. Cir.), cert. denied, 403 U. S. 923 (1971) ....17, 20

Hertz v. Woodman, 218 U. S. 205 (1910) ............ 19

Hess & Clark Div. of Rhodia, Inc. v. FDA, 495 F. 2d 975

ae i sb dias ee wplvie k we 6 ab a 23

Homan v. United States, 279 F. 2d 767 (8th Cir.), cert.

denied, 364 U. S. 866 (1960) ................... 18

Hotch v. United States, 212 F. 2d 280 (9th Cir. 1954) .. 26

BLEED THROUGH

Industrial Union Dept., AFL-CIO v. Hodgson, 449 F. 2d

ee NN abies hoa cao oceans 13

International Harvester Co. v. Ruckelshaus, 478 F. 2d 615

Oe eS NN nd ccc awake 8 dee ecdan 16, 17, 23

Kennecott Copper Corp. v. EPA, 462 F. 2d 846 (D. C.

I ne er ON ee Ue 20, 23

Portland Cement Ass’n v. Ruckelshaus, 486 F. 2d 375

(D. C. Cir. 1973), cert. denied, 417 U. S. 921 (1974)

ee ee ar 17, 20, 23

Reserve Mining Co. v. EPA, 514 F. 2d 492 (8th Cir.

ay ed OS ON OCR SET ON are er ae 13,14

Rodway v. U. S. Dept of Agriculture, 514 F. 2d 809 (D.C.

I ahs Pei a careers suk we oe oe La bs 20, 22

SEC v. Chenery Corp., 332 U. S. 194 (1947) ........ 20

Sierra Club v. Morton, 405 U. S. 727 (1972) ........ 16

Society of the Plastics Indus., Inc. v. OSHA, 509 F. 2d

1301 (2d Cir.), cert. denied, 421 U. S. 992 (1975) ... 13

South Terminal Corp. v. EPA, 504 F. 2d 646 (1st Cir.

cn ARES OR Re Om rr eet ra ne 23

United States v. American-Foreign SS. Corp., 363 U. S.

I aa es alle pi cued ee ho: 18

United States ex rel. Robinson v. Johnston, 316 U. S.

oR RS I i yee a ie 18

Universal Cameia Corp. v. NLRB, 340 U. S. 474 (1951) 17

Wagner Elec. Corp. v. Volpe, 466 F. 2d 1013 (3d Cir.

ile APRA GE Sah ERCSEY Sevier in ge orien Get Rene SO ee 26

Walter Holm & Co. v. Hardin, 449 F. 2d 1009 (D. C.

I eu alee whee ee as ew ie a et 23, 26

POOR COPY

attic LA PLT Ree gia PSS Hae Ye apie ae ene

a eS

EBON ry 0g EM TEE Be Ms Se non

iv

Statutes.

Administrative Procedure Act:

Be as <A 6s 4p Sw oe @ weak 10, 20, 29

ee Ne Soe ehh Re ook 8 A iw ee ORK Ce 17

eS Oe a Sage ak ood eas ghd glaly’ a pee ant 15, 20

Clean Air Amendments of 1970:

ae ae eS oe ey 11

mee, fue, S22 UU... 0. § 90S red oo kc ca laies 11,12

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

Pilg hala ur tare ane ect Lane ees 3, 8,9, 11, 12, 15, 16

See. Sar, 42 UE C. SUBST vn ve cikve dace. 5

, oe Some: | 5} ee emradr ay arc la 2

Miscellaneous.

116 Cong. Rec. Part 14, 19229-31, 32921 (June, 1970) 11, 17

Handler, A Rebuttal: The Need for a Sufficient Scientific

Base for Government Regulation, 43 Geo. Wash. L. Rev.

Ee og koe ev eek oes pea ree Ree 15

The Random House Dictionary, The English Language

SEE, ax codices <5 oO EG a ERE ee eee eee i2

Webster’s Third New International Dictionary of the En-

SR Be ot re ee re re errs 12

BLEED THROUG

IN THE

Supreme Court of the Gnited States

OCTOBER TERM, 1975.

NALCO CHEMICAL COMPANY,

Petitioner,

vs.

ENVIRONMENTAL PROTECTION AGENCY,

Respondent.

PETITION FOR WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE DISTRICT OF COLUMBIA CIRCUIT.

Petitioner, Nalco Chemical Company, prays that a Writ of

Certiorari issue to review the opinions and judgment of the

United States Court of Appeals for the District of Columbia

entered in this case, en banc, on March 19, 1976.

OPINIONS BELOW.

The opinions and judgment of the Court of Appeals are re-

ported at 8 ERC 1785. Because of their extraordinary length,

they are filed in a separate, bound Appendix with this Court.*

and supplemented by respondent on March 28, 1974 and April 19,

1974,

Emphasis is supplied herein unless otherwise noted.

POOR COPY

JURISDICTION.

The judgment of the Court of Appeals was entered on March

19, 1976. Issuance of the mandate has been stayed, pending

the filing of a petition for a Writ of Certiorari, by order of

the Court of Appeals.

The jurisdiction of this Court is invoked under 28 U. S. C.

§ 1254(1).

QUESTIONS PRESENTED.

1. Whether the Administrator of the Environmental Pro-

tection Agency has inherent discretion to limit the use of lead

additives in gasoline on the basis of fear of an uncertain or

unknown harm, notwithstanding that the Clean Air Act author-

ized the Administrator to regulate only if the emission products

of such fuel additive “will endanger the public health or welfare”.

2. Whether judicial review of environmental regulations,

which involve highly technical areas, should be limited, and if

so, what is the correct standard of procedural and substantive

review of such regulations.

3. Whether the adoption of the final lead additive phase-

down regulations by the Administrator of the Environmental

Protection Agency was in violation of the Administrative Pro-

cedure Act and a clear error of judgment.

4. Whether the Environmental Protection Agency met the

requirements of the Administrative Procedure Act when it did

not provide adequate notice and opportunity to comment to the

public and interested persons on new medical and scientific

evidence which was substituted for prior evidence and became

the basis for its final regulations.

s — ee ee ee en

sfeswetee: me Otel t eed

Pere

ees

et

5. Whether the reviewing court may properly go outside

the administrative record and initiate after oral argument, an ex

parte investigation for the purpose of supplementing that record

to determine when the public and interested persons received

notice of material upon which the regulations were based.

DPS ARES See SD wierd ere asec gattand lwo ates

SO. OF SA

BLEED THROU:

STATUTES AND REGULATIONS INVOLVED.

The pertinent provisions of the Clean Air Act (42 U. S. C.

§§ 1857c-3, 1857f-1 and 1857f-6c), the Administrative Proce-

dure Act (5 U.S. C. §§ 553 and 706) and the regulations in-

volved (40 CFR § 80.1, 80.2(c), 80.20, 80.25 and 80.26)

are set forth in Appendix A, hereto.

STATEMENT OF THE CASE.

Chronology of the Regulations.

On January 30, 1971, within one month after the enactment

of the Clean Air Act Amendments, the Administrator of the

Environmental Protection Agency (EPA) issued an advance

notice of proposed rulemaking to reduce the permissible lead

content of gasoline under Section 211(c)(1)(A) of the Act

(36 Fed. Reg. 1486). More than one year later, on February

23, 1972, the EPA published its first set of proposed regulations

(App. 23). This first set of regulations proposed a reduction in

the use of lead additives in gasoline over a four-year period

beginning January 1, 1974, based on EPA’s conclusion that:

“Airborne lead levels exceeding 2 ng per cubic meter... .

are associated with a sufficient risk of adverse physiological

effects to constitute endangerment of the public health.”

(App. 23.)

This proposed rulemaking was accompanied by the EPA’s

first health justification document, “Health Hazards of Lead”

(App. 292) and a subsequent position paper, “Atmospheric

Lead and Public Health”, to bolster its conclusion as to the

alleged need for a 60-65% reduction in airborne lead (App.

276). Comments were invited for a 90-day period (37 Fed.

Reg. 11786-87). Within two months, EPA made corrections

and additions to the “Health Hazards of Lead” paper because of

“miscalculations” (App. 272).

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ae Oe Ligaen < om

4

Hearings were held on these regulations and numerous com-

ments and statements were submitted from the industrial,

medical, scientific and governmental communities which severely

criticized EPA’s medical and scientific justification for these

regulations (See, e.g., App. 2118, 2413, 2431, 2438, and

2481).

EPA then reevaluated its health justification, “changed it

substantially” (App. 2), and reproposed regulations on January

10, 1973 (App. 14).* The reproposed health regulations were

accompanied by another EPA health justification paper, en-

titled “EPA’s Position on the Health Effects of Airborne Lead”

(App. 158). As the majority opinion notes, EPA had com-

pletely “abandoned” its earlier “discredited” approach for esti-

mating the reduction in airborne lead necessary to protect

public health, by the time that the Second Health Document

was issued (Maj. Op. A-3).

The comment period for this second set of proposed regula-

tions closed on March 11, 1973. Despite the substantial changes

in EPA's position, criticism from the scientific and medical com-

munities as well as other governmental agencies continued un-

abated (See, e.g., App. 2477, 2479 and 2494).

On October 28, 1973, while EPA was considering the com-

ments on the second proposed regulations, the Court of Appeals

for the District of Columbia Circuit issued a single-page order

directing the EPA Administrator to reach a final decision on the

matter within 30 days.**

On November 28, 1973, the final regulations were announced

and were promulgated on December 6, 1973 (App. 1). The final

* At the same time, the EPA issued final regulations requiring the

marketing of lead-free gasoline. These regulations (“the marketing

regulations”) were approved in Amoco Oil Co. v. EPA, 501 F. 2d

722 (D. C. Cir. 1974).

** National Resources Defense Council v. EPA, No. 72-2233

(D. C. Cir., Oct. 28, 1973). Petitioner herein was not a party to this

case. The order was entered on the motion of the plaintiff and was

unreported.

BLEED THROU

5

regulations were accompanied by still another health justification

document, this time entitled “Health Implications of Airborne

Lead” (App. 27). The regulations, as promulgated in the

Federal Register, are accompanied by a lengthy Preamble which

summarizes EPA support for its health position (App. 1-5).

No comment period was allowed on the final regulations.

Petitioner filed its petition to review these regulations on De-

cember 27, 1973, pursuant to Section 307 of the Clean Air

Act (42 U. S. C. § 1857h-5). On December 20, 1974, the

panel of the Court of Appeals which heard the petition, ordered

the regulations set aside in an 87-page opinion (with a 96-page

dissent) published on January 28, 1975 (7 ERC 1353).

“Because of the importance of the issues presented,” the Court of

Appeals for the District of Columbia granted EPA’s petition for

rehearing, set the case for argument en banc on May 30, 1975

and reversed the panel opinion in a 5 to 4 decision published on

March 19, 1976, with two ccncurring and two dissenting

opinions.

Background Facts

At the outset, it is impertant to recognize that lead occurs

naturally in the earth’s crust and atmosphere (App. 319) and is

a part of every living thing (App. 54). Lead is not harmful

per se (App. 2611) and in fact, it is now thought that lead

may be a necessary element for growth (Doc. 459).

Mere exposure to lead is not indicative of harm to health.

The absorption of lead without retention is not indicative of

harm, since it is undisputed that lead is continuously excreted by

the body, by means of known biological mechanisms and is

stored in bone, teeth and hair where it is biologically inert and

thus without harmful health effects (App. 324-25). In normal

circumstances, human beings achieve a steady state of lead

body levels and maintain this steady state with the rate of

output approximately equal to the rate of input (App. 326).

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5 Ate DE SIE ANA lr Si

6

Dr. Paul B. Hammond, Chairman of the Pancl on Lead of the

National Academy of Sciences summarized this background:

“It is not a question of whether or not people have lead.

They all do. It is rather a question of how much lead they

have and how much is harmful. So far as adults are con-

cerned, the general population is exposed to far less lead

than are workers in battery factories and lead smelters who

remain in good health in spite of their high exposure as

compared to the general public.” (App. 2611.)

The principal source of lead to human beings, by far, is the

food and fluids of the normal diet—not the respiration of air-

borne lead (App. 1970, 1996-97). Even though there has been a

rise in the use of leaded gasoline—a 70% increase from

1959-1969 (App. 2427)—there has not been a corresponding

rise in the average concentrations of airborne lead in major

urban areas, as shown by the conclusion of the National

Academy of Science that with:

“

. the high degree of dispersion associated with the

venting of burned lead alkyls into the air . . . the average

lead content of the air over most major cities apparently

has not changed greatly over the last 15 years. The net

result is that correspondingly little change in the character

and magnitude of the effects of atmospheric lead on bio-

logic systems will likely occur for some years to come.

We are, in short, not dealing with a rapidly shifting scene

in this respect.” (App. 356-57.)

Lead compounds have been used as additives in gasoline for

over 50 years, for the purpose of increasing the octane or “anti-

knock” quality required by high compression engines. Increas-

ing the compression ratio in automobile engines adds to efficiency

and economy of operation, but the gasoline octane must be

increased accordingly. If lead cannot be used, then additional

“aromatics”, derived from crude oil itself, must be substituted.

The production of additional aromatics requires more severe

refining conditions and the use of substantial additional quanti-

ties of crude oil (App. 1414-15). Thus, these regulations will

BLEED THROUGH

7

inevitably result in the consumption of large quantities of ad-

ditional barrels of crude oil each year as well as imposing sub-

stantial financial requirements on refiners for construction of

new facilities and modifications of those now in existence.

REASONS FOR GRANTING THE WRIT.

I. The Lower Court Unjustifiably Attributed Inherent Dis-

cretion in the EPA to Regulate, Despite a Limited Con-

gressional Grant of Authority.

The majority opinion below concludes that in the area of the

environment and public health, EPA has inherent discretion

to regulate, with standards of agency rationality similar to the

standards used to review Congressional legislation. This inherent

discretion, according to the majority opinion, comes necessarily

into play because the regulation deals with the environment,

despite the specific language of the Congressional grant of

authority and despite the absence of a scientific or medical “data

base” for regulation. The opinion of the lower court will be

undoubtedly quoted for this proposition as long as it stands

unreviewed. However, if this is to be the law of environmental

regulation, it should be decided by this Court and not by the

lower court in a 5 to 4 decision.

The opening paragraph of the majority opinion presages its

holding that even in the absence of medical or scientific evi-

dence, the EPA may regulate:

“It is only recently that we have begun to appreciate the

danger posed by unregulated modification of the world

around us, and have created watchdog agencies whose task

it is to warn us, and protect us, when technological ‘ad-

vances’ present dangers unappreciated—or unrevealed—

by their supporters. . . . Necessarily, they must deal with

predictions and uncertainty, with developing evidence, with

conflicting evidence, and, sometimes, with little or no

evidence at all.” (Maj. Op. 6.)

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8

é The majority opinion after extensive discussion, repeats the

theme—EPA has inherent discretion to regulate:

| “Questions involving the environment are particularly

: prone to uncertainty. . . . How else can they act, given a

mandate to protect the pubiic health but only a slight or

non-existent data base upon which to draw?” (Maj. Op.

46-47.)

To be sure, the majority opinion argued that they were not

allowing the EPA Administrator “to set policy on his own terms”

and that Congress did set policy euidelines (Maj. Op. 55). But

those guidelines are so broad that it matters very little whether

Congress attempted to specifically limit or condition the EPA’s

| power. Once the majority assumed that the issue of the health

effects of lead was “on the frontiers of scientific knowledge”.

the EPA could act based on no more than a “fear of an un-

j known harm” (Maj. Op. 56).

; The dissent was well aware that the majority was enunciating

a different and lower standard for environmental regulation:

Mog Se La naa

“From the pages of the court's opinion there seeps the

theme that this is an environmental case: hence, the court

i like the agency need not labor by the usual rules. We

: recognize no such exemption for this or any other type

case .. .” (Dis. Op. 50.)*

A. Threshold Determination.

In Section 211(c)(1)(A) of the Clean Air Act, Congress

authorized EPA to regulate gasoline additives only “if any

emission products of such fuel or fuel additive will endanger

the public health.” But the majority argues that instead of call-

ing for “the Administrator to make a threshold factual deter-

mination of endangerment”:

“[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 cither

the procedural or the substantive rigor proper for questions

of fact.” (Maj. Op. 46.)

*SeealsoDis.Op.35.5 $ |}

. Fin wets eat

BEE et

BLEED THROUGH

y

However, as the dissent points out, the “question” of whether

the EPA may “assess risks” in regulating fuel additives is a

strawman (Dis. Op. 52). The issue is whether Congress required

the EPA to decide, based upon its expertise, that there is

a causal connection between lead additive emissions and an

endangerment to public health. As even the majority admits,

Congress set up “a legal mechanism by which the [medical]

evidence could be weighed in a more objective tribunal”

(Maj. Op. 12).*

The only prior decision dealing with this section of the Clean

Air Act (Amoco Oil Co. v. EPA, 501 F. 2d 722 (D. C. Cir.

1974)) dealt with Section 211(c)(1)(B) giving the EPA Ad-

ministrator authority to regulate fuel additives on other than a

health endangerment basis, “if emission products of such fuel

or fuel additive will impair to a significant degree” the perform-

ance of emissions control devices. The court held there that this

section requires a:

“. . . threshold determination whether or not to regulate a

particular fuel or additive. In effect. the provision estab-

lishes a rebuttable presumption that the Agency should

maintain a laissez faire posture with regard to fuel regula-

tion. . . . The findings are to show why regulation, as op-

posed to no regulation, is necessary or otherwise advisable.

These findings constitute a condition precedent to em-

barking upon the exercise of regulatory power.” (501 F.

2d at 736.)

The court went on to find that EPA had quasi-legislative powers

in deciding how to regulate.

However, in dealing with the companion provision giving the

Administrator power to regulate fuel additives “if any emissions

products or such fuel or fuel additive will endanger the public

health or welfare,” the majority argues that this section is “in-

herently” different. Unlike subsection (B), which is “highly

* In fact, Congress clearly believed that EPA should embark upon

a course of regulation “only with trepidation”, as the majority notes,

because such regulation would be “telling manufacturers how to make

their fuels.” (Maj. Op. 16, n. 14.)

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10

suitable to factual proof.” the “Section 211(c)(1)(A) threshold

determination . . . is inherently unlike that of its sister section”

and the question of endangerment “is a risk, and so must

be decided by assessment of risks as well as by proof of facts.”

(Maj. Op. 45.) Thus, the majority opinion, in attempting to

: distinguish its interpretation in Amoco, falls back on unjustified

assumptions of “inherent” differences. *

: The majority also concedes that Amoco held that Section 4

: of the Administrative Procedure Act (5 U. S. C. § 553) neces-

sarily calls for a “factual threshold determination” in connection

with subsection (B) (“if .. . will impair”) (Maj. Op. 45-46).

Why does not the parallel subsection (A) (“if . . . will

endanger”) call for such a threshold determination?

ae

B. Legislative History.

The majority attempted to find support in the legislative his-

tory, but all that exists points to the opposite conclusion. The

majority argues that an early House bill called for a “specific

findings” under the ‘will endanger’ standard (Maj. Op. 38).

and that the deletion of that findings requirement was:

“a recognition by Congress that a determination of en-

dangerment 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.” (Maj. Op.

46.)

This assertion is unsound. If the statute as first written called

for “specific findings,” the “will endanger” standard could not

“necessarily” be a question of policy. How could it inherently

become so, if the “specific findings” requirement were removed?

The fact is that the House bill never did call for * ‘specific find-

Ee gs ARE a aa oar ote koo

Se

Aes ey

Sy RAC ai aces

"* The only apparent ground for such an argument, is that a deter-

mination of * ‘impairment” is. less complex scientifically than a deter-

mination of “endangerment”. The absence of legislative history to

; support such 2 reading of parallel sections, makes it merely an opinion

based on the clarity of hindsight.

i

LAN DEERE NARS ARNE RM EGE D G0 AD

BLEED THROUGH

ings” in connection with endangerment.* The legislative history

shows that both the House and Senate intended that if fuel

additives were to be regulated either because of impairment to

an emission control device or endangerment of the public health,

a factually based determination must be the basis.**

C. Comparison with Other Sections.

The majority opinion engages in a lengthy comparison of

Section 211(c)(1)(A) with Sections 108 and 202 of the Clean

Air Act, in order to bolster its construction of Section 211

(Maj. Op. 22-28). This comparison results in interpretations

of these sections which makes determination of EPA’s powers

under the Clean Air Act ambiguous at best.

The majority opinion argues that Section 108 of the Act,

relating to the EPA Administrator's power to set air quality

criteria for pollutants which “in his judgment” have an ad-

verse effect on public health, “requires proof of demonstrable

harm” (Maj. Op. 23-24). This, of course, ignores the fact that

Congress expressly left this decision in Section 108 to the “judg-

ment” of the EPA Administrator.

Section 202 grants the Administrator authority to prescribe:

“

** Representative Staggers of the Interstate and Foreign Com-

merce Committee: “. . . if he has the facts, and he has proven thus by

facts, that they are a danger”. Representative Rogers (House Manager

of the Bill): “whenever the facts show that . . . and additive .

adversely affects the health or prevents the emission standards from

being met”. Senator Baker (ranking minority member of the Confer-

ence Committee): “when he finds that . . . emissions . . . endanger

the public health”. (116 Cong. Rec. 19229-30, 19231, 32921)

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12

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”.

As to the portion of Section 202 dealing with automobile emis-

sions which “in his judgment” cause or contribute or are “likely”

to cause air pollution, the majority states that the standard is

“more lenient than Section 211” (Maj. Op. 26-27). However,

as to the phrase “air pollution which endangers the public health

or welfare”, the majority argues that “regulation may not be

premised on a threshold determination of likely danger; rather

regulation must be premised on a determination of danger.”

Thus, the majority concludes that: “This is essentially the same

finding of endangerment as under Section 211”; and that “in

making the threshold determination of danger both sections

(202 and 211] are the same” (Maj. Op. 26-27).

Thus, the majority agrees that under 211 a “threshold de-

termination” of danger must be made, which cannot be satisfied

by a finding of “likely danger.”* This contradicts its conclusion

that the “will endanger” requirement is met by something less

than “likely danger” and that even “fear of uncertain or un-

known harm” is enough (Maj. Op. 56).

S202 Carnal

NAO REY Ora LU SLED Mabe raiel Wa MU ens:

D. Generalized Attribution of Discretion.

The majority seeks to encompass Section 211 in its broad

category of questions involving the environment, to justify its

claim of wide grant of discretion to EPA:

“Never before have massive quantities of asbestiform tail-

ings 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

* The dictionary synonyms for “likely” include “in all probability,

probably” (Webster’s Third New International Dictionary of the

English Language 1971); “reasonably to be believed or expected”

(The Random House Dictionary, The English Language, 1966).

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thousands of tons of lead emissions been disgorged annually

into the air we breathe”. (Maj. Op. 47.)

In support of this hortatory attempt to measure all environmental

matters by a single standard, despite the varied approaches

authorized by Congress, the majority cites several other lower

court decisions.* The majority suggests that the same standard

should be applied in all such cases to “avoid environmental

catastrophe” (Maj. Op. 48).

This attempt to blur the specific questions involved in con-

nection with the lead regulation is unjustified. First, all of the

Cases cited by the majority deal with carcinogens as to which the

lower court itself has said that “the concept of a threshold

exposure level has no practical significance where carcinogens

are concerned.”** (Environmental Defense Fund v. EPA (Shell),

510 F. 2d 1292, 1298). The Society of Plastics Industry and

Hodgson decisions did not question whether the carcinogen

should be regulated, but only the manner of regulation. In both

cases, the Secretary of Labor was required by the law to establish

safe levels as a maximum for exposure. In Environmental

Defense Fund v. EPA, supra, dealing with the pesticides

aldrin/dieldrin, the court noted that not only was broad discre-

tion granted on the Administrator. but the statute on its terms

“places the burden of establishing the safety of a product on...

the applicant” (510 F. 2d at 1297).

The Reserve Mining decision does not stand for the proposi-

tion that regulation in the environmental field can be based on a

“non-existent data base.” Instead, the Eighth Circuit Court of

* Reserve Mining Co. v. EPA, 514 F. 2d 492 (8th Cir. 1975);

The Society of the Plastics Industry, Inc. v. OSHA, 509 F. 2d 1301

(2d Cir.) cert. denied, 421 U.S. 992 (1975); Industrial Union Dept.,

AFL-CIO v. Hodgson, 449 F. 2d 467 (D. C. Cir. 1974); Environ-

mental Defense Fund v. EPA (Coahoma), 465 F. 2d 528 (D. C.

Cir. 1972); and Environmental Defense Fund v. EPA (Shell), 510

F. 2d 1292 (D. C. Cir. 1975).

** In Reserve Mining, the National Academy of Sciences had em-

phasized that there was no known safe level of the carcinogenic

asbestos fibers (514 F. 2d at 508).

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Appeals weighed the existing health evidence as to the car-

cinogenicity of the asbestos tailings in the context of a court

of equity determining the need for abatement because:

“As will be evident from the discussion that follows, we

adhere to our preliminary assessment that the evidence is

insufficient to support the kind of demonstrable danger 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 public health

and, if so, whether the risk is one which is legally cogni-

zable.” (514 F. 2d at 507.)

Throughout the majority opinion there runs the strain that

the question of the health effects of environmental lead is on

“the frontiers of scientific knowledge” and therefore EPA may

rely on “guesstimates” and “theoretical extrapolations” and

“speculation” (Maj. Op. 46-47). However, lead has been used

as an additive in gasoline for over 50 years and its health effects

have been studied for as long. The subject of the health effects

of lead has received massive attention and has been a continu-

ing source of study for decades. *

The nature of scientific inquiry in the field of environmental

health is identical to that in other scientific fields, irrespective

of “the problems faced by EPA in deciding whether lead auto-

motive emissions pose a threat . . .” (Maj. Op. 48). As the

President of the National Academy of Sciences recently stated

in an article referred to by the majority:

“Government regulation of technical products and proces-

ses must rest on a rational and sufficient scientific base.

. . . Government regulations or programs intended to com-

bat those hazards must, as a minimum, rest on detailed

appraisal of the nature and magnitude of those risks, of

the monetary and other costs of measures intended to

reduce the severity of each risk, and of the nature and mag-

* In fact, the number of studies involved in this area is so great

that EPA recently published an annotated bibliography on the “Bio-

logical Aspects of Lead” which iists over 4,100 studies during the

decade prior to 1964. (See Addendum I to Nalco Supp. Br.).

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15

nitude of the benefits involved in the process or product

under consideration.” Handler, A Rebuttal: The Need for

a Sufficient Scientific Base for Government Regulation, 43

Geo. Wash. L. Rev. 808, 812 (1975).

Characterizing this matter as “environmental”, as justi-

fication for unbridled agency discretion is simply a subtle form

of prejudgment of the issues, as reflected in the majority remark

that: “For years the lead anti-knock industry has refused to

accept the developing evidence that lead emissions contribute

significantly to the total human lead body burden” (Maj. Op.

12). But Congress did not intend regulation on the basis of a

“non-existent data base”. If that were the intent there would

have been no need to qualify the EPA Administrator’s authority

by the “will endanger” language of Section 211(c)(1)(A).

Il. The Lower Court Unjustifiably Limited the Scope of Its

Review Because This Case Involved Environmental

Regulations.

A. The Conflict Within the Lower Court as to Scope of Review.

The five divergent opinions in the lower court raise a substan-

tial issue under the Administrative Procedure Act (5 U. S. C.

$706) as to the thoroughness of the court’s review of highly

technical environmental regulations.

The majority essentially argues that EPA “should not be bound

by either the procedural or the substantive rigor proper for ques-

tions of fact” (Maj. Op. 46).

The opinion of Judge Bazelon (joined in by Judge Mc-

Gowan) while concurring in the construction of Section 211,

asserts that “I cannot agree that this automatically relieves the

Administrator’s decision from the ‘procedural . . . rigor proper for

questions of fact’.” (Bazelon Op. 1). On the other hand, Judge

Bazelon argues that a lower standard of substantive review must

apply “. . . in cases of great technological complexity,” and the

court should not “scrutinize the technical merits of each deci-

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sion” but rather “establish a decision-making process that assures

a reasoned decision that can be held up to the scrutiny of the

scientific community and the public” (/d.).

Judge Leventhal reads the other concurring judges as advo-

cating “engaging in no substantive review at all, whenever the

substantive issues at stake involve technical matters that the

judges involved consider beyond their individual technical com-

petence,” and that this is in effect “a signal to judges to abstain

from any substantive review’ (Leventhal Op. 1).

The dissent asserts that: “From the pages of the Court's

opinion there seeps the theme that this is an environmental case;

hence the Court like the agency need not labor by the usual

rules. We recognize no such exemption for this or any other type

case; certainly Congress did not give it to us” (Dis. Op. 50).

The concurring dissent, although agreeing with the majority

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

“strong precautionary powers,” does not agree with its opinion

that these powers can be exercised on a “nonexistent data base”

(MacKinnon Op. 2-3).

The concept that environmental cases represent a “new era”

is not unique. (See International Harvester Co. Vv. Ruckelshaus,

478 F. 2d at 615, 650-51 (D. C. Cir. 1973) concurring opinion,

C. J. Bazelon.)* However, it has been suggested that the im-

portance and impact of environmental legislation on public

health and the economy, calls for more supervision by the Court,

not less. Environmental Defense Fund v. Ruckelshaus, 439 F.

2d 584, 597-98 (D. C. Cir. 1971), pointed out that the super-

visory power of the court “has come into more frequent use”

and that “courts are increasingly asked to review administrative

action that touches on fundamental personal interests in life,

health and liberty . . . To protect these interests from adminis-

trative siirenns, it is necessary, but not sufficient, to insist

° See also Environmental Defense Fund \ Vv. -Ruckelshaus, 439 F. 2d

584, 597 (D. C. Cir. 1971); Sierra Club v. Morton, 405 U. S. 727,

755 (1972) (Dissent).

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17

on strict judicial scrutiny of administrative action . . .” (Chief

Judge Bazelon). See also, Portland Cement Association v.

Ruckelshaus, 486 F. 2d 375, 393 (D. C. Cir. 1973), cert.

denied, 417 U. S. 921 (1974).

Indeed, the increasing impact of environmental regulations

would appear to dictate a continued scrutiny by reviewing

courts, to prevent administrative action from becoming, as this

Court said in Burlington Truck Lines v. United States, 371

U. S. 156, 167 (1962) “a monster which rules with no prac-

tical limits on its discretion.”* The need for review, though

approached “with utmost diffidence” because of “technical

complexities”, is apparent (/nternational Harvester v. Ruckel-

shaus, 478 F. 2d at 641).**

The need for a resolution of the issue of the scope of review

is illustrated by the variety of views expressed by Chief Judge

Bazelon who, in Environmental Defense Fund v. Ruckelshaus,

439 F. 2d at 597-98, called for an increase in the rigor of review

of environmental regulations, and in /nternational Harvester v.

Ruckelshaus, 487 F. 2d at 651 suggested that this did not mean

the courts would “dig deeper”, but now suggests a restriction on

substantive review akin to the exclusion of 5 U. S. C. § 701(a)

(2) for “agency action . . . committed to agency discretion by

law”, which as this Court said in Citizens to Preserve Overton

* There is no reason to assume that because the subject matter is

the environment, that agency personnel will somehow be free of all

possibility of “impermissible whim, improper influence, misplaced

zeal .. . the clutch of unconscious preference and irrelevant prejudice”

Greater Boston Television Corp. v. FCC (D. C. Cir. 1971), 444

F. 2d 841, 852 (D.C. Cir.), cert. denied, 403 U. S. 923 (1971).

** Congress expected that interested parties taking issue with the

actions of the Administrator would have the benefit “of an appeal

to the court from [under] the Administrative Procedure Act” and if

it was felt “that there were not the facts and that the ruling was

wrong, the court would have the final decision” (116 Cong. Rec.

(Part 14) at 19230-31 House) (10 June 1970). See Universal

Camera Corp. v. NLRB, 340 U. S. 474 (1951), holding that in

determining scope of review the court must consider both the Ad-

ministrative Procedure Act and Congressional intent in adopting the

regulatory legislation.

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Park v. Volpe, 401 U. S. 402, 410 (1971), “is a very narrow

exception”.

The conflict within the circuit cannot be decided here by a

rehearing en banc (U. S. ex rel. Robinson vy. Johnston, 316

U. S. 649 (1942)), for a rehearing has already been held.

Thus, the purpose of en banc hearings, to avoid “conflicts

within” and promote “finality of decision” in a court of appeals

and to “determine the major doctrinal trends of the future’ for

4 the circuit cannot be achieved. United States v. American-For-

: eign SS. Corp., 363 U. S. 685, 689-90 (1960). Unless this

| Court reviews, there will inevitably be conflicting decisions

within the circuit depending upon the composition of the par-

ticular panels.* This is particularly important because the Court

of Appeals for the District of Columbia is the sole venue for

review under several key sections of the Clean Air Act whereby

Congress intended to avoid the very problem of conflicting de-

cisions which arises here. Also, because of this circuit’s leader-

ship in this area, conflicts within the circuit will no doubt

engender conflicts among other circuits, depending upon which

of the several views of the lower court are followed.**

rai Lac’

a Further, review of this issue is necessary because the law of

d the case may not have been decided below. Assuming that

Judges Bazelon and McGowan did not engage in any substan-

tive review, consistent with their opinion—and if their opinion

as to the proper scope of review is wrong—then in fact there

was no majority and only three of the nine active judges have

* Thus 3 judges assert a reduced rigor of both procedural and

substantive review in environmental cases; 2 judges oppose any

reduction in procedural rigor but would substantially abdicate all

substantive review; and the 4 dissenting judges assert that the same

procedural and substantive rigor applies as in other cases.

** While decisions as to the law rendered in one circuit are not

binding in other circuits, in the interest of uniformity such decisions

j should be followed unless the other circuit is convinced that the

: decision is clearly wrong. E.g., Homan v. United States, 279 F. 2d

$ 767, 773 (8th Cir.), cert. denied, 364 U. S. 866 (1960). In this

instance, other circuits would have a variety of choices.

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“affirmed” the regulation.* The impact of the lead phasedown

regulation on the nation’s future and economy is too important,

and the controversy over its validity too substantial, to let this

regulation stand on such a hybrid vote.

B. The Record Does Not Support the Regulation and Its

Promulgation Constitutes a Clear Error of Judgment.

One of the most difficult issues, as reflected in more than

a hundred pages of opinion in the court below, is whether

EPA here committed a “clear error of judgment” when it

determined to regulate lead additives.** In order to justify the

regulation, EPA must provide a record for the reviewing court

which is of sufficient completeness as to the factors considered

and reasons for regulation that the Court can, through a “search-

ing and substantial inquiry”, satisfy itself that the decision was

“based on a consideration of the relevant factors.” Citizens to

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

the court below stated in Environmental Defense Fund v. En-

vironmental Protection Agency, 465 F. 2d 528, 540-41 (D. C.

Cir. 1972):

“We cannot discharge our role adequately unless we

hold EPA to a high standard of articulation . . . The im-

portance and difficulty of subject matter entail special

responsibilities when the EPA undertakes to explain and

defend its actions in court.”

** The majority opinion contains an extensive footnote [Maj. Op.

pp. 69-71 fn. 74] which indicates uncertainty as to the meaning of

“clear error of judgment” as enunciated by this Court in Citizens to

Preserve Overton Park v. Volpe, 401 U. S. 402 (1971). The variety

of views below as to the scope of review and circumstances which

would require the setting aside or remand of the regulation here, is

evidence of that uncertainty.

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Also in Greater Boston Television Corp. v. FCC, 444 F. 2d

841, 852 (D. C. Cir. 1970), the same court held:

“The function of the court is to assure that the agency

has given reasoned consideration to all of the material facts

and issues. This calls for insistence that the agency articu-

late with a reasonable clarity its reasons for decision, and

identify the significance of the crucial facts. . . .”*

If an administrative agency has not complied with the notice

provisions of the Administrative Procedure Act (5 U. S. C.

§ 553) so that the reviewing court has the benefit of comments

by interested parties, and the agency’s response, the reviewing

court does not have the “whole record” which it is required to

review under § 706. See Rodway v. U. S. Dept. of Agriculture,

514 F. 2d 809, 817 (D. C. Cir. 1975); Portland Cement As-

sociation Vv. Ruckelshaus, 486 F. 2d 375, 400 (D. C. Cir.

1973), cert. denied, 417 U. S. 921 (1974); and Greater Boston

Television Corp. v. FCC, supra, 444 F. 2d at 850 (D. C.

Cir. 1970).

This Court has held: “We may not supply a reasoned basis

for the agency’s action that the agency itself has not given.”

Bowman Transportation v. Arkansas-Best Freight System, Inc.,

419 U. S. 281, 286 (1974). The court “must judge the

propriety of such [administrative] action solely by the grounds

invoked by the agency. If those grounds are inadequate or

improper, the court is powerless to affirm the administrative

action by what it considers to be a more adequate or proper

basis.” Securities Comm'n v. Chenery Corp., 332 U. S. 194, 196

(1947).

The following are illustrations of the lack of EPA reasoned

decision-making here that require the regulation be set aside

as a clear error of judgment or, at the least, that it be remanded

to the EPA.

* See also EDF v. Ruckelshaus, 439 F. 2d 584, 597 (D. C. Cir.

1971), and Kennecott Copper Corp. v. EPA, 462 F. 2d 846 (D. C.

Cir. 1972).

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21

1. As the dissent points out, to permit its conclusion that

there is an over-exposure to lead in the general adult population,

EPA rejected several major studies dealing with blood lead

levels in adults (some partially sponsored by EPA itself) show-

ing the absence of excessive blood lead in urban adults, on the

ground that the studies contained the methodological flaws of no

measurement of lead intake from sources other than airborne

lead (Dis. Op. 68-74). Yet EPA relied on two older epidemio-

logical studies, which show a small percentage of slightly “ex-

cessive” blood lead levels, despite the fact that those studies are

subject to the same alleged imperfect methodology. There is no

articulation of the reasons for this picking and choosing.

The majority sought to supply an explanation for the EPA

by asserting that the amount of intake of lead from dietary

sources might well be assumed to be constant within particular

metropolitan areas but assumed to vary between different

areas (Maj. Op. 85-86).* As the concurring opinion pointed

out, this may only be a “homespun scientific aphorism” well

beyond the competency of the majority to judge (Bazelon

Op. 3).

2. The other basis for the EPA’s claim of “significant risk

of harm” is the alleged contribution of automobile lead emis-

sions to blood lead levels in urban children through childhood

ingestion of lead-laden dirt. The EPA however, admitted that

lead in paint is “the primary cause of clinical lead poisoning in

children” (38 Fed. Reg. 33736), and its conclusion as to the

significance of the contribution of automobile lead emissions is

put forward solely as an unproven “hypothesis” (Dis. Op.

79-80). The majority asserts that in any event EPA made this

hypothesis only “a secondary basis for the regulations” and

therefore placed “only limited reliance on it” (Maj. Op. 90, 95).

* As the dissent argued, not only is this explanation a post-hoc

rationalization by the court, but it is illogical on its face, since there

is no reason to believe that dietary sources of lead would be any

more uniform as “between Scarsdale and Harlem”, than as between

“greater Philadelphia” and “greater New York” (Dis. Op. 77).

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In fact, EPA’s own scientists, in commenting upon the Third

Health Document stated that: “we should like to emphasize that

none of the studies cited directly implicated lead from automo-

tive exhausts as being responsible for the harming of any human

being” (App. 1057; Dis. Op. 82).

3. Another clear error of judgment by the EPA is the sub-

stantial reliance on the new studies as the basis for the final

regulation without adequate notice and opportunity for comment

(See infra pp. 22-25). This, in and of itself makes the adoption

of the regulation “arbitrary, capricious, and an abuse of dis-

cretion”. Rodway v. United States Dept. of Agriculture, supra,

$14 F. 2d at 817.

Ill. The Regulation Should Be Set Aside or Remanded to the

EPA Because of Failure to Provide Meaningful Oppor-

tunity for Comment.

From the outset, one of the principal issues before the lower

court involved the lack of meaningful opportunity afforded to in-

terested parties to comment on the scientific studies and “private

communications” which formed, in substantial part, the basis

for the final regulations (See, Nalco Main Br. 5, 17-18, 22-24

and 3!; and Nalco Supp. Br. 44). Now the en banc opinions of

the lower court have created a related question: whether the

reviewing court could properly go outside the administrative

record, on an ex parte basis after oral argument, and attempt to

“reconstruct” the chronology of public notice.

Both issues may have resulted from the rush to regulate

which occurred here in part because of the one-page order of

the Court of Appeals on October 28, 1973.* But this order could

* As Judge MacKinnon noted in his concurring dissent:

“This complex and lengthy lawsuit was foreordained when, on

October 29, 1973, a panel of this court directed the Adminis-

trator of the Environmental Protection Agency to reach a final

decision within 30 days . . . Although the proposed rulemaking

had then been in progress for nearly three years, it was patently

(Continued on next page)

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23

not alter the need for scrupulous attention to fundamentally

fair procedures. The order did not mandate that the EPA

jettison its prior medical and scientific bases and rely materially

on medical evidence which was never brought to the attention of

the public for meaningful comment.

As the Court of Appeals has held on numerous occasions, in

complex administrative decision-making, EPA must be held

to a high standard of articulation and fairness of procedure in

order for the reviewing court to properly function. In Portland

Cement Association Vv. Ruckelshaus, supra, 468 F. 2d at 393

the court held that:

“It is not consonant with the purpose of a rulemaking

proceeding to promulgate rules on the basis of inadequate

data, or on data that [to a] critical degree is known o. ly to

the agency.”

“What counts is the reality of an opportunity to submit an

effective presentation. . . .” Walter Holm Co. v. Hardin, 449 F.

2d 1009, 1016 (D. C. Cir. 1971).* The majority did not require

the agency to adhere to these principles in this case.

The Third Health Document which was issued by the EPA

simultaneous with the final regulations, was described by the

EPA as “a presentation of the pertinent evidence upon which

a decision could be made as to whether or not there is a

health justification to regulate lead in gasoline” (App. 30).

unrealistic to believe that the agency could sift through its ac-

cumulated data, afford the public and other agencies an op-

portunity to review any evidence contributed since the end of

the last comment period on March 11, 1973, reach a proper

decision based on all the evidence and draft the complicated

regulations within the required 30 days.” (MacKinnon Op. 1.)

* See also Chief Judge Bazelon concurring in Jnternational Har-

vester Co. Vv EPA, 478 F. 2d 615, 651 (D. C. Cir. 1973); Hess &

Clark v. FDA, 495 F. 2d 975, 990 n. 45 (D. C. Cir. 1974); En-

vironmental Defense Fund v. EPA, 465 F. 2d 528, .... (D.C. Cir.

1972), and Kennecott Copper Corp. v. EPA, 462 F. 2d 846, 850

(D. C. Cir. 1972). Other circuit courts of appeals agree: South

Terminal Corp. v. EPA, 504 F. 2d 646, 665 (1st Cir. 1974);

Great Lakes Screw Corp. v. NLRB, 409 F. 2d 375, 379 (7th Cir.

1969); and Austin v. Jackson, 353 F. 2d 910. 911 (4th Cir. 1965).

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The “evidence” on which the EPA Administrator actually re-

lied in support of the final decision to regulate, was discussed

in the extensive Preamble to the regulations (App. 5; Dis. Op.

A-1 to A-14). The Preamble made no attempt to defend the

earlier studies relied on in prior Health Documents, but instead

“weighed against these criticisms, [new] studies which have

shown that airborne lead does contribute significantly to lead

exposure in the general population” (App. 3).

As the basis for the final regulations, the EPA Administra-

tor discusses six studies relating to airborne lead as an endanger-

ment to health of adults* and in the Preamble the EvA dis-

cusses these six studies—and only these six studies (App. 3-4).

Thus, these studies form the principal, if not complete, EPA

basis for the regulations.

For the second aspect of its health justification (lead in dirt

contributing to childhood lead poisoning), EPA again relies

almost entirely on new studies and “private communications”:

two Newark studies; and studies from Chicago, Philadelphia

and Rochester.** As the dissent points out, these studies were

not only referred to in the “New Information” section of the

Preamble, but were also fully discussed in the EPA Adminis-

trator’s summary of information upon which he relied (Dis. Op.

30). The majority opinion’s argument that these studies “play

no role in the Administrator’s decision to regulate” (Maj. Op.

107) is incredible: The majority opinion itself, which dis-

cusses the “evidence tying children to leaded dust”, discusses

only five studies, three of which are the new studies referred to

above (Maj. Op. B-1 et seq.).***

* Two pilot lead isotope studies (App. 678 and 704) “an un-

published study in Japan” (App. 1092); Chamber studies (App.

596 and 391); the Seven Cities Study re-analysis (Doc. 228); and

the Daines Study (App. 466).

** See, App. 5, 138, 140, 662, 718, 738 and 967.

*** That these studies are crucial to the EPA’s dustfall

“hypothesis” is further evidence by EPA’s statement in the Third

Health Document that:

“Studies from Philadelphia, Chicago and Newark discussed

above provide persuasive evidence to strongly suggest that

(Continued on next page)

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25

Thus, these studies are not simply makeweight for the EPA but

serve as a fundamental basis for the second part of the EPA’s

health justification basis for the regulations.

EPA admitted that the reproposal of the regulations on

January 10, 1973 occurred not only because the EPA’s basis for

the reduction was “substantially revised,” but because its

basis “had not been available for review by the scientific com-

munity” (App. 29). Yet, in November, 1973, the EPA was

willing to propose final regulations when the new basis for those

regulations had not been available for scientific scrutiny. The

opinions discuss, in detail, when these new studies may have

become available for comment (Maj. Op. pp. 101 to 106;

Dis. Op. pp. 27 to 29). Several of these studies may have

become “available” for the first time at the Conference on Low

Lead Toxicity on October 1-2, 1973 in the month prior to the

promulgation of the final regulations (Maj. Op. 101; Dis.

Op. 25). However, even in November, 1973 when the EPA’s

Third Health Document was completed, EPA admitted that:

“A detailed evaluation of all presentations at the conference is

beyond the scope of the [Third Health] document” (App. 31).

Other new material relied on had not even been published at the

time the regulations were promulgated and were either in draft

form, “in press” or simply unavailable “private communica-

tions”.*

sources of lead other than paint, including that resulting from

the presence of lead in gasoline, play an important role in

childhood lead exposure.” (App. 130.)

*The “unpublished Japanese study”, second Newark study,

the so-called “Chicago Study” which was a “personal communication

from Coordinator of the Chicago Lead Poisoning Program to Dr.

J. S. Lin-Fu” (App. 140) and “personal communication from Phila-

delphia Dept. of Public Health” (App. 138).

The majority opinion argued that petitioner Nalco was able to

comment upon some of the newly disclosed bases for the regulations

as evidenced by petitioner’s “cxteasive comments” on these new

studies (Maj. Op. 102, n. 106). These “extensive” comments on an

EPA tentative draft consisted of all of three pages in a 54 page

document (Doc. 821, pp. 7-9). Further, these comments could not

(Continued on next page)

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26

To discern the dates on which some of these drafts and new

studies became “available” the lower court relied upon a series

of unsupported and unsworn assertions made by EPA counsel

in letters sent to the Court of Appeals after the en banc argu-

ment. The majority mistakenly assumed that counsel for peti-

tioner was kept informed of these ex parte communications,

and that the “facts” asserted in these letters were not dis-

puted and therefore usable by the court.* That assumption is

incorrect:

(a) Counsel for petitioner did not receive the letter of

September 26, 1975 (see Appendix B., B2-4, hereto), until the

next week, when it was sent to counsel because counsel for

3 petitioner had learned that such a letter had been sent and

specifically requested a copy.

(b) Counsel for petitioner learned of the October 2, 1975

j letter for the first time upon reading the en banc opinions of the

. court below. This letter was never sent to petitioner’s counsel

as shown by the face of the letter which does not bear any certif-

icate of service or carbon copies to petitioners counsel (see

Appendix B., B8, hereto).

(c) It has also now been learned that a third letter was sent

to the Court of Appeals dated September 22, 1975. This letter

was also not sent to counsel for petitioner (Appendix B., B1,

hereto).

Sait oe ah hain

have been received, if mailed to the EPA, more than one weck prior

to final announcement of the regulations and EPA’s 117 page sup-

porting document. The fact that one interested party may have ap-

preciated that the EPA planned to rely substantially on new, un-

commented upon material, is not relevant to the issue of the lack

: of opportunity for meaningful public comment to governmental

; agencies concerned, with the protection of the public health. See:

Walter Holm & Co. v. Hardin, 449 F. 2d 1009, 1016 (D. C. Cir.

; 1971); Wagner Electric Corp. v. Volpe, 466 F. 2d 1013, 1019 (3d

Cir. 1972); Hotch v. United States, 212 F. 2d 280, 282 (9th Cir.

1954).

*“Copies of these letters were sent by EPA to counsel for all

parties to this litigation. No party commented on either letter.” (Maj.

Op. 101, n. 104.)

ESS SOT IS IRE EI et ERY EEL EGE LILES I TIPLE NL IEE IE IE EI

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27

(d) When counsel for petitioner requested information as to

documents which had been sent to the lower court, counsel for

EPA sent a letter dated October 15, 1975 (Appendix B., B9-11,

hereto) which did not disclose the existence of the October y §

1975 letter but merely enclosed a copy of a partial list of docu-

ments sent to the lower court.

Thus, the fact that a complaint was not made by “able and

experienced counsel for petitioners” (Maj. Op. 101), is hardly

relevant, since it was impossible for counsel to complain about

a situation about which it was uninformed.

Even this attempt to supplement the record failed to “disclose

when each piece of new information is received and when and

how it was made available for comment” (Bazelon Op. 5).

For example, the September 26, 1975 letter from EPA

counsel to the lower court said as to the first isotope study

(Doc. 113) that “the files of the Office of General Counsel . . .

indicate that the abstracts were sent . . . to the public file on

October 4, 1973” (Appendix B., B3, hereto). EPA counsel

apparently did not know when they were actually placed in the

files to be theoretically “available” to whomever might be can-

vassing through the “public file”. This letter also states that the

second isotope study was “sent to the Office of the General

Counsel on August 6, 1973 for transmittal to . . . the public

file.” The letter further asserts, without record support, that the

Japanese study “was sent to the Office of General Counsel on

July 22. 1973 for transmittal . . . to the public file’. As to each

assertion there is no indication when the documents were

actually transmitted to and placed in the “public file”.

The letter of EPA counsel to the clerk of the lower court

dated September 22, 1973 refers to a court inquiry as to

“docket records”, possibly questioning whether there are any

records of the actual date of deposit of materials in the public

information file (Appendix B., B1, hereto). Counsel for peti-

tioner is still not privy to these communications.

SNR ERENT ae TS ag LET eS TY

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RSE REIN RIMS DYN NRF ILA IESE TONER

one sen er |

Rae TASS A aA a

28

Finally, the October 2, 1975 letter, enclosing a report on

“preliminary results of the first isotope study” says, “The letter

was filed and indexed with the public comments under ‘Califor-

nia University’ and I overlooked it before” (Appendix B., B8,

hereto). With such a filing system, confusing to EPA’s own

counsel, how can it appropriately be suggested that petitioner

was “on notice” of everything which might be deposited, at

some time or other, in the EPA public information files?*

Two of the concurring judges (Judges Bazelon and

McGowan) noted, “the failure of the record to clearly disclose

the procedural steps followed by EPA,” stating that the Court

was forced to “reconstruct these steps by inferences and sur-

mise.” Thus the concurring judges concluded that: “Ordinarily,

. . . I think a record which so burdens judicial review would

require remand for clarification”, but in this case the court chose

not to do so (Bazelon Op. 4-5).

The action of the reviewing court here goes well beyond the

power of an appellate court and is in direct conflict with deci-

sions of this Court. If the record is insufficient or even unclear

on such a crucial issue as the opportunity to comment, the

action must be remanded to provide such an opportunity. In

Camp V. Pitts, 411 U. S. 138 (1973) (per curiam), this Court

dealt with a similar question where the case presented a “nar-

row, but substantial, question with respect to the proper proce-

dure to be followed when a reviewing court determines that an

administrative agency’s stated justification for informal action

does not provide an adequate basis for judicial review.” (411

U. S. at 138.) The Court held that in applying the “arbitrary

and capricious” test:

* In the EPA counsel’s letter of October 15, 1975, responding to

petitioner’s counsel’s telephone inquiry, EPA counsel did not “make

note of all the documents requested shortly after oral argument”,

but attached a list showing “The type of document is indicated and

the list is otherwise complete”, and that “several letters from in-

dustry” were requested, presumably by the Court, but “specific

document numbers were not noted” (Appendix B., B9-11, hereto).

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a EAR PETRA RE ERR HIS RAS MRE A RNR STEEN

29

“. . . the focal point for judicial review should be the

administrative record already in existence, not some new

record made initially in the reviewing court.” (411 U. S.

at 142.)

Here, the lower court did make a new record as to when docu-

ments were perhaps made available for public comment and

petitioner was severely prejudiced by this ex parte action.

In summary, consideration of procedural issues under 5

U. S. C. § 553 of the Administrative Procedure Act raises the

following issues:

(a) Does the melange of alleged notices through presenta-

tion of material during “by invitation only” seminars, transmis-

sion to one interested party, or deposit in “public files” at

some undetermined dates at intermittent times during the months

immediately preceding issuance of the regulations, comply with

the statute’s requirement for notice and opportunity to comment?

(b) Is it a reasonable construction of Section 553 to hold

that interested members of the public must make in effect a

daily check of the deposit of materials in inadequately indexed

“public files” of the agency, guess as to which materials the

agency will seek to rely on, and file their comments sufficiently

in advance of rule-making to assure that the agency has had

an opportunity to consider them, all at the peril of being held to

have waived right of comment on new materials substantially

relied on by the agency if they do not do so?

(c) Does the fact that the EPA previously published notices

of proposed regulations and material on which it proposed to

rely and provided a period for comment thereon, excuse the

failure to follow such procedure when the final regulation is

based substantially on new scientific and medical materials as

to which there has been no notice and opportunity to comment?

(d) Can the reviewing court properly rely upon ex parte

unsworn and unsupported assertions of agency counsel to add

to the administrative record on review on an important issue

such as notice and the opportunity to comment?

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a ke wt bea:

JRE I Rs na uae Sra

A MORAN eat. pw

30

CONCLUSION.

The questions presented raise issues of national importance,

which have generated widely divergent opinions in the lower

court. The petition for a writ of certiorari should be granted.

Respectfully submitted,

Victor P. KAYSER,

JoHN C. BERGHOFF, JR.,

135 South LaSalle Street,

Chicago, Illinois 60603,

Davip MACHANIC,

WILLIAM H. FITZ,

1200 18th Street, N. W.,

Washington, D. C. 20036,

Attorneys for Petitioner.

Of Counsel:

CHADWELL, KAYSER, RUGGLES,

McGEE & HASTINGS,

135 South LaSalle Street,

Chicago, Illinois 60603,

(312) 726-2545,

PIERSON, BALL & DowD,

1200 18th Street, N. W.,

Washington, D. C. 20036,

(202) 331-8566.

mene a

MELE IMAL PPLE A ERENT VRSCA ROD AT Cys TEIN

lal

RIL EEN THRO

GH

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Appendix

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Al

APPENDIX A.

1. Clean Air Amendments of 1970, Pub. L. 91-604, Dec. 31,

1970, 84 Stat. 1698-1700.

42 U.S.C. § 1857c-3(a)(1).

Sec. 108.(a)(1) For the purpose of establishing national

primary and secondary ambient air quality standards, the Ad-

ministrator shall within 30 days after the date of enactment

of the Clean Air Amendments of 1970 publish, and shall from

time to time thereafter revise, a list which includes each air

pollutant—

(A) which in his judgment has an adverse effect on public

health or welfare;

(B) the presence of which in the ambient air results from

numerous or diverse mobile or stationary sources, and

(C) for which air quality criteria had not been issued before

the date of enactment of the Clean Air Amendments of 1970,

but for which he plans to issue air quality criteria under this

section.

42 U.S.C. § 1857f-1(a)(1).

Sec. 202. (a) Except as otherwise provided in subsection

(d)—

(1) The Administrator shall by regulation prescribe (and

from time to time revise) in accordance with the provisions of

this section, standards applicable to the emission of any air pol-

lutant from any class or classes of new motor vehicles or new

motor vehicle engines, which in his judgment causes or con-

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

which endangers the public health or welfare. Such standards

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A2

shall be applicable to such vehicles and engines for their useful

life (as determined under subsection (d)), whether such vehicles

and engines are designed as complete systems or incorporate

devices to prevent or control such pollution.

42 U.S.C. § 1857f-6c{c).

Sec. 211. (c)(1) The Administrator may, from time to

time on the basis of information obtained under subsection (b)

of this section or other information available to him, by regula-

tion, control or prohibit the manufacture, introduction into com-

merce, offering for sale, or sale of any fuel additive for use in

a motor vehicle or motor vehicle engine (A) if any emission

products or such fuel or fuel additive will endanger the public

health or welfare, or (B) if emission products of such fuel or

fuel additive will impair to a significant degree the performance

of any emission control device or system which is in general use,

or which the Administrator finds has been developed to a point

where in a reasonable time it would be in general use were such

regulation to be promulgated.

(2)(A) No fuel, class of fuels, or fuel additive may be

controlled or prohibited by the Administrator pursuant to clause

(A) of paragraph (1) except after consideration of all relevant

medical and scientific evidence available to him, including con-

sideration of other technologically or economically feasible

means of achieving emission standards under section 202.

(B) No fuel or fuel additive may be controlled or prohibited

by the Administrator pursuant to clause (B) of paragraph (1)

except after consideration of available scientific and economic

data, including a cost benefit analysis comparing emission con-

trol devices or systems which are or will be in general use and

require the proposed control or prohibition with emission con-

trol devices or systems which are or will be in general use and

do not require the proposed control or prohibition. On request

of a manufacturer of motor vehicles, motor vehicle engines, fuels,

EIT ORE are e ~s te eee Oe ae we

A3

or fuel additives submitted within 10 days of notice of proposed

rulemaking, the Administrator shall hold a public hearing and

publish his findings with respect to any matter he is required

to consider under this subparagraph. Such findings shall be pub-

lished at the time of promulgation of final regulations.

(C) No fuel or fuel additive may be prohibited by the Ad-

ministrator under paragraph (1) unless he finds, and publishes

such finding, that in his judgment such prohibition will not

cause the use of any other fuel or fuel additive which will

produce emissions which will endanger the public health or

welfare to the same or greater degree than the use of the fuel

or fuel additive proposed to be prohibited.

42 U.S.C. § 1857h-S.

Sec. 307. (b)(1) A petition for review of action of the

Administrator in promulgating any national primary or sec-

ondary ambient air quality standard, any emission standard un-

der section 112, any standard of performance under section 111,

any standard under section 202 (other than a standard required

to be prescribed under section 202(b)(1)), any determination

under section 202(b)(5), any control or prohibition under sec-

tion 211, or any standard under section 231 may be filed only

in the United States Court of Appeals for the District of

Columbia.

2. Administrative Procedure Act

5 U.S.C. § 553(b)

General notice of proposed rule making shall be published

in the Federal Register, unless persons subject thereto are

named and either personally served or otherwise have actual

notice thereof in accordance with law. The notice shall in-

clude—

(1) a statement of the time, place, and nature of public

rule making proceedings;

a — - << -_— -

A4

(2) reference to the legal authority under which the

rule is proposed; and

(3) either the terms or substance of the proposed rule

or a description of the subjects and issues involved.

Except when notice or hearing is required by statute, this sub-

section does not apply—

(A) to interpretative rules, general statements of policy,

or rules of agency organization, procedure, or practice; or

(B) when the agency for good cause finds (and incorpo-

rates the finding and a brief statement of reasons therefor

in the rules issued) that notice and public procedure there-

on are impracticable, unnecessary, or contrary to the public

interest.

(c) After notice required by this section, the agency shall

give interested persons an opportunity to participate in the rule

making through submission of written data, views, or arguments

with or without opportunity for oral presentation. After con-

sideration of the relevant matter presented, the agency shall

incorporate in the rules adopted a concise general statement of

their basis and purpose. When rules are required by statute to

be made on the record after opportunity for an agency hearing,

sections 556 and 557 of this title apply instead of this subsection.

5 U.S.C. § 706(1) & (2)

Scope of review

To the extent necessary to decision and when presented, the

reviewing court shall decide all relevant questions of law, inter-

pret constitutional and statutory provisions, and determine the

meaning or applicability of the terms of an agency action. The

reviewing court shall—

(1) compel agency action unlawfully withheld or un-

reasonably delayed; and

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AS

(2) hold unlawful and set aside agency action, find-

ings, and conclusions found to be—

(A) arbitrary, capricious, an abuse of discretion,

or otherwise not in accordance with law;

(B) contrary to constitutional right, power, priv-

ilege, or immunity;

(C) in excess of statutory jurisdiction, authority,

or limitations, or short of statutory right; :

(D) without observance of procedure required by f

law;

(E) unsupported by substantial evidence in a case

subject to sections 556 and 557 of this title or

otherwise reviewed on the record of an agency hear-

ing provided by statute; or

(F) unwarranted by the facts to the extent that

the facts are subject to trial de novo by the review-

ing court.

EAI wmataee

In making the foregoing determinations, the court shall review

the whole record or those parts of it cited by a party, and due

account shall be taken of the rule of prejudicial error.

3. The Fuel Additive Regulation

Fep. REG. Vor. 38, No. 234, Dec. 6, 1973

Part 80 of Chapter I, Title 40 of the Code of Federal Regu-

lations is amended as follows:

1. In § 80.1, the second sentence is revised to read as

follows:

§ 80.1 Scope.

* * * These regulations are based upon a determination by

the Administrator that the emission product of a fuel or additive

will endanger the public health, or will impair to a significant

degree the performance of a motor vehicle emission control ‘

device in general use or which the Administrator finds has been i

x

-

&

ae Sn eS Te |

A6

developed to a point where in a reasonable time it would be in

general use were such regulations promulgated; and certain

other findings specified by the Act.

2. In § 80.2, a new paragraph (m) is added as follows:

§ 80.2 Definitions.

(m) “Lead additive manufacturer” means any person who

produces a lead additive or sells a lead additive under his own

name.

3. A new § 80.20 is added as follows:

§ 80.20 Controls applicable to gasoline refiners.

(a)(1) in the manufacture of gasoline at any refinery, no

gasoline refiner shall exceed the average lead content per gallon

specified below for each 3-month period (January through

March, April through June, July through September, October

through December) :

(i) 1.7 grams of lead per gallon, after January 1, 1975;

(ii) 1.4 grams of lead per gallon, after January 1, 1976;

(iii) 1.0 grams of lead per gallon, after January 1, 1977;

(iv) 0.8 grams of lead per gallon, after January 1, 1978:

(v) 0.5 grams of lead per gallon, after January 1, 1979.

(2) For each 3-month period (January through March,

April through June, July through September, October through

December) the average lead content per gallon shall be com-

puted by dividing total grams of lead used at a refinery in the

manufacture of gasoline by total gallons of gasoline manufac-

tured at such refinery.

(3) For each 3-month period (January through March,

April through June, July through September, October through

December) commencing with the period January 1, 1975

through March 31, 1975, each refiner shall submit to the Ad-

ministrator a report showing for each refinery (i) the total

grams of lead in lead additive inventory on the first day of the

4 *

in .

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AP Dresses ey:

A7

period, (ii) the total grams of lead received during the period,

(iii) the total grams of lead in lead additive inventory on the

last day of the period, (iv) the total gallons of gasoline produced

by such refinery during the period, and (v) the average lead

content in each gallon of gasoline produced during the period.

Reports shall be submitted within 15 days after the close of the

reporting period, on forms supplied by the Administrator upon

request.

(b) The provisions of paragraph (a) (1)(i) and (ii) of this

section shall not be applicable to any refiner which does not have

more than 30,000 barrels per day crude oil or bona fide feed

stock capacity from owned or leased facilities or from facilities

made available to such refiner under an arrangement such as,

but not limited to, an exchange agreement (except one on a

refined product for refined product basis), or throughput or

other form of processing agreement, with the same effects as

though such facilities had been leased.

4. A new § 80.25 is added as follows:

§ 80.25 Controls applicable to lead additive manufac-

turers.

For each 3-month period (January through March, April

through June. July through September, October through

December) commencing with the period January 1, 1975 through

March 31, 1975, each lead additive manufacturer shall submit

to the Administrator a report showing the total grams of lead

shipped to each refinery by such lead additive manufacturer

during the period. Reports shall be submitted within 15 days

after the close of the reporting period, on forms supplied by the

Administrator upon request.

5. A new § 80.26 is added as follows:

§ 80.26 Confidentiality of information.

Information obtained by the Administrator or his repre-

sentative pursuant to this part shall be treated, in so far as

its confidentiality is concerned, in accordance with the pro-

visions of 40 CFR Part 2.

DREW LOR ROE SSE EEN CBRL OY

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- flD.~ 2 eS ite Vie Tah ONO? ee

hae Restetses

Bl

APPENDIX B.

ENVIRONMENTAL PROTECTION AGENCY.

September 22, 1975

Ms. Terry Jalbert

Office of the Clerk

U. S. Court of Appeals for the

District of Columbia Circuit

U. S. Courthouse

Third Street and Constitution Avenue

Washington, D. C.

Dear Ms. Jalbert:

Enclosed in two folders are the documents from the record

in Ethyl Corporation v. EPA requested by the Court this

morning.

Will you ask Mr. Cathay to call me at his convenience tomor-

row? I do not think EPA maintained in the past the type of

docket records mentioned in his request to Mr. Clark of the

Justice Department, but I would like to clarify the request.

My telephone number is 755-0766.

Also, Mr. Shawaker, the Justice Department attorney assigned

to this matter will be out of the country for the next three weeks.

If additional documents are needed, I suggest that your office

contact me directly during this period. The record is stored in

my office, and we will be able to respond promptly.

Sincerely yours,

Leslie Carothers,

Attorney

Air Quality Noise and

Radiation Division (A-133)

——— -. .- ——_ -_— <<. =)

B2

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

Washington, D. C. 20460

September 26, 1975

Mr. Dan Cathey

Office of the Clerk

U. S. Court of Appeals for the

District of Columbia Circuit

U. S. Courthouse

Third Street and Constitution Avenue

Washington, D. C.

Co ae a

Re: Ethyl Corporation v. EPA (73-2205)

Dear Mr. Cathey:

This is in reply to your request for information on the dates

when EPA received Documents 113 and 468 in the record of the

rulemaking regarding lead additives in gasoline. The informa-

: tion you requested is as follows:

’ A. Document No. 113

This document in the record consists of two separate studies

by Rabinowitz, Wetherill, and Kopple using lead isotope tracers

to investigate human lead metabolism.

1. The first study listed in the Certified Index to the Record

and entitled “Studies of human lead metabolism using stable

isotope tracers” was presented at a joint EPA-HEW Symposium

on lead on October 1-2, 1973. There is no evidence in the

4 record or elsewhere that EPA received an advance copy of the

: full text of this paper.

F EPA did receive advance abstracts of most of the papers pre-

sented shortly before the Symposium. These abstracts, includ-

ing an abstract of the Rabinowitz paper, appear in the record

SSR RNAS TT I EMILE LIT LEH OLE IETS ELLIE EILEEN LEELA POE OER BOT

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B3

as Document No. 1092. The files of the Office of General

Counsel, which reviewed many documents before transmittal to

Ethyl Corporation under a Freedom of Information Act Agree-

ment, indicate that the abstracts were sent to Ethyl Corporation

and to the public file on October 4, 1973.

2. The second study by the same authors indexed as Docu-

ment 113 is “Lead Metabolism in the Normal Human: Stable

Isotope Studies.” The copy of the study appearing in Document

113 is the study as published in the November, 1973 issue of

Science Magazine.

The isotope study reported in Science was conducted before

the similar study reported at the EPA/HEW symposium. An

early draft of the study ultimately published in November,

1973, was sent to EPA by one of the authors on May 5, 1973.

The covering letter and the attached draft appear in the record

as Document No. 470. A copy of that document is enclosed.

In addition, a revised and final draft of the same study was

subsequently received by EPA and sent to the Office of General

Counsel on August 6, 1973 for transmittal to Ethyl Corpora-

tion and the public file. This typed draft does not appear in the

Certified Index to the Record, because I directed the librarian

who assisted me in preparing the index to remove drafts of

scientific articles that were also available in published form by

the time the regulations were promulgated, provided that the

typed draft was identical to the published version. I retained

in my files of duplicates the copy of the typewritten draft with

the notation that it was withdrawn from the public file on Janu-

ary 22, 1974, during the period when we prepared the index.

I will be glad to forward this draft and the notation if the Court

desires it.

B. Document No. 468

The study by Tsuchiya, et el. entitled “Study of Lead Con-

centrations in Atmosphere and Population in Japan” was sent

to the Office of General Counsel on July 22, 1973, for trans-

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B4

mittal to Ethyl Corporation and to the public file. The docu-

ment was therefore received by EPA before that date.

If I can be of further assistance, please let me know.

Sincerely yours,

/s/ LESLIE CAROTHERS

Leslie Carothers

Attorney

Air Quality Noise and

4 Radiation Division (A-133)

; Enclosure.

i

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et Tee es

Saison Nee, ee

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ee ee eee re ey

PLEA OIE RP EL EIDE MEL IONS IOI LALIT CLE EO RIM GES SEE SRLS RN UEP ERTIES:

i psdahyn Ns

BS

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

Washington, D. C. 20460.

’

September 29, 1975

David Mechanic, Esq.

Pierson, Bell & Dowd

1000 Ring Building

Washington, D. C. 20036

Dear Mr. Mechanic:

Re: Ethyl Corporation v. EPA (73-2205) and

related cases

Last week, the Clerk of the Court requested information on

the dates when EPA received Documents No. 113 and 468 in

the Certified Index to the Record. Our letter in response to this

request is enclosed for your information.

Sincerely yours,

/s/ LESLIE CAROTHERS

Leslie Carothers

Attorney

Air Quality Noise and

Radiation Division (A-133)

-— —_ -~ — - «~

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Nike Sil B02 nw viel ZS

SSR Re a ONE oe cs ds Se acca

B6

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,

Washington, D. C. 20460.

October 1, 1974

Mr. Robert Bonner

Chief Deputy Clerk

U. S. Court of Appeals for the

District of Columbia Circuit

U. S. Courthouse

Washington, D. C.

Re: Ethyl Corp. v. EPA, 73-2205; Nalco Chemical

Co. v. EPA, 73-2270; NPRA v. EPA, 74-1021;

PPG Industries v. EPA, 73-2268; E. I. DuPont

De Nemours v. EPA, 73-2269.

Dear Mr. Bonner:

Per your request, I am enclosing eight (8) copies of the

article entitled “Atmospheric Lead: Its Relationship to Traffic

Volume and Proximity to Highways” by Robert H. Daines,

Harry Motto, and Daniel M. Chilko. The article was published

in the April, 1970 issue of Environmental Science and Tech-

nology. This study is cited in other articles reproduced in the

Joint Appendix (see, ¢€.g., p. 269 n. 17 and 467 n. 1), buta

copy of this reference was not included in the Certified Index to

the Record.

I am also enclosing copies of a second article with a similar

title by the same authors in case there was any confusion about

the reference desired. That article is entitled “Lead in Soils and

Plants: Its Relationship to Traffic Volume and Proximity to

Highways” by Harry L. Motto, Daniel H. Daines, Daniel M.

Chilko, and Carlotta K. Motto. This reference is Document

No. 102 in the Certified Index to the Record, but it is not

included in the Joint Appendix.

cc:

B7

A complete copy of Airborne Lead in Perspective, the Report

of the National Academy of Sciences is also included as you

requested. It is Document No.

14 in the Certified Index.

Excerpts from the report are reproduced in the Joint Appendix

at pp. 309-363.

Copies of this letter and the two enclosed articles are being

sent to counsel of record. If I can be of further assistance,

please let me know.

Sincerely yours,

/s/ LESLIE CAROTHERS

Leslie Carothers

EG-333

Edward J. Shawaker, Esq.

Department of Justice

Washington, D.C. 20530

Joseph C. Carter, Esq.

Hunton, Williams, Gay & Gibson

700 East Main Street

Richmond, Virginia 23212

John J. Adams, Esq.

Hunton, Williams, Gay & Gibson

Suite 1060

1730 Pennsylvania Avenue, N.W.

Washington, D.C. 20006

John C. Berghoff, Jr., Esq.

Chadwell, Kayser, Ruggles,

McGee & Hastings

135 South LaSalle Street

Chicago, Illinois 60603

Attorney

Air Quality Noise and

Radiation Divison (EG-333)

David Machanic, Esq.

Pierson, Ball & Dowd

1000 Ring Building

Washington, D. C. 20036

Daniel Gribbon, Esq.

Allan Topol, Esq.

Covington & Burling

888 16th Street, N.W.

Washington, D. C. 20006

H. Edward Dunkelberger, Esq

Theodore L. Garrett, Esq.

Covington & Burling

888 16th Street, N.W.

Washington, D. C. 20006

B8

October 2, 1975

Mr. Dan Cathey

Office of the Clerk

U. S. Court of Appeals for the

District of Columbia Circuit

U. S. Courthouse

Third Street and Constitution Avenue

Washington, D.C.

Re: Ethyl Corporation v. EPA (73-2205) and

related cases

Dear Mr. Cathey:

Enclosed is a copy of Document No. 875, a letter to EPA

dated August 28, 1972, reporting preliminary results of the

first isotope study in Document No. 113. The letter was filed

and indexed with the public comments, under “California

University” and I overlooked it before.

I am also enclosing a copy of the letter sent to opposing

counsel with the copy of my letter to you of September 26,

1975. Identical letters were sent to each counsel.

Sincerely yours,

/s/ LESLIE CAROTHERS

Leslie Carothers

Attorney

Air Quality Noise and

Radiation Division (A-133)

BLEED THROUGH

B9

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ;

Washington, D. C. 20460. '

October 15, 1975

Victor P. Kayser, Esq.

Chadwell, Kayser, Ruggles,

McGee & Hastings

135 South LaSalle Street

Chicago, Illinois 60603

Re: Nalco Chemical Company v. EPA (73-2270)

Dear Mr. Kayser:

Mr. Fitz told me that you were interested in knowing what

documents the Court had requested from the record of the lead

litigation. I am enclosing a copy of our list of the documents

requested to date. As the enclosure indicates, I did not make

note of all the documents requested shortly after the oral argu-

ment; but the type of document is indicated, and the list is

otherwise complete.

Sincerely yours,

/s/ LESLIE CAROTHERS

Leslie Carothers

Attorney

Air Quality Noise and

Radiation Division (A-133)

ce: Mr. William Fitz

DR aie Rr kN ARR IIE IRENE ET EL me

POOR COPY

_r

~ FO ee RAE ieee M7

oO a

i oe ak Pe me

BLO

DOCUMENTS FROM THE ETHYL RECORD

REQUESTED BY THE COURT.

9/22/75

160

170

180

345

835

836

Summary of Comments Relative to EPA Position on Lead

in Gasoline. Undated.

Summary Relative to EPA Position on Lead. Undated.

EPA Reopens Record on Proposed Lead Regulations.

Undated.

Summary of EPA’s Position for Controlling Lead in

Leaded Gasoline. Undated.

International Lead Zinc Research Organization, Inc.

Letter from J. F. Cole, July 30, 1973.

Letter from J. F. Cole, March 9, 1973.

9/3/75

84

85

11]

141

142

143

433

486

Knelson, Role of Clinical Research, etc. (also in

Appendix ).

Knelson, Kinetics of Respiratory Lead Intake in Humans,

May 1973. (Also in Appendix).

Proceedings of Luxemburg Conference.

EPA’s Position on the Health Effects of Lead. (Draft

of Health Paper), October 19, 1973.

EPA's Position on the Health Effects of Lead. (Draft of

Health Paper), July 25, 1973.

EPA’s Position on the Health Effects of Lead. (Draft of

Health Paper), June 22, 197..

Ethyl Transcript of EPA/HEW Symposium, Oct. 1-3,

1973.

Briefing memo for Train, October 1973.

1109 Unsigned, untitled draft of Briefing paper, July 12, 1973.

BLEED THROUGH

Bil

6/9/75

807 DuPont Submission, 3/9/73.

821 Nalco (Calandra) critique of EPA Health Position

Paper, November 19, 1973.

Several letters from industry received just before the Court-

ordered decision date were requested. Specific document num-

bers were not noted.

POOR COPY

See REN ee |

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AOPREME GOMIRT! UL fi

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75-16 '2, 1613, 16/9,

IN THE

Supreme Court of the United States

Ocroper Term, 1975

Eruyn Corpvoration, Petitioner

v.

I.NVIRON MENTAL Prorection AGency, Respondent

PPG Ixpvusrrirs, Ixc., Petitioner

e.

NVIRONMENTAL Prorection Acency, Respondent

K. 1. DePoxr pe Nemours axnp Company, Petitioner

v.

IINVIRON MENTAL Protection AGency, Respondent

Natco Cvemican Company, Petitioner

e.

NVIRONMENTAL Prorection AGENcy, Respondent

NationaL Perrotecm Rerimers Association, Petitioner

v.

NVIRONMENTAL Prorection AGENcy, Respondent

JOINT APPENDIX TO

PETITIONS FOR WRIT OF CERTIORARI

Press oF Byron S. ApamMs Printinc, INc., WASHINGTON, D. C.

~~

BLEED ‘

bes: z

1ROUGH

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 orde

r 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

E. I. DUPONT DE NEMouRs & COMPANY, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

POOR COPY

od

2

No. 73-2270

NALCO CHEMICAL COMPANY, PETITIONER

V.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 74-1021

NATIONAL PETROLEUM REFINERS ASSOCIATION, PETITIONER

V.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

Petitions for Review of an Order of the

Environmental Protection Agency

On Rehearing En Bane

Argued En Banc 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 * * *.”

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

as eo ts eae

am

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, Inc., 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 Administrator’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 Environmental Protection Agency

is

Affirmed.

RYT APEL AONE TS ETI APRONS OR

5

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 Edward J. Shawaker, Attor-

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

spondent. Raymond 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.

Befcre BAZELON, Chief Judge, and WRIGHT, McGowan,

TAMM, LEVENTHAL, ROBINSON, MACKINNON, Ross, 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 Circuit Judge MACKINNON.

Dissenting opinion, in which Circuit Judges TAMM

and Ross join, filed by Circuit Judge WILKEY.

WRIGHT, Circuit Judge: Man’s ability to alter his

environment has developed far more rapidly than his

ability to foresee with certainty the effects of his 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(c) (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 were added

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

31, 1970, 84 Stat. 1698-1700.

PO Heo ee eS PL ek »

7

ficant risk of harm” to the public health. Accordingly,

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 211(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-6c(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.

teh fen td

© eRe ate aN et del

oe

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 cor

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 Tetraethy! 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, “Environmental 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.

BLEED THRO

7

a

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).

POOR COPY

a

i Rel) le lee eed

OOOO EOE EO Eel

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.

SOT eg ET ee SER TEs |

BLEED THRO!

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 Ethyl 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 approach, considered and rejected by EPA,

is to trap and remove lead emissions from the exhausts of

automobiles using leaded gasoline. See note 66 infra.

eNO aE TE PE

ade Os

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 newly-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-developed catalytic converter

emission contro] system.” 36 FED. REG. 1486 (1971).

* See, e.g., 116 CoNG. 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).

*° Regulations promulgated for the latter reason were ap-

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

supra.

ee race ng EES ALO aa 4

PAGED LE NE LET IO LOOM EL DLE EE A NIE

BLEED THRO!

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 FED. REG. 1254; approved in Amoco

Oil Co. v. EPA, 163 U.S.App.D.C. 162, 501 F.2d 722

(1974), reproposed the health-based regulations now at

issue. 38 FED. REG. 1258. The reproposal was supported

by a second health document, EPA’s Position on the

Health Effects of Airborne Lead (hereinafter Second

Health Document), JA 158, and was necessitated by a

modification of EPA’s analysis of the health effects of

lead emissions. The Agency concluded, after considering

the comments received, that it was virtually impossible

to identify the precise amount of airborne lead that will

endanger public health. Instead, the control strategy

would concentrate on evaluating the cumulative effect of

airborne lead on total human lead exposure and the 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 ADDITIONS TO HEALTH HAZARDS

or LEAD (April 27, 1972), JA 272.

POOR COPY

14

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

Natural Resources Defense Council, Inc. v. EPA, D.C.

Cir. No. 72-2233, this court ordered EPA to reach within

30 days a final decision on whether lead additives should

be regulated for health reasons. EPA published its final

health document, entitled EPA’s Position on the Health

Implications of Airborne Lead, on November 28, 1973.

JA 27. This document, the Third Health Document, 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 information, and ultimately concludes that lead

from automobile emissions will endanger the public health.

The same day, based largely on the conclusions of the

Third Health Document, EPA promulgated its final

regulations, accompanied by a thorough discussion of its

health conclusions, the impact of the regulations, and

the alternative courses of action considered and re-

jected. 38 Fep. 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

standards for permissible lead use by each refiner on

the basis of grams of lead per gallon of leaded gasoline

produced (leaded pool averaging), the final regulations

base the standards on grams of lead per gallon of all

gasoline produced (total pool averaging). The quantity of

lead emitted into the atmosphere is the same under both

systems; EPA simply converted its leaded pool figures

into total pool figures. Under the final regulations, lead

in all gasoline would be reduced over a five-year period

to an average of 0.5 grams per gallon.”

—

wiht hatte ae

** 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]

Po LOLOL OLLI AA OI

RBRLEED THR

LIGH

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 g/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).

3 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).

POOR COPY

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 may,

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(c) (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."

1% 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]

5h OE LIEBE GENEL NED LEE IES AISLE EPAS SEE LN ELSIE CGS INE

ENE

BLEED TI

? OUGH

Ee RTE VRE Sa REET tL SS NT my SE RT SRT EAA ES EET DA OE TOP AE

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. § 1857f-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 “will endanger the

public health or welfare,” the Administrator provided

his interpretation 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 Fep. 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.

POOR COPY

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(¢) (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

t

** 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

RI EFEnD '

YR OLICH

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. v. White, 296 U.S. 176, 186

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

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

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

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

59 (1958).

** 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.

DOHHOR COHORDY

Soy

"RESO oN

~ ons

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, 488 (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.

8 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

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 FED. REG. 33734. We agree with the Administrator’s

interpretation. This conclusion is reached not only by

reference to the plain meaning of the statute, but by

juxtaposition of Section 211(¢c)(1)(A) with other 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-

é 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

ce-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

i 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

er ee ee ee

helpful legislative history. What little there is of relevance

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

*° Should there be any doubt about this conclusion, it is

quickly resolved by reference to § 109. There Congress

AOL REI ALIN SG ie EL EF IEICE A TOE MIG IES INET ED A

BLEED THROL

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, —— USS.

——, 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.

** 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. Sec-

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.”

Soe tall

j air pollutants under § 108 is mandatory. Its petition for

4 review of these regulations raising that issue was dis-

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

: sources Defense Council, Inc. v. EPA, 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).

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

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

*8 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-

SEES T LOT EELS OIE ETE

BLEED THRO

GH

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; Naleo 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 42-43. This ignores the fact that once a pollutant is

listed under § 108 the decision to regulate is made; standards

under § 109 must follow. On the other hand, additives 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, precautionary. 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.

POOR COPY

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

F 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

y the air pollution which is found dangerous. Here the

j 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

Bre othe bi atti ¢

ON NOR EE 66 ee

kh ae rca the BIA ES

*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

7 likely to cause or contribute to, air pollution which causes

3 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.

Pentrenicns.. r

3

3

3

s

BLEED THR

UGH

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 health; 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

POOR COPY

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

4 At a RCNA lc

ae RNB iL wry 4

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. Id.

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

; oat caused by air pollutants that are, themselves, dangerous. Thus

. hydrocarbons, whose emission is regulated by § 202, are not

3 themselves always dangerous, but are properly regulated

j because they react in sunlight to form smog, which is danger-

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

i EPA Supp. Br. at 18 n.15. Thus, far from stating a tautology,

~§ 202 allows for the regulation of such apparently innocent

pollutants, which indirectly cause dangerous pollution.

Soll Oh Aina lo gk

anal o 2H abel val

2m AE Ma 8

AMAR ncn: ES UY Nad.

BLEED TH

}OUGH

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 Mininy 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

28 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. v. EPA (Coahoma), 160 U.S.App.D.C. 123,

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

2° 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-

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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. 812, 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

Eighth 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 vy. 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,

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

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 decistons 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

27 ee Oe eT ee ee nts

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.

** 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. Vv. 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

PARI ELENA IIIT PINES PEM

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 “endangering” 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 al) steps

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

EPA, supra note 13, 514 F.2d at 588. 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

3 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 be “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:

as

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.

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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 5386 (emphasis added). Thus the court only ordered

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

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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

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Petition for Writ of Certiorari — E. I. du Pont de Nemours & Co. v. Environmental Protection Agency · 426 U.S. 941 | Frix