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

Supreme Court brief1976

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— = x 7 — aera —- irevene feet. ©. te

a , fobs FILED

No W75-}614 MACHAEL RODAK, JR., CLEAR

IN THE

Suprene Court of the United States

Ocroper Term, 1975

NATIONAL PrrroLeuM REFINERS ASSOCTATION,

ASHLAND Onn, INc..

CLARK Orn & REFINING CORPORATION,

Kerr-McGer Corroration,

Mounawk Perroceum Corroratrion, INC..,

Petitioners,

ENVIRONMENTAL Prorection AGENCY, Respondent.

PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE DISTRICT OF COLUMBIA CIRCUIT

STEPS REA TNS amg

bibl ELI igor

OSL I TE PR are np BD

Trae. A

;

Hi. Epwarp DUN KELBERGER, JR. }

THropore L. Garrerr i

COVINGTON & BURLING

SSS Sixteenth Street, NW,

Washington, D.C. 20006

Afforneys for Petitioners

Mav 5. 1976

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TABLE OF CONTENTS

Page

ee a i a ne eee 2

eI Ps ean ac oa eb ae Raed Si oie

Og eee ee re Pre ere 2

STATUTES AND REGULATIONS INVOLVED .............-. 3

STATEMENT OF THE CASE ...........cccccccccccccecs 4

Proceedings Before the Agency ................ 6

ee Se dL dicce kh deewasuadeouuwoem 8

REASONS FOR GRANTING THE WRIT .............eee00- 10

I. The Decision Below Which Upheld EPA Regu-

lations Based Upon New Evidence Which Was

Never Brought to the Public’s Attention So As

To Allow for Informed Public Participation Is

Contrary to This Court’s Decision in Bowman

Transportation and Inconsistent With the Re-

quirements of the APA and Fundamental Re-

quirements of Due Process .................-.

II. The Decision Below Is Contrary to the Mandate

of Congress in Holding That the Administrator

Has Quasi-Legislative Power To Reach a De-

termination Which ‘‘Is Necessarily a Question

of Policy’’ and Which Need Not Be Based Upon

SO We. Nob ck doe end bees Woke eee ree

III. The Decision Below Presents Important Ques-

IV.

CoNCLUSION

tions As To the Proper Role of the Judiciary

in Reviewing Agency Action and Conflicts With

This Court’s Decision in Citizens To Preserve

Overton Park

The Decision Below Is Inconsistent With Con-

gressional Policy Requiring EPA To Consider

Alternative Means of Limiting Lead Emissions

GAY PONIES AIT RT AA

TABLE OF AUTHORITIES

Page

CASES:

Bowman Transportation Inc. v. Arkansas-Best Freight

System, 419 U.S. 28 (1974) ................ 11, 12, 13

Buckeye Power Inc. v. EPA, 481 F.2d 162 (6th Cir.

ee rnd awe ihadoe Ameen e eas 13

Citizens to Preserve Overton Park, Inc. v. Volpe, 401

8 a eee ee 18, 19, 20

International Harvester Company v. Ruckelshaus, 478

pe pf 8. oe Se: eer 13

NRDC vy. EPA, D.C. Cir. No. 72-2233 (1973) ........ 7

NRDC v. Train, 8 ERC 1695 (S.D.N.Y. 1976) ....... 23

Portland Cement Association v. Ruckelshaus, 486 F.2d

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

Ee ada cacik wane ao se¥ sess 13

S.E.C. v. Chenery Corp., 332 U.S. 194 (1947) ........ 14

Train v. NRDC, 421 U.S. 60 (1975) ................ 4

STaTUTEs:

Administrative Procedure Act

Te lun a agebees-e ee.ew 12

EE ee 18

Clean Air Act, As Amended

gS ene .» op ey ae

a a wc ek scene nnwceenes 4, 22, 23

nee 4, 21, 22, 23

42 U.S.C. § 1857c-5(a)(2)(B) .................. 22

cw wnecececsvess 4, 5, 22

42 U.S.C. § 1857f-6e(e)(1) ............... 3, 16, 17, 22

42 U.S.C. § 1857f-6e(e)(1)(A) ......... 5, 9, 16, 18, 22

42 U.S.C. § 1857f-Ge(e)(2)(A) ................. 22

42 U.S.C. § 1857f-6e(c)(4)(C) ................. 22

UBL. § Wre-ore Cs) ..... 2... 22.0. ...00ee 8

Judicial Code, 28 U.S.C. § 1254(1) ................. 2

REGULATIONS:

eo nec ccccccncncvecces 6

a I OD cnn nn cnc cc cccccncscscene 7

ae Ped. Mow. So7st (1973) ................. 4, 8, 15, 16, 22

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SPURTE SS APES IN AE Ree Lee ee Re

Table of Authorities Continued ili

Page

LEGISLATIVE MATERIAL:

H. Rep. No. 91-1146, 91st Cong., 2d Sess. (1970) ...... 17

S. Rep. No. 91-1196, 91st Cong., 2d Sess. (1970) ...... 17

SEG Cee, TN, Te CAO nc iic rece cccewecscunvene 17

Se Se CINE a voc vn ss senecsinnccceee 22

ee 17

Cong. Research Service, A Legislative History of The

Clean Air Amendments of 1970 (1974) .......... 19

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IN THE

Supreme Court of the United States

OcrToBeR TERM, 1975

NATIONAL PETROLEUM REFINERS ASSOCIATION,

ASHLAND OIL, INC.,

CLARK OIL & REFINING CorPoRATION,

Kererr-McGEE Corporation,

Mouwawk PetTROLEUM Corporation, INC.,

Petitioners,

Vv.

ENVIRONMENTAL ProTecTION AGENCY, Respondent.

PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE DISTRICT OF COLUMBIA CIRCUIT

Petitioners National Petroleum Refiners Associa-

tion et al. pray that a writ of certiorari issue to review

the opinion and judgment of the United States Court

of Appeals for the District of Columbia in this ease.

OPNION BELOW

The opinion of the court of appeals below, on re-

hearing en banc, is unofficially reported at 8 E.R.C.

1785 and is reprinted in the Appendix to this Petition.’

JURISDICTION

The judgment of the court of appeals was entered

on March 19, 1976. Issuance of the mandate of the

court of appeals has been stayed pending the filing of

this petition. The jurisdiction of this Court is invoked

_ pursuant to 28 U.S.C. § 1254(1).

QUESTIONS PRESENTED

The regulations at issue involve fundamental ques-

tions concerning the use of the nation’s limited petro-

leum supplies. The use of lead additives in gasoline

is of paramount importance to the refining industry.

The split decision below, reversing a decision of a

panel of the court of appeals, upholds EPA regula-

tions limiting lead usage based upon an admittedly

speculative health concern that is said to be essentially

unreviewable by the courts. The questions presented

are:

1. Whether the Administrator of the Environ-

mental Protection Agency, acting under the command

of the court of appeals to complete his action within

thirty days, satisfied the requirements of due process

and the Administrative Procedure Act where inter-

ested persons were not provided notice of and an

opportunity to comment on new evidence that was

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3 1This Appendix is also submitted as the joint appendix in

: four related petitions. All five cases involved the same regula-

‘ tions and were jointly decided in the opinion below.

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relied on by him in determining that emission products

of lead additives in gasoline will endanger the public

health.

2. Whether authority has been delegated by Con-

gress to the Administrator to limit the use of lead

additives in gasoline on the basis of a policy judgment

even though the available scientific and medical evi-

dence is speculative and inconclusive as to the effect of

such additives on the public health.

3. Whether appellate review of administrative

agency rulemaking that is based upon scientific and

medical evidence requires examination of the evidence

relied upon by the ageney or is satisfied by a determi-

nation that the agency received and gave considera-

tion to such evidence.

4. Whether, in any event, it was an abuse of dis-

eretion for the Administrator to impose nationally

uniform limitations on the lead content of gasoline,

instead of establishing ambient air quality standards

and providing for regional controls.

STATUTES AND REGULATIONS INVOLVED

Section 211(¢) (1) of the Clean Air Act, as amended,

(‘the Act’’), 42 U.S.C. § 1857f-6e(¢c) (1), grants the

EPA Administrator certain authority to control the

sale of any fuel additive which has emission products

that will endanger the public health, as follows:

‘*(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 regulation, control or pro-

hibit the manufacture, introduction into com-

merce, offering for sale, or sale of any fuel or fuel

additive for use in a motor vehicle or motor vehicle

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a Jo a PWN 8 EEO GL PILI NIRA AS OE DLL RES

engine (A) if any emission products of such fuel

or fuel additive will endanger the public health

or welfare... .’’

“©(2)(A) No fuel, class of fuels, or fuel additive

may be controlled or prohibited by the Adminis-

trator pursuant to clause (A) of paragraph (1)

except after consideration of all relevant medical

and scientifie evidence available to him, including

consideration of other technologically or econom-

ically feasible means of achieving emission stand-

ards under section 1857f-1 of this title.”’

The regulations involved, ‘‘Regulation of Fuels and

Fuel Additives, Control of Lead Additives in Gaso-

line,’ were published in 38 Fed. Reg. 33734 (December

6, 1973) (R. 1) *

STATEMENT OF THE CASE

The principal means by which the Clean Air Act, as

amended in 1970, provides for the protection of public

health and welfare from the harmful effects of air

pollution is the promulgation of national ambient air

standards by EPA under Section 109 of the Act, and

the adoption under Section 110 of state implementation

plans providing for attainment and maintenance of the

standards by such means as emission limitations for

stationary and moving sources, and land use and trans-

portation controls.*

The Act contains supplementary provisions specific-

ally directed at automotive emissions. The preferred

methods of control, as expressed by Congress, are di-

2 References to ‘‘R’’ are to the record as set forth in the

Joint Appendix below.

$49 11.S.C, §§ 1857e-4, 1857-5; see Train v. NRDC, 421 US.

60, 66-67 (1975).

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rect limits on vehicle emissious to be met by auto manu-

facturers under Section 202 of the Act. A different

means of control is provided in Section 211(¢) (1) (A)

of the Act, involved here, which grants EPA certain

authority to control the sale of fuel additives if it finds

on the basis of medical and scientifie evidence that

emission products of such additives ‘‘will endanger”’

the public health.’

The lead additives which are the subject of the regu-

lations at issue in this case are of paramount im-

portance to the refining industry. The use of lead

additives enables refiners to inerease the yield of gaso-

line, at a given octane, which is produced from a quan-

tity of crude oil. It also permits refiners to produce

gasoline of desired octane levels with a minimum of

refinery and processing equipment. The regulations

at issue will have an adverse impact upon the nation’s

energy crisis, and will result in substantial increases

in crude oil usage.” The regulations will also result

in huge added production costs which will be borne by

the consuming public and the refining industry,’ and

442 U.S.C. § 1857f-1.

549 U.S.C. § 1857f-6e(@) (1) (A).

®EPA estimated an increase of between 102,000 and 351,000

barrels per day crude oil usage by 1985, (R. 1538-39). The

Department of the Interior estimated an increase of one million

barrels per day (R. 2494), and the Department of Commerce

projected even higher figures. (R. 2459).

TEPA estimated increased consumer costs from $14 to $75

million by 1980, and additional annual investment costs of #82 to

$113 million by 1980 (R. 1542-43). The Department of the In-

terior estimated consumer costs of over $48 billion in this decade

(R. 2498).

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will have a particularly severe impact on smaller

refiners.*

Proceedings Before the Agency

On February 23, 1972, the Administrator proposed

regulations affecting the use of lead additives in gaso-

line. These proposed regulations would have required

a four-stage reduction of lead in gasoline to 1.25 grams

per gallon by 1977. The reduction portion of the

proposed regulations was based upon an EPA health

paper entitled ‘‘Health Hazards of Lead,’’ which ac-

cepted a certain relationship between air and blood

levels, and made assumptions about the volume of air

inhaled by a person.”” Public hearings were held by

EPA on the proposed regulations in Washington,

D. C., Dallas and Los Angeles in the spring of 1972."

Much of the testimony at the hearings and many of

the written comments received by EPA were critical

of the proposed regulations and EPA’s scientific

assumptions.”

In the light of these criticisms and subsequent pub-

lie comments received, on January 10, 1973, EPA an-

nounced reproposed regulations which would require

a four-stage reduction of lead in gasoline to 1.25 grams

per gallon by 1978. The basis for the new proposal

was that the Administrator had ‘‘re-evaluated’’ his

position and concluded that ‘“‘it is difficult if not im-

SEPA consultants predicted that a number of small refiners

would close as a result of the regulations. R. 1592, 1674-78, 1653.

937 Fed. Reg. 3882-84 (1972) (R. 22).

10 R. 292, 295-96, 254, 272.

"1 R. 1970-2116.

12 R. 2022-69, 2245, 2070.

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possible to rely on the analysis presented in the earlier

proposal”? and that ‘‘the original health position can

no long[er] be considered sufficient.”’’* The repro-

posed regulations were accompanied by a second health

document summarizing EPA’s ‘‘new health position’’ ™

which was based upon the assertion that ‘‘considerable

numbers”’’ of people have elevated blood lead levels,

and that emissions from automobiles contribute thereto.

EPA invited public comment for 60 days on the re-

proposed regulations, and in response to this request,

extensive comments criticizing the new EPA position

and its supporting health document were received, in-

cluding comments from other government agencies.

On October 29, 1973, while EPA was considering these

comments and certain other new data which it had

received, the ageney was required by the court of ap-

peals, in dismissing a premature petition for review,

to reach a final decision on the matter within 30 days."

In response to the court’s order, EPA on November

28, 1973, announced that the Administrator had de-

cided to promulgate in revised form final regulations

to reduce lead levels in gasoline.” The final regula-

tions, published in the Federal Register on December

6, 1973, provided for a five-stage reduction in the

amount of lead in gasoline to an average lead content

13 38 Fed. Reg. 1258 (January 10, 1973) (R. 15).

14 This second health document was entitled ‘‘EPA’s Position

on the Health Effects of Airborne Lead—November 29, 1972.’’

(R. 158).

15 Natural Resources Defense Council, Ine. v. Environmental

Protection Ageney (D.C. Cir. No, 72-2233) (unpublished order).

See Wright Op. 14.

7% R. 1143.

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of 0.5 grams per gallon over a period of five years.

The regulations were accompanied by a preamble”

which refers to new technical documents relied upon

to justify the regulations, including a third lengthy

health position paper.”* Prior to the promulgation of

these regulations, EPA did not provide interested

parties with notice of or an opportunity to comment

either on the new health document upon which the

agency based the regulations, or the new scientific and

medical evidence upon which the agency had heavily

relied.

The Decisions Below

Petitions for review of the final regulations were

filed by these petitioners and others pursuant to See-

tion 307(b)(1) of the Act, 42 U.S.C. § 1857h-5(b) (1).

Petitioners argued that the regulations should be held

unlawful and set aside on several grounds. First, we

argued that EPA’s health concern is speculative and

that the evidence could not support the conclusion,

required by the statute, that the use of lead additives

‘*will endanger the public health.”’ Petitioners also

argued that the regulations should be remanded for an

opportunity to comment on the new evidence relied

upon by EPA. Further, we argued that EPA’s fail-

ure to consider alternative means of limiting auto-

mobile emissions rendered these regulations invalid.

A divided panel of the court of appeals issued its

decision setting aside the regulations on January 28,

1975. The majority opinion by Judge Wilkey, in which

Judge Tamm joined, found the regulations defective

1738 Fed. Reg. 33734 (1973) (R. 1).

1S“*EPA’s Position on the Health Implications of Airborne

Lead,’’ November 28, 1973 (R. 27).

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on the independent grounds that EPA incorrectly in-

terpreted Section 211(¢)(1)(A) of the Act, and that

the Administrator’s decision ‘reflected a clear error

of judgment upon the available evidence.”’ (Panel Op.

69). Judge Wright filed a lengthy dissent which criti-

cized the “‘rigor of the majority’s review,’ and what

he viewed as its undue sensitivity to ‘tthe energy

crisis.’ (Wright Diss. 94).

EPA thereaiter successfully petitioned for rehear-

ing en bane. The court ordered that supplemental

briefs be filed, the case was argued in May 1975, and

on March 19, 1976 the court rendered a deeply divided

(5 to 4) decision affirming the regulations. This time

Judge Wright wrote the principal opinion for the ma-

jority, and Judge Wilkey wrote a dissenting opinion

in which Judges Tamm and Robb joined. In addition,

separate coneurring opinions were filed by Judges

Bazelon and Leventhal, and a separate dissent was

filed by Judge MacKinnon.

Judge Wright’s opinion held (1) that the Adminis-

trator properly interpreted Section 211(¢)(1)(A) to

allow him to make ‘tan essentially legislative policy

judgment, rather than a_ factual determination”

(Wright Op. 37, 46): (2) that the court need not de-

cide whether the Administrator's decision is supported

by substantial evidenee, but only whether it has a ra-

tional basis in evidence (id. at 74-75); and (3) that

EPA’s procedures in failing to provide for comments

prior to issuing the final regulations did not violate the

APA or due process. (Jd. at 98, 110).”

®% Judge Wright's opinion also rejected other arguments raised

by petitioners in challenging the validity of the regulations.

(Wright Op. 110, n. 24).

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In a separate opinion in which Judge McGowan

joined, Judge Bazelon stated that substantive review

of scientific issues by the courts ‘‘is dangerously un-

reliable,’’ but coneurred only because in his view the

majority’s “legislative policy’’ holding would bar a

‘‘close analysis of the evidence.’’ (Bazelon Op. 4).

The principal dissenting opinion by Judge Wilkey

concluded, contrary to the majority, (1) that even aec-

cepting EPA’s interpretation of the statute, the

agency's ‘‘analysis reflected a clear error of judgment

upon the available evidence’? (Wilkey Op. 85), (2)

that the requirements of the APA and due process

were not satisfied because EPA did not bring to the

publie’s attention the new scientific data upon which

it relied in a manner that made informed public com-

ments possible (id. at 32, 86), and (3) that a review-

ing court cannot supply reasons absent from the

agency's formal explanation, and must engage in a

‘substantial inquiry”’ to consider whether the agency’s

decision was based upon a consideration of relevant

factors and whether there was a ‘“‘clear error of judg-

ment.’’ (Jd. at 58, 65).”

REASONS FOR GRANTING THE WRIT

The granting of the petition for certiorari in this

case is supported by several of the grounds that are

traditionally deemed sufficient by this Court to justify

plenary review. The majority opinion expressly ree-

ognized the ‘‘importance of the issues raised’’ (Wright

Op. 113), and it is clear that the questions presented

by the deeply divided opinions in this case raise issues

of national and continuing importance concerning the

20 Judge Wilkey did not find it necessary to reach the other

arguments presented by petitioners. (Wilkey Op. 85, n. 194).

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procedures for public participation in agency rule-

making, the role of the courts in reviewing agency ac-

tion, and the implementation of the Clean Air Act.

This case also raises important questions concerning

the use of the nation’s limited petroleum supplies.

I. The Decision Below Which Upheld EPA Regulations Based

Upon New Evidence Which Was Never Brought to the

Public’s Attention So as To Allow for Informed Public

Participation Is Contrary to This Court's Decision in Bow-

man Transportation and Inconsistent with the Require-

ments of the APA and Fundamental Requirements of Due

Process.

The absence of an opportunity for comment on the

data which formed the basis for the final regulations,

and the resulting due process and APA issues raised

thereby, deeply divided the court below. The regula-

tions involved here were twice proposed, and were

twice the subject of extensive criticism by other gov-

ernment agencies and the public which persuaded EPA

that its hypotheses could not be supported. Despite

the fact that these uncertainties were expressed by the

agency itself in promulgating the final regulations, as

the dissent notes, EPA ‘‘did not risk the same fate

with the Third Health Document.’’ (Wilkey Op. 16).

Instead, in response to a court order that EPA act

within thirty days, the agency rushed into an ill con-

sidered decision based upon a new health document

and new scientifie data.

The ‘‘majority’’ opinion by Judge Wright (one of

the judges who had ordered action within thirty days)

held that the requirements of the APA and due proc-

ess were satisfied because, as reconstructed by the ma-

jority, the agency’s general ‘‘theories’’? (but not the

data relied upon) were the same in the Third Health

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Document, because some of the underlying scientific

data were placed in the agency’s public information

file, and because the remaining data (according to the

majority) were not needed to support EPA’s conclu-

tion or were merely a reexamination of earlier data.

(Wright Op. 98-99, 104-08). In contrast, two con-

curring judges (Bazelon and McGowan) felt that there

was a “failure of the record to clearly disclose the

procedural steps followed by EPA,” and stated that

‘‘ordinarily’’ there should have been ‘‘a remand for

clarification’? except for the possibility that the court

of appeals’ ‘‘thirty-day order interfered with the op-

portunity to do so.’’ (Bazelon Op. 4-5).

The four dissenting judges concluded that the re-

quirements of the APA and due process were not com-

plied with, and that the majority was guilty of sanc-

tioning a departure from ‘‘the usual rules’’ because

“this is an environmental case.’ (Wilkey Op. 50).

The dissent specifically concluded that making certain

information available to a party as a result of a FOIA

suit, and placing information in a public file without

providing any notice as to which data would be relied

upon rendered the opportunity to comment effectively

‘*farciceal.”’ (Id. at 47).

The lack of an opportunity to comment on EPA’s

new health documents and supporting data is totally

inconsistent with an orderly administrative proceeding.

The Administrative Procedure Act requires that an

Agency provide notice of and ‘tan opportunity to par-

ticipate in the rule making through submission of

written data, views, or arguments ...7° 5 U.S.C. § 553

(«). The importance of the right to comment on evi-

denee in an administrative proceeding was empha-

sized by this Court in Bowman Transportation Ine. v.

PIE IEE LIE LIGA IIL EIDE RIE IEE ELS: mel

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Arkansas-Best Freight System, 419 U.S. 281, 288 n. 4

(1974) :

‘‘A party is entitled . . . to know the issues on

which decision will turn and to be apprised of

the factual material on which the agency relies for

decision so that he may rebut it. Indeed, the Due

Process Clause forbids an agency to use evidence

in any way that forecloses an opportunity to offer

a contrary presentation.”’

The decision below is in conflict not only with this

Court’s decision in Bowman Transportation, supra,

but also with previous stated positions of the court of

appeals, and decisions in other circuits.”

In this case, a request for an opportunity to comment

on the new basis for the regulations by one of the peti-

tioners was denied by EPA in a letter dated after the

regulations were promulgated. (See Wilkey Op. 37).

Perhaps, as Judge Macixinnon noted, given the time

constraints imposed on the agency by the thirty-day

order, ‘it was impossible for it to comply with the no-

tice and comment requirements of the Administrative

Procedure Act... .’? (MacKinnon Op. 1). If allowed

to stand, however, this case would sanction a wide de-

parture from this Court’s decision in Bowman Trans-

portation and previous cases interpreting the require-

ments of the Administrative Procedure Act. As noted

by the dissent, ‘‘[i]n no previous case, environmntal

or otherwise, has this court tolerated such ‘public no-

21. 8ee International Harvester Company v. Ruckelshaus, 478

F.2d 615 (D.C. Cir. 1973) ; Portland Cement Association v. Ruckel-

shaus. 486 F.2d 375 (D.C. Cir. 1973), cert. denied, 417 U.S. 921

(1974); Buckeye Power Ine. v. EPA, 481 F.2d 162 (6th Cir.

1973).

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tice’ and ‘opportunity to comment’ as it sanctions

here.”’ (Wilkey Op. 50).

There is a related aspect of the decision below which

warrants review by this Court. As noted by Judges

Bazelon and McGowan, there is a ‘‘failure of the rec-

ord to clearly disclose the procedural steps followed

by EPA.” (Bazelon Op. 5). It is clear that the ma-

jority’s conclusions as to the procedure followed by

EPA were not set forth by EPA, but were rather re-

constructed by the court.” This reconstruction not

only consisted of examining the factual record, but of

evaluating the scientific significance of data to deter-

mine whether its unavailability was prejudicial,” and

filling in gaps in the record and EPA’s explanation

thereof, far beyond any reasonable discernment there-

of, as the dissent makes clear.‘ In doing so, the

majority violated this Court’s admonition that the

courts cannot supply post hoc rationalizations for

agency action. SEC v. Chenery Corp., 332 U.S. 194,

196 (1947).”

Review by this Court is essential to make it clear to

administrative agencies and reviewing courts that

agencies cannot be permitted to base regulations upon

material that was never brought to the public’s atten-

tion in a manner that makes informed public comment

possible.

*2 See Wright Op. 97-110.

23 See e.g. Wright Op. 104 n. 112; compare Wilkey Op. 28, n. 62.

24 See Wilkey Op. 17-50.

25 See also cases cited in Wilkey Op. 65, n. 140.

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II. The Decision Below Is Contrary to the Mandate of Con-

gress in Holding that the Administrator Has Quasi-Legisla-

tive Power To Reach a Determination Which “Is Nec-

essarily A Question of Policy” and Which Need Not Be

Based Upon the Facts.

In promulgating the lead health regulations the Ad-

ministrator has not purported to base them upon a fac-

tual determination that the emission products of leaded

gasoline ‘‘will endanger the public health or welfare.”

Indeed, EPA expressly concludes that the percentage

of total lead exposure from automobile emissions can-

not be determined, that the primary causes of lead ex-

posure are not automotive emissions but rather are

ingestion of lead-based paint in the case of urban

children and ingestion of food in the case of the general

population, and that ‘‘the contention that lead con-

tamination of dust and dirt by automotive emissions

is a significant source of lead exposure’ is simply ‘ta

hypothesis”? which is not supported by data ‘‘to con-

clusively prove or disprove the hypothesis.’ * I:PA

admits that it is ‘difficult to determine what impact

would be achieved by partial or total reduction of lead

from any one souree.’’ At best, EH PA’s action is prem-

ised on its puzzling conclusion that ‘it would be pru-

dent to reduce preventable lead exposure’? and that

since leaded gasoline is a source of lead which can be

2638 Fed. Reg. 33735-36 (1973) (R. 3-4) (emphasis added).

Neither the Administrator nor the EPA health document has taken

the position that the evidence relating lead in gasoline to human

health is reasonably definitive or that further information is

not required. Explanations such as ‘‘a hypothesis’’, ‘‘ preliminary

data show’’, ‘‘not all links in the argument have been established

beyond dispute,’’ ‘‘failure to find consistent correlations’’ and

‘further information is required’? ovcur throughout the preamble

to the regulations and the final health document. (R. 2, 3, 1478,

4, 123).

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‘‘readily’’ controlled by EPA ‘‘in comparison to other

sources”? the agency felt obligated to do so.”

The majority opinion concedes that ‘Shard proof of

any danger caused by lead automotive emissions has

been hard to come by”? (Wright Op. 9), but upheld

the Administrator’s action based upon its decision that

the determination of endangerment to publie 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.”’. (Jd. at 46). In support of this

conclusion, the majority attempts to make a virtue of

necessity by arguing that EPA action based on **spec-

ulation, conflicts in evidence and theoretical extrapola-

tion’’ should be upheld. ‘* How else can they act, given

a mandate to protect the public health but only a slight

or nonexistent data base upon which to draw?” (Jd.

at 47).

The majority’s question is not a rhetorical one, As

the dissent persuasively demonstrates, the court’s hold-

ings flies in the face of the fact that the ‘‘will endan-

ger’’ standard is not a delegation of quasi-legislative

power, and that Congress intended EPA’s determin-

ation under Section 211(¢)(1)(A) to ‘tbe a reasoned

factual determination based solely en the medical and

scientifie evidence.’? (Wilkey Op. 55).

When Congress enacted Section 211(¢)(1) of the

Clean Air Act,” it realized that the authority to regu-

late gasoline and its additives posed complex and im-

portant questions concerning this country’s use of one

*7 38 Fed Reg. 33734 (R. 2).

*8 42 U.S.C. § 1857f-6¢(c) (1).

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of its most vital natural and economic resources, the

proper uses of which have become even more acute

with the recent energy crisis. Accordingly, Congress

expressly required that before the Administrator exer-

cise his authority under Section 211(¢)(1) of the Act,

he would have to make a determination based on ‘‘con-

sideration of all relevant medical and scientific evi-

dence available to him,’’ that the use of an additive

‘will endanger the public health... .’’ Congress did

not have in mind the speculative and hypothetical

health effects which the Administrator relied upon in

the preamble to the regulations and in the new health

document. The Senate and Tfouse Reports empha-

sized that there would have to be ‘ta direct endanger-

ment to the public health,’ and that any standards

established would have to be based on a consideration

of all of the medical and scientific evidence.”

The split decision below has potential significance

far beyond the particular statutory provisions in-

volved. EPA took the step of requesting a rehearing

because the agency felt that it was important to estab-

lish the principle that the Administrator not be re-

quired to act upon “the type of evidence” required by

the original panel. (IPA Supp. Br. 6). The decision

2S. Rep. No. 91-1196, 91st Cong., 2d Sess. 34 (1970) (em-

phasis added); H. R. Rep. No. 91-1146, 91st Cong., 2d Sess. 18

(1970). The Chairman of the House Committee which reported

the bill, Representative Staggers, stated that the Administrator

could control additives ‘*{i]f he has the facts, and he has proven

this by facts, that they are a danger and poisonous.’’ 116 Cong.

Ree. 19230 (1970) (emphasis added). And Senator Baker, rank-

ing minority member of the Conference Committee, stated that

controls could be adopted only if the Administrator found that

the combustion of a given fuel ‘twas, in and of itsclf,’’ an en-

dangerment of the public health. 116 Cong. Ree. 32921 (1970)

(emphasis added).

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ees

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below in accepting EPA’s argument raises the con-

verse issue, namely whether where Congress has ex-

pressly required, as it has in Section 211(¢c)(1) (A),

that a determination be based on a ‘consideration of

all relevant medical and scientific evidence,’’ agency ac-

tion can validly be grounded upon a ‘‘nonexistent data

base’? and vague considerations of ‘‘policy.’? Con-

gress could have provided for an EPA determination

based upon ‘‘policy’’, but it did not do so. This Court

should make it clear that the courts in reviewing

agency action cannot substitute their views for the

express mandate of Congress as to the weight to be

given policy considerations as opposed to scientific

facts relating to health and safety.

III. The Decision Below Presents Important Questions as to

the Proper Role of the Judiciary in Reviewing Agency

Action and Conflicts with This Court's Decision in Citizens

To Preserve Overton Park.

The absence in the record of any support for a

determination that lead emissions from automobiles

are a danger to public health compels the conclusion

that the majority of the court below could not have

subjected that determination to the statutory standard

of judicial review required by the Administrative

Procedure Act and decisions of this Court. That

standard requires a reviewing court to hold unlawful

and set aside agency action which is ‘‘arbitrary, ¢a-

pricious, an abuse of discretion, or otherwise not in

accordance with law.’? 5 U.S.C. §706(2)(A). The

applicable test was discussed at length in this Court’s

decision in Citizens To Preserve Overton Park, Ine.

v. Volpe, 401 U.S. 402 (1971). There the Court em-

phasized that an agency’s determination must be sub-

jected to a ‘‘thorough, in-depth review’’ by ‘‘engag-

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[ing] in a substantial inquiry’ and ‘‘review[ing] the

whole record.’”’? This Court made it clear that although

“It]he court is not empowered to substitute its judg-

ment for that of the agency,’ the ‘tinquiry into the

facts is to be searching and careful,”’ and in every case

the court must determine whether ‘‘the decision was

based on a consideration of relevant factors.’? Id. at

415, 419, 416.

The five-man majority in the court below was itself

deeply divided on this fundamental issue of the role

of the court in reviewing action of the Administrator

under the Clean Air Act. Judge Wright’s definition

of this standard of review on pages 66-74 of his opin-

ion for the most part indicates that he at least under-

took a ‘close serutiny of the evidence’? (Wright Op.

72), but his extensive discussion in footnote 74 at page

69 of his opinion appears to be nothing less than a

rejection of the “clear error of judgment’’ language

of this Court in its Overton Park decision. Further,

Judge Wright refused to give significance to the fact

that the Conference Committee on the Clean Air Act

eliminated the provision in the Senate-passed version

whieh would have provided an express presumption

of validity for action of the Administrator in promul-

gating regulations.”

This uncertainty on the part of Judge Wright in

reconciling his approach to the administrative record

in the light of the Clean Air Act and its legislative

history, as well as the decision of this Court in Over-

ton Park, is compounded by the fact that two members

39 Wright Op. 68 n. 72. See Cong. Reserach Service, A Legis-

lative History of the Clean Air Amendments of 1970 (1974),

Vol. 1 at 386, 149.

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of the majority explicitly refused to accept even Judge

Wright’s approach in reviewing the record. The con-

curring opinions of Judges Bazelon and McGowan,

expressly reject the notion that appellate judges should

steep themselves in technical matters ‘‘to determine

whether the agency has exercised a reason discretion.”’

(Bazelon Op. 1). Instead, these two Judges, which

were essential to the majority, concurred in the deci-

sion only because as they ‘tread the court’s opinion, it

severely limits judicial weighing of the evidence by

construing the Administrator’s decision to be a matter

of ‘legislative policy,’ and consequently not subject to

review with the ‘substantive rigor proper for questions

of fact’ ’’ since **this result would bar the panel’s close

analysis of the evidence....’? (Id. at 4).

As a result of the confusion as to the proper scope

of substantive review of agency action under the Ad-

ministrative Procedure Act and this Court’s decision

in Overton Park, a bizarre result has been reached.

The coneurring opinion of Judges Bazelon and

McGowan indicates that they did not find it necessary

to engage in a close analysis of the evidence. As a

result, only three of the five judges in the majority

were able to form any conclusion as to the adequacy of

the evidence relied upon by the Administrator. On

the other hand, four dissenting judges found that ‘‘no

ralid administrative procedure would countenance

launching an enterprise drastically affecting a sub-

stantial portion of our economy on such a shaky foun-

dation as that relied upon in this case.’’ (Wilkey Op.

35). Review by this Court is essential to eliminate the

uncertainty which the court of appeals found in apply-

ing this Court’s decision in Overton Park, as that deci-

ES eee ee

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sion applies to all agency action based upon scientific

and technical evidence.

IV. The Decision Below Is Inconsistent with Congressional

Policy Requiring EPA To Consider Alternative Means of

Limiting Lead Emissions.

In promulgating these regulations, the Administrator

attempted to deal with what he perceived to be a prob-

lem involving the emission products of lead additives in

gasoline by imposing national, uniform limitations on

the lead content of gasoline. In deciding on this course

of action, the Administrator expressly rejected an

alternative approach of providing for regulation on a

regional basis under Section 108 of the Clean Air Act.

42 U.S.C. § 1857¢-3.

The Administrator’s failure to consider air quality

standards for lead has great significance. In the pre-

amble to the regulations the Administrator concededly

was concerned with air lead levels only in certain

urban areas. (R. 15-16). It is therefore impossible to

justify the Administrator’s adoption of nationwide

rather than regional controls. Under this statutorily

preferred approach, EPA would have published an

ambient air quality standard for lead, which would be

made effective by the adoption of implementation plans

by the states pursuant to Section 110 of the Act. In

those regions of a state where airborne lead could be

shown to result in ambient air levels in excess of the

standard, the state implementation plan could prescribe

emission limitations and ‘‘transportation control mea-

sures’? as necessary to achieve the standard in those

regions. Such measures can include limitations on ve-

hicle use, parking controls, emission limitations for

vehicles, requirement of lead traps on individual

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vehicles, or even controls on the use of lead in gasoline

sold in the region or state.”

The failure of the Administrator adequately to con-

sider this alternative means of control renders his

decision to promulgate regulations under Section 211

an abuse of discretion in view of the admittedly speeu-

lative and inconclusive nature of the available health

evidence, and the fact that the amount of lead in the

atmosphere concededly varies widely from region to

region.

No explanation was offered for the Administrator’s

rejection of the air quality standard and regional ap-

proach under Sections 108-110, other than the Admin-

istrator’s assertion that the choice between these regu-

latory approaches is ‘discretionary with the Admin-

istrator.”’** The Administrator’s conclusion on this

point is inconsistent with both the language of Section

108, and the Congressional mandate that means other

than the control of fuel additives be given preference

by EPA. As recognized by the majority opinion be-

low, when EPA acts under Section 211(¢) (1) (A) “it

is essentially telling manufacturers how to make their

fuel, a task Congress felt the Agency should enter upon

only with trepidation.” ** Congress made its prefer-

ence for alternate means of controls clear by expressly

providing that before EPA exercises its Section 211

authority, it must first consider ‘‘other technologically

or economically feasible means of achieving emission

standards’’ under Section 202. 42 U.S.C. § 1857f-6e

(e)(2)(A).

31 See 42 U.S.C. § 1857e-5(a)(2)(B). Section 211(¢) (4) (C)

provides that state fuel additive limitations can be approved (or

promulgated by the Administrator) only if ‘‘necessary’’ to meet a

national ambient standard. 42 U.S.C. § 1857f-6e(e) (4) (C).

8238 Fed. Reg. 33740 (R. 8).

33 Wright Op. 16 n. 14; see 116 Cong. Ree. 32920 (1970).

PETAR AS RATE ETE PELE RE

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The Administrator’s conclusion concerning Section

108 of the Act not only ignores this Congressional pref-

erence, but also is based on an erroneous legal premise.

According to the majority opinion, the Administrator

had claimed, ‘‘with some statutory support, that action

under Section 108 is discretionary with him.”’ (Wright

Op. at 110-11, n. 124). The Administrator’s conclusion

on this point is inconsistent with the language of Sec-

tion 108, which does not confer discretionary authority,

but which instead provides that if a substance has an

adverse effect on public health and the other criteria

of the statute are met, the Administrator ‘‘shall’’ issue

ambient air quality standards. The conclusion of the

majority below is directly in conflict with a recent de-

cision of the United States District Court for the South-

ern Distriet of New York, which held that in view of

the Administrator’s health position, EPA was required

to take action under Sections 108-110 to deal with auto-

mobile lead, and that this was not a matter of discre-

tion.** Review by this Court is thus warranted to re-

%#NRDC v. Train, 8 E.R.C. 1695 (S.D.N.Y. 1976).

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solve the conflicting positions taken in different cir-

cuits regarding this important matter.

CONCLUSION

For the reasons stated, the Petition for Certiorari

should be granted.

Respectfully submitted,

H. Epwarp DUNKELBERGER, JR.

THEopoRE L. GARRETT

CoviInecTton & BURLING

888 Sixteenth Street, N.W.

Washington, D.C. 20006

May 5, 1976 Attorneys for Petitioners

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IN THE

Supreme Court of the United States

Ocroper Term, 1975

Eruyt Corporation, Petitioner

IeNVIRON MENTAL Prorection AGENCY, Respondent

PPG Ixpusrnrisrs, Ixc., Petitioner

?..

M.NVIRON MENTAL Protection AGEncy, Respondent

KK. 1. DePoxr pe Nemours axnp Company, Petitioner

NVIRONMENTAL Prorection Acency, Respondent

Nanco CHemicaL Company, Petitioner ’

ENVIRONMENTAL Prorection AGENcY, Respondent

Nation at. Perroteum Rerivers Association, Petitioner

IeNVIRON MENTAL Proreerion AGENCY, Respondent

JOINT APPENDIX TO

PETITIONS FOR WRIT OF CERTIORARI

Press oF Byron S. ADAMS PrinTING, INC., WASHINGTON, D. C.

Notice: This opinion is subject to formal revision before publication

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

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

made before the bound volumes go to press.

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

No. 73-2205

ETHYL CORPORATION, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 73-2268

PPG INDUSTRIES, INC., PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 73-2269

K. I. DUPONT DE NEMouRS & COMPANY, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

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——

ot BE se AEE GAS « tee Dei RR

Te PRS es,

No. 73-2270

NALCO CHEMICAL COMPANY, PETITIONER

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 74-1021

NATIONAL PETROLEUM REFINERS ASSOCIATION, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

Petitions for Review of an Order of the

Environmental Protection Agency

On Rehearing En Banc

Argued En Bane May 30, 1975

Decided March 19, 1976

SYLLABUS

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

the Administrator of the Environmental Protection Agency

to regulate gasoline additives whose emission products

“will endanger the public health or welfare * * *,”

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

“

APRS WATE RI + NS

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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 v. 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.

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ee acetate

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

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

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

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

a ee

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

i 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.

7 Pp. 77-97.

; The order of the Environmental Protection Agency

; is

Affirmed.

BLEED THROL

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, Ine. et al. as amici curiae

urging affirmance.

Before BAZELON, Chief Judge, and WRIGHT, MCGowAN,

TAMM, LEVENTHAL, ROBINSON, MACKINNON, Ross, and

WILKEY, Circuit Judges, sitting en bane.

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.

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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(e) (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, Dec.

31, 1970, 84 Stat. 1698-1700.

BROIL EM II — CEE

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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 contro! 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. Rec. 11990.

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.

LEE LE ee ie LAR ppc PR Saw Os

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{re Pee Ae ete a

I. THE FACTS, THE STATUTE, THE PROCEEDINGS

AND THE REGULATIONS

Hard on the introduction of the first gasoline-powered

automobiles came the discovery that lead “antiknock”

compounds, when added to gasoline, dramatically increase

the fuel’s octane rating. Increased octane allows for

higher compression engines, which operate with greater

efficiency. Since 1923 antiknocks have been regularly

added to gasoline, and a large industry has developed to

supply those compounds. Today, approximately 90 percent

of motor gasoline manufactured in the United States con-

tains lead additives, even though most 1975 and 1976

model automobiles are equipped with catalytic conver-

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

' ginning, however, scientists have questioned whether the

addition of lead to gasoline, and its consequent diffusion

into the atmosphere from the automobile emission, poses

a danger to the public health.? As use of automobiles,

* The principal studies and symposia over the years on the

subject have included Sayers et al., “Experimental Studies

on the Effect of Ethyl Gasoline and Its Combustion Prod-

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

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

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

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

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

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

HEW, “Symposium on Environmental Lead Contamination,”

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

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

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

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

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

European Communities, Proceedings of International Sym-

posium, “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.

—-

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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).

OE SRE RET TIES

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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.’

OP Soi Se eet PP OTR REE Gat te BO OOM RE

A second major source of the body’s lead burden, at

least among urban children, is regarded as controllable,

j 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

t 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

2 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.

BLEED THROUGH

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

simp!y 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.

7 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.

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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-

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

De a a a ot et

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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.

11 JA 292. This document was subsequently revised by

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

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

JA 276; and CORRECTIONS AND ADDITIONS TO HEALTH HAZARDS

oF LEAD (April 27, 1972), JA 272.

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awe

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

j 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.

q JA 27. This document, the Third Health Document, ex-

; tensively details and reviews the state of knowledge of

4 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 FED. 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.”

** 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]

BLEED THROUG

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).

13 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. v. EPA, 514 F.2d

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

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wat Se SSA RD a aed esc a ak So PE SA

| Lar ts

)

‘

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). Sec-

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

ministrator to set standards for emission of pollutants

from automobiles (as opposed to standards for the com-

position of the gasoline that produces the emissions), and

is thus the preferred—although not the mandatory—

alternative under the statutory scheme, presumably be-

cause it minimizes Agency interference with manufac-

turer prerogatives."

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

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

gress felt the Agency should enter upon only with trepidation.

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

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

[continued]

BLEED THROU

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(¢) (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 FED. 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.

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that the statutory language * * * does not require

a determination that automobile emissions alone cre-

ate the endangerment on which controls may be

based. Rather, the Administrator believes that in

providing this authority, the Congress was aware

that the public’s exposure to harmful substances re-

sults from a number of sources which may have

varying degrees of susceptibility to control.

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

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

(A) by not sufficiently appreciating the rigor demanded

by Congress in establishing the “will endanger’ stand-

ard. Therefore, petitioners argue, the Administrator’s

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

tion 10(e)(2)(C) of the Administrative Procedure Act

(APA), 5 U.S.C. § 706(2)(C) (1970).

Petitioners argue that the “will endanger” standard

requires a high quantum of factual proof, proof of ac-

tual harm rather than of a “significant risk of harm.”

See Supplemental brief of petitioner Ethyl Corporation

(hereinafter Ethyl Supp. Br.) at 20. Since, according to

petitioners, regulation under Section 211(c) (1) (A) must

be premised upon factual proof of actual harm, the Ad-

ministrator has, in their view, no power to assess risks

or make policy judgments in deciding to regulate lead

additives. Moreover, petitioners argue, regulation must

be based on the danger presented by lead additives “in

and of themselves,” so it is improper to consider, as the

Administrator did, the cumulative impact of lead addi-

tives on all other sources of human exposure to lead.

We have considered these arguments with care and find

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

** At oral argument, petitioners claimed the regulations

were void because the Administrator had failed to couch his

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

Supplemental brief of petitioner National Petroleum Refiners

BLEED THROL

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 Bor & 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 Vv. Natural Resources Defense Council, Inc., 421 U.S.

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

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PALE DO op Se he DEE eee

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

Case law and dictionary definition agree that endanger

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

endangered, harm is threatened; no actual injury need

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

gered” by a threatening plague or hurricane and yet

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

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

dangered” without actually being harmed. Nonetheless, some

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

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

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

THIRD NEW INTERNATIONAL DICTIONARY 748 (1961) (empha-

sis added).

Not all courts have agreed that “probability” of harm is the

proper determinant of danger. Where grounds for divorce

are few, for instance, courts have interpreted laws allowing

divorce because of inhuman treatment that “endangers the

life” to require only the slightest possibility of actual loss of

life. Thus action that endangers health has been held to

endanger life on the theory that the former cannot be en-

dangered without threatening the latter. See Cole v. Cole, 23

Iowa 433, 438 (1867); Beebe v. Beebe, 10 Iowa 133, 139

(1859). In one of the latest of these cases, mistreatment

that deprived a spouse of needed rest and peace of mind was

held to “endanger” life. Smith v. Smith, 258 Iowa 557, .

138 N.W.2d 453, 456 (1966). We need not decide here how

remote the possibility of actual harm could be under the

“will endanger” standard since we accept the Administrator’s

determination in this case that a “significant” risk to health

falls within the statutory language. See pages 31-36 infra.

® 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

A sice

BLEED THROUGH

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

(ec) (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).

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

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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-

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

: ministrator to list, for the purpose of establishing national

primary and secondary ambient air quality standards

pursuant to Section 109, each air pollutant “which in

his judgment has an adverse effect on public health or

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

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

to set standards for each automobile emission “which

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

cause or contribute to, air pollution which endangers

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

; U.S.C. § 1857f-1(a) (1).

Petitioners suggest that the threshold decision to reg-

ulate under both Section 108 and Section 202 can be

based on less evidence than required under Section 211

and that, therefore, the proof necessary for action under

Section 211 must be particularly firm. Petitioners mis-

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

verse effect” on health before an air pollutant may be

listed for regulation; actual harm ~ ust result.” This

eck sd aS ses

; 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

BLEED THROUGH

PERT ISAS CML IN PIS = TENN

firm threshold finding is reasonable in light of the con-

siderable disruption caused by action under Sections 108-

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

Administrator must issue national ambient air quality

standards under Section 109 within a year. Promulga-

tion of standards begins the implementation plan process

of Section 110 under which the states must control, on

a mandatory timetable, the listed pollutants to the ex-

tent necessary to achieve the federal standards. Sec-

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

“technology forcing” provisions; the attainment of the

primary, health-based standards takes precedence over

the cost and present technological feasibility of achieving

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

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

, 44 US. 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

dverse 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, 7.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

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SEV ET P RL NO RPL LTP APM

meg

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-

3 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.**

Cet loony sea alta

3 air pollutants under § 108 is mandatory. Its petition for

review of these regulations raising that issue was dis-

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

sources Defense Council, Inc. Vv. 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.

dle ns nena ite ne ai

23 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-

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Petitioners also rely on Section 202 to support their

strict reading of Section 211. Ethyl suggests that Section

202 is more lenient than Section 211 in that it allows

regulation of “likely” dangers. Ethyl Supp. Br. at 18-19.

See also Nalco Supp. Br. at 20-21; NPRA Supp. Br.

directed. Nalco Chemical Company (Nalco) and Ethyl! argue

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

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

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

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

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

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

Nalco points to the “margin of safety” language of § 109

as proof of a “lower standard” under § 108, Nalco Supp. Br.

at 22, without recognizing that the margin of safety refers

only to the implementing requirement of formulating stand-

ards and not to the threshold decision to regulate. NPRA

likewise confuses this point by suggesting that the listing re-

quirement of §108 is like the reporting requirements of

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

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

Br. at 42-43. 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.

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at 31-36. Section 202 provides that the Administrator

may regulate

the emission of any air pollutant {from any new

motor vehicle] which in his judgment causes or con-

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

air pollution which endangers the public health or

welfare.

42 U.S.C. § 1857f-1(a)(1) (emphasis added). While

this language may be unnecessarily opaque, we think a

fair reading disproves petitioners’ suggestion. The itali-

cized language upon which petitioners rely refers not

to the causal relationship between air pollution and

health, but to the relationship between automobile emis-

sions and air pollution.* Thus regulation may not be

premised on a threshold determination of likely danger;

rather regulation must be premised on a determination

of danger, a finding that “air pollution which endangers

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

be regulated. This is essentially the same finding of

endangerment as under Section 211. “Likely” enters

the equation only in determining whether the emitted

air pollutant, which would be regulated, contributes to

the air pollution which is found dangerous. Here the

statute allows for a somewhat attenuated chain of causa-

tion. Regulation may be premised on a determination

that an air pollutant emitted from a new automobile is

likely to contribute to air pollution which endangers the

public health. In establishing this chain of causation

Pre eee re

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Bia aN ORNL Bice is Silene a ENS INN ae

*In essence, petitioners are suggesting § 202 is more

properly read to provide for regulation of any automotive

emission

which in his judgment causes or contributes to, or is

likely to cause or contribute to, air pollution which causes

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

the endangerment of the public health or welfare.

Quite obviously, this is not what Congress said.

tr ny Coe ie See een ek ee! FN

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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

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Re a POO eS aS a

Thus the two sections of the Clean Air Act presented

by petitioners in support of their stringent reading of

the threshold requirement for action under Section 211

turn out, upon analysis, to be of no support at all. Sec-

tion 108 only bolsters our reading of Section 211 as a

precautionary statute while Section 202 includes the

same standard as Section 211 and thus is of no guidance

one way or the other. While petitioners have little more

to offer to prove that the “will endanger” standard

demands proof of actual harm and is not precautionary

in nature, we may turn, in support of our interpretation,

to the relevant case law. While cases interpreting the

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

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

acceptable, although linguistically incorrect, alternative. Jd.

at 33. NPRA argues that the above reading would require

the Administrator to determine whether “the emission

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

to, air pollution... .”

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

NPRA argues, the Administrator would always reach a posi-

tive conclusion, this reading must be incorrect. We agree that

this reading is of little value, but we do not think it is the

proper result of our analysis above. Rather, we think that

to regulate under § 202 the Administrator must find that

emission of the air pollutant is likely to cause or contribute

to dangerous air pollution. This addition is important,

for not all air pollutants contribute to dangerous air pollution

and, more importantly, not all dangerous air pollution is

caused by air pollutants that are, themselves, dangerous. Thus

hydrocarbons, whose emission is regulated by § 202, are not

themselves always dangerous, but are properly regulated

because they react in sunlight to form smog, which is danger-

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

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.

ARSE HL OE ENED SL DD PERIL ERE OW ER RE oe a

PPE MES

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

recent case is directly on point and fully in accord

with our view.

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

Cir. 1975) (en banc), the Eighth Circuit addressed,

among other issues, the meaning of the phrase “endanger-

ing the health or welfare of persons” under Section 1160

of the Federal Water Pollution Control Act of 1970

(FWPCA), 33 U.S.C. § 1160. FWPCA and the Clean

Air Act together constitute the bulk of this nation’s

substantive environmental protection legislation.” As

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. § 4821 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-

4 he >

See AAPA PERRET SNE

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such, and because of their contemporaneous enactment,

interpretations of provisions of one Act have frequently

been applied to comparable provisions of the other. See,

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

166 U.S.App.D.C. 312, 321-822, 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:

ALR STAIR

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

i 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

BS Lit we eaawedeer in ew keas car sk Re ec

ingly according substantive weight to the NEPA language.

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

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

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

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

BLEED THROU

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

8° See Green, The Risk-Benefit Calculus in Safety Deter-

minations, 48 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 decisfons 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

POOR COPY

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

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

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

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

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

recognizes that a risk to public health is not necessarily a

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

of widespread lead poisoning constitutes such a danger. To

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

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

port of its position, Nalco quotes the following language from

Reserve Mining, in which the en banc 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

——— Stet HGR DARDEN SRT VEPA ISSN 229 OTE ES

Bes SERENA MN LENA EPS IE RN sil

BLEED THRC

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 all steps

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

EPA, supra note 13, 514 F.2d at 588. With respect to the

ey SIE ag cn gece

JGH

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waters formed the drinking supply of several surround-

ing communities, while a medical theory, bolstered only

by inconclusive evidence, suggested that ingestion of the

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

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

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

danger cognizable under the Act. The court did not

find that the danger was probable; rather it found the

wastes to 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:

The record shows that Reserve is discharging a

substance into Lake Superior waters which under

an acceptable but unproved medical theory may be

considered as carcinogenic. As previously discussed,

this discharge gives rise to a reasonable medical

concern over the public health. We sustain the dis-

trict court’s determination that Reserve’s discharge

into Lake Superior constitutes pollution of waters

“endangering the health or welfare of persons”

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

the Federal Water Pollution Control Act and is

subject to abatement.

514 F.2d at 529 (footnote omitted) (emphasis added).

The court thus allowed regulation of the effluent on only

a “reasonable” or “potential” showing of danger, hardly

the “probable” finding urged by Ethyl as the proper

reading of the “endanger” language in Section 211.

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

probabilities of danger to be

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

harm attributable to ingestion but on a medical theory

implicating the ingestion of asbestos fibers as a causa-

tive factor in increasing the rates of gastrointestinal

cancer among asbestos workers.

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

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

alien

BLEED THROUGH

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.” Id. at 538.

Reserve Mining convincingly demonstrates that the

magnitude of risk sufficient to justify regulation is in-

versely proportional to the harm to be avoided. Cf.

Carolina Environmental Study Group v. United States,

supra. It would be a bizarre exercise in balancing

horrors to determine whether cancer or lead poisoning

is a greater harm to be avoided,** but fortunately such

balancing is unnecessary in this case. Undoubtedly, the

harm caused by lead poisoning is severe; nonetheless,

the Administrator does not rely on a “potential” risk

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

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

no known safe human exposure level for carcinogens. Nalco

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

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

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

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

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

caused by lead poisoning is less significant than that caused

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

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

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

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

line reduced to the lowest detectable levels, but rather directed

a phased cutback to what he deemed a safe level.

In any case, however, even if cancer is considered more

serious than lead poisoning, the Administrator acted based on

an assessment that the risk of lead poisoning from automobile

emissions wa#@tensiderably greater than the cancer risk that

motivated the Reserve Mining court. Thus this greater risk

of an arguably lesser harm still constitutes endangerment.

POOR COPY

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

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

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

siderably more certain than the risk that justified regu-

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

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

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

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

this still less than certain risk the Administrator did not

order the cessation of use of lead additives, but rather

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

conclude that however far the parameters of risk and

harm inherent in the “will endanger” standard might

reach in an appropriate case, they certainly present a

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

avoided is widespread lead poisoning and the risk of that

occurrence is “significant.” “

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

a sufficient probability of occurrence to fall within the “will

endanger” standard is bolstered by the fact that Congress

did not employ various modifiers frequently used (in the

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

dangerment. Thus Congress did not require that the lead

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

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

sions pose an “imminent and substantial endangerment” to

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

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

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

528. We find these omissions more significant than the use

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

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

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

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

a conclusion with which we agree.

Whether the evidence relied upon by the Administrator is

sufficient to support his finding of a “significant risk of harm”

is discussed below at pp. 66-97 infra.

- —s in > ve Sines eine hia "7

g Rea rn ery ns Saree os se os

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POLES SS IT

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

titioners argue that Section 211 requires the Adminis-

trator to make a “threshold factual determination” that

automobile emissions “will endanger” the public health,

Naleo Supp. Br. at 15-20; Ethyl Supp. Br. at 24-26,

and dispute EPA’s claim that the Administrator may

make “an essentially legislative policy judgment, rather

than a factual determination, concerning the relative

risks of underprotection as compared to overprotection.”

Industrial Union Department, AFL-CIO v. Hodgson,

162 U.S.App.D.C. 331, 339, 499 F.2d 467, 475 (1974).

We must reject petitioners’ argument, since the power

to assess risks, without relying solely on facts, flows

inexorably from the nature of the “will danger” stand-

ard. We have already found that Section 211 allows

the Administrator to regulate fuel content when he finds

that emissions cause a significant risk of harm to the

public health. Yet, how can the Administrator deter-

mine that a risk is a significant risk if he cannot

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

not make policy judgments? Surely reliance on “facts”

as contemplated by petitioners will provide little guid-

ance. However, sole reliance on facts was not demanded

by Congress.”

* Besides the arguments discussed below, petitioners sup-

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

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

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

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

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

ment ignores an important difference between the cited sec-

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

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

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

Because of the mandatory nature of the provisions, express

provision for administrative discretion via the “judgment”

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

Administrator “may” regulate if emissions “will endanger”

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wy tee

i sl

Originally, it is true, it appeared that Congress would

severely restrict the Administrator’s ability to assess

risks and make policy judgments to protect public health.

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

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

trol fuels or fuel additives only if the determination that

their emission products would endanger the public health

were established

on the basis of specific findings derived from rele-

vant medical and scientific evidence, including * * *

a finding that it is not otherwise technologically or

economically feasible to achieve the emission stand-

ards established pursuant to section 202 of this Act.

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

(emphasis added). The specific findings requirement had

more than procedural significance. It limited the scope

of evidence on which the Administrator could proceed,

made alternative action under Section 202 mandatory

if possible, and was widely interpreted in the House, as

the extracts of debate relied upon by petitioners show,

Ethyl Supp. Br. at 24; NPRA Supp. Br. at 30; Nalco

Supp. Br. at 15, as requiring that any EPA action be

the public health. Since discretion is provided in the directive

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

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

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

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

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

The irrelevancy of the omission is shown by the Amoco

decision, where the court construed § 211(c) (1) (B), which,

like its sister section at issue here, does not contain the phrase

“in his judgment.” Nonetheless, the court recognized the Ad-

ministrator must, necessarily, have the power to assess risks

and make policy decisions under that section whenever the

determinations called for are judgmental. Amoco Oil Co. Vv.

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

at 740-741, quoted in text at pp. 43-44 infra.

FEE IE RRL LS EIR SE

rey

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

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

** Petitioner Nalco argues that if the specific requirement,

and its subsequent deletion, have substantive effect at all,

that effect relates not to the threshold decision to regulate,

but to the subsequent implementing decisions about how to

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

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

gests that specific findings are required in setting “stand-

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

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

was intended to exempt the threshold decision to regulate

from the specific findings requirement, and equally doubtful

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

practical matter it is questionable whether specific findings

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

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

prerequisite to any subsequent specific findings. Second, the

legislative history makes it clear that the House intended the

specific findings requirement to apply to the threshold regu-

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

ber Rep. Staggers, chairman of the committee that drafted

the bill, was confronted with questions about the basis on

which the Administrator could regulate fuel additives. Rep.

Staggers responded that the Administrator could regulate

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

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

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

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

gers then quoted the specific findings provision that Nalco

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

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

tee, made clear that the threshold determination—that the

gasoline additive endangers health—must be made on the

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

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

are made by knowledgeable committee members the legisla-

tive history is clear that specific findings were intended for

the threshold decision to regulate.

This conclusion is bolstered by § 211(c)(1)(B) and its

interpretation by the Amoco court. Section 211(c) (1) (B),

unlike § 211(c) (1) (A), retain- the finding requirement and

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PE LINE GUO A AEE INES, TOE RETO MOS AED

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

preference for less restriction of EPA freedom in regu-

lating fuel additives for health reasons* was adopted

the requirement is phrased as ambiguously as the specific

findings requirement in the House version of § 211(c) (1)

(A). The Amoco court recognized that a literal reading of

this findings requirement (which it termed “awkwardly

drafted,” Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.

D.C. at 179, 501 F.2d at 739), would produce an anomalous

result, just as the literal reading now urged by Nalco of the

deleted findings requirement would produce an anomalous

result. “Thus in a literal sense the provision requires ‘find-

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

ministrator must ‘consider.’” Jd., 163 U.S.App.D.C. at 176,

501 F.2d at 736 (emphasis in original). The court rejected

this literal, nonsensical, reading and instead read the statute

to require a threshold factual finding that regulation was

necessary under § 211(c)(1)(B). Jd., 163 U.S.App.D.C. at

176-178, 501 F.2d at 736-738.

Based on the legislative history of the House proposed

§ 210(g) and the Amoco precedent relating to the parallel

section, it is clear that had the proposed specific findings re-

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

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

tual finding for the threshold decision to regulate, and not

necessarily specific findings for all the subsequent implement-

ing decisions.

** The original Senate version of the bill provided:

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

formation obtained under subsection (b) of this section

[which required fuel manufacturers to furnish various

information to the Secretary] or other information avail-

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

duction into commerce of any fuel or fuels for use in

vehicle engines if the combustion or evaporation of such

fuel produces emissions which endanger the public

health or welfare * * *.

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

ate bill drew a distinction between regulation on public health

and public welfare grounds and required that regulation for

the latter reason be preceded by public hearings. Id. § 212

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

tas ial

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by the conference committee and ultimately enacted into

law.*° Although the legislative history does not expressly

health-welfare dichotomy the Senate version became § 211

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

templated a factual threshold determination. Nalco Supp.

Br. at 15-16; Ethyl Supp. Br. at 24-26; NPRA Supp. Br. at

30. Their arguments are without merit. While the House

debate contains several references to the need for such a de-

termination, always coupled with discussion of the “specific

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

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

ceedings to the need for a factual threshold finding. Instead

they identify discussions of danger and suggest that these

somehow imply that the assessment of danger be factually

based. The implication is nonsensical; the cited discussions

do no more than reiterate the language of the statute, which

does not in terms require a factual finding. See S. Rep. No.

91-1196, 91st Cong., 2d Sess. 117 (1970) (“if the combustion

or evaporation of such fuel produces emissions which en-

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

sion that is a direct endangerment to the public health’)

(see notes 25 & 36 supra); 116 CONG. REC. 32921 (1970)

(statement of Sen. Baker) (“emissions that, in and of them-

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

infra). When compared with the explicit House discussion

of the need for a factual finding, these statements only show

that the Senate intended no such thing. Ethyl also cites this

excerpt from the Senate Report:

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

in commerce which may provide emissions that, he finds,

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

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

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

bill explicitly deleted the finding requirement for action un-

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

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

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

only demonstrates the judgmental nature of the Administra-

tor’s decision. See note 37 supra.

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

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

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discuss the reasons for the change,’ the contrast in lan-

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

“finding” the Administrator is required to make is that

any fuel additive that might replace one that is pro-

hibited does not cause emissions that will pose the same

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

assess legislative intent. House discussion centered on a

significantly more rigorous bill, and statements such as those

offered by petitioners from the House debate prove only the

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

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

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

instance, directly relates the need for a factual threshold

determination to the “specific findings” requirement. As

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

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

ous threshold requirement. See note 38 supra.

** Neither the House managers’ conference report nor the

summary of the conference agreement prepared for the Sen-

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

See Conference Agreement on the Clean Air Amendments of

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

(1970) ; Summary of the Provisions of Conference Agreement

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

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

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

need for flexibility in applying § 211 is made clear:

[T]he conference committee wishes to call the attention

of the Administrator to the broad environmental, esthe-

tic and health considerations underlying the enactment

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

ing these determinations [to control or prohibit a fuel

or fuel additive].

116 CONG. REC. 42386 (1970). See Amoco Oil Co. v. EPA,

supra note 2, 163 U.S.App.D.C. at 173-174, 501 F.2d at 733-

734. In the absence of legislative history discussing the

change, we must rely on the language of the present law and

its contrast to the rejected House version.

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

quoted in text at p. 64 infra.

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impact of the change is clear. All of the requirements

for specific findings quoted above are replaced by re-

quirements that the Administrator “consider” the speci-

fied evidence. The mandatory deference to Section 202

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

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

Amoco, construing a similar change in parallel Section

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

a deliberated one and was meant to have significance.”

Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 178,

501 F.2d at 733.

In this case the decision has even more significance

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

at issue in Amoco, the Administrator was still required

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

adjective “specific.” For regulation under Section 211

ment was dropped, and no greater restriction was placed

on the Administrator than that required by the “basis

and purpose” statement of Section 4(b) of the APA, 5

U.S.C. §553(c). We interpreted the meaning of the

limited findings requirement for acting under Section

211(c) (1) (B) in Amoco:

[W]e read Section 211(c) (2)(B) as incorporating

the commonsense approach which the courts have

*3 See note 14 supra.

**The House bill required the Administrator to act only

on the basis of the required specific findings. The Senate and

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

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

manufacturers to furnish the Administrator with information

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

various tests on the compounds and furnish him with descrip-

tions of testing techniques. The Administrator is also free

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

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

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

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EY PPE Re

Te Une iaaD:

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

Where EPA’s regulations turn crucially on factual

issues, we will demand sufficient attention to these

in the statement to allow the fundamental ration-

ality of the regulations to be ascertained. Where,

by contrast, the regulations turn on choices of pol-

icy, On an assessment of risks, or on predictions

dealing with matters on the frontiers of scientific

knowledge, we will demand adequate reasons and

explanations, but not “findings” of the sort familiar

from the world of adjudication.

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

; 181, 501 F.2d at 740-741 (emphasis added). Thus the

, Amoco court read the limited findings necessary for ac-

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

ment that demanded actual findings for questions of fact

and something less—“adequate reasons and explanations”

—for questions of policy.

As petitioners correctly point out, the Amoco court

applied this approach by holding that the threshold

determination whether to regulate at all under Section

211(c)(1)(B) was essentially a question of fact, for

3 which a factual finding must be offered. In suggesting

4 that such a finding is necessary for action under Sec-

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

pletely ignore the fact that a finding is required for

action under Section 211(c)(1)(B) and is not required

under Section 211(c)(1)(A). By so glossing over the

language of the statute, petitioners miss a vital differ-

ence between the threshold determinations under Sec-

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

ministrator must find in order to act under Section 211

Suttle cas

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

the agency to “incorporate in the rules adopted a concise

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

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

2 Re FSS 6G RE LAME Ris RODS CIB

De as athe aS a ca worry .

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additive to be regulated

will impair to a significant degree the performance

of any emission control device or system which is

in general use, or which the Administrator finds

has been developed to a point where in a reasonable

time it would be in general use were such regula-

tion to be promulgated.

42 U.S.C. § 1857f-6e(c) (1) (B). At its core, this is a

peculiarly factual finding. Will the emission impair

the performance of a control device? Is the device

in general use, or has it the potential to be? These

were the questions, highly suitable to factual proof, that

the Amoco court construed. Contrary to petitioners’

implication, the court did not hold that any threshold

determination to regulate must be based on factual

proof, but that this threshold determination must be

factually based. The Section 211(c)(1)(A) threshold

determination, however, is inherently unlike that of its

sister section. “Endanger,” as we have suggested above,

is not a standard prone to factual proof alone. Danger

is a risk, and so must be decided by assessment of risks

as well as by proof of facts.

Thus a reason emerges for the deletion of the findings

requirement for action under the “will endanger’ stand-

ard. The Amoco court held the findings requirement of

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

mal demands of the basis and purpose statement of the

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

at 179, 501 F.2d at 739. What Congress was doing,

then, was using the findings requirement to indicate

which section demanded a factual threshold determina-

tion and which section did not. While inclusion of the

phrase was unnecessary in that the APA would have

demanded a factual threshold determination under Sec-

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

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findings requirement served to emphasize to the Ad-

ministrator the demands of the APA and the intent of

the Congress. While Congress did not discuss the extent

of the Administrator’s power under the “will endanger”

standard, its actions—the statute it enacted and the one

it rejected—make the legislative intent clear. We find

that deletion of the findings requirement for action

under Section 211(c) (1) (A) was a recognition by Con-

gress that a determination of endangerment to public

health is necessarily a question of policy that is to be

based on an assessment of risks and that should not be

5 bound by either the procedural or the substantive rigor

proper for questions of fact.

This conclusion follows not only from the language

of Section 211(c)(1)(A) and its legislative history,

but from the nature of the Administrator’s charge:

to protect the public from danger. Regulators such as

the Administrator must be accorded flexibility, a flexi-

bility that recognizes the special judicial interest in

favor of protection of the health and welfare of people,

even in areas where certainty does not exist. Environ-

mental Defense Fund, Inc. v. Ruckelshaus, 142 U.S.

App.D.C. 74, 88, 489 F.2d 584, 598 (1971).

Questions involving the environment are particularly

prone to uncertainty. Technological man has altered

his world in ways never before experienced or antici-

pated. The health effects of such alterations are often

unknown, sometimes unknowable. While a concerned

Congress has passed legislation providing for protection

of the public health against gross environmental modifi-

cations,*® the regulators entrusted with the enforcement

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

Pollution Control Act, 833 U.S.C. § 1151 et seq.; Federal In-

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

et seq.

| oe ne

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of such laws have not thereby been endowed with a

prescience that removes all doubt from their decision-

making. Rather, speculation, conflicts in evidence, and

theoretical extrapolation typify their every action. How

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

health but only a slight or nonexistent data base upon

which to draw? Never before have massive quantities

of asbestiform tailings been spewed into the water we

drink.” Never before have our industrial workers been

occupationally exposed to vinyl chloride“ or to asbestos

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

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

never before have hundreds of thousands of tons of

lead emissions been disgorged annually into the air we

breathe. Sometimes, of course, relatively certain proof

of danger or harm from such modifications can be

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

cal concerns” and theory long precede certainty. Yet the

statutes—and common sense—demand regulatory action

to prevent harm, even if the regulator is less than

certain that harm is otherwise inevitable.

Undoubtedly, certainty is the scientific ideal—to the

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

But certainty in the complexities of environmental medi-

cine may be achievable only after the fact, when scientists

‘7 Reserve Mining Co. v. EPA, supra note 13.

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

pra note 35.

4° Industrial Union Department, AFL-CIO v. Hodgson,

supra note 35.

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

supra note 28.

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

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

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

with high probabilities of validity. Scientists typically speak

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

POOR COPY

have the opportunity for leisurely and isolated scrutiny

of an entire mechanism. Awaiting certainty will often

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

titioners suggest that anything less than certainty, that

any speculation, is irresponsible. But when statutes seek

to avoid environmental catastrophe, can preventive, albeit

uncertain, decisions legitimately be so labeled?

The problems faced by EPA in deciding whether lead

automotive emissions pose a threat to the public health

on probabilities that statistically constitute “certainties.” See

generally T. KUHN, THE STRUCTURE OF SCIENTIFIC REVOLU-

TIONS. While awaiting such statistical certainty may consti-

tute the typical mode of scientific behavior, its appropriate-

ness is questionable in environmental medicine, where regu-

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

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

The uncertainty of scientific fact parallels the uncertainty

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

selves nothing more than risks, or statistical probabilities.

See D. HUME, A TREATISE OF HUMAN NATURE, bk. I, pt. III,

§ 6, at 87 (L.A. Selby-Bigge ed. 1958).

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

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

considerably less than certain:

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

which was developed at the hearing; this evidence is

substantial enough to support the conclusions of the Ad-

ministrator, although it possibly might support contrary

conclusions as well. Considering the evidence as a whole,

we cannot say that the Administrator’s decision was not

based on substantial evidence, even if the hazardous

nature of DDT has not been proved beyond a reasonable

doubt. Sufficient evidence has been adduced to show

potentially great dangers from DDT, and the Adminis-

trator’s decision to cancel the DDT registration is well

within his statutory authority.

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

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

phasis added).

BLEED THROUGH

highlight the limitations of awaiting certainty. First,

lead concentrations are, even to date, essentially low-

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

terialize until after a lifetime of exposure. Contrary

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

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

emissions at present levels have been with us for no

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

the ambient air is pervasive, so that valid control groups

cannot be found against which the effects of lead on

our population can be measured. Third, the sources

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

difficult to isolate the effect of automobile emissions.

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

siderations of decency and morality limit the flexibility

of experiments on humans that would otherwise accele-

rate lead exposure from years to months, and measure

those results. Cf. Environmental Defense Fund, Inc.

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

1299 (1975).

The scientific techniques for attempting to overcome

these limitations are several: toxicology can study the

distribution and effect of lead in animals; epidemiological

techniques can analyze the effects of lead emissions on

entire populations; clinical studies can reproduce in

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

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

greater than air lead concentrations over the mid-Pacific

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

The Panel attributed these high concentrations primarily to

automotive emissions. /d.

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

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

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

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

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

See note 97 infra.

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laboratories atmospheric conditions and measure under

controlled circumstances the effects on humans. All of

these studies are of limited usefulness, however. Dr.

J. H. Knelson, Director of EPA’s Human Studies Lab-

oratory, has described, in the context of setting ambient

air standards, the limitations of these various investiga-

tive tools:

Each of these investigative approaches—classic

toxicology, epidemiology, and clinical research has

its advantages and disadvantages. The toxicologist

can control the dose and use invasive or destructive

techniques in measuring response in the animal, but

is always faced with the problem of extrapolating

results to humans. Epidemiology is most relevant

because it studies phenomena actually occurring in

humans under “natural” conditions, but can only

draw inference from observed correlations rather

than prove cause and effect relationships. Clinical

research can provide the most accurate dose-

response relationships in the species of interest.

Precisely because the study subjects are humans,

however, many experimental design problems are

encountered in assuring their safety. Although the

dose of an atmospheric pollutant can be carefully

controlled and measured in the clinical laboratory,

_ qualitative comparability to the multiplex variable

of atmospheric pollution eannot always be assured.

The *best scientific criteria for establishing air

quality standards result from interactions between

these disciplines. Clinical studies must be preceded

by exhaustive toxicological assessment in other

species; observations from population studies should

play an important role in the experimental design

of clinical research. Biomedical data from all these

sources, taken in their entirety, should be used for

the prudent definition of air pollution control needs.

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

rived from relating all three research approaches. This

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

xT ee HF a

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EEE PIE AEDT PT

basis to disagree is hardly surprising, since the results

are still uncestain, and will be for some time. But if

the statute accords the regulator flexibility to assess risks

and make essentially legislative policy judgments, as we

believe it does, preventive regulation based on conflict-

ing and inconclusive evidence may be sustained. Recent

cases have recognized thts flexibility in similar situations.

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

son, supra, this court considered the Secretary of Labor’s

delegated power under the Occupational Safety and

Health Act (OSHA), 29 U.S.C. § 651 et segq., to protect

the health of industrial workers by setting standards

for exposure to industrial pollutants. Under review was

a standard for exposure to asbestos dust, thought to be

carcinogenic. Judge McGowan, writing for the division,

laid down the rule:

From extensive and often conflicting evidence, the

Secretary in this case made numerous factual de-

terminations. With respect to some of those ques-

tions, the evidence was such that the task consisted

primarily of evaluating the data and drawing con-

clusions from it. The court can review that data in

the record and determine whether it reflects sub-

stantial support for the Secretary’s findings. But

some of the questions involved in the promulgation

of these standards are on the frontiers of scientific

knowledge, and consequently as to them insufficient

data is presently available to make a fully informed

factual determination. Decision making must in

that circumstance depend to a greater extent upon

policy judgments and less upon purely factual analy-

sis."*

** Where existing methodology or research in a new era

of regulations is deficient, the agency necessarily enjoys

broad discretion to attempt to formulate a solution to

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

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

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

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

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This rule was likewise applied in The Society of the

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

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

Second Circuit reviewed regulations limiting industrial

exposure to vinyl chloride, also considered a carcinogen:

As in Industrial Union Department, AFL-CIO v.

Hodgson, supra, the ultimate facts here in dispute

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

though the factual finger points, it does not con-

clude. Under the command of OSHA, it remains

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

ingman, and to act even in circumstances where

existing methodology or research is deficient. The

Secretary, in extrapolating the MCA study’s finding

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

missible level to the lowest detectable one. We find

no error in this respect.

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

cuit agreed. Although reviewing the determination of a

District Court, not an expert Administrator, the court

recognized that it must nonetheless apply the test of the

preventive statute before it:

[W]e note that many of the issues in this case do

not involve “historical” facts subject to the ordinary

means of judicial resolution. Indeed, a number of

the disputes involve conflicting theories and experi-

mental results, about which it would be judicially

presumptuous to offer conclusive findings [quoting

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

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

such circumstances, the finder of fact must accept

certain areas of uncertainty, and the findings them-

selves cannot extend further than attempting to as-

sess or characterize the strengths and weaknesses

of the opposing arguments.

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

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These cases, recognizing as they do the developing

nature of environmental medicine, fortify our analysis

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

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

°° Ethyl argues that Industrial Union and Society of the

Plastics Industry are distinguishable from this case in that

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

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

while action under § 211 is discretionary with the Adminis-

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

the source of the flexibility granted the Secretary, while

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

Clean Air Act the Administrator’s flexibility is derived

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

that necessarily includes risk assessment if its preventive

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

flexibility to the regulator under both acts, the cited cases

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

be exercised.

Nalco asserts that the cases are distinguishable in that

Industrial Union and Society of the Plastics Industry involve

the manner in which standards are set under OSHA, rather

than the Secretary’s power to set standards at all. Nalco Supp.

Br. at 12. This purported distinction is no more than a

factual difference between the cases. Flexibility is necessary

under OSHA only in the manner of setting standards, since

the command to set standards is clear. Under the Clean Air

Act, on the other hand, flexibility is necessary both in

standard-setting and in deciding whether to regulate. The

teaching of the cases is nonetheless applicable.

Reserve Mining shows the spurious nature of both asserted

distinctions. In that case, as here, there was no command to

regulate, only a statutory term of a precautionary nature—

“endangering”—to justify flexibile decision-making (in Re-

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

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

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

theless, Reserve Mining is fully consistent with Industrial

Union and Society of the Plastics Industry, and al. three

cases support our conclusion here.

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

See note 56 supra.

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1S SORTER SIM RIEN ORSH PME NS)

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

on the frontiers of scientific knowledge, the regulations

designed to protect the public health, and the decision

that of an expert administrator, we will not demand

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

proof may be impossible to obtain if the precautionary

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

are not suggesting that the Administrator has the power

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

clear that his conclusions must be rationally justified.

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

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

such cases the Administrator may assess risks. He must

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

quiry does not end there. The Administrator may apply

his expertise to draw conclusions from suspected, but

not completely substantiated, relationships between facts,

from trends among facts, from theoretical projections

from imperfect data, from probative preliminary data

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

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

if rational, form the basis for health-related regulations

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

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

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

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

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

attempting to expand its powers; rather, petitioners seek to

constrict the usual flexibility of the fact-finding process.

Petitioners argue that the Administrator must decide that

lead emissions “will endanger” the public health solely on

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

of scientific facts or reasoning leading [the Administrator]

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

tioners demand sole reliance on scientific facts, on evidence

that reputable scientific techniques certify as certain. Typi-

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

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

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

contrary, the policy guidelines are largely set, both in

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

}

ability of error, by standard statistical measurement, is les

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

Such certainty has never characterized the judicial or the

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

able doubt” standard of criminal law demands 95‘: cer-

tainty. Cf. McGill v. United States, 121 U.S.App.D.C. 179,

185 n.6, 348 F.2d 791, 797 n.6 (1965). But the standard of

ordinary civil litf¥ation, a preponderance of the evidence, de-

mands only 51° certainty. A jury may weigh conflicting

evidence and certify as adjudicative (although not scientific)

fact that which it believes is more likely than not.

Since Reserve Mining was adjudicated in court, this standard

applied to the court’s fact-finding. Inherently, such a standard

is flexible; inherently, it allows the fact-finder to assess risks,

to measure probabilities, to make subjective judgments. None-

theless, the ultimate finding will be treated, at law, as fact

and will be affirmed if based on substantial evidence, or, if

made by a judge, not clearly erroneous.

The standard before administrative agencies is no less

flexible. Agencies are not limited to scientific fact, to 95%

certainties. Rather, they have at least the same fact-finding

powers as a jury, particularly when, as here, they are engaged

in rule-making.

Looking to the future, and commanded by Congress to

make policy, a rule-making agency necessarily deals less

with “evidentiary” disputes than .with normative con-

flicts, projections from imperfect data, experiments and

simulations, educated predictions, differing assessments

of possible risks, and the like.

Amoco Oil Co. Vv. EPA, supra note 2, 163 U.S.App.D.C. at

175, 501 F.2d at 735. An agency’s finding of fact differs from

that of a jury or trial judge primarily in that it is accorded

more deference by a reviewing court. See note 74 infra. Thus,

as a matter of ehialiadicatben law, the Administrator found

as fact that lead emissions “will endanger” the public health.

That in so doing he did not have to rely solely on proved

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

These prescriptions direct the Administrator’s actions.

Operating within the prescribed guidelines, he must con-

sider all the information available to him. Some of the

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

speculative—scientific estimates and “guesstimates” of

probable harm, hypotheses based on still-developing data,

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

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

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

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

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

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

known harm—contemplates no more.

3. Propriety of the Cumulative Impact Approach. In

addition to demanding that the Administrator act solely

on facts, petitioner Ethyl insists that those facts con-

vince him that the emission product of the additive to be

regulated “in and of itself,” i.e., considered in isolation,

endangers health. The Administrator contends that the

impact of lead emissions is properly considered together

with all other human exposure to lead. See page 18

supra. We agree.

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First, Ethyl points to the language of Section 202

allowing regulation of any automobile emission that

“eauses or contributes to, or is likely to cause or con-

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