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

Page

Opinion below----~..----------------------- 1

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Questions presented___.....-.~-------------- 2

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CITATIONS

Cases:

Amoco Oil Co. v. Environmental Protection

Agency, SOA. F. 20 TEB nnn reine nen +

Citizens to Preserve Overton Park v. Volpe,

OD TE, Bie icicectanincnnscnimnnin 19

Industrial Union Department, AFL-CIO v.

Hodgson, 499 F. 2d 467_--------------- 16

Natural Resources Defense Council v. En-

vironmental Protection Agency, No. 72-

2233, decided April 27, 1973 (C.A.D.C.)- 5

Reserve Mining Co. v. Environmental Pro-

tection Agency, 514 F. 2d 492_-----___-- 14

Society of the Plastics Industry, Inc. v.

Occupational Safety and Health Admin-

istration, 509 F. 2d 1301, certiorari de-

hed GR UB. CR nciinccnccccncimansene 16

Statutes:

Administrative Procedure Act (5 U.S.C.):

I TID ciiatisernsitpreitiiciieittseviniigenaiine 22

I T pitctncrts ttickicitecncictenencnsinds 22, 2:

Section 706(2)(A)....--....~......<= 19

(t)

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Statutes—Continued

Page

Clean Air Act, as amended: :

Section 108, 42 U.S.C. 1857e-3__------ 6

Section 109, 42 U.S.C. 1857c-4____----- 6, 29

Section 211(ce)(1)(A), 42 U.S.C.

1857f-6e(e)(1)(A) ----- 2, 14, 17, 18, 23, 28

Federal Water Pollution Act of 1970 (33

eS, | 15

Occupational Safety and Health Act (29

RE FS eae 15

Miscellaneous:

116 Cong. Rec. 19229 (1970) ..-_---------- 2

116 Cong. Ree. 32920 (1970) _._----------- 29

I i crea ienseipnctinnseachonnsionnes 3

rs i atnencacia chien caninentniemasioons 3

EET Le eer 4

Ce a ee 4

caldera eneninien 4

38 Fed. Reg. 33734_.-.--.------ 3, 6, 9, 10, 14, 25

38 Fed. Reg. 33735-33737___--.--.-.~-- 8, 24, 25

ee 10

National Academy of Sciences Report, Air-

borne Lead in Perspective_------------- 3

S. Rep. No. 91-1196, 91st Cong., 2d Sess.

eee 29

Gn the Supreme Court of the nited States

OctoBER TERM, 1975

Nos. 75-1602, 75-1612, 75-1613, 75-1614

E. I. DuPont pE NEMOURS AND COMPANY, ET AL.,

PETITIONERS

v.

ENVIRONMENTAL PROTECTION AGENCY

ON PETITIONS FOR A WRIT OF CERTIORARI TO THE UNITED

STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA

CIRCUIT

BRIEF FOR THE ENVIRONMENTAL PROTECTION AGENCY

IN OPPOSITION

OPINION BELOW

The opinion of the court of appeals, together with

concurring and dissenting opinions, is unofficially re-

ported at 8 E.R.C. 1785, and is reproduced in the

Joint Appendix to the petitions.

JURISDICTION

The judgment of the court of appeals was entered

on March 19, 1976. The petition in No. 75-1602 was

filed on May 3, 1976; the three other petitions were

filed on May 5, 1976. This Court’s jurisdiction is in-

voked under 28 U.S.C. 1254(1).

(1)

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2

QUESTIONS PRESENTED

1. Whether Section 211(¢)(1)(A) of the Clean Air

Act, which authorizes the Administrator of the En-

vironmental Protection Agency to regulate motor

vehicle fuel additives, the emissions of which “will

endanger the public health or welfare,” empowers the

Administrator to regulate lead additives upon a deter-

mination that they pose a significant risk of harm to

the public health, even if it cannot be conclusively

proven as a scientific fact that they cause actual harm.

2. Whether the judicial review of the agency rule-

making in this case was adequate.

3. Whether the Administrator’s decision to regulate

lead additives has a rational basis in the record.

4. Whether on the facts of this case petitioners were

afforded adequate notice of and opportunity to com-

ment on certain materials considered by the Adminis-

trator in formulating his regulations.

5. Whether the Administrator abused his discretion

in deciding to regulate lead additives under Section

211(c)(1)(A) rather than under the provisions of

the Clean Air Act authorizing him to establish

ambient air quality standards.

STATUTES INVOLVED

The relevant statutes are set forth at pages 3-4 of

the petition in No. 75-1602.

STATEMENT

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

amended, 42 U.S.C. 1857f-6e(c) (1) (A), authorizes the

3

Administrator of the Environmental Protection

Ageney (“EPA’’) to control or prohibit the use of

any motor vehicle fuel or fuel additive, the emission

products of which “will endanger the public health or

welfare.’’ Based on a review of the medical and scien-

tific evidence received during an informal rulemaking

proceeding lasting nearly three years, the Adminis-

trator concluded that “lead particle emissions from

motor vehicles present a significant risk of harm to

the health of urban populations, particularly to the

health of city children,” and, on December 6, 1973,

he accordingly promulgated regulations reducing the

use of lead additives in gasoline by 60 percent over

a period of five years. 38 Fed. Reg. 33734 (Jt. App.

2).’ These cases seek review of those regulations.

1. THE ADMINISTRATIVE PROCEEDINGS

On January 30, 1971, the Administrator issued an

advance notice of proposed rulemaking announcing

that he was considering the regulation of lead addi-

tives to gasoline to protect the public health. 36 Fed.

Reg. 1486 (Jt. App. 26). On February 23, 1972,

having concluded that levels of airborne lead ex-

ceeding two micrograms per cubic meter of air were

associated with a risk of harm to public health, the

Administrator proposed regulations requiring the

“Jt. App.” refers to the Joint Appendix to the briefs filed in

the court of appeals, “R. Doc.” refers to documents contained in

the certified index to the record. “NAS Report” refers to Airborne

Lead in Perspective, a report of the National Academy of Sciences

(R. Doc. 14).

PC oe fe ee ee ae a ee a i Sa

4

gradual reduction in the lead content of leaded gaso-

line in order to achieve acceptable air levels of lead

throughout the country by 1977. 37 Fed. Reg. 3882

(Jt. App. 23). An extensive evalution of the medical

and scientific evidence supporting the regulations was

issued simultaneously (Jt. App. 292), comments were

invited to be submitted within 90 days, and public

hearings were held in three cities. On June 14, 1972,

the Administrator reopened the comment period for

an additional 30 days to obtain comments on a num-

ber of specific scientific and policy issues concerning

the health effects of lead. 837 Fed. Reg. 11786 (Jt.

App. 20).

Evaluation of the information and comments re-

ceived led the Administrator to revise his approach

to the evaluation of the health effects of automotive

lead emissions. He determined that the precise micro-

gram level at which airborne lead creates a risk of

harm to public health is difficult if not impossible to

identify, and that in considering the problem of human

lead levels the cumulative effect and relative signif-

* The January 30, 1971 notice also announced that the EPA was

considering regulations requiring the sale of lead-free gasoline

to protect catalytic converter emission control devices on automo-

biles. Such regulations were proposed along with the lead-

reduction regulations on February 23, 1972, and were promulgated

on January 10, 1973. 388 Fed. Reg. 1254. They were upheld in

Amoco Oil Co.y. Environmental Protection Agency, 51 F.2d 722

(C.A.D.C.). and are not at issue here. The use of unleaded fuel

in vehicles requiring it is expected to account for most of the 60-

percent reduction in lead usage projected to occur under both the

lead-free and the lead reduction regulations, 38 Fed, Reg. 33734,

33739-33740 (Jt. App. 7-8).

5

icance of multiple sources of human lead exposure

should be taken into account. On the basis of this re-

analysis the Administrator reproposed lead additive

regulations on January 10, 1973 (38 Fed. Reg. 1258

(Jt. App. 15)), and issued a second evaluation of the

evidence, or “health document,’ explaining the basis

for his conclusions (Jt. App. 158). Conunents were

requested to be submitted within 60 days, although

EPA in fact received and evaluated comments sub-

mitted by interested persons, incitiding petitioners,

up to the time of the promulgation of the final regula-

tions. All comments were placed in the Agency's

public file as they were received,

Shortly after the reproposal the Natural Resources

Defense Council (*NRDC'’) brought an action in the

United States Court of Appeals for the District of

Columbia Circuit to compel EPA to reach a decision

on lead additives forthwith. On April 27, 1973, Judges

Yamm and Robb denied NRDC’s motion for pre-

hearing conference, summary reversal, or expedition

“without prejudice to [NRDC’s] renewing that as-

pect of their motion seeking to compel agency action

unreasonably delayed * * * if final action has not been

taken within 60 days from the date of this order.’’*

On July 3, 1973, EPA advised the court that it ex-

pected to announce its decision by August 31.

Although this prediction proved overly optimistic,

the preamble to the final regulations, the final health

8 Natural Resources Defense Council vy. Environmental Protec-

tion Agency, No. 72-2233, decided April 27, 1973 (C.A.D.C.).

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document, and other technical and economic analyses

were substantially complete by October, 1973 (Jt. App.

1502, R. Doe. 486 (preamble); R. Doc. 141 (health

document) ; Jt. App. 1527 (cost and energy impacts) ).

On October 28, 1973, in response to another motion by

NRDG, the court ordered EPA to decide within 30

days whether to issue the lead regulations, EPA

sought no further modification or review of this order,

and in fact announced its decision on November 28,

1973.

The final regulations were promulgated on Decem-

ber 6, 1973, accompanied by a comprehensive preamble

and a final health document reviewing the medical and

scientific evidence accumulated throughout the rule-

making. 38 Fed. Reg. 337384 (Jt. App. 1, 27). The

final health document differed from the second in two

respects: it incorporated the information received

during the third comment period and it presented a

more extensive discussion of the scientific studies

relied upon by the opponents of the regulation." The

Administrator’s justification for regulating lead addi-

tives to protect the public health did not change be-

* This expanded discussion of the studies relied upon by oppo-

nents of regulation considerably increased the number of refer-

ences cited in the final document, as noted in Ethyl’s petition at

page 22.

5 The Administrator considered and rejected the alternative of

setting national ambient air standards for lead under Sections 108

and 109 of the Clean Air Act, 42 U.S.C, 1857c-3 and 1857c-4, as a

means to require state or local regulation of lead emissions where

necessary, on the grounds that uniform national controls were a

more efficient and effective means of regulating gasoline content

ARG AGRE IMAP TITAS ETE AE PRE AE HERB NEE SND

7

tween reproposal and promulgation of the final lead

regulations.”

2, THE BASIS FOR THE REGULATIONS

The preamble to the regulations (Jt. App. 1) and

the final health document (Jt. App. 27), and the sum-

mary of those documents set forth in the majority

opinion of the court of appeals (pp. 74-97 and Ap-

pendices A and B), explain at considerable length

the evidentiary basis for the Administrator’s regula-

tions. Only the briefest recapitulation is presented

here.

Automotive lead emissions are a massive source

of lead exposure and the only man-made source not

yet subject to control. More than 250,000 tons of lead

per year are used in the production of gasoline addi-

tives, and motor vehicle emissions contribute more

the 90 percent of airborne lead concentrations (Jt.

App. 46, 47). According to the United States Public

Health Service, blood lead levels in human beings of

80 micrograms of lead per 100 grams of blood (80

ugs./100 gs.) indicate unequivocal lead poisoning pos-

sibly resulting in anemia, nekye damage, mental re-

tardation, and even death (Jt. App. 71). Levels of

50-70 ugs. justify immediate evaluation for possible

lead poisoning (Jt. App. 71). The health effects of

blood lead levels in the 40-60 ugs./100 gs. range re-

te

t

’

and that a proliferation of state and local controls would be con-

trary to the intent of Congress and to the expressed preference of

the petroleum industry for uniform national requirements (Jt.

App. 1937, 1939-1940).

4

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main uncertain, although physiological change is

known to occur and several studies have associated

anemia and behaviorial disorders in children with

elevated blood lead levels in this range (Jt. App.

59-60, 71-73). At levels in excess of 40 micrograms,

inhibition of the enzyme ALAD, associated with the

formation of red blood cells, is likely to oceur (Jt.

App. 343), and under the Public Health Service

Guidelines blood lead levels exceeding 40 micrograms

indicate excessive lead absorption (Jt. App. 71).

The Administrator found that the blood lead levels

of many children, particularly those living in urban

areas, and of a significant number of adults who are

exposed to automobile fumes in an outdoor environ-

ment exceed the 40 microgram mark (Jt. App. 143-

145, 344, 822; NAS Report, R. Doc. 14, p. 139). He

pointed out that because of the multiple sources

of human lead exposure, however—such as_ food,

water, air, dust, and leaded paint—the certain

identification of the source of lead in any group of

individuals has proved to be all but impossible. The

Administrator concluded, however, that airborne lead

contributes significantly to the human body burden of

lead. 38 Fed. Reg. 33734, 33735-33736 (Jt. App. 3-4).

Three kinds of scientific evidence led the Adminis-

trator to this conclusion: (1) epidemiological studies

showing higher blood lead levels in urban as compared

to suburban dwellers, in persons living near roadways,

and in persons whose employment exposes them to

constantly high air lead levels (such as city police-

ee et ee

9

men) (Jt. App. 465, 840, 1092, 789) ; (2) experimental

calculations of human lead absorption and intake at

various levels of airborne lead, based on knowledge of

volumes of air inhaled, ambient lead concentrations,

and the rate of deposition in the lung (Jt. App. 86-87,

326, 500); and (3) clinical studies of volunteer sub-

jects exposed to lead in controlled environments (Jt.

App. 580, 678, 704). The epidemiological studies pro-

vided qualitative evidence of the contribution of air-

borne lead, while the experimental calculations and

clinieal studies each indicated that, at airborne lead

levels common in American cities, inhaled lead con- — ~

tributes nearly 30 percent of the lead absorbed by the

hody (Jt. App. 580, 596, 704).°

The Administrator acknowledged that none of these t

methodological approaches produces scientifically un-

assailable results (Jt. App. 2-3). Taking into account

possibilities for misestimate in the three types of

studies, however, and weighing all of the other scien- 7

tific and medical evidence accumulated during the

rulemaking proceedings, the Administrator con-

cluded that lead from automobiles presents a_sig-

nificant risk of harm to the public health: harm to

adults from inhaling lead in the air, and harm to

children both from inhaling lead and from consum-

ing it in dust and dirt.

*'The evidence also indicates that children may ingest lead

found to exist in high levels in dust and dirt in areas of high motor

vehicle activity (the “dustfall hypothesis”) (Jt. App. 111-117). ©

Approximately 50 percent of children between the ages of one and |

three exhibit the tendency to eat nonfood items, including dust

and dirt, known as “pica” (NAS Report, R. Doc. 14, p. 133).

a ee ee

10

The Administrator also concluded that additives

that pose a significant risk of harm to the public

health “will endanger the public health or welfare”

within the meaning of Section 211(c)(1)(A) (Jt.

7

App. 3).

3. THE COURT OF APPEALS” DECISION

A divided panel of the United States Court of

Appeals for the District of Columbia Circuit initially

set aside the regulations.” On rehearing ex bane after

supplemental briefing and reargument, the court up-

held the regulations.

The court’s opinion carefully considered the mean-

ing of the “will endanger the public health or

welfare” standard of Section 211, and thoroughly re-

viewed both the substantive scientific evidence under-

lying the regulations and the procedural regularity

of the agency proceedings leading to their promulga-

tion. The court held that the Administrator's con-

struction of the statutory language was entitled to

great deference, and that there was nothing in the

statute or its legislative history to vitiate his con-

* The Administrator also determined, based upon the results of

economic studies performed by EPA and its contractors, that the

cost attributable to the health-based regulations under “worst case

assumptions” would be less than one-tenth of a cent per gallon by

1980 and that the increase in crude oil requirements would be less

than four-tenths of one percent of projected crude oi] demand.

EPA projected no further increases in cost by 1985 and a crude

oil “penalty” of only one-and-one-half percent. 38 Fed. Reg.

33734, 33739 (J. App. 1527. 1538-1543).

* Ethyl Corp. v. Environmental Protection Agency, 7 ERC 1387

(January 28, 1975).

i OO NE AE DS ihre ST

11

clusion that the statute is precautionary in nature and

authorizes regulation of additives that pose a signifi-

cant risk of harm to the public health even if actual

harm can not be conclusively proven as a matter of

seientifie fact (Maj. Op. 17, 37). The court also held

that the Administrator was correct in his view that,

when the record contains evidence of significant risk

of harm, but the scientific studies supporting that

conclusion are conflicting and the subject is “on the

frontiers of scientific knowledge,’’ the question of en-

dangerment becomes in some measure a policy judg-

ment to be made upon an assessment of the risk

posed and the likelihood of its occurrence (Maj. Op.

54).

After an exhaustive review of the record, the court

held that the Administrator's determination that auto-

motive lead emissions present such a risk has a

rational basis in the evidence (Maj. Op. 57-83).

Finally, the court noted that the Administrator had

invited comments for three specific periods during the

extended rulemaking proceedings, and indeed had ac-

cepted comments throughout the entire proceeding:

that he had placed in the agency public files all of the

evidence that was received and had sent copies of

much of the evidence directly to petitioner Ethyl; and

that all of the petitioners had had ample notice of and

opportunity to comment upon the evidence relied upon

by the Administrator in promulgating the regulations

(Maj. Op. 97-111). The court concluded that EPA

procedures leading to the rulemaking had therefore

fully complied with the notice and comment require-

eccamncenabieitic ace

12

ments of the Administrative Procedure Act (Maj. Op.

109-110).

Judge Wilkey, joined by Judges Tamm and Robb,

dissented. Although they generally agreed with the

Administrator and the majority that a finding of a

significant risk of harm satisfies Section 211(¢) (1)

(A)’s endangerment standards,’ they concluded that

the statute does not permit regulation unless the Ad-

ministrator is first able to make a determination, based

“purely on the scientific and medical data” (Min. Op.

55), that lead additives actually cause a significant

health hazard (Min. Op. 52). They also agreed with

the majority opinion as to the scope of review (Min.

Op. 57-64), although they concluded upon their

evaluation of the underlying evidence that the Admin-

istrator’s determination to regulate lead additives was

arbitrary and capricious (Min. Op. 64-85). Joined by

Judge McKinnon, the dissenting judges would have

held the procedures leading to the regulations inade-

quate on the ground that, in their view, the Adminis-

trator did not give sufficient notice of and opportunity

* £.g.,“[o]n reargument the dissenting judges conclude that the

disagreement with regard to the legal standard reduces itself to

semantics, and while the Administrator did not couch his princi-

pal determinations in the language of the statute, the language

that he did use, properly interpreted in accordance with the

statute. did provide a sufficient standard for his determinations”

(Min. Op. 4). See also éd, at 50-52, 85.

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13

for comment on the evidence upon which he relied in

reaching his decision to regulate (Min. Op. 4-50).”°

ARGUMENT

The decision of the court of appeals is correct and

no further review is warranted. There is neither a

conflict among the circuits regarding the statutory

standard of endangerment to health, nor a plain dis-

agreement of any consequence among the judges of the

en bane court regarding the proper scope of review.

The majority correctly concluded that the Administra-

tor’s decision to regulate has a rational basis in the

record evidence, and in any event this factual ruling

does not merit further consideration by this Court.

Similarly, the majority’s conclusion that the pro-

cedures followed by EPA afforded petitioners a mean-

ingful opportunity to comment upon the regulations

was correct and was disputed by the dissent on largely

factual grounds peculiar to this case alone. Finally,

the Administrator did not abuse his discretion in de-

*° Judge Bazelon (joined by Judge McGowan), concurring in

the majority opinion, wrote that he considered the court to have

engaged in a study of the substantive evidence beyond that called

for by the court’s reviewing function (Bazelon Op. 1-5). Judge

Leventhal, who concurred in the majority opinion “without res-

ervation,” objected to Judge Bazelon’s opinion insofar as it ap-

peared to advocate engaging in no substantive review at all (al-

though Judge Leventhal was not certain that Judge Bazelon

actually held such a view) (Leventhal Op. 1-4).

ae ee

14

ciding to regulate lead additives under Section 211-

(c)(1)(A) rather than to adopt alternative control

strategies authorized by the Clean Air Act.

1. The Administrator determined that automotive

lead emissions present “a significant risk of harm to

the health of urban populations, particularly to the

health of city children.’’ 38 Fed. Reg. 33734 (Jt. App.

2). He then construed Section 211(¢)(1)(A) to em-

power him to act, reasoning that additives posing such

a risk “will endanger the public health’? within the

meaning of the statute. All of the judges on the court

of appeals apparently agreed with this interpretation

of Section 211. They differed over whether, when the

subject matter is on the frontiers of scientific knowl-

edge, an assessment of risk of harm to health may

encompass predictions based on imperfect evidence

and policy judgments, as the majority concluded (Maj.

Op. 61-63), or whether risk assessment must be based

on precise, quantifiable, and conclusive proof of facts

alone, as contended by the dissent (Min. Op. 52).

We submit that the majority view is correct. It is

firmly grounded in the terms and intent of Section

211 of the Clean Air Act and is supported by every

recent court of appeals’ decision construing statutory

standards for regulation to protect public health. In

Reserve Mining Co. v. Environmental Protection

Agency, 514 F. 2d 492, 528 (C.A. 8) (en banc), for

instance, the court construed the term “endanger” in

15

the Federal Water Pollution Act of 1970, 33 U.S.C.

1160(g) (1), as follows:

In the context of this environmental legisla-

tion, we believe that Congress used the term “en-

dangering’’ in a precautionary or preventive

sense, and, therefore, evidence of potential harm

as well as actual harm comes within the pur-

view of that term.

Citing the dissent from the initial panel decision in

the instant case, the Eighth Circuit unanimously recog-

nized that a determination of endangerment under

precautionary statutes may in some circumstances re-

quire risk assessment based on inconclusive evidence

(514 F. 2d at 507, n. 20):

[We]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 experimental results, about which

it would be judicially presumptuous to offer

conclusive findings. * * *

* * * * *

In such cireumstances, the finder of fact must

accept certain areas of uncertainty, and the

findings themselves cannot extend further than

attempting to assess or characterize the

strengths and weaknesses of the opposing argu-

ments.

Similarly, decisions reviewing the Secretary of

Labor’s authority under the Occupational Safety and

Health Act, 29 U.S.C. 651 et seq., recognize that fre-

or OO ET A BOP TT SL OE NET SE OLN ERE T IES LAT SIA PH Pry SSR PSE

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16

quently the establishment of standards to protect

human health will of necessity involve policy judg-

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

Hodgson, 499 F. 2d 467, 474-479 (C.A.D.C.), the court

upheld the Secretary’s standard for exposure to

asbestos dust, stating:

From extensive and often conflicting evi-

dence, the Secretary in this case made numer-

ous factual determinations. With respect to some

of those questions, the evidence was such that

the task consisted primarily of evaluating the

data and drawing conclusions from it. The court

can review that data in the record and deter-

mine whether it reflects substantial support for

the Secretary’s findings. But some of the ques-

tions involved in the promulgation of these

standards are on the frontiers of scientific

knowledge, and consequently as to them insuf-

ficient 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

‘ely factual analysis.”

he Second @ireuit concurs. In Society of the

Plastics Industry, Ine. v. Occupational Safety and

Health Administration, 509 F. 2d 1301, certiorari

denied, 421 U.S. 992, the court upheld the occupational

< Where existing methodology or research in a new area of regu-

lation 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 information. Permian Basin Area Rate Cases,

300 U.S. 747, 811 * * *. |

TRS IR SESE ee Aa Sie KS II ORL LES ID

17

health standards limiting industrial exposure to vinyl

chloride to one part per million even though the evi-

dence did not show concrete adverse effects below the

50 ppm level. The court said (509 F, 2d at 1508) :

As in Industrial Union Department, AFL-

CIO vy. Hodgson, supra, the ultimate facts here

in dispute are “on the frontiers of scientific

knowledge,” and, though the factual finger

points, it does not conclude. Under the com-

mand of OSHA, it remains the duty of the Sec-

retary to act to protect the workingman, and to

act even in cireumstances where existing

methodology or research is deficient. The Sec-

retary, in extrapolating [a particular] study’s

finding from mouse to man, has chosen to re-

duce the permissible level to the lowest detec-

table one. We find no error in this respect.

The majority view below is thus in keeping with the

approach followed by each of the circuits to have

faced issues involving the administrative decision-

making process under regulatory schemes designed to

protect the public health in areas where scientific cer-

tainty may not always be obtainable. This approach,

which recognizes that “step-by-step proof of cause and

effect may be impossible’? in some cases (Maj. Op.

54), is necessary if the precautionary purpose of

statutes such as Section 211 are to be served.

The majority opinion does not, contrary to the sug-

eestion of the dissent (Min, Op. 54), “legitimize the

se

Administrator playing hunches.” The majority ob-

“ara e

_— . saceunes “ Ms eee oe ee ore a ee Te

18

served (Maj. Op. 54-55) that, although the Adminis-

trator may properly apply his expertise to draw con-

clusions “from probative preliminary data not yet

certifiable as ‘‘ ‘fact,’” his discretion is bounded by

the terms of the statute and his conclusions must be

rationally justified on the basis of the record

evidence.

In determining the risk of injury to the public

health created by particular products or practices, it

would be a rare case in which the exact degree of

risk could be unequivocally established by scientific

evidence. The subject involves probabilities, not cer-

tainties, and ordinarily it is incapable of exact proof

or demonstration. When Congress authorized the Ad-

ministrator to ban or set limits upon fuel additives

that ‘will endanger the public health,” it was legis-

lating in the light of these practical realities of scien-

tific knowledge, and was not imposing upon the Ad-

ministrator an impossible burden of proof.

In short, disabling the Administrator from acting

except in those circumstances where action may be

premised solely on proven scientific fact would sig-

nificantly frustrate the goal of Section 211(c) (1)

(A). The court correctly concluded that the Admin-

istrator may properly decide whether fuel additives

“will endanger the public health” on the basis of

policy judgments as well as factual analyses.

2. Petitioners urge that review should be granted

19

because of an uncertainty they perceive among the

members of the court of appeals regarding the proper

scope of review of agency rulemaking. The disagree-

ment among the majority as to the extent to which

reviewing courts should scrutinize the evidence in

scientifically or technologically complex administra-

tive agency cases is also cited in support of the argu-

ment that review is warranted here (Dupont Pet.

23-29; Naleo Pet. 15-19; National Petroleum Re-

finers Association Pet. 18-21).

There is no dispute, however, between the majority

and minority over the appropriate scope of review:

both agreed that the Administrator’s decision must

be upheld unless it was ‘‘arbitrary and capricious”

under Section 10(e)(2)(A) of the Administrative

Procedure Act, 5 U.S.C. 706(2)(A) (Maj. Op. 67;

Min. Op. 57-58). Although both opinions discussed

the effect on the “arbitrary and capricious” standard

of this Court’s statement in Citizens to Preserve

Overton Park v. Volpe, 401 U.S. 402, 416, that the

reviewing court should consider ‘‘whether there has

been a clear error of judgment” (Maj. Op. 69-70

n. 74; Min. Op. 58-59), the conclusions drawn were

substantially identical. Indeed, the dissenting judges

themselves observed (Min. Op. 64 n. 139) that “[w]Je

find our colleagues do not differ materially with us

on the standard for review.” In short, the majority

and minority differed, not as to the proper standard

Oak IAE a NMOL Sa Pe SEP OTE S CIR APRONS REE a tia yf

of review, but only in its application to the particular

facts of this case.”

Judge Bazelon, joined by Judge McGowan, ¢x-

pressed the view that the court’s evaluation of the

scientific evidence underlying the Administrator's

rulemaking in this case was unnecessarily exhaustive

(Bazelon Op. 1-5). But the extent of the disagreement

anong the majority is too uncertain to warrant review

by this Court, assuming that an intracirenit conflict

would properly command the Court’s attention in any

event. Even Judge Leventhal, who wrote separately

in support of judges steeping themselves in technical

matters in order adequately to discharge their review-

ing function (Leventhal Op. 1-4), was uncertain

whether Judge Bazelon was advocating a difference in

degree of substantive review or a difference in kind.

Moreover, it is difficult to perccive especially since

Judge Leventhal was uncertain about the import of

Judge Bazclon’s opinion—the basis for petitioner Du-

Pont’s assertion (Pet. 12, 24) that Judges Bazelen

and McGowan “refused to examine the scientific and

technical evidence relied upon by the Administrator m

reaching his decision.” It does not follow from the

statement (Bazelon Op. 4, n. 10) that the exhaustive

11 Dupont mischaracterizes the majority opinion when it states

(DuPont Pet. 12) that it held that “the court was not required to

examine carefully the scientific evidence relied on by the Admin-

istrator.” It is difficult to imagine a more careful review of the

evidence than that which both the majority and minority made in

this case, and indeed petitioner National Petroleum Refiners Asso-

ciation (Pet. 19) acknowledges that the majority opinion indicates

that a “‘close scrutiny of the evidence’ ” was undertaken.

21

analysis of the scientific evidence in this case was un-

necessary either that Judges Bazelon and McGowan

themselves refused to examine the evidence or that

(DuPont Pet. 28) “only three of the five majority

judges were able to form any conclusion as to the ade-

quacy of the evidence relied upon by the Administra-

tor.’’ In any event, given the thoroughgoing consider-

ation and discussion of the evidence by both the

majority and minority opinions, we submit that

Judges Bazelon and McGowan were — sufficiently

familiar with the substantive evidence to allow them

adequately to determine whether the Administrator’s

action was arbitrary and capricious.

Finally, even if the position espoused by Judges

Bazelon and McGowan was as starkly at odds with the

views of the rest of the court as has been suggested,

seven of the nine judges on the court now appear to be

in unqualified agreement as to the reviewing court’s

responsibility. This decision thus settles the law of the

circuit, and the court presumably will follow it.

3. On the basis of the explanation contained in the

preamble to the regulations and in the accompanying

health document (Jt. App. 1 and 27), and for the rea-

sons set out in the opinion of the court (Maj. Op. 66-

97), we submit, contrary to the contention of peti-

tioner Nalco (Pet. 19-22), that the record evidence

supports the regulations and that accordingly the Ad-

ministrator was not arbitrary and capricious in

pronuilgating them. This issue, in any event, has now

been fully examined twice, first by the panel of the

SSE AOR RRIF LO IE FO UP 8 IN LMT MOEN SOMES TAT SENET HF

ANY RET BMI AIT ae |

RETIN EIR BAT

court of appeals and now by the court of appeals sit-

ting en banc. There is no reason for this Court to

examine the 30,000-40,000-page administrative record

to consider anew the factual question whether the

regulations are rationally based upon the evidence.

4. All petitioners argue that they were denied a

meaningful opportunity to comment on the regula-

tions in violation of due process and the notice and

comment requirements of the Administrative Pro-

cedure Act, 5 U.S.C. 553(b) and (¢). They contend

that the lead regulations were based principally on

new information received during the third comment

period and unavailable to them, and that the Ad-

ministrator was required to provide formal notice of

his intent to rely on certain comments and studies and

to solicit a fourth round of public comments on EPA’s

position (DuPont Pet. 12-19; Ethyl Pet. 21-27; Na-

tional Petroleum Refiners Association Pet. 13-17;

Naleo Pet. 22-30). As with the claim that the regula-

tions are without rational basis in the record, however,

these objections to the procedures followed by the

Administrator turn largely on factual issues that were

resolved adversely to petitioners below and warrant

no further review.

Section 4 of the Administrative Procedure Act re-

quires that notice of a proposed rulemaking be pub-

lished in the Federal Register and that the notice in-

clude “either the terms or substance of the proposed

rule or a description of the subjects and issues in-

volved.”? 5 U.S.C. 553(b). The agency must provide

“an opportunity to participate in the rulemaking

23

through submission of written data, views, or argu-

ments with or without opportunity for oral presenta- ;

tion. After consideration of the relevant matter

presented, the agency shall incorporate in the rules

adopted a concise general statement of the basis and

purpose.”’ 5 U.S.C. 553(¢).

In this case EPA not only met but even exceeded

these requirements. Although, as the court correctly

observed (Maj. Op. 99), Section 4 does not require

“new notice whenever the agency responsibility adopts

the suggestions of interested parties,’? EPA neverthe-

less reproposed the lead regulations to obtain addi-

tional comments on the revised health position adopted

by the Administrator in response to critical comments

and additional information received during the two

previous comment periods. Indeed, charged with the

statutory duty to consider “all relevant medical and

TY RINNE te ony

MERE NG OH, DIDO

scientific evidence,’ the Administrator continued ;

to accept information submitted beyond the expira- '

tion of the noticed 60-day period and made every '

effort to evaluate all of the material received and to '

incorporate it in the final health document.” :

The dissent below did not disagree with the court's

perception of the governing legal standard under

Section 4 (Min. Op. 26). Rather, the dissent was

predicated on the factual assertion (Min. Op. 19-20)

that the Administrator, upon reviewing the evidence

-

AL. De RC RIN

coe Ex

#2 Section 211(c) (2) (A), 42 U.S.C. 1857f-Ge(c) (2) (A).

*® For example, two studies submitted to the Administrator by '

petitioner Ethy] Corporation in late October, 1973 were considered s

and discussed in the final health document (Jt. App. 72-73,. ;

125-126). ig

;

'

:

A 5 PLSD ELIE EAE LEAP ALL ES OER OL TY FF orem

RES IT

24

and the comments received, did not attempt to defend

earlier studies that had been subject to criticism, but

instead relied heavily on new studies received during

the third comment period indicating that airborne

lead contributes significantly to lead exposure in the

general population.

We submit that, on the contrary, most of the evi-

dence relied upon by the Administrator was not

new: a review of the preamble’s summary of the evi-

dence relied upon (Jt. App. 1) shows that it refers

principally to studies that were available and dis-

cussed in the second health document issued with the

reproposed regulations. The ‘‘new studies” to which

the minority referred (Min. Op. 20-23) consisted of

a Japanese epidemiological study sponsored by the

jead industry’s research organization and submitted

to EPA in July 1973, certain lead isotope tracer

studies, and an additional statistical analysis of an

earlier “Seven Cities” study (see Jt. App. 985).

EP.A’s characterization of the results of the isotope

and Japanese studies as ‘*preliminary” (38 Fed. Reg.

33735 (Jt. App. 3)) indicates that only limited reli-

ance was placed on this evidence, and in any event

these studies only confirmed the other, principal epi-

demiological and clinical studies that the Administra-

tor relied upon. Similarly, as the court pointed out

(Maj. Op. 104), the .acts “vitiate [the minority’s]

criticism of the Administrator’s reliance on” the

additional analysis of the Seven Cities study, pre-

pared in response to comments on its statistical

methods, since it “merely reconfirmed the validity”

of the urban-suburban differences previously cited by

Ne Deeeeat a Pn et et ele aed

RE I KO I ane te A Tg RE Ua

25

both EPA and the authors of the study themselves

(Jt. App. 89; Maj. Op. 105-105).

The summary of evidence relied upon in support of

the “dustfall hypothesis” (that children ingest lead

fall-out in dust and dirt), itself but a secondary basis

for the conclusion that automotive lead emissions con-

tribute to a risk of harm to health (Maj. Op. 88-95),

similarly refers mainly to studies that were pointed

out in the second health document.“ 38 Fed. Reg.

33734, 33735-33737 (Jt. App. 3-5). The “new” evi-

dence pertinent to the dustfall hypothesis is summar-

ized in a separate section of the preamble entitled

‘What new information has become available since :

reproposal of the regulation and as a result of the

additional comment period”? Id. at 33737 (Jt. App.

5). It is apparent from the summary that this evi-

dence was evaluated separately and was, again,

strictly confirmative of the principal findings.” The

majority perceived the facts correctly in concluding

(Maj. Op. 106-107) : ;

[T]he Administrator’s placement of the dis- i

cussion of these studies makes clear [that] the

** These included evidence as to the high levels of lead inside

and outside buildings in urban areas, the prevalence of “pica” in

young children, the E] Paso study implicating dustfal] lead in

causing high blood lead levels in children, and the existence of

high blood levels in many children with no known exposure to

leaded paint (Jt. App. 231-238). ;

2° E.g., the Administrator stated that it has been “reaffirmed” :

that high dust lead levels have been found in children’s play areas,

that new evidence “reaffirms” that such levels can be caused by

automotive lead emissions, that cases of exposure to lead “con- E

tinue” to be reported from areas in which leaded paint would not 3

he expected to be the predominant factor. 38 Fed. Reg. 33737 (Jt.

App. 5). 4

26

studies are not needed or used to support the

conclusion that the dustfall hypothesis is rea-

sonable. That conclusion is a sufficient hasis for

regulation under the statute [for reggons al-

ready stated]. * * * These additional tuidies,

which are corroborative of the dustfall hy-

pothesis * * * play no role in the Adminis-

trator’s decision to regulate.

Moreover, none of the information at issue was

“new” in the sense that it had previously been un-

available for public comment and criticism. .\s the

court observed (Maj. Op. 97-100 & n. 99-102), all

of the evidence on which the Administrator relied was

made available to the public at least three months be-

fore the final regulations were issued, and the APA

notice and comment requirements are fully satisfied

when, as here, the agency placed all the evidence it

received in a designated public access file and re-

peatedly announced the existence and location of the

file in the Federal Register.

The dispute between the majority and the dissent,

in any event, is at bottom a factual disagreement not

warranting further review. The dissenting judges

themselves recognized that (Min. Op. 31-32), “there

appears to be little, if any, difference in our position

on EPA’s responsibilities under the APA and our

colleagues’ position on this subject.” Rather, the issue

dividing the court was whether opportunity for mean-

ingful comment was afforded in respect of certain

information received by EPA subsequent to the third

27

comment period (Min. Op. 32). Resolution of this

issue turns on an assessment of complicated facts

peculiar to this case alone.”

16 Similarly, the effect of the court’s order of October 28, 1973,

directing the Administrator to reach a decision with respect to

lead additives within 30 days (see pages 5-6, supra), is a factual

matter that was resolved adversely to petitioners below. Peti-

tioner DuPont errs (Pet. 15) in asserting that “Two of the

requisite members of the majority * * * conceded that the 30-

day order may have ‘interfered with’ deliberate consideration by

the agency (Bazelon op. p. 5).” The quoted language, when read

in the context of Judge Bazelon’s opinion, shows that he was

referring to the state of the record, not with the agency’s ability to

give “deliberate consideration” to the subject before it:

“Tt is regrettable that EPA did not give the same care to clearly

setting forth procedural matters for the record as it gave to sub-

stantive matters. It may well be that this court’s 30-day order

interfered with the opportunity to do so.”

17 Although in the court of appeals petitioners did not assert

that they were prejudiced by EPA’s public file system, petitioner

Nalco now complains of the filing system’s failure to disclose the

dates when certain documents were received, and contends that

the court improperly relied upon a letter dated September 26,

1975, from agency counsel which set forth, based on other agency

records, the approximate dates when certain documents were in

fact received and transmitted to the file. The failure of the filing

system to record dates of entry does-not vitiate EPA’s compliance

with the notice requirements of the APA. See Maj. Op. 97-98

n. 99; 100-101 n. 102; 102 n. 106. The September 26, 1975 letter

from agency counsel was written in response to a request

from the court; copies were sent to all parties of record (includ-

ing Naleo) (Nalco Pet. 26), and no party commented in response.

(Nalco’s statement (Pet. 26) that it received this letter only after

a specific request is incorrect.)

EPA counsel did send two letters to the court (again in response

to court request) that were not served upon opposing counsel

(Nalco Pet. B1, B8). While the better practice would have been

to have served opposing counsel, the substance of the communi-

cations were not prejudicial to petitioners or otherwise improper.

re ea

BRA KARRI 8 ES

28

5. Petitioners DuPont (Pet. 3 n. 2) and National

Petroleum Refiners Association (Pet. 21-23) claim

that the Administrator abused his discretion in de-

ciding to regulate lead additives under Section 211-

(c)(1)(A) rather than to establish ambient air

quality standards for lead under Section 109. We sub-

mit, on the contrary, that the Administrator’s decision

in this regard is both reasonable and in harmony with

the terms and legislative history of the Clean Air Act.

The Administrator chose to set national fuel stand-

ards for lead gasoline because this technique pro-

vides the most efficient and effective means of accom-

plishing a reduction in lead emissions. It is easier for

industry to comply with a single standard rather than

with the proliferation of differing state or regional

regulations that would likely arise under ambient air

quality standards. Moreover, federal controls at the

refinery level are more efficient than state or local

controls aimed at thousands of fuel distributors and

retailers.

The Administrator was also aware that the states

were having difficulty implementing the six ambient

air quality standards that have already been promul-

gated, and considered it desirable to avoid giving

them another major regulatory task when more effec-

tive alternatives were available (see EPA’s supple-

mental reply brief in the court of appeals at 20).

Moreover, the oil industry itself largely prefers a

uniform nationwide standard instead of a patchwork

of different state and local standards (see td. at 23-

25). Finally, Congress enacted Section 211(¢) (1) (A):

29

with the expectation that control or prohibition of lead

additives in gasoline might be necessary.’* That pro-

vision specifically authorizes EPA to impose such

standards of a nationwide basis, and it contains no

mention whatever of Section 109.

The court of appeals correctly concluded that the

Administrator did not abuse his discretion in deter-

mining that the establishment of uniform nationwide

standards for lead additives was preferable to a regu-

latory scheme subject to variations among state and

local jurisdictions.

CONCLUSION

The petitions for a writ of certiorari should be

denied.

Respectfully submitted.

Robert H. Bork,

Solicitor General.

Peter R. Tart,

Assistant Attorney General.

EpmunpD B. CuaRK,

Epwarp J. SHAWAKER,

Attorneys.

Ropert V. ZENER,

General Counsel,

MicHakEu A, JAMES,

LEsLIE A. CAROTHERS,

Attorneys,

Environmental Protection Agency.

May 1976.

** See, e.g., S. Rep. No. 91-1196, 91st Cong., 2d Sess. 33 (1970) ;

116 Cong. Rec. 19229 (1970) (remarks of Representative Rogers) ;

116 Cong. Rec. 32920 (1970) (remarks of Senator Baker).

U.S. GOVERNMENT PRINTING OFFICE: 1976