Petition — Lead Industries Ass'n v. Environmental Protection Agency

x Supreme Court, U.S.

xy FILED

80-48 2 SEP 25 1980

No. MICHAEL RODAK, JR., CLERK

IN THE

Supreme Court of the Gnited States

OCTOBER TERM, 1980

LEAD INDUSTRIES ASSOCIATION, INC.,

Petitioner,

ENVIRONMENTAL PROTECTION AGENCY,

Respondent.

PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR THE

DISTRICT OF COLUMBIA CIRCUIT

EpDwIn H. SEEGER

CARL B. NELSON, JR.

PRATHER SEEGER DOOLITTLE & FARMER

1101 Sixteenth Street, N. W.

Washington, D. C. 20036

(202) 296-0500

Attorneys for Petitioner

September 25, 1980 Lead Industries Association, Inc.

EOE LES SE ER NEOTEL ORE CSO RNAI CONE SEO AR NS EEN ch

PRESS OF BYRON S. ADAMS PRINTING, INC., WASHINGTON, D.C.

QUESTIONS PRESENTED

1. Whether, in light of the Court’s decision in /n-

dustrial Union Dep’t v. American Petroleum Inst., 100

S.Ct. 2844 (1980) (the benzene case) and the provisions

of the Clean Air Act, the Environmental Protection

Agency (EPA) may establish a primary air quality stan-

dard designed to prevent the occurrence of human

biological responses which have not been found to pre-

sent a significant risk of harm to health.

2. Whether EPA may not only design a primary air

quality standard to prevent the occurrence of biological

responses not shown to present a significa.* risk of

harm, but may incorporate in that standard multiple

margins of safety that further remove the standard from

legitimate health protection.

3. Whether EPA may establish a secondary air

quality standard to protect the public welfare at the same

level as a primary standard without making any indepen-

dent findings to support the secondary standard.

LIST OF PARTIES TO THE PROCEEDINGS

BELOW

Petitioners below were the Lead Industries Associa-

tion, Inc. (LIA), a non-profit trade association whose 78

member companies include most U.S. producers and

commercial consumers of lead, and St. Joe Minerals

Corporation. EPA was the respondent. The Bunker Hill

Company was an intervenor. The Natural Resources

Defense Council, Inc., and the Air Resources Board of

the State of California participated as amici curiae.

iii

TABLE OF CONTENTS

PAGE

cra. Sula od cece ebsesecctens l

ee ck ade dednseeseceeccees 1

STATUTE AND REGULATIONS INVOLVED.............005: 2

I ccc cceccceeebecscsces 3

EE EES 9

I. The Decision Below Is In Conflict With The

Court’s Recent Decision in J/ndustrial Union

Co cece ees ioeeene 10

Il. This Case Presents Questions Of Exceptional

Importance Under The Clean Air Act That

Should Be Decided By The Court ............ 14

A. Primary standards may not be de-

signed to prevent biological responses

not shown to be adverse or to present

a significant risk of harm to health... 14

B. EPA exceeded its authority by adopt-

ing multiple margins of safety........ 17

C. EPA must make independent findings

to support secondary standards even

though they are set at the same level

as primary standards................ 20

EE 21

ee =~

|

iV

TABLE OF AUTHORITIES

CASES PAGE

Environmental Defense Fund v. EPA, 598 F.2d 62 (D.C.

Cie BPP eck k Aaa TNS OP aOR UEREEE) Chea ees’ 19

Ethyl Corp. v. EPA, 541 F.2d 1 (D.C. Cir.) (en on

cert. denied, 426 U.S. 941 SUE fi wa RaRR ae ake’s 3, Li

Industrial Union Dep’t v. American Petroleum Inst., 100

AAs ee CEC cA ahs naéeekuaanba Vanmakaw 6nd 8,9

10, 11, 12, 13, 14, 17 18

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

| Bere ere re tore er hee 20

STATUTES

RA TR ee er er ere ork Perry re |

Clean Air Act, as amended

REE Da ee PRS PO oo cb bob vices aciceeneus be 2

Section 109, 42 U.S.C. §7409.......... 2, 8, 9, 14, 16, 19

I SO, ee Shes PI ho habeas canes due ewnes 14

Oy Bes ee Wlils UE hc iN vices cei eadvecenes 20

ke RE ee | ee eee 8

CONGRESSIONAL MATERIALS

S. Rep. No. 91-1196, 91st Cona., 2d Sess. (1970) . 15, 17, 19

Hearings on S. 251, S. 252 and §. 253 Before Subcomm.

on Environmental Pollution of Senate Comm. on

Environment and Public Works, 95th Cong., Ist

BOR. PUNE BOTs Sow cater kee ba adae see vees 15

H.R. REP. No. 95-294, 95th Cona., Ist Sess. (1977) .. 11, 15

123 ConG. REC. S 9423 (daily ed. June 10, 1977) ....... 16

IN THE

Supreme Court of the Gnited States

OCTOBER TERM, 1980

No.

LEAD INDUSTRIES ASSOCIATION, INC.,

Petitioner,

V.

ENVIRONMENTAL PROTECTION AGENCY,

Respondent.

PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR THE

DISTRICT OF COLUMBIA CIRCUIT

OPINIONS BELOW

The opinion of the Court of Appeals, not yet of-

ficially reported, is reproduced in Appendix A. The

regulation in question was published in 43 Fed. Reg.

46246-63, October 5, 1978, and is reproduced in Appen-

dix B.

JURISDICTION

The judgment of the Court of Appeals was entered

on June 27, 1980. This petition is being filed within 90

days of that date. The Court’s jurisdiction is invoked

under 28 U.S.C. §1254(1).

s

2

STATUTE AND REGULATIONS INVOLVED

Sections 108(a)(1) and (2) of the Clean Air Act, as

amended, 42 U.S.C. §§7408(a)(1) and (2), require EPA’s

Administrator to publish a list of airborne pollutants

which, in his judgment, ‘‘may reasonably be anticipated

to endanger public health or welfare,’’ and then to issue

‘‘air quality criteria’? (more familiarly known as

‘Criteria Documents’’) reflecting ‘‘the latest scientific

knowledge useful in indicating the kind and extent of all

identifiable effects on public health or welfare which

may be expected from the presence of such pollutant in

the ambient air, in varying quantities.’’ The statutory

provisions in question in this case, Sections 109(b)(1) and

(2) of the Act, 42 U.S.C. §§7409(b)(1) and (2), provide

for adoption of national primary and secondary air

quality standards for listed pollutants, as follows:

*“(1) National primary ambient air quality stan-

dards, prescribed under subsection (a) of this section

shall be ambient air quality standards the attainment

and maintenance of which in the judgment of the

Administrator, based on such criteria and allowing

an adequate margin of safety, are requisite to pro-

tect the public health. Such primary standards may

be revised in the same manner as promulgated.

(2) Any national secondary ambient air quality stan-

dard prescribed under subsection (a) of this section

shall specify a level of air quality the attainment and

maintenance of which in the judgment of the Ad-

ministrator, based on such criteria, is requisite to

protect the public welfare from any known or an-

ticipated adverse effects associated with the presence

of such air pollutant in the ambient air. Such

secondary standards may be revised in the same

manner as promulgated.’’

The regulation in question sets forth EPA’s national

ambient air quality standards for lead, 40 C.F.R. §50.12

(Appendix B).

3

STATEMENT OF THE CASE

This case, which concerns EPA’s establishment of

national primary (public health) and secondary (public

welfare) ambient air quality standards for lead under the

Clean Air Act, raises questions with respect to EPA’s

standard-setting powers that are of importance to all in-

dustries regulated by EPA and that have never before

been considered by the Court.

In the regulatory proceedings beiow, EPA developed

the primary lead standard by first determining what it

considered the highest safe concentration of lead in the

blood of children, the most sensitive segment of the

population. The Agency then made a series of calcula-

tions to determine what limit on concentrations of lead

in the air was necessary to assure that individual

children’s blood lead concentrations would not exceed

the safe level.

A blood lead concentration of 40 micrograms per

deciliter' has heretofore been considered to be safe for

children. This is based on the premise that the threshold

adverse health effect associated with lead exposure is

anemia which occurs at blood lead concentrations well

above 40 ug/dl. Consistent with that view, in its 1975

proceedings to reduce the lead content of gasoline EPA

concluded that blood lead concentrations threaten the

health of children at some level above 40 ug/dl, and

established its lead-in-gasoline phasedown rules on the

assumption that a blood lead level of 40 ug/dl was a

safe upper limit for children, see Ethyl Corp. v. EPA,

541 F.2d 1, 38-39 (D.C. Cir.) (en banc), cert. denied,

426 U.S. 941 (1976).

' Concentrations of lead in blood, or blood lead levels, are ex-

pressed as micrograms of lead per deciliter of blood (ug/dl).

-*

4

However, the Criteria Document published by EPA

in December 1977, when it first proposed the lead stan-

dards at issue here, contained passages discussing a

biological response known as erythrocyte protoporphyrin

(EP) elevation that is associated with lead and is detect-

able at blood lead levels below 40 ug/dl.? The Criteria

Document concluded that EP elevation is ‘‘relevant to

human health’’ because it ‘‘indicates’’ impaired heme

synthesis and mitochondrial function (42 Fed. Reg.

63078, December 14, 1977).?

When it published the lead Criteria Document, EPA

simultaneously proposed a national primary air quality

standard limiting airborne concentrations of lead to 1.5

micrograms of lead per cubic meter of air (ug/m’)

because of the Agency’s concern over the health implica-

tions of EP elevation (42 Fed. Reg. 63075, 63078). In

doing so, EPA acknowledged that there was ‘‘scientific

controversy’’ about ‘‘the health significance of abnormal

biological effects associated with blood lead levels below

traditional levels of concern’’ (42 Fed. Reg. 63077). EPA

simultaneously proposed a national secondary air quality

standard at the same level as the primary standard

> A biological response or effect is a deviation from the norm

that is usually detectable only by special laboratory tests. The body

constantly experiences many such deviations with no adverse impact

on health.

’ The reference to heme synthesis impairment means that lead af-

fects certain chemical steps in the production of heme, a constituent

of hemoglobin, the oxygen-carrying component of the body’s red

blood cells. This does not, however, mean that the production of

heme or hemoglobin is reduced, or that the body is in any way in-

jured. Mitochondria are part of the body’s cells and play an impor-

tant role in cell respiration. What the Criteria Document meant by

impairment of mitochondrial function is unclear, but there was no

suggestion in the Criteria Document that cell respiration is affected

in any way at blood lead levels below 40 ug/dl.

stating only that it could find no grounds for a second-

ary standard more stringent than the primary one (42

Fed. Reg. 63081-82).

Because of the admitted scientific controversy over

the health significance of the biological responses that

occur at low blood iead levels, EPA sought public com-

ment ‘‘on whether what is known, or anticipated, about

EP elevations or other subclinica! effects has sufficient

implications to warrant a role in determining the level of

the standard’’ (42 Fed. Reg. 63079). EPA further noted

that it ‘‘could take the position that EP elevation, while

of concern to public health, is not sufficiently adverse to

health, and that the standard should be based on the

more severe effects such as anemia, or CNS [central ner-

vous system] deficits’’ (id.).

A hearing was held at which only three medical

witnesses testified in support of the proposed standard,

while a number of medical authorities in the fields of

hematology and pediatric lead health effects testified or

filed statements challenging the scientific and medical

bases of the standard.‘ The witnesses in opposition

stated that elevated EP is not harmful but instead serves

as an indicator of biological change or response, that

heme synthesis is not impaired unless the production of

‘ The latter witnesses included Dr. J. Julian Chisolm, Jr., Senior

Staff Pediatrician, Baltimore City Hospital and Associate Professor

of Pediatrics, Johns Hopkins University School of Medicine, and a

consultant to EPA’s Science Advisory Board; Dr. James Jandl,

Minot Professor of Medicine, Harvard Medical School; Dr. Edward

McCabe, Assistant Professor of Pediatrics, University of Wisconsin

Medical School; Dr. Henrietta K. Sachs, a pediatrician and former

director of the Chicago Lead Clinic; and Drs. James McNeil and

Ronald Panke, practicing physicians who had conducted studies of

the effects of lead on children living near lead smelters.

-*

6

heme is in fact reduced, and that no studies had shown

reduced hemoglobin at blood lead levels below 40 ug/dl.

Testimony and comments were also submitted

demonstrating that the proposed primary standard not

only was designed to prevent the occurrence of biological

responses that had not been shown to be harmful, but

was further removed from legitimate health protection

by the incorporation of multiple and cumulative safety

margins. An example of such a margin is the fact that,

though the Criteria Document states that lead sulfide is

virtually insoluble (and, it follows, is unlikely to be ab-

sorbed in children’s blood to any appreciable extent) and

that children are unlikely to inhale particles above a cer-

tain size, lead sulfide and iarge lead particles were not

excluded from the standard. Another example is the fact

that at numerous points in the arithmetical process used

to determine the maximum air lead level required to

maintain children’s blood lead levels below 30 ug/dl,

EPA took an excessively conservative approach, thereby

adding a series of safety factors that had the effect of

cumulating and compounding the safety margin.

LIA also submitted evidence showing that the 1.5

ug/m?’ standard was impossible to attain and would

result in a virtual shutdown of U.S. lead production by

forcing the closure of 45 primary and secondary lead

smelters representing over 80 percent of total U.S. lead

production capacity.°

* This point was never disputed by EPA, and upon promulgation

of the final lead standard EPA’s Administrator acknowledged that

‘“‘some nonferrous smelters may not be able to technically or

economically achieve the standard,’’ 9 Envir. Rep. (BNA) 1091

(Current Developments, October 6, 1978).

7

Nonetheless, in October 1978 EPA adopted final air

lead standards at the same level it had proposed, 1.5

ug/m’. The primary standard was designed to maintain

children’s blood lead levels below 30 ug/dl, though the

Agency failed to find any significant risk of harm at this

level. While EPA found that blood lead levels below 20

ug/dl presented no ‘‘significant risk’? and that those

above 40 ug/dl were ‘‘clearly adverse’? (App. 143a), it

made no clear-cut findings concerning the health

significance of a 30 ug/dl blood lead level.* Thus, at one

point in the preamble to the final regulation EPA said

that it did not have ‘‘sufficient information’’ to rule out

the possibility of harm at blood lead levels below 40

ug/dl (App. 127a). At another point EPA stated that im-

paired heme synthesis is ‘‘potentially adverse’’ to health

at blood lead levels of 30 ug/dl (App. 143a), while

elsewhere in the preamble EPA found that heme syn-

thesis is not impaired until blood lead levels exceed 40

ug/dl (App. 153a), and in still another place EPA found

only that impaired heme synthesis is ‘‘not without health

significance’ and that EPA has ‘‘concern’’ about its ef-

fects at blood lead levels above 30 ug/dl (App.

135a, 150)a. At no point did EPA find that blood lead

levels between 30 and 40 ug/dl present a significant risk

of harm to health.

In addition to showing uncertainty as to the medical

significance of blood lead levels between 30 and 40

ug/dl, EPA did not define what it meant by ‘‘adverse to

health.’’ Most importantly, EPA did not find that heme

* Using EPA’s formula for calculating the lead standard,

establishment of 40 ug/dl, rather than 30 ug/dl, as the maximum

safe blood lead level would have resulted in a standard of about 4

ug/m', one which would have caused much less harm to the lead

industry than the 1.5 ug/m* standard EPA adopted.

r*

synthesis impairment at blood lead levels below 40 ug/dl

causes illness, reduces a child’s functional or learning

capacity, results in shortened life span, leads to higher

susceptibility to disease, or causes any other manifesta-

tion of health impairment. As an apparent fallback posi-

tion, EPA said that it was adopting 30 ug/dl as the max-

imum safe blood lead level in order to protect against

anemia (App. 128a), yet EPA in fact found that anemia

does not occur until blood lead levels reach 40 ug/dl,

and even then EPA found only that ‘‘symptoms’’ of

anemia ‘‘may’’ occur at that level (id.).’

Following the promulgation of the final lead stan-

dards, LIA petitioned EPA to reconsider and stay the

regulations and petitioned for judicial review in the

District of Columbia Circuit pursuant to Section 307(b)

of the Act, 42 U.S.C. §7607(b). EPA denied the petition

in February 1979, and the court below affirmed the rules

in its opinion which is the subject of this petition for

certiorari.

The opinion of the court below, which was issued

before this Court’s decision in /ndustrial Union Dep’t v.

API, did not focus on EPA’s duty to set standards on

the basis of significant risks of harm to health, but held

that Section 109 authorizes EPA to establish primary air

quality standards without showing ‘‘that there is a

medical consensus that the effects on which [such stan-

dards are] based are ‘clearly harmful to health’ ’’ (App.

47a). Instead, under the court’s holding, all that the

’ The Criteria Document does not state that anemia has been

found to occur at a blood lead level of 40 ug/dl, and there was

abundant evidence that it occurs above that level (App. 56a n. 67,

143a).

y

statute requires ‘‘is evidence in the record which substan-

tiates [EPA’s] conclusions about the health effects on

which the standards were based’’ (id.).

The court also affirmed EPA’s use of multiple

margins of safety in setting the standards, ruling that

under Section 109(b), which authorizes a ‘‘margin of

safety,’” EPA’s approach constituted ‘‘a policy choice of

the type that Congress specifically left to the Ad-

ministrator’s judgment,’’ and the court ‘‘must allow him

the discretion to determine which approach will best

fulfill the goals of the Act’’ (App. 61la-62a).

In addition, the court ruled that EPA’s setting the

secondary standard at the same level as the primary stan-

dard, without supporting findings showing that the

secondary standard is necessary to protect the public

welfare, was not improper because this ‘“‘imposed no ad-

ditional burdens on the industryv’’ (App. 103a).

The court also rejected several other challenges by

the industry petitioners, and EPA’s 1.5 ug/m’ primary

and secondary lead standards were affirmed.

ARGUMENT

The Court should exercise its discretionary jurisdic-

tion to review the decision of the Court of Appeals in

this case. The opinion below authorizes EPA to adopt

health standards without finding that such standards are

reasonably necessary to eliminate significant risk of harm

to health and thus conflicts with the Court’s decision in

Industrial Union Dep’t v. API, 100 S.Ct. 2844 (1980),

and the provisions of the Clean Air Act. The decision of

the court below that EPA may use multiple and com-

pounded margins of safety, and may adopt a standard to

protect the public welfare without making independent

10

findings in support of the standard, likewise conflicts

with the Clean Air Act and presents important issues of

Federal law that should be finally resolved by the Court.

I. The Decision Below Is In Conflict With The

Court’s Recent Decision In Industrial Union

Dep’t v. API.

The plurality opinion in the benzene case held that

the Occupational Safety and Health Administration may

adopt a health standard limiting the concentrations of a

pollutant in workplace air only when such a standard is

supported by findings demonstrating that the standard is

‘treasonably necessary’’ to prevent a ‘‘significant risk’’

of ‘‘harm’’ or ‘‘material health impairment’? from a

‘*proven hazard,’’ Jndustrial Union Dep’t v. API, 100

S.Ct. 2855, 2863, 2869. Moreover, the plurality opinion

states that the agency must show that its findings as to

what constitutes harm to health are supported by ‘‘a

body of reputable scientific thought,’’ id. at 2871.

OSHA’s benzene standard, which established a 1 ppm

maximum concentration limit, was overturned because

OSHA failed to show that workers are exposed to

‘*significant risk’? of ‘‘material harm’’ at benzene air

concentrations below 10 ppm, but had developed only

‘*sketchy evidence’’ on that subject, id. at 2859.

While the language of the Clean Air Act governing

the establishment of air quality health standare's is dif-

ferent from that of the Occupational Safety and Health

Act, the thrust and purpose of the two laws are identical

insofar as health protection is concerned. Both acts

direct the respective agencies to set standards only on the

1]

basis of ‘‘significant’’ risk of material health harm.® Fur-

ther, as we will show below, the legislative history of the

Clean Air Act makes it clear that the requirement of the

Act that national primary ambient air quality standards

shall be ‘‘requisite to protect the public health’? means

that such standards must be designed to prevent effects

that are clearly adverse to health (infra, pp. 14-17). In-

deed, Congress explicitly recognized that attempts to

develop standards that would eliminate all health effects,

not merely those that are clearly harmful, would cause

unacceptable damage to the Nation’s economy, and

Congress warned EPA against adopting ‘‘no effects’’

standards (infra, p. 15).

Hence, there is no substantive difference between

the requirement imposed on OSHA that standards be

‘*reasonably necessary’’ to prevent ‘‘significant risk’’ of

‘*material health impairment’’ and the requirement that

EPA’s standards be designed to prevent effects that are

adverse to health. In both instances, Congress intended

the agencies to restrict their standard-setting activities to

the prevention of real harm. And there is no reason why

the plurality’s requirement that OSHA’s_ medical

judgments be supported by a ‘‘body of reputable scien-

tific thought’’ would apply any less to EPA’s judgments.

* The legislative history of the Clean Air Act expressly endorses

the ‘significant risk’’ approach. In Ethyl Corp. v. EPA, 541 F.2d

at 13, the court held that EPA must regulate on the basis of a

‘significant risk of harm.’’ In enacting the 1977 Amendments to

the Clean Air Act, Congress specifically adopted this position and

applied it to all sections of the Act concerning public health protec-

tion. See H.R. Rep. No. 95-294, 95th Cona., Ist Sess. 43-49 (1977).

In setting the lead standard, EPA itself has spoken in terms of

‘*significant risk.’’ See p. 7, supra.

12

In sum, the following principle expressed by the Chief

Justice in his concurring opinion in the benzene case ap-

plies with equal force to EPA’s lead standard:

‘‘When the administrative record reveals only scant

or minimal risk of material health impairment,

responsible administration calls for avoidance of ex-

travagant, comprehensive regulation. Perfect safety

is a chimera; regulation must not strangle human

activity in the search for the impossible’’ (100 S.Ct.

at 2875).

It is readily apparent, following the reasoning of the

benzene case, that EPA’s lead standard suffers from the

same defect as OSHA’s benzene standard — in neither

case did the agency find, or was it able to show, that its

health standard was required to prevent a significant risk

of harm. In EPA’s case, the Agency was simply unable

ultimately to find or to demonstrate that blood lead

levels between 30 and 40 ug/dl present a significant risk

of harm. All that EPA was ever able to find was that

lead affects a bodily function at 30 ug/dl, and that this

was grounds for ‘‘concern’’ (App. 127a, 150a).

Thus, although EPA determined that EP elevation

and associated impaired heme synthesis may occur at

blood lead levels as low as 30 ug/dl, it never explained

how these phenomena are harmful at levels below 40

ug/dl. While EPA found that blood lead levels below 20

ug/dl presented ‘‘no significant risk’? and that those

above 40 ug/dl were ‘‘clearly adverse’ (App. 143a), it

was never able to conclude that a significant risk of

harm exists at levels between 30 and 40 ug/dl, confining

itself to statements that blood lead levels within this

range present ‘‘some degree’’ of health risk or are ‘‘not

without health significance’ (42 Fed. Reg. 63079, App.

135Sa).

13

Such an approach to establishing national en-

vironmental standards is clearly prohibited by the

benzene plurality opinion. Moreover, EPA was no more

able to point to ‘‘a body of reputable scientific thought’’

supporting its conclusion that 30 ug/dl is the maximum

safe blood lead level than was OSHA in concluding that

benzene presents a cancer hazard at exposure levels

below 10 ppm.’

In its search of the record, the court below was as

unsuccessful as EPA was in pinpointing adverse health

effects at blood lead levels of 30 ug/dl. The court was

able to state only that EP elevation ‘‘indicates’’ that lead

has begun to ‘‘affect’’ biological functions in the body;

that it is an ‘‘indication’’ of an impairment which ‘‘af-

fects’’ human health; that it ‘‘indicates’’ an impairment

of the mitochondria and that lead has begun to ‘‘affect’’

heme synthesis; that it ‘‘may indicate’’ a reduction in

reserve capacity; and that impairment of heme synthesis

“*suggests’’ that lead ‘‘may’’ also interfere with other

heme proteins (App. 52a).'°

* Of the three medical witnesses who supported EPA’s proposed

lead standard at the Agency’s hearing, two appear to take the view

that lead should be eliminated from the environment entirely

because it is not beneficial to humans and is harmful at high blood

lead levels, an approach akin to OSHA’s carcinogen policy which

branded benzene dangerous at any exposure level because it was im-

plicated as a carcinogen at high exposure levels (App. 123a, 167a,

169a).

'' The court attempted to bolster this discussion by citing an

earlier section of its opinion (App. Sla n. 57), but there the court

was addressing ‘‘severe neurological effects of high lead exposure’’

which occur at 80-100 ug/dl in children and at 100-200 ug/dl in

adults, and ‘‘impaired neural and cognitive functions’? which ap-

pear to start for some children at a range of 50-60 ug/dl (App.

13a-14a). In short, neither EPA nor the court below succeeded in

explaining how blood lead levels below 40 ug/dl adversely affect the

public health.

14

The Court of Appeals’ affirmance of EPA’s regula-

tion thus has the practical effect of leaving EPA free to

adopt whatever health standards it wishes merely by

finding that the pollutant in question affects a bodily

function or causes some deviation from an ideal state

whether or not a significant health risk is present. Con-

gress no more intended such a broad grant of authority

to EPA than it did to OSHA, and this petition should be

granted so as to make clear the bounds of EPA’s

standard-setting authority.

II. This Case Presents Questions Of Exceptional

Importance Under The Clean Air Act That

Should Be Decided By The Court.

Quite apart from the conflict with the plurality’s

opinion in /ndustrial Union Dep’t v. API, EPA’s ap-

proach to standard-setting in the lead case is at odds

with the Clean Air Act, and grant of this petition is

necessary to prevent EPA from persisting in similar ef-

forts to impose standards that are both crippling to in-

dustry and unnecessary to protect the public health.

A. Primary standards may not be designed to

prevent biological responses not shown to

be adverse or to present a significant risk

of harm to health.

Primary ambient air quality standards are not goals

but enforceable requirements that must be met within

prescribed deadlines pursuant to state implementation

plans under Section 110, 42 U.S.C. §7410. As we have

pointed out earlier, the possibility that excessively severe

primary standards could cause serious economic disloca-

tion was not lost on Congress, and the legislative history

of the Clean Air Act makes it clear that EPA’s authority

15

under Section 109(b) is limited to the establishment of

standards to protect the public from effects that are

clearly adverse to health. That same history also shows -

that Congress did not intend to authorize EPA to adopt

primary standards which would force the virtual closure

of an important United States industry in order to pre-

vent biological responses without showing how those

responses are harmful.

The Senate Report on the 1970 amendments to the

Clean Air Act, which established the present standard-

setting scheme of Section 109, stated that EPA ‘‘would

be required to set a national minimum standard of air

quality,’’ S. Rep. No. 91-1196, 91st Cona., 2d Sess. 10

(1970). Senator Muskie, the Act’s chief sponsor in the

Senate, later explained that the concept of ‘‘minimum

standards’’ meant that there were limits as to what the

standards could be expected to accomplish in the way of

health protection:

‘*With respect to the national primary and second-

ary air quality standards, those are not clean air

standards. Those are minimal standards. We made

them minimal in order to achieve a realistic goal for

cleanup in dirty air areas, so they are minimal... .

They were written as the minimal burden we could

impose upon the dirty air areas of the country to

clean up without bringing their economies to a

screeching halt.’’ Hearings on S. 251, S. 252 and S.

253 Before Subcomm, on Environmental Pollution

of Senate Comm. on Environment and Public

Works, 95th Cong., Ist Sess., Part 3 at 37 (1977).

The approach outlined by Senator Muskie is echoed

in other statements in the Act’s legislative history that

‘‘no effects’? thresholds are not only impossible to

achieve, but are impractical and unwise from an

economic and social standpoint. See, e.g., H.R. Rep.

No. 95-294, supra, at 127. The fact that Congress did

16

not contemplate that the primary standards would lead

to serious economic dislocation, and that primary stan-

dards were never expected to eliminate all health ‘‘ef-

fects’? but only those that are clearly adverse, is further

emphasized in the following statement by Senator

Muskie during the debate on the 1977 amendments to

the Act:

‘(T]he national primary and secondary standards

were set for dirty air areas as the minimum

necessary and the minimum reasonably attainable in

the dirty air areas, in order to put them up to

minimal health standards. They are not ultimate;

they are not maximum; they are minimal. * * *

Even at the national primary standard level, which

is the health standard, there are health effects that

are not protected against.’’ 123 Conc. REc. S 9423

(daily ed. June 10, 1977) (emphasis added).

The very language of Section 109 reflects the con-

cern expressed by Congress that primary standards not

be imposed in a fashion that seeks to achieve a ‘‘no ef-

fects’? level at any cost. Unlike the primary standards

which must be met within tight deadlines, the secondary

or welfare-based standards must be met within a

‘reasonable’ time, and issues of technological and

economic feasibility enter into state implementation plan

timetables for meeting secondary standards. For that

reason, Congress established the extremely broad-

reaching requirement that secondary standards ‘‘must be

requisite to protect the public welfare from any known

Or anticipated adverse effects,’’ Section 109(b)(2), 42

U.S.C. §7409(b)(2). By contrast, Congress specified in

the case of the primary standards only that they be ‘‘req-

uisite to protect the public health,’’ Section 109(b)(1), 42

U.S.C. §7409(b)(1), and according to the Senate Report

to the 1970 legislation, ‘‘requisite to protect the public

17

health’’ means requisite to protect against ‘‘adverse ef-

fects,’’ S. Rep. No. 91-1196, supra, at 10.

The court below rejected the foregoing interpreta-

tion of the Act, stating that the Act was intended to be

precautionary and standards may be designed to protect

against ‘‘effects that have not yet been uncoyered by

research’’ (App. 45a). While the thrust of the Act is un-

questionably precautionary, there is no way to avoid the

fact that the legislative history passages quoted above

show that Congress wanted precaution taken only

against significant risks of harm, not unknown risks of

possible harm. Moreover, the interpretation of the court

below gives EPA’s Administrator no guidance as to the

limits of his standard-setting authority and leaves him

free to interpret the statutory requirement that primary

standards be ‘‘requisite to protect the public health’’ any

way he wishes. The ruling of the court below is in con-

flict with the Clean Air Act and would sanction precisely

the kind of standardless delegation that Mr. Justice

Rehnquist found objectionable in his concurring opinion

in the benzene case, 100 S.Ct. at 2878-87. For these

reasons, and because these questions concerning EPA’s

standard-setting powers have such far-reaching conse-

quences for American industry, the decision below

should be reviewed by the Court.

B. EPA exceeded its authority by adopting

multiple margins of safety.

While EPA’s decision to adopt an air lead standard

designed to maintain children’s blood leads below 30

ug/dl would in and of itself have resulted in an ex-

cessively stringent standard, the stringency of the stan-

dard was greatly aggravated by the fact that EPA built

in multiple and compounded margins of safety when it

calculated the standard.

18

Thus, safety margins were applied not only in

EPA’s determination of the maximum safe blood lead

level for children, but in its selection of an air

lead/blood lead ratio of one unit in the air equals two

units in the blood (App. 133a), as well as its estimate of

the amount of blood lead attributable to non-air sources

(App. 134a). Including non-respirable particles and those

that are virtually insoluble in the primary standard (App.

137a) adds still another ‘‘margin of safety’’ since doing

so has the effect of applying the standard to particles

which cannot be deposited in the respiratory system or

absorbed in the blood and thereby overestimates the con-

tribution to blood lead from air sources (see infra, p. 6).

The point concerning the inclusion of large and vir-

tually insoluble particles deserves emphasis. EPA conced-

ed in the preamble to the final regulation that ‘‘some

lead particles are too small or too large to be deposited

in the respiratory system’’ (App. 137a). As noted earlier,

the Criteria Document also observes that lead sulfide is

virtually insoluble and absorption of lead sulfide through

the lungs may be slight (App. 73a n.105). EPA never

focussed on the question of solubility, and rejected

LIA’s contentions concerning particle size by saying that

large particles ‘‘may, at some point, become respirable

through weathering’’ (App. 137a). The court below sus-

tained EPA’s position in view of ‘‘the paucity of the in-

formation’’ on the subject of solubility and particle size

(App. 73a). The fact remains that there was sufficient in-

formation for the drafters of the Criteria Document to

make specific findings on these subjects and, as the

plurality opinion in the benzene case points out, the

burden is on the agency proposing a standard to develop

the information needed to support its position, 100 S.Ct.

2870.

19

The importance of EPA’s multiple safety margins to

the level of the final standard cannot be overemphasized.

Given the methodology EPA used in calculating the

primary standard, relatively minor changes in such fac-

tors as the one employed to determine the impact of air

lead exposure on blood lead levels (the so-called air

lead/blood lead ratio) result in very significant changes

in the standard. For example, had EPA chosen the air

lead/blood lead ratio recommended in the first draft of

the Criteria Document, rather than the ratio it ultimately

employed, the final standard would have been 3 ug/m’,

twice as high as the standard it adopted, even assuming

no change in the 30 ug/dl blood lead threshold.

Section 109(b)(1) of the Act, 42 U.S.C. §7409(b)(1),

requires EPA to adopt primary air standards requisite to

protect the public health ‘‘allowing an adequate margin

of safety.’’ Although the 1970 Senate Report said that a

margin of safety should afford only a ‘‘reasonable

degree of protection,’’ S. Rep. No. 91-1196, supra, at

10, and an ‘‘adequate’’ margin of safety has been held

to embrace something less than an ‘‘ample’’ margin of

safety, Environmental Defense Fund v. EPA, 598 F.2d

62, 81 (D.C. Cir. 1978), the court below nonetheless ap-

proved EPA’s use of multiple and compounded margins

of safety in setting the lead standard as a proper ‘‘policy

choice’’ (App. 61a).

To say that Congress left EPA free to build in

multiple and compounded margins of safety at each

point in the analysis can only result in a final standard

far more stringent than is necessary or achievable. Ac-

cordingly, the Court should review this issue, as the deci-

sion of the court below granting EPA unfettered discre-

tion to construct margins of safety makes meaningless

Section 109’s directive that standards be limited to pro-

tecting the public health.

20

C. EPA must make independent findings to

support secondary standards even though

they are set at the same level as primary

standards.

In establishing the secondary, or welfare-based,

standard for lead at the same level as the primary, or

health-based, standard, EPA merely said that there was

no evidence that a secondary standard more restrictive

than the primary one would be justified (App. 156a).

This in turn was based on the conclusion that ‘‘animals

do not appear to be more susceptible to adverse effects

from lead than man, nor do adverse effects in animals

occur at lower levels of exposure than comparable effects

in humans” (id.). The court below affirmed the

establishment of a secondary standard on this basis

because, in its view, no additional burdens on industry

were imposed (App. 103a). However, the court below

was unable to cite the Clean Air Act, EPA’s regulations

or any judicial decisions in support of its holding.

In any event, if as we have urged the primary stan-

dard is invalid, the secondary standard must fall as well,

for EPA made no findings that would independently

support the secondary standard. Thus, EPA made no at-

tempt to establish a rational connection between infor-

mation in the Criteria Document on the effects of lead

on plants, animals, climate, visibility, economic values,

and other ‘‘welfare’’ considerations listed in Section

302(h), 42 U.S.C. §7602(h), and the adoption of a 1.5

ug/m?’ secondary standard. See Kennecott Copper Corp.

v. EPA, 462 F.2d 846, 850 (D.C. Cir. 1972), where the

secondary standard for sulfur oxides was remanded

because EPA’s Administrator had failed ‘‘to enlighten

the court as to the basis on which he reached the [secon-

dary] standard from the material in the Criteria.’’ Accor-

dingly, this issue also merits review by the Court.

21

CONCLUSION

For the foregoing reasons, the petition for a writ of

certiorari should be granted.

Respectfully submitted,

EDWIN H. SEEGER

CARL B. NELSON, JR.

Attorneys for Petitioner

Lead Industries Association, Inc.

September 25, 1980