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

§0-48 2 FILED

80-48 3

. CLERK

IN THE

Supreme Court of the Gnited States

OCTOBER TERM, 1980

LEAD INDUSTRIES ASSOCIATION, INC., Petitioner,

Vv.

ENVIRONMENTAL PROTECTION AGENCY, Respondent.

St. JOE MINERALS CORPORATION, Petitioner,

We

ENVIRONMENTAL PROTECTION AGENCY, Respondent.

APPENDIX TO

PETITIONS FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE DISTRICT OF COLUMBIA CIRCUIT

EpwIn H. SEEGER JoHN MCN. CRAMER

CarL B. NELSON, JR. REED SMITH SHAW & McCLay

PRATHER SEEGER DOOLITTLE 747 Union Trust Building

& FARMER Pittsburgh, Pa. 15219

1101 Sixteenth Street, N.W. (412) 288-3131

Washington, D. C. 20036

Lee A. Rau

(202) 296-0500 RoBERT A. EMMETT

Attorneys for Petitioner DaNIEL A. MASUR

Lead Industries Association, REED SMITH SHAW & McCLay

Inc. 1150 Connecticut Avenue, N.W.

Washington, D. C. 20036

(202) 457-6100

Attorneys for Petitioner

September 25, 1980 St. Joe Minerals Corporation

AS

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

TABLE OF CONTENTS

PAGE

APPENDIX A

ey te Oe GND OD ov nn. nk tacavecnucdsseees la

APPENDIX B

EPA’s Final Air Quality Standards for Lead, 43 Fed.

SE St, BOO o hwvs ceecesacsicen'ess 113a

APPENDIX C

Excerpt from Testimony of Dr. Herbert L.

Needleman, February 15, 1978 .............e0e00: 167a

APPENDIX D

Excerpt from Testimony of Dr. Sergio Piomelli,

ee coe Vel cuss rk Ged bso 0am oka 169a

la

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. 78-2201

LEAD INDUSTRIES ASSOCIATION, INC., PETITIONER

v.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

BUNKER HILL COMPANY, INTERVENOR

No. 78-2220

ST. JOE MINERALS CORPORATION, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

BUNKER HILL COMPANY, INTERVENOR

Petitions to Review Action of the

Administrator of the Environmental Protection Agency

Argued November 7, 1979

Decided June 27, 1980

Bills of costs must be filed within 14 days after entry of judgment. The

court looks with disfavor upon motions to file bills of costs out of time.

2a

Edwin H. Seeger, with whom Gary M. Welsh and

Richard T. Witt were on the brief, for petitioner in No.

78-2201 and for intervenor in both cases.

Robert A. Emmett, with whom John McN. Cramer

was on the brief, for petitioner in No. 78-2220.

James N. Cahan, Attorney, Environmental Protection

Agency, and Michael P. Carlton, Attorney, Department

of Justice, with whom Sanford Sagalkin, Acting As-

sistant Attorney General, Angus MacBeth, Attorney, De-

partment of Justice, Joan Z. Bernstein, General Counsel,

Environmental Protection Agency, and Gerald K. Glea-

son, Deputy Associate General Counsel, Environmental

Protection Agency, were on the brief, for respondent.

James W. Moorman, Attorney, Department of Justice,

and Jeffrey O. Cerar, Attorney, Environmental Protec-

tion Agency, also entered appearances for respondent.

David Schoenbrod for amici curiae Natural Resources

Defense Council, Inc. e¢ al. urging affirmance in both

cases.

Kathleen W. Mikkelson, Deputy Attorney General,

State of California, was on the brief for amicus curiae

Air Resources Board, State of California, urging affirm-

ance in both cases.

Before WRIGHT, Chief Judge, and ROBINSON and

MACKINNON, Circutt Judges.

Opinion for the court filed by Chief Judge WRIGHT.

WRIGHT, Chief Judge: This is the third occasion on

which this court has been asked to review Environmental

Protection Agency (EPA or Agency) regulations prom-

ulgated under authority of the Clean Air Act, as

amended, 42 U.S.C. § 7401 et seg. (Supp. I 1977) (the

Act), and specifically designed to deal with the health

problems associated with lead in the ambient air. In

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

3a

we upheld regulations prohibiting the sale of leaded gaso-

line for use in automobiles equipped with “catalytic con-

verter” devices for controlling exhaust emissions and re-

quiring widespread retail marketing of at least one grade

of unleaded gasoline. And in Ethyl Corp. v. EPA, 541

F.2d 1 (D.C. Cir.) (en banc), cert. denied, 426 U.S. 941

(1976), we affirmed an EPA order requiring annual re-

ductions in the lead content of leaded gasoline. In the

present consolidated cases we are asked to review EPA

regulations establishing national ambient air quality

standards for lead. These air quality standards prescribe

the maximum concentrations of lead that will be per-

mitted in the air of our country. We must decide

whether EPA’s Administrator acted within the scope of

his statutory authority in promulgating these regulations

and, if so, whether the evidence adduced at the rule-

making proceeding supports his final determinations. In

addition, we must examine the petitioners’ claims that

infirmities in the procedures employed by EPA in this

rulemaking warrant remand of the regulations to the

Agency. Petitioners are the Lead Industry Association,

Inc. (LIA), a nonprofit trade association whose 78 mem-

bers include most of the country’s producers and com-

mercial consumers of lead (No. 78-2201), and St. Joe

Minerals Corporation (St. Joe) (No. 78-2220).

I. BACKGROUND

Man’s ability to alter his environment to achieve per-

ceived goals has undoubtedly made an enormous contri-

bution to his economic and social well-being. This under-

taking is not, however, without attendant costs. One of

these costs is the toll that these alterations may exact

1 The Bunker Hill Company is an intervenor, and the Nat-

ural Resources Defense Council, Inc. and the Air Resources

Board of the State of California were granted permission to

participate as amici curiae.

4a

on the environment itself and, in turn, the dangers that

this may pose for the public health and welfare. Un-

fortunately, man’s ability to alter the environment often

far outstrips his ability to foresee with any degree of

certainty what untoward effects these changes may

bring. The issues presented by these cases illustrate this

sad fact.

Lead’s environmental significance is a consequence of

both its abundance and its utility. The relative abun-

dance of lead in the earth’s crust makes it unique among

the toxic heavy metals. EPA’s “Air Quality Criteria

For Lead” (hereinafter cited as CD) 1-1, Joint Appendix

(JA) 1105. And centuries of mining and smelting, and

the use of lead in a variety of human activities, have

increased the natural background concentration of lead

in the environment. 7d. But it is only since the indus-

trial age and the use of lead as a gasoline additive that

lead has become pervasive. Id. at 1-2 - 1-38, JA 1106-1107.

Today lead is ubiquitous. It is found in almost every

medium with which we come into contact—food, water,

air, soil, dust, and paint, id. 1-1, JA 1105, each of which

represents a potential pathway for human lead exposure

through ingestion or inhalation. The widespread presence

of this toxic metal in the environment poses a significant

health risk. Lead is a poison which has no known bene-

ficial function in the body, id. 1-12, JA 1116, but when

present in the body in sufficient concentrations lead at-

tacks the blood, kidneys, and central nervous and other

systems and can cause anemia, kidney damage, severe

brain damage, and death. Jd. 1-6-1-9, JA 1110-1113.?

There are three major sources of the body’s lead bur-

den. In most people the largest source is diet. CD 7-9,

2 See generally EPA’s “Air Quality Criteria For Lead”

(hereinafter cited as CD), Chapter 11, JA 1223-1276.

Sa

JA 1179. Another source, particularly in children, is

the habit of placing hands, objects, and materials in the

mouth.* The third major source is the ambient air; air-

borne lead is deposited in the respiratory tract as a

person breathes lead-contaminated air and is subsequently

absorbed into the bloodstream. CD 1-5, JA 1108. Once

the lead is in the bloodstream its source is immaterial;

total lead intake is the sum of the intake from all these

sources. The multiplicity of sources of lead intake in-

creases the difficulty of controlling human lead exposure.

Much of the protective activity in this area has focused

on limiting the amount of lead in the ambient air, the

most controllable source of lead exposure. In this coun-

try, by far the largest source of lead emissions—account-

ing for 88 percent of total lead emissions according to

EPA estimates—is the exhaust of motor vehicles powered

by gasoline containing lead additives. CD 5-3, JA 1140.

Another eight percent of lead emissions is the result of

solid waste incineration and combustion of waste oil. Jd.

Industrial facilities account for the remaining four per-

cent of total lead emissions. /d.

Acting pursuant to authority conferred on it by Con-

gress in the Clean Air Act, as amended, 42 U.S.C. § 7401

et seq., EPA has been involved in regulation of lead emis-

sions almost since the Agency’s inception.’ Its initial

8 Estimates of daily lead intake from diet in adult males

range between 100 to 500 grams/day. Only a fraction of the

lead ingested is actually absorbed. CD 7-9, 10-1-10-4, JA

1179, 1212-1215.

* Pica, the habitual ingestion of nonfood substances, is a

particularly important source of lead exposure for children

who live in urban areas. CD 1-5, JA 1109.

‘EPA and other federal agencies, including the Depart-

ment of Housing and Urban Development, the Occupational

Health and Safety Administration, and the Consumer Prod-

uct Safety Commission, are involved in a variety of regulatory

efforts aimed at controlling other sources of lead exposure.

See 48 FED. REG. 46256-46257, JA 2958-2959.

6a

approach to controlling the amount of lead in the ambient

air was to limit lead emissions from automobiles by re-

stricting the amount of lead in gasoline. To this end it

promulgated the regulations which we upheld in Amoco

Oil Corp. v. EPA, supra, and Ethyl Corp. v. EPA, supra.

However, in 1975 the Natural Resources Defense Council,

Inc. (NRDC), and others brought suit against EPA

claiming that the Agency was required by Section 108

of the Clean Air Act, 42 U.S.C. § 7408, to list lead as a

pollutant for which an air quality criteria document

would be prepared, and for which national ambient air

quality standards should be promulgated under Section

109 of the Act, 42 U.S.C. § 7409. The District Court

agreed with NRDC and directed the Administrator to

list lead as a pollutant under Section 108 of the Act, by

March 31, 1976. Natural Resources Defense Council,

Inc. v. Train, 411 F.Supp. 864 (S.D. N.Y. 1976). The

Second Circuit affirmed, 545 F.2d 320 (1976), and EPA

initiated the proceedings outlined in the statute which

are under review here.

II. THE STATUTORY SCHEME

The first step toward establishing national ambient air '

quality standards for a particular pollutant is its addition

to a list, compiled by EPA’s Administrator, of pollutants

that cause or contribute to air pollution “which may

reasonably be anticipated to endanger public health or

welfare[.]”’ Section 108(a) (1), 42 U.S.C. § 7408(a) (1).

Within twelve months of the listing of a pollutant under

Section 108(a) the Administrator must issue “air quality

criteria” for the pollutant. Section 108 makes it clear

that the term “air quality criteria” means something dif-

ferent from the conventional meaning of “criterion”;

such “criteria” do not constitute “standards” or “guide-

lines,” but rather refer to a document to be prepared by

EPA which is to provide the scientific basis for promul-

———

Ta

gation of air quality standards for the pollutant. This

criteria document must “accurately reflect the latest

scientific knowledge useful in indicating the kind and

extent of all identifiable effects on public health or wel-

fare which may be expected from the presence of such

pollutant in the ambient air, in varying quantities.”

Section 108 (a) (2), 42 U.S.C. § 7408 (a) (2).

At the same time as he issues air quality criteria for

a pollutant, the Administrator must also publish proposed

national primary and secondary air quality standards for

the pollutant. Section 109(a) (2), 42 U.S.C. § 7409(a)

(2). National primary ambient air quality standards are

standards “the attainment and maintenance of which in

the judgment of the Administrator, based on such cri-

teria and allowing an adequate margin of safety, are

requisite to protect the public health.” Section 109(b) (1),

42 U.S.C. § 7409(b) (1). Secondary air quality standards

“specify a level of air quality the attainment and main-

tenance of which in the judgment of the Administrator,

based on such criteria, is requisite to protect the public

welfare from any known or anticipated adverse effects

associated with the presence of such air pollutant in the

ambient air.” Section 109(b) (2), 42 U.S.C. § 7409(b)

(2). Effects on “the public welfare” include “effects on

soils, water, crops, vegetation, manmade materials, ani-

mals, wildlife, weather, visibility, and climate, damage

to and deterioration of property, and hazards to trans-

portation, as well as effects on economic values and on

personal comfort and well-being.” Section 302(h), 42

U.S.C. § 7602(h). The Administrator is required to sub-

mit the proposed air quality standards for public com-

ment in a rulemaking proceeding, the procedure for which

is prescribed by Section 307(d) of the Act, 42 U.S.C.

§ 7607 (d).

Within six months of publication of the proposed

standards the Administrater must promulgate final pri-

mary and secondary ambient air quality standards for

8a

the pollutant. Section 307(d) (10), 42 U.S.C. § 7607(d)

(10). Once EPA has promulgated national ambient air

quality standards, responsibility under the Act shifts

from the federal government to the states. Within nine

months of promulgation of the standards each state must

prepare and submit to EPA for approval a state imple-

mentation plan. Section 110(a) (1), 42 U.S.C. § 7410(a)

(1). These state implementation plans must contain

emission limitations and all other measures necessary to

attain the primary standards “as expeditiously as prac-

ticable,” but no later than three years after EPA ap-

proval of the plan, and to attain the secondary standards

within a reasonable period of time. Section 110(a) (2)

(A) & (B), 42 U.S.C. § 7410(a) (2)(A) & (B). The

Administrator is authorized to extend the deadline for

attainment of the primery air quality standards by two

years, but thereafter it must be met. Section 110(e), 42

U.S.C. § 7410(e).

III. THE LEAD STANDARDS RULEMAKING PROCEEDINGS

As required by statute, EPA’s first step toward prom-

ulgating air quality standards for lead was to prepare

a criteria document. The Lead Criteria Document was

the culmination of a process of rigorous scientific and

public review, and thus is a comprehensive and thought-

ful analysis of the most current scientific information on

the subject. The Lead Criteria Document went through

three major drafts, and three separate reviews, including

public meetings by the Subcommittee on Scientific Cri-

teria for Environmental Lead of EPA’s Science Advisory

Board (SAB Lead Subcommittee).* The Agency reviewed

‘This Subcommittee was composed of individuals with ex-

tensive expertise in various fields relevant to the task of pre-

paring the Lead Criteria Document, including toxicology,

environmental medicine, environmental health engineering,

epidemiology, and chemical engineering. A list of the mem-

bers of the Subcommittee and their credentials appears in

9a

over 280 public comments, most of a sophisticated scien-

tific nature, before it issued the final Criteria Document.

Members of the public, industry (including the petition-

ers in these cases), environmental groups, the scientific

community, and state and federal government agencies

actively participated in the review of the drafts. Notice

of the meetings of the SAB Lead Subcommittee was pub-

lished in the Federal Register, and the drafts of the

Criteria Document which were to be reviewed were avail-

able before the meetings. A formal record and a tran-

script of the proceedings were kept, and a review of the

transcript shows that scientists with differing views could

—and did-—exchange ideas with each other as well as

agency staff, and that all were questioned by the members

of the Subcommittee.

A. The Lead Criteria Document?

EPA released its “Air Quality Criteria For Lead” on

December 14, 1977. 42 FED. Rec. 63076, JA 1480. The

7 The first draft of the Criteria Document was released for

public comment on November 18, 1976. This draft was se-

verely criticized for its lack of scholarship, poor analysis, and

low overall quality by most of the experts who reviewed it.

By a 4-3 vote the SAB Subcommittee adopted a resolution

that the draft’s fundamental flaws made it an inadequate

basis for future drafts and recommended that EPA prepare

an entirely new draft. JA 268-270. The second draft of the

Criteria Document was released on May 27, 1977 and, while

the reaction to it was slightly more favorable, the SAB Sub-

committee concluded that the draft was inadequate as a

basic scientific support document for development of health-

related air quality standards. JA 821-824. The third draft

of the Criteria Document was released on August 22, 1977,

and this time the consensus of the SAB Subcommittee was

that the draft was basically sound and represented a vast

improvement over the previous drafts. JA 935, 1069-1073.

The Subcommittee agreed that another meeting to review the

final draft of the Criteria Document was unnecessary. In-

stead, each individual member would submit written com-_

y*%

10a

document was “prepared to reflect the current state of

knowledge about lead—specifically, those issues that are

most relevant to establishing the objective scientific data

base that will be used to recommend an air quality stand-

ard for lead that will adequately safeguard the public

health.” CD 1-1, JA 1105. Accordingly, the Criteria

Document examined a large number of issues raised by

the problem of lead in the environment. One of these

was the effects of lead exposure on human health. The

Criteria Document concluded that, among the major organ

systems, the hematopoietic (blood-forming) and neuro-

logical systems are the areas of prime concern. CD 1-12,

JA 1116. Its discussion of the effects of lead on these

two organ systems is central to our review of the lead

standards.*®

The Criteria Document identified a variety of effects

of lead exposure on the blood-forming system. We will

discuss only the effects that played an important role in

the Administrator’s analysis. Anemia, which can be

caused by lead-induced deformation and destruction of

erythrocytes (red blood cells) and decreased hemoglobin

synthesis,® is often the earliest clinical manifestation of

ments, if any, on the final draft. In his final report to the

Agency the chairman of the Subcommittee stated that on

the whole the final draft “accurately reflect[ed] the available

scientific literature and provid[ed] an adequate scientific

basis for promulgation and issuance of a standard for air-

borne lead.” JA 9138-914. The only other comments on the

final draft were from two consultants retained by the Sub-

committee who found the draft sound on many points but

declined to endorse it because they disagreed with some of

its conclusions. JA 915-920, 2107-2114.

8Lead also affects the renal, reproductive, endocrine,

hepatic, cardiovascular, immunologic, and gastrointestinal

systems. CD Chapter 11, JA 1223-1276.

* Hemoglobin is the protein which transports life-sustaining

oxygen from the respiratory system to all cells in the body.

CD 11-8, JA 1230. It consists of a combination of heme

lla

lead intoxication. CD 11-7-11-8, 11-13, JA 1229-1230,

1235. Symptoms of anemia include pallor of the skin,

shortness of breath, palpitations of the heart, and fatig-

ability."° The Criteria Document concluded, after a re-

view of various studies, that in “children, a threshold

level for anemia is about 40 u[g] Pb/dl, whereas the

corresponding value for adults is about 50 ug Pb/dl.”

CD 11-138, JA 1235. (The concentration of lead in the

blood is measured in micrograms of lead per deciliter of

blood—ug Pb/dl.)

The Criteria Document also examined other more subtle

effects on the blood-forming system, associated with lower

levels of lead exposure. The most pertinent of these “sub-

clinical’ " effects for purposes of these cases is lead-

related elevation of erythrocyte protopophyrin (EP ele-

vation). According to the Criteria Document, this phe-

and globin, and lead interferes with hemoglobin synthesis

by inhibiting synthesis of the globin moiety and affecting

several steps in synthesis of the heme molecule. See CD

11-13 - 11-14, JA 1235-1236.

10 STEDMAN’S MEDICAL DICTIONARY 94 (Unabridged Law-

yers’ Edition 1961).

11 According to the Criteria Document, “subclinical” effects

“are disruptions in function, which may be demonstrated by

special testing but not by the classic techniques of physical

examination; using the term ‘subclinical’ in no way implies

that those effects are without consequences to human health.”

CD 18-4, JA 1334. STEDMAN’s MEDICAL DICTIONARY, supra

note 10, defines “subclinical” as “[d]enoting a period prior

to the appearance of manifest symptoms in the evolution of

a disease.” Id. at 1433.

12 A major function of the hematological system is the

production of red blood cells (erythrocytes) which carry ox-

ygen to the cells of the body by chemically binding oxygen

to the protein hemoglobin, one of the components of erythro-

cytes. See note 9 supra. Heme, one of the components of

hemoglobin, is formed through a series of biochemical steps

y*%

12a

nomenon must, for a number of reasons, be regarded as

an indication of an impairment of human health. CD

11-11, JA 1233. First, EP elevation indicates an im-

pairment in the functioning of the mitochondria, the sub-

cellular units which play a crucial role in the production

of energy in the body, and in cellular respiration. CD

1-6, 11-11, 11-14, 18-5, JA 1110, 1233, 1236, 1335. Sec-

ond, it indicates that lead exposure has begun to affect

one of the basic biological functions of the body—produc-

tion of heme within the red blood cells.'* Heme is critical

to transporting oxygen to every cell in the body. Third,

EP elevation may indicate that any reserve capacity

there may be in the heme synthesis system has been re-

duced. CD 11-11, JA 1233. Finally, the Criteria Docu-

ment noted that lead’s interference with the process of

heme synthesis in the blood may suggest that lead inter-

feres with production of heme proteins fh other organ

systems, particularly the renal and neurological systems.

CD 11-11, JA 1233. The Criteria Document reported

that the threshold for EP elevation in children and

women is at blood lead levels of 15-20 ug Pb/dl, and

25-30 ug Pb/dl in adult males. CD 13-8 (Table 13-2),

(heme synthesis), the final step in which is incorporation of

iron into the protein protopophyrin IX. This process takes

place in the mitochondria of the cell, and one of the ways in

which lead affects heme synthesis is by interfering with this

final step. The result is that protopophyrin IX, without

iron, is incorporated in the hemoglobin molecule in the eryth-

rocytes. Then phenomenon is detected as an elevation of

protopophyrin in the erythrocyte, t.e., EP elevation. CD 11-7 -

11-14, JA 1229-1236.

18 See note 12 supra. Lead also interferes with heme syn-

thesis by inhibiting production of an enzyme which acts as

a catalyst in an early step in production of heme. See CD

11-8- 11-10, JA 1230-1232. Although the threshold for de-

tection of inhibition of this enzyme is about 10 ug Pb/dl, the

Criteria Document concluded that this effect should not be

considered a physiological impairment until blood lead con-

centrations reach levels of 40 ug Pb/dl. CD 1-6, 11-10, JA

13a

JA 1338 (Table 13-2). While suggesting that some of

the initial hematological effects of lead exposure may

constitute relatively mild effects at low blood lead levels,

the Criteria Document concluded that “they nevertheless

signal the onset of steadily intensifying adverse effects

as blood lead elevations increase. Eventually, [these]

* * * effects reach such magnitude that they are of clear-

cut medical significance as indicators of undue lead

exposure.” CD 1-13, JA 1117. The Criteria Document

did not identify a particular blood lead level at which

regulatory response was appropriate, but it did note with

approval the 1975 guidelines issued by the Center For

Disease Control, which use elevated EP at blood lead

levels of 30 ug Pb/dl as the cut-off point in screening

children for lead poisoning. CD 13-5, JA 1335.

The Criteria Document also examined the effects of

lead exposure on the central nervous system. Among

the most deleterious effects of lead poisoning are those as-

sociated with severe central nervous system damage at

high exposure levels. The Criteria Document noted that

neurological and behavioral deficits have long been known

to be among the more serious effects of lead exposure, but

it pointed out that there is disagreement about whether

these effects are reversible, and about what exposure levels

are necessary to produce specific deleterious effects. CD

11-14, JA 1236. Much of the impetus for the debate

on these questions has been provided by the continual

emergence of new information suggesting that lead ex-

posure levels previously thought to be harmless actually

cause significant neurological damage. Jd. The more

severe neurological effects of high level lead exposure are

the clinical syndrome of lead encephalopathy. Early

symptoms include duliness, restlessness, irritability, head-

aches, muscular tremor, hallucinations, and loss of mem-

ory. These symptems rapidly progress (sometimes with-

in 48 hours) to delirium, mania, convulsions, paralysis,

coma, and death. 7d. at 11-15, JA 1237. The Criteria

Document expressed particular concern that the onset of

|

l4a

these serious symptoms can be quite abrupt, even in the

absence of prior overt or clinical symptoms of disease.

Id. at 18-6, JA 1836. After a review of various studies,

the Criteria Document concluded that the blood lead

threshold for these neurological effects of high level

exposure is 80-100 ug Pb/dl in children, and 100-200 ug

Pb/dl in adults. Jd. at 1-18, 11-18, 11-25, 13-6, JA 1117,

1240, 1247, 1336.

The Criteria Document also went on to consider the evi-

dence on whether lower level lead exposures can affect

the central nervous system, particularly in children. It

acknowledged that the issue is unsetiled and somewhat

controversial, but it was able to conclude, after a careful

review of various studies on the subject, that “a rather

consistent pattern of impaired neural and cognitive func-

tions appears to be associated with blood lead levels be-

low those producing the overt symptomatology of lead

encephalopathy.” CD 1-7, JA 1111. The Criteria Docu-

ment reported that “[t|]he blood lead levels at which

neurobehavioral deficits occur in otherwise asymptomatic

children appear to start at a range of 50 to 60 ug/dl, al-

though some evidence tentatively suggests that such ef-

fects may occur at slightly lower levels for some children.”

Id."

144 See CD 11-18 - 11-26, JA 1240-1248. Some of these stud-

ies suggested that low level lead exposure may cause central

nervous system deficits, resulting in impaired concept for-

mation and altered behavioral profiles, may interfere with the

normal intellectual development of lead-exposed children, and

may cause subtle neurological damage. /d.

16 The Criteria Document also discussed the possibility that

adverse health effects, including neurobehavioral deficits, may

be induced by in utero exposure of the human fetus to lead.

It pointed out that the potential for deleterious health effects

from lead exposure in the areas of reproduction and devel-

opment is particularly large, but felt that the paucity of in-

formation and confirmatory studies precluded any firm con-

conclusions about threshold blood lead levels. CD 11-45 - 11-58,

15a

In addition to examining the health effects of lead

exposure, the Criteria Document also discussed other is-

sues critical to the task of setting air quality standards

for lead. One of these issues is the relationship between

air lead exposure and blood lead levels—a relationship

commonly referred to as the air lead/blood lead ratio.

The Criteria Document acknowledged that derivation of

a functional relationship between air lead exposure and

blood lead levels is made difficult by the fact that the re-

lationship is not a linear one; rather, the ratio tends to

increase as air lead levels are reduced, CD 12-24, JA

1311. The Document was nevertheless able to conclude,

after a detailed examination of the relevant studies,

CD 12-22 - 12-29, JA 1809-1316, that air lead/blood lead

ratios fall within a range of 1:1 to 1:2 (ug Pb/m* air):

(ug Pb/dl blood) at the levels of lead exposure generally

encountered by the population, 7.e., blood lead levels in-

crease by between 1 and 2 ug Pb/dl of blood for every

1 ug Pb/m' of air. (Air lead content is measured in

micrograms of lead per cubic meter of air—ug Pb/m*.)

CD 12-38, JA 1325. The Criteria Document reported that

the studies indicate that the ratio for children is at the

upper end of this range or even slightly above it. 7d.

Finally, the Criteria Document also examined the dis-

tribution of blood lead levels throughout the population,

concluding that there is a significant variability in in-

dividual blood lead responses to any particular level of

air lead exposure. It further found that this variability

is consistent and predictable, and that the application of

established statistical techniques to the distribution of

individual blood lead levels would make it possible to pre-

dict what proportion of the population would be above or

below any particular blood lead level at a given level of

air lead exposure.’® The Criteria Document looked into

16 The statistical distribution of individual blood lead levels

in a homogeneous population was found to be lognormal;

i.e., the log values of blood lead levels would fall in the

16a

the question whether any sub-groups within the popula-

tion are particularly vulnerable to the effects of lead ex-

posure. It concluded that preschool-age children and

pregnant women are particularly sensitive to lead ex-

posure, the latter mainly because of the risk to the unborn

child. CD 13-11 - 18-14, JA 1341-1344.

B. The Proposed Standards

Simultaneously with the publication of the Lead Cri-

terial Document on December 14, 1977, the Administra-

tor proposed a national primary ambient air quality stand-

ard for lead of 1.5 ug Pb/m*® monthly average. 42 FED

Rec. 63076, JA 1480. He also proposed that the second-

ary air quality standard be set at the same level as the

primary standard because the welfare effects associated

with lead exposure did not warrant imposition of a

stricter standard. 42 FED REG. 63081-63082, JA 1485-

1486. In the preamble to the proposed standards the Ad-

ministrator explained the analysis EPA had employed in

setting the standards.

The Administrator first pointed out that a number of

factors complicate the task of setting air quality stand-

ards which will protect the population from the adverse

health effects of lead exposure. First, some sub-groups

within the population have a greater potential for, or

are more susceptible to the effects of, lead exposure. Id.

at 63077, JA 1481. Second, there are a variety of ad-

verse health effects associated with various levels of lead

exposure. Jd. Third, the variability of individual re-

sponses to lead exposure, even within particular sub-

groups of the population, would produce a range of blood

familiar bell-shaped curve. CD 12-1, JA 1288. This means

that for any given level of air lead exposure the population

will have a range of blood lead levels rather than a single

level, with about half the population having blood lead levels

above the geometric mean and the other half below it.

17a

lead levels at any given air lead level. Id. at 63079, JA

1483. Fourth, airborne lead is only one of a number of

sources of lead exposure and the relative contribution

from each source is difficult to quantify. Id. at 63080,

JA 1484. Finally, the relationship between air lead ex-

posure and blood lead levels is a complex one. Id. at

63079, JA 1483.

In response to the first problem the Administrator

began by noting that protection of the most sensitive

groups within the population had to be a major consid-

eration in determining the level at which the air quality

standards should be set. And he determined that child-

ren between the ages of 1 and 5 years are most sensi-

tive to the effects of lead exposure both because the hema-

tologic and neurologic effects associated with lead expo-

sure occur in children at lower threshold levels than in

adults, and because the habit of placing hands and other

objects in the mouth subjects them to a greater risk of

exposure. /d. at 63077-63078, JA 1481-1482. Next, the

Administrator examined the various health effects of

lead exposure and proposed that EP elevation should be

considered the first adverse health effect of lead exposure

because it indicates an impairment of cellular functions,

and should be the pivotal health effect on which the lead

standards are based. Id. at 63078, JA 1482. Accordingly,

he proposed that the air lead standards be designed to

prevent the occurrence of EP elevation in children. In

order to accomplish this, and to address the problem

of variable responses to lead exposure, the ‘Administrator

selected 15 ug Pb/dl, the lowest reported threshold blood

lead level for EP elevation in children, as the target mean

population blood lead level.'? He reasoned that setting the

17 The target mean population blood lead level is the blood

lead level that will ensure that the great majority of the

target population is protected from the adverse health effects

of lead. Given the variability in individual biood lead re-

eee ee er)

18a

target mean population blood lead level at the lowest re-

ported threshold blood lead level for EP elevation would

ensure that most of the target population would be kept

below blood lead levels at which adverse health effects oc-

cur. Id. at 63079, JA 1483. The Administrator also dis-

cussed the alternative approaches of basing the standard

on more severe effects such as anemia, or attempting to

decide the actual level of EP elevation which represents

an adverse effect on health, and then making an adjust-

ment to allow a margin of safety. Jd. He specifically in-

vited comments on these alternative approaches. Id.

Finally, the Administrator outlined another approach to

calculating the target mean population blood lead level in-

volving the use of statistical techniques discussed in the

Criteria Document. Id,"*

Having selected a target mean population blood lead

level, the Administrator’s next step was to allow for the

multiplicity of sources of lead exposure. He thus had to

estimate the amount of blood lead that should be attrib-

uted to non-air sources. The Administrator admitted

that any amount he selected could be no more than a

sponses to lead exposure, a population with a mean blood

lead level of 15 ug Pb/dl will have individuals with blood

lead levels higher and lower than 15 ug Pb/dl, but since

15 ug Pb/di is the lowest blood lead level at which EP eleva-

tion has been detected, most children will be kept below blood

lead levels at which adverse health effects occur.

18 See CD 12-1 - 12-3, 12-38, JA 1288-1290, 1325. This al-

ternative approach would use lognormal! statistical procedures

to determine what mean population blood lead levels would

keep a specified percentage of the population below a blood

lead level chosen to represent the safe blood lead blood level

for the average individual. The Administrator pointed out

that he had misgivings about this approach because it might

overestimate the degree to which the mean population level

should be below the threshold blood lead level, particularly

since 15 ug Pb/dl is the lowest reported threshold blood

level for EP elevation. 42 Frp. REG. 63079, JA 1483.

19a

theoretical national average, and on the basis of the

evidence available he proposed that the lead standards

should be based on the general assumption that 12

ug Pb/dl of blood lead should be attributed to non-

air sources. Jd. at 63080-63081, JA 1484-1485. Given

the target mean population blood lead level of 15 ug Pb/

dl and the assumed contribution from non-air sources of

12 ug Pb/dl, the maximum allowable contribution from

ambient air is 3 ug Pb/dl. The final step in his an-

alysis was to determine what air lead level would pre-

vent the ambient air contribution to blood lead levels

from exceeding 3 ug Pb/dl. This step required determin-

ing the relationship between air lead exposure and blood

lead levels, i.e., the air lead/blood lead ratio. On the

basis of the information in the Criteria Document, the

Administrator selected a ratio of 1:2 as appropriate for

calculating the effect of air lead exposure on blood lead

levels in children. Jd. at 63079, JA 1483.

Thereafter, calculation of the air quality standard

was a mathematical exercise as shown in the following

table.

1. Target mean blood lead level 15 ug Pb/dl

2. Assumed non-air contribution —12 ug Pb/dl

8. Allowable air contribution = 8 ug Pb/dl

4, Permissible air lead concen-

tration given assumed air lead/

blood lead ratio

3 ug Pb/dl x 1 ug Pb/m?’ air

2 ug Pb/dl blood

The Administrator concluded, on the basis of available

information, that the averaging period for the lead stand-

ard should be a calendar month. 7d. at 68081, JA 1485.

= 1.5 ug Pb/m*

C. Public Comments

The public comment period ran from December 14,

1977 to March 17, 1978, and public hearings on the pro-

20a

posed standards were held on February 15 and 16, 1978.

43 FED. Rec, 46246, JA 2948. The comments on the pro-

posed standards were sharply divided. The comments sub-

mitted by the lead industry and its experts uniformly

opposed the proposed standards, and many endorsed a

standard of 5 ug Pb/m’, the standard proposed in the

discredited first draft of the Criteria Document, see

note 7 supra, as adequate to protect the public health.

43 Fep. Rec. 46248, JA 2950. On the other hand,

environmental groups, medical experts, and state, local,

and federal agencies either endorsed the proposed stand-

ards or called for even stricter standards. Jd. None

of the comments seriously questioned the selection of

children between the ages of 1 and 5 years as the tar-

get population group, or the estimate of a contribu-

tion from non-air sources of 12 ug Pb/dl. The major

areas of controversy were the Administrator’s choice of

EP elevation as the pivotal adverse health effect and his

conclusion that the threshold blood lead level for EP

elevation in children is 15 ug Pb/dl, the selection of an

appropriate air lead/blood lead ratio, the appropriate al-

lowance for an adequate margin of safety, and the aver-

aging time period for the standards. Id.'®

A number of comments challenged the selection of EP

elevation as the pivotal adverse health effect, insisting

that EP elevation merely indicates a biological change or

response which is in no way harmful to health,” and in

addition they criticized the Administrator’s determination

that the blood lead threshold for EP elevation in children

19 A summary of the significant comments that were sub-

mitted and EPA’s responses to them can be found in the

preamble to the final regulations. 43 FED. REG. 46248-46252,

JA 2950-2954.

20 See, e.g., JA 2176, 2193-2194 (statement of St. Joe Min-

erals Corp.); JA 1843 (statement of E. Jacobs, duPont

Corp.) ; JA 2067 (statement of G. Ter Haar, Ethyl Corp.) ;

JA 2388-2390, 2393 (statement of J. Jandl, LIA); JA 1773-

1774 (1. Chisholm. LILA :

2la

is 15 ug Pb/dl.** These comments suggested that a de-

crease in hemoglobin levels, which begins at blood lead

levels no lower than 40 ug Pb/dl, should be the pivotal

adverse health effect on which the standards are based.”

Other experts, however, agreed with the Administrator’s

conclusion that EP elevation must be considered an ad-

verse health effect of lead exposure, and argued that using

EP elevation as the pivotal adverse health effect would,

in addition, allow an adequate margin of safety in pro-

tecting against the more serious health effects associated

with higher levels of lead exposure.” Finally, several

industry experts appeared to indicate a preference for the

lognormal statistical procedures that the Administrator

had, in the proposed standards, suggested as an alterna-

tive method for determining the target mean population

blood lead level.”

D. The Final Air Quality Standards for Lead

The Administrator promulgated the final air quality

standards on October 5, 1978, prescribing national pri-

mary and secondary ambient air quality standards for

lead of 1.5 ug Pb/m®, averaged over a calendar quarter.

43 FED. Rec. 46246, JA 2948. Although the final stand-

21 See, e.g., JA 1775-1779 (J. Chisholm, LIA) ; JA 2362-2366

(comments of LIA); JA 2492-2498 (E. Jacobs, duPont

Corp.); JA 1848-1845 (statement of E. Jacobs, duPont

Sorp.).

22 See, e.g., JA 2193-2194 (statement of St. Joe Minerals

Jorp.) ; JA 2263-2271 (Asarco) ; JA 1774-1775 (J. Chisholm,

UIA) ; JA 1831-1832 (J. Cole, LIA).

23 See, e.g., JA 2161-2167 (D. Schoenbrod, NRDC); JA

2168-2169 (H. Needleman); JA 1563-1564 (P. Landrigan,

Senter for Disease Control); JA 2499-2508 (S. Piomelli) ;

[A 2580-2588 (H. Needleman and S. Piomeili); JA 2612-

1614 (E. Silbergeld).

*4 See text and note at note 18 supra. See JA 2100-2101

(J. Chisholm, LIA) ; JA 2223-2224 (St. Joe); JA 2368-2369

(LIA) ; JA 1881-1832 (J. Cole, LIA).

ee

22a

ards were the same as the proposed standards (with the

exception of the change in the averaging period from

30 to 90 days), the Administrator arrived at the final

standards through somewhat different analysis. The

preamble to the final standards reveals that the comments

on the proposed standards had led the Administrator to

reconsider his analysis. In particular, he seemed to

feel that legitimate questions had been raised concerning

the health significance of the early stages of EP eleva-

tion and about the threshold blood lead level for this

condition. 43 FED. REG. 46248, 46253, JA 2950, 2955.

The Administrator’s reexamination focused on two key

questions: (1) What is the maximum safe individual

blood lead level for children? and (2) what proportion

of the target population should be kept below this blood

lead level? Jd. at 46249, 46252-46253, JA 2951, 2954-

2955. Addressing the first issue required a review of the

health effects of lead exposure discussed in the Criteria

Document. The Administrator concluded that, although

EP elevation beginning at blood lead levels of 15-20 ug

Pb/dl is potentially adverse to the health of children, only

when blood lead concentration reaches a level of 30 ug

Pb/dl is this effect significant enough to be considered

adverse to health. Jd. at 46253, JA 2955. Accordingly,

he selected 30 ug Pb/dl as the maximum safe individual

blood lead level for children. Jd. The Administrator based

this choice on three mutually supporting grounds. First,

it is at this blood lead level that the first adverse health

effect of lead exposure—impairment of heme synthesis

—begins to occur in children. Second, a maximum safe

individual blood lead level of 30 ug Pb/dl would allow

an adequate margin of safety in protecting children

against more serious effects of lead exposure—anemia,

symptoms of which begin to appear in children at blood

lead levels of 40 ug Pb/dl, and central nervous system

deficits which start to occur in children at blood lead levels

of 50 ug Pb/dl. Third, the Administrator reasoned that

the maximum safe individual blood lead level should be

23a

no higher than the blood lead level used by the Center

for Disease Control in screening children for lead poison-

ing—30 ug Pb/dl. Zd.

Having determined the maximum safe individual blood

lead level for the target population, the Administrator next

focused on the question of what percentage of children be-

tween the ages of 1 and 5 years the standard should at-

tempt to keep below this blood lead level. According to

the 1970 census, there are approximately 20 million

children under the age of 5 years in the United States,

12 million of them in urban areas and 5 million in inner

cities where lead exposure may be especially high. The

Administrator concluded that in order to provide an ade-

quate margin of safety, and to protect special high risk

sub-groups, the standards should aim at keeping 99.5%

of the target population below the maximum safe in-

dividual blood lead level of 30 ug Pb/dl.** Jd. at 46253,

46255, JA 2955, 2957. The next step in the analysis was

to determine what target mean population blood lead

level would ensure that 99.5% of the children below the

age of 5 years would be kept below the maximum safe

individual blood lead level of 30 ug Pb/dl. Using the

lognormal statistical technique he had alluded to in the

proposed standards,”* he calculated that a target mean

population blood lead level of 15 ug Pb/dl (the same

number as in the proposed standards, but arrived at

through different analysis), would accomplish this task.?’

25 Some of the industry comments on the proposed stand-

ards had, in calculating alternative standards, also chosen

to protect 99.5% of the target population. See JA 2223

(St. Joe) ; JA 2368 (LIA).

26 See text and note at note 18 supra.

27 The procedure involved determining the geometric mean

blood lead level that would place 99.5% of the target popula-

tion below a blood lead level of 30 ug Pb/dl (7.e., given the

variability in individual responses to lead exposure, sce text

—

24a

Id. at 46253, 46254, JA 2955, 2956. Thereafter, the

Administrator used the same estimate of the contribution

from non-air sources, 12 ug Pb/dl, and the same air

lead/blood lead ratio, 1:2, that he had used in calculat-

ing the proposed standards,** to compute the final am-

bient air quality standards for lead. The result was an

ambient air quality standard of 1.5 ug Pb/m*, the same

as the proposed standard. Jd. at 46254, JA 2956. The

Administrator did, however, change the averaging period

for the standards from one calendar month to one cal-

endar quarter, id. at 46255, JA 2957, because he felt

that this change would significantly improve the validity

of the data to be used in monitoring the progress toward

attainment of the standards without rendering the stand-

ards less protective. Id.

On December 8, 1978 LIA petitioned EPA for recon-

sideration and a stay of the lead standards. JA 2980-

3000. The Administrator denied the petition on February

2, 1979. JA 3001-3007. These petitions for review of

the iead standards regulations followed. Before examin-

ing the petitioners’ challenges to the regulations, we con-

sider the limits of our reviewing function.

IV. STANDARD OF REVIEW

The scope of judicial review of the Administrator’s

decisions and actions is delineated by Section 307(d) of

the Act, 42 U.S.C. § 7607(d). We must uphold the Ad-

ministrator’s actions unless we find that they were: (1)

and note at note 16 supra, it was necessary to base the stand-

urds on a blood lead level of 15 ug Pb/dl in order to ensure

that 99.5% of the children below the age of 5 years are kept

under a blood lead level of 30 ug Pb/dl). In performing the

calculation the Administrator used a geometric standard de-

viation of 1.8. 43 Feb. REG. 46253, JA 2955.

28 See —— F.2d at —— (pp. 18-19) supra.

— + ee

25a

“arbitrary, capricious, an abuse of discretion, or other-

wise not in accordance with law”; (2) “contrary to con-

stitutional right, power, privilege, or immunity”; (3)

“in excess of statutory jurisdiction, authority, or limita-

tions, or short of statutory right[.]” Section 307(d) (9),

42 U.S.C. § 7607(d) (9). In addition, we may set aside

any action found to be “without observance of procedure

required by law,” if (i) the failure to follow the pre-

scribed procedure was arbitrary or capricious, (ii) the

procedural objection was raised during the public com-

ment period, or there were good reasons why it was not,

and (iii) the procedural errors “were so serious and re-

lated to matters of such central relevance to the rule

that there is a substantial likelihood that the rule would

have been significantly changed if such errors had not

been made.” Jd. Section 307(d) (8), 42 U.S.C § 7607(d)

(8).

These statutory provisions and a considerable body of

case law demonstrate that our role as a reviewing court

is limited. The “arbitrary and capricious” standard of

review is highly deferential, and presumes agency ac-

tion to be valid. Citizens to Preserve Overton Park, Inc.

v. Volpe, 401 U.S. 402, 415 (1971); Ethyl Corp. v.

EPA, supra, 541 F.2d at 34. Moreover, the reviewing

court may not substitute its judgment for the agency’s,

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

401 U.S. at 416, and must affirm the agency’s decision if

a rational basis for it is presented. Bowman Transporta-

tion, Inc. v. Arkansas-Best Freight Systems, Inc., 419 U.S.

281, 290 (1974); United States v. Allegheny-Ludlum

Steel Corp., 406 U.S. 742, 749 (1972). Of course a review-

ing court does not serve as a mere rubber stamp for

agency decisions. Rather, the function of judicial review

is to ensure that agency decisions are “based on a consid-

eration of the relevant factors.” Citizens to Preserve

Overton Park, Inc. v. Volpe, supra, 401 U.S. at 416,

26a

In addition, the court must undertake a “substantial

inquiry” into the facts, one that is “searching and care-

ful.” Id. at 415, 416; Ethyl Corp. v. EPA, supra, 541

F.2d at 34. In cases such as the ones we have before

us, cases which involve complex scientific and technical

questions, conducting a “substantial inquiry” into the

facts may require the court to delve into the scientific

literature. The purpose of this scrutiny of the evidence

in the record is to educate the court. As we pointed out

in Ethyl Corp. v. EPA, supra, the court “must under-

stand enough about the problem confronting the agency

to comprehend the meaning of the evidence relied upon

and the evidence discarded; the questions addressed by

the agency and those bypassed; the choices open to the

agency and those made.” 541 F.2d at 36. Only by doing

this can the court “penetrate to the underlying decisions

of the agency, to satisfy itself that the agency has exer-

cised a reasoned discretion, with reasons that do not

deviate from or ignore the ascertainable legislative in-

tent.” Greater Boston Television Corp. v. FCC, 444 F.2d

841, 850 (D.C. Cir. 1970), cert. denied, 403 U.S. 923

(1971).2° However, it is appropriate to sound some notes

2°To be sure, Greater Boston Television Corp. v. FCC,

444 F.2d 841 (D.C. Cir. 1970), cert. denied. 403 U.S. 923

(1971), was a case involving “substantial evidence” review.

However, its explication of the proper scope of a reviewing

court’s examination of the evidence has been adopted in a

number of cases involving “arbitrary and capricious” review.

E.g., Ethyl Corp. v. EPA, 541 F.2d 1, 36 (D.C. Cir.) (en

banc), cert. denied, 426 U.S. 941 (1976); Portland Cement

Ass'n v. Ruckelshaus, 486 F.2d 375, 402 (D.C. Cir. 1973),

cert. denied, 417 U.S. 921 (1974); International Harvester

Co. v. Ruckelshaus, 478 F.2d 615, 648 (D.C. Cir. 1971).

Moreover, this court has embraced ‘“‘the emerging consensus

of the Courts of Appeals that the distinction between the

arbitrary and capricious standard and substantial evidence

review is largely semantic[.]” Pacific Legal Foundation v.

Dep’t of Transportation, 593 F.2d 1388, 1348 n.35 (D.C. Cir.

1979). And in Ethyl Corp. v. EPA, supra, we explained that

—

27a

of caution about the limits of this exercise. First, we

would be less-than candid if we failed to acknowledge

that we approach the task of examining some of the

complex scientific issues presented in cases of this sort

with some diffidence.” More important, we stress that our

review of the evidence is not designed to enable us to

second-guess the agency’s expert decisiomaker. Ethyl

Corp. v. EPA, supra, 541 F.2d at 36. Congress has en-

trusted the Agency with the responsibility for making

these scientific and other judgments, and we must respect

both Congress’ decision and the Agency’s ability to rely

on the expertise that it develops. Market Street Rail-

way v. Railroad Commission, 324 U.S. 548, 559-561

(1945) ; Ethyl Corp. v. EPA, supra, 541 F.2d at 36. As

we explained in Ethyl Corp. v. EPA:

{|A]jfter our careful study of the record, we must

take a step back from the agency’s decision. We

must look at the decision not as the chemist, biolo-

gist or statistician that we are qualified neither by

training nor experience to be, but as a reviewing

court exercising our narrowly defined duty of hold-

ing agencies to certain minimal standards of ration-

ality. “Although [our] inquiry into the facts is to

be searching and careful, the ultimate standard of

review is a narrow one.” * * * We must affirm un-

less the agency decision is arbitrary or capricious.

541 F.2d at 36-37 (citations and footnotes omitted:

brackets in original).

scrutiny of even the most complex evidentiary issues is not

inconsistent with the deferential standard of review, so long

as the purpose of such scrutiny is to enable the court to better

understand the issues before the agency. See 541 F.2d at

36-37.

80 See Portland Cement Ass’n v. Ruckelshaus, supra note

29, 486 F.2d at 402; International Harvester Co. v. Ruckels-

haus, supra note 29, 478 F.2d at 647.

28a

It is also important to note that although the pertinent

sections of the Clean Air Act outline the policy objec-

tives to be sought and the procedural framework to be

followed in promulgating ambient air quality standards,

Congress left the formulation of the specific standards to

EPA’s Administrator. This task presents complex ques-

tions of science, law, and social policy under the Act. The

record is lengthy—approximately 10,000 pages—and it

is highly technical. The Administrator’s task required

both “a legislative policy determination and an adjudica-

tive resolution of disputed facts.” Mobil Oil Corp. v. FPC,

483 F.2d 1238, 1257 (D.C. Cir. 19738).

These are conceptually distinct types of decisions, and

it is important that we keep this in mind in reviewing

the Administrator’s decisions. See Industrial Union Dep't,

AFL-CIO v. Hodgson, 499 F.2d 467, 474-475 (D.C. Cir.

1974). Where factual determinations were necessary

the Administrator often had to make decisions in the face

of conflicting evidence. In some instances this merely

required that he draw conclusions from the evidence in

the record. In reviewing these conclusions we can ex-

amine the record to ascertain whether there is substan-

tial evidence in the record when considered as a whole

which supports the Administrator’s determinations. /d.

at 474. Other questions involved in the standard-set-

ting process, however, are at the very “frontiers of

scientific knowledge.” ** Consequently, the information

available may be insufficient to permit fully informed

factual determinations. In such instances the Administra-

tor’s decisions necessarily had to rest largely on policy

judgments. Policy choices of this sort “are not suscept-

ible to the same type of verification or refutation by ref-

erence to the record as are [other] factual questions.”

499 F.2d at 475. While we will indeed scrutinize such

judgments carefully, we must adopt a different mode of

judicial review. I/d.; accord, Nat'l Asphalt Pavement

*! See generally Ethyl Corp. v. EPA, supra note 29, 541

F.2d at 24-27.

29a

Ass’n v. Train, 589 F.2d 775, 788-784 (D.C. Cir. 1976) ;

Automotive Parts & Accessories Ass’n, Inc. v. Boyd, 407

F.2d 330, 336, 338 (D.C. Cir. 1968). As this court has

previously stated:

What we are entitled to * * * is a careful identi-

fication by the [Administrator], when his proposed

standards are challenged, of the reasons why he

chooses to follow one course rather than another.

Where that choice purports to be »ased on certain

determinable facts, [he] must, in form as well as

substance, find those facts from evidence in the

record. By the same token, when the [Administra-

tor] is obliged to make policy judgments where no

factual certainties exist or where facts alone do not

provide the answer, he should so state and go on to

identify the considerations he found persuasive.”

Industrial Union Dep’t, AFL-CIO v. Hodgson, supra,

499 F.2d at 475-476. In short, “[t]he paramount ob-

jective is to see whether the agency, given an essentially

legislative task to perform, has carried it out in a manner

calculated to negate the dangers of arbitrariness and

irrationality in the formulation of rules for general ap-

plication in the future.” Automotive Parts & Accessories

Ass’n, Inc. v. Boyd, supra, 407 F.2d at 388.

Finally, although we may set aside the Administrator’s

decisions if we find that he exceeded his authority under

the statute, we note that EPA’s construction of the Clean

Air Act has been accorded considerable deference by the

courts. Union Electric Co. v. EPA, 427 U.S. 246, 256

(1976); Train v. Natural Resources Defense Council,

Inc., 421 U.S. 60, 75 (1975) ; Ethyl Corp. v. EPA, supra,

541 F.2d at 12 n.16.% Where different interpretations of

82 Deference to EPA’s interpretation is particularly war-

ranted where, as here, the Act and its amendments were en-

acted with the advice and cooperation of EPA and its pre-

decessor agencies. See FE. I. du Pont de Nemours & Co. v.

Train, 480 U.S. 112, 184-185 (1977); Hercules Inc. v. EPA,

598 F.2d 91.101 (D.C. Cir 1978) i ie

30a

the statute are plausible, so long as EPA’s construction

of the statute is reasonable we may not substitute our

own interpretation for the Agency’s. Train v. Natural

Resources Defense Council, Inc., supra, 421 U.S. at 75.**

“(T]he construction of a statute by those charged with

its execution should be followed unless there are com-

pelling indications that it is wrong[.]” ed Lion Broad-

casting Co. v. FCC, 395 U.S. 367, 381 (1967); accord,

Beal v. Doe, 482 U.S. 488 (1977). Deference to the Ad-

ministrator’s interpretation is particularly appropriate in

construing a statute that invests him with a considerable

amount of discretion. Unless it can be shown that the

Administrator’s construction of the statute is plainly un-

reasonable, we must uphold his interpretation. Motor &

Equipment Manufacturers Ass’n, Inc. v. EPA, —— F.2d

, (D.C. Cir. No. 78-1896, decided August 3,

1979) (slip op. at 17).

Thus mindful of our restricted role, we turn to con-

sider petitioners’ claims. Petitioners posit three basic

questions for decision. First, did the Administrator ex-

ceed his authority under the statute in promulgating the

lead standards? Second, were key elements in the Ad-

ministrator’s analysis arbitrary or capricious? Third, do

alleged procedural shortcomings in the lead standards

rulemaking warrant a remand of the regulations to

EPA?

33 Thus in Train v. Natural Resources Defense Council, Inc.,

421 U.S. 60, 75 (1975), the Supreme Court, in upholding

EPA’s interpretation of a provision of the Clean Air Act

despite the contrary views of a number of circuits, stated:

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 ac-

cepted by the reviewing courts.

—

3la

V. STATUTORY AUTHORITY

The petitioners’ first claim is that the Administrator

exceeded his authority under the statute by promulgating

a primary air quality standard for lead which is more

stringent than is necessary to protect the public health

because it is designed to protect the public against “sub-

clinical’ effects which are not harmful to health. Accord-

ing to petitioners, Congress only authorized the Admin-

istrator to set primary air quality standards that are

aimed at protecting the public against health effects which

are known to be clearly harmful. They argue that Con-

gress so limited the Administrator’s authority because it

was concerned that excessively stringent air quality

standards could cause massive economic dislocation.

In developing this argument St. Joe contends that EPA

erred by refusing to consider the issues of economic and

technological feasibility in setting the air quality stand-

ards for lead. St. Joe’s claim that the Administrator

should have considered these issues is based on the statu-

tory provision directing him to allow an “adequate margin

of safety” in setting primary air quality standards. In

St. Joe’s view, the Administrator must consider the

economic impact of the proposed standard on industry

and the technological feasibility of compliance by emis-

sion sources in determining the appropriate allowance

for a margin of safety.* St. Joe argues that the Admin-

istrator abused his discretion by refusing to consider

these factors in determining the appropriate margin of

safety for the lead standards, and maintains that the

84 See brief for petitioner St. Joe Minerals Corp. at 17-21.

Other factors that should, in St. Joe’s view, be considered are

the severity of the associated health effects and the adequacy

of the scientific base for determination of the health protec-

tive threshold level. Jd.

32a

lead air quality standards will have a disastrous economic

impact on industrial sources of lead emissions.

This argument is totally without merit. St. Joe is

unable to point to anything in either the language of the

Act or its legislative history that offers any support for

its claim that Congress, by specifying that the Adminis-

trator is to allow an “adequate margin of safety” in

setting primary air quality standards, thereby required

the Administrator to consider economic or technological

feasibility. To the contrary, the statute and its legisla-

tive history make clear that economic considerations play

no part in the promulgation of ambient air quality stand-

ards under Section 109.

Where Congress intended the Administrator to be con-

cerned about economic and technological feasibility, it

expressly so provided. For example, Section 111 of the

Act, 42 U.S.C. § 7411, directs the Administrator to con-

sider economic and technological feasibility in establish-

ing standards of performance for new stationary sources

of air pollution based on the best available control tech-

nology. See Nat'l Asphalt Pavement Ass’n v. Train,

supra, 5389 F.2d 775; S. Rep. No. 91-1196, 91st Cong.,

2d Sess. 416 (1970).*° In contrast, Section 109(b) speaks

only of protecting the public health and welfare.*® Noth-

ing in its language suggests that the Administrator is

35 See also, e.g., §110(e) (1), 42 U.S.C. § 7410(e) (1) ; § 118

(d) (4) (c) (ii), 42 U.S.C. § 7418(d) (4) (c) (ii); § 202(a)

(3)(C), 42 U.S.C. § 7521(a) (8) (C); §281(b), 42 U.S.C.

§ 7571 (b).

36 Section 302(h), 42 U.S.C. § 7602(h), defines “welfare”

to include “effects on economic values.” This definition does

not, however, include the cost of compliance with the air

quality standards. It only refers to the economic costs of

pollution. Motor & Equipment Manufacturers Ass’n, Inc. v.

EPA, F.2d : (D.C. Cir. No. 78-1896, decided

Aug. 3, 1979) (slip op. at 43).

ne —s

33a

to consider economic or’ technological feasibility in set-

ting ambient air quality standards.”

The legislative history of the Act also shows the Ad-

ministrator may not consider economic and technological

feasibility in setting air quality standards; the absence

of any provision requiring consideration of these fac-

tors was no accident; it was the result of a deliberate

decision by Congress to subordinate such concerns to the

achievement of health goals. Exasperated by the lack of

significant progress toward dealing with the problem of

air pollution under the Air Quality Act of 1967, 81 STAT.

485, and prior legislation, Congress abandoned the ap-

proach of offering suggestions and setting goals in favor

of “taking a stick to the States in the form of the Clean

Air Amendments of 1970 * * *.” Train v. Natural Re-

sources Defense Council, Inc., supra, 421 U.S. at 64; see

Union Vlectric Co. v. EPA, 427 U.S. 246, 256-257 (1976).

37 Other provisions of the Act closely related to § 109 con-

firm the view that the Administrator is not required or al-

lowed to consider economic and technological feasibility in

setting air quality standards. Section 108(a) (2), 42 U.S.C.

§ 7408(a) (2), which outlines the criteria on which the air

quality standards are to be based, makes no mention of such

factors. Similarly, § 110, 42 U.S.C. § 7410, provides that once

ambient air quality standards have been promulgated, each

state must prepare and submit an implementation plan out-

lining the measures to be taken to ensure that the standards

are met. It is these state implementation plans which actually

impose pollution control requirements and, consequently, if

Congress had wanted the economics of pollution contro] con-

sidered, it would have so provided in § 110. While states may

consider economic and technological feasibility in selecting

the mix of control devices, they may do so only insofar as

this does not interfere with meeting the strict deadlines for

attainment of the standards. Section 110(a) (2), 42 U.S.C.

§ 7410(a) (2). See Union Electric Co. v. EPA, 427 U.S. 246,

257-258, 266 (1976). Moreover, the Administrator, in review-

ing a state implementation plans, may not consider economic

or technological feasibility. Jd. at 265.

34a

Congress was well aware that, together with Sections

108 and 110, Section 109 imposes requirements of a

“technology-forcing” character. Id. at 257; Train v.

Natural Resources Defense Council, Inc., supra, 421 U.S.

at 91; Ethyl Corp. v. EPA, supra, 541 F.2d at 14. The

Senate Report on the 1970 Amendments declared:

The protection of public health—as required by

the national ambient air quality standards * * *—

will require major action throughout the Nation.

Many facilities will require major investments in

new technology and new processes. Some facilities

will need altered operating procedures * * *. Some

may be closed.

-_ e * 5

In the Committee discussions, considerable con-

cern was expressed regarding the use of the concept

of technical feasibility as the basis of ambient air

standards. The Committee determined that 1) the

health of people is more important tnan the ques-

tion of whether the early achievement of ambient air

quality standards protective of health is technically

feasible; and, 2) the growth of pollution load in

many areas, even with application of available tech-

nology, would still be deleterious to public health.

The Report concluded:

Therefore, the Committee determined that exist-

ing sources of pollutants either should meet the

standard of the law or be closed down, and in addi-

tion that new sources should be controlled to the

maximum extent possible to prevent atmospheric

emissions.

S. Rep. No. 91-1196, supra, at 2-3. It is difficult to recon-

cile these statements of legislative intent with St. Joe’s

claim that Congress wanted the Administrator to consider

economic and technological feasibility in setting air quality

standards. The “technology-forcing” requirements of the

Act “are expressly designed to force regulated sources to

35a

develop pollution control devices that might at the time

appear to be economically or technologically infeasible.”

Union Electric Co. v. EPA, supra, 427 U.S. at 257.

Furthermore, St. Joe’s attempt to find a mandate for

the Administrator to consider economic or technological

feasibility in the Act’s “adequate margin of safety” re-

quirement is to no avail. The Senate Report explained

the purpose of the margin of safety requirement:

Margins of safety are essential to any health-related

environmental standards if a reasonable degree of

protection is to be provided against hazards which

research has not yet identified.

S. Rep. No. 91-1196, supra, at 10. We are unable to

discern here any congressional intent to require, or even

permit, the Administrator to consider economic or tech-

nological factors in promulgating air quality standards.

And when Congress directs an agency to consider only

certain factors in reaching an administrative decision,

the agency is not free to trespass beyond the bounds of

its statutory authority by taking other factors into ac-

count. American Overseas Airlines, Inc. v. CAB, 254

F.2d 744, 748 (D.C. Cir. 1958). A policy choice such as

this is one which only Congress, not the courts, and not

KPA, can make. Indeed, the debates on the Act indicate

that Congress was quite conscious of this fact. For ex-

ample, Senator Muskie, one of the prime architects of

the Act, in speaking about the automobile emission stand-

ards and the automobile industry, noted:

* * * T think that we have an obligation to lay

down the standards and requirements of this bill.

I think that the industry has an obligation to try

to meet them. If, in due course, it cannot, then it

should come to Congress and share with the Con-

gress—the representatives of the people—the need

to modify the policy.

36a

1 LEGISLATIVE HISTORY OF CLEAN AIR ACT AMENDMENTS

OF 1970 at 232 (Senate Debate on S. 4358, Sept. 21,

1970) (hereinafter Legis. Hist.). See also id. at 236-

240.°* In the same manner, if there is a problem with ©

the economic or technological feasibility of the lead stand-

ards, St. Joe, or any other party affected by the stand-

ards, must take its case to Congress, the only institution

with the authority to remedy the problem.”

88 Congress has in fact acted to change the requirements of

the Act in particular instances. For example, the 1977

Amendments to the Act relaxed and extended the automobile

emission standards. Section 202, 42 U.S.C. § 7521; 123 ConG.

REC. $13702-S13704 (daily ed. Aug. 4, 1977); id. H8659-

H8662. The lead industry was a beneficiary of such a change

when Congress added the nonferrous smelter orders provi-

sion to the Act in the 1977 Amendments. Section 119, 42

U.S.C. § 7419. That section provides that the deadline for

compliance with limitations necessary to meet the air quality

standards for sulphur dioxide may, under certain conditions,

be extended for up to 10 years.

39 Indeed, at least some industry representatives have

shown that they were aware of the fact that the Adminis-

trator may not consider economic or technological factors in

setting air quality standards. At the time of the 1977 Amend-

ments to the Act, industry spokesmen unsuccessfully at-

tempted to persuade Congress to amend § 109 to require the

Administrator to consider these factors. In a letter to Sen-

ator Muskie, a prime architect of the 1977 Amendments, Dow

Chemical Company urged:

Recommendations for Change in the Law

In order to avoid the undesirable strangulation of

reasonable economic development within major contrib-

uting sections of American society, we recommend that

the Clean Air Act be amended to incorporate several

concepts as follows:

Revise section 109 * * * to include allowance for the

consideration of social and economic factors in the defini-

tion of “health” and “welfare.” * * *

Hearings before the Subcommittee on Environmental Pollu-

tion of the Committee on Environment and Public Works,

37a

It may well be that underlying St. Joe’s argument is

its feeling that Congress could not or should not have

intended this result, and that this court should supply

relief by grafting a requirement of economic or tech-

nological feasibility onto the statute. The Supreme Court

confronted a similar suggestion in the Tellico Dam case.

TVA v. Hill, 487 U.S. 153 (1978). There TVA argued

that the Endangered Species Act should not be construed

to prevent operation of the dam since it had already been

completed at a cost of approximately $100 million, Con-

gress had appropriated funds for the dam even after the

Act was passed, and the spécies at risk—the snail darter

—was relatively unimportant and ways might ultimately

be found to save it. The Court rejected the invitation to

“view the * * * Act ‘reasonably,’ and hence shape a

remedy that ‘accords with some modicum of common

sense and the public weal.’” Jd. at 194. The Court

pointed out:

Our individual appraisal of the wisdom or un-

wisdom of a particular course consciously selected

by the Congress is to be put aside in the process of

interpreting a statute. Once the meaning of an

enactment is discerned and its constitutionality de-

termined, the judicial process comes to an end. We

do not sit as a committee of review, nor are we

vested with the power of veto. * * *

Id. at 194-195. Without suggesting that the Administra-

tor’s interpretation of the statute does not “accord[]

with some modicum of common sense and the public

weal,” the Supreme Court’s admonition reinforces our

decision to reject St. Joe’s invitation to construe the

United States Senate, 95th Cong., 1st Sess. Part 1 at 1085

(Committee Print 1977). Obviously if, as St. Joe claims,

§ 109 already required the Administrator to take such factors

into consideration, Dow Chemical’s proposed amendment

would have been unnecessary.

38a

statute as requiring the Administrator to consider eco-

nomic and technological feasibility in promulgating air

quality standards.

For its part, LIA maintains that its claim that the

Administrator exceeded the bounds of his statutory au-

thority does not depend on the supposition that he is

required, or even permitted, to consider economic and

technological feasibility in setting air quality standards.

LIA contends that, instead, its argument is based on the

fact that Congress itself was concerned about the ques-

tion of the economic feasibility of compliance with air

quality standards, a concern which was reflected in the

statute it enacted. According to LIA, Congress was mind-

ful of the possibility that air quality standards which

are too stringent could cause severe economic dislocation.

For this reason it only granted the Administrator au-

thority to adopt air quality standards which are ‘“de-

signed to protect the public from adverse health effects

that are clearly harmful[.]” *° LIA finds support for its

interpretation of congressional intent in various portions

of the legislative history of the Act. For example, it

notes that the Senate Report on the 1970 legislation

states that EPA “would be required to set a national

minimum standard of air quality,” S. Rep. No. 91-1196,

supra, at 10 (emphasis added), and that Senator Muskie

pointed out during the floor debates that “air quality

standards which will protect the public must be set as

minimum standards * * *.” 1 Legis. Hist., supra, at 125

(emphasis added) .*! LIA then argues that the Adminis-

49 Brief for petitioner LIA at 17-18.

41 LIA also argues that the legislative history of the 1977

Amendments provides further support for its interpretation.

It points out that the House Report on the Amendments

stated:

Some have suggested that since the standards are to

protect against all known or anticipated effects and since

39a

trator based the lead air quality standards on protecting

children from “subclinical” effects of lead exposure which

have not been shown to be harmful to health, that in so

doing the Administrator ignored the clear limitation that

Congress imposed on his standard-setting powers, and

that the Administrator’s action will in fact cause the

very result that Congress was so concerned about avoid-

ing.

LIA’s argument appears to touch on two issues. The

first concerns the type of health effects on which the

Administrator may base air quality standards, 1.e., the

point at which the Administrator’s regulatory authority

no safe thresholds can be established, the ambient stand-

ards should [ble set at zero or background levels. Obvi-

ously, this no-risk philosophy ignores all economic and

social consequences and is impractical. This is particu-

larly true in light of the legal requirement for manda-

tory attainment of the national primary standards within

3 years.

H.R. Rep. No. 95-294, 95th Cong., lst Sess. 127 (1977). LIA

further notes that Senator Muskie remarked during the floor

debates on the 1977 Amendments:

In the first place, the 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. And, if I may highlight this, testimony

on the health question over the last 7 years over and

over again has made the point that there is no such

thing as a threshold for health effects. Even at the

national primary standard level, which is the health

standard, there are health effects that are not protected

against.

123 ConG. REc. 89423 (daily ed. June 10, 1977) (quoted in

brief for petitioner LIA, LIA’s emphasis). All these state-

ments, in LIA’s view, demonstrate that Congress limited the

Administrator’s standard-setting powers to protecting against

effects which are clearly harmful to health.

40a

may be exercised. This issue, as LIA suggests, does con-

cern the limits that the Act, and its legislative history,

may place on the Administrator’s authority. The second

issue appears to be more in the nature of an evidentiary

question: whether or not the evidence in the record sub-

stantiates the Administrator’s claim that the health ef-

fects on which the standards were based do in fact satisfy

the requirements of the Act. Although these two issues

are closely related, they are conceptually distinct, and

they are best examined separately.

Section 109(b) does not specify precisely what Con-

gress had in mind when it directed the Administrator to

prescribe air quality standards that are “requisite to

protect the public health.” The legislative history of the

Act does, however, provide some guidance. The Senate

Report explains that the goal of the air quality standards

must be to ensure that the public is protected from ‘“ad-

verse health effects.” S. Rep. No. 91-1196, supra, at 10.

And the report is particularly careful to note that espe-

cially sensitive persons such as asthmatics and emphyse-

matics are included within the group that must be pro-

tected. It is on the interpretation of the phrase “adverse

health effects” that the disagreement between LIA and

EPA about the limits of the Administrator’s statutory

authority appears to be based. LIA argues that the

legislative history of the Act indicates that Congress only

intended to protect the public against effects which are

known to be clearly harmful to health,*?. maintaining that

this limitation on the Administrator’s statutory authority

is necessary to ensure that the standards are not set at

a level which is more stringent than Congress contem-

plated. The Administrator, on the other hand, agrees

42 LIA notes that in Ethyl Corp. v. EPA, supra note 29, 541

F.2d at 14 n.20, this court suggested that the term “adverse

effect,” when used without the modifier “known or antici-

pated,” refers to “known adverse effects or actual harm.”

ee oe cee

4la

that primary air quality standards must be based on

protecting the public from “adverse health effects,” but

argues that the meaning LIA assigns to that phrase is

too limited. In particular, the Administrator contends

that LIA’s interpretation is inconsistent with the precau-

Lionary nature of the statute, and will frustrate Con-

gress’ intent in requiring promulgation of air quality

standards.

The Administrator begins by pointing out that the

Act’s stated goal is “to protect and enhance the quality

of the Nation’s air resources so as to promote the public

health and welfare and the productive capacity of its

population[.]” Section 101(b) (1), 42 U.S.C. § 7401(b)

(1). This goal was reaffirmed in the 1977 Amendments.

For example, the House Report accompanying the Amend-

ments states that one of its purposes is “[t]o emphasize

the preventive or precautionary nature of the act, i.e.,

to assure that regulatory action can effectively prevent

harm before it occurs; to emphasize the predominant

value of protection of public health[.]” H.R. Rep. No.

95-294, 95th Cong., 1st Sess. 49 (1977). The Adminis-

trator notes that protecting the public from harmful ef-

fects requires decisions about exactly what these harms

are, a task Congress left to his judgment. He notes that

the task of making these decisions is complicated by the

absence of any clear thresholds above which there are

adverse effects and below which there are none. Rather,

as scientific knowledge expands and analytical techniques

are improved, new information is uncovered which indi-

cates that pollution levels that were once considered harm-

less are not in fact harmless. Congress, the Adminis-

trator argues, was conscious of this problem, and left

these decisions to his judgment partly for this reason.‘

43 Section 109(b), 42 U.S.C. § 7409(b), specifically states

that the Administrator is to use his judgment in determining

what air quality standards are necessary to protect the public

42a

In such situations the perspective that is brought to bear

on the problem plays a crucial role in determining what

decisions are made. Because it realized this, Congress,

the Administrator maintains, directed him to err on the

health 1 task which requires him to make factual determina-

tions as well as policy judgments.

The Administrator notes that the issue of the uncertainty

that surrounds attempts to set air quality standards which

protect the public health featured prominently in the discus-

sion about the 1977 Amendments. For example, noting that

the primary standards are based on the assumption that there

is a discoverable no-effects threshold, the House Report on the

Amendments observed:

However, in no case is there evidence that the threshold

levels have a clear physiological meaning, in the sense

that there are genuine adverse health effects at and above

some level of pollution, but no effects at all below that

level. On the contrary, evidence indicates that the amount

of health damage varies with the upward and downward

variations in the concentration of the pollutant, with no

sharp lower limit.

H.R. Rep. No. 95-294, swpra note 41, at 110 (quoting 1974

National Academy of Sciences Report at 17). See H.R. Rep.

No. 95-294, swpra, at 105-127. And during the Senate debate

on the Amendments Senator Muskie summarized the prob-

lems the Administrator faces in attempting to set air quality

standards:

* * * IT wish it were possible for the Administrator to

set national primary and secondary standards that fully

implement the statutory language * * *.

* * * The fact is, as testimony and documents disclose,

the standards do not fully protect in accordance with the

statutory language which gives the Administrator au-

thority to provide for additional protection. He has had

to make a pragmatic judgment in the face of the fact

that he found there is no threshold on health effects,

which makes it very difficult then to apply absolute

health protection, and he has not been able to do that.

123 ConG. REc. $9426 (daily ed. June 10, 1977).

43a

side of caution in making these judgments. First, Con-

gress made it abundantly clear that considerations of

economic or technological feasibility are to be subordi-

nated to the goal of protecting the public health by pro-

hibiting any consideration of such factors. Second, it

specified that the air quality standards must also protect

individuals who are particularly sensitive to the effects

of pollution. Third, it required that the standards be set

at a level at which there is “an absence of adverse effect”

on these sensitive individuals. Finally, it specifically di-

rected the Administrator to allow an adequate margin

of safety in setting primary air quality standards in

order to provide some protection against effects that re-

search has not yet uncovered. The Administrator con-

tends that these indicia of congressional intent, the pre-

cautionary nature of the statutory mandate to protect

the public health, the broad discretion Congress gave him

to decide what effects to protect against, and the un-

certainty that must be part of any attempt to determine

the health effects of air pollution, are all extremely diffi-

cult to reconcile with LIA’s suggestion that he can only

set standards which are designed to protect against ef-

fects which are known to be clearly harmful to health.

We agree that LIA’s interpretation of the statute is

at odds with Congress’ directives to the Administrator.

As a preliminary matter, though it denies this, LIA does

ut times seem to be arguing, along with St. Joe, that the

Administrator should have considered economic and tech-

nological feasibility in setting the standards,‘ a claim

that must be rejected for reasons we have already

stated.” Be that as it may, it is not immediately clear

why LIA expects this court to impose limits on the Ad-

ministrator’s authority which, so far as we can teil, Con-

44 Sec, e.g., brief for petitioner LIA at 13, 16-17, 29-30.

45 See F.2d at - (pp. 32-38) supra.

44a

gress did not. The Senate Report explains that the Ad-

ministrator is to set standards which ensure that there

is “an absence of adverse effects.” The Administrator

maintains that the lead standards are designed to do just

that, a claim we will examine in due course. But LIA

would require a further showing—that the effects on

which the standards were based are clearly harmful or

clearly adverse. We cannot, however, find the source of

this further restriction that LIA would impose on the

Administrator’s authority.*’ It may be that it reflects

LIA’s view that the Administrator must show that there

is a “medical consensus that [the effects on which the

standards were based] are harmful * * *.”* If so, LIA

is seriously mistaken. This court has previously noted

that some uncertainty about the health effects of air

pollution is inevitable.** And we pointed out that

‘6 Perhaps a charitable interpretation of LIA’s position is

that it does not really question the Administrator’s claim that

the statutory scheme only requires him to show that the effects

on which the standards are based are “adverse to health.”

However, LIA does challenge the Administrator’s conclusion

that the particular effects on which the lead standards were

based are in fact adverse to health. If so, LIA’s attack is not

directed at the Administrator’s statutory authority. Rather, it

is aimed at the evidentiary support for the Administrator’s

conclusion. As we have said, we will examine this question in

due course. We note, however, that LIA presents its claim as

an attack on the Administrator’s authority under the Act,

and at this point we are treating it as such.

‘* Brief for petitioner LIA at 20.

‘In Ethyl Corp. v. EPA, supra note 29, 541 F.2d at 24-25,

we pointed out:

Questions involving the environment are particularly

prone to uncertainty. Technological man has altered his

world in ways never before experienced or anticipated.

The health effects of such alterations are often unknown,

sometimes unknowable. While a concerned Congress has

passed legislation providing for protedtion of the public

45a

“la]waiting certainty will often allow for only reactive,

not preventive regulat[ory action].” Ethyl Corp. v. EPA,

supra, 541 F.2d at 25. Congress apparently shares this

view; it specifically directed the Administrator to allow

an adequate margin of safety to protect against effects

which have not yet been uncovered by research and ef-

fects whose medical significance is a matter of disagree-

ment.*® This court has previously acknowledged the role

health against gross environmental modifications, the reg-

ulators entrusted with the enforcement of such laws have

not thereby been endowed with a prescience that removes

all doubt from their decisionmaking. Rather, speculation,

conflicts in evidence, and theoretical extrapolation typify

their every action. How else can they act, given a man-

date to protect the public health but only a slight or non-

existent data base from which to draw? * * * Sometimes,

of course, relatively certain proof of danger or harm

from such modifications can readily be found. But, more

commonly, “‘reasonable medical concerns” :nd 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 in-

evitable.

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 medicine

may be achievable only after the fact, when scientists

have the opportunity for leisurely and isolated scrutiny of

an entire mechanism. * * *

(Footnotes omitted.)

47 In Environmental Defense Fund v. EPA, 598 F.2d 62, 81

(1978), we discussed the significance of the margin of safety

requirement, pointing out that “the use of the term * * * was

* * * meant by Congress to take into account and compensate

for uncertainties and lack of precise predictions in the area of

forecasting the effects of toxic pollutants * * *.” Quoting Hall,

The Control of Toxic Pollutants Under the Federal Water

Pollution Control Act Amendments of 1972, 68 Iowa L. REV.

609, 629-630 (1979).

——— —— ——-

46a

of the margin of safety requirement. In Environmental

Defense Fund v. EPA, 598 F.2d 62, 81 (1978), we

pointed out that “[i]f administrative responsibility to

protect against unknown dangers presents a difficult

task, indeed, a veritable paradox—calling as it does for

knowledge of that which is unknown—then, the term

‘margin of safety’ is Congress’s directive that means

be found to carry out the task and to reconcile the para-

dox.” Moreover, it is significant that Congress has re-

cently acknowledged that more often than not the “mar-

gins of safety” that are incorporated into air quality

standards turn out to be very modest or nonexistent, as

new information reveals adverse health effects at pollu-

tion levels once thought to be harmless. See H.R. Rep.

No. 95-294, supra, at 103-117. Congress’ directive to

the Administrator to allow an “adequate margin of

safety” alone plainly refutes any suggestion that the

Administrator is only authorized to set primary air qual-

ity standards which are designed to protect against health

effects that are known to be clearly harmful.

Furthermore, we agree with the Administrator that

requiring EPA to wait until it can conclusively demon-

strate that a particular effect is adverse to health before

it acts is inconsistent with both the Act’s precautionary

and preventive orientation and the nature of the Admin-

istrator’s statutory responsibilities. Congress provided

that the Administrator is to use his judgment in setting

air quality standards precisely to permit him to act in

the face of uncertainty.*° And as we read the statutory

5° The House Report on the 1977 Amendments discussed

the significance of the provision that the Administrator is to

use his judgment in making the decisions required under the

Act. It explained that the purpose is:

To reflect awareness of the uncertainties and limita-

tions in the data which wil! be available to the Adminis-

trator in the foreseeable future to enable him to execute

his rulemaking duties under this act, because of the limi-

47a

provisions and the legislative history, Congress directed

the Administrator to err on the side of caution in making

the necessary decisions. We see no reason why this court

should put a gloss on Congress’ scheme by requiring the

Administrator to show that there is a medical consensus

that the effects on which the lead standards were based

are “clearly harmful to health.” All that is required by

the statutory scheme is evidence in the record which sub-

stantiates his conclusions about the health effects on which

the standards were based.*' Accordingly, we reject LIA’s

tations on research resources and the fact that decision-

making about the risks to public health from air pollu-

tion falls on “the frontiers of scientific and medical knowl-

edge’’; to provide for adequate judicial review of the rea-

sonableness of the Administrator’s judgment in assessing

risks, while restraining the courts from attempting to

act “as the equivalent of a combined Ph.D. in chemistry,

biology, and statistics” or from applying a standard of

review which is appropriate only to review of adjudica-

tions or formal fact finding.

H.R. Rep. No. 95-294, supra note 41, at 50. Although this

discussion specifically relates to the use of the phrase “in

‘the Administrator’s] judgment” in sections of the Act other

than $109(b), the discussion undoubtedly also illuminates

Congress’ intentions with regard to its use in § 109(b).

‘! We find nothing in the portions of the legislative history

cited by LIA, see text and note at note 41 supra, that supports

the claim that Congress limited the Administrator’s authority

in the manner LIA suggests. The passage in the Senate Re-

port which describes the national air quality standards as

“minimum standards” merely refers to the fact that the

states are free to adopt air quality standards which are more

stringent than the national standards. S. Rep. No. 91-1196,

Gist Cong., 2d Sess. 10 (1970). See 42 U.S.C. § 7416. More-

over, it is difficult to see how the suggestion that the national

standards are “minimum standards” implies that the Ad-

ministrator must wait until there is a consensus among medi-

cal experts that certain effects are clearly adverse to health

before he can base air quality standards on these effects. And

the sugyestions by Senator Muskie and the 1977 House Re-

48a

claim that the Administrator exceeded his statutory au-

thority and turn to LIA’s challenge to the evidentiary

basis for the Administrator’s decisions.

port that the air quality standards should not be set at zero

or background levels by no means imply that the standards

may only be based on eifects which all the experts agree are

clearly harmful to health. The Administrator has not sug-

gested that he has the authority to protect against all effects

of air pollution, whether or not they are adverse to health.

Indeed, he specifically noted that the health effects of lead

exposure begin at blood lead levels of 15-20 ug Pb/dl, and

concluded that these effects are not significant enough to be

regarded as adverse to health until blood lead concentrations

reach a level of 30 ug Pb/dl. 43 Frep. Rec. 46253, JA 2955.

As should be evident from the numerous references we have

made to it, the House Report on the 1977 Amendments pro-

vides support for the Administrator’s interpretation of the

Act, not LIA’s.

LIA’s reliance on our statement in the Ethyl case that the

term ‘adverse effects’ refers to “known adverse effects or

actu;l harm,” 541 F.2d at 14 n.20, is misplaced. First, this

statement does not suggest, as does LIA, that “adverse ef-

fects” only encompasses effects that are clearly adverse or

clearly harmful. Second, the statement was made in the con-

text of our discussion of the threshold showing that was re-

quired to justify listing of a pollutant under then § 108(a)

(1) (A), 42 U.S.C. § 1857c-8(a) (1) (A) (1976). We pointed

out that the Administrator was required to show that the

nollutant causes actual harm before it could be listed for reg-

ulation. But we also made it clear that while the threshold

decision to regulate under then § 108 was not precautionary,

once the decision to regulate was made § 109 required that

the standards promulgated be preventive in nature. See 541

F.2d at 14-15. The 1977 Amendments changed § 108 by mak-

ing the threshold decision to regulate precautionary in nature.

See 42 U.S.C. § 7408(a) (1) (A) (Supp. I 1977); H.R. Rep.

No. 95-294, supra note 41, at 49-51.

Finally, even if we did disagree with the Administrator’s

interpretation of the term “adverse effects,” we would never-

theless be constrained to accept it since it is reasonable and

consistent with the goals of the statute. See Train v. Natural

Resources Defense Council, Inc., supra, note 33, 421 U.S. at 75,

87; Ethyl Corp. v. EPA, supi'a note 29, 541 F.2d at 12 n.16.

49a

VI. HEALTH BASIS FOR THE LEAD STANDARDS

LIA does not question a number of the steps in the Ad-

ministrator’s analysis. It does not disagree with his selec-

tion of children between the ages of one and five years

as the target population, or the decision to set a stand-

ard that would keep 99.5 percent of the children below the

maximum safe individual blood lead level. In addition, LIA

does not challenge the Administrator’s suggestion that

the standards should be based on an assumption that non-

air sources contribute 12 ug Pb/dl to blood lead levels.

LIA does, however, challenge other key elements in the

Administrator’s analysis.

A. Maximum Safe Individual Blood Lead Level

LIA attacks the Administrator’s determination that 30

ug Pb dl should be considered the maximum safe in-

dividual blood lead level for children, maintaining that

there is no evidence in the record indicating that children

suffer any health effects that can be considered adverse

at this blood lead level. As previously noted,” the Ad-

ministrator’s selection was based on bh s finding that EP

elevation at 30 ug Pb/dl is the first adverse health effect

of lead exposure, and his determination that a max-

imum safe individual blood lead level of 30 ug Pb/dl will

allow an adequate margin of safety in protecting children

against the more serious effects of lead exposure—anemia,

symptoms of which appear at blood lead levels of 40

ug Pb/dl and central nervous system deficits which be-

gin to occur at blood lead levels of 50 ug Pb/dl.

LIA challenges each of these findings. First, it con-

tends that nothing in the record supports the suggestion

that EP elevation at 30 ug Pb/dl is harmful to health,

arguing that EP elevation is a mere “subclinical effect”—

a biological response to lead exposure—which is without

" Sco —— F.2d at —— (pp. 22-23) supra,

50a

health significance, and noting that a number of its ex-

perts brought this matter to EPA’s attention in their

comments on the proposed standards.** In LIA’s view, the

Administrator did not explain precisely how impairment

of heme synthesis at blood lead levels of 30 ug Pb/dl

adversely affects the health of children.“ Second, LIA

challenges the Administrator’s determination that a maxi-

mum safe individual blood lead level of 30 ug Pb/dl is

justified by the need to allow an adequate margin of safety

in protecting children against anemia and central nerv-

ous system deficits. It maintains that the evidence in the

record does not support the Administrator’s conclusion

that the blood lead threshold for the symptoms of anemia

in children is 40 ug Pb/dl. LIA claims that this error

was brought to the Administrator’s attention by com-

ments on the proposed standard, but that he failed to re-

spond to these comments, thereby violating the statutory

provision requiring him to respond to “significant com-

ments, criticisms, and new data submitted * * * during

the comment period.” * Third, LIA contends that the

preamble to the final regulations does not state the basis

for the Administrator’s finding that central nervous

system deficits occur in children at blood lead levels of 50

ug Pb/dl, thereby precluding this court from being able

to test the soundness of this determination. Finally, LIA

argues that even if it were to concede that EPA’s con-

clusions about the blood lead thresholds for anemia and

™ LIA cites comments and statements by Chisolm (JA 1773-

1774); McCabe (JA 1756, 1760-1761); McNeil (JA 1790-

1794); Sachs (JA 2149-2150); Jandl (JA 2888-2390, 2393,

2399); Panke (JA 2344).

“4 In LIA’s view, the first clearly adverse effect of lead ex-

posure is anemia which occurs in children at blood lead levels

well in excess of 40 ug Pb/dl. See brief for petitioner LIA

at 24-25.

"5 42 U.S.C. § 7607 (d) (6) (B).

Sla

central nervous system deficits are correct, there is still

no explanation of why the Administrator concluded that

a maximum individual safe blood lead level of 30 ug

Pb/dl—rather than 35 ug Pb/dl, for example—is neces-

sary to provide an adequate margin of safety against

these effects.

Our review of the record persuades us that there is

adequate support for each of the Administrator’s con-

clusions about the health effects of lead exposure and,

consequently, that LIA’s challenges to the evidentiary sup-

port for these findings must be rejected. Under the

statutory scheme enacted by Congress, the Criteria Docu-

ment prepared with respect to each pollutant is to pro-

vide the scientific basis for promulgation of air quality

standards for the pollutant. We have already noted that

the Lead Criteria Document was the product of a process

that allowed the rigorous scientific and public review

that are essential to the preparation of a document “ac-

curately reflect[ing] the latest scientific knowledge useful

in indicating the kind and extent of all identifiable effects

[of lead exposure] on [the] public health * * *.”°* In

our view, the Criteria Document provides ample support

for the Administrator’s findings.

The Criteria Document concluded that EP elevation,

which begins in children at blood lead levels of 15-20 ug

Pb/dl, is one of the more significant effects of low

level lead exposure because it indicates that lead has al-

ready begun to affect basic biological functions in the

body. We have already examined in some detail the find-

ings that led the Criteria Document to the conclusion that

EP elevation is an indication of a physiological impair-

ment which affects human health.’ Briefly stated, it con-

5642 U.S.C. § 7408(a) (2). See —— F.2d at —— (pp. 10-

11) supra and note 7 supra.

ST See ——- F.2d at ——— (pp. 11-13) supra.

y%

52a

cluded that EP elevation indicates an impairment of the

functioning of the mitochondria"; that EP elevation in-

dicates that lead has begun to affect the process of heme

synthesis; that EP elevation may indicate a reduction in

any reserve capacity there might be in the heme syn-

thesis system; and that lead’s impairment of heme syn-

thesis in the blood suggests that lead may also interfere

with production of heme proteins in other organ systems.

Relying on the Criteria Document’s discussion, as well as

other evidence in the record, the Administrator made a

judgment that for purposes of setting air quality stand-

ards for lead, EP elevation at 30 ug Pb/dl must be con-

sidered the first adverse effect on the health of children,

and he determined that the maximum safe individual

blood lead level should be no higher than 30 ug Pb/dl.

The Administrator’s judgment echoes the consensus

of a group of clinicians who, in 1975, participated in

preparation of a statement issued by the Center For

Disease Control and endorsed by the American Academy

of Pediatrics. These experts agreed that EP elevation

“should be used as an indicator of a significant and

worrisome body burden of lead.” CD 11-14, JA 1236.

Moreover, the Center For Disease Control uses EP eleva-

tion at 30 ug Pb/dl as the cutoff point for detection of

lead poisoning in children in its screening programs,”

58 LIA disputes this conclusion, arguing that the Adminis-

trator ignored comments which challenged the basis for the

finding. Brief for petitioner LIA at 34. We do not agree. The

Administrator simply decided, in the face of contrary evi-

dence, both in the Criteria Document, CD 11-8 - 11-14, 13-5,

JA 1230-1236, 1335, and elsewhere in the record, JA 2607-

2611 (Piomelli) ; JA 2612-2616 (Silbergeld); JA 1563-1564

(Landrigan), that EP elevation indicates an impairment of

mitochondrial function. 48 FED. REG. 46249, JA 2951.

"* CENTER FOR DISEASE CONTROL, INCREASED LEAD ABSORP-

TION AND LEAD POISONING IN YOUNG CHILDREN (1975), JA

1401-1409.

——*

53a

a factor that influenced the Administrator’s decision. 43

Frep. Rec. 46253, JA 2955. The Administrator’s re-

liance on this was, in our view, entirely appropriate. While

the Center has indicated that children with a blood lead

concentration of 30 ug Pb/dl have a lead problem,” it is

also significant that the Center’s screening program has

much the same preventive and precautionary approach that

Congress directed the Administrator to apply to the task

of setting air quality standards designed to protect the

public health.*' Further support for the Administrator’s

decisions is provided by the testimony of various medical

and other scientific experts who participated in the lead

standards rulemaking. These experts endorsed the Ad-

ministrator’s (and Criteria Document’s) conclusions

about the effects of low level lead exposures, and agreed

with his assessment of the health significance of these

effects."° The Administrator’s decision is, of course, pre-

cisely the sort of issue that Congress specifically left to

” Dr. Landrigan, testifying on behalf of the Center at the

hearing on the proposed standards, stated that EP elevation

at 30 ug Pb/dl is used to

indicate the children in a screening program who have

already absorbed too much lead from their environment,

who already have manifested abnormalities in the red cell

enzyme systems * * *, and who may already possibly at

least have subclinical alteration in the functioning of their

central and peripheral nervous systems.

JA 1565-1°.66.

“' Indeed, whereas the Center’s screening program has the

option of resorting to individual medical intervention to pro-

tect the health of the children affected, the Administrator

must rely solely on the air quality standards to fulfill his

statutory responsibility to protect the public health.

“2 Sec JA 2168-2169 (Needleman); JA 2499-2508, 2607-

2610, 1608-1610 (Piomelli); JA 2581-2582 (Needleman and

Piomelli) ; JA 2612-2614 (Silbergeld); JA 1563-1564, 2156-

2159 (Landrigan).

54a

his judgment, and where there is evidence in the record

which supports these judgments, this court is not at lib-

erty to substitute its judgment for the Administrator’s.

In this instance the Administrator has acted properly un-

der the terms of the statute. He has explained his fac-

tual findings and policy judgments, and there is an ade-

quate basis in the record for these decisions. No more

is required of him.

LIA’s challenge to the Administrator’s findings con-

cerning the health significance of EP elevation also stres-

ses that this phenomenon is only a “subclinical” effect.

But the clinical/subclinical distinction has little to do

with the question whether a particular effect is properly

viewed as adverse to health. Rather, the distinction per-

tains to the means through which the particular effect may

be detected: observation or physical examination in the

case of clinical effects, and laboratory tests in the case of

subclinical effects.** Thus describing a particular effect as

a “subclinical” effect in no way implies that it is im-

proper to consider it adverse to health.“ While EP eleva-

tion may not be readily identifiable as a sign of disease,

the Administrator properly concluded that it indicates

a lead-related interference with basic biological func-

tions. Expert medical testimony in the record confirms

that the modern trend in preventive medicine is to

detect health problems in their “subclinical” stages, and

thereupon to take corrective action. Moreover, as we

have already noted, the Center For Disease Control

63 See note 11 supra.

' The Criteria Document suggests that death from lead

poisoning may in fact occur without any prior clinical symp-

toms. CD 18-4, JA 1334.

%S See JA 2608 (Piomelli) ; JA 2612 (Silbergeld) ; JA 2168-

2169 (Needleman). Examples given include the use of abnor-

malities of the electrical current of the heart to detect heart

problems, liver chemistry profiles to detect liver ailments, and

55a

uses the same “subclinical” effect as the key indicator

of the need for medical intervention in its lead poisoning

screening program. The accepted use of this “subclinical”

effect to determine the need for medical observation or

intervention properly influenced the Administrator’s de-

cision.” Thus the fact that the effects the Administrator

relied on in setting the lead standards are “subclinical”

does not detract from their significance for human health,

or make them an improper basis for setting air quality

standards.

We also reject LIA’s claim that the evidence in the

record does not support the Administrator’s determina-

tion that the blood lead threshold for symptoms of anemia

in children is 40 ug Pb/dl. According to the Criteria

Document, the onset of anemia is marked by a decline

in the level of hemoglobin per unit of blood, CD 13-4, JA

1334. And the Criteria Document states that “|r]eports

on children indicate that statistically significant decreases

in hemoglobin levels begin to appear at a blood lead level

of 40 ug [Pb]/dl or somewhat below.” 7d. At another

point the Criteria Document explains, “In children, a

threshold blood lead level for production of * * * symp-

toms of anemia is approximately 40 ug Pb/dl * * *.” CD

1-6, JA 1110. See id. 11-13, JA 1235; JA 2583-2585

‘Needleman and Piomelli). The Criteria Document’s con-

changes in blood chemistry to detect a variety of health prob-

lems, including undue lead exposure. JA 2808 (Piomelli).

In an article one of LIA’s experts expressed approval for the

approach of trying to detect lead poisoning in the “subclini-

cal” stage and taking preventive action based on these effects.

See JA 858-860 (Chisolm).

°° A number of LIA’s experts testified that they agree that

the Center’s use of EP elevation at 30 ug Pb/dl as the cutoff

point in screening children for lead poisoning is sound pre-

ventive practice. See JA 1775 (Chisolm) ; JA 1766 (McCabe).

56a

clusions were reached after a review of various studies

that have examined the subject, and we cannot, in light

of these findings, say that the Administrator’s decision

about the threshold blood lead level for the symptoms of

anemia in children does not have an adequate basis in the

record.”

Finally, our examination of the record also reveals

ample support for the Administrator’s determination that

lead-induced central nervous system deficits begin to

oecur in children at blood lead levels of 50 ug Pb/dl.

The central nervous system damage about which the Ad-

ministrator was concerned was not the severe brain dam-

age that can occur at relatively high levels of lead ex-

posure—80-100 ug Pb/dl.** Rather, his focus was on

more subtle and largely irreversible neurological and be-

havioral impairment that has been detected in children

at lower blood lead levels, 48 FED. REG. 46253, JA

“7 Two of LIA’s experts point out that a World Health Or-

ganization Report, “Environmental Health Criteria for Lead,”

also lists (to be sure, incorrectly in the view of these experts)

the blood lead threshold for anemia at 40 ug Pb/dl. JA 2096

(Chisolm) ; JA 2087 (McCabe).

Petitioners and a number of their experts do not disagree

with the Criteria Document’s statement that a statistically

significant decline in hemoglobin levels begins to occur in

children at blood lead levels of 40 ug Pb/dl. See JA 18381,

2368 (LIA); JA 2178 (St. Joe); JA 2096 (Chisolm); JA

1760 (McCabe). Their disagreement with the Administrator’s

conclusion appears to center around the questions whether the

statistically significant decline in hemoglobin levels at 40 ug

Pb/dl is adverse to health, and whether this decline is a signal

indicating the onset of anemia. Sce reply brief for petitioner

LIA at 18.

68 See

F.2d at —— (pp. 43-14) supra.

57a

2955." The Criteria Document candidly admitted that

“ft}he literature on this subject is somewhat limited and

controversial,” but it was nevertheless able to conclude

that “certain statements [can] be made about the pos-

sible hazard of low to moderate lead exposure levels.” CD

11-18, JA 1240. The conclusion it reached, after a de-

tailed review of various studies that have examined the

subject, was that:

[The] evidence tends to confirm that some type

of neural damage does exist in asymptomatic chil-

dren, and not necessarily only at very high levels of

blood lead. The body of studies on low- or moderate-

level lead effects on neurobehavioral functions * * *

present overall a rather impressive array of data

pointing to that conclusion. Several well-controlled

studies have found effects that are clearly statistic-

ally significant, whereas others have found nonsig-

nificant but borderline effects. Even some studies

reporting generally nonsignificant findings at times

contain data confirming statistically significant ef-

fects, which the authors attribute to various ex-

traneous factors. * * *

CD 11-26, JA 1248. The Criteria Document reported that

the blood lead levels associated with these neurobehav-

ioral deficits are 50-60 ug Pb/dl. Jd. These conclusions

were endorsed by several of the exnerts who participated

in the lead standards rulemaking proceedings, includ-

ing one of LIA’s experts.” Some of these experts even

suggested that these effects may occur at blood lead levels

lower than the levels indicated by the Criteria Docu-

°? The manifestations of these impairments include dimin-

ished capacity to think, reason, and control behavior, and

emotional instability. See CD 11-18- 11-28, JA 1240-1248.

7 See JA 365-368 (NRDC) ; JA 976-981, 2612-2613 (Silber-

geld); JA 853-855, 1564-1565 (Landrigan); JA 1621-1626

(Needleman) ; JA 2586-2588 (Needleman and Piomelli) ; JA

454 (David) ; JA 858-860 (Chisolm, LIA).

3

58a

ment.”’ Contrary to LIA’s suggestion, the evidence in the

Criteria Document and the testimony of the experts pro-

vides an adequate basis for this court to undertake a re-

view of the Administra‘or’s findings concerning these ef-

fects. Accordingly, we reject LIA’s challenge to the Ad-

ministrator’s conclusion that central nervous system de-

ficits begin to occur in children at blood lead levels of 50

ug Pb/dl.

Our conclusion that there is ample support for the

Administrator’s determination that EP elevation at 30

ug Pb/dl is the first adverse health effect that children

experience as a result of lead exposure is, of course, suf-

ficient to sustain his selection of 30 ug Pb/dl as the maxi-

mum safe individual blood lead level. Given this, we can-

not say that his further determination that a maximum

safe individual blood lead level of 30 ug Pb/dl would in

addition provide protection against the more serious

adverse health effects of lead exposure was irrational.

To be sure, the Administrator’s conclusions were not

unchallenged; both LIA and the Administrator are able to

point to an impressive array of experts supporting each

of their respective positions.” However, disagreement

among the experts is inevitable when the issues involved

are at the “very frontiers of scientific knowledge,” and

such disagreement does not preclude us from finding that

the Administrator’s decisions are adequately supported by

the evidence in the record. It may be that LIA expects

this court to conclude that LIA’s experts are right, and

the experts whose testimony supports the Administrator

are wrong.”* If so, LIA has seriously misconceived our

™ See JA 853-855, 1564-1565 (Landrigan); JA 365-868

(NRDC).

72 Compare citations in note 53 supra with citations in notes

62 and 70 supra.

78 See, e.g., brief for petitioner LIA at 8 n.7, 12; reply brief

for petitioner LIA at 4, 28.

5

59a

role as a reviewing court. It is not our function to resolve

disagreement among the experts or to judge the merits of

competing expert views. AFL-CIO v. Marshall, F.2d

" & n.66 (D.C. Cir. No. 78-1562, decided Octo-

ber 24, 1979) (slip op. at 26-27 & n.66); cf. Hercules

Inc. v. EPA, 598 F.2d 91, 115 (D.C. Cir. 1978)

(“‘{e]hoice among scientific test data is precisely the type

of judgment that must be made by EPA, not this court’).

Our task is the limited one of ascertaining that the

choices made by the Administrator were reasonable and

supported by the record. Ethyl Corp. v. EPA, supra,

541 F.2d at 35-36. That the evidence in the record may

also support other conclusions, even those that are incon-

sistent with the Administrator’s,“* does not prevent us

from concluding that his decisions were rational and sup-

ported by the record. AFL-CIO v. Marshall, supra,

—— F.2d at n.66, slip op. at 27 n.66; Environ-

mental Defense Fund, Inc. v. EPA, 510 F.2d 1292, 1298

(D.C. Cir. 1975); accord, Bayside Enterprises, Inc. v.

NLRB, 425 U.S. 248, 302 (1976). Cf. Universal Camera

Corp. v. NLRB, 340 U.S. 474, 488 (1951) (“a court may

[not] displace the [agency’s] choice between two fairly

conflicting views, even though the court would justifiably

have made a different choice had the matter been before

it de novo’).

Having determined that we must uphold the Adminis-

trator’s decisions concerning the health effects that are

the basis for the lead standards, we turn to petitioners’

other challenges to the Administrator’s analysis.

B. Margin of Safety

Both LIA and St. Joe argue that the Administrator

erred by including multiple allowances for margins of

safety in his calculation of the lead standards. Petition-

™ We, of course, intimate no views about whether the evi-

dence in the record in these cases supports conclusions that

are inconsistent with the Administrator’s.

60a

ers note that the statute directs the Administrator to

allow an “adequate margin of safety” in setting primary

air quality standards, and they maintain that as a matter

of statutory construction the Administrator may not in-

terpret “margin” of safety to mean “margins” of safety.

In petitioners’ view, the Administrator in fact did just

this insofar as he made allowances for margins of safety

at several points in his analysis. They argue that margin

of safety allowances were reflected in the choice of the

maximum safe individual blood lead level for children,

in the decision to place 99.5 percent of the target popula-

tion group below that blood lead level, in the selection of

an air lead/blood lead ratio of 1:2, and in the Adminis-

trator’s estimate of the contribution to blood lead levels

that should be attributed to non-air sources.” The net re-

sult of these multiple allowances for margins of safety,

petitioners contend, was a standard far more stringent

than is necessary to protect the public health. St. Joe

suggests that EPA should have adopted an approach

which required decisions on:

1) The maximum level of lead in air which is

protective of health; 7.e., a threshold beyond which

the public health is not protected; and

2) An adequate margin of safety by which the

level which is protective of health must be re-

duced. '**!

EPA responds by maintaining that allowances for a

margin of safety were made only at two points in its

analysis: in the selection of a maximum safe individual

blood lead level of 30 ug Pb/dl and in the decision to set

75 Petitioners also contend that the Administrator’s decision

not to exclude non-respirable particles from the lead stand-

ards, see text and notes at notes 95-107 infra, provides yet

another margin of safety because it overestimates the con-

tribution to blood lead from air sources.

** Brief for petitioner St. Joe at 14.

>!

[

6la

a standard designed to keep 99.5 percent of the target

population below that blood lead level. It argues that the

statutory requirement of a margin of safety does not man-

date adoption of the method suggested by St. Joe. Rather,

EPA suggests, it indicates the precautionary orientation

the Administrator is to bring to bear on the task of set-

ting air quality standards. How conservative he must

be in making particular judgments must, the Agency

maintains, depend on such factors as the amount of un-

certainty involved, the size of the population affected, and

the severity of the effect. EPA argues that petitioners’

claims about multiple allowances for margins of safety

indicate that they have failed to recognize the difference

between providing for a margin of safety and making a

scientific judgment in the face of conflicting evidence.”

We agree with the Administrator that nothing in the

statutory scheme or the legislative history requires him

to adopt the margin of safety approach suggested by St.

Joe.’* Adding the margin of safety at the end of the

analysis is one approach, but it is not the only possible

method. Indeed, the Administrator considered this ap-

proach but decided against it because of complications

raised by the multiple sources of lead exposure.” The

choice between these possible approaches is a policy choice

77 For example, EPA argues that selection of an air lead/

blood lead ratio of 1:2 and assumption of a contribution to

blood lead levels from non-air sources of 12 ug Pb/dl were

both best estimates based on the evidence available to the

Administrator, rather than attempts to provide for an addi-

tional margin of safety.

7% Quite the contrary, the House Report on the 1977 Amend-

ments recognized that the absence of any clear threshold below

which there are no adverse health effects from exposure to

a pollutant and above which there are such effects makes the

margins of safety purportedly added at the end of the analy-

sis more of an illusion than a reality. See H.R. Rep. No. 95-

294, supra note 41, at 110-112.

™ See 43 FED. REG. 46255, JA 2957.

62a

of the type that Congress specifically left to the Admin-

istrator’s judgment. This court must allow him the dis-

cretion to determine which approach will best fulfill the

goals of the Act. As we pointed out in Hercules Inc. v.

EPA, supra, 598 F.2d at 108, “Decision between the al-

ternatives is a quintessential policy judgment within the

discretion of EPA. We cannot accept [the] notion that

the administrator of the agency created to protect the

environment lack[s] even the capability to exercise the

discretion with which he was entrusted by Congress.”

(Emphasis in original.) Where, as here, the Adminis-

trator has provided an explanation of why he chose one

method rather than another, and this explanation and

his choice are not irrational, we must accept his decision.

See Industrial Union Dep’t, AFL-CIO v. Hodgson, supra,

499 F.2d at 475-476.

We also agree with the Administrator’s suggestion

that petitioners have ignored the distinction between sci-

entific judgments based on the available evidence and

allowances for margins of safety. In every instance in

which the Administrator’s judgment on a particular issue

differed from petitioners’ they attributed his decision to

an allowance for a margin of safety. To be sure, there

is no bright line that divides these two types of decisions,

but they are nonetheless conceptually distinct. In any

event, whatever the nature of the decision, the real test,

as petitioners recognize," is whether the decision is rea-

* Thus, in contrast to the approach he adopted in the lead

standards rulemaking, the Administrator, in setting air qual-

ity standards for ozone, decided that adjusting the final num-

ber was a reasonable and feasible method of providing for an

appropriate margin of safety. See 44 Fep. REG. 8202, 8215-

8217 (Feb. 8, 1979).

‘| Thus petitioners argue that a number of the Adminis-

trator’s conclusions (the same ones they claim include allow-

ances for margins of safety) were arbitrary and capricious,

a. claim that we will examine next.

63a

sonable when examined in light of the evidence in the

record. We have already found that at least one of the

decisions that the petitioners attribute to an allowance

for a margin of safety—the selection of the maximum

safe individual blood lead level for children—satisfies

this test. Accordingly, we turn to petitioners’ claims

that the other steps in the Administrator’s analysis can-

not withstand critical scrutiny.

VII. ALLEGED ARBITRARY AND CAPRICIOUS DECISIONS

Petitioners contend that a number of the findings which

constitute the very core of the Administrator’s analysis

violate one or more of the decisionmaking requirements

of the Act. While arguing that each of these violations

is sufficient ground for remand of the regulations to

EPA, LIA maintains that “cumulatively they paint a

picture of an agency that had prejudged the result from

the very outset and was bent on adhering to its original

proposal no matter what the evidence showed, the very

converse of the fair and impartial rulemaking to which

litigants * * * are entitled.” “

A. Air Lead/Blood Lead Ratio

LIA contends that the Administrator’s choice of an air

lead/blood lead ratio of 1:2 as the appropriate ratio for

calculating the lead standards was arbitrary and capri-

cious. LIA’s claim is largely based on its disagreement

with the Administrator’s interpretation of the results of

three studies that have examined the relationship be-

tween air lead exposure and blood lead levels. It argues

that the Administrator’s analysis of these studies is in-

consistent and designed solely to support his decision to

arrive at an air quality standard of 1.5 ug Pb/m*.® In

** Brief for petitioner LIA at 33.

*} The results of these studies appear in a table in the Cri-

teria Document which sets out the ratios found by several

studies at various levels of air lead exposure. CD 12-25 (Table

64a

addition, LIA contends that the Administrator erred by

calculating the air lead/blood lead ratio on the basis of

studies involving both adults and children, when the

standards are designed to protect children. LIA main-

tains that the Administrator would have arrived at a

ratio of 1:1.8, had he focused solely on the studies in-

volving children.

We do not agree that the Administrator’s selection of

an air lead/blood lead ratio of 1:2 was arbitrary or

capricious. The Criteria Document reported that air

lead/blood lead ratios for the whole population, adults

as well as children, range between 1:1 and 1:2, with

children at the upper end of the range or even slightly

above it. CD 12-38, JA 1825. And the range of ratios

for children reported by the studies that were reviewed

in the Criteria Document was 1:1.2 to 1:2.8. CD 12-25

(Table 12-28), JA 1812 (Table 12-28),* The Adminis-

trator’s choice of a ratio of 1:2 for purposes of calculat-

ing the lead standards is consistent with each of these

findings. Moreover, the Administrator calculated that

12-28), JA 1312 (Table 12-28). LIA points out that the

three studies discussed by the Administrator do not show

any ratios for the 1.5 ug Pb/m®* level at which the lead

standard was set. As such the Administrator estimated a ratio

for each of the studies, and in doing so he used a different

method for calculating the ratio for each study. LIA contends

that the only consistency in his approach was that in each

instance he adopted the method that would produce a ratio

supporting the 1.5 ug Pb/m* standard.

* Thus there is little merit to LIA’s complaint about the

fact that the Administrator’s calculations were based on

studies which included ratios for adults as well as children.

If anything, including the ratios for adults probably resulted

in lower numbers since, according to both the Criteria Docu-

ment and expert witnesses, children have higher air lead/

blood lead ratios than do adults. See CD 12-38, 12-25 (Table

12-28), 12-29, JA 1325, 1312 (Table 12-28), 1816; JA 2499-

2508 (Piomelli) ; JA 853-855 (Landrigan).

65a

each of three particularly relevant and well-documented

studies that were reviewed by the Criteria Document

suggested an air lead/blood lead ratio close to 1:2. 438

FepD. REG. 46250, 46254, JA 2954, 2956. Finally, the

Administrator’s choice of a ratio of 1:2 was endorsed by

several experts who participated in the rulemaking pro-

ceedings.” Indeed, the issue of the proper relationship

between air lead exposure and blood lead levels was ex-

tensively discussed in the comments on the initial drafts

of the Criteria Document, with several experts severely

criticizing the suggestions in early drafts that the ap-

85 The three studies selected were studies by Azar et al.,

Griffen et al., and Yankel et al. The Azar study was chosen

because its use of personal dosimeters on the subjects’ bodies

to measure air lend exposure made it one of the strongest adult

epidemiological studies. 43 FED. REG. 46250, JA 2952. The

study by Griffin was selected because it was a well controlled

clinical study of adults exposed to lead aerosol in a sealed

chamber. 7d. The Yankel study was examined because it was

a well controlled study of children alone. Jd. See CD 12-21 -

12-29, JA 1308-1316. The Administrator’s calculations yielded

ratios of 1:1.8 for the Azar study, 1:1.7 for the Griffen study,

and 1:1.95 for the Yankel study. 43 FED. REG. 46250, 46254,

JA 2952, 2956. We reject LIA’s attempt to impute improper

motives to the Administrator’s use of different methods to

calculate the ratio indicated by each study. The Administra-

tor explained that the differences in approach were designed

tc correct for apparent errors in the studies, see 43 FED. REG.

46254, JA 2956, an explanation that does not strike us as ir-

rational. Moreover, even if we were to disregard these calcu-

lations, we would still conclude that the Criteria Document

and the expert testimony in the record provide adequate sup-

port for the Administrator’s choice of an air lead/blood lead

ratio of 1:2.

“See, e.g., JA 2499-2508 (Piomelli); JA 427-430 (Brid-

bord) ; JA 853-855 (Landrigan) ; JA 125-127 (Needleman and

Maher); JA 73 (National Institute for Occupational Safety

and Tiealth (NIOSH) ).

66a

propriate ratio is 1:1.*° Given all the evidence in the

record which supports the Administrator’s choice of a

ratio of 1:2, we would be exceeding the scope of our

reviewing function if we were to agree with LIA’s sug-

gestion that the Administrator’s decision was either arbi-

trary or capricious.

B. Changes in Method

LIA next argues that the Administrator contravened

the decisionmaking requirements of Section 307(d), 42

U.S.C. § 7607(d), by failing to explain the reasons for

a change in the method he used in calculating the lead

standards between the proposed and the final standards.”

LIA correctly points out that the final standard was

based on an adverse health effects threshold of 30 ug

Pb/dl, whereas the proposed standards had been based on

a threshold of 15 ug Pb/dl. It notes that one reason why

both the proposed and the final standards nevertheless ar-

87 See, e.g., JA 73 (Finklea, NIOSH) ; JA 75 (Baker, CDC) ;

JA 104 (Piomelli); JA 121-122 (Wallis, Texas Air Control

Board); JA 127-128, 415-419 (Needleman and Maher); JA

424 (Piomelli).

*8 The source of LIA’s calculation that the Administrator

would have arrived at a ratio of 1:1.3 had he focused solely

on the studies involving children is apparently a study by Dr.

Snee of duPont Corp., submitted during the development of

the Criteria Document. JA 1842-1847. This study was severe-

ly criticized both by members of EPA’s SAB Lead Subcom-

mittee and by other experts who participated in the rulemak-

ing proceedings. See JA 414-419 (Needleman and Maher) ;

JA 427-430 (Bridbord, CDC); JA 547-551 (Schwartz, N.Y.

City Health Dep’t); JA 553-554, 569, 482-485 (Levine); JA

455-457 (Goldsmith, Cal. Dep’t of Health) ; JA 479-480 (Cor-

liss, United States Public Health Service).

8° 42 U.S.C. § 7607(d) (6) (A) requires the Administrator

to give “an explanation of the reasons for any major changes

in the promulgated rule from the proposed rule.”

67a

rived at an air quality standard of 1.5 ug Pb/m* was

that the Administrator employed different statistical pro-

cedures in determining the target mean population blood

level for the two standards.” While intimating that the

change in methods was not unrelated to EPA’s desire to

arrive at a final standard of 1.5 ug Pb/m*, LIA contends

that the Administrator did not explain the reasons for

this change in method as required by the Act. LIA fur-

ther argues that the Administrator failed to reconcile

his adoption of the statistical procedure used in calcu-

lating the final standard with his earlier suggestion (in

the proposed standards) that this method “may over-

estimate the degree to which the population mean should

be below the threshold blood lead level.” 42 FED. RE.

63079, JA 1483. LIA maintains that the Administrator

should either have corrected for the use of such an over-

protective procedure or explained the reasons why he

chose not to do so.

We find LIA’s contentions to be without substantial

merit. In evaluating the significance of these claims, we

cannot help noticing that in spite of the misgivings the

Administrator had expressed about the lognormal statis-

tical procedure, both LIA and its experts endorsed the

use of this procedure in their comments on the proposed

standards, and in fact used it to calculate the alternative

*° In calculating the proposed standards the Administrator

selected the lowest reported blood lead level at which EP

elevation has been detected—15 ug Pb/dl—as the targest

mean population blood lead level. 42 FED. REG. 63079, JA 1483.

But in calculating the final standards he first determined the

adverse health effects threshold—30 ug Pb/dl—and then ap-

plied lognormal] statistical procedures to obtain the target

mean population blood lead level which would keep 99.5%

of the children between the ages of 1 and 5 years below that

blood lead level—15 ug Pb/dl. 43 Fep. REG. 46252-46253,

JA 2954-2955. See text and note at note 27 supra.

>

68a

standards that they recommended.”' LIA’s newly discov-

ered objection to the use of this procedure thus really seems

directed at the result it produced, rather than the mere fact

that the Administrator used it.* Be that as it may, we are

satisfied that the Administrator complied with the re-

quirements of Section 307(d). At the time he issued the

proposed standards the Administrator informed the public

that use of lognormal statistical procedures was an alter-

native approach to the method he had employed in calcu-

lating the proposed standards, and he candidly explained

that he had some reservations about the procedure. 42

FED. REG. 63079, JA 1488. A fair reading of the Admin-

istrator’s discussion of the issue in the final regulations

suggests that the comments on the proposed standards,

including the comments submitted by LIA and its ex-

perts, persuaded him to reexamine his analysis, and to

conclude that his earlier misgivings about the lognormal

procedure were exaggerated. 43 FED. REG. 46252-46253,

JA 2954-2955. And we are satisfied that it is possible to

discern the reasons why the Administrator decided to

adopt this procedure from his discussion. /d.** Accord-

*! See JA 2368-2369 (LIA); JA 2137-2139 (Cole, LIA) ;

JA 2100-2101 (Chisholm, LIA) ; JA 2178 (St. Joe).

* It is evident from the comments cited in note 91 supra

that if the Administrator had adopted LIA’s recommendation

of an adverse health effects threshold of 40 ug Pb/dl and then

used the lognormal statistical procedure to determine the tar-

get mean population blood lead level, LIA would have no

complaints about the use of this procedure.

%’ While the Administrator did not discuss in detail his

earlier misgivings about the lognormal procedure, it is rea-

sonable to assume that these were overcome by the endorse-

ments of this procedure by the comments on the proposed

standards. In addition, we note that one factor that had ac-

69a

ingly, we must conclude that his discussion of the alter-

native methods and the reasons for the change in his

approach were more than adequate to comply with the

requirements of Section 307 (d).

Finally, we have uncovered nothing in the record that

indicates that the procedure is unreliable, or that the

Administrator’s decision to use it was unreasonable.

Moreover, so far as we can tell, at no time during the

course of the rulemaking proceedings did LIA raise any

objections to, or even express any reservations about, the

lognormal statistical procedure, this in spite of the mis-

givings the Administrator expressed in the proposed

standards.* LIA did not even mention this issue in the

petition it filed with EPA for reconsideration and stay

of the lead standards. In these circumstances, remanding

the regulations to EPA is totally unwarranted. LIA

counted for the Administrator’s suggestion that the procedure

might be overprotective was his feeling that there was al-

ready a margin of safety built into the selection (in the pro-

posed standards) of the lowest reported, threshold for EP

elevation—15 ug Pb/dl—as the target blood lead level. 42

FED. Rec. 63079, JA 14838. Since the final standards were

based on an adverse health effects threshold of 30 ug Pb/dl

(rather than the level at which EP elevation is first detected),

the built-in safety margin that made the Administrator re-

luctant to use the lognormal procedure in calculating the pro-

posed standards was no longer present.

“ The point here is not that LIA should have known that

the Administrator would adopt the lognormal procedure in

calculating the final standards; it obviously had no way of

predicting this. Rather, the point is that, given its detailed

criticisms of other aspects of the Administrator’s analysis,

LIA’s comments would have included its objections to the

method if in fact it genuinely believed the method to be over-

protective or otherwise flawed. Moreover, LIA would cer-

tainly not have used a procedure that it felt was overpro-

tective in calculating its own recommended alternative stan-

dards.

70a

would do well to remember the Supreme Court’s admoni-

tion that “administrative proceedings should not be a

game or a forum to engage in unjustified obstructionism

by making [no reference to an issue] and then, after

failing to * * * bring the matter to the agency’s atten-

tion, seeking to have that agency determination vacated

on the ground that the agency failed to consider [the

matter] * * *.” Vermont Yankee Nuclear Power Corp.

v. Natural Resources Defense Council, Inc., 485 U.S. 519,

553-554 (1978).

C. Insoluble and Non-Respirable Particles

Both LIA and St. Joe argue that the Administrator

acted arbitrarily and capriciously by refusing to ex-

clude lead particles that are insoluble, or non-respirable

because of their size, from the ambient air quality stand-

ards, despite the fact that this issue was brought to his

attention. LIA points out that the Criteria Document

suggests that particle size and solubility may affect ab-

sorption of lead emissions through the lungs.®* Petition-

ers conclude from this that the Administrator should have

excluded insoluble and non-respirable particles from the

standards, arguing that his failure to do so is particu-

larly unfair to stationary emission sources because a sig-

nificant portion cf lead emissions from such sources are

of this nature. St. Joe maintains that exclusion of these

particles from the standards would minimize the adverse

economic impact that the lead standards will have on the

industry. And LIA argues that the Administrator’s re-

sponse to its comments on this issue ignored the question

of solubility, thereby violating the requirement that he

respond to significant comments and criticisms.**

% See CD 7-18, 10-1 - 10-2, JA 1183, 1212-1213.

6 42 U.S.C. § 7607 (d) (6) (B).

Tla

The Administrator offers a number of justifications

for his decision not to exclude insoluble particles from the

lead standards. First, the Administrator dismisses LIA’s

suggestion that he was required to respond to the claim

that certain lead particles are insoluble, pointing out that

very littie evidence was presented to support this claim

and that such evidence as there was focused on high level

occupational exposures and was therefore of little rele-

vance to the task of setting air quality standards for the

whole population.*’ He further notes that studies discussed

in the Criteria Document indicate that non-industry-

employed populations living in the vicinity of smelters

show high blood lead levels and severe health impair-

ment,** and he argues that these revelations refute the

suggestion that a significant portion of emissions from

such sources is insoluble and cannot be absorbed into the

blood. Finally, EPA contends that even if the Adminis-

trator erred in not explaining why he rejected the sugges-

tion that he exclude insoluble particles from the standard,

this was at most a harmless procedural error which is

not ground for remand of the lead standards.

The Administrator also offers several justifications for

his decision not to exclude from the lead standards parti-

cles which are supposedly non-respirable because they are

too large. He begins by noting that these larger parti-

cles—those that are over one micron in size—constitute

only a very small percentage of overall airborne lead,”

and that the data available on particle size retention in

the lungs and subsequent absorption into the bloodstream

*7 The Administrator points out that the only evidence on

this issue was a two-page discussion. See JA 2212-2213 (St.

Joe).

CD 12-14- 12-18, JA 1301-1305.

% See CD 6-1 - 6-4, JA 1143-1146.

72a

is very limited. Next, he points out that studies dis-

cussed in the Criteria Document and other evidence in

the record indicate that these larger particles are also

retained in the lungs and subsequently absorbed into the

blood, although to a lesser degree than are smaller par-

ticles.'** As such, some percentage of these larger par-

ticles are in fact respirable. In addition, the Adminis-

trator notes that the Criteria Document indicates that

some portion of these larger particles are cleared from

the throat and lungs, swallowed, and subsequently ab-

sorbed into the blood through the intestines.’”

These facts alone, the Administrat:~ argues, are suffi-

cient to sustain the decision not to distinguish between

respirable and non-respirable particles. But he also points

out that one other consideration played a role in the deci-

sion and provides further support for it. The Adminis-

trator explains that in areas with high concentrations of

airborne lead, such as near lead smelters or major high-

ways, much of the lead settles on the ground and may

eventually become a source of human lead exposure

through ingestion of lead-contaminated food or, particu-

larly in children, placing hands and other contaminated

objects in the mouth. 438 FEp. ReEG. 46251, JA 2953.

While acknowledging that some allowance was made for

the contribution of non-air sources to blood lead levels in

calculating the lead standards, the Administrator stresses

that the 12 ug Pb/dl estimate is merely a minimum na-

10 CD 10-1, JA 1212.

LCD 10-1-10-2, JA 1212-1213; JA 2595-2596 (Needle-

man and Piomelli).

12 Td. The Administrator also suggested, although there

appears to be no evidence in the record to substantiate this,

that some portion of the larger particles that fall to the ground

are reintroduced into the atmosphere in smaller, more easily

respirable size through natural weathering and mechanical

action. 43 FED. REG. 46251, JA 2953.

73a

tional average which does not reflect the true non-air

contribution to blood lead levels near major emission

sources.’ The Administrator argues that for this reason,

as well as the others previously stated, the decision not

to exclude non-respirable particles was based on firm

evidence that these particles do in fact contribute to

blood lead levels.

We find that the Administrator’s decision not to ex-

clude insoluble particles from the lead standards was

neither arbitrary nor capricious. The only information

in the record on the issue of insolubility that petitioners

are able to point to is a two-page discussion in St. Joe’s

comments on the proposed standards,’ and even this

discussion does not suggest that lead emissions from

smelters or other industrial sources are insoluble. The

Criteria Document merely states that the exposure of

lead miners may “depend to some extent on the solubility

of the lead from the ores.” CD 7-13, JA 1183.1° Given

the paucity of the information presented on this question,

there was nothing arbitrary or capricious about the Ad-

ministrator’s decision to include such particles in the lead

103 See 43 Fen. REG. 46253, JA 2955.

104 See JA 2212-2213 (St. Joe). The Criteria Document

states that ‘““[m]easurements are not available to confirm the

chemical form of lead emissions from stationary sources,” and

can make no more definite a statement than that “although

the compounds generally associated with stationary sources

are not particularly soluble, the possibility of conversion to

more soluble compounds or accumulation of the particles in

the lungs of exposed populations should not be ignored.” CD

6-8, JA 1150.

‘5 [Tt goes on to point out that the “lead sulfide (PbS) in

galena is insoluble, and absorption through the lung may be

slight. It is not really known how readily absorption takes

place. In the stomach, however, some lead sulfide may be

converted to slightly soluble lead chloride, which may then

be absorbed in moderate amounts.” CD 7-13, JA 1183.

74a

standards. Furthermore, LIA’s contention that the Ad-

ministrator was required to respond to its suggestion

that insoluble particles should be excluded from the

standards borders on the ludicrous. Section 307(d) (6)

(B) only requires the Administrator to respond to “sig-

nificant comments.” LIA’s unsupported claim simply did

not rise to the level of a comment which required a re-

sponse from the Administrator.

We also conclude that the Administrator’s decision not

to exclude non-respirable particles from the lead stand-

ards was reasonable and supported by the record. The

Criteria Document and other evidence in the record pro-

vide an adequate basis for his determination that some

portion of these respirable particles are eventually ab-

sorbed into the bloodstream, and we agree with the Ad-

ministrator that this fact alone is sufficient to demon-

state that his decision was neither arbitrary nor capri-

cious.’ As we have previously said, our task is at an

end once we have ascertained that the agency “has given

reasoned consideration to all the material facts and is-

106 That the available data was insufficient to generate con-

clusions about the precise percentage of these larger particles

that eventually find their way into the bloodstream is, given

the preventive orientation of the statutory scheme, insigni-

ficant. Cf. Hercules Inc. v. EPA, supra note 32, 598 F.2d at

116-117 (agency decision on complex issue is acceptable as

long as it is within the ‘“‘zone of reasonableness”’).

We also agree with the Administrator’s suggestion that the

higher-than-average exposure of the population living in the

immediate vicinity of major emission sources to non-air

sources of blood lead was an appropriate factor to consider in

making the decision. Contrary to petitioners’ contentions, the

mere fact that the Administrator had already provided for a

non-air component does not make this double counting. The

Administrator was careful to point out that the non-air con-

tribution estimate was only a minimum national average.

See 43 FED. REG. 46258, JA 2955; see also 42 FED. REG. 63080-

63081, JA 1484-1485.

ry

75a

sues,” Greater Boston Television Corp. v. FCC, supra,

444 F.2d at 851, and that its decision is supported by

the record. In this case we are satisfied that the Admin-

istrator’s decision meets both tests.’

VIII. PROCEDURAL OBJECTIONS

LIA also raises a variety of procedural objections to

the lead standards rulemaking which, in its view, man-

date remand of the lead standards to EPA.

107 LIA presents two other objections to the Administrator’s

decisions. First, it contends that he failed to respond to the

evidence it presented which indicated that there are no ad-

verse health effects at blood lead levels below 40 ug Pb/dl.

Because we have already upheld the Administrator’s selection

of an adverse effects threshold of 30 ug Pb/dl, this claim

merits little additional discussion other than to point out that

the preamble to the final standards did in fact specifically

address the question of adverse health effects at blood lead

levels below 40 ug Pb/dl. See 43 FED. REG. 46248-46249, JA

2950-2951. No additional response to petitioner’s comments

was required.

Second, LIA argues that the Administrator failed to con-

sider the evidence pointing to the alleged adverse environ-

mental impact of the lead standards. It notes that comments

submitted by NL Industries, Inc. suggested that if the lead

standards forced closure of secondary smelters which produce

lead principally by recycling batteries, the alternative means

of disposing of these batteries may increase the volume of

hazardous wastes. See JA 2272-2274. EPA responds by point-

ing out that an environmental impact statement was prepared

for the lead standards, and that in it the Administrator ac-

knowledged that the lead standards may cause short-term ad-

verse environmental effects but concluded that the long-term

environmental benefits from having the standards far out-

weigh these possible short-term adverse effects. See JA 2938-

2941. In light of this conclusion, we are satisfied that the

lead-battery disposal issue was not of sufficient significance

to merit separate discussion in the preamble to the final

standards.

ry

76a

A. The Needleman Study

LIA argues that EPA erred by relying on a study

submitted after the close of the public comment period

without first allowing interested parties an opportunity

to comment on it. The “Needleman Study” ** examined

the relationship between lead exposure measured by lead

concentration in teeth and the psychological performance

of young children. The study was first mentioned by Dr.

Needleman when he referred briefly to a study he had

conducted but had not yet published which, he said, indi-

cated “that children who have a mean blood lead level in

the past of 35 micrograms per deciliter are significantly

impaired on a large number of psychological outcomes

when compared to children who had a mean level in the

past of 24 micrograms, a 10 microgram difference * * *.”

JA 1626. The study itself was not submitted to EPA

until June 7, 1978, after the close of the public comment

period, and it was placed in the public docket on August

17, 1978.

LIA acknowledges that the Administrator did not men-

tion the study in the preamble to the lead standards, but

it nevertheless argues that EPA clearly relied on the

study in formulating the final standards. In support of

this allegation LIA notes that the preamble refers to

“the possibility that nervous system damage may occur

in children even without overt symptoms of lead poison-

ing” and the “possibility that lead exposure resulting in

blood lead levels previously considered safe may in fact

influence the neurological development and learning abili-

ties of the young child.” 43 FED. REG. 46246, 46255, JA

2948, 2957. Both these statements, LIA claims, are para-

phrases of Dr. Neddleman’s findings. In addition, LIA

points to a number of internal agency memoranda which

purportedly show that the agency placed increasing reli-

8 See JA 2617-2655.

T7Ta

ance on the supposed low level neurological effects of

lead exposure to justify the standard after it received

the study.”

EPA disclaims any reliance on the Needleman study

in the formulation of the lead standards, pointing out

that its conclusions about the effects of low level blood

lead concentrations on the central nervous system and

psychological performance were based on other evidence

in the record. In addition, EPA notes that the lead

standards were not in fact based on protecting children

from neurological disorders at blood lead levels of 25-30

ug Pb/dl, which is what the Needleman study found, and

points out that the only neurological effects that played

a role in the Administrator’s analysis were the central

nervous system deficits which occur at blood lead levels

of 50-60 ug Pb/dl. EPA also contends that none of the

intra-agency discussions of the Needleman study to which

LIA refers suggests that it was being relied on in the

formulation of the standards.’ Finally, EPA argues

that soliciting comments on the Needleman study was

unnecessary because comments on the study would not

109 L.JA refers to three internal agency memoranda which

it obtained through a Frecdom of Information Act request.

These documcnts were lodged with the court in connection

with this case. See note 156 infra.

110 RPA points out that in the first memorandum the ref-

erence to the Needleman study is only a minor element in a

paragraph discussing the health effects of lead exposure, and

the memorandum notes that the Needleman study is open to

methodological criticism. See Appendix to Lodged Documents

(hereinafter ALD) 109. The second memorandum does not

even refer to the study. It merely mentioned that there was

“suggestive evidence that some neurological effects may be

associated with blood [lead levels below 50-60 ug Pb/dl].”

ALD 115. The third memorandum merely inquires about

whether the Needleman study and other evidence in the record

could provide a basis for a lower standard than the 1.5 ug

Pb/m* level that was ultimately promulgated. See ALD 172.

78a

have changed the standard since the standard was not

based on the study." We agree.

In our view, LIA has not adduced any evidence to

substantiate its claim that the Administrator relied on

the Needleman study in formulating the lead air quality

standards. We have already found that the Administra-

tor’s conclusions about the health effects of lead exposure

—including the statements in the preamble to which LIA

refers—are amply supported by the evidence in the rec-

ord. Accordingly, we have no reason to reject the Admin-

istrator’s disclaimer of reliance on the Needleman study.

B. Cross-Examination

LIA’s next procedural challenge stems from the denial

of its request for an opportunity to cross-examine the

medical and scientific witnesses who testified in support

of the then-proposed standards at the public hearings on

the lead standards. Acknowledging that the Act does not

provide for cross-examination, LIA argues that this case

presents a situation in which “constitutional constraints”

or “extremely compelling circumstances,” see Vermont

Yankee Nuclear Power Corp. v. Natural Resources De-

fense Council, Inc., supra, 485 U.S. at 543, justify im-

position of additional procedures on an agency by a re-

viewing court. In support of this claim LIA first alleges

that EPA failed to submit the scientific issues raised by

the lead standards for review by the Independent Scien-

tific Review Committee as required by statute,'’* thereby

111 EPA notes that 42 U.S.C. § 7607(d) (8) states that only

procedural errors that “were so serious and related to matters

of such central relevance to the rule that there is a substantial

likelihood that the rule would have been significantly changed

if such errors had not been made” may invalidate the regula-

tions.

112 We will examine this claim at a later point. See ——

F.2d at (pp. 83-84) infra.

79a

“foreclos[ing] an independent, objective and unbiased

review of the crucial medical and scientific data[.]” *™

LIA further notes that this court has intimated that in

some situations “cross-examination of live witnesses on

a subject of critical importance which could not be ade-

quately ventilated under the general procedures” may be

appropriate even though not required by statute. Inter-

national Harvester Corp. v. Ruckelshaus, 478 F.2d 615,

631 (1973). Finally, LIA contends that EPA itself dem-

onstrated that it recognized the desirability of cross-

examination on these issues by allowing “intensive and

at times hostile cross-examination” of experts who testi-

fied against the proposed standards.* LIA argues that

EPA offended “fundamental notions of fairness implicit

in due process,” Home Box Office, Inc. v. FCC, 567 F.2d

9, 56 (D.C. Cir.), cert. denied, 484 U.S. 828 (1977), by

refusing to permit similar cross-examination of experts

who testified in favor of the standards.

As LIA itself acknowledges, it faces an extremely heavy

burden in its attempt to persuade this court to impose on

EPA a procedure that is not required by statute. The

Supreme Court’s decision in the Vermont Yankee case

makes it absolutely clear that courts must be extremely

reticent about going beyond the procedures established

by Congress and requiring agencies to provide additional

procedures in rulemaking proceedings. Judicial restraint

in this matter is all the more important where, as here,

Congress considered and deliberately decided against a

particular procedure. Section 307(d)(5), 42 U.S.C.

$ 7607(d) (5), which governs the procedure at public

hearings, was added by the

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