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

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Appendix
- **Published:** January 1, 1980
- **Citation:** 449 U.S. 1042

## Text

§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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385007_0499%3A2. Public record. Not legal advice.