Petition for Writ of Certiorari — E. I. du Pont de Nemours & Co. v. Environmental Protection Agency
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LiBRAnyY °F. FiuirD
SUPREME GOURT; VU. B MAY 3 1976
No.G 5 o} 6 0 2 MICHAEL ROBAX, IR, cLénx
IN THE f
Supreme Court of the United States
Ocrover Term, 1975 j
a 7
;
E. I. Du Pont pe Nemours ann Company, AND f
PPG Ixpustrries, Inc, Petitioners,
Ue ¢
ENVIRONMENTAL PROTECTION AGENCY, Respondent, i
|
PETITION FOR WRIT OF CERTIORARI TO THE :
UNITED STATES COURT OF APPEALS FOR
THE DISTRICT OF COLUMBIA CIRCUIT 4
4
DANIEL M. Grippox :
ALLAN J. Topor
S88 Sixteenth Street, NW.
Washington, D.C. 20006
Attorneys for Petitioners
BI. Du Pont de Nemours and
Company, and PPG Tndus-
tric s, Ine. f
Of Counsel: i
COVINGTON & BURLING '
SSS Sixteenth Street. NW, :
Washington, DLC. 20006 '
EI EERE MARIE NR TNR. OR ERE TS
TABLE OF CONTENTS
Page
EN EEE Cielo ve cravat ua vawsunen<thetamn 1
SN stg ee nukes todas Gace aed cease aces 2
TINE IIIIOUI nak a vas cuban Su cnncaccdacdees 2
NN IN ic pin cy ac canerns Gas eke eee bek 3
Prenat Er We CAWOO kas sos in ide daw bccc vases 4
Proceedings Before MPA... 606s c icc ccccccccs 4)
Proceedings in the Court of Appeals .............. 9
Reasons for Granting the Writ .................... 13
I. The Administrator Violated the Requirements
of Due Process and the Administrative Proce-
WN Ps Oa ee a ene recs 14
II. Authority Has Not Been Delegated by Congress
to the Administrator to Make a Discretionary
Policy Judgment Based Upon Speculative and
Inconclusive Scientific and Medical Evidence.. 19
III. Judicial Review of Agency Rulemaking That
Is Based Upon Scientific and Medical Evidence
Requires a Thorough Examination by the Court
of the Evidence Relied Upon by the Agency To
Determine Whether There Has Been a Clear
PORE OR PO oan vik ks on cackscceccns 23
ee I Moran ip AR. 29
A Rte
il
TABLE OF AUTHORITIES
Page
CAsEs:
Amoco Oil Co. v. EPA, 163 U.S. App. D.C. 162, 501
Neen kan ans gesa sec 6
Bowman Transp. Inc. v. Arkansas-Best Freight Sys.,
ee io naekawemennacveces 17
Buckeye Power Ine. v. Environmental Protection
Agency, 481 F.2d 162 (6th Cir. 1973) .......... 17
Citizens to Preserve Overton Park v. Volpe, 401 U.S.
RE a lies ae ea ee 13, 23, 25, 26, 28
International Harvester Co. v. Ruckelshaus, 155 U.S.
App. D.C. 411, 478 F.2d 615 (1973) 2.22.2... 17, 26, 27
Industrial Union Department v. Hodgson, 162 U.S.
App. D.C. 351, 358-9, 499 F.2d 467, 474-5 (D.C.
NN ie argh hag a Wi ic ee s'n ba ain 26
National Tire Dealers and Retreaders Association v.
Brinegar, 160 U.S. App. D.C. 238, 244, 491 F.2d
a I ee ee ae. 26
Natural Resources Defense Council, Ine. v. Environ-
mental Protection Agency, 163 U.S. App. D.C. 111,
114, 512 F.2d 1351, 1354 (D.C. Cir. 1975) 2.2.2... 27
Natural Resources Defense Council, Ine. v. Environ-
mental Protection Agency (No. 72-2233
“I
“ee ee ewe
O*Donnelly v. Schatfer, 160 U.S. App. D.C. 266, 269,
oot P20 oo, GE (PA. Cir. 1974) ................ 27
Portland Cement Ass'n. v. Ruckelshaus, 158 U.S. App.
D.C. 308, 486 F.2d 375, 393 (1973), cert. denied 417
Os Se wd n wc coors 17, 26
Rodway v. United States Department of Agriculture,
168 U.S. App. D.C. 387, 514 F.2d 809 (D.C. Cir
1975)
Table of Authorities Continued iil
Statutes aND RuLgEs:
Federal Rules of Appellate Procedure Rule 41(b) ... 2
ae Re Sa Rega RE 4,16
Ce NE es 16
Be ee ND oo ine oh dwiew ca dndareasdansQewess 2
Oe re ee ha he a eae bacaua 27
ca nay Sed se wwe cos eur omasieres 5, 22
SS WIS, BIGGIE Role) (A) (A) ©. onc cvcccccccccccccs 22
© PEO ic ous cancdanccvavceves 3
eT Re ee 27
42 U.S.C. § 1857¢-6, 1857-7, 1857f-1, 1857f-6e, 1857f-9 27
NNN MN dig aes duiakw x Ohad whe dawn oeves 27
MISCELLANEOUS:
Hf. Rep. No. 91-1146, 91st Cong., 2d Sess. 13 (1970) .. 22
IN THE
Supreme Court of the United States
OcToBER TERM, 1975
No.
EK. I. Du Pont DE NEMouRS AND CoMPANY, AND
PPG Invustriks, Inc. Petitioners,
Vv.
IENVIRONMENTAL PROTECTION AGENCY, Respondent.
PETITION FOR WRIT OF CERTIORARI TO THE
UNITED STATES COURT OF APPEALS FOR
THE DISTRICT OF COLUMBIA CIRCUIT
Petitioners, E. I. Du Pont de Nemours and Company,
and PPG Industries, Inc., pray that a writ of certio-
rari issue to review the opinion and judgment of the
United States Court of Appeals for the District of
Columbia Circuit.
OPINIONS BELOW
The opinion en bane of the United States Court of
Appeals for the District of Columbia Circuit of March
19, 1976, is reported at 8 ERC 1785. It is also set
eet ARN TD ORES SPAS NI RENN
"HROUGH POOR COPY
es
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a
et ee a DRS COLE EAM gS
. Set at
2
forth in a volume separately submitted to the Court as
a Joint Appendix by these petitioners and other parties
who participated in the case below.’| The opinion of the
Administrator of the Environmental Protection Agen-
ey (hereinafter ‘‘EPA’’) in the form of a preamble to
the regulations challenged in this case appears at 38
Fed. Reg. 33734-33741. Pertinent portions of his opin-
ion are included in the Joint Appendix.
JURISDICTION
The judgment of the Court of Appeals was entered on
Mareh 19, 1976. Issuance of the mandate has been
stayed pending the filing of a petition to this Court for
a Writ of Certiorari, as provided in Rule 41(b) of the
Federal Rules of Appellate Procedure, by an order of
the Court of Appeals entered pursuant to a joint mo-
tion submitted by all petitioners and the EPA. The
jurisdiction of this Court is invoked under 28 U.S.C.
§ 1254(1).
QUESTIONS PRESENTED
1. Whether the Administrator of the Environmen-
tal Protection Agency, acting under an order of the
Court of Appeals directing final action within thirty
days, satisfied the requirements of due process and the
Administrative Procedure Act where interested per-
! This Appendix represents the Court’s opinion in E. I. Du Pont
de Nemours and Company v. Environmental Protection Agency
(No, 73-2269), PPG Industries, Inc. v. Environmental Protection
Agency (No, 73-2268), Ethyl Corporation v. Environmental Pro-
tection Agency (No, 73-2205), Nalco Chemical Company vy. En-
vironmental Protection Agency (No. 73-2270), and National Petro-
leum Refiners Association vy. Environmental Protection Agency
(No. 74-1021), all of which involve judicial review of the same
EPA regulations. It is petitioners’ understanding that Ethyl,
Nalco and National Petroleum Refiners Association are separately
filing petitions for Writ of Certiorari.
3
sous were not provided notice of and an opportunity to
comment on new evidence that was importantly relied
on by the Administrator in deciding to regulate the lead
content of gasoline.
2. Whether Congress has delegated to the Adminis-
trator the authority to regulate the use of lead additives
in gasoline on the basis of a discretionary policy judg-
ment where the scientific and medical evidence as to the
effect on the publie health of emission products from
such additives is speculative and inconclusive.
3. Whether the court below engaged in proper
review of administrative agency rulemaking that pur-
ports to be based upon scientifie and medical evidence
where two members of the majority refused to examine
the evidence relied upon by the agency to determine
whether the ageney had made a clear error of judgment.
4. Whether, in any event, it was an abuse of discre-
tion for the Administrator to impose nationally uni-
form limitations on the lead content of gasoline instead
of establishing ambient air quality standards, or pro-
viding for regional controls.
STATUTES INVOLVED
The regulations challenged in this case were promul-
gated by the Administrator of EPA pursuant to See-
tion 211(¢) of the Clean Air Act, 42 U.S.C. § 1857f-6e
(c), which provides in pertinent part:
‘*(¢) Control or prohibition of offending fuels and
fuel additives.
**(1) The Administrator may, from time to time
on the basis of information obtained under sub-
* This question is discussed in detail in the Petition for a
Writ of Certiorari filed on behalf of National Petroleum Re-
finers Association from the same Court of Appeals decision ;
these petitioners incorporate by reference the discussion on this
question in that petition.
sre Mer JR ARLENE MAL TD wD eee
we Fees et ees
4
section (b) of this section or other information
available to him, by regulation, control or prohibit
the manufacture, introduction into commerce, of-
fering for sale, or sale of any fuel or fuel additive
for use in a motor vehicle or motor vehicle engine
(A) if any emission products of such fuel or fuel
additive will endanger the public health or welfare,
or (B) if emission products of such fuel or fuel ad-
ditive will impair to a significant degree the per-
formance of any emission contro] device or system
which is in general use, or which the Administra-
tor finds has been developed to a point where in a
reasonable time it would be in general use were
such regulation to be promulgated.
‘¢(2)(A) No fuel, class of fuels, or fuel addi-
tive may be controlled or prohibited by the Admin-
istrator pursuant to clause (A) of paragraph (1)
except after consideration of all relevant medical
and scientific evidence available to him, including
consideration of other technologically or econom-
ically feasible means of achieving emission stand-
ards under section 1857f-1 of this title.’
The pertinent portion of 5 U.S.C. §553 (c) provides:
‘¢ After notice required by this section, the agency
shall give interested persons an opportunity to par-
ticipate in the rule making through submission of
written data, views, or arguments with or without
opportunity for oral presentation. After consid-
eration of the relevant matter presented, the
agency shall....”
STATEMENT OF THE CASE
Section 211 (c)(1) of the Clean Air Act authorizes
the Administrator of EPA to ‘‘control or prohibit’’
the sale of any fuel or fuel additive ‘‘if any emission
products of such fuel or fuel additive will endanger
the public health or welfare.”’
Lead additives have been used by refiners of gasoline
for more than fifty years. EPA estimated that sales in
BLEED THROUG
5
1973 would exceed $400 million.* The use of lead addi-
tives rests upon the basie economies of the refining in-
dustry, which require that refiners blend the different
distil!ation preducts of crude cil to form gasoline with
the desired octane rating. Lead additives contribute
significantly to energy conservation and cost savings
by permitting refiners to increase the yield of gasoline
that can be produced from a given volume of crude oil.
If lead concentrations are reduced, refiners will be re-
quired to add extensive new equipment and to prozess
a significantly greater quantity of crude oil to produce
the same quantity of gasoline of a given octane.* The
emission products of lead additives are not a factor in
the photochemical air pollution or smog caused in part
by automobile emissions, which is the subject of a reg-
wlatory pregram developed under Section 202 of the
Clean Air Act.5
Procecdings Before EPA, Acting under Section
211(c)(1), the Administrator published on January
30, 1971, an advance notice of proposed rulemaking
relating to the use of lead additives in gasoline.® More
than a year later on February 23, 1972, the Adminis-
trator published proposed regulations requiring a sub-
stantial reduction in the lead content of gasoline over
% A. 1615. Record references ‘‘A’’ are to the Joint Appendix filed
with the Court of Appeals. In response to a request to transmit that
Appendix to this Court, the Clerk of the Court of Appeals advised
petitioners that the preferred practice was not to transmit any rec-
ords in connection with petitions for certiorari, but rather to
respond to requests from this Court for such records.
4See testimony on April 27 and 28, 1972, of William Burnap
(pp. 211-212); Allan V. Hoffman (p. 24); Fred L. Hartley (pp.
78-79, 113-114); and Walter Famariss (pp. 516-517). (A. 1998,
9005, 2008-2009, 2013-2014, 2017-2018, 2095-2096) See also testi-
mony on May 2, 1972, of Osborne Fremd (p. 202). (A. 1970, 1980)
542 U.S.C. § 1857-1.
636 Fed. Reg. 1486. (A. 26)
POOR COPY
Ph LLM LILES
6
the next four years, and mandating the general avail-
ability of lead-free gasoline by July 1, 1974.7 The re-
duction portion of the proposed regulations was based
upon a finding that air lead levels in some, but not all,
urban areas were excessive, that motor vehicles were
the predominant source of this airborne lead, and that
the proposed regulations would result in a reduction of
airborne lead to acceptable levels.* Interested persons
were invited to submit written comments, and public
hearings were held on the proposed regulations in the
spring of 1972.°
Taking into account the criticism that was received
from interested parties, including petitioners and gov-
ernmental agencies, in the comments and at the public
hearings, the Administrator decided not to promulgate
that portion of the regulations calling for a reduction
in the lead content of gasoline.” Instead, he reproposed
737 Fed. Reg. 3882-3884. (A. 22
‘These findings were described in the Federal Register state-
ment of February 23, 1972. 37 Fed. Reg. 3882 (A. 22) They
were described more fully in a position paper which accompanied
the proposed regulations and was entitled ‘‘Health Hazards of
Lead** (A. 292); as revised and corrected in A. 254 and A. 272.
® A. 1970; A. 1998; and A. 2107.
The Administrator did publish in final form on January
10, 1973, regulations requiring, infer alia, the general availability
of at least one grade of lead-free gasoline by July 1, 1974. These
regulations were not based on any determination as to the effect
of lead additives upon the public health. They were issued under
Section 211 (¢)(1)(B) on the basis of a finding that lead-free
gasoline was required to permit proper operation of pollution
reducing catalytic converters which were expected to appear in
1975 and later model antomobiles. 38 Fed. Reg. 1254-1256.
(A. 10) These regulations were sustained by the United States
Court of Appeals for the District of Columbia in Amoco Oil Co.
v. EPA, 163 U.S. App. D.C. 162. 501 F.2d 722 (1974), and are
not at issue in this case.
BLEED THROUGH
7
on January 10, 1973, regulations calling for a four-
stage reduction in the lead content of gasoline. The Ad-
ministrator stated that he had ‘‘reevaluated”’ his posi-
tion on the health effects of airborne lead, that ‘‘it is
difficult if not impossible’? to establish an acceptable
leve] for airborne lead, and that ‘‘the original health
position can no longfer] be considered sufficient.’’™
A *‘new health position’? was adopted based on his
opinion that ‘‘considerable numbers of urban residents
have abnormally elevated’’ blood lead levels, and that
emissions from automobiles contribute to these elevated
blood lead levels.”
In the January 10, 1973 notice, the Administrator in-
vited public comment for 60 days on the proposed regu-
lations. In response to the request, extensive comments
criticizing the Administrator’s new position and sup-
porting documents were again received from petition-
ers and other interested persons, including governmen-
tal agencies.
While the Administrator was cousidering these com-
ments, the Natural Resources Defense Council (NR
DC) sought an order from the United States Court of
Appeals for the District of Columbia Cireuit to compel
the Administrator to promulgate lead-limiting regula-
tions. Natural Resources Defense Council, Ine. v. En-
vironmental Protection Agency (No. 72-2233). The
Administrator opposed the NRDC_ request on the
1138 Fed. Reg. 1258-1261. (A. 14)
2 38 Fed. Reg. 1258. (A. 15) The reproposed regulations were
accompanied by a second position paper presenting the agency's
appraisal of the evidence on this subject. This second position
paper was entitled ‘‘EPA’s Position on the Health Effects of
Airborne Lead,’’ November 29, 1972. (A. 158)
POOR COPY
8
ground that very extensive medical and scientifie data
had been presented and that he was attempting to
‘**make a good faith evaluation of the materials pre-
sented to determine the nature of the medical problem
of airborne lead, if any, and the most cost effective
method of dealing with this problem.’’* The Court of
Appeals denied the Administrator’s plea and on Oc-
tober 29, 1973, entered an order requiring the Adminis-
trator to make a final decision on the matter within
30 days.
In response to the Court’s order, the Administrator
announced on November 28, 1975, and published in the
Federal Register of December 6, 1973, his decision to
promulgate regulations calling for a phased reduction
in the lead content of gasoline."* The regulations were
accompanied by a lengthy preamble in which the Ad-
ministrator, in justifying his decision, relied to a
substantial extent upon ‘‘new evidence’’ consisting of
scientifie and medical studies that had only recently
become available to the Administrator and that had
not been cited in any previous statement on the sub-
ject." According to the Administrator, these new
studies established in the ease of adults that ‘‘airborne
lead does contribute significantly to lead exposure in
SEPA Opposition to Petitioners ‘‘Renewal of Motion for
Summary Judgment’’, pp. 2-3, filed on July 3, 1973 in No. 72-2233.
438 Fed. Reg. 33734-33741. (A. 1) The regulations were ae-
companied by still a third position paper, entitled ‘‘EPA’s Posi-
tion on the Health Implications of Airborne Lead.”’ (A. 27) The
first position paper was entitled “‘Ilealth Hazards of Lead”’ (A.
292), and the second was ‘*‘EPA‘s Position on the Health Effects
of Airborne Lead,"’ November 29, 1972 (A. 158). The shift in
titles is indicative of the general weakening in the Administra-
tor’s position in response to criticism by the scientifie community.
% A. 3-5.
BLEED THROLIGH
9
the general population,’’*® and that children present a
special problem because they may ingest non-food
items subject to contamination with lead.”
Prior to the promulgation of the final regulations,
the Adminstrator did not provide interested parties
with notice of or an opportunity to comment on the new
scientific and medical evidence relied upon or the new
position paper which accompanied the regulations."
This occurred despite the fact that the Administrator
had received, prior to promulgation, a request from
one of the petitioners for an opportunity to comment
in the event that the final regulations were based upon
different scientific and technical information.”
Proceedings in the Court of Appeals. Petitioners
sought judicial review of the Administrator’s action,
contending that the regulations should be invalidated
for three basic reasons. First petitioners argued that
the evidence does not establish that the emission prod-
ucts of lead additives will endanger public health. In
support of this argument they contended that blood
a |
at |
“The ‘‘new’’ evidence relied on by the Administrator did
nothing to eliminate the uncertainties that had been exposed in
his first two attempts to ascertain whether the use of lead additives
in gasoline endangers the public health. The studies were largely
inconclusive and were conceded by their authors to be preliminary.
Nowhere, in the new evidence or in the old evidence, is there any
study comparable to the Surgeon General’s report on the effect of
cigarette smoking on health. (A. 3-5)
™ See the request from E. I. Du Pont de Nemours and Company,
(A. 1965) and EPA’s response (A. 1967).
IR SO PP tee a
CR fo SRR Bey Dean Py
Omer
10
lead levels in the general adult population are not cle-
vated above the limit that the Administrator conceded
to be free of adverse health effects... That limit is 40
micrograms of lead per 100 grams of whole blood,
referred to as 40 ug.*’ Petitioners argued that lead in
the air in community environments dees not make a
significant contribution to blood lead levels.” In the
ease of children, petitioners argued that, although
some children suffer from lead poisoning and elevated
blood lead levels, the clear cause is the ingestion of
20 A. 27, 64 and 97.
*! There is only one recent comprehensive study which has de-
termined blood lead levels of the general population using sub-
jects throughout the United States. That is the Seven Cities
Study which was supported and direeted in part by EPA and
completed in 1972 (A. 840). Only three of the entire 1,935
people whose blood lead levels were measured in that study
(0.15% )had blood lead levels of 40 ug. or greater, and when the
original blood samples drawn from these three people were later
reanalyzed by the same laboratory, the results were 31 ug, 9 ug,
and 36 ug. (A. 2368, 2381) A statistical analysis of the Seven
Cities data showed that the number of people having blood lead
levels above 40 ug was ‘‘zero to four decimal places.’’ (A. 2322,
2351)
*? This point is well illustrated by data relied upon by Dr.
Edward E. David, Jr., then Director of the White Honse Office
of Science and Technology, in criticizing EPA’s proposed regu-
lations. (A. 2470-72) The data were as follows:
Table I
Air Lead Blood Lead Level
(micrograms/M3) (micrograms/100m1)
Pasadena 3.4 17.5
Ardmore (a Philadelphia
suburb) 1.15 18.
Los Alamos 0.2 15.
PS PEER OG ARIE Se MS MES SPEIRS TPS RE LE BES EERE RL RIF EE BEI III
rm rwereT™ ~—f res XE treet
11
leaded house paint and not lead from automobile emis-
sions in dust and dirt.”
Second, petitioners argued that Congress had not
delegated to the Administrator the authority to limit
the use of lead additives in gasoline where the evi-
dence of their effect on health was speculative and
inconclusive.
Third, petitioners argued that the Administrator had
not provided an opportunity for interested persons to
comment on the recent medical and scientific studies
and the position paper which formed the basis for the
Administrator’s promulgation of the regulations, and
that the Administrator had abused his discretion in
failing to publish ambient air quality standards for
lead.
On December 20, 1974, the Court entered an order
setting aside the Administrator’s order and regula-
tions. The majority (Judges Wilkey and Tamm)
found that the regulations promulgated by the Ad-
ministrator were invalid on the ground that the Ad-
ministrator incorrectly interpreted Section 211 (c)
(1)(A) of the Clean Air Act, and that, ‘‘even assum-
ing the incorrect statutory standard employed by the
ageney,’’ the Administrator’s analysis reflected ‘‘a
clear error of judgment upon the available evidence.’’
23 For example, the Administrator’s hypothesis that children in-
gest lead from automobile emissions in dust and dirt was rejected
by Dr. Henrietta Sachs, a pediatrician who established the City of
Chicago lead poisoning clinic and directed the screening of ap-
proximately 200,000 children in the period from October 1966
to July 1972. Dr. Sachs stated: ‘*I consider the danger from
eating dirt infinitesimal unless broken plaster has been thrown
into the yard from buildings under repair.’’ (A. 2444, 2448)
SE RET RE NTL AO Ae EGET
DAND CODYV
SSC NINE Ne Weir ae iene east Areas pese|
STAN
SOOO CANE CEE
aa”. eee See
12
(Panel Op. at 69-70) <A dissenting opinion was filed
by Judge Wright.
On March 17, 1975, the Court granted EPA’s peti-
tion for rehearing en bane, and vacated the opinion of
the panel. The case was argued before eight of the
nine judges of the Court on May 30, 1975. (Chief
Judge Bazelon was not present at the oral argument. )
On March 19, 1976, the Court handed down a five to
four decision affirming the Administrator’s order and
regulations. Five separate opinions were filed, re-
flecting sharp disagreement about the major issues in
this case.
The primary opinion for the majority, which was
written by Judge Wright,* concluded that petitioners
were not deprived of administrative due process by the
procedures employed by the Administrator, that the
Administrator had properly interpreted Section 211 (c)
(1) of the statute, that the Administrator’s determina-
tion had support in the evidence, but that, in any event,
the court was not required to examine carefully the
scientific evidence relied on by the Administrator. A
separate opinion was filed by Chief Judge Bazelon
and Judge MeGowan,*” who coneurred in the result
reached by the majority but refused to examine
the scientific and technical evidence relied upon by the
Administrator in reaching his decision. Judge Leven-
thal filed a separate coneurring opinion, asserting that
the court was required to conduct a significant review
*4 Judge Wright was one of the two judges who had entered the
order of October 29, 1973 compelling the Administrator to make
a final decision in thirty days.
* Judge MeGowan was the second judge who joined in the
court’s thirty day order of October 29, 1973.
ROLES: ALD SELL I ENT AT RE
BLEED THROUGI
13
of the factual evidence which was before the Admin-
istrator.
The primary dissenting opinion was written by
Judge Wilkey with whom Judges Tamm and Robb
joined. They concluded that the action of the Admin-
istrator was both procedurally and substantively de-
ficient and could not be sustained. A separate dissent-
ing opinion was filed by Judge MacKinnon, who con-
cluded that the Administrator, acting under the im-
petus of the court’s thirty-day order, had failed to com-
ply with the requirements of the Administrative Pro-
cedure Act.
REASONS FOR GRANTING THE WRIT
This case raises important questions of federal law
which have not been, but should be, settled by this
Court. It presents fundamental issues involving the
obligations and responsibilities of administrative agen-
cies and reviewing courts in rulemaking proceedings,
particularly those that involve assessment of medical
and other scientifie evidence. The action of the Ad-
ministrator and the opinions of the Court of Appeals
make imperative the need for clarification of the pro-
cedures for publie participation and comment to be
followed by agencies during rulemaking proceedings
involving such evidence and the statutory requirement
that agencies rest their actions upon factual evidence.
In addition, the majority decision of the Court below
is in conflict with the decision of this Court in Citizens
to Preserve Overton Park vy. Volpe, 401 U.S. 402
(1971) as to the role that the reviewing courts should
play in environmental regulation.
The lengthy and sharply divided opinions of the
Court of Appeals demonstrate the clear need for guid-
RSIS 22 SEG OREN
POOR COPY
NTR GFN IRONS SHE iD: Malate ed tem al
ALORA
Fgh SORTER =
14
ance from this Court. Nine experienced appellate
judges differed widely as to whether the Administrator
had given due process and otherwise acted in aeccord-
ance with the mandate of Congress, and as to their own
proper function in reviewing the action of the Admin-
istrator. The majority opinion expressly recognized
‘‘the importance of the issues raised.’? (Wright Op.
p. 113)
In concluding that EPA’s action should be sustained,
the majority fashioned novel theories of administrative
law. It swept aside the well-settled right of interested
parties to comment on evidence critical to the ageney’s
decision, the established requirement that an agency
make a determination based upon factual evidence, and
the safeguard of effective and meaningful judicial re-
view. A determination by this Court is thus essential
to clarify for administrative agencies, reviewing courts
and the increasingly numerous affected parties, the
guidelines for the imposition of pervasive environmen-
tal and public health regulations under the Constitu-
tion and the mandate of Congress.
I. The Administrator Violated the Requirements of Due
Process and the Administrative Procedure Act.
Six members of the Court of Appeals, including two
who joined in the majority, seriously questioned the
procedure followed by the Administrator. The Ad-
ministrator had twice before attempted and failed to
ascertain, even to his own satisfaction, whether emis-
sion products of lead additives in gasoline endangered
the public health. He was in the process of evaluating
new evidence precisely at the moment when the Court
of Appeals, over the Administrator’s objection, entered
an order requiring final action in 30 days. Faced with
RNS PRET NT AOE ST NE AT RIN 5 BE TERE PY LTE LTO NIE ST TEE MI LOR TT ETE PEP GI IES NTE TED
RI EFEN THWROITIC
RS LLL ORI AMIS IE SE ERIC i EIS BEN I
15
such an order, the Adminisrator did not give interested
persons notice of and an opportunity to comment on
the new evidence. Instead, he rushed to judgment in
response to the order of the Court entered at the behest
of a group that demanded a limitation on lead addi-
tives, and he promulgated regulations that were based
to a substantial extent upon this new evidence.”*
Two of the requisite members of the majority (Chief
Judge Bazelon and Judge MeGowan concurring), con-
ceded that the 30-day order may have ‘interfered
with’’ deliberate consideration by the agency (Bazelon
Op. p. 5), acknowledged that the reviewing court was
able only *‘by inference and surmise’’ to determine the
procedural steps followed by the Administrator, and
observed that ‘‘ordinarily’’ a case in this procedural
posture ‘would require a remand for clarification.”
(Bazelon Op. p. 5) The four dissenting judges were
in agreement that the Administrator had violated the
requirements of the Administrative Procedure Act by
failing to give interested persons, including petition-
ers and other governmental agencies, notice of and an
opportunity to comment upon the new evidence which
played an important role in the Administrator’s delib-
erations and upon which the Administrator ‘relied
materially”’ in promulgating the regulations. (Wilkey
Op. pp. 19, 32; MacKinnon Op. p. 1)
The extent to which the Administrator relied upon
evidence that he did not make available for publie
comment is set forth in Judge Wilkey’s dissenting
opinion: five of the six studies relied wpon by the Ad-
ministrator as indicating that lead additives are a
26 As to the inconclusive character of the evidence, see footnote
18, supra.
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SEIS LADLE A af ADRS bn de tan
16
hazard to the adult population—the two lead isotope
studies, the unpublished Japanese study, the chambers
study, and the reanalysis of the Seven Cities study
(Wilkey Op. pp. 20-23); and, all five of the studies
(two from Newark and one from Philadelphia, Chi-
‘ago and Rochester) which ‘were absolutely crucial...
to the Administrator’s entire conclusions in regard to
the lead danger to urban children.’’ (Wilkey Op. p.
95) 27
The majority decision on this issue was contrary to
the requirements of the APA, to the teachings of nu-
merous decisions of this Court and even to other de-
cisions of the Court of Appeals—all of which recognize
the right of interested persons to participate in rule-
making by commenting upon important evidence
relied upon by the ageney.* This conclusion follows
from Section 553(c) of the APA, which provides:
‘After notice required by this section, the agency
shall give interested persons an opportunity to
participate in the rule making through submisssion
of written data, views, or arguments with or with-
out opportunity for oral presentation. After con-
sideration of the relevant matter presented, the
agency shall... .’’ 5 U.S.C. § 553(e).
Unless interested persons are given notice of and an
opportunity to comment upon the evidence critical to
an administrative agency’s decision, they obviously
27 Indeed the Administrator characterized this new evidence as
‘‘significant new information received since the regulations were re-
proposed ....’’ (A. 3)
*°The APA provides that a reviewing court ‘‘shall hold un-
lawful and set aside’? agency action taken ‘‘without observance
of procedure required by law.’’ 5 U.S.C. § 706(2)(D).
PANEL Ae ERNIE ELENA RPT IN PR YUN PES TH ORT LL ET RINE TT HDI Wee oN BEN
BLEED THROL
17
‘cannot ‘‘ participate’? meaningfully in rulemaking pro-
ceedings.
Only two years ago, this Court stressed the impor-
tance of the right to comment on evidence in an admin-
istrative procecding in Bowman Trausp. Inc. v. Arkan-
sas-Best Freight Sys., 419 U.S. 281 (1974). The Court
stated:
‘‘A party is entitled ... to know the issues on
which decision will turn and to be apprised of the
factual material on which the ageney relies for
decision so that he may rebut it. Indeed, the Due
Process Clause forbids an agency to use evidence
in a way that forecloses an opportunity to offer
a contrary presentation.’? 419 U.S. at 288, n. 4.°
“9 Tn International Harvester Co. v. Ruckelshaus, 155 U.S. App.
D.C. 411, 478 F.2d 615 (1973), the United States Court of Ap-
peals for the District of Columbia Circuit remanded regulations
under the Clean Air Act to EPA where the agency had not given
interested persons an opportunity to comment upon the. reli-
ability of the methodology which formed the basis for EPA’s
regulations. Similarly in Portland Cement Ass‘n. v. Ruckelshaus,
158 U.S. App. D.C. 308, 486 F.2d 375 (1973), cert. denied 417
U.S. 921 (1974) it held that EPA rulemaking under the Clean
Air Act was defective where the ageney had failed to make
available for comment the test results and methodology which
formed the basis for the emission control level adopted in the
regulations. The Court observed that ‘‘it is not consonant with
the purpose of a rule-making proceeding’? to promulgate rules
on the basis of data which to a ‘‘critical degree, is known only
to the agency.’’ 158 U.S. App. D.C. at 326, 486 F.2d at 393.
See also Rodway vy. United States Department of Agriculture,
168 U.S. App. D.C. 387, 514 F.2d 809 (D.C. Cir. 1975) (holding
that USDA’s reliance upon ageney expertise rather than soliciting
comments from interested persons on the basis for the promul-
gation of food stamp regulations was a violation of See, 553(e)
of the APA); and Buckeye Power Ine. vy. Environmental Protee-
tion Agency, 481 F.2d 162 (6th Cir. 1973) (holding that See. 553
(c) of the APA was violated where EPA did not allow interested
parties an opportunity to comment in a rulemaking procedure
under the Clean Air Act.)
© PAP SKS Sat Ewe ween Te
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18
The right to comment on the new evidence in this
case involves very significant substantative issues, On
the two previous occasions that the Administrator had
exposed to public and scientific scrutiny his appraisal
of the evidence bearing on the effect of lead additives
in gasoline upon the public health, that appraisal was
severely criticized by numerous persons, including
other responsible governmental agencies. The new
evidence that the Administrator finally relied upon
should have been subject to the same public serutiny.
That evidence, as the Administrator and the majority
of the Court of Appeals acknowledged, is at best speeu-
lative and inconclusive; it deserved more deliberate and
complete consideration.
Consideration by this Court of the Administrator’s
procedure is all the more necessary because it was an
order of the Court below that made it difficult, if not
impossible, for the Administrator to grant the right of
comment assured by the Administrative Procedure
Act.” As Judge MacKinnon noted, ‘tit was patently
unrealistic’? for the Court of Appeals ‘‘to believe that
the agency could sift through its accumulated data,
afford the publie and other agencies an opportunity
to review any evidence contributed since the end of
the last comment period on March 11, 1973, reach a
proper decision based on all the evidence and draft
the complicated regulations within the required 30
%° Prior to the promulgation of these regulations, on November
19, 1973, E. 1. Du Pont de Nemours and Company requested an op-
portunity for further comment in the event that the final regu-
lations differed from the previously proposed regulations or were
based upon different scientifie and technical arguments and data
than those previously announced. (A. 1965) This request was
denied on December 4, 1973—after the regulations were promul-
gated. (A, 1967)
Pe RRP VET
PRT HARE NIL RAEI EIN IM HLH IMRT Keys RNR RM RO PPD
19
days.’’ (MacKinnon Op. p. 1)“ The Administrator
was faced with time constraints imposed by the court
that made it ‘‘impossible ... to comply with the no-
tice and comment requirements of the Administrative
Procedure Act.’? (MacKinnon Op. p. 1)
Review by this Court is thus appropriate to make
clear to administrative agencies and reviewing courts
that the right to comment on critical evidence cannot
be short-circuited in rulemaking proceedings—even
under the pressure of a court order. As the dissent
noted, the approach taken by the majority in this case
permits the agency to ‘‘keep secret information im-
portant to its decision’’ and ‘‘affords no opportunity
for informed publie comment.’ (Wilkey Op. pp. 32-
03) This approach should not be permitted to stand.
Agencies cannot be permitted to maintain critical evi-
dence in secret, divulging it only when rules are pro-
mulgated.
II. Authority Has Not Been Delegated by Congress to the
Administrator to Make a Discretionary Policy Judgment
Based Upon Speculative and Inconclusive Scientific and
Medical Evidence.
In promulgating these regulations, the Administra-
tor never claimed in the preamble or in the accom-
panying position paper that the evidence bearing on
the effect of lead additives on the public health is
definitive or that further information is not required.
31 According to Judge MacKinnon, the result of the court’s
order was to force ‘‘a hasty decision’’ from the agency on a
“highly complicated matter.’ (MacKinnon Op. p. 2) The
anomaly here is that two members of the majority felt that the
facts in this case were too complex for them to review meaning-
fully; and yet the Court did not believe that the complexity of
the matter precluded an order requiring final agency action
within an arbitrary 30 days.
ee, bees EV A ETI PATI RAS NSE OIE
ra Ar SAAS
20
Instead, the Administrator acknowledged that he was
acting upon the basis of ‘ta hypothesis,’ that ‘‘not
all links in the argument have been established beyond
dispute,’ and that ‘[f]urther information is re-
quired,”*** Similar expressions of uncertainty oceur
throughout the preamble to the regulations and in the
position paper. In short, the Administrator has con-
ceded the speculative nature of his determination that
the emission products from lead in gasoline will endan-
ger the public health. Even the majority opinion noted
that “hard proof of any danger caused by lead auto-
motive emissions has been hard to come by.” (Wright
Op. p. 9)
The majority concluded that the Administrator was
warranted in acting under Section 211(¢) notwith-
standing the state of the evidence because the deter-
mination under that section is ‘‘necessarily a question
of policy that is to be based on an assessment of risks
and that should not be bound by either the procedural
or the substantive rigor proper for questions of fact.”’
(Wright Op. p. 46) The majority expressly stated
that it would ‘‘not demand rigorous step-by-step proof
of cause and effect’? because questions ‘‘involving the
environment are particularly prone to uncertainty.”’
(Wright Op. pp. 54, 46) The majority tolerated
‘speculation, conflicts in evidence, and theoretical
ae ee ee eee
3238 Fed. Reg. 33735. (A. 3)
3338 Fed. Reg. 33736. (A. 4)
*# EPA’s Position on the Health Implications of Airborne Lead,
p. VI-13. (A. 123) See also, an EPA internal memorandum of
August 3, 1973, in which two officials of EPA’s Office of Planning &
Evaluation stated that ‘‘no concrete link has been established be-
tween lead from automotive exhausts and harmful health effects.”’
(A. 1053, 1057)
- eT sewem, see Be: PAPI eons . a ie Ee “ See: ae Ae oe LETS APOE 2 4
RES PO BE RS I ae i he ~y = ~ ERAS Seat e rs
21
extrapolation”? because the agency is “‘given a man-
date to protect the public health but only a slight or
nonexistent data base upon which to draw.’’ (Wright
Op. p. 47)
In contrast, the dissenting opinion rejected the view
that Section 211(¢)(1)(A) is a “delegation of quasi-
legislative power to the Administrator and not a re-
quirement that he reach a reasoned determination
purely on the scientific and medical data.’’? (Wilkey
Op. p. 55) It emphasized that the majority's view is
directly inconsistent with the intention of Congress
as shown by the legislative history and the language of
Section 211, particularly when compared with other
sections of the statute. From its analysis of the legis-
lative history and the statute, the dissent concluded
that the threshold determination of whether lead addi-
tives ‘twill endanger’’ the public health turns ‘‘eru-
cially on factual issues and not upon choices of policy.”
(Wilkey Op. p. 57) *
It is respectfully suggested that the view of the dis-
sent is correct. The legislative history makes clear
that Congress, in enacting Section 211(¢), realized
that the regulation of gasoline and its additives poses
complex and important questions coneerning this eoun-
try’s use of a vital natural and eeonomie resource.
Accordingly Congress, despite strong urgings from
* The dissenting opinion reached an alternative conclusion that.
even assuming the correctness of the Administrator’s interpretation
of the statute, ‘“‘his analysis reflected a clear error of judgment
upon the available evidence.’’ (Wilkey Op. p. 85) According to
the dissenting opinion, the Administrator’s ‘‘choice here is only a
guess, not an expert judgement drawn from conflicting evidence’’;
‘the logic of his conclusion has great gaps in the chain’’: and “the
evidence to support his conelusion is totally insufficient.’ (Wilkey
Op. p. 16, n.28)
aiden tee eat
ume
22
environmental groups, refused to ban lead additives
in gasoline as a matter of legislative policy. Instead,
it required that before the Administrator exercises the
authority delegated to him he must find on the basis
of scientific and medical evidence that the use of the
additive involved ‘‘will endanger the public health;”’
and it specified that no fuel additive may be controlled
or prohibited by the Administrator except upon the
basis of such evidence. Congress did not contem-
plate action on the basis of surmise, or apprehension
on the part of environmental groups, of which it was
fully aware when it delegated limited authority to
the Administrator.”
If the Court of Appeals decision is permitted to
stand, administrative regulations in many enviren-
mental and public health areas could be justified as a
‘legislative policy judgment’? despite the lack of a
solid factual basis or even with a ‘‘nonexistent data
base.”’ (Wright Op. p. 47) Relieved of the necessity
of being responsible to reviewing courts, administra-
tive agencies would then be encouraged to act without
% Section 211(e¢)(2)(A). 42 U.S.C. § 1857f-6e(e) (2) (A).
7H. Rep. No. 91-1146, 91st Cong., 2d Sess. 13 (1970). The
Chairman of the House Committee which reported the Act, Rep.
Staggers, stated that the Administrator could control additives
**[i]f he has the facts, and he has proven this by facts, that they
are a danger and poisonous.’’ 116 Cong. Ree. 19230. The Adminis-
trator does have authority under different provisions of the Act, to
adopt regulations dealing with indirect or inadequately proven
health effects of auto emissions. See, e.g. Section 202 (a) of the
Clean Air Act, 42 U.S.C. § 1857f-1, which gives the Administrator
authority to control the emission of a pollutant which ‘‘in his judg-
ment causes or contributes to, or is likely to cause or to contribute
to, air pollution which endangers the public health or welfare.’’
(Emphasis added.)
BLEED THROUGH
23
a careful or thorough analysis of the relevant scientific
and medical evidence.
III. Judicial Review of Agency Rulemaking That Is Based
Upon Scientific and Medical Evidence Requires a Thor-
ough Examination by the Court of the Evidence Relied
Upon by the Agency To Determine Whether There Has
Been a Clear Error of Judgment.
The opinions of the members of the Court of Ap-
peals reflect quite different understandings of, and
sharp disagreement as to, the scope of judicial review
of agency rulemaking based upon scientific and tech-
nieal evidence. (See Wright Op. pp. 66-74; Bazelon
Op. pp. 1-4; Leventhal Op. pp. 1-4; and Wilkey Op.
pp. 57-64)
The opinion of Judge Wright found confusion in
the language of this Court in Citizens to Preserve
Overton Park vy. Volpe, 401 U.S. 402 (1971), observ-
ing that ‘‘the Court’s intent in Overton Park [is]
somewhat difficult to plumb and its standard even
more uncertain of application.’”?” (Wright Op. p. 70,
n.74) Beeause Judge Wright thought that the lan-
guage in Overton Park ‘‘may unintentionally prompt
judicial distortion of the ‘arbitrary and capricious’
standard,’’ he acknowledged that the Court was re-
quired to engage in a ‘‘close scrutiny of the evidence’’;
indeed ‘‘the more technical the case, the more intensive
must be the court’s effort to understand the evidence.”’
(Wright Op. pp. 70-72)
Judge Wright’s analysis of the evidence, however,
was not the basis for the majority opinion. Rather
he coneluded that ‘‘the ultimate standard of [judi-
cial] review is a narrow one,’ and that the
Court’s obligation to review was fully satisfied by a
determination that ‘‘the agency decision was rational
and based on consideration of the relevant factors.”’
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POMEL SPEIER Lire
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24
(Wright Op. pp. 72-73) Thus, in sustaining what it
regarded as the Administrator’s determination of pol-
icy, the majority declined to let judicial review ‘‘be
bound by either the procedural or the substantive
rigor proper for questions of fact.’’ (Wright Op.
p. 46)
The concurring opinion of Judges Bazelon and
McGowan, whose votes were necessary to sustain the
Administrator’s action, not only subseribed to the lim-
ited concept of review actually applied by the majority,
but refused to make any examination of the underlying
evidence. Their concept of judicial review, as perceived
by Judge Leventhal in a separate concurrence, ‘‘advo-
cates engaging in no substantive review at all, when-
ever the substantive issues at stake involve technical
matters that the judges involved consider beyond their
individual technical competence.’’ (Leventhal Op. p. 1)
; Indeed, the concurring opinion of Judges Bazelon and
McGowan candidly recognizes that the extended dis-
cussion of the evidence in Judge Wright’s opinion is
unnecessary and distracting in light of the standard
of review that ultimately governed the action of the
majority. They concurred in the Court’s opinion only
because it would ‘tbar’’ a ‘‘close analysis of the evi-
denee,’’ and they rejected the majority’s ‘exhaustive
analysis of the scientific evidence’’ as ‘“‘unnecessary.”’
(Bazelon Op. p. 4)** This conclusion followed from
their expressed view that ‘‘substantive review of math-
: ematical and scientifie evidence by technically illiter-
aa SiS et st i A
Si iehenitig tapes!
: 8 Chief Judge Bazelon and Judge McGowan also observed that
: they concurred in the opinion of Judge Wright only because it
“severely limits judicial weighing of the evidence by construing the
Administrator’s decision to be a matter of ‘legislative policy’, and
consequently not subject to review with the ‘substantive rigor
proper for questions of fact.’’’ (Bazelon Op. p. 4)
PLAT N AT TER TS ee RET “ SEER EES PLONE IO OES |
NIRS ae SP TATE CPN TIN Ie SPEER EEO OPEN GES Ss
BLEED THROIIGH
25
ate judges is dangerously unreliable.’’ (Bazelon Op.
p. 3) 39
Nowhere in the concurring opinion of Judges Ba-
zelon and McGowan is there any attempt to show by
reference either to statutory language or legislative his-
tory why judicial review of the Administrator’s action
in this case should differ so substantially from judi-
cial review of agency action in other situations. Cer-
tainly the language of the Clean Air Act contains no
suggestion that the review envisaged by Congress is
to be any less rigorous than the review Congress has
traditionally provided for in numerous regulatory stat-
utes passed over the years. In the course of the argu-
ment Judge McGowan questioned whether substantive
judicial review might unconstitutionally involve the
courts in what he characterized as essentially legislative
activity. Any uncertainty as to the permissibility, in-
deed perhaps necessity, under the Constitution of pro-
viding for meaningful judicial review of agency action
in health and scientific matters should certainly be dis-
pelled by this Court.
Judge Leventhal disagreed with Judges Bazelon and
MeGowan as to the proper scope of judicial review of
agency action in cases of this kind and asserted the pro-
priety of ‘‘substantive review of administrative action”’
under this Court’s decision in Overton Park, which
‘“‘requires the reviewing court to scrutinize the facts.”’
*° As Judge Leventhal noted, courts are frequently called upon
to decide cases involving scientific and technical facts in a number
of substantive areas including of course patent infringement. Con-
gress obviously could have created specialized courts to review
such actions, but by not doing so, Congress intended that the
Courts of Appeal would attempt to educate themselves on the
issues involved. (See Leventhal Op. p. 2)
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bald
“ey:
HRI EWI PL PAC Ry a RR ra tL tee RN ot
26
(Leventhal Op. pp. 2-3) In his view ‘‘if there is some
factual support for the challenge, there must be either
evidence or judicial notice available explicating the
agency’s result, or a remand to supply the gap.”’
(Leventhal Op. p. 3) The dissenting opinion by Judge
Wilkey found no confusion or uneertainty in this
Court’s decision in Overton Park and stated that it
meant that reviewing courts are ‘obligated to engage in
a ‘substantial inquiry’ ’’ into the facts to determine if
the agency had made a ‘‘clear error of judgment.”
(Wilkey Op. p. 58)
These sharp differences among the members of the
Court of Appeals reflect widespread uneertainty on
their part as to the proper scope of judicial review in
light of Overton Park. The same difficulties have been
expressed in numerous other decisions of that court.*°
See e.4.. the following decisions holding that judicial review
of agency action requires a thorough examination of the scien-
tifie facts and evidence relied upon by administrative agencies:
International Harvester Company v. Ruckelshans. 155 U.S. App.
D.C. 411. 478 F.24 615 (D.C. Cir. 1973) (opinion by Judge Leven-
thal, exhaustively reviewing the scientific evidence relied upon
by EPA and concluding that the technical facts require ‘‘a
different approach”’ from that taken by the agency); National
Tire Dealers and Retreaders Association v. Brinegar, 160 U.S. App.
D.C. 238, 244, 491 F.2d 31, 35 (D.C. Cir. 1974) (opinion by Judge
Wilkey, holding invalid Department of Transportation regu-
lations on the ground that the agency’s conclusions were cast into
doubt by specifie technical! comments in the record); Portland
Cement Association vy. Ruckelshaus, 158 U.S. App. D.C. 308,
486 F.2d 375, 402 (1972), cert. denied 417 U.S. 921 (1974)
(opinion by Jndze Leventhal observing that judicial review
of agency decisions requires ‘‘steeping in technical matters.’’)
In contrast, see e.g., the following decisions holding that the
court’s responsibility is not to examine in detail the scientific facts
and evidence relied wpon by agencies: Industrial Union Depart-
ment v. Hodgson, 162 U.S. App. D.C. 331, 338-9, 499 F.2d 467,
474-5 (D.C. Cir. 1975) (opinion by Judge McGowan characterizing
BLEED THROUGI
hi a a Co
27 ;
Tius, depending upon the panel assigned to a given
case, 1 Court May engage in an analysis of the agency’s ‘
evidence, or it may merely limit itself to determining
whether the agency gave consideration to the evidence
ina formal sense. These uncertainties are particularly
unsettling because the Court of Appeals for the District :
of Columbia Circuit has been entrusted with exclusive
review of administrative agency action under numerous
statutory provisions, including Section 211 of the Clean
Air Act." In view of the exclusive judicial review
SOP RRP AnerT NR
the promulgation of regulations ‘‘on the frontiers of scientific
knowledge’’ as questions of ‘‘policy’’ not subject to the same re-
view as questions of fact); O’Donnelly v. Schaffer, 160 U.S.
App. D.C. 266, 269, 491 F.2d 59, 62 (D.C. Cir. 1974) (opin-
ion by Chief Jndee Bazelon, giving great deference to the decision F
of the agency where ‘‘complex technical issues are involved’’) ; :
and see also the concurring opinion of Chief Judge Bazelon in
International Harvester Company v. Ruckelshaus, 155 U.S. App.
D.C, 411, 478 F.2d 615 (D.C. Cir. 1973), observing that ‘‘in
cases of great technological complexity, the best way for courts
to guard against unreasonable or erroneous administrative deci-
sions is not for the judges themselves to scrutinize the technical
merits of each decision.’’ :
OKIE 6 PERN
MARRS EN
4149 U.S.C. §1857h-5(b)(1) provides that judicial review of
EPA action under Section 211 shall be available exclusively
in the United States Court of Appeals for the District of Co-
lumbia Circuit. See also 42 U.S.C. $4915 (promulgation of noise
control regulations by EPA); 42 U.S.C. § 300j-6 (promulgation ‘
of national primary drinking water regulations under the Safe
Drinking Water Act). Similarly other provisions of the Clean
Air Act involving nationwide regulatory programs vest exclu-
sive jurisdiction for judicial review in the United States Court
of Appeals for the District of Columbia Circuit. See Sections
1857¢-6, 1857e-7, 1857f-1, 18457f-6e, 1857f-9. As the Court of
Appeals for the District of Columbia Circuit pointed out in Nat-
ural Resources Defense Council, Ine. v. Environmental Protection
Agency, 168 U.S. App. D.C. 111, 114, 512 F.2d 1351, 1354 (D.C. ‘
Cir. 1975), Congress considered such exclusive judicial review :
“necessary to preserve the ‘even and consistent national applica- ;
tion of standards .. .’ (citing S. Rep. No. 91-1196, 91st Cong.,
¥
2d Sess. 40-41 (1970)).”? 5
a
th ie .:-00 il i i ee a a ae eee |
POOR COPY
28
vested in that court, the disagreement among the mem-
bers of the court as to the nature of their review func-
tion has an effect comparable to a conflict between cir-
cuit courts of appeals and affords a further reason for
granting a writ in this case.
Only this Court can remove the ambiguity found by
the majority of the Court of Appeals to be inherent in
Overton Park, as that decision applies to agency action
based upon scientific and technical evidence. The Court
should make clear that reviewing courts have an obliga-
tion to make a searching and careful inquiry into the
facts in reviewing such action, and that on the basis of
such an inquiry the reviewing court must determine
whether the agency has made a clear error of judgment.
Such review is essential if the courts are to perform the
j important role that Congress has entrusted to them.
Congress expected reviewing courts to provide balance
and proportion to the process of administrative regula-
tion in environmental and other technical areas. Ad-
ministrators by their nature are the subject of intense
political pressures. <All too often the most vocal or most
persistent group ultimately prevails; the most popular
i at OR 0 dit th!
cause is adopted. The reviewing court can scrutinize
: agency action free of such pressures, and Congress
: meant that it should.
It is particularly important for the Supreme Court
4 to resolve this issue in this case. The concurring opin-
‘ ion of Judges Bazelon and McGowan indicates that
; they did not scrutinize the evidence relied upon by the
‘ Administrator as required by Overton Park. Indeed,
this was precisely Judge Leventhal’s interpretation of
their concurring opinion. As a result, only three of the
five majority judges were able to form any conclusion
as to the adequacy of the evidence relied upon by the
BLEED THROUC
29
Administrator. On the other hand, four dissenting
judges found that the evidence did not meet the re-
quired standard. A five to four decision affecting very
substantial rights should not be permitted to stand
where two members of the majority did not examine,
in the manner required by this Court, the evidence re-
lied upon by the Administrator.
CONCLUSION
Petitioners respectfully request that this Petition
for a Writ of Certiorari be granted.
Respectfully submitted,
DANIEL M. GRIBBON
ALLAN J. TOPOL
888 Sixteenth Street, N.W.
Washington, D.C. 20006
Attorneys for Petitioners
E. I. Du Pont de Nemours and
Company, and PPG Indus-
tries, Ine.
Of Counsel:
CovINGTON & BURLING
888 Sixteenth Street, N.W.
Washington, D.C. 20006
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OE SAAN sia DR RE , — errno ‘
— “EIRAIT Mm FILE
-)
>
a MRE ME GOULET U, Mm i
Ber: 4 3 1 6 () 2 } MAY 3 19
ae : os j
"e Nos. .7.9%%...>.
¢ . NE RODAK, JR.,
{
y IN THE
Supreme Court of the United States
Ocroper Term, 1975
Kruyn Corporation, Petitioner
v,
NVIRONMENTAL PROTECTION Agency, Respondent
t PPG Ixpusrnirs, Ine. Petitioner
v.
NVIRONMENTAL Proreerion AGENcy, Respondent
KH. 1. DePoxr pe Nemours axp Company, Petitioner
’,
NVIRONMENTAL Proreerion Acency, Respondent
Nanco CHemMicaL Com PANY, Petitioner
v,
ENVIRONMENTAL Prorection AGENcy, Respondent
Nationa Perrouecm Rerixers Association, Petitioner
Y.
NVIRONMENTAL PRrorge rion AGENCY, Respondent
JOINT APPENDIX TO
PETITIONS FOR WRIT OF CERTIORARI
Press or Byron S. ADAMS Printinc, INc., WASHINGTON, D .
i
—
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
F No. 73-2205
| ETHYL CORPORATION, PETITIONER
V.
ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT
No. 73-2268
PPG INbustriEs, INC., PETITIONER
Vv.
ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT
No. 73-2269
E. I. DUPONT DE NEMourRsS & COMPANY, PETITIONER
Vv.
ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT
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2
No. 73-2270
NALCO CHEMICAL COMPANY, PETITIONER
V.
ENVIRONMENTAL PROTECTION AGEN CY, RESPONDENT
No. 74-1021
NATIONAL PETROLEUM REFINERS ASSOCIATION, PETITIONER
Vv.
ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT
Petitions for Review of an Order of the
Environmental Protection Agency
On Rehearing En Banc
Argued En Bane May 30, 1975
Decided March 19, 1976
SYLLABUS
Section 211/c)(1)(A) of the Clean Air Act authorizes
the Administrator of the Environmental Protection Agency
to regulate gasoline additives whose emission products
“will endanger the public health or welfare * * Pa
42 U.S.C. § 1857f-6e(e)(1)(A) (1970). Acting pur-
RLEED THROILIGH
3
suant to that power in rule-making proceedings, the Ad-
ministrator determined that leaded gasoline automotive
emissions present “a significant risk of harm” to the
public health, thereby endangering it within the con-
templation of the statute. Based on this finding, the
Administrator issued regulations requiring annual re-
ductions in the lead content of leaded gasoline. Held:
1. The Administrator’s interpretation of the statutory
“will endanger” standard is entitled to great deference.
Train v. Natural Resources Defense Council, Inc., 421
U.S. 60, 75 (1975). We find no basis in the language
of the statute or in its legislative history to fault his
interpretation. In applying the “will endanger” stand-
ard, the Administrator is authorized to assess risks of
harm and, where the risk is found to be significant, to
act to prevent the harm from happening. Thus the regu-
latory action under this precautionary statute should pre-
cede, and hopefully prevent, the perceived harm. Pp. 17-
66.
a. Some of the questions involved in promulga-
tion of environmental regulations “are on the fron-
tiers of scientific knowledge, and consequently as to
them insufficient data is presently available to make
a fully informed factual determination. Decision
making must in that circumstance depend to a
greater extent upon policy judgments and less upon
purely factual analyses.” Industrial Union Depart-
ment, AFL-CIO v. Hodgson, 162 U.S.App.D.C. 331,
338, 499 F.2d 467, 474 (1974). Pp. 45-56.
b. In making his policy judgment by assessing
risks the Administrator is not required to limit his
consideration to the danger presented by lead ad-
ditives “in and of themselves.” He may consider
the cumulative impact of lead additives with other
sources of human exposure to lead. Pp. 56-61.
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2. The Administrator’s determination that lead emis-
sions “present a significant risk of harm to the health
of urban populations, particularly to the health of city
children,” is not “arbitrary, capricious, an abuse of dis-
cretion, or otherwise not in accordance with law * * *.”
5 U.S.C. § 706(2)(A) (1970). His determination has
a rational basis in the evidence. Pp. 66-97.
a. We must look at the Administrator’s decision
4 not as the chemist, biologist, or statistician that we
are qualified neither by training nor experience to
4 be, but as a reviewing court exercising our narrowly
defined duty of holding agency action to certain
minimal standards of rationality. Pp. 66-74.
b. We need not seek a single dispositive scientific
study that fully supports the Administrator’s de-
termination. Science does not work that way; nor
:
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;
does agency fact-finding. Rather, the Administrator’s
decision may be fully supportable if it is based, as
it is here, on the inconclusive but suggestive results
of numerous studies. By its nature, scientific evi-
dence is often cumulative; the more supporting,
albeit inconclusive, evidence available, the more
likely the accuracy of the conclusion. Pp. 75-76.
ec. The vast bulk of the evidence before the Ad-
: ministrator provides inferences, no one of which
: is dispositive, which support the Administrator’s
findings. Particularly in light of the precautionary
nature of the “will endanger” standard, we can-
not find the Administrator’s conclusion that lead
automotive emissions present a significant risk of
4 harm to the public health arbitrary or capricious.
Pp. 77-97.
The order of the Environmental Protection Agency
; is
Affirmed.
4
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Joseph C. Carter, Jr., with whom John J. Adams and
David F. Peters were on the brief, for petitioner in
No. 73-2205. Arnold H. Quint also entered an appear-
ance for petitioner in No. 73-2205.
Daniel M. Gribbon, with whom Allan J. Topol and
Charles Lister were on the brief, for petitioners in Nos.
73-2268 and 73-2269.
Victor P. Kayser, with whom John C. Bergho ff, Jr.,
Robert E. Nord, David Machanic, and William H. Fitz
were on the brief, for petitioner in No. 73-2270.
H. Edward Dunkelberger, Jr.. with whom Theodore
L. Garrett was on the brief, for petitioner in No. 74-
1021.
Robert V. Zener, General Counsel, Environmental Pro-
tection Agency, and Leslie A. Carothers, Attorney, En-
vironmental Protection Agency, with whom Wallace H.
Johnson, Assistant Attorney General, and Edmund B.
Clark, Martin Green, and Edward J. Shawaker, Attor-
neys, Department of Justice, were on the brief, for re-
spondent. Raymond N. Zagone, Attorney, Department
of Justice, also entered an appearance for respondent in
No. 73-2268.
David Schoenbrod filed a brief on behalf of Natural
Resources Defense Council, Inc. et al. as amici curiae
urging affirmance.
Before BAZELON, Chief Judge, and WRIGHT, McGowan,
TAMM, LEVENTHAL, ROBINSON, MACKINNON, Ross, and
WILKEY, Circuit Judges, sitting en banc.
Opinion for the court, in which Chief Judge BAZELON
and Circuit Judges McGowan, LEVENTHAL, and RoBIN-
SON concur, filed by Circuit Judge WrRiGHT.
Concurring opinion, in which Circuit Judge McGowAN
joins, filed by Chief Judge BAZELON.
Concurring statement filed by Circuit Judge LEVEN-
THAL.
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Dissenting opinion filed by Circuit Judge MACKINNON.
Dissenting opinion, in which Circuit Judges TAMM
and Ross join, filed by Circuit Judye WILKEY.
WRIGHT, Circuit Judge: Man’s ability to alter his
environment has developed far more rapidly than his
ability to foresee with certainty the effects of his altera-
tions. It is only recently that we have begun to ap-
preciate the danger posed by unregulated modification
of the world around us, and have created watchdog
agencies whose task it is to warn us, and protect us,
when technological “advances” present dangers unap-
preciated—or unrevealed—by their supporters. Such
agencies, unequipped with crystal balls and unable to
read the future, are nonetheless charged with evaluat-
ing the effects of unprecedented environmental modifica-
tions, often made on a massive scale. Necessarily, they
must deal with predictions and uncertainty, with de-
veloping evidence, with conflicting evidence, and, some-
times, with little or no evidence at all. Today we ad-
dress the scope of the power delegated one such watch-
dog, the Environmental Protection Agency (EPA). We
must determine the certainty required by the Clean Air
Act before EPA may act to protect the health of our
populace from the lead particulate emissions of auto-
mobiles.
Section 211(¢)(1)(A) of the Clean Air Act? autho-
rizes the Administrator of EPA to regulate gasoline ad-
ditives whose emission products “will endanger the pub-
lic health or welfare * * *.” 42 U.S.C. § 1857f-6e(e) (1)
(A). Acting pursuant to that power, the Administrator,
after notice and comment, determined that the automo-
tive emissions caused by leaded gasoline present “a signi-
‘ All sections of the Act pertinent to this case were added
by the Clean Air Amendments of 1970, Pub. L. 91-604, Dec.
51, 1970, 84 Stat. 1698-1700.
7
ficant risk of harm” to the public health. Accordingly,
he promulgated regulations that reduce, in step-wise
fashion, the lead content of leaded gasoline? We must
decide whether the Administrator properly interpreted
the meaning of Section 211(c) (1) (A) and the scope of
his power thereunder, and, if so, whether the evidence
adduced at the rule-making proceeding supports his final
determination. Finding in favor of the Administrator
on both grounds, and on all other grounds raised by
petitioners, we affirm his determination.
* The new regulations, together with regulations requiring
all gasoline refiners to market at least one line of lead-
free gasoline, are set out in 40 C.F.R. § 80 (1975). The lead-
free regulations serve a different purpose than the low-lead
regulations now before us. Leaded gasoline fouls the cata-
lytic converter emission control system developed by the major
automobile companies to meet the air pollutant emission
standards set by Congress in § 202 of the Clean Air
Act. 42 U.S.C. § 1857f-1. So as to allow implementation of
the catalytic converter, the Administrator ordered the market-
ing of lead-free gasoline pursuant to his authority under
§ 211(c) (1) (B), the sister section to §211(c)(1)(A) at
issue here. Section 211(c)(1)(B) gives EPA authority to
regulate gasoline additives whose emission products “will
impair to a significant degree the performance of any emis-
sion control device or system which is in general use * * *.”
42 U.S.C. § 1857f-6c(c) (1) (B). The lead-free regulations
were approved by this court in Amoco Oil Co. v. EPA, 163
U.S.App.D.C. 162, 501 F.2d 722 (1974).
On March 5, 1975, the Administrator suspended the 1977
statutory standards for automobile emissions of hydrocarbons
and carbon monoxide, establishing interim standards for that
model year equal to those now in effect. 40 FED. REG. 11900.
This action was taken to slow the emission reduction sched-
ule and thereby minimize a potential health hazard posed by
the gradual increase in sulfuric acid emissions produced by the
catalytic converter. So far as this decision is relevant to
this case, it bears noting that the lead-free gasoline regu-
lations will continue in effect and automobiles will continue
to be equipped with catalytic converters for the foreseeable
future. See note 68 infra.
DBAMND CDV
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EPEC IPEET TERE OO
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I. THE FACTS, THE STATUTE, THE PROCEEDINGS
AND THE REGULATIONS
Hard on the introduction of the first gasoline-powered
automobiles came the discovery that lead “antiknock”
compounds, when added to gasoline, dramatically increase
the fuel’s octane rating. Increased octane allows for
higher compression engines, which operate with greater
efficiency. Since 1923 antiknocks have been regularly
added to gasoline, and a large industry has developed to
supply those compounds. Today, approximately 90 percent
of motor gasoline manufactured in the United States con-
tains lead additives, even though most 1975 and 1976
model automobiles are equipped with catalytic conver-
ters, which require lead-free gasoline. From the be-
ginning, however, scientists have questioned whether the
addition of lead to gasoline, and its consequent diffusion
into the atmosphere from the automobile emission, poses
a danger to the public health. As use of automobiles,
* The principal studies and symposia over the years on the
subject have included Sayers et al., “Experimental Studies
on the Effect of Ethyl Gasoline and Its Combustion Prod-
ucts,” Bureau of Mines, 1927; HEW, “Public Health Aspects
of Increasing Tetraethyl Lead Content in Motor Fuel,” Pub-
lic Health Service Pub. No. 712, 1959; Kehoe, “The Metabo-
lism of Lead in Man in Health and Disease,”” The Harben
Lectures, 1960, JA 500-579; HEW, “Survey of Lead in the
Atmosphere of Three Urban Communities,” JA 789-839;
HEW, “Symposium on Environmental Lead Contamination,”
Public Health Service Pub. No. 1440, 1966, JA 975-984;
Tepper & Levin, “A Survey of Air and Population Lead
Levels in Selected American Communities,” 1972, JA 840-
916; National Academy of Sciences, “Airborne Lead in Per-
spective,” 1972, JA 309-362: EPA and Commission of
European Communities, Proceedings of International Sym-
posium, “Environmental Health Aspects of Lead,” Luxem-
bourg, 1973, JA 676-677: EPA and National Institute of
Environmental Health Services, Conference on “Low-Level
Lead Toxicity,” Raleigh, N.C., 1973.
BLEED THROU(
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and emission of lead particulates, has accelerated in the
last quarter century, this concern has mounted. The rea-
sons for concern are obvious (and essentially undisputed
by petitioners): (1) lead in high concentrations in the
body is toxic; (2) lead can be absorbed into the body
from the ambient air; and (3) lead particulate emis-
sions from gasoline engines account for approximately
90 percent of the lead in our air. Despite these apparent
reasons for concern, hard proof of any danger caused
by lead automotive emissions has been hard to come by.
Part of the reason for this lies in the multiple sources
of human exposure to lead.
Lead is an ubiquitous element. It is found in the land,
in the sea, in plants, in animals, and, ultimately, in
humans. Traces of lead ranging from 10 to 40 micro-
grams per 100 grams of blood (10-40 ug/100g)* are
found in everyone, including those living in environments
with almost no atmospheric lead. NATIONAL ACADEMY OF
SCIENCES COMMITTEE ON BIOLOGIC EFFECTS OF ATMOS-
PHERIC POLLUTANTS, AIRBORNE LEAD IN PERSPECTIVE 118
(1972) (hereinafter NAS Report). Despite its uni-
versal presence, however, lead serves no known purpose
in the human body, and at higher concentrations is
toxic, causing anemia, severe intestinal cramps, paral-
ysis of nerves, fatigue, and even death. Clinical symp-
toms of lead poisoning appear at blood lead levels of
80-100 ug or higher, and symptomatic lead poisoning
may appear at levels of 50-60 ug, particularly in the
* Some of the data discussed herein speak of micrograms of
lead per 100 grams of blood, while other data report micro-
grams per 100 milliliters of blood. Since the density of blood
is close to 1.0, these figures are directly comparable. There-
fore, lead concentrations, unless otherwise indicated, will
hereafter simply be given in micrograms. See NATIONAL
ACADEMY OF SCIENCES COMMITTEE ON BIOLOGIC EFFECTS OF
ATMOSPHERIC POLLUTANTS, AIRBORNE LEAD IN PERSPECTIVE
61 n. * (1972) (hereinafter NAS Report).
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presence of anemia. EPA’s PosITION ON THE HEALTH
IMPLICATIONS OF AIRBORNE LEAD (hereinafter Third
Health Document) at III-1, Joint Appendix (hereinafter
JA) 54-55.
Human body lead comes from three major sources. In
most people, the largest source is the diet. EPA esti-
mates daily dietary lead intake for adults to average
200-300 ug per day, with a range of 100-500 ug a day.
Third Health Document at V-2, JA 82. Absorption of
dietary lead into the bloodstream is estimated at about
10 percent, although in children absorption may be as
high as 50 percent. Thus the average adult adds 20-30
ug of lead to his bloodstream daily from his diet alone.
This daily intake, which may be highly variable depend-
ing on individual diets, NAS Report at 50, is generally
regarded as, for all practical purposes, uncontrollable.°
A second major source of the body’s lead burden, at
least among urban children, is regarded as controllable,
although effective control may be both difficult and ex-
pensive to achieve. Ingestion of lead paint by children
with pica (the abnormal ingestion of non-food substances,
a relatively common trait in pre-school children, particu-
larly ages 1-3) is generally regarded as “the principal
environmental source in cases of severe acute lead poi-
soning in young children.” NAS Report at 140. Lead-
based paint was widely used in pre-1940 housing, for
both interiors and exteriors, so children living in older
housing, particularly in urban ghettos where such paint
is both present and peeling, are most susceptible to this
form of lead poisoning. Limited control has been
achieved in that lead paints are now rarely used, and
5 Lead in food and water ultimately can be traced to lead in
soil and this, of course, is uncontrollable. The NAS Report
concluded that “[t]here is no evidence that the amount of
lead in the diets of people has changed substantially since
1940.” NAS Report at 206.
RBRLEED THR
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are frequently banned by statute, for interior surfaces.
But while some local laws require removal of existing
peeling lead paints, and there is federal legislation to
aid states and municipalities in such efforts, Lead-Based
Paint Poisoning Prevention Act, 42 U.S.C. §§ 4801 et
seq., (1970), there is no concentrated national effort at
removal, and the danger to children living in dilapidated
housing will remain for some time.*
The last remaining major source of lead exposure for
humans is the ambient air. This source is easily the most
controllable, since approximately 90 percent of lead in
the air comes from automobile emissions,’ and can be
simply eliminated by removing lead from gasoline.* While
the extent to which such lead actually enters the body
is vigorously contested by petitioners and lies at the heart
of this appeal, all parties agree that, to some extent at
least, airborne lead can be absorbed through the lungs
as a person breathes lead-contaminated air and that it
can be eaten by children with pica after larger lead
particles fall to the ground and mix with dust. Once
the lead is in the body, however. its source becomes irre-
levant; all lead in the bloodstream, from whatever source,
is essentially fungible. Thus so long as there are multi-
° A list of local laws regarding control and/or removal of
lead-based paints can be found in NAS Report at 77.
* This is EPA’s figure, Third Health Document at II-4, JA
37, and Ethyl Corporation (hereinafter Ethyl), alone among
the petitioners, contests it. Supplemental brief of petitioner
Ethyl Corporation (hereinafter Ethyl Supp. Br.) at 40. We
cannot say that EPA’s estimate is unreasonable. It was de-
termined by discounting the NAS Panel’s conclusion that
“about 98° of the airborne lead that can be traced to its
source comes from combustion of gasoline.” NAS Report at
31. See also id. at 12-13.
* An alternative approach, considered and rejected by EPA,
is to trap and remove lead emissions from the exhausts of
automobiles using leaded gasoline. See note 66 infra.
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ple sources of lead exposure it is virtually impossible to
isolate one source and determine its particular effect on
the body. The effect of any one source is meaningful
only in cumulative terms.
The multiple sources of human exposure to lead explain
in part why it has been difficult to pinpoint automobile
lead emissions as a danger to public health. Obviously,
any danger is caused only by the additive effect of lead
emissions on the other, largely uncontrollable, sources
of lead. For years the lead antiknock industry has re-
fused to accept the developing evidence that lead emis-
sions contribute significantly to the total human lead
body burden. In the Clean Air Act Amendments of 1970,
Pub. L. 91-604, December 31, 1970, 84 STAT. 1698-1700,
however, Congress finally set up a legal mechanism by
which that evidence could be weighed in a more objective
tribunal. It gave the newly-created EPA authority to
control or prohibit the sale or manufacture of any fuel
additive whose emission products “will endanger the pub-
lic health or welfare * * *.” 42 U.S.C. § 1857£-6e(c) (1)
(A) (1970). It is beyond question that the fuel additive
Congress had in mind was lead.”
Given this mandate, EPA published on January 31,
1971 advance notice of proposed rule-making. The Ad-
ministrator announced he was considering possible con-
trols on lead additives in gasolines, both because of their
possible danger to health and because of their incom-
patibility with the newly-developed catalytic converter
emission control system.’ 36 FED. REG. 1486 (1971).
* See, e.g., 116 CONG. REC. 19207 (1970) (remarks of Rep.
Skubitz) (“the Government can require that the oil com-
panies get the lead out”); id. at 19228-19230 (colloquy be-
tween Reps. Waggoner & Staggers); id. at 19234 (remarks
of Rep. Williams) ; id. at 19239 (remarks of Rep. Sebelius).
*° Regulations promulgated for the latter reason were ap-
proved in Amoco Oil Co. v. EPA, supra note 2. See note 2
supra.
13
Proposed regulations were issued a year later, Febru-
ary 23, 1972, supported by a document Health Hazards
of Lead" ‘hereinafter First Health Document), pre-
pared by the EPA scientific staff. Comments were in-
vited for a 90-day period, later reopened for an additional
30 days. 387 Feb. REG. 11786-11787 (1972). At the
same time public hearings were held in Washington,
D. C., Dallas, and Los Angeles.
On January 10, 1973 the Administrator, while issuing
final regulations requiring availability of some lead-free
gasoline to allow implementation of the catalytic con-
verter system, 38 FED. REG. 1254; approved in Amoco
Oil Co. v. EPA, 163 U.S.App.D.C. 162, 501 F.2d 722
(1974), reproposed the health-based regulations now at
issue. 38 FED. REG. 1258. The reproposal was supported
by a second health document, EPA’s Position on the
Health Effects of Airborne Lead (hereinafter Second
Health Document), JA 158, and was necessitated by a
modification of EPA’s analysis of the health effects of
lead emissions. The Agency concluded, after considering
the comments received, that it was virtually impossible
to identify the precise amount of airborne lead that will
endanger public health. Instead, the control strategy
would concentrate on evaluating the cumulative effect of
airborne lead .on total human lead exposure and the sig-
nificance of that contribution. 38 FED. REG. 1258. The
reproposed regulations themselves were similar to the
original proposal, requiring a phased cutback to 1.25
grams of lead per gallon of leaded gasoline, but, in
recognition of the industry’s lead-time problems, pushing
the timetable for reduction back one year. The Agency
again invited public comment, this time for a 60-day
period.
"JA 292. This document was subsequently revised by
HEALTH HAZARDS OF LEAD (rev. April 11, 1972), JA 254;
ATMOSPHERIC LEAD AND PUBLIC HEALTH, (April 11, 1972),
JA 276; and CORRECTIONS AND ADDITIONS TO HEALTH HAZARDS
OF LEAD (April 27, 1972), JA 272.
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On October 28, 1973, as a result of a motion filed in
Natural Resources Defense Council, Ine. v. EPA, D.C.
Cir. No. 72-2233, this court ordered EPA to reach within
30 days a final decision on whether lead additives should
be regulated for health reasons. EPA published its final
health document, entitled EPA’s Position on the Health
Implications of Airborne Lead, on November 28, 1973.
JA 27. This document, the Third Health Document, ex-
tensively details and reviews the state of knowledge of
the health effects of airborne lead. It candidly discusses
the various scientific studies, both pro and con, underly-
ing this information, and ultimately concludes that lead
from automobile emissions will endanger the public health.
The same day, based largely on the conclusions of the
Third Health Document, EPA promulgated its final
regulations, accompanied by a thorough discussion of its
health conclusions, the impact of the regulations, and
the alternative courses of action considered and _ re-
jected. 38 FED. REG. 33734. The final regulations re-
quire the same step-wise reduction of lead additives but,
in response to the comments of a majority of refiners,
calculate the reduction in a slightly different manner.
Whereas the original and reproposed regulations set
standards for permissible lead use by each refiner on
the basis of grams of lead per gallon of leaded gasoline
produced (leaded pool averaging), the final regulations
base the standards on grams of lead per gallon of all
gasoline produced (total pool averaging). The quantity of
lead emitted into the atmosphere is the same under both
systems; EPA simply converted its leaded poo] figures
into total pool figures. Under the final regulations, lead
in all gasoline would be reduced over a five-year period
to an average of 0.5 grams per gallon."
* The reduction would proceed in the following steps:
1.7 g/gal. after Jan. 1, 1975
1.4 g/gal. after Jan. 1, 1976
[continued]
RIFEN trupotiic
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Petitioners, various manufacturers of lead additives
and refiners of gasoline, appealed the promulgation of
low-lead regulations to this court under Section 307 of
the Clean Air Act, 42 U.S.C. § 1857h-5. The appeal was
heard by a division of the court on September 9, 1974.
On December 20, 1974, the division, one judge dissent-
ing, ordered the regulations set aside. The majority and
dissenting opinions were published on January 28, 1975.”
Because of the importance of the issues presented, we
granted EPA’s petition for rehearing en bane on March
17, 1975, vacating the judgment and opinions of the
division and setting the case for reargument on May 30,
1975. All parties were invited to submit supplementary
briefs addressing the issues raised by the division
opinions.
The regulations are challenged by petitioners on a vari-
ety of grounds, all of which will be addressed below.
Their primary claims, and the ones on which the division
1.0 g/gal. after Jan. 1, 1977
0.8 g/gal. after Jan. 1, 1978
0.5 g/gal. after Jan. 1, 1979
40 C.F.R. § 80.20 (1975). According to EPA calculations,
when the overall lead content of both leaded and unleaded
gasoline averages 0.5 grams per gallon, leaded gasoline would
contain an average of 1.25 grams of lead per gallon, the same
as under the original regulations. See 38 FED. REG. at 33739
(1973).
*s Commentators have been uniformly critical of the ma-
jority opinion. See Gardner, Federal Courts and Agencies:
An Audit of the Partnership Books, 75 CoLuM. L. REV. 800,
801 & n.77 (1975); Note, Judicial Review of the Facts in In-
formal Rulemaking: A Proposed Standard, 84 YALE L.J. 1750,
1767-68 & nn. 81-82 (1975); Note, Reserve Mining—The
Standard of Proof Required to Enjoin an Environmental
Hazard to the Public Health, 58 MINN. L. REV. 893, 918-19
n.116 (1975). See also Reserve Mining Co. v. EPA, 514 F.2d
492, 519-520 (8th Cir. 1975) (en banc).
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majority based its reversal, are that the Administrator
misinterpreted the statutory standard of “will endanger”
and that his application of that standard is without
Support in the evidence and arbitrary and capricious.
II]. THE STATUTORY REQUIREMENTS
Under Section 211(¢) (1) (A) the Administrator may,
on the basis of all the information available to him,
promulgate regulations that
control or prohibit the manufacture, introduction
into commerce, offering for sale, or sale of any fuel
or fuel additive for use in a motor vehicle or motor
vehicle engine (A) if any emission products of such
fuel or fuel additive will endanger the public health
or welfare * * *,
42 U.S.C. § 1857-6e(a) (1) (A). The Administrator can-
not act under Section 211(c) (1) (A), however, until
after “consideration of all relevant medical and scientific
evidence available to him, including consideration of
other technologically or economically feasible means of
achieving emission standards under [Section 202].” See-
tion 211(¢) (2) (A), 42 U.S.C. § 1857f-6e(c) (2) (A). Sec-
tion 202 of the Act, 42 U.S.C. § 1857f-1, allows the Ad-
ministrator to set standards for emission of pollutants
from automobiles (as opposed to standards for the com-
position of the gasoline that produces the emissions), and
is thus the preferred—although not the mandatory—
alternative under the statutory scheme, presumably be-
cause it minimizes Agency interference with manufac-
turer prerogatives."
** When EPA acts under § 211(c) (1) (A) it is essentially
telling manufacturers how to make their fuels, a task Con-
gress felt the Agency should enter upon only with trepidation.
See, e.g., 116 Conc. REc. 32920 (1970) (remarks of Sen.
Baker) ; id. at 19229 (remarks of Reps. Rogers & Waggoner).
[continued]
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The Administrator is also required, before prohibiting
a fuel or fuel additive under Section 211(c) (1) (A), to
find, and publish the finding, that in his judgment any
fuel or fuel additive likely to replace the prohibited one
will not “endanger the public health or welfare to the
same or greater degree * * *.” Section 211(c) (2) (C), 42
U.S.C. § 1857f-6e(c) (2)(C). It is significant that this
is the only conclusion the Administrator is expressly re-
quired to “find” before regulating a fuel or fuel additive
for health reasons.
A. The Threshold Determination
In making his threshold determination that lead par-
ticulate emissions from motor vehicles “will endanger the
public health or welfare,” the Administrator provided
his interpretation of the statutory language by couch-
ing his conclusion in these words: such emissions “pre-
sent a significant risk of harm to the health of urban
populations, particularly to the health of city children.”
38 FED. REG. 33734. By way of further interpretation,
he added that it was his view
On the other hand, when the Agency acts under § 202, it is
only mandating an end product—regulated emissions. The
method for achieving the required result is entirely in the
hands of the manufacturers.
Nonetheless, deference to regulation under § 202 is not
mandatory. The Administrator is only required to “consider”
the possibility of regulating under that section instead of un-
der §211. This language is in sharp contrast to the version
of § 211 that was passed by the House. The House version
would have allowed regulation under § 211 only after the Ad-
ministrator made a specific finding “that it is not otherwise
technologically or economically feasible to achieve the emission
standards established pursuant to section 202 of this Act.”
H.R. 17255, 91st Cong., 2d Sess. § 210(g) (1) (1970). This
mandatory deference to § 202 regulation was removed in con-
ference and the present more flexible language was substi-
tuted. See pages 40-43 infra.
LOE LT ME FRU TE OM tt
18
that the statutory language * * * does not require
a determination that automobile emissions alone cre-
ate the endangerment on which controls may be
based. Rather, the Administrator believes that in
providing this authority, the Congress was aware
that the public’s exposure to harmful substances re-
sults from a number of sources which may have
varying degrees of susceptibility to control.
Id. It is petitioners’ first claim of error that the Admin-
istrator has erroneously interpreted Section 211(c) (1)
(A) by not sufficiently appreciating the rigor demanded
by Congress in establishing the “will endanger” stand-
ard. Therefore, petitioners argue, the Administrator’s
action is “short of statutory right,” in violation of Sec-
tion 10(e)(2)(C) of the Administrative Procedure Act
(APA), 5 U.S.C. § 706(2)1C) (1970).
Petitioners argue that the “will endanger” standard
requires a high quantum of factual proof, proof of ac-
tual harm rather than of a “significant risk of harm.”
See Supplemental brief of petitioner Ethyl Corporation
; (hereinafter Ethyl Supp. Br.) at 20. Since, according to
petitioners, regulation under Section 211(¢) (1) (A) must
be premised upon factual proof of actual harm, the Ad-
ministrator has, in their view, no power to assess risks
or make policy judgments in deciding to regulate lead
additives. Moreover, petitioners argue, regulation must
be based on the danger presented by lead additives “in
and of themselves,” so it is improper to consider, as the
Administrator did, the cumulative impact of lead addi-
tives on all other sources ef human exposure to lead.
We have considered these arguments with care and find
them to be without merit.’’ It is our view that the
dit Vit Pénntthe%.. die whe Me es see
** At oral argument, petitioners claimed the regulations
were void because the Administrator had failed to couch his
ultimate finding in the language of the statute itself. See also
: Supplemental brief of petitioner National Petroleum Refiners
an - ee einen te
; ITI NE ES me
19
Administrator’s interpretation of the standard is the cor-
rect one.”
1. The Precautionary Nature of “Will Endanger.”
Simply as a matter of plain meaning, we have difficulty
crediting petitioners’ reading of the “will endanger”
Association (hereinafter NPRA Supp. Br.) at 5. The short
answer to the argument is that petitioners’ view of the facts
is erroneous. While interpreting the “will endanger” standard
to mean “presents a significant risk of harm,” 33 FEp. REG.
33734, the Administrator ultimately did make his finding in
the language of the statute:
These regulations are based upon a determination by the
Administrator that the emission product of a fuel or
additive will endanger the public health * * *.
Id. at 33741. See 40 C.F.R. § 80.1 (1974).
In any case, however, the issue is spurious. It is well estab-
lished that ultimate findings do not have to be expressed at
all, let alone be expressed in the language of the statute.
Rather, absent compelling countervailing considerations, an
ultimate finding will be implied from the action taken. Pa-
cific States Bor & Basket Co. v. White, 296 U.S. 176, 186
(1935) ; Martin v. Mott, 25 U.S. (12 Wheat.) 19, 32-33 (1827)
(Story, J.). Cf. Joseph v. FCC, 131 U.S.App.D.C. 207, 211-
212, 404 F.2d 207, 211-212 (1968). The law is fully developed
in 2 K. Davis, ADMINISTRATIVE LAW TREATISE § 16.07 at 455-
59 (1958).
** We note that even if we did not agree fully with the
Administrator’s interpretation of the Act, we would be obliged
to accord it considerable deference. As the Supreme Court
recently held in approving, despite the contrary views of
several circuits, the Administrator’s reading of another sec-
tion of the Clean Air Act:
Without going so far as to hold that the Agency’s con-
struction of the Act was the only one it permissibly
could have adopted, we conclude that it was at the very
least sufficiently reasonable that it should have been
accepted by the reviewing courts.
Train V. Natural Resources Defense Council, Inc., 421 U.S.
60, 75 (1975). See also id. at 87.
my LA in. |
afro eae!
DENCE th aR oN
20
standard. The meaning of “endanger” is not disputed.
Case law and dictionary definition agree that endanger
means something less than actual harm.’ When one is
endangered, harm is threatened; no actual injury need
ever occur. Thus, for example, a town may be “endan-
gered” by a threatening plague or hurricane and yet
emerge from the danger completely unscathed.’* A stat-
** It is linguistically clear, of course, that one can be “en-
dangered” without actually being harmed. Nonetheless, some
risk of harm is necessary. State v. Fine, 324 Mo. 194, 23
S.W.2d 7, 9 (1929). Webster defines “endanger” as “to bring
into danger or peril of probable harm or loss.” WEBSTER’S
THIRD NEW INTERNATIONAL DICTIONARY 748 (1961) (empha-
sis added).
Not all courts have agreed that “probability” of harm is the
proper determinant of danger. Where grounds for divorce
are few, for instance, courts have interpreted laws allowing
divorce because of inhuman treatment that “endangers the
life” to require only the slightest possibility of actual loss of
life. Thus action that endangers health has been held to
endanger life on the theory that the former cannot be en-
dangered without threatening the latter. See Cole v. Cole, 23
Iowa 433, 438 (1867); Beebe v. Beebe, 10 Iowa 133, 139
(1859). In one of the latest of these cases, mistreatment
that deprived a spouse of needed rest and peace of mind was
held to “endanger” life. Smith v. Smith, 258 Iowa 557, .
138 N.W.2d 453, 456 (1966). We need not decide here how
remote the possibility of actual harm could be under the
“will endanger” standard since we accept the Administrator’s
determination in this case that a “significant” risk to health
falls within the statutory language. See pages 31-36 infra.
*s Petitioner Ethyl suggests that while these may indeed be
examples of endangerment they differ from the threat from
automotive lead emissions in that
plagues do cause death and illness; violent storms do
cause damage—known facts that may be experienced by
the threatened community.
Ethyl Supp. Br. at 11 (footnote omitted). We may prelimi-
narily observe that the absorption of lead does cause lead
poisoning, a known fact that may be evaluated by the public
nmi cers Lire AA Eset
21
ute allowing for regulation in the face of danger is, nec-
essarily, a precautionary statute. Regulatory action may
be taken before the threatened harm occurs; indeed, the
very existence of such precautionary legislation would
seem to demand that regulatory action precede, and,
optimally, prevent, the perceived threat. As should be
apparent, the “will endanger” language of Section 211
(ec) (1) (A) makes it such a precautionary statute.
The Administrator read it as such, interpreting “will
endanger” to mean “presents a significant risk of harm.”
38 FED. REG. 33734. We agree with the Administrator’s
interpretation. This conclusion is reached not only by
reference to the plain meaning of the statute, but by
juxtaposition of Section 211(c)(1)(A) with other sec-
tions of the Clean Air Act and by analysis of pertinent
precedent.**
and the EPA. However, in so far as Ethy] is complaining
that the mechanism by which plagues and storms cause
damage is well known while the question of the relation be-
tween lead automobile emissions and the absorption of lead
is less certain, Ethyl’s observation only supports the reading
of §211(c) (1) (A) as a precautionary statute. The massive
diffusion of airborne lead is a gross environmental modi-
fication never before experienced. Of course, there are no
past disasters of the kind anticipated by the Administrator
on which the community’s experience may be based. This,
however, is inherent in such a threat and does not imply that
no danger is posed by it. We believe the precautionary lan-
guage of the Act indicates quite plainly Congress’ intent that
regulation should precede any threatened, albeit unprecedent-
ed, disaster. Ethyl is correct that we have not had the oppor-
tunity to learn from the consequences of an environmental
overdose of lead emissions; Congress, however, sought to
spare us that communal experience by enacting § 211(c)
(1) (A).
** Since Congress seemed to assume that the meaning of
the threshold determination required by § 211(c) (1) (A)
would be self-evident, there is a complete absence of
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:
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4
»
E
YT EIT GE NS IIRL TY gr adr
SPR rey ae reg re
yea e OAT nny:
22
Petitioners support their view of the rigorous nature
of the “will endanger” standard by relying on two other
sections of the Clean Air Act that also allow for regula-
tion of air pollutants for health reasons. Ethyl Supp.
Br. at 18-23; supplemental brief of petitioner Nalco
Chemical Company (hereinafter Nalco Supp. Br.) at
20-25; NPRA Supp. Br. at 31-46. However, we find in the
Same sections relied upon by petitioners firm support for
our view of the precautionary nature of Section 211(c¢)
(1) (A). The provisions identified by petitioners are Sec-
tions 108 and 202 of the Act. Section 108 directs the Ad-
ministrator to list, for the purpose of establishing national
primary and secondary ambient air quality standards
pursuant to Section 109, each air pollutant “which in
his judgment has an adverse effect on public health or
welfare * * *.” Section 108(¢) (1) (A), 42 U.S.C. § 1857
e-3(a)(1)(A). Section 202 authorizes the Administrator
to set standards for each automobile emission “which
in his judgment causes or contributes to, or is likely to
cause or contribute to, air pollution which endangers
the public health or welfare.” Section 202(a) (1), 42
U.S.C. § 1857f-1(a) (1).
Petitioners suggest that the threshold decision to reg-
ulate under both Section 108 and Section 202 can be
based on less evidence than required under Section 211
and that, therefore, the proof necessary for action under
Section 211 must be particularly firm. Petitioners mis-
read both sections. Section 108 requires an actual “ad-
verse effect” on health before an air pollutant may be
listed for regulation; actual harm must result.*? This
helpful legislative history. What little there is of relevance
is discussed at pages 38-43 in fra. See also note 89 infra.
*° Should there be any doubt about this conclusion, it is
quickly resolved by reference to § 109. There Congress
BLEED THROU
23
firm threshold finding is reasonable in light of the con-
siderable disruption caused by action under Sections 108-
110. After a pollutant is listed under Section 108, the
Administrator must issue national ambient air quality
standards under Section 109 within a year. Promulga-
tion of standards begins the implementation plan process
of Section 110 under which the states must control, on
a mandatory timetable, the listed pollutants to the ex-
tent necessary to achieve the federal standards. Sec-
tion 110, 42 U.S.C. § 1857-5. Sections 108-110 are
“technology forcing” provisions; the attainment of the
primary, health-based standards takes precedence over
the cost and present technological feasibility of achieving
the requisite control. Union Electric Co. v. EPA, 515
F.2d 206, 215-16 (8th Cir.), cert. granted, —— USS.
» 44 US. L. WEEK 3200 (Oct. 6, 1975). Cf. Train
v. Natural Resources Defense Council, 421 U.S. 60, 90-
91 (1975). See also S. Rep. No. 91-1196, 91st Cong.,
2d Sess. 1-3 (1970).
Thus, before ordering this extensive chain of action
to begin, Congress demanded a threshold determination
that the pollutant causes actual harm.” In this sense
made it quite clear how it would refer to anything other than
actual harm. Section 109(b) (2) provides that national second-
ary ambient air quality standards for pollutants listed under
§ 108 be prescribed with a margin of safety; they should
be sufficient to protect against “any known or anticipated
adverse effects associated with the presence of such air
pollutant in the ambient air.” 42 U.S.C. § 1857c-4 (b) (2)
(emphasis added). When Congress uses the phrase in § 108
without the modifier “known or anticipated” it plainly
embraces only the usual meaning of adverse effects, i.e., known
adverse effects or actual harm.
*t The Administrator appears to have a measure of discre-
tion in determining whether to list a pollutant under § 108,
which, by its terms, speaks of the exercise of his “judg-
ment.” See 38 FED. REG. 33740 ( 1973). Amicus Natural Re-
sources Defense Council (NRDC) has argued that listing of
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24
Section 108 is not a precautionary statute at all, and so
differs sharply from Section 211. However, the effects
of such after-the-fact regulation are somewhat amelio-
rated by the Act; Congress did provide a precautionary
element in standard-setting under Sections 108-110. Sec-
tion 109 expressly requires that the ambient air stand-
ards ultimately issued provide for “an adequate margin
of safety.” 42 U.S.C. § 1857c-4(b) (1). Thus, while the
threshold decision to regulate under Sections 108-110
is not precautionary but rather requires proof of demon-
strable harm caused by the Suspect pollutant, once the
decision is made the standards promulgated must be
preventive in nature. Congress’ choice of this scheme
is in direct contrast to the procedures it established
under Section 211. Under that section the decision to
regulate is based on perceived danger. Unless we are
; to assume Congress chose its language carelessly, regula-
tion in the face of “danger” rather than in the face of
“adverse effects’ must mean that the threshold decision
to regulate under Section 211 is precautionary.** The
contrast between the standards of Sections 108-110 and
of Section 211 supports our view of the precautionary
nature of the “will endanger” standard.”*
ei ical chi:
air pollutants under § 108 is mandatory. Its petition for
review of these regulations raising that issue was dis-
missed by the division for want of jurisdiction, Natural Re-
sources Defense Council, Inc. v. EPA, No. 74-1023 (D.C. Cir.
September 11, 1974), and NRDC has since brought a success-
ful citizen’s suit under § 304 of the Act, 42 U.S.C. § 1857h-2, to
compel issuance of national ambient air standards for lead.
Natural Resources Defense Council, Inc. Vv. Train, No. 74-
Civ-4617 (S.D.N.Y. decided March 1, 1976).
** Thus we must reject amicus NRDC’s suggestion that the
standards for action under §§ 108 and 211 are the same.
RAS WRG ind da Mat Sand SS 3h OR ia tea
NE ORES IND TONG eee Lela
*® Petitioners’ arguments that the threshold determination
under the “adverse effect” standard is less rigorous than un-
der the “will endanger” standard are either spurious or mis-
Pe a ae ts tile
*
g
:
pene EES LI HN
BLEED THROLI
25
Petitioners also rely on Section 202 to support their
strict reading of Section 211. Ethyl suggests that Section
202 is more lenient than Section 211 in that it allows
regulation of “likely” dangers. Ethyl Supp. Br. at 18-19.
See also Naleo Supp. Br. at 20-21 ; NPRA Supp. Br.
directed. Nalco Chemical Company (Nalco) and Ethyl argue
that the presence of the phrase “in his judgment” in § 108,
and its absence in § 211, means the Administrator has greater
discretionary power under the former section. Ethyl Supp. Br.
at 21; Nalco Supp. Br. at 22. As we shall explain below, see
note 37 infra, the Administrator retains the same (if not
greater, see note 21 supra) discretionary power under § 211.
Nalco points to the “margin of safety” language of § 109
as proof of a “lower standard” under § 108, Nalco Supp. Br.
at 22, without recognizing that the margin of safety refers
only to the implementing requirement of formulating stand-
ards and not to the threshold decision to regulate. NPRA
likewise confuses this point by suggesting that the listing re-
quirement of § 108 is like the reporting requirements of
§ 211(a), so that the “margin of safety” language is com-
parable to § 211 (c) (1) (A), only more generous. NPRA Supp.
Br. at 42-43. This ignores the fact that once a pollutant is
listed under § 108 the decision to regulate is made; standards
under § 109 must follow. On the other hand, additives re-
ported under § 211(a) are not necessarily regulated; regula-
tions are premised only on a § 211(c) (1) (A) finding of en-
dangerment. Thus, as suggested in the text, the threshold
determination under §108 is properly compared to the
threshold determination under § 211(c) (1) (A).
Ethyl argues that an “adverse effect”? does not have as
severe a connotation as “endangerment.” Ethyl Supp. Br. at
19 n.27. Even if true, however, this argument has nothing
to do with whether the threshold determination to regulate
is, or is not, precautionary. Even if § 108 allowed regu-
lation of less severe effects than does § 211, regulations
could still be premised only on a finding of an actual effect,
while § 211 regulations could still be premised on a pre-
cautionary finding of threatened, albeit more severe, harm.
POOR COPY
26
at 31-36. Section 202 provides that the Administrator
may regulate
the emission of any air pollutant [from any new
motor vehicle] which in his judgment causes or con-
tributes to, or is likely to cause or contribute to,
air pollution which endangers the public health or
welfare.
42 U.S.C. §1857f-1(a)(1) (emphasis added). While
this language may be unnecessarily opaque, we think a
fair reading disproves petitioners’ suggestion. The itali-
cized language upon which petitioners rely refers not
to the causal relationship between air pollution and
health, but to the relationship between automobile emis-
sions and air pollution. Thus regulation may not be
premised on a threshold determination of likely danger;
rather regulation must be premised on a détermination
of danger, a finding that “air pollution which endangers
the public health” is the end product of the emission to
be regulated. This is essentially the same finding of
endangerment as under Section 211. “Likely” enters
the equation only in determining whether the emitted
air pollutant, which would be regulated, contributes to
the air pollution which is found dangerous. Here the
statute allows for a somewhat attenuated chain of causa-
tion. Regulation may be premised on a determination
that an air pollutant emitted from a new automobile is
likely to contribute to air pollution which endangers the
public health. In establishing this chain of causation
**In essence, petitioners are suggesting § 202 is more
properly read to provide for regulation of any automotive
emission
which in his judgment causes or contributes to, or is
likely to cause or contribute to, gir pollution which causes
or contributes to, or is likely to cause or contribute to,
the endangerment of the public health or welfare.
Quite obviously, this is not what Congress said.
BLEED THRO!
27
Section 202 is more lenient than Section 211,%* but in
making the threshold determination of danger both sec-
tions are the same:* air pollution must endanger the
public health before regulation is justified.*’
** Section 211 simply skips this chain of causation and re-
quires instead that the emission products of the fuel additive
to be regulated endanger the public health. This omission of
a step does not support petitioners’ “in and of itself” theory,
see pages 56-61 infra, but rather is responsive to the different
intendments of §§ 101 and 211. See note 27 infra. In any
case, it is plain that for regulation under § 211 the emission
products must directly (although not necessarily by them-
selves) endanger the public health; whether they contribute
to air pollution that in turn endangers the public health, as
required by § 202, is irrelevant. Since the Administrator
found that lead emissions directly endanger the public health,
whatever leniency § 202 provides is irrelevant to this case.
Nalco takes issue with the dismissal of this question and
asks sarcastically, “If causation is irrelevant to the regula-
tion of fuel additives, why is EPA concerned about meeting
any standard at all in these regulations.” Nalco Supp. Br.
at 20-21. Nalco is confusing two separate causation issues.
There is undoubtedly a causation issue about whether lead
emissions cause a danger to public health. On the other hand,
however, there is no causation issue about whether lead
emissions contribute to lead air pollution. There is no such
issue, first, because § 211, unlike § 202, does not demand such
a finding and, second, because in any case petitioners could
not, and do not, contest the validity of that assertion. It is
only this issue of causation, to which the “likely” language
of § 202 relates, that EPA argues, and we agree, is irrelevant
to this case. See EPA Supp. Br. at 17-18.
*° Thus while Congress preferred emission regulation un-
der § 202 to fuel content regulation under § 211, see note 14
supra, there is no reason to assume, as NPRA argues, NPRA
Supp. Br. at 31-35, that in situations where § 211 regulation
is proper, the Administrator must find greater potential harm
before acting. Cf. note 23 supra.
**NPRA recognizes that a literal reading of § 202 pro-
duces the result suggested above. Thus it argues that this
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28
Thus the two sections of the Clean Air Act presented
by petitioners in support of their stringent reading of
the threshold requirement for action under Section 211
turn out, upon analysis, to be of no support at all. Sec-
tion 108 only bolsters our reading of Section 211 as a
precautionary statute while Section 202 includes the
same standard as Section 211 and thus is of no guidance
one way or the other. While petitioners have little more
to offer to prove that the “will endanger” standard
demands proof of actual harm and is not precautionary
in nature, we may turn, in support of our interpretation,
to the relevant case law. While cases interpreting the
result is “meaningless, or at best tautological,” NPRA Supp.
Br. at 32, so that its “likely” danger theory emerges as an
acceptable, although linguistically incorrect, alternative. Jd.
at 33. NPRA argues that the above reading would require
the Administrator to determine whether “the emission
of any air pollutant .. . is likely to cause or to contribute
to, air pollution ....”
Id. at 32 (emphasis in original). Since under this reading,
NPRA argues, the Administrator would always reach a posi-
tive conclusion, this reading must be incorrect. We agree that
this reading is of little value, but we do not think it is the
proper result of our analysis above. Rather, we think that
to regulate under § 202 the Administrator must find that
emission of the air pollutant is likely to cause or contribute
to dangerous air pollution. This addition is important,
for not all air pollutants contribute to dangerous air pollution
and, more importantly, not all dangerous air pollution is
caused by air pollutants that are, themselves, dangerous. Thus
hydrocarbons, whose emission is regulated by § 202, are not
themselves always dangerous, but are properly regulated
because they react in sunlight to form smog, which is danger-
ous. See S. Rep. 89-192, 89th Cong., Ist Sess. 5-6 (1965) ;
EPA Supp. Br. at 18 n.15. Thus, far from stating a tautology,
§ 202 allows for tho regulation of such apparently innocent
pollutants, which indirectly cause dangerous pollution.
BLEED THROII
29
meaning of “endanger” are few in number,” at least one
recent case is directly on point and fully in accord
with our view.
In Reserve Mining Co. v. EPA, 514 F.2d 492 (8th
Cir. 1975) (en banc), the Eighth Circuit addressed,
among other issues, the meaning of the phrase “endanger-
ing the health or welfare of persons” under Section 1160
of the Federal Water Pollution Control Act of 1970
(FWPCA), 33 U.S.C. § 1160. FWPCA and the Clean
Air Act together constitute the bulk of this nation’s
substantive environmental protection legislation.** As
** See note 17 supra. See also Environmental Defense
Fund, Inc. v. EPA, 150 U.S.App.D.C. 348, 465 F.2d 528
(1972), where in interpreting the more rigorous statutory
language “imminent hazard” which must be found before the
registration for a pesticide may be suspended pending the
conclusion of cancellation proceedings, 7 U.S.C. § 136d (c)
(Supp. II 1972), we concluded, per Judge Leventhal:
It is enough if there is substantial likelihood that seri-
ous harm will be experienced during the year or two
required in any realistic projection of the administrative
process.
Id. at 360, 465 F.2d at 540 (emphasis added).
In another case interpreting the standards for cancellation
of a pesticide under the same statute, we held, per Judge
Wilkey, that a showing of “potentially great dangers from
DDT” sufficed as a basis for cancellation. Environmental De-
fense Fund, Inc. v. EPA (Coahoma), 160 U.S.App.D.C. 123,
128, 489 F.2d 1247, 1252 (1973).
** Cf. Environmental Education Act, 20 U.S.C. § 1531 et
seq.; Environmental Quality Improvement Act of 1970, 42
U.S.C. § 4371 et seq.; National Environmental Policy Act of
1969 (NEPA), 42 U.S.C. § 4321 et seg. While initially the
procedural requirements of NEPA consumed judicial en-
ergies most conspiciously, see, e.g., Natural Resources Defense
Council v. Morton, 148 U.S.App.D.C. 5, 458 F.2d 827 (1972);
Calvert Cliffs’ Coordinating Committee, Inc. v. AEC, 146
U.S.App.D.C. 33, 449 F.2d 1109 (1971), courts are increas-
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such, and because of their contemporaneous enactment,
interpretations of provisions of one Act have frequently
been applied to comparable provisions of the other. See,
e.g., Natural Resources Defense Council, Inc. vy. Train,
166 U.S.App.D.C. 312, 321-322, 510 F.2d 692, 701-702
(1975). Thus Reserve Mining’s interpretation of “en-
dangering” is relevant to the meaning of the term “en-
danger” in the Clean Air Act. Indeed, it is particularly
relevant because in construing the language before it the
provision, comparison with other sections of that Act,
and reference to our division’s dissent, the Eighth
Circuit’s unanimous conclusion fully supports our view
of the “will endanger” standard:
In the context of this environmental legislation, we
believe that Congress used the term “endangering”
in a precautionary or preventive sense, and, there-
fore, evidence of potential harm as well as actual
harm comes within the purview of that term.
Id. at 528.
In sum, based on the plain meaning of the statute, the
juxtaposition of Section 211 with Sections 108 and 202,
and the Reserve Mining precedent, we conclude that the
“will endanger” standard is precautionary in nature and
ingly according substantive weight to the NEPA language.
See Sierra Club vy. Morton, U.S.App.D.C. ,
31
does not require proof of actual harm before regulation
is appropriate.”
Perhaps because it realized that the above interpreta-
tion was the only possible reading of the statutory
language, petitioner Ethyl addresses this interpretation
and argues that even if actual harm is not required for
action under Section 211(c)(1)(A), the occurrence of
the threatened harm must be “probable” before regula-
tion is justified. Ethyl Supp. Br. 12. While the diction-
ary admittedly settles on “probable” as its measure of
danger,” we believe a more sophisticated case-by-case
analysis is appropriate. See note 17 supra. Danger, the
Administrator recognized, is set not by a fixed probability
of harm, but rather is composed of reciprocal elements
of risk and harm, or probability and severity. Cf.
Carolina Environmental Study Group v. United States,
166 U.S.App.D.C. 416, 419, 510 F.2d 796, 799 ( 1975) ;
Reserve Mining Co. v. EPA, supra, 514 F.2d at 519-520.
That is to say, the public health may properly be found
endangered both by a lesser risk of a greater harm and
by a greater risk of a lesser harm.” Danger depends
* See Green, The Risk-Benefit Calculus in Safety Deter-
minations, 43 Geo. WaSH. L. REV. 791 (1975); Handler, A
Rebuttal: The Need for a Sufficient Scientific Base for Gov-
ernment Regulation, id. at 808. Both authors agree that
government safety determinations should be preventive and
based on assessment of risks. Dr. Handler differs from Pro-
fessor Green in arguing that risks should be quantified be-
fore regulatory decistons are made. Professor Green believes
that quantification is not always necessary or possible, and
that the public health is better served by the making of value
judgments, however inexact.
" See note 17 supra.
“ This proposition must be confined to reasonable limits,
however. In Carolina Environmental Study Group v. United
States, 166 U.S.App.D.C. 416, 510 F.2d 796 (1975), a division
of this court found the possibility of a Class 9 nuclear reactor
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upon the relation between the risk and harm presented
by each case, and cannot legitimately be pegged to “prob-
able” harm, regardless of whether that harm be great
or small. As the Eighth Circuit found in Reserve Min-
ing, these concepts “necessarily must apply in a de-
termination of whether any relief should be given in
cases of this kind in which proof with certainty is im-
possible.” * 514 F.2d at 520.
disaster, a disaster of ultimate severity and horrible conse-
quences, to be so low that the Atomic Energy Commission’s
minimal consideration of the effects of such a disaster in an
environmental impact statement prepared for a new reactor
was sufficient. Likewise, even the absolute certainty of de
minimis harm might not justify government action. Under
§ 211 the threatened harm must be sufficiently significant
to justify health-based regulation of national impact. Ulti-
mately, of course, whether a particular combination of slight
risk and great harm, or great risk and slight harm, consti-
tutes a danger must depend on the facts of each case.
* Naleo devotes several pages of its brief to arguing that
there is a distinction between “risk” and “danger” that EPA
fails to recognize. Nalco Supp. Br. at 9-11, citing Reserve
Mining Co. v. EPA, supra note 13, and Power Reactor Devrel-
opment Co. Vv. International Union of Electricians, 367 U.S.
396 (1961). To the extent Nalco argues that risk and danger
are not synonymous, Nalco battles with a straw man. EPA
recognizes that a risk to public health is not necessarily a
danger to public health; it only argues that a significant risk
of widespread lead poisoning constitutes such a danger. To
the extent Nalco argues there is no element of risk in danger,
it is plainly wrong, as the cases it cites demonstrate. In sup-
port of its position, Nalco quotes the following language from
Reserve Mining, in which the en banc court compares its
present opinion with the “stay” opinion of a division of the
court, Reserve Mining Co. v. United States, 498 F.2d 1073
(8th Cir. 1974), in which the division stayed the District
Court’s injunction ordering the immediate closing of the Re-
serve Mining plant:
As will be evident from the discussion that follows, we
adhere to our preliminary assessment that the evidence
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In Reserve Mining the issue was whether asbestiform
wastes flushed into Lake Superior by the Reserve Min-
ing Company endangered health.“ The polluted lake
is insufficient to support the kind of demonstrable dan-
ger to the public health that would justify the immediate
closing of Reserve’s operations. We now address the
basic question of whether the discharges pose any risk
to the public health, and, if so, whether the risk is one
that is legally cognizable.
514 F.2d at 507. The Eighth Circuit is not drawing a sharp
line between “danger” and “risk,” but is only contrasting
degrees of danger. Nalco fails to note that the “legally cog-
nizable” risk ultimately found was that Reserve’s discharges
were “endangering” the public health within the meaning of
the Federal Water Pollution Control Act. See page 34
infra. Necessarily, “risk” is an element of “danger,” and the
Reserve Mining court explicitly recognized that fact. 514
F.2d at 520.
The Power Reactor case is likewise of no support to Nalco.
There the Supreme Court simply recognized that when regu-
lations juxtaposed, and ordered, findings of “undue risk” and
“endanger,” an “undue risk” was not intended to mean “en-
danger.” The Court did not say that risk was not an element
of danger, only that in the regulations before it an “undue”
risk was not necessarily a sufficient risk to constitute a “dan-
ger.”
“ Reserve Mining involved issues not only under FWPCA,
but under § 407 of the Rivers and Harbors Act of 1899, 33
U.S.C. § 401 ef seq., the federal common law of public nui-
sance, and various Minnesota air and water pollution laws,
Minn. Stat. Ann. § 116.081(1) : id. $ 115.07(1) ; id. § 105.41.
Finding the evidence of danger posed by Reserve Mining’s
waste emissions into the air more compelling than that of
the danger posed by the water emissions (since a correlation
between inhalation, but not ingestion, of asbestos fibers and
cancer could be found), the Eighth Circuit found the con-
tinued air emissions to be in violation of various Minnesota
regulations and ordered Reserve to “promptly take all steps
necessary to comply” with the law. Reserve Mining Co. v.
EPA, supra note 13, 514 F.2d at 538. With respect to the
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waters formed the drinking supply of several surround-
ing communities, while a medical theory, bolstered only
by inconclusive evidence, suggested that ingestion of the
wastes caused cancer. See pages 93-94 infra. Applying
the “endangering the health or welfare of persons” stand-
ard of the FWPCA, the court found the wastes to be a
danger cognizable under the Act. The court did not
find that the danger was probable; rather it found the
wastes to be “potentially harmful,” 514 F.2d at 528, and
potential harm to be embraced by the “endangering”
standard, id. See page 30 supra. The court concluded:
The record shows that Reserve is discharging a
substance into Lake Superior waters which under
an acceptable but unproved medical theory may be
considered as carcinogenic, As previously discussed,
this discharge gives rise to a reasonable medical
concern over the public health. We sustain the dis-
trict court’s determination that Reserve's discharge
into Lake Superior constitutes pollution of waters
“endangering the health or welfare of persons”
within the terms of §§ 1160(c) (5) and (g)(1) of
the Federal Water Pollution Control Act and is
subject to abatement.
514 F.2d at 529 (footnote omitted) (emphasis added).
The court thus allowed regulation of the effluent on only
a “reasonable” or “potential” showing of danger, hardly
the “probable” finding urged by Ethyl as the proper
reading of the “endanger” language in Section 211.
water pollution, as described in the text, the court found the
probabilities of danger to be
low for they do not rest on a history of past health
harm attributable to ingestion but on a medical theory
implicating the ingestion of asbestos fibers as a causa-
tive factor in increasing the rates of gastrointestinal
cancer among asbestos workers.
Id. at 536 (emphasis added). Thus the court only ordered
cessation of dumping within a “reasonable time.” Jd. at 538.
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The reason this relatively slight showing of probability
of risk justified regulation is clear: the harm to be
avoided, cancer, was particularly great. However, be-
cause the risk was somewhat remote, the court did not
order the immediate cessation of asbestiform dumping,
but rather ordered such cessation within “a reasonable
time.” Jd. at 538.
Reserve Mining convincingly demonstrates that the
magnitude of risk sufficient to justify regulation is in-
versely proportional to the harm to be avoided. Cf.
Carolina Environmental Study Group v. United States,
supra. It would be a bizarre exercise in balancing
horrors to determine whether cancer or lead poisoning
is a greater harm to be avoided,** but fortunately such
balancing is unnecessary in this case. Undoubtedly, the
harm caused by lead poisoning is severe; nonetheless,
the Administrator does not rely on a “potential” risk
or a “reasonable medical concern” to justify the regula-
* Petitioners properly point out that, unlike lead, there is
no known safe human exposure level for carcinogens. Nalco
Supp. Br. at 9; Ethy! Supp. Br. at 29. See The Society of the
Plastic Industry, Inc. v. OSHA, 509 F.2d 1301, 1307 (2d Cir.),
cert. denied, 421 U.S. 992 ( 1975) ; Industrial Union Depart-
ment, AFL-CIO v. Hodgson, 162 U.S.App.D.C. 331, 499 F.2d
467 (1974). This does not, however, imply that the harm
caused by lead poisoning is less significant than that caused
by cancer, only that safe human exposure levels to the causes
of the two diseases may differ. This the Administrator recog-
nized. Unlike the actions of the Secretary of Labor in the
above cited cases, he did not order the lead content of gaso-
line reduced to the lowest detectable levels, but rather directed
a phased cutback to what he deemed a safe level.
In any case, however, even if cancer is considered more
serious than lead poisoning, the Administrator acted based on
an assessment that the risk of lead poisoning from automobile
emissions was considerably greater than the cancer risk that
motivated the Reserve Mining court. Thus this greater risk
of an arguably lesser harm still constitutes endangerment.
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36
tions before us. Instead, he finds a “significant” risk
of harm to health. While this finding may be less than
the “probable” standard urged by Ethyl, it is con-
siderably more certain than the risk that justified regu-
lation in Reserve Mining of a comparably “fright-laden”
harm. Cf. Environmental Defense Fund, Inc. v. EPA,
150 U.S.App.D.C. 348, 358, 465 F.2d 528, 538 (1972).
Moreover, like the Reserve Mining court, in the face of
this still less than certain risk the Administrator did not
order the cessation of use of lead additives, but rather
directed a phased step-down to a plateau level. Thus we
conclude that however far the parameters of risk and
harm inherent in the “will endanger” standard might
reach in an appropriate case, they certainly present a
“danger” that can be regulated when the harm to be
avoided is widespread lead poisoning and the risk of that
occurrence is “significant.” “
* This conclusion that a “significant risk of harm” states
a sufficient probability of occurrence to fall within the “will
endanger” standard is bolstered by the fact that Congress
did not employ various modifiers frequently used (in the
Clean Air Act and elsewhere) to mandate more certain en-
dangerment. Thus Congress did not require that the lead
emissions “clearly endanger” the public health, cf. 21 U.S.C.
§ 454(c); id. § 661(c): 50 U.S.C. § 1517, or that the emis-
sions pose an “imminent and substantial endangerment” to
the public health, cf. 33 U.S.C. § 1364 (Supp. 1974); 42
U.S.C. §300i(a); id. § 1851¢-10(b); id. § 1857c-7(c) (1).
See Reserve Mining Co. v. EPA, supra note 13, 514 F.2d at
528. We find these omissions more significant than the use
of the modifier “will,” which Ethyl argues adds “a particular
degree of certainty to the probability that must be shown.”
Ethyl Supp. Br. at 12. To the contrary, “will” only makes
it clear that the standard is one of danger and nothing less,
a conclusion with which we agree.
Whether the evidence relied upon by the Administrator is
sufficient to support his finding of a “significant risk of harm”
is discussed below at pp. 66-97 infra.
RPIEFEnN rwpeo}:
37
2. The Administrator’s Power to Assess Risks. Pe-
titioners argue that Section 211 requires the Adminis-
trator to make a “threshold factual determination” that
automobile emissions “will endanger” the public health,
Nalco Supp. Br. at 15-20; Ethyl Supp. Br. at 24-26,
and dispute EPA’s claim that the Administrator may
make “an essentially legislative policy judgment, rather
than a factual determination, concerning the relative
risks of underprotection as compared to overprotection.”
Industrial Union Department, AFL-CIO v. Hodgson,
162 U.S.App.D.C. 331, 339, 499 F.2d 467, 475 (1974).
We must reject petitioners’ argument, since the power
to assess risks, without relying solely on facts, flows
inexorably from the nature of the “will danger” stand-
ard. We have already found that Section 211 allows
the Administrator to regulate fuel content when he finds
that emissions cause a significant risk of harm to the
public health. Yet, how can the Administrator deter-
mine that a risk is a significant risk if he cannot
assess risks? And how can he assess risks if he can-
not make policy judgments? Surely reliance on “facts”
as contemplated by petitioners will provide little guid-
ance. However, sole reliance on facts was not demanded
by Congress.*"
** Besides the arguments discussed below, petitioners sup-
port their claim that a “factual” not judgmental decision is
required by pointing to the absence in § 211 of a phrase ex-
pressly allowing the Administrator to use his “judgment,” in
contrast to the presence of such a phrase in $$ 108 and 202.
Nalco Supp. Br. at 21-22; Ethy] Supp. Br. at 21-22. The argu-
ment ignores an important difference between the cited sec-
tions and § 211. Sections 108 and 202 are mandatory in their
terms; under both sections the Administrator “shall” reru-
late if “in his judgment” the pollutants warrant regulation.
Because of the mandatory nature of the provisions, express
prevision for administrative discretion via the “judgment”
phrase is necessary. By contrast, §211 is permissive: the
Administrator “may” regulate if emissions “will endanger”
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38
Originally, it is true, it appeared that Congress would
severely restrict the Administrator’s ability to assess
risks and make policy judgments to protect public health.
The bill sent to the floor of the House, and eventually
passed by the House, would have allowed EPA to con-
trol fuels or fuel additives only if the determination that
their emission products would endanger the public health
were established
on the basis of specific findings derived from rele-
vant medical and scientific evidence, including * * *
a finding that it is not otherwise technologically or
economically feasible to achieve the emission stand-
ards established pursuant to section 202 of this Act.
H.R, 17255, 91st Cong., 2d Sess. § 210(g)(1) (1970)
(emphasis added). The specific findings requirement had
more than procedural significance. It limited the scope
of evidence on which the Administrator could proceed,
made alternative action under Section 202 mandatory
if possible, and was widely interpreted in the House, as
the extracts of debate relied upon by petitioners show,
Ethyl Supp. Br. at 24; NPRA Supp. Br. at 30; Nalco
Supp. Br. at 15, as requiring that any EPA action be
the public health. Since discretion is provided in the directive
to the Administrator, the safety valve of a “judgment” phrase
is unnecessary. On the other hand, since we find the exercise
of judgment to be implicit in a determination of “danger,”
there is no need for an express statement of that power and
no reason to ascribe significance to the omission of the phrase.
The irrelevancy of the omission is shown by the Amoco
decision, where the court construed § 211(c) (1) (B), which,
like its sister section at issue here, does not contain the phrase
“in his judgment.” Nonetheless, the court recognized the Ad-
ministrator must, necessarily, have the power to assess risks
and make policy decisions under that section whenever the
determinations called for are judgmental. Amoco Oil Co. V.
EPA, supra note 2, 163 U.S.App.D.C. at 180-181, 501 F.2d
at 740-741, quoted in text at pp. 43-44 infra.
39
based solely on facts.** See also H.R. Rep. No. 91-1146,
91st Cong., 2d Sess., at 13 (1970).
** Petitioner Nalco argues that if the specific requirement,
and its subsequent deletion, have substantive effect at all,
that effect relates not to the threshold decision to regulate,
but to the subsequent implementing decisions about how to
regulate. Nalco Supp. Br. at 17-20. It is true that a literal
reading of the House version, proposed § 210(g) (1), sug-
gests that specific findings are required in setting “stand-
ards” for fuel additives rather than for the threshold deci-
sion to regulate. Nonetheless, it is doubtful that the language
was intended to exempt the threshold decision to regulate
from the specific findings requirement, and equally doubtful
that a court would ever have so interpreted it. First, as a
practical matter it is questionable whether specific findings
on “standard” setting could be made without a specific find-
ing as to danger. The threshold finding would seem to be a
prerequisite to any subsequent specific findings. Second, the
legislative history makes it clear that the House intended the
specific findings requirement to apply to the threshold regu-
latory decision. In presenting the proposed bill to that cham-
ber Rep. Staggers, chairman of the committee that drafted
the bill, was confronted with questions about the basis on
which the Administrator could regulate fuel additives. Rep.
Staggers responded that the Administrator could regulate
only “[i]f he has the facts, and he has proven this by facts,
that they are a danger and poisonous * * *.” 116 CoNnG. REC.
19229 (1970). To confirm that regulation could proceed only
upon a threshold factual determination of danger, Rep. Stag-
gers then quoted the specific findings provision that Nalco
now argues is inapplicable to this question. Jd. at 19230.
Likewise, Rep. Rogers, a member of Rep. Staggers’ commit-
tee, made clear that the threshold determination—that the
gasoline additive endangers health—must be made on the
basis of facts and findings. Jd. at 19231. These are the only
specific comments on proposed § 210(g)(1), and as they
are made by knowledgeable committee members the legisla-
tive history is clear that specific findings were intended for
the threshold decision to regulate.
This conclusion is bolstered by § 211(c)(1)(B) and its
interpretation by the Amoco court. Section 211(c) (1) (B),
unlike § 211(c) (1) (A), retains the finding requirement and
ee ee ee
40
But the House bill did not become law. The Senate’s
preference for less restriction of EPA freedom in regu-
lating fuel additives for health reasons*’ was adopted
the requirement is phrased as ambiguously as the specific
findings requirement in the House version of § 211(c) (1)
(A). The Amoco court recognized that a literal reading of
this findings requirement (which it termed “awkwardly
drafted,” Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.
D.C. at 179, 501 F.2d at 739), would produce an anomalous
result, just as the literal reading now urged by Nalco of the
deleted findings requirement would produce an anomalous
result. “Thus in a literal sense the provision requires ‘find-
ings with respect to’ the actual items of data which the Ad-
ministrator must ‘consider.’” Jd., 163 U.S.App.D.C. at 176,
501 F.2d at 736 (emphasis in original). The court rejected
this literal, nonsensical, reading and instead read the statute
to require a threshold factual finding that regulation was
necessary under § 211(c)(1)(B). Jd., 168 U.S.App.D.C. at
176-178, 501 F.2d at 736-738.
Based on the legislative history of the House proposed
§ 210(g) and the Amoco precedent relating to the parallel
section, it is clear that had the proposed specific findings re-
quirement been enacted into law, it would have been inter-
preted, as suggested in the text, as requiring a specific fac-
tual finding for the threshold decision to regulate, and not
necessarily specific findings for all the subsequent implement-
ing decisions.
*° The original Senate version of the bill provided:
The Secretary may from time to time on the basis of in-
formation obtained under subsection (b) of this section
[which required fuel manufacturers to furnish various
information to the Secretary] or other information avail-
able to him, by regulation control or prohibit the intro-
duction into commerce of any fuel or fuels for use in
vehicle engines if the combustion or evaporation of such
fuel produces emissions which endanger the public
health or welfare * * *,
S. 4358, § 212(c) (1), 91st Cong., 2d Sess. (1970). The Sen-
ate bill drew a distinction between regulation on public health
and public welfare grounds and required that regulation for
the latter reason be preceded by public hearings. Jd. § 212
(c) (2). With minor verbal changes and deletion of the
41
by the conference committee and ultimately enacted into
law.*® Although the legislative history does not expressly
health-welfare dichotomy the Senate version became § 211
(c) (1).
Petitioners argue that the Senate as well as the House con-
templated a factual threshold determination. Nalco Supp.
Br. at 15-16; Ethyl Supp. Br. at 24-26; NPRA Supp. Br. at
30. Their arguments are without merit. While the House
debate contains several references to the need for such a de-
termination, always coupled with discussion of the “specific
findings” requirement, see notes 38 supra and 40 infra, peti-
tioners can point to no express reference in the Senate pro-
ceedings to the need for a factual threshold finding. Instead
they identify discussions of danger and suggest that these
somehow imply that the assessment of danger be factually
based. The implication is nonsensical; the cited discussions
do no more than reiterate the language of the statute, which
does not in terms require a factual finding. See S. Rep. No.
91-1196, 91st Cong., 2d Sess. 117 (1970) (“if the combustion
or evaporation of such fuel produces emissions which en-
danger the public health or welfare’’) ; id. at 33-34 (“emis-
sion that is a direct endangerment to the public health’)
(see notes 25 & 36 supra); 116 CoNG. REC. 32921 (1970)
(statement of Sen. Baker) (“emissions that, in and of them-
selves, endanger the public health or welfare”) (see page 58
infra). When compared with the explicit House discussion
of the need for a factual finding, these statements only show
that the Senate intended no such thing. Ethy] also cites this
excerpt from the Senate Report:
“The [Administrator] may prohibit the use of any fuel
in commerce which may provide emissions that, he finds,
would endanger the public health.” Sen. Rep. No. 91-
1196, 91st Cong., 2d Sess. 64 (1970).
Ethyl Supp. Br. at 25 (emphasis in original). Since the Senate
bill explicitly deleted the finding requirement for action un-
der § 211(c) (1) (A), this language can hardly be taken as
supporting its sub silentio inclusion. If anything, the lan-
guage, which uses “finds” in its colloquial, not legal, sense,
only demonstrates the judgmental nature of the Administra-
tor’s decision. See note 37 supra.
* For this reason, statements made in the House about the
bill should be used only with great care in any attempt to
42
discuss the reasons for the change,’ the contrast in lan-
guage is stark. As Section 211 now reads, the only
“finding” the Administrator is required to make is that
any fuel additive that might replace one that is pro-
hibited does not cause emissions that will pose the same
or greater danger to the public health.*? The substantive
assess legislative intent. House discussion centered on a
significantly more rigorous bill, and statements such as those
offered by petitioners from the House debate prove only the
effect of the ultimate deletion of the “specific findings” re-
quirement. See Ethyl Supp. Br. at 24; Nalco Supp. Br. at
15; NPRA Supp. Br. at 30. Rep. Staggers’ statement, for
instance, directly relates the need for a factual threshold
determination to the “specific findings” requirement. As
such, it is strong support for the conclusion that deletion of
the requirement was intended to do away with such a rigor-
ous threshold requirement. See note 38 supra,
AS Se
* Neither the House managers’ conference report nor the
summary of the conference agreement prepared for the Sen-
ate address directly the effect of the changes here at issue.
See Conference Agreement on the Clean Air Amendments of
1970, H.R. Rep. No. 91-1783, 91st Cong., 2d Sess. 52-53
(1970) ; Summary of the Provisions of Conference Agreement
on the Clean Air Amendments of 1970, 116 CoNG. REC. 42384,
42385-42386 (1970). The most relevant discussion, which is
only oblique, is in the Senate conference report, where the
need for flexibility in applying § 211 is made clear:
[T]he conference committee wishes to call the attention
of the Administrator to the broad environmental, esthe-
tic and health considerations underlying the enactment
of this legislation which should be kept in mind in mak-
ing these determinations [to control or prohibit a fuel
or fuel additive].
116 CONG. REC. 42386 (1970). See Amoco Oil Co. v. EPA,
supra note 2, 163 U.S.App.D.C. at 173-174, 501 F.2d at 733-
734. In the absence of legislative history discussing the
change, we must rely on the language of the present law and
its contrast to the rejected House version.
** Section 211(c) (2) (C), 42 U.S.C. § 1857f-6c (c) (2) (C),
quoted in text at p. 64 infra.
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43
impact of the change is clear. All of the requirements
for specific findings quoted above are replaced by re-
quirements that the Administrator “consider” the speci-
fied evidence. The mandatory deference to Section 202
is removed.** And the Administrator may act based on
all information available to him.** As we recognized in
Amoco, construing a similar change in parallel Section
211(c) (1) (B), the conference committee’s decision “was
a deliberated one and was meant to have significance.”
Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 173,
501 F.2d at 733.
In this case the decision has even more significance
than it did in Amoco, for under Section 211(c) (1) (B),
at issue in Amoco, the Administrator was still required
to make “findings.” All the conferees dropped was the
adjective “specific.” For regulation under Section 211
(c)(1)(A), at issue here, however, the entire require-
ment was dropped, and no greater restriction was placed
on the Administrator than that required by the “basis
and purpose” statement of Section 4(b) of the APA, 5
U.S.C. §553(c). We interpreted the meaning of the
limited findings requirement for acting under Section
211(c) (1) (B) in Amoco:
[W]e read Section 211(c)(2)(B) as incorporating
the commonsense approach which the courts have
*3 See note 14 supra.
**The House bill required the Administrator to act only
on the basis of the required specific findings. The Senate and
final bill allows him to act on the basis of information ob-
tained under § 211(b), which requires fuel and fuel additive
manufacturers to furnish the Administrator with information
about their products’ content and, at his request, to conduct
various tests on the compounds and furnish him with descrip-
tions of testing techniques. The Administrator is also free
to act on the basis of any “other information available to
him,” § 211(c) (1) (emphasis added), thus making the basis
for action under § 211(c) (1) (A) unlimited.
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developed in applying Section 4(b)'**! of the APA.
Where EPA’s regulations turn crucially on factual
issues, we will demand sufficient attention to these
in the statement to allow the fundamental ration-
ality of the regulations to be ascertained. Where,
by contrast, the regulations turn on choices of pol-
icy, On an assessment of risks, or on predictions
dealing with matters on the frontiers of scientific
knowledge, we will demand adequate reasons and
explanations, but not “findings” of the sort familiar
from the world of adjudication.
Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 180-
181, 501 F.2d at 740-741 (emphasis added). Thus the
Amoco court read the limited findings necessary for ac-
tion under Section 211(c)(1)(B) as a flexible require-
ment that demanded actual findings for questions of fact
and something less—‘adequate reasons and explanations”
—for questions of policy.
As petitioners correctly point out, the Amoco court
applied this approach by holding that the threshold
determination whether to regulate at all under Section
211(c)(1)(B) was essentially a question of fact, for
which a factual finding must be offered. In su gesting
that such a finding is necessary for action urfder Sec-
tion 211(c)(1)(A) as well, however, petitioners ¢om-
pletely ignore the fact that a finding is required for
action under Section 211(¢)(1)(B) and is not required
under Section 211(¢c)(1)(A). By so glossing over the
language of the statute, petitioners miss a vital differ-
ence between the threshold determinations under Sec-
tions 211(c)(1)(A) and (B). Recall what the Ad-
ministrator must find in order to act under Section 211
“ The opinion refers to § 4(c), but § 4(b), which requires
the agency to “incorporate in the rules adopted a concise
statement of their basis and purpose,” was obviously intended.
See § 4 of the APA, 60 Stat. 239 (1946), 5 U.S.C. § 553.
taeiiieiaitgisaliie an
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45
(c)(1)'B): that the emission products of the fuel or
additive to be regulated
will impair to a significant degree the performance
of any emission control device or system which is
in general use, or which the Administrator finds
has been developed to a point where in a reasonable
time it would be in general use were such regula-
tion to be promulgated.
42 U.S.C. § 1857f-6e(c) (1)(B). At its core, this is a
peculiarly factual finding. Will the emission impair
the performance of a control device? Is the device
in general use, or has it the potential to be? These
were the questions, highly suitable to factual proof, that
the Amoco court construed. Contrary to petitioners’
implication, the court did not hold that any threshold
determination to regulate must be based on factual
proof, but that this threshold determination must be
factually based. The Section 211(c)(1)(A) threshold
determination, however, is inherently unlike that of its
sister section. “Endanger,” as we have suggested above,
is not a standard prone to factual proof alone. Danger
is a risk, and so must be decided by assessment of risks
as well as by proof of facts.
Thus a reason emerges for the deletion of the findings
requirement for action under the “will endanger” stand-
ard. The Amoco court held the findings requirement of
Section 211‘¢)(1)(B) no more than reiterated the mini-
mal demands of the basis and purpose statement of the
APA. Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C.
at 179, 501 F.2d at 739. What Congress was doing,
then, was using the findings requirement to indicate
which section demanded a factual threshold determina-
tion and which section did not. While inclusion of the
phrase was unnecessary in that the APA would have
demanded a factual threshold determination under Sec-
tion 211(¢c)(1)(B) in any case, the selective use of the
a
POOR COPY
46
findings requirement served to emphasize to the Ad-
ministrator the demands of the APA and the intent of
the Congress. While Congress did not discuss the extent
of the Administrator’s power under the “will endanger”
standard, its actions—the statute it enacted and the one
it rejected—make the legislative intent clear. We find
that deletion of the findings requirement for action
under Section 211(c) (1) (A) was a recognition by Con-
gress that a determination of endangerment to public
health is necessarily a question of policy that is to be
based on an assessment of risks and that should not be
bound by either the procedural or the substantive rigor
proper for questions of fact.
This conclusion follows not only from the language
of Section 211(c)(1)(A) and its legislative history,
but from the nature of the Administrator’s charge:
to protect the public from danger. Regulators such as
the Administrator must be accorded flexibility, a flexi-
bility that recognizes the special judicial interest in
favor of protection of the health and welfare of people,
even in areas where certainty does not exist. Environ-
mental Defense Fund, Inc. v. Ruckelshaus, 142 US.
App.D.C. 74, 88, 439 F.2d 584, 598 (1971).
Questions involving the environment are particularly
prone to uncertainty. Technological man has altered
his world in ways never before experienced or antici-
pated. The health effects of such alterations are often
unknown, sometimes unknowable. While a concerned
Congress has passed legislation providing for protection
of the public health against gross environmental modifi-
cations,“ the regulators entrusted with the enforcement
“Clean Air Act, 42 U.S.C. § 1857 et seq.; Federal Water
Pollution Control Act, 33 U.S.C. § 1151 et seq.; Federal In-
secticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 135
et seq.
BLEED THROUGH
47
of such laws have not thereby been endowed with a
prescience that removes all doubt from their decision-
making. Rather, speculation, conflicts in evidence, and
theoretical extrapolation typify their every action. How
else can they act, given a mandate to protect the public
health but only a slight or nonexistent data base upon
which to draw? Never before have massive quantities
of asbestiform tailings been spewed into the water we
drink. Never before have our industrial workers been
occupationally exposed to vinyl chloride * or to asbestos
dust.** Never before has the food we eat been permeated
with DDT * or the pesticides aldrin and dieldrin.’ And
never before have hundreds of thousands of tons of
lead emissions been disgorged annually into the air we
breathe. Sometimes, of course, relatively certain proof
of danger or harm from such modifications can be
readily found. But, more commonly, “reasonable medi-
cal concerns” and theory long precede certainty. Yet the
statutes—and common sense—demand regulatory action
to prevent harm, even if the regulator is less than
certain that harm is otherwise inevitable.
Undoubtedly, certainty is the scientific ideal—to the
extent that even science can be certain of its truth.”
But certainty in the complexities of environmental medi-
cine may be achievable only after the fact, when scientists
*“* Reserve Mining Co. Vv. EPA, supra note 13.
“ The Society of the Plastics Industry, Inc. v. OSHA, su-
pra note 35.
* Industrial Union Department, AFL-CIO v. Hodgson,
supra note 35.
* Environmental Defense Fund, Inc. v. EPA (Coahoma),
supra note 28.
“ Environmental Defense Fund, Inc. v. EPA (Shell), 167
U.S.App.D.C. 71, 510 F.2d 1292 (1975).
= Even scientific “facts” are not certain, but only theories
with high probabilities of validity. Scientists typically speak
not of certainty, but of probability; they are trained to act
2 ORD EN MER Ey * (OPE AR 0 1 gen Har ae
Fee Pe GP Sy eT
a Batak ois aly
48
have the opportunity for leisurely and isolated scrutiny
of an entire mechanism. Awaiting certainty will often
allow for only reactive, not preventive, regulation.” Pe-
titioners suggest that anything less than certainty, that
any speculation, is irresponsible. But when statutes seek
to avoid environmental catastrophe, can preventive, albeit
uncertain, decisions legitimately be so labeled?
The problems faced by EPA in deciding whether lead
automotive emissions pose a threat to the public health
on probabilities that statistically constitute “certainties.” See
generally T. KUHN, THE STRUCTURE OF SCIENTIFIC REVOLU-
TIONS. While awaiting such statistical certainty may consti-
tute the typical mode of scientific behavior, its appropriate-
ness is questionable in environmental medicine, where regu-
lators seek to prevent harm that often cannot be labeled “cer-
tain” until after it occurs. See note 58 infra.
The uncertainty of scientific fact parallels the uncertainty
of all fact. Ina metaphysical sense, at least, facts are them-
selves nothing more than risks, or statistical probabilities.
See D. HUME, A TREATISE OF HUMAN NATURE, bk. I, pt. III,
§ 6, at 87 (L.A. Selby-Bigge ed. 1958).
** Thus this court, per Judge Wilkey, affirmed EPA’s gen-
eral ban on the use of DDT even though the evidence was
considerably less than certain:
[T]here is a great mass of often inconsistent evidence
which was developed at the hearing; this evidence is
substantial enough to support the conclusions of the Ad-
ministrator, although it possibly might support contrary
conclusions as well. Considering the evidence as a whole,
we cannot say that the Administrator’s decision was not
based on substantial evidence, even if the hazardous
nature of DDT has not been proved beyond a reasonable
doubt. Sufficient evidence has been adduced to show
potentially great dangers from DDT, and the Adminis-
trator’s decision to cancel the DDT registration is well
within his statutory authority.
Environmental Defense Fund, Inc. v. EPA (Coahoma), su-
pra note 28, 160 U.S.App.D.C. at 128, 489 F.2d at 1252 (em-
phasis added).
TAL ee LGR CO PRO ROBT = aot
49
highlight the limitations of awaiting certainty. First,
lead concentrations are, even to date, essentially low-
level, so that the feared adverse effects would not ma-
terialize until after a lifetime of exposure. Contrary
to petitioners’ suggestion, however, we have not yet suf-
fered a lifetime of exposure to lead emissions. At best,
emissions at present levels have been with us for no
more than 15-20 years.** Second, lead exposure from
the ambient air is pervasive, so that valid control groups
cannot be found against which the effects of lead on
our population can be measured. Third, the sources
of human exposure to lead are multiple, so that it is
difficult to isolate the effect of automobile emissions.
Lastly, significant exposure to lead is toxic, so that con-
siderations of decency and morality limit the flexibility
of experiments on humans that would otherwise accele-
rate lead exposure from years to months, and measure
those results. Cf. Environmental Defense Fund, Ine.
v. EPA (Shell), 167 U.S.App.D.C. 71, 78, 510 F.2d 1292,
1299 (1975).
The scientific techniques for attempting to overcome
these limitations are several: toxicology can study the
distribution and effect of lead in animals; epidemiological
techniques can analyze the effects of lead emissions on
entire populations; clinical studies can reproduce in
** According to the NAS Panel, present air lead concentra-
tions, which over the largest American cities are 2,000 times
greater than air lead concentrations over the mid-Pacific
Ocean, have existed for 15 years. NAS Report at 205, JA 356.
The Panel attributed these high concentrations primarily to
automotive emissions. /d.
*° It is for these reasons that, although lead additives have
been used for over 50 years, the danger posed by lead emis-
sions is still a question “on the frontiers of scientific knowl-
edge.” Industrial Union Department, AFL-CIO v. Hodgson,
supra note 49, 162 U.S.App.D.C. at 338, 499 F.2d at 474.
See note 97 infra.
Re eat dae ie eee ene ee |
50
laboratories atmospheric conditions and measure under
controlled circumstances the effects on humans. All of
these studies are of limited usefulness, however. Dr.
J. H. Knelson, Director of EPA’s Human Studies Lab-
oratory, has described, in the context of setting ambient
air standards, the limitations of these various investiga-
tive tools:
Each of these investigative approaches—classic
toxicology, epidemiology, and clinical research has
its advantages and disadvantages. The toxicologist
can control the dose and use invasive or destructive
techniques in measuring response in the animal, but
is always faced with the problem of extrapolating
results to humans. Epidemiology is most relevant
because it studies phenomena actually occurring in
humans under “natural” conditions, but can only
draw inference from observed correlations rather
than prove cause and effect relationships. Clinical
research can provide the most accurate dose-
response relationships in the species of interest.
Precisely because the study subjects are humans,
however, many experimental design problems are
encountered in assuring their safety. Although the
dose of an atmospheric pollutant can be carefully
controlled and measured in the clinical laboratory,
qualitative comparability to the multiplex variable
of atmospheric pollution cannot always be assured.
The best scientific criteria for establishing air
quality standards result from interactions between
these disciplines. Clinical studies must be preceded
by exhaustive toxicological assessment in other
species; observations from population studies should
play an important role in the experimental design
of clinical
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