Record and brief — American Petroleum Institute v. Gorsuch

Supreme Court brief1982

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Text

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Office-Supreme Court, US

PEL ED

ALEXANDER L. STEVAS,

CLERK

OCTOBER TERM, 1981

AMERICAN PETROLEUM INSTITUTE, ef ai.,

Petitioners,

ANNE M. GORSUCH, ADMINISTRATOR,

AND ENVIRONMENTAL PROTECTION AGENCY,

Respondents.

JOINT PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Epwarp W. WarRREN*

Ropert F. VANVOORHEES

Joun S. HAHN

KirKLAND & ELLs

Of Counsel: 1776 K Street, N.W.

STARK RITCHIE Washington, D.C. 20006

Davip T. DEAL (202) 857-5000

American Petroleum Counsel for American

Institute Petroleum Institute

EpMUND B. Frost and Member Company Petitioners

Chemical Manufacturers JouN H. PICKERING

Association WiittiaM H. Lewis, Jr.

Davin R. JOHNSON

Witmer, CutLer & PICKERING

1666 K Street, N.W.

Washington, D.C. 20006

Counsel for Chemical

Manufacturers Association

November 10, 1981 *Counsel of Record

Additional counsel listed inside cover.

EE ENS CT A TTT A TR LT

J. MarsHALL COLEMAN

ATTORNEY GENERAL OF VIRGINIA

Rocer L.. CHAFFE

ASSISTANT ATTORNEY GENERAL

Suite 308

11 South 12th Street

Richmond, Virginia 23219

Counsel for the Commonwealth

of Virginia, ex rel. the State

Air Pollution Control Board

BERNARD J. REILLY

1007 Market Street

Wilmington, Delaware 19898

Counsel for E. 1. du Pont

de Nemours & Company

Wixkes C. Rosinson

J. Scott Brown

Gutr Coast & Great PLAINs

LEGAL FOUNDATION

127 West 10th Street

Room 1022

Kansas City, Missouri 64105

Counsel for St. Louis Regional

Commerce and Growth Association

Jan Eric CARTWRIGHT

ATtToRNEY GENERAL OF OKLAHOMA

Neat LEADER

ASSISTANT ATTORNEY GENERAL

112 State Capitol Building

Oklahoma City, Oklahoma 73105

Counsel for State of Oklahoma

QUESTIONS PRESENTED

The questions presented for review by this Court are:

1. Whether the court below correctly construed § 307(d)

(8) of the Clean Air Act as excusing the Environmental Protec-

tion Agency’s violation of mandatory statutory requirements,

with the practical effect of undermining any opportunity for

meaningful judicial review of the Agency’s decisions.

2. Whether the court below correctly construed § 109 of

the Clean Air Act as imposing no substantive limitations on the

Environmental Protection Agency’s discretion to establish

national ambient air quality standards, and if so, whether that

provision constitutes an excessively sweeping and unfettered

delegation of legislative authority in violation of the Constitu-

tion.

LIST OF PARTIES

The parties before the court of appeals included the American

Petroleum Institute and 15 of its member companies, ' the

Chemical Manufacturers Association and four of its member

companies, * the Commonwealth of Virginia, ex re/. the State

Air Pollution Control Board, E. I. du Pont de Nemours &

Company, the St. Louis Regional Commerce and Growth

Association, the State of Oklahoma and the City of Houston. ’

' Atlantic Richfield Company, Continental Oil Company, Exxon Com-

pany U.S.A., Getty Oil Company, Gulf Oil Corporation, Grace Petroleum

Corporation, Kerr-McGee Corporation, Mobil Oil Corporation, Pennzoil

Company, Shell Oil Company, Standard Oil Company (Indiana), The

Standard Oil Company (Ohio), Texaco Inc. , Union Oil Company of Califor-

nia, and Witco Chemical Corporation.

? American Cyanamid Company, Diamond Shamrock Corporation, Ethyl!

Corporation, and Northern Petrochemical Company.

} The parties below also included the Natural Resources Defense Council,

the Delaware Valley Citizens Committee for Clean Air, Inc., the Connecti-

cut Lung Association, Inc., the American Lung Association, and the Sierra

Club.

TABLE OF CONTENTS

Page

NE Sewer ac euch ibcw beset ChewneeN seus 2

I ed Oe Cee een eee en baw 2

STATUTES AND REGULATIONS INVOLVED .................. 2

TE EE go bc nscce sedctcdennoseedeaaves 3

A. Geatatory Background... .... cc cccsccccceses 3

B. EPA Quome Relomaking ..........ccccseees 6

ae >: 10

REASONS FOR GRANTING THE WRIT ................-0000- 11

I. By Construing Section 307(d)(8) of the Clean Air Act to

License Flagrant Violation of Mandatory Statutory Provi-

sions, the Decision Below Raises Far-Reaching Questions

About the Function and Scope of Judicial Review That

Should Be Addressed by This Court ............... 13

Il. The Decision Below Raises Grave Constitutional Ques-

tions By Construing Section 109 of the Clean Air Act as

Placing No Limitations on EPA’s Standard-Setting Dis-

: ceasun vanes eee al Vek beeee ee alesse Giwes 18

PED uchuveweuuaeuwe danke neeewemdwrenbensent 24

” od *

APPENDIX

A. Court of Appeals Decision on the Merits. ...... la

B. Court of Appeals Decision Correcting the Record 33a

C. Environmental Protection Agency Promulgation of

MEE cuayunnedeces cesdenscekebeceees 6 43a

D. Statutory and Regulatory Provisions ........... 103a

TABLE OF AUTHORITIES

CASES: Page

American Textile Mfg. Institute v. Donovan, US. .

ey EEE | bi ceWesssvececastescesenees 12

Braniff Airways, Inc. v. CAB, 379 F.2d 453 (D.C. Cir. 1967) = 16

Brown v. EPA, 521 F.2d 827 (9th Cir. 1975), vacated and

remanded, 431 U.S. 99 (1977) ....... 0.000.002 eee 3

Calvert Cliffs’ Coordinating Committee, Inc. v. United States

Atomic Energy Comm'n, 449 F.2d 1109 (1971) ...... 18

Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402

Dut dcr kuueedaveneenuedsk esses keen ss li, i2

City of Santa Rosa v. EPA, 534 F.2d 150 (9th Cir.), cert.

dismissed sub nom., California v. EPA, 429 U.S. 952

Dt teaieeasidekenhecey basteuaeeanseKeiets os 10

Duck River Preservation Assoc. v. Tennessee Valley Authority,

410 F. Supp. 758 (E.D. Tenn. 1974), aff'd mem., 529

ee NS ED 0650 unvecrucsccrccccecess 18

Ethyl Corp. v. EPA, 541 F.2d 1, cert. denied sub nom., E.1. du

Pont de Nemours & Co. v. EPA, 426 U.S. 941 (1976) 5, 12

Flint Ridge Development Co. v. Scenic Rivers Assoc., 426 U.S.

SD a nan cade wakes ed outie sos b0k6es bes 17

Hampton & Co. v. United States, 276 U.S. 394 (1928) ... 19

Industrial Union Dept., AFL-CIO v. Hodgson, 499 F.2d 467

ES I. Se errr ne rrerer il

Industrial Union Dept., AFL-CIO v. American Petroleum In-

Stitute, 448 U.S. 607 (1980) ............. 12, 13, 19-23

International Harvester Co. v. Ruckelshaus, 478 F.2d 615

uve cewhccddusebees 6000s kh bne¥e 5, 13

Kleppe v. Sierra Club, 427 U.S. 390 (1976) ............ 17

Lead Industries Ass'n v. EPA, 647 F.2d 1130(D.C. Cir.), cert.

denied, 449 U.S. 1042 (1980) .................... il

Lichter v. United States, 334 U.S. 742 (1948) ........... 21

National Cable Television Association v. United States, 415

ee cea a cue eu nk aewahe 6s 21

Panama Refining Co. v. Ryan, 293 U.S. 388 (1935) ... 19, 21

Portland Cement Ass'n v. Ruckelshaus, 486 F.2d 375 (D.C.

Cir. 1973), cert. denied, 417 U.S. 921 (1974) ....... 5

Table of Authorities Continued

Page

Schechter Corp. v. United States, 295 U.S. 495 (1935) ... 21

Train v. NRDC, 421 U.S. 60 (1975) ...............2.... 3

Union Electric Co. v. EPA, 427 U.S. 246 (1976) ........ 3, 10

Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519

SE ccddaeddeksutetbuee taeda 12

CONSTITUTIONAL PROVISIONS:

U.S. Constitution, Asticofe §,§ 1... 2. ccc cccccvcccces 2

STATUTES AND REGULATIONS:

Clean Air Act, 42 U.S.C. §§ 7401 et seq.

Sf BT ee) eer passim

Ge ee OF PED bcc ucanceedesueusesess 3

fo fee) Perera passim

a, Oe 6.k.u cc uwececdconcnrenuiu 3

42 U.S.C. § 7409(b\ 1) ................ 4, 21, 22

4 8 * al re rt ee 4,14

GB U.S. BS PERUMED 2. cc vcvecvccvescceses 5

ee cs OS PE nce nccudaccaceeeeus 10

Bi me G6 * a & - Sererserrt rer 23

§§ 171-78, 42 U.S.C. §§ 7501-08 ................... y

S 17Rad, 42 U.S.C. § TERBeD .. cc ccc cc ccccctocces i)

42 U.S.C. § 7502%(b\ 11) .............008.. y

§ 307(b)(1), 42 U.S.C. § 7607(b\1) .. 2... ee eee. 10

= aT dl S000: 14

gZb' Me) = passim

ie ine Uk CEL .. cs o ve ou ca.eun baad 17

‘2 U.S.C. § 7607(d9KD) .......... 11, 15, 17

Environmental Research, Development, and Demonstration Author-

ization Act of 1978, § 8

og FS Peer passim

ie as GUD 66-6.0-600500005094500008s0n 5

Federal Advisory Committee Act

FOr: GE Be PO occ ceccnsecsscsenseen 2

Table of Authorities Continued

Page

National Environmental Policy Act

EE PUES Sic cccscevcecessecsccsens 17

meee OKT Safety and Health Act

OS voc nvvccuvautdcvccncesees 20

iS ccc hc cc esneceeeseeceseoeses 20

ED ovsocncsevecevevesesecsuens 20

LEGISLATIVE MATERIALS:

H.R. Rep. No. 294, 95th Cong., Ist Sess., reprinted in |1977]

U.S. Code Cong. & Ad. News 1077 ............ 16, 17

H.R. 1K No. 564, 95th Cong., Ist Sess., reprinted in |1977|

U.S. Code Cong. & Ad. News 1502 ............ 16, 17

H.R. Rep. No. 722, 95th Cong., Ist Sess. (1977) ........ 4,5

S. Rep. No. 1196, 9ist Cong., 2d Sess. (1970) ........... 22

Staffs of the House Interstate and Foreign Commerce Commit-

tee and the House Science and Technology Committee,

94th Cong., 2d Sess., Report on Joint Hearings on the

Conduct of the Environmental Protection Agency's “Com-

munity Health and Environmental Surveillance System”

(CHESS) Studies (Comm. Print 1976) .............. 4

MISCELLANEOUS:

I, CPOE wcccccccccceccccceecessecces 23

40 Fed. Reg. 9532 (197S) .. ccc cece ccc ccc cececes 23

MPD ss cas cescecccecncccecseece 23

IE oo ccc ccscorscccceecencsece 23

i ED vccccceccccescdecsccsecvens 7

i ED oc ccc cccvcrdececcecscsceses 7

SE ED wesc cccceccccccceeecececees 23

46 Fed. Reg. 7182 (1981) ...........cccccceeeeeeeees 10

IN THE

Supreme Court of the United States

OCTOBER TERM, 1981

No,

AMERICAN PETROLEUM INSTITUTE, ef al.,

Petitioners,

Vv.

ANNE M. GoORSUCH. ADMINISTRATOR,

AND ENVIRONMENTAL PROTECTION AGENCY,

Respondents.

JOINT PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE DISTRICT OF COLUMBIA CIRCUIT

The American Petroleum Institute and its member company

petitioners,‘ the Chemical Manufacturers Association, the

Commonwealth of Virginia, ex re/. the State Air Pollution

Control Board, E. I. du Pont de Nemours & Company, the St.

Louis Regional Commerce and Growth Association, and the

State of Oklahoma respectfully petition for a Writ of Certiorari

to review the decision of the United States Court of Appeals for

the District of Columbia Circuit in the case of American Pet-

*Continental Oil Company, Exxon Corporation, Getty Oil Company,

Gulf Oil Corporation, Grace Petroleum Corporation, Kerr-McGee Corpora-

tion, Mobil Oil Corporation, Pennzoil Company, Shell Oil Company,

Standard Oil Company (Indiana), Texaco Inc., and Witco Chemical Cor-

poration.

—

roleum Institute v. Costle, et al., No. 79-1104, and consoli-

dated cases. °

OPINIONS BELOW

The opinion of the court of appeals is reported at ____ F.2d

—_., Slip op. (D.C. Cir. 1981) (Petitioners’ Appendix A). A

previous opinion of the court ordering corrections to the record

is reported at 609 F.2d 20 (D.C. Cir. 1979) (Petitioners’

Appendix B). The Environmental Protection Agency’s state-

ment of basis and purpose for the ozone standard is reported at

44 Fed. Reg. 8202 (1979) (Petitioners’ Appendix C).

JURISDICTION

The judgment of the court of appeals was entered on Septem-

ber 3, 1981. The jurisdiction of this Court is invoked under 28

U.S.C. § 1254(1).

STATUTES AND REGULATIONS INVOLVED

This case involves review of the national ambient air quality

standard for ozone, 44 Fed. Reg. 8202 (1979), codified at 40

C.F.R. § 50.9, as promulgated pursuant to the Clean Air Act,

42 U.S.C. §§ 7401 et seq. This case also involves application

of § 8 of the Environmental Research, Development, and De-

monstration Authorization Act of 1978 (ERDDAA), 42 U.S.C.

§ 4365, the Federal Advisory Committee Act, 5 U.S.C. app.

§$§ 3 et seq., and Article I, § 1 of the United States Constitu-

tion, which provides that “All legislative Powers herein granted

shall be vested in a Congress. . . .” Pertinent provisions of the

* Pursuant to Supreme Court Rule 40.3, the case caption on this Petition

has been changed because Anne M. Gorsuch has replaced Douglas M.

Costle as Administrator of the Environmental Protection Agency. A list of

the corporate petitioners’ parent companies, subsidiaries and affiliates is

being filed as a Supplemental Appendix, pursuant to Supreme Court Rule

28.1.

applicable regulation and statutes are appended to this Petition

(Petitioners’ Appendix ° D).

STATEMENT OF THE CASE

A. Statutory Background

The Clean Air Act, 42 U.S.C. §§ 740! et seq., establishes a

comprehensive scheme for the regulation of air pollutants that

threaten public health or welfare. The paramount provisions of

the Act are §§ 108 and 109, P.A. 103a-104a, which authorize

the Administrator of the Environmental Protection Agency

(EPA) to promulgate national ambient air quality standards

establishing the maximum permissible levels of pollutants in

the ambient (outdoor) air. Section 110, 42 U.S.C. § 7410,

requires the states to prepare and implement whatever pollution

control measures are necessary to ensure timely attainment of

the national standard.

This Court twice has reviewed provisions of § 110 governing

implementation of national ambient air quality standards, Train

v. NRDC, 421 U.S. 60(1975), and Union Electric Co. v. EPA,

427 U.S. 246 (1976), but never has construed the seminal

standard-setting provisions of §§ 108 and 109, which are at

issue in this case. ’

Section 108(a)(2) directs the Administrator to prepare an “air

quality criteria” document which “accurately reflect|s] the

latest scientific knowledge” about the effects of selected pollu-

tants on public health and welfare. P.A. 103a. Section 109(a)

authorizes the Administrator to promulgate “primary” national

’ The Court also granted writs of certiorari in Brown v. EPA, 521 F.2d

827 (9th Cir. 1975) and related cases, in which states challenged EPA’s

authority to require adoption of motor vehicle inspection programs to imple-

ment the previous ozone standard. The Court declined to review these cases

on the merits, however, after EPA conceded that the disputed regulations

were invalid. EPA v. Brown, 431 U.S. 99 (1977).

ambient air quality standards, which are described in

§ 109(b)(1) as standards “the attainment and maintenance of

which in the judgment of the Administrator, based on such

criteria and allowing an adequate margin of safety, are requisite

to protect the public health.” P.A. 104a. Apart from the provi-

sions of §§ 108 and 109, the statutory text provides no express

guidance or limits on what factors the Administrator may con-

sider in setting such standards. *

In 1977, Congress provided for an independent Science

Advisory Board to which EPA was required to submit for

review and comment all proposed criteria documents and all

proposed standards, along with supporting scientific informa-

tion, under the Clean Air Act and all other statutes administered

by EPA. ° Review of proposed criteria documents and standards

*Section 307(d) prescribes administrative procedures applicable to set-

ting ambient air quality standards. P.A. 106a-1 12a.

* Environmental Research, Development, and Demonstration Authoriza-

tion Act of 1978 (ERDDAA), § 8, 42 U.S.C. § 4365, P.A. 112a-1 13a.

ERDDAA requires independent scientific review of regulations issued

not only under the Clean Air Act, but also under the Federal Water Pollution

Control Act, the Resource Conservation and Recovery Act of 1976, the

Noise Control Act, the Toxic Substances Control Act, the Safe Drinking

Water Act, and “any other authority of the Administrator.” /d. at 113a.

In 1976, Congressional committees had found serious deficiencies in

EPA's research on the health effects of air pollution, including an apparent

tendency to stretch interpretations to support EPA’s regulatory positions.

Staffs of the House Interstate and Foreign Commerce Committee and the

House Science and Technology Committee, 94th Cong., 2d Sess., Report

on Joint Hearings on the Conduct of the Environmental Protection Agency's

“Community Health and Environmental Surveillance System” (CHESS)

Studies (Comm. Print 1976). As a result of this investigation, § 8 of

ERDDAA was enacted in 1977. H.R. Rep. No. 722, 95th Cong. , Ist Sess.

16-18 (1977).

In the 1977 Clean Air Act Amendments, Congress also required indepen-

dent scientific review of all air quality criteria documents and standards on

an ongoing basis. 42 U.S.C. § 7409(d), P.A. 104a-105a. The responsibility

by the Science Advisory Board was envisioned as a major

reform of the standard-setting process. The Board’s comments

would provide the Administrator with authoritative scientific

advice, independent of the Agency's own staff, and thereby

improve the quality of EPA’s standards. " At the same time, the

Board—composed of persons “qualified by education, training

and experience to evaluate scientific and technical information”

(42 U.S.C. § 4365(b))—would provide an evaluation of prop-

osed rules that would facilitate and enhance judicial review of

EPA’s decisions. "'

The Clean Air Act Amendments of 1977 required EPA to

revise, “as may be appropriate,” all existing air quality criteria

and standards. 42 U.S.C. § 7409(d)(1), P.A. 104a. In that

year, EPA initiated rulemaking proceedings to review the

ozone standard at issue in this case. "

for conducting independent scientific review as required by ERDDAA and

the Clean Air Act is held now by the Clean Air Scientific Advisory Commit-

tee, a subcommittee of EPA's Science Advisory Board.

In passing § 8 of ERDDAA, Congress intended for the Science Advis-

ory Board “to review conflicting claims and advise the Administrator on the

adequacy and reliability of the technical basis for rules and regulations.”

H.R. Rep. No. 722, 95th Cong., Ist Sess. 16 (1977).

'' Prior to the enactment of ERDDAA, courts repeatedly had noted the

difficulties posed for appellate judges charged with reviewing scientific and

technical issues underlying EPA regulations. See International Harvester

Co. v. Ruckelshaus, 478 F.2d 615, 647-48 (D.C. Cir. 1973), Portland

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

denied, 417 U.S. 921 (1974). Compare Ethyl Corp. v. EPA, 541 F.2d 1,

cert. denied sub nom., E.1. du Pont de Nemours & Co. v. EPA, 426 U.S.

941 (1976), concurring op. of J. Bazelon at 67 (“substantive review of

mathematical and scientific evidence by technically illiterate judges is

dangerously unreliable”), with concurring op. of J. Leventhal, at 68 (“[ojur

present system of review assumes judges will acquire whatever technical

knowledge is necessary as background for decision of the legal questions”).

'2 Ozone (O.) is a form of oxygen that can be formed in the ambient air

from chemical reactions involving organic compounds. Joint Appendix

(from the proceedings in the court of appeals; hereinafter “J.A.") Ex. | at

B. EPA Ozone Rulemaking

Throughout the ozone rulemaking, EPA’s actions raised

questions about its willingness to comply with prescribed statu-

tory requirements, and to review the existing standard with an

open mind. EPA began the proceedings, not by seeking Science

Advisory Board review of a draft criteria document, but rather

by convening another group of advisers to recommend a con-

clusion on the ultimate issue of the rulemaking, i.e., “the

translation of health data into an ambient air quality standard.”

P.A. 23a-24a. This group, which EPA named its “Advisory

Panel on Health Effects of Photochemical Oxidants,” was

empanelled and met without public notice. The Panel was

chaired by a former EPA official who also was serving as the

public spokesman for an interest group favoring no revision of

the standard. J.A. 258. The Panel’s Report, prepared in June,

1977 with EPA staff assistance, advocated retention of the

existing standard. J.A. 259, 277-79.

3-3. Therefore, emissions of fuels and other organic compounas are control-

led to reduce ambient ozone levels.

Ambient ozone also results, however, from two natural sources over

which man has no control. The first is organic compounds emitted by

vegetation which, like organic emissions from man-made sources, can

produce ozone by chemical reaction. J.A. Ex. |. at 4-62. A second signifi-

cant natural source is the transfer to ground level of ozone from the stratos-

phere (J.A. Ex. | at 4-48), where ozone is considered beneficial in screening

the earth from ultra-violet radiation.

Ambient ozone levels sometimes have been associated with temporary

irritation of the respiratory tract, but have not been shown to increase

mortality or to cause long-term effects in humans. J.A. 647. Consequently,

a major factual issue in setting the primary ozone standard was whether EPA

reasonably could interpret various scientific studies as showing a significant

risk of short-term health effects at various ambient ozone levels.

The original ozone standard was denominated a “photochemical oxidant”

standard when set in 1971. J.A. 57. The initial standard was set at the

unrealistically stringent level of 0.08 parts per million (ppm), based on

EPA's concededly mistaken reading of a single study. J.A. 440.

Only after that report was written did EPA provide the

statutory Science Advisory Board with drafts of the criteria

document, which were reviewed at public meetings in Novem-

ber, 1977 and February, 1978. The Board consistently criti-

cized those drafts as scientifically deficient and biased in favor

of an excessively stringent standard. J.A. Ex. 2. In ballots cast

in March, 1978, not one of the eleven Board members was

willing to advise EPA that the existing draft could be considered

a “scientifically acceptable criteria document” without major

revisions. J.A. 287-310. The Board’s Chairman, Dr. James

Whittenberger, '’ wrote: “I found the authors had responded

insufficiently to many criticisms made by members of the

Subcommittee and by others. The health risk assessments are

largely speculative, incomplete, and heavily dependent on stu-

dies of questionable validity ” J.A. 293.

After the Science Advisory Board had repeatedly criticized

the scientific quality of EPA’s draft criteria document, EPA

terminated the Board’s role in the rulemaking. Without seeking

the Board’s advice, EPA issued a final criteria document and

proposed a barely revised standard of 0.10 ppm. J.A. 437. The

proposal was based substantially on the conclusions presented

in the Advisory Panel Report noted above and on the results of a

“decision analysis” technique that EPA had withheld from

review by the Science Advisory Board. J.A. 441.

Petitioners urged EPA to submit the proposal for review by

the Science Advisory Board, as was EPA’s clear duty under

ERDDAA. Nevertheless, EPA refused to do so. '* Although the

"8 Like all of the members of the Science Advisory Board, Dr. Whit-

tenberger is a highly respected scientist, who is a Professor and the former

Dean of the Harvard School of Public Health. J.A. 291-92.

'* No practical reason prevented EPA from submitting the proposal to the

Science Advisory Board. The proposal was published in the Federal Regis-

ter on june 22, 1978 (43 Fed. Reg. 26962), and the comment period did not

close until October 16, 1978 (43 Fed. Reg. 43331 (1978)), almost four

months later. Three additional months elapsed before the final standard was

promulgated on January 26, 1979. P.A. 43a.

proposal was not reviewed by the Science Advisory Board, it

was addressed in public comments by President Carter's Reg-

ulatory Analysis Review Group, an interagency group of reg-

ulatory analysts assembled to improve the scientific quality and

cost-effectiveness of major federal regulations.

The Review Group concluded that EPA’s proposed ozone

standard would result in little or no discernible benefit to public

health, at the staggering cost of $14.3 to $18.8 billion annually

(J.A. 661-62), or almost one percent of the Nation's gross

national product. Accordingly, the Review Group suggested

that an ozone standard of 0.16 ppm would still protect public

health, while saving vast resources that society could use better

to protect the public from other, far more serious, health

hazards. J.A. 647-49, 665. '° EPA rejected the Review Group’s

recommended standard of 0.16 ppm, without submitting its

own proposal to the Science Advisory Board, and instead

promulgated a far more stringent and costly standard of 0.12

ppm. '° P.A. 43a.

In promulgating the standard, EPA rejected not only the

requirement of independent scientific review, but also any

meaningful substantive constraints on its standard-setting dis-

cretion. It refused to define what constitutes impairment of

“public health” under § 109, or to acknowledge any limits on

what “margin of safety” may be considered “adequate.” P.A.

46a-48a. Similarly, EPA concluded that no other factors limit

its discretion to determine what level of protection is “requisite

to protect the public health,” saying: “The Clean Air Act, as the

'S The Review Group found that “the marginal costs of EPA’s proposed

standard may be in the range of $1 ,100-$4, 100 per reduced person-hour of

ozone exposure, which causes discomfort but is reversible and apparently

has no long-term debilitating effects.” J.A. 637.

'© The Review Group estimated that a standard of 0.12 ppm would cost

$12.4 to $15 billion annually, which is almost $3 billion more annually than

a standard of 0.16 ppm. J.A. 661.

Administrator interprets it, does not permit him to take factors

such as cost" or attainability'* into account in setting the

standard.” P.A. 82a.

The practical consequences of an ozone standard as stringent

as that set by EPA are immense. The standard, which is violated

in most parts of the country where ambient ozone is measured

(P.A. 100a), must be attained by 1982, with an extension

available only until 1987. 42 U.S.C. § 7502(a). Thus, states

will be required to implement an array of control measures by

next year to assure attainment by no later than 1987. ' Even by

'? This view is rendered all the more inexplicable by EPA’s recognition

“that controlling ozone to very low levels is a task that will have significant

impact on economic and social activities.” P.A. 82a. EPA then stated that

“[t}his recognition causes [the Administrator] to reject as an option the

setting of a zero-level standard . . . However, it is public health, and not

economic impact, that must be the compelling factor in the decision.” /d.

No one disputes that public health is the “compelling factor” in setting a

standard. But EPA never attempted to explain how practical factors could be

irrelevant as a matter of law, while EPA may rely on those factors as the

reason for avoiding a standard set at zero. Nor did EPA explain what factors

bear on where the standard should be set, given the conceded fact that no

standard provides absolute protection against all risks of health effects.

'’ During the rulemaking, EPA had funded private research which re-

vealed that 80 percent of organic emissions come from vegeiation rather than

man-made sources. Because of the obvious significance of this information

to the issue of whether the ozone standard could be attained by control of

man-made emission sources, petitioners urged EPA during the comment

period to consider the information in setting the standard. J.A. 1003. EPA

refused to consider this evidence or to include it in the rulemaking record,

claiming that whether a standard can be attained is irrelevant as a matter of

law. J.A. 1071.

' States violating the ozone standard are subject to a variety of strict

emission control requirements under section 1 10 (42 U.S.C. § 7410) and

Part D(42 U.S.C. §§ 7501-08) of the Act. In addition, states unable to attain

the primary ozone standard by 1982 must establish inspection and mainte-

nance programs to control emissions from motor vehicles, among other

measures. 42 U.S.C. § 7502(b)(11).

EPA’s own estimates, ozone control measures required in 1982

and thereafter will cost billions of dollars annually. J.A. 659.”

C. The Decision Below

On petitions for review by industry groups and state and local

governments, the court below upheld the standards in every

respect. *' The court ruled that EPA had violated § 8(e) of

ERDDAA by failing to submit the proposed standards to the

Science Advisory Board (P.A. 22a-23a), but excused the viola-

tion under § 307(d)(8) of the Act, * because “we cannot hold

EPA concedes that a number of states will be unable to attain the

standard by the statutory deadlines, despite the implementation of all

“reasonably available” control measures. When it promulgated the standard,

EPA acknowledged that “[e}ven with aggressive control programs, howev-

er, it will be very difficult for some urban areas to achieve the standard

within the next 10 years.” P.A. 101la. Indeed, EPA already is establishing

policies for states that will be unable to meet the final statutory deadline in

1987. 46 Fed. Reg. 7182 (1981). If EPA finds that, notwithstanding adop-

tion of all reasonable measures, a state will not meet the standard, EPA may

impose on the state a variety of more severe measures, including a ban on

construction of major emission sources. 42 U.S.C. § 7410(a)(2)(1).

Once standards are established, neither technological nor economic in-

feasibility will relieve states or industrial sources from complying with these

implementation requirements. Union Electric Co. v. EPA, 427 U.S. 246

(1976). One court upheld EPA regulations that could completely ban the sale

of gasoline in Los Angeles if necessary to attain the ozone standard. City of

Santa Rosa v. EPA, 534 F.2d 150 (9th Cir.), cert. dismissed sub. nom.,

California v. EPA, 429 U.S. 952 (1976).

! The U.S. Court of Appeals for the District of Columbia Circuit is the

sole forum for review of rules of nationwide scope under the Clean Air Act.

42 U.S.C. § 7607(b)(1), P.A. 107a. Accordingly, no conflict can develop

among the circuits on some of the most important questions raised by the

decision below.

Section 307(d)(8) provides, in pertinent part: “In reviewing alleged

procedural errors, the court may invalidate the rule only if the errors were so

serious and related to matters of such central relevance to the rule that there is

a substantial likelihood that the rule would have been significantly changed

that the standard would likely have been significantly changed

had it been submitted to the Board.” P.A. 23a. * The court also

endorsed EPA’s construction of § 109, even though that con-

struction places no effective limits on EPA’s discretion, permit-

ting EPA to set a standard of whatever stringency it chooses

P.A. 14a-1Sa.

REASONS FOR GRANTING THE WRIT

The decision below poses fundamental questions about

whether Congress intended, or the Constitution permits, an

administrative agency to exercise unchanneled and unreview-

able discretion in making decisions of vast importance for

public health and the economic well-being of the Nation. Un-

less reversed, the erroneous decision of the court of appeals will

have far-reaching consequences for other cases by seriously

undermining judicial review of administrative action.

There is a perplexing irony in the result reached below.

Previous decisions of this Court and the court below have

established a “highly deferential standard” of review for agen-

cies’ factual or policy determinations, especially those involv-

ing scientific or technical matters. * Judicial review in such

if such errors had not been made.” P.A. I | 1a. Although this requirement is

incorporated by reference in § 307(d)(9)(D), P.A. 112a, the court below

relied expressly on the provision of § 307(d)(8) in excusing EPA’s statutory

violations. P.A. 23a, 25a.

**The court declined to reach the issue of whether EPA violated the

Federal Advisory Committee Act in privately convening its Advisory Panel,

on the ground that such violations also would have been excusable. P.A.

25a. The court further down-graded the role of the Science Advisory Board

by finding no reversible error in EPA's failure to respond to the Board's

comments on the draft criteria document.

** See, e.g., Lead Industries Ass'n v. EPA, 647 F.2d 1130, 1145 (D.C.

Cir.), cert. denied, 449 U.S. 1042 (1980) (citing Citizens to Preserve

Overton Park v. Volpe, 401 U.S. 402, 416(1971)), Industrial Union Dept.,

AFL-CIO v. Hodgson, 499 F.2d 467, 475 (D.C. Cir. 1974).

cases thus has focused on strict compliance with procedures

required by law* or on issues of statutory interpretation and

authority. * But the decision below, if allowed to stand, would

close off even this limited scope of review by effectively

immunizing EPA against claims of procedural irregularity in

the development of standards, ” and by confirming EPA’s view

that the statute gives it essentially unfettered discretion in

setting those standards.

The court’s reliance on § 307(d)(8) of the Clean Air Act not

only absolves the Agency’s flagrant violation of an express

statutory requirement, but also defeats Congress’ purpose in

enacting § 8 of ERDDAA, which was to improve Agency

decisionmaking and to enhance judicial review of EPA rules

involving scientific issues. Only if ERDDAA is enforced can

the independent scientific review process designed by Congress

assist appellate courts in their review of Agency decisions on

scientific and technical issues. *

*5 Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 549,

n.21 (1978) (“the court must determine whether the agency complied with

the procedures mandated by the relevant statutes”) (citing Citizens to Pre-

serve Overton Park v. Volpe, 401 U.S. at 417); Ethyl Corp. v. EPA, 541

F.2d at 67 (concurring opinion of Judge Bazelon) (“we will do more to

improve administrative decision-making by concentrating our efforts on

strengthening administrative procedures”).

26 See Industrial Union Dept. v. American Petroleum Inst. 448 U.S. 607

(1980); American Tex. Mfg. Inst. v. Donovan, ___. U.S. ___, 101 S.Ct.

2478 (1981).

77In Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519

(1978), this Court admonished reviewing courts not to impose on adminis-

trative agencies procedures beyond those required by Congress. /d. at

546-49. The opinion below does just the opposite by announcing that courts

need not enforce even procedural requirements, such as § 8 of ERDDAA,

that Congress expressly provided.

6 Judge Bazelon presaged the rationale for ERDDAA when he wrote:

“[IJn cases of great technological complexity, the best way for courts to

guard against unreasonable or erroneous administrative decisions is not for

This withdrawal of procedural checks exacerbates the grave

constitutional questions posed by the court’s interpretation of

§ 109 of the Clean Air Act. As interpreted by the court below,

§ 109 permits EPA to set a standard of whatever stringency it

chooses. In contrast to OSHA’s standard-setting authority re-

cently construed by this Court in /ndustrial Union Dept. v.

American Petroleum Inst., 448 U.S. 607 (1980), EPA’s stan-

dard-setting authority here is said not to be confined by any

consideration of whether the risk to be prevented is significant

(P.A. 15a), or even whether the standard can be attained by

human effort. P.A. 14a-15a. Such a construction of § 109 thus

would give EPA, even more than OSHA, “unprecedented pow-

er over American industry” and permit it to impose “enormous

costs that might produce little, if any, discernible benefit.” 448

U.S. at 645.

I. By Construing Section 307(d)(8) of the Clean Air Act to License

Flagrant Violation of Mandatory Statutory Provisions, the De-

cision Below Raises Far-Reaching Questions About the Func-

tion and Scope of Judicial Review That Should Be Addressed by

This Court.

The decision below presents a critical question about the

nature and scope of judicial review under the Clean Air Act:

may an appellate court, basing its decision on nothing but

speculation, excuse as inconsequential error an agency’s failure

to comply with explicit and fundamental requirements laid

down by Congress?

The court below answered this question in the affirmative,

even though it agreed that ERDDAA “explicitly mandates that

standards be submitted to the Board for review,” and that

the judges themselves to scrutinize the technical merits of each decision.

Rather, it is to establish a decision-making process which assures a reasoned

decision that can be held up to the scrutiny of the scientific community and

the public.” International Harvester Co. v. Ruckelshaus, 478 F.2d 615, 652

(D.C. Cir. 1973) (Bazelon, C.J., concurring).

“[alccordingly, the failure to submit the standards was a viola-

tion of procedure required by law.” P.A. 22a-23a. Neverthe-

less, the court excused this express statutory violation as only

an inconsequential “procedural” error under § 307(d)(8) of the

Act, on the ground that EPA probably would have issued the

same standard in any event. P.A. 23a.

The court’s sweeping interpretation of § 307(d)(8), if

allowed to stand, would eliminate effective judicial review of

most, if not all, rulemaking requirements for Clean Air Act

standards and regulations. Nothing could be of more “central

relevance” to the establishment of an air quality standard than

the advice of the Science Advisory Board as to whether the

standard is supported by credible scientific evidence. When it

enacted § 8 of ERDDAA, Congress decided that independent

review of EPA’s proposed standards was essential to ensure that

final standards are based on adequate and reliable assessments

of the scientific evidence. * By excusing EPA’s flagrant viola-

tion of ERDDAA, the court’s decision nullifies Congress’

effort to ensure scientifically sound standards. Even more im-

portant, the court’s opinion would preclude reversal of Clean

Air Act rules for violation of virtually any rulemaking require-

ment. For if EPA may exclude the statutory Science Advisory

Board from the standard-setting process, it may curtail public

** Submission of the proposed standard to the Science Advisory Board

was explicitly required by Congress in addition to submission of the draft

criteria document. And for good reason, for it is at the proposal stage that

EPA first draws factual conclusions and makes policy judgments that trans-

late the underlying scientific information into a health standard affecting

millions of people and vast amounts of society's resources. Although EPA is

not required slavishly to follow the Board's advice, it is required to listen and

to set forth the basis for its disagreement, if it disagrees. CAA

§ 307(d)(6B), P.A. Illa. Cf. CAA § 307(d)(3), P.A. 109a (requiring

EPA to explain the reasons for any significant differences between EPA's

proposal and the recommendations of the Scientific Review Committee

established under § 109d), P.A. 104a-105a).

participation or otherwise tailor the rulemaking process to its

convenience, based on no more than supposition that the final

standard would not be substantially changed anyway.

In support of its holding, the court offered essentially no legal

or factual analysis, reasoning simply that “|bjecause any SAB

review of the standard would have involved review of the

criteria document, i.e., the scientific and technical basis for the

standard, we cannot hold that the standard would likely have

been significantly changed had it been submitted to the Board.”

P.A. 23a. This conclusion rests on nothing but the court’s

view of its limited review function (P.A. 13a), and bare spe-

culation about what effect Science Advisory Board review of

the proposal might have had on the final standard.

The court implied that EPA’s violation of ERDDAA was

inconsequential because the record contained support for the

rule as promulgated. P.A. 23a." The difficulty with this

rationale is that the record as a whole might not have provided

adequate support for, or as a practical matter have allowed the

Administrator to adopt, a final standard of 0.12 ppm if the

* Remarkably, the court excused EPA's violation of ERDDAA by

accepting the same EPA rationale that it had rejected in finding the violation

in the first instance, i.e., that the Board's review of the proposal, after

having reviewed the draft criteria document, would have been redundant.

P.A. 22a-23a. Under the court’s broad reasoning, the Board's review of any

proposed standard would be redundant.

“The court's rationale is tantamount to requiring that the standard be

unsupportable by the record before it can be reversed on procedural grounds.

This approach effectively collapses the basis for procedural reversal into the

“arbitrary and capricious” standard for substantive review, even though

§ 307(d)(9)(D) establishes a separate and independent basis for reversal

where a procedural error might have affected the final standard. P.A. | 12a.

Under § 307(d)(8), the question is not whether the standard is supported by

the existing incomplete record, but rather whether the Administrator might

have reached a different result if he had followed the standard-setting

process prescribed by Congress.

Board had been allowed to comment on the proposed rule. ”

Even the most dedicated proponent of EPA’s final standard

could not readily have defended that result if both the Regula-

tory Analysis Review Group (supra at 8) and the Science

Advisory Board had supported a higher standard. *

The legislative history of § 307(d)(8) shows that it was never

intended to curtail judicial review or to sanction the blanket

immunity from statutory violations granted by the court below.

Thus, the House Committee where § 307(d) originated empha-

sized that “in the committee’s view, appropriately broad admi-

nistrative discretion to promulgate regulations to protect health

or the environment musi be restrained by thorough and careful

procedural safeguards. . . .” “ Later, the Conference Commit-

tee reiterated that “the conferees intend that the courts continue

their thorough, comprehensive review which has characterized

judicial proceedings under the Clean Air Act thus far.” *

’ There is, of course, every reason to believe that the Board would have

advocated a higher standard than the one actually adopted. Chairman Whit-

tenberger concluded that the health sections of the draft criteria document

were “speculative, incomplete, and heavily dependent on studies of ques-

tionable validity.” J.A. 293. Another member, Dr. McCarroll, emphasized

that “| what comes through loud and clear in most of these chapters to me is

the fact that there is no demonstrable health effect before .25 ppm, either

human or animal exposure.” J.A. Ex. 2 at 507.

*’ The court made its prediction under § 307(d)(8) without the benefit of

any showing by EPA that the Board's review would have been irrelevant. In

remanding a case based on agency error, the late Judge Leventhal concluded

that “whether the agency would have reached the same result if it had not

made these erroneous findings . . . is the type of issue on which we think it is

appropriate to insist on further guidance from the agency.” Braniff Airways,

Inc. v. CAB, 379 F.2d 453, 467 (D.C. Cir. 1967).

“H.R. Rep. No. 294, 95th Cong., Ist Sess., reprinted in [1977] U.S.

Code Cong. & Ad. News 1077, 1398 (emphasis is added throughout this

Petition unless otherwise noted).

> H.R. Rep. No. 564, 95th Cong., Ist Sess., reprinted in [1977] U.S.

Code Cong. & Ad. News 1502, 1559.

Indeed, it is questionable whether § 307(d)(8) has any ap-

plication at all to EPA’s vioiation of ERDDAA. By its own

terms, § 307(d)(8) applies only to “procedural determinations

made by the Administrator under this subsection,” P.A. 11 1a, *

and not to violations of entirely different statutes such as

ERD )AA.*” Moreover, § 8 of ERDDAA ‘s more fairly char-

acterized as a mandatory prerequisite to EPA’s exercise of its

standard-setting authority, i.e., a “statutory limitation” within

the meaning of § 307(d)(9)(C), P.A. 112a,™ rather than a

“procedural” requirement subject to §§ 307(d)(8) and

(d)(9)(D). ”

*The Committee Report for H.R. 6161, where § 307(d) originated,

shows that § 307(d)(8) was included to underscore the Administrator's

discretion to grant cross-examination under § 307(d) based on the circumst-

ances of each case. H.R. Rep. No. 294, 95th Cong., Ist Sess., reprinted in

[1977] U.S. Code Cong. & Ad. News 1401, 1399-1400. The Conference

Committee deleted the discretionary provision for cross-examination, but

without explanation neglected to delete the companion provision of

§ 307(d)(8). H.R. Rep. No. 564, 95th Cong., Ist Sess., reprinted in {1977]|

U.S. Code Cong. & Ad. News 1557-59.

* Congress enacted ERDDAA several months after § 307(d)(8) became

law, without any suggestion that violations of ERDDAA should be excused

under § 307(d)(8).

“Section 307(d)(9)(C) of the Act requires reversal whenever EPA’s

action is “in excess of statutory jurisdiction, authority, or limitations, or

short of statutory right.” P.A. i 12a.

* Science Advisory Board review should be treated as just such a “statu-

tory limitation” on EPA’s authority. Unlike most “procedural” rules, the

requirement for Science Advisory Board review concerns not access by

interested parties to the decision-making process, but rather access by the

decisionmaker to the views of the especially qualified, disinterested review-

ers comprising the Science Advisory Board.

See also provisions of the National Environmental Policy Act, 42 U.S.C.

§ 4332(2)(C) (which have been treated as mandatory adjuncts to an agency's

exercise of its authority; Kleppe v. Sierra Club, 427 U.S. 390, 409 (1976),

Flint Ridge Dev. Co. v. Scenic Rivers Ass'n, 426 U.S. 776, 787 (1976),

Accordingly, because the court below erroneously construed

§ 307(d)(8) in a manner that not only will excuse violations of a

critical standard-setting reform provision, but also severely

curtail judicial review of future Clean Air Act rulemakings, this

is a compelling case for the exercise of this Court's discretion-

ary jurisdiction.

II. The Decision Below Raises Grave Constitutional Questions By

Construing Section 109 of the Clean Air Act as Placing No

Limitations on EPA’s Standard-Setting Discretion.

The decision below removes all effective constraints on

EPA’s discretion, permitting it to set national ambient air

quality standards of whatever stringency it chooses. Given the

court’s expansive interpretation of § 307(d)(8) to permit depar-

tures from the rulemaking process, it becomes all the more

critical that there be discernible substantive limits on EPA’s

standard-setting authority. But the court below found none.

EPA’s authority to promulgate primary air quality standards

derives entirely from § 109 of the Act, which describes those

standards simply as “standards the attainment and maintenance

of which in the judgment of the Administrator, based on such

criteria and allowing an adequate margin of safety, are requisite

to protect the public health.” P.A. 104a. The conceded purpose

of such standards thus is to “protect the public health.” No-

where, however, does the Act specify exactly what degree of

protection Congress meant to provide when it used terms such

as “adequate margin of safety,” or “requisite to protect the

public health.” Obviously EPA must choose a specific level of

protection when it sets a standard. But as interpreted by EPA,

§ 109 would merely exhort EPA to pursue a worthy objective,

while excluding consideration of any factors bearing on how far

to go in pursuit of that goal.

Calvert Cliffs’ Coordinating Comm. v. U.S. Atomic Energy Comm'n, 449

F.2d 1109, 1114-15 (D.C. Cir. 1971), Duck River Preservation Ass'n v.

TVA, 410 F. Supp. 758, 766-67 (E.D. Tenn. 1974), aff'd mem., 529 F.2d

524 (6th Cir. 1976)).

Neither EPA nor the court below defined key terms in § 109

in such a way as to place any constraints on EPA’s discretion to

set a standard of whatever stringency it chooses. Rather than

confining its standard-setting mandate within bounds capable

of review by the courts, EPA simply recited the statutory text,

and emphasized the paramount role of its “judgment” in iden-

tifying the desirable level of public health protection. “ EPA

conceded that unspecified economic and social considerations

would preclude setting a zero-level standard to avoid all health

risks, but nowhere did EPA or the court even attempt to limit the

Agency's judgment to protecting against significant risks to

public health. Moreover, both expressly rejected other factors

that could provide a check on EPA’s discretion, by precluding

consideration of all practical matters, including whether the

standard could be attained through human effort. P.A. 14a-15a.

This extreme construction of § 109 would grant EPA such

unchecked discretion as to render the provision an unconstitu-

tional delegation of legislative authority. Congress may not

simply leave legislative decisions with enormous consequ-

ences, such as setting the ozone standard, to the unconfined

“judgment” of an administrative officer. Rather, the decisions

of this Court require that Congress set out an “intelligible

principle” to guide administrative decisions, and to serve as a

standard against which the administrative decision may be

reviewed by the courts. Hampton & Co. v. United States, 276

U.S. 394, 409 (1928), Panama Refining Co. v. Ryan, 293 U.S.

388, 430 (1935), Industrial Union Dept. v. American Pet-

roleum Institute, 448 U.S. 607, 685-87 (1980) (concurring

opinion of Justice Rehnquist).

“EPA explained the statutory provision for an “adequate margin of

safety” by saying simply that “EPA feels that the decision regarding an

adequate margin of safety is a judgment which must be made by the

Administrator after weighing ali the medical evidence bearing on ozone.”

(emphasis in original). P.A. 70a. EPA offered no more limited construction

of the term.

The severe problems posed by sweeping delegations of leg-

islative authority are vividly illustrated by this Court's recent

decision in Industrial Union Dept. v. American Petroleum

Institute (the Benzene case), 448 U.S. 607 (1980), which inter-

preted analogous provisions of the Occupational Safety and

Health (OSH) Act, 29 U.S.C. § 651 et seq., to avoid an

unconstitutional delegation. The OSH Act gives OSHA broad

discretion to issue health and safety standards, but requires that

those standards be “feasible” (§ 6(b)(5), 29 U.S.C.

§ 655(b)(5)), as well as “reasonably necessary or appropriate to

provide safe or healthful employment” (§ 3(8), 29 U.S.C.

§ 652(8)). OSHA claimed that these provisions required it to

set standards at the lowest technologically feasible level that

would not impair the viability of the industries regulated. 448

U.S. at 639. The Court rejected OSHA's contention, and con-

strued § 3(8) as requiring OSHA to make a threshold finding of

“significant risk” before issuing a standard. 448 U.S. at 642.

Justice Stevens reasoned that, unless § 3(8) were so construed,

“the statute would make such a ‘sweeping delegation of legisla-

tive power’ that it might be unconstitutional” under the Court's

prior decisions. /d. at 646.

The Clean Air Act as construed by EPA and the court below

would present an even more grievous delegation problem than

did the OSH Act. Even before this Court’s Benzene decision,

OSHA’s discretion was conceded to be constrained by the

requirement that standards protect only against “material im-

pairment” of health, and that standards be technologically and

economically “feasible.” 29 U.S.C. § 655(b)(5). By contrast,

the court below construed § 109 of the Clean Air Act not only to

dispense with any requirement of material health impairment or

significant risk (P.A. 15a-16a), but also to preclude any consid-

eration of feasibility. P.A. 14a-15a.

The constitutional deficiency resulting from the lower

court’s interpretation of § 109 is compounded by its construc-

tion of § 307(d)(8), which would preclude judicial enforcement

of even the most fundamental procedural requirements. *' Here,

the court of appeals essentially nullified applicable procedural

requirements, even while affirming a sweeping grant of sub-

stantive authority to the Agency. By so doing, the court has left

no effective judicial checks, either substantive or procedural,

on EPA’s discretion.

The standard-setting provisions of § 109 can be upheld as

constitutional if properly construed to impose effective limita-

tions on EPA’s authority. “* Although the decision below gives

EPA no meaningful guidance on the degree of protection to

provide for public health, the statutory text of § 109(b)(1) can

be and should have been construed to place reasonable con-

straints on EPA’s standard-setting authority.

By describing primary standards in § 109(b)(1) as those

“requisite to protect the public health,” Congress indicated that

standards should be no more stringent than necessary to provide

protection against significant risks to health. Therefore, like the

OSH Act requirement that standards be “reasonably necessary

or appropriate to provide safe or healthful employment,”

§ 109(b)(1) should have been construed to require EPA to make

*! The presence of mandatory administrative procedures may be important

in upholding broad substantive grants of authority from constitutional in-

firmity. Lichter v. United States, 334 U.S. 742, 786-87 (1948). See also

Schechter Corp. v. United States, 295 U.S. 495, 553 (1935), where the

Court found the statutory provision to be unconstitutional because, in part, it

lacked the procedural requirements found in other regulatory statutes; Pana-

ma Refining Co. v. Ryan, 293 U.S. at 432.

* Grants of administrative authority should be reasonably construed

whenever possible to avoid having to reach the constitutional question posed

by the nondelegation doctrine. Industrial Union Dept. v. American Pet-

roleum Institute, 448 U.S. 607, 646 (1980), National Cable Television

Ass'n v. United States, 415 U.S. 336. 341-43 (1974).

a threshold finding of significant risk before setting the

standard. **

The legislative history supports such a requirement of signifi-

cant risk for ambient air quality standards. Thus, the Senate

Committee in which § 109 originated said that primary stan-

dards should provide a “reasonable degree of protection. . .

against hazards which research has not yet identified... .”*

The decision below goes far beyond these limitations to permit

EPA to set standards at any point on the continuum of risk.

Nor did Congress intend for EPA, while protecting the public

health, to blind itself to practical considerations such as whether

a standard can be attained at all, or whether an additional

increment of protection is “reasonable” in light of what society

must sacrifice to achieve it. The entire structure of the Act

contemplates the attainment of standards. In the absence of an

express provision to the contrary, § 109(b)(1) should be con-

strued to require the Administrator to consider both expected

health benefits and attainment costs in deciding what standard

provides an “adequate margin of safety.” This result comports

with a common-sense reading of the statute. *

** In the Court's Benzene decision, Justice Stevens said that “* ‘safe’ [and

presumably ‘healthful’ as well] is not the equivalent of ‘risk-free.’ There are

many activities that we engage in every day—such as driving a car or even

breathing city air — that entail some risk of accident or material health

impairment: nevertheless, few people would consider these activities “un-

safe." ” 448 U.S. at 642.

“S. Rep. No. 1196, 91st Cong., 2d Sess. 10 (1970).

* Any other interpretation would waste society's scarce resources, and

thereby diminish society's ability to protect public health or to achieve other

important objectives. Justice Stevens made a similar point in the Benzene

case when he concluded that “[i]n the absence of a clear mandate in the Act,

it is unreasonable to assume that Congress intended to give the Secretary the

unprecedented power over American industry that would result from the

Government's view. . . . [T]he Government's theory would give OSHA

power to impose enormous costs that might produce little. if any. discernible

benefit.” 448 U.S. at 645.

Indeed, EPA itself is unable to interpret § 109 in a manner

that excludes practical considerations altogether. “ Thus EPA

concedes that without some consideration of practical factors in

determining what level of protection is “adequate,” there would

be no reason to accept less than the absolute safety of a zero

standard. P.A. 82a. But given its own concession that such

factors preclude a zero-level standard, EPA cannot argue that

the statute bars consideration of the same factors in determining

whether a “margin of safety” is “adequate” for standards set at a

level above zero. Rather, EPA’s inconsistency can only be

interpreted as an attempt to maintain unfettered discretion to

consider practical factors whenever it wants, without being held

accountable on judicial review.

In short, § 109 of the Clean Air Act should be construed as

placing reasonable limits on EPA’s standard-setting discretion.

Otherwise, § 109 must be invalidated as an unconstitutional

delegation because Congress failed to make the “hard choices”

on “quintessential” legislative issues of great importance. 448

U.S. at 686 (concurring opinion of Justice Rehnquist).

* Practical factors should be considered also because EPA construes the

related provisions of § 112 of the Clean Air Act, P.A. 105a, to permit

consideration of such factors in setting emission standards for “hazardous”

air pollutants. 44 Fed. Reg. 58642, 58661 (1979). Section 112 differs from

§ 109 in that § 112 governs the class of more serious “hazardous” pollu-

tants, and therefore requires an “ample” rather than just an “adequate”

margin of safety. Yet in construing the phrase “ample margin of safety” in

§ 112, EPA has said that “there is no reason to believe that Congress

intended to make air pollution practically the sole facet of American ".fe

from which the government would attempt to eliminate risk entirely.” /d.

Accordingly, EPA considered economic and technological factors in prom-

ulgating standards under § 112 for both asbestos and vinyl chloride. See 38

Fed. Reg. 8820 (1973) (asbestos); 40 Fed. Reg. 59532 (1975), 41 Fed. Reg.

46560 (1976), 42 Fed. Reg. 28154 (1977) (vinyl chloride).

CONCLUSION

For the foregoing reasons, the Court should grant this Peti-

tion for Certiorari.

Respectfully submitted,

Epwarp W. Warren*

Ropert F. VANVoorHEES

Joun S. Hann

KIRKLAND & ELLs

Of Counsel: 1776 K Street, N.W.

Stark RITCHIE Washington, D.C. 20006

Davin T. DEAL (202) 857-5000

American Petroleum Counse! for American

Institute Petroleum Institute

EpMuNp B. Frost and Member Company Petitioners

Chemical Manufacturers Joun H. PICKERING

Association WituiaM H. Lewis, Jr.

David R. JoHNsON

Witmer, CuTLer & PICKERING

1666 K Street, N.W.

Washington, D.C. 20006

Counsel for Chemical

Manufacturers Association

November 10, 1981 J. MarsHALt COLEMAN

ATTORNEY GENERAL OF VIRGINIA

Rocer L. CHarre

ASSISTANT ATTORNEY GENERAL

Suite 308

11 South 12th Street

Richmond, Virginia 23219

Counsel for the Commonwealth

of Virginia, ex rel. the State

Air Pollution Control Board

BERNARD J. REILLY

1007 Market Street

Wilmington, Delaware 19898

Counsel for E. 1. du Pont

de Nemours & Company

*Counsel of Record

Wirkes C. Ropinson

J. Scort Brown

Gute Coast & Great PLAINs

LeGat FOUNDATION

127 West 10th Street

Room 1022

Kansas City, Missouri 64105

Counsel for St. Louis Regional

Commerce and Growth Association

Jan Eric CARTWRIGHT

ATTORNEY GENERAL OF OKLAHOMA

Neat Leaver

ASSISTANT ATTORNEY GENERAI

112 State Capitol Building

Oklahoma City, Oklahoma 73105

Counsel for State of Oklahoma

OCTOBER TERM, 1981

AMERICAN PETROLEUM INSTITUTE, ef al.,

Petitioners,

ANNE M. GorSUCH, ADMINISTRATOR,

AND ENVIRONMENTAL PROTECTION AGENCY,

Respondents.

APPENDIX TO

JOINT PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Of Counsel: Epwarp W. WarREN*

Stark RITCHIE Ropert F. VANVooRHEES

Davip T. Dear Joun S. HAHN

American Petroleum KIRKLAND & ELLis

Institute 1776 K Street, N.W.

Washington, D.C. 20006

i Te (202) 857-5000

Chemical Manufacturers

Counsel for American

Petroleum Institute

and Member Company Petitioners

Association

November 10, 1981

Joun H. PickERING

WituiaM H. Lewis, Jr.

Davip R. JoHNSON

Wiimer, CuTLer & PICKERING

1666 K Street, N.W.

Washington, D.C. 20006

Counsel for Chemical

Manufacturers Association

*Counsel of Record

Additional counsel listed inside cover.

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

J. MarsHatt CoLEMAN

ATTORNEY GENERAL OF VIRGINIA

Rocer L. CHAFFE

ASSISTANT ATTORNEY GENERAL

Suite 308

11 South 12th Street

Richmond, Virginia 23219

Counsel for the Commonwealth

of Virginia, ex rel. the State

Air Pollution Control Board

BERNARD J. REILLY

1007 Market Street

Wilmington, Delaware 19898

Counsel for E. 1. du Pont

de Nemours & Company

Wirkes C. Rosinson

J. Scott Brown

Gutr Coast & Great PLains

LEGAL FouNDATION

127 West 10th Street

Room 1022

Kansas City, Missouri 64105

Counsel for St. Louis Regional

Commerce and Growth Association

Jan Eric CARTWRIGHT

ATTORNEY GENERAL OF OKLAHOMA

Neat LEADER

ASSISTANT ATTORNEY GENERAL

112 State Capitol Building

Oklahoma City, Oklahoma 73105

Counsel for State of Oklahoma

APPENDIX A

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

No. 79-1104

AMERICAN PETROLEUM INSTITUTE, PETITIONER

Vv.

DouGLAS M. CosTLE, ADMINISTRATOR, and

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

AMERICAN PETROLEUM INSTITUTE AND 15

OF ITS MEMBER COMPANIES,

CHEMICAL MANUFACTURERS ASSOCIATION,

THE ST. Louis REGIONAL COMMERCE &

GROWTH ASSOCIATION,

NATURAL RESOURCES DEFENSE COUNCIL, ET AL.,

THE STATE OF OKLAHOMA,

E.I. Du Pont DE Nemours & Co., INTERVENORS

No. 79-1201

E.I. Du PonT DE NEMOURS AND COMPANY, PETITIONER

Vv.

DouGLas M. CosTLE, ADMINISTRATOR, and

ENVIRON MENTAL PROTECTION AGENCY, RESPONDENT

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

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

No. 79-1222

AMERICAN PETROLEUM INSTITUTE, ET AL., PETITIONERS

ENVIRONMENTAL PROTECTION AGENCY, and

DoucLas M. COSTLE, ADMINISTRATOR

No. 79-1290

CHEMICAL MANUFACTURERS ASSOCIATION, PETITIONER

DouG.Las M. CoSTLE, ADMINISTRATOR, and

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 79-1335

THE NATURAL RESOURCES DEFENSE COUNCIL, INC.,

ET AL., PETITIONERS

Vv.

DouGLas M. CosTLE, ADMINISTRATOR OF THE

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 79-1359

CHEMICAL MANUFACTURERS ASSOCIATION, PETITIONER

Vv.

DoucLas M. CosTLE, ADMINISTRATOR, and

ENVIRON MENTAL PROTECTION AGENCY, RESPONDENT

No. 79-1362

THE CONNECTICUT LUNG ASSOCIATION, INC., PETITIONER

Vv.

DouGLAS M. CoSTLE, ADMINISTRATOR OF THE

U.S. ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 79-1356

SIERRA CLUB, PETITIONER

Vv.

DouGLas M. COSTLE, ADMINISTRATOR OF THE

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT

No. 79-1365

COMMONWEALTH OF VIRGINIA, ex rel.

THE STATE AIR POLLUTION CONTROL BOARD, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY and

DouGLAS M. COSTLE, ADMINISTRATOR, RESPONDENT

No. 79-1367

CITY OF HOUSTON, TEXAS, PETITIONER

Vv.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

and DouGLAS M. COSTLE, ADMINISTRATOR, RESPONDENT

Petitions for Review of Orders of the

Environmental Protection Agency

Argued February 26,1980 ~~ Pe — xa |

C2 we ws +

Decided September 3,1981 ~" § -..

Edward W. Warren with whom Robert F. Van Voor-

hees, John S. Hahn, Stark Ritchie and David T. Deal

were on the brief, for American Petroleum Institute

petitioner in Nos. 79-1104 and 79-1222 and intervenor

in Nos. 79-1335, 79-1356 and 79-1362.

Roger L. Chaffe, Assistant Attorney General, for Com-

monwealth of Virginia, etce., petitioner in No. 79-1365.

Frederick S. Fisher and James E. Ryan, Jr., also en-

tered appearances for Commonwealth of Virginia, etc.,

petitioner in No. 79-1365.

Courtenay Ellis with whom David A. Donohoe was on

the brief, for City of Houston, Texas, petitioner in No.

79-1367. Daniel Joseph also entered an appearance for

City of Houston, Texas, petitioner in No. 79-1367.

Richard Ayres with whom David D. Doniger was on

the brief, for Natural Resources Defense Council, Inc.,

et al., petitioner in Nos. 79-1335, and 79-1362 and in-

tervenor in No. 79-1104.

John H. Pickering, Andrew T. A. MacDonald and

Edmund B. Frost were on the brief, for Chemical Manu-

facturers Association petitioner in Nos. 79-1290 and 79-

1359 and Intervenor in Nos. 79-1104, 79-1335, 79-1356

and 79-1362. David R. Johnson and John Stephen Law-

rence, Jr., also entered appearances for Chemical Manu-

facturers Association, petitioner in Nos. 79-1290 and 79-

1359 and intervenors in Nos. 79-1335, 79-1356 and

79-1362.

Joseph J. Brecher was on the brief, for Sierra Club,

Petitioner in No. 79-1356. Peter J. Herzberg also entered

an appearance for Sierra Club, petitioner in No. 79-1356.

Patrick K. O’Hare, Attorney, Environmental Protec-

tion Agency and Patrick J. Cafferty, Jr., Attorney, De-

partment of Justice with whom Angus Macbeth, Acting

Assistant Attorney General, Donald W. Stever, Attorney,

Department of Justice and Gerald K. Gleason, Deputy

Associate General Counsel, Environmental Protection

Agency were on the brief, for respondents. Jeffrey O.

Cerar, Attorney, Environmental Protection Agency also

entered an appearance for respondent, Environmental

Protection Agency.

Christopher S. Bond and Charles A. Blackman were

on the brief, for the St. Louis Regional Commerce and

Growth Association, intervenor in Nos. 79-1104, 79-1335,

79-1356 and 79-1362.

Charles S. Rogers, Assistant Attorney General, State

of Oklahoma also entered an appearance for State of

Oklahoma, etc., intervenor in No. 79-1104.

Robert R. Bonezek, Carl B. Everett, and Bernard J.

Reilly also entered appearances for E.I. DuPont De

Nemours and Company petitioner in No. 79-1201 and

intervenor in Nos. 79-1104, 79-1335, 79-1356 and 79-1362.

Before: RoBB, WALD and Mikva, Circuit Judges.

Opinion for the Court filed by Circuit Judge Ross.

Opinion dissenting in part filed by Circuit Judge WALD.

Ross, Circuit Judge: The petitions for review con-

solidated in this case challenge the primary and second-

ary national ambient air quality standards’ for ozone

promulgated by the Environmental Protection Agency

(EPA) under the Clean Air Act, as amended. 42 U.S.C.

§§ 7401, et seg. (Supp. III 1979). EPA established both

the primary and secondary standards for ozone at 0.12

*These regulations are codified at 40 C.F.R. § 50.9(a)

(1980).

parts per million (ppm) in final regulations published

on February 8, 1979. 44 Fed. Reg. 8202. Petitioners

American Petroleum Institute (API), et al., the City of

Houston, and the Commonwealth of Virginia contend

that the Administrator of EPA erred by establishing too

stringent standards. Petitioner National Resources De-

fense Council (NRDC), et al., argues that the Admin-

istrator erred by establishing standards that are too

lenient. Various petitioners raise procedural challenges,

and certain petitioners challenge regulations which im-

plement the standards. We uphold the ozone standards

because they are proper under the Act and such pro-

cedural errors as did occur do not require invalidation

of the final standards.

The standards challenged in this case establish re-

strictions on permissible levels of ozone. As with other

photochemical oxidants, ozone is not emitted directly into

the air, but is produced by complex chemical reactions

between organic compounds (precursors) and nitrogen

oxides in the presence of sunlight. Oxidant precursors

are organic compounds which can occur naturally but

are in large measure man-made. Sources of precursors

include automobile emissions of hydrocarbons, chemical

plant emissions, and gasoline vapors. Photochemical oxi-

dant concentrations can also exist where ozone from the

stratosphere intrudes into the lower atmosphere or where

naturally occurring nitrogen oxides react with hydro-

carbons produced by vegetatio:z.. Although ozone is but

one of many photochemical oxidants, total oxidant pol-

lution has been measured by reference to the ozone level

in the air since 1971.

Ozone is the primary cause of the ill effects associated

with sinog, of which it usually comprises 65-100%. At

certain concentration levels, ozone irritates the respira-

tory system and causes coughing, wheezing, chest tight-

ness, and headaches. Due to its irritating nature, ozone

can aggravate asthma, bronchitis, and emphysema. Some

studies indicate that chronic exposure to fairly low levels

of ozone may reduce resistance to infection and alter

blood chemistry or chromosone structure. Ozone can de-

stroy vegetation, reduce crop yield, and damage exposed

materials by causing cracking, fading, and weathering.

‘the goal of the Clean Air Act is to protect the public

health and welfare by improving the quality of the na-

tion’s air. 42 U.S.C. § 7401/b). Improved air quality

is accomplished by the establishment of national am-

bient air quality standards (NAAQS) and by implemen-

tation thereof through state programs to control local

sources of pollution. 42 U.S.C. § 7410. The Act directs

the Administrator to establish two types of NAAQS.

Primary ambient air quality standards are “standards

the attainment and maintenance of which in the judg-

ment of the Administrator, based on such criteria and

allowing an adequate margin of safety, are requisite to

protect the public health.” 42 U.S.C. § 7409(b) (1).

Secondary standards “specify a level of air quality the at-

tainment and maintenance of which in the judgment of

the Administrator, based on such criteria, is requisite

to protect the public welfare from any known or antici-

pated adverse effects associated with the presence of such

air pollutant in the ambient air.” 42 U.S.C. § 7409

(b) (2). State control programs must provide for the

attainment of primary standards “as expeditiously as

practicable but . . . in no case later than three years from

the date of aproval of such plan...” 42 U.S.C § 7410

(a) (2) (A) (i). State programs that implement seccnd-

ary standards must specify a “reasonable time at which

such secondary standard will be attained”. 42 U.S.C.

§ 7410(a) (2) (A) (ii). Thus, the ozone standards at is-

sue in this case must be implemented through state plans

within three years for the primary standard and within

a reasonable time for the secondary standards.? Lead

Industries Ass’n v. EPA, No. 78-2201 (D.C. Cir. June

27, 1980) slip op. at 7-8, cert. denied, 49 U.S.L.W. 3428

(Dec. 8, 1980).

EPA promulgated primary and secondary standards

for photochemical oxidants (i.e., ozone) in 1971. Both

standards were established at an 0.08 ppm hourly aver-

age not to be exceeded more than once a year. 36 Fed.

Reg. 8187 (1971). The method used to determine com-

pliance with the 1971 standards measured only ozone.

43 Fed. Reg. 26967 (1978). In 1976 EPA began to

revise the 1971 standards and in April 1977 requested

data and information relevant to the revision. 42 Fed.

Reg. 20493 (1977).

As part of the revision, EPA established a working

group within the Criteria and Special Studies Office of

its Office of Research and Development to develop a

“criteria document”. A criteria document “accurately

reflect[s] the latest scientific knowledge useful in in-

dicating the kind and extent of all identifiable effects on

public health or welfare which may be expected from the

presence of such pollutant in the ambient air, in varying

quantities.” 42 U.S.C. § 7408(a)(2); see 42 U.S.C.

§ 7409(a). In the early stages of preparing the ozone

criteria document EPA retained a panel of expert en-

vironmental consultants (the Shy Panel) and sought

their opinions on the ozone concentration levels at which

adverse health effects might be experienced. The Shy

Panel concluded that “short term exposures to ozone

in the range of 0.15 to 0.25 ppm may impair mechanical

function of the lung, and may induce respiratory and

2 Under 42 U.S.C. § 7501(a) (2) a state that cannot meet

the NAAQS for ozone by December 31, 1982 despite the im-

plementation of “‘all reasonably available measures” may seek

approval of a plan that extends the deadline for compliance

to December 31, 1987.

related symptoms in sensitive segments of the popula-

tion”. (J.A. 270) The panel recommended that the pri-

mary standard remain at 0.08 ppm. (J.A. 277) The

panel’s recommendations and conclusions were included

in the draft criteria document.

In 1974 the Administrator of the EPA established a

Science Advisory Board (SAB) to assist in establish-

ing NAAQS, among other functions. During the re-

vision of the ozone standards Congress passed the En-

vironmental Research, Development, and Demonstration

Authorization Act of 1978, PuB.L. 95-155, 91 Stat. 1260

(1978) (ERDDAA), which requires the Administrator

to submit to the SAB any “proposed criteria document,

standard, limitation, or regulation, together with rele-

vant scientific and technical information in the posses-

sion of the [EPA] . . . on which the proposed action is

based.” 42 U.S.C. § 4365(e). During the revision of the

ozone standard the SAB reviewed two full drafts and a

third draft of the summary chapter of the ozone cri-

teria document and offered comments on its content.

After examining the summary of the third draft, six

of the eleven SAB members voted to approve the cri-

teria document, with reservations and recommended

changes. Two members rejected the document, and three

members offered no judgment. The parties dispute the

effect of this “approval” under the Clean Air Act.

Neither the final criteria document nor the final ozone

standards were made available to the SAB for comment.

As a further aid to the Administrator in establishing

the ozone standards, EPA conducted a “risk assessment

study”. This study combined medical opinions as to the

necessary ozone levels for creation of certain adverse

health effects (e.g., aggravation of emphysema) with pre-

dictions as to peak ozone levels in a five-year period.

(J.A. 561-73) The study attempted to predict the prob-

ability of creating certain health problems under vari-

10a

ous possible standards. The Shy Panel relied on the

results of this study in recommending that the primary

standard remain at 0.08 ppm. Although the risk assess-

ment study results were summarized in the preamble

to the final regulations, 44 Fed. Reg. 8216 (1979), the

Administrator acknowledged that the method used in

arriving at the results was not completely reliable. 44

Fed. Reg. 8210-11 (1979). The parties dispute whether

the results of the risk assessment study played a sig-

nificant role in the establishrrent of the ozone standards.

On June 22, 1978 EPA published the proposed primary

and secondary standards for ozone. 43 Fed. Reg. 26962.

The proposed primary standard was raised to 0.10 ppm,

while the proposed secondary standard remained at 0.08

ppm. EPA also proposed a revision in the measuring

standard (the one-exceedance-per-year attainment meas-

ure) by substitution of a new standard. Under the old

standard, as long as the 6.08 ppm standard was not

exceeded more than once a year, the standard was met.

The new measuring standard is met when “the expected

number of hour[s] per calendar year with concentra-

tions above 0.10 ppm is less than or equal to one [over

a three year period)”. 43 Fed. Reg. 26968 (1978). In

setting the proposed primary standard at 0.10 ppm the

Administrator relied on studies showing adverse health

effects at ozone concentrations of 0.15 to 0.35 ppm. 43

Fed. Reg. 26966 (1978). He also relied on medical

opinions and some of the conclusions of the risk assess-

ment study. /d. at 26966-67. The proposed secondary

standard was based on predictions as to the effects of

certain ozone concentrations on crop yields due to leaf

damage. 43 Fed. Reg. 26969 (1978).

After publication of the proposed standards, EPA con-

ducted four public hearings on the standards and re-

ceived numerous comments. Various governmental agen-

cies commented on the proposed standards, including the

lla

Departments of Interior, Energy, and Transportation,

the United States Public Health Service, the Virginia

Air Pollution Control Board, and various White House

officials. 44 Fed. Reg. 8206-07 (1979). Some of these

comments occurred after the official comment period

closed and are the subject of dispute in this case.

In February 1979 EPA published final primary and

secondary standards for ozone, raising both to 0.12

ppm. 44 Fed. Reg. 8202. The Administrator determined

that “the most probable level for adverse health effects in

sensitive persons, as well as in healthier (less sensitive)

persons who are exercising vigorously, falls in the range

of 0.15 to 0.25 ppm.” 44 Fed. Reg. 8216 (1979). He

based his conclusion on the criteria document, the com-

ments submitted on the proposed standards, the report

of the Shy Panel, and medical opinions collected during

the risk assessment study. 44 Fed. Reg. 8215-16 (1979).

The Administrator also concluded that the 0.12 ppm

standard provides an adequate margin of safety. 44 Fed.

Reg. 8216-17 (1979). He raised the proposed secondary

standard based on a determination that average daily

maximum ozone concentrations of 0.12 ppm would not

harm crop yields. 44 Fed. Reg. 8217-18 (1979). Finally,

in addition to establishing ozone standards, EPA pub-

lished four models for determining the amount of hydro-

carbon reduction necessary to meet the standards. 44

Fed. Reg. 8234 (1979). No petitions for reconsideration

of the standards were filed with EPA. Petitions for re-

view pursuant to 42 U.S.C. § 7607(b) (1) followed.

II.

ISSUES PRESENTED By THE PETITIONS

The petitions for review present both substantive and

procedural challenges to the primary and secondary ozone

standards promulgated by EPA. Some petitioners con-

tend that the standards are irrational and unsupported

12a

by the record. Other petitioners argue that the stand-

ards do not contain an adequate margin of safety, are

too stringent given naturally occurring ozone levels, and

are not economically feasible. It is also argued that the

measurement standards and control strategies promul-

gated by EPA are unreasonable and unsupported by the

record. As to the procedural allegations, it is argued

that the Administrator erred in his use of the Science

Advisory Board, the Shy Panel, and the risk assessment

study. Various petitioners contend that certain items

excluded from the record should have been included, while

other petitioners argue that some material was untimely

inserted in the record. After discussing the standard of

review which governs petitions for review under the

Clean Air Act, we address each significant argument in

turn.

III.

STANDARD OF REVIEW

Section 3¢7 of the Clean Air Act provides, in relevant

part:

(b) (1) A petition for review of action of the Ad-

ministrator in promulgating any national

primary or secondary ambient air quality

standard . . . may be filed only in the United

States Court of Appeals for the District of

Columbia.

. - =

(d) (1) This subsection applies to—

(A) the promulgation or revision of any

national ambient air quality standard under

section 7409 of this title.

(9) In the case of review of any action of the

Administrator to which this subsection ap-

plies, the court may reverse any such action

found to be—

l3a

(A) arbitrary, capricious, an abuse of dis-

cretion, or otherwise not in accordance with

law;

(B) contrary to constitutional right, power,

privilege or immunity ;

thority, or limitations, or short of statutory

right; or

(D) without observance of procedure re

quired by law, if (i) such failure to observe

such procedure is arbitrary or capricious,

(ii) the requirement of .. . [a timely objec-

tion] has been met, and (iii) [the errors

were so serious and related to matters of

such central relevance to the rule that there

is a substantial likelihood that the rule

would have been significantly changed if

such errors had not been made] ....

42 U.S.C. § 7607.

These provisions of the Act assign this court a re-

stricted role in reviewing air quality standards. Lead

Industries Ass’n, Inc. v. EPA, supra at 30. The Ad-

ministrator’s construction of the Act will be upheld if it

is reasonable, id. at 29-30, and though it is our duty to

undertake a “searching and careful” inquiry into the

facts, our view of the evidence “is not designed to en-

able us to second-guess the agency’s expert decision-

maker.” Jd. at 26, 27. Reversal for procedural defaults

under the Act will be rare because the court must first

find that the Administrator was arbitrary or capricious,

that he overruled a relevant and timely objection on the

point in question, and that the errors were so sig-

nificant that the challe:.zed rule would likely have been

different without the error. 42 U.S.C. § 7607(d) (9) (D);

Sierra Club v. Costle, No. 79-1565 (D.C. Cir. April 29,

1981) slip op. at 182-83, 193-94.

I4a

IV.

SUBSTANTIVE CHALLANGES TO THE OZONE STANDARDS

Petitioner American Petroleum Institute contends that

the primary ozone standard is not rational because, it

alleges, no adverse health effects have been proven below

0.25 ppm with two hours exposure. (Br. for API at 31-

44) API also argues that EPA must consider whether

the 0.12 ppm standard is attainable and whether the

anticipated costs of meeting that standard are justified

when compared with the results to be achieved. Jd. at

51-68. Petitioner Houston contends that the ozone stand-

ards are arbitrary and capricious because natural ozone

levels and other physical phenomena in the Houston area

prevent it from meeting the standards. (Br. for Houston

at 4-22) Houston argues that the standards are also

arbitrary and capricious because the control strategies

promulgated by EPA will not reduce ozone levels. Id.

at 22-26.

Petitioner Commonwealth of Virginia contends that

EPA acted arbitrarily and capriciously in retaining the

single hour averaging test for measuring compliance

with the ozone standards. Virginia argues that the

method chosen is not supported by logic or medical evi-

dence, is costly, and will have no demonstrable bene-

ficial effect on air quality. (Br. for Virginia at 3-13)

Petitioner Natural Resources Defense Council contends

that the Administrator misinterpreted the Act in adopt-

ing standards for ozone alone and thus rescinding exist-

ing standards for other photochemical oxidants. (Br.

for NRDC at 35-44) NRDC also argues that the Ad-

ministrator failed to establish an adequate margin of

safety in the primary ozone standard. /d. at 44-66.

API’s argument that the Administrator erred in not

considering attainability and cost justifications for the

ozone standards was specifically rejected in the Lead In-

dustries case, supra at 32. We stated there that under

15a

section 109 of the Act “the Administrator may not con-

sider economic and technological feasibility in setting

air quality standards . . . [because] of a deliberate

decision by Congress to subordinate such concerns to the

achievement of health goals.” Lead Industries, supra at

33. In a lengthy analysis of the Act and its legislative

history we concluded that the “technology-forcing” re-

quirements of the Act were expressly designed to force

regulated sources to develop pollution control devices that

might at the time appear to be economically or tech-

nologically infeasible. Lead Industries, supra at 34-35.

API’s other argument is that the standards are not

suported by substantial evidence. We reject this argu-

ment because the record is replete with support for the

final standards. The studies discussed in the criteria

document constitute a rational basis for the finding that

adverse health effects occur at ozone levels of 0.15 to

0.25 ppm for sensitive individuals. We need not find

that each study discussed in the criteria document is

accurate and reliable. The proper function of the court

is not to weigh the evidence anew and make technical

judgments; our role is limited to determining if the Ad-

ministrator made a rational judgment. We find that the

Administrator’s conclusion that normal body functions

are “disrupted” at low ozone levels, 44 Fed. Reg. 8213

(1979), is supported by the studies of DeLucia and

Adams (effects at 9.15 to 0.30 ppm) (J.A. Ex. 1 at 9-18),

Hazucha (effects at 0.25) (J.A. Ex. 1 at 1-15), Wayne

(effects at 0.15) (J.A. Ex. 1 at 10-57), Herman (effects

at 0.15 to 0.39) (J.A. Ex. 1 at 1-22-23), among others

indicated in the record. The court finds no reason to hold

that the Administrator abused his discretion in crediting

the various studies relied on, even given the acknowledged

uncertainties in some of the conclusions. The Adminis-

trator noted that “a clear threshold of adverse health

effects cannot be identified with certainty for ozone.”

44 Fed. Reg. 8213 (1979). Because the Administrator

16a

acknowledged the uncertainty of his task and made a

rational judgment, we cannot second-guess his conclu-

sion. Lead Industries, supra, at 25-28; See Motor &

Equipment Manufacturers Ass’n v. EPA, 201 U.S. App.

D.C. 109, 119-20, 627 F.2d 1095, 1105-06 (1979), cert.

denied, 446 U.S. 952 (1980); Hercules, Inc. v. EPA,

194 U.S. App. D.C. 172, 598 F.2d 91 (1978).

Houston’s argument that because natural factors make

attainment impossible the Administrator acted arbitrarily

and capriciously in setting the primary ozone standard

at an “unattainable” level is addressed in part by our

analysis of API’s attainability argument. Attainability

and technological feasibility are not relevant considera-

tions in the promulgation of national ambient air quality

standards. Lead Industries, supra at 32-33. Further,

the agency need not tailor national regulations to fit each

region or locale. NRDC v. EPA, No. 79-1639 (D.C. Cir.

May 7, 1981) slip op. at 34. We also note that com-

pliance extensions are available in some cases, 42 U.S.C.

§ 7501(a)(2) (Supp. III 1979), and that Congress is

aware that some regions are having difficulty in meeting

the national standards. See 42 U.S.C. § 7501, et seq.

(Supp. III 1979) (Part D of Title I, setting special re-

quirements for states which have not met standards).

Houston also contends that EPA’s strategies for de-

ducing ozone concentrations rely on a faulty premise:

that ozone is caused in part by high concentrations of

hydrocarbons in the air. In arguing this point Houston

relies on a study which allegedly establishes that reduc-

tion of hydrocarbon levels will not reduce ozone levels.’

* Houston aiso appended to its brief as Exhibit A a recent

study which it contends supports its position in this regard.

That exhibit is not part of the record and cannot under-

cut the Administrator’s conclusions on review. 42 U.S.C.

§ 7607(d) (7) (A) (Supp. III 1979) ; see American Petroleum

Institute v. Costle, 197 U.S. App. D.C. 254, 609 F.2d 20

(1979).

17a

The study in question was considered by EPA and re-

jected on several grounds which undercut the reliability

of its conelusions. 44 Fed. Reg. 8235 (1979). Because

control of ozone by reduction of hydrocarbon levels is

an established methodology (J.A. Ex. 1 at 1-2, 1-3) and

because Houston’s record evidence in rebuttal is sparse,

we cannot find that the Administrator is wrong on this

issue.

Petitioner Commonwealth of Virginia challenges the

method which EPA selected to measure compliance with

the primary standard. The method chosen by EPA meas-

ures the highest average ozone level in any one hour

to determine compliance. 44 Fed. Reg. 8217-18 (1979).

Virginia argues that it would be better to use a daily

average ozone level to measure exposure. We find that

the Administrator’s selection of the maximum hourly

average method is reasonable because it is calculated to

measure the maximum exposure, which has been found

to be a relevant factor in determining the likely .con-

sequences of ozone exposure.

Petitioner National Resources Defense Counsel argues

that the Administrator has abdicated responsibility for

regulation of photochemical oxidants other than ozone by

relabeling the regulations here at issue. In 1971 when

the first air quality standards were promulgated, the title

of the regulation was “National primary and secondary

ambient air quality standards for photochemical oxi-

dants”. 36 Fed. Reg. 8187 (1971). The title was some-

what misleading because the 1971 standards applied only

to ozone, which was the sole photochemical oxidant meas-

ured for compliance. 43 Fed. Reg. 26967 (1978). The

new standards challenged in this case expressly apply

only to ozone and do not attempt to establish permissible

levels for other photochemical oxidants. 43 Fed. Reg.

26985 (1978).

l8a

Despite NRDC’s characterization of the Administra-

tor’s action, it appears that EPA has not abandoned its

statutory responsibility to regulate pollutants which “may

reasonably be anticipated to endanger public health or

welfare.” 42 U.S.C. § 7408(a) (1) (A) (Supp. III 1979).

Rather, the Administrator has chosen to regulate the

photochemical oxidant (ozone) that, in his judgment pre-

sents a predictable danger. (J.A. Ex. 1 at 1-31) The

setting of the ozone standard is not the only action taken

by the agency with regard to photochemical oxidants;

research concerning the less well known oxidants con-

tinues. 44 Fed. Reg. 8204 (1979). The Administrator’s

approach to photochemical oxidants is reasonable, given

the uncertain information concerning the class as a whole.

NRDC also argues that the Administrator failed to es-

tablish an adequate margin of safety in the primary

standard. As required by the statute, the Administrator

promulgated air quality standards that are calculated

to “protect individuals who are particularly sensitive to

the effects of pollution.” Lead Industries, supra, at 43.

In setting margins of safety the Administrator need not

regulate only the known dangers to health, but may

“err” on the side of overprotection by setting a fully

adequate margin of safety. See Environmental Defense

Fund v. EPA, 194 U.S. App. D.C. 148, 161-62, 598

F.2d 62, 80-81 (1978). Of course the Administrator’s

conclusions must be supported by the record, and he may

not engage in sheer guesswork. Where the Administra-

tor bases his conclusion as to an adequate margin of

safety on a reasoned analysis and evidence of risk, the

court will not reverse. NRDC argues that the Adminis-

trator erred in setting a primary standard that does not

protect sensitive individuals against easily predicted

risks. In so arguing NRDC essentially ignores the mixed

results of the medical studies evident in the record, choos-

ing instead to rely only on the studies that favor its

position. The Administrator, however, was required to

19a

take into account all the relevant studies revealed in the

record. Because he did so in a rational manner we will

not overrule his judgment as to the margin of safety.

The Administrator concluded that the medical evidence

“suggest(ed) the real possibility of significant human ad-

verse health effects below 0.15 ppm. Consequently...

[he] determined that a standard of 0.12 ppm is necessary

and is sufficiently prudent unless and until further studies

demonstrate reason to doubt that it adequately protect

public health”. 44 Fed. Reg. 8217 (1979). Having de-

termined that the “probable level for adverse effects in

sensitive persons is in the range of 0.15-0.25 ppm”, 44

Fed. Reg. 8216 (1979), the Administrator considered the

evidence in the record that related to less predictable

risks of ozone exposure, a relevant consideration in set-

ting margins of safety. The Administrator considered

the lack of medical evidence concerning especially sensi-

tive persons, the possibility that ozone and other pollu-

tants might combine to create cumulative effects, the

significance of long-term exposure to otherwise safe

ozone levels, inconclusive studies indicating very low

ozone damage thresholds, and uncertainties arising from

meterological and calibration errors in measurements. /d.

The Administrator also indicated that the results of the

risk assessment study, described at page 4, supra, did

not support any safety margin above 0.12 ppm. 44 Fed.

Reg. 8217 (1979). Given the nature of the task assigned

to the Administrator, which is to make an informed

judgment based on available evidence, we find that the

Administrator’s selection of a margin of safety is ra-

tional. See Lead Industries, supra at 62.

Vv.

PROCEDURAL CHALLENGES

Petitioners allege numerous procedural errors: EPA’s

relationship with the Science Advisory Board (SAB) and

20a

Advisory Panel on Health Effects of Photochemical Oxi-

dants (Shy Panel), post-comment period contacts between

EPA and the White House, exclusion of documents from

the record, and last-minute additions to the record by

EPA.

Under the procedural provisions of the Clean Air Act,

42 U.S.C. § 7607(d), we may invalidate the ozone stand-

ard because of procedural error only if (1) the agency's

failure to observe procedural requirements was arbitrary

and capricious, (2) an objection was raised during the com-

ment period, or, where the grounds for such an objection

arose after the comment period and the objection is of

“central relevance to the outcome of the rule,” the objec-

tion was raised on a petition for reconsideration before the

agency, and (3) “the errors were so serious and related to

matters of such central relevance to the rule that there is

a substantial likelihood that the rule would have been sig-

nificantly changed if such errors had not been made.” 42

U.S.C. § 7607(d) (7) & (8). As we noted in Sierra Club

v, Costle, supra at 183, “(t]he essential message of so rig-

orous a standard is that Congress was concerned that EPA’s

rulemaking not be casually overturned for procedural rea-

sons, and we of course must respect that judgment.”

1. Science Advisory Board (SAB)

API and Houston contend that in promulgating the

ozone standards EPA violated section 8(e) of ERDDAA,

42 U.S.C. § 4365(e) (Supp. III 1979) by failing to obtain

approval of the criteria document from the SAB and to

submit the proposed standards to the SAB for review. Sec-

tion 8(e) provides, in relevant part, that

(e)(1) The Administrator, at the time any pro-

posed criteria document, standard, limitation, or reg-

ulation under the Clean Air Act .. . is provided

to any other Federa] agency for formal review and

comment, shall make available to the [Science Ad-

2la

visory] Board such proposed criteria document,

standard, limitation, or regulation, together with

relevant scientific and technical information... .

(2) The Board may make available to the Ad-

ministrator, within the time specified by the Ad-

ministrator, its advice and comments on the ade-

quacy of the scientific and technical basis of the pro-

posed criteria document, standard, limitation, or

regulation, together with any pertinent information

in the Board’s possession. (Emphasis supplied)

The language of the statute indicates that making a pro-

posed criteria document and standard available to the SAB

for comment is mandatory but that SAB approval is not

required before proceeding to the final stage of rulemaking.

This interpretation is supported by the Conference Report

underlying this provision of the ERDDAA, which states

in pertinent part that

The Science Advisory Board is intended to be

advisory only. The Administrator will still have the

responsibility for making the decisions required of

him by law. The reviews and comments of the

Board are to be provided to the Administrator for

his use... .

H.R. Rep. No. 95-722, 95th Cong., Ist Sess. 16 (1977).

While “the intent of [the statutory] language is to insure

that the Board is able to comment in a well-informed man-

ner on any regulation that it so desires”, “it should not be

mandatory that they comment on all proposed regulations.

... Id, at 17 and 16. In short, the EPA was required

urder ERDDAA to submit the criteria document and

standard to the SAB for comment, but it was not obligated

to obtain SAB approval of either before promulgation of

a fina] standard.

The parties do not dispute that EPA submitted two

drafts of the criteria document to the SAB and that sub-

stantial revisions were requested by the Board. The SAB

22a

agreed to cast ballots indicating approval or disapproval

of the document based upon a third draft of only the “sum-

mary and conclusions” chapter of the document. After

submission of the chapter, six of the eleven members of the

SAB voted to approve the document subject to (1) stated

reservations and (2) the assumption that the revised chap-

ter accurately reflected corresponding changes in the entire

document. (J.A. at 289-306) Two SAB members found the

document unacceptable, and the remaining three said that

they were unable to make a judgment at that time. Jd.

The petitioners contend that the final criteria document,

which was never submitted to the SAB, did not incorporate

the changes requested by the Board, while EPA argues

that the final criteria document adequately addressed the

SAB’s concerns.

The EPA action does not constitute a violation of section

8(e) of the ERDDAA. The Act requires only that the EPA

submit the criteria document to the Board for advice and

comment; it does not require that the Administrator obtain

approval of the SAB or incorporate all suggested changes.

While it might have been preferable for the EPA to have

submitted the final criteria document to the SAB, we note

that the SAB itself agreed to the course followed. (J.A. Ex.

2 at 563, 578) Given the extent of SAB comment on the

criteria document, we cannot find that the document was

not “made available” to the Board within the meaning of

Section 8(e).

The proposed ozone standard, on the other hand, was

never made available to the Board for advice and comment.

Section 8(e) makes the submission of any proposed stand-

ard to the SAB mandatory. EPA contends that because

the standard is based on the criteria document, submission

of the standard to the SAB would have been redundant.

This argument is unversuasive; the statute explicitly man-

dates that standards be submitted to the Board for review.

Accordingly, the failure to submit the standards was a vio-

23a

lation of procedure required by law. We cannot find, how-

ever, that this error was “so serious and related to matters

of such central relevance to the rule that there is a sub-

stantial likelihood that the rule would have been signif-

icantly changed” had the proposed standards been sub-

mitted to the SAB. 42 U.S.C. § 7607(d) (8). The final

standard of 0.12 ppm represents an allowance for a margin

of safety in light of the adverse health effects range stated

in the criteria document (0.15-0.25 ppm). Because any

SAB review of the standard would have involved review

of the criteria document, i.e., the scientific and technical

basis for the standard, we cannot hold that the standard

would likely have been significantly changed had it been

submitted to the Board. The Administrator’s fina] stand-

ard, as noted supra at 8, is rational and supported by the

record. Although the failure to submit the proposed stand-

ards to the SAB was a violation of section 8(e) of the

ERDDAA, the circumstances indicate that the error was

not so central as to constitute grounds for invalidating the

final standards.

2. Shy Health Effects Panel and Risk Assessment Study

API and Houston also argue that the EPA Advisory

Panel on Health Effects of Photochemical Oxidants (Shy

Panel) was an advisory committee within the meaning of

the Federal Advisory Committee Act (FACA). 5 U.S.C.

app. I, § 1 et seg. (Supp. I 1977). Petitioners assert that

because EPA failed to observe several requirements of

FACA, the actions of the Shy Panel and the EPA reliance

on the panel’s risk assessment study require invalidation

of the standard.

In early 1977 EPA officials responsible for developing

the ozone standard asked Dr. Car! Shy of the Institute for

Environmental Studies, University of North Carolina at

Chapel Hill, to head a panel of paid environmental experts

which would prepare “a detailed report on the translation

24a

of health data into an ambient air quality standard for

photochemical oxidants.” (Br. of API at 20) Dr. Shy was

a leading advocate of the existing 0.08 ppm ozone standard.

Id. The panel met privately on June 7 and 8, 1977. A first

draft of the panel report, co-authored by Shy and an EPA

official, strongly endorsed the existing 0.08 standard. Fol-

lowing some minor revisions, the final draft of the Shy

Panel report was submitted to the EPA in late 1977, made

available for public comment in December 1977, and placed

in the rulemaking docket on March 22, 1978. (Br. of EPA

at 126) The report, which used a “risk assessment” tech-

nique to conclude that 0.08 ppm was the proper ozone stand-

ard, was made part of the criteria document and cited as

one of the bases for the fina] 0.12 ppm standard. (Br. of

API at 29)

The FACA defines an advisory committee, in relevant

part, as “any ... panel... which is. . . established or

utilized by one or more agencies, in the interest of ob-

taining advice or recommendations for . . . one or more

agencies... .” 5 U.S.C. app. § 3(2) (C). Petitioners con-

tend that because the Shy Panel clearly is an advisory

committee within the meaning of this provision, the con-

duct of the panel violates several provisions of FACA

and that EPA reliance on the panel’s study as a basis

for the final rule requires invalidation of the standard.

For example, it is argued that the choice of a known

partisan to chair the panel violates the FACA require

ments that the committee be “fairly balanced” and that

it not be “inappropriately influenced” by any “special

interest.” 5 U.S.C. app. § 5(b)(2)-(3). It is also as-

serted that the private meetings of the panel violate the

FACA requirement that public notice and opportunity for

public participation be given. 5 U.S.C. app. §§ 10(a) (2)

and (d)(3). EPA asserts, on the other hand, that the

Shy Panel is not subject to FACA because the group con-

sisted of paid consultants and the legislative history of

25a

FACA indicates that the Act was not intended to apply

to persons having contractual relationships with the gov-

ernment. CONF. REP. No. 92-1403, 92d CoNG., 2d SEss.

(1972). See Lombardo v. Handler, 397 F. Supp. 792

(D.D.C. 1975), aff'd mem., 178 U.S. App. D.C. 277, 546

F.2d 1043 (1976), cert. denied, 431 U.S. 932 (1977). In

any event, argues EPA, none of the Shy Panel actions

violated FACA.

We need not reach the questions whether the Shy Panel

was an advisory committee within the meaning of FACA

and whether violations of FACA occurred. Even were we

to find that the panel was subject to FACA, that viola-

tions of the Act occurred, and that reliance on the risk

assessment study was therefore illegal, we would not be

able to say that there is a substantial likelihood that the

0.12 ppm standard would have been significantly different

if such errors had not been made. The ultimate adoption

of a 0.12 ppm standard constitutes a rejection of the Shy

Panel’s conclusion that the ozone standard should not be

relaxed. Moreover, even though the Shy Report was cited

as one of the bases for the final standards, the criteria

document otherwise fully supports the 0.12 ppm standard

as a figure representing a margin of safety below the

0.15-0.25 ppm danger zone. In short, absent the Shy

Panel report, there is a substantial] likelihood that the

standard would have been the same. We therefore cannot

invalidate the standard based on the alleged procedural

irregularities.

3. EPA Exclusion of API Submission Regarding

Natural Hydrocarbons

API asserts that the EPA erred i failing to consider

and by excluding from the docket and record an API post-

comment period submission concerning natural organic

emissions from vegetation.

26a

Section 307(d) (4) (B) of the Clean Air Act, 42 U.S.C.

$ 7607(d) (4) (B) requires the Administrator to place in

the docket all documents, even those not submitted during

the comment period, determined to be “centrally relevant”

to the rulemaking. API, in submitting the above docu-

ments, noted in its request that they related to the issue

of whether “attainment of the proposed standards would

be precluded in most areas of the nation by natural back-

ground levels of ozone resulting in part from natural

hydrocarbon emissions.” (J.A. at 1003) EPA refused to

docket most of the documents submitted by API on the

ground that the question of attainability is not relevant

to the setting of ambient air quality standards under the

Clean Air Act. As noted, supra at 10, the EPA position

that attainability is not central to a rulemaking of this

type is correct. Accordingly, EPA’s decision to exclude

the API submission was proper.

4. EPA’s Last-Minute Addition to the Record

Finally, NRDC contends that EPA violated the admin-

istrative procedure requirements of the Clean Air Act by

placing in the record, after the close of the comment

period and one day before promulgation of the final rule,

an EPA staff paper entitled “Evaluation of Alternative

Secondary Ozone Air Quality Standards”. The statement

accompanying the final rule indicated that this study was

the primary basis for the change from an 0.08 ppm to

0.12 ppm secondary standard. 44 Fed. Reg. 8217 (1979).

NRDC argues that the failure to give notice or oppor-

tunity to comment on any analysis so central to the final

decision warrants invalidation of the secondary standard.

The last-minute addition to the record of a study which

constituted the basis for the final secondary standard is

disturbing. The study was never exposed to public scru-

tiny or comment. However, the procedural requirements

of the Clean Air Act do not permit NRDC to raise this

27a

objection for the first time on appeal. See Oljato Chapter

of the Navajo Tribe v. Train, 169 U.S. App. D.C. 195,

207-08, 515 F.2d 654, 666-67 (D.C. Cir. 1975). Section

307(d) (7) (B) of the Act, 42 U.S.C. § 7607(d) (7) (B)

provides that:

(B) Only an objection to a rule or procedure

which was raised with reasonable specificity during

the period for public comment (including any pub-

lic hearing) may be raised during judicial review.

If the person raising an objection can demonstrate

to the Administrator that it was impracticable to

raise such objection within such time or if the

ground for such objection arose after the period for

public comment (but within the time specified for

judicial review) and if such objection is of central

relevance to the outcome of the rule, the Adminis-

trator shall convene a proceeding for reconsidera-

tion of the rule and provide the same procedural

rights as would have been afforded had the informa-

tion been available at the time the rule was proposed.

If the Administrator refuses to convene such a pro-

ceeding, such person may seek review of such re-

fusal in the United States court of appeals for the

appropriate circuit (as provided in subsection (b)

of this section). Such reconsideration shall not post-

pone the effectiveness of the rule. The effectiveness

of the rule may be stayed during such reconsidera-

tion, however, by the Administrator or the court for

a period not to exceed three months.

The statute states that before this court may review a

procedural objection the parties must raise the objection

on petition for reconsideration before the EPA when the

grounds for such objection “arose after the period for

public comment (but within the time specified for judicial

review”. This reading is confirmed by the legislative

history of this provision, which states in pertinent part:

Section 307(d)(7)(B) would specify the circum-

stances in which a reviewing court may consider

28a

data and arguments that were not presented to the

agency during the rulemaking. Even in such cases,

however, the Agency must first be given an opportun-

ity to pass on the significance of the materials and

determine whether supplementary proceeding [sic}

are called for or not. Thus, the committee bill

confirms the court’s decision in Oljato Chapter of

the Navajo Tribe v. Train, 515 F.2d 654 (D.C. Cir.

1975).

H.R. Rep. 95-294, 95th ConG., Ist Sess. 323 (1977). See

generally, Sierra Club v. Costle, supra at 193-94.

The record before us does not suggest that any party,

including NRDC, filed petitions for reconsideration with

the EPA. The grounds for NRDC’s objection were clear

as of the date of promulgation of the final rule. Had

NRDC complied with the sta\utory requirement of filing

a petition for reconsideration, it could have commented

on the staff study and the EPA could have responded

during the period when the petition was pending. Be-

cause the required petition for reconsideration was never

filed, we cannot reach the merits of the NRDC objection.

See generally, Sierra Club v. Costle, supra at 200-201 &

n.497.

Although we refer to a “petition for reconsideration”

in this opinion, it should be noted that any formal com-

munication to the Administrator that specifically states

an objection, requests reconsideration of Agency action

because of the objection, and provides notice to interested

parties, would satisfy the statutory requirement for an

“objection . . . raised with reasonable specificity.” 42

U.S.C. § 7607(d)(7)(B). The record reflects no such

formal communication from NRDC.

NRDC contends that a series of post-comment period

oral contacts between officials of the EPA and the White

House and its agencies were not documented in the docket

29a

or the record. NRDC argues that this constitutes a viola-

tion of Clean Air Act Section 307(d) (4) (B) (ii), 42

U.S.C. § 7607 (d) (4) (B) (ii) (1976), which provides that:

(ii) The drafts of proposed rules submitted by

the Administrator to the Office of Management and

Budget for any interagency review process prior to

proposal of any such rule, all documents accompany-

ing such drafts, and all written comments thereon

by other agencies and all written responses to such

written comments by the Administrator shall be

placed in the docket no later than the date of pro-

posal of the rule. The drafts of the final rule sub-

mitted for such review process prior to promulgation

and all such written comments thereon, all docu-

ments accompanying such drafts, and written re-

sponses thereto shall be placed in the docket no later

than the date of promulgation.

As we have said, a petitioner must raise a procedural

objection with the EPA if this court is to consider the

objection. 42 U.S.C. § 7607(d) (7) (B). This rule applies

even when the grounds for the objection first became

known to the petitioner after the comment period ended,

but before the period for petitioning for review expired.

This is evident from the statute: “. . . if the grounds for

such objection arose after the period for public comment

(but within the time specified for judicial review) and if

such objection is of central relevance to the outcome of

the rule, the Administrator shall convene a proceeding

for reconsideration of the rule and provide the same pro-

cedural rights as would have been afforded had the infor-

mation been available at the time the rule was proposed.”

42 U.S.C. § 7607(d) (7) (B).

According to NRDC, it was alerted to the White House

contacts as early as February 26 and 27, 1979, when

hearings on executive branch review of environmental

regulations were held by the Senate Subcommittee on

Environmental Pollution. (NRDC Br. at 19, n.46, 28,

30a

n.53) The Subcommittee examined the role of White

House economic advisers. The fina] regulations were pub-

lished in the Federal Register on February 8, 1979. 44

Fed. Reg. 8202. Thereafter NRDC had sixty days to file

its petition for review. 42 U.S.C. § 7607(b) (1). In that

period NRDC could have petitioned the EPA for recon-

sideration based on its objection to the White House con-

tacts. Because NRDC failed to exhaust the administra-

tive remedy specifically required by the Act we may not

and do not consider this objection to the Administrator’s

action. 42 U.S.C. § 7607(d)(7)(B); § 7607(d) (9) (D)

(ii).

VI.

CONCLUSION

In summary, we hold that the primary and secondary

standards for ozone emission are supported by a rational

basis in the record. Although the EPA procedures were

not a model of regulatory action, we hold that none of the

alleged procedural errors warrants invalidation of the

final standards.

Affirmed.

3la

WALD, Circuit Judge, dissenting in part: I concur in

all respects with Judge Robb’s majority opinion, save

one: I am troubled by the manner in which the court

refuses to decide the ex parte issue for failure to raise it

properly under section 307.

The majority opinion disposes of NRDC’s challenge

concerning post-comment period White House contacts by

holding that NRDC failed to raise this objection before

EPA in a timely manner, and is therefore precluded

from doing so here under 42 U.S.C. § 7607(d) (9) (D);

§ 7607 (d) (7) (B). EPA itself, however, nowhere claims

such a bar to deciding this issue on the merits, and I find

the present record inconclusive on whether this issue

was appropriately brought to EPA’s attention. I would

therefore have posed a single interrogatory to the parties

to ascertain whether a timely objection by NRDC was in

fact made on this issue so as to bring it within the scope

of our review under this statute.

As the majority recognizes, the relevant section, 42

U.S.C. § 7607(d) (7) (B), requires only an “objection [of

central relevance] . . . raised with reasonable specificity”

to require the Administrator to convene a proceeding for

reconsideration.

While we may be confident here that any formal peti-

tions for reconsideration would appear in the record, we

cannot be as sure about the presence of other, less formal

objections to the rulemaking. The latter would not neces-

sarily appear in the record on appeal, because the record

for judicial review as defined in section 307(d) (7) (A)

does not include all post-promulgation objections. It is

also possible that an objection made to the alleged ex

parte contacts even before promulgation might not have

been placed in the record as being “centrally relevant.”

Without more reliable knowledge that no reasonably

specific, timely objection was made by NRDC regarding

32a

post-comment period communications, I would not find the

issue barred in this court without some statement by the

parties addressing this point. My suspicion that an

appropriate objection may in fact have been made is

fueled by (1) Environmental Defense Fund testimony in

the February, 1979 hearings before the Senate Subcom-

mittee on Environmental Pollution,' that it had written

Administrator Costle two weeks before about White

House-EPA ex parte contacts; and (2) EPA’s own fail-

ure to object to NRDC’s claims on the ground that the

claims were not properly raised before the agency. EPA,

in fact, defends exclusively on the merits, asserting that

the post-comment period White House communications

were proper and duly recorded. See Brief for Respond-

ent EPA at 101-10.

In short, I do not think it reasonable to assume, on the

record before us and in the absence of any such assertion

by EPA, that no timely objection was made on the ex

parte issue. I would instead have resolved this factual

ambiguity in the record before deciding whether to pass

on the merits of the ex parte issue.

' See Executive Branch Review of Environmental Regula-

tions: Hearings Before the Subcomm. on Environmental

Pollution of the Senate Comm. on Environment and Public

Works, 96th Cong., Ist Sess. 57 (Feb. 26, 1979) (testimony

of Robert Rauch, Staff Attorney, Envt’'l Def. Fund).

33a

APPENDIX B

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

No. 79-1104

AMERICAN PETROLEUM INSTITUTE, PETITIONER *

DouGLas M. CosTLE, ADMINISTRATOR, AND

ENVIRONMENTAL PROTECTION AGENCY, RESPONDENTS *

AMERICAN PETROLEUM INSTITUTE and 15

of its member companies

CHEMICAL MANUFACTURERS ASSOCIATION

THE ST. Louis REGIONAL COMMERCE &

GROWTH ASSOCIATION

NATIONAL RESOURCES DEFENSE COUNCIL, et al.

THE STATE OF OKLAHOMA

E.I. Du Pont De Nemours & Co.

INTERVENORS

* Consolidated with the following cases (identified by this

Circuit’s case number and petitioner), in all of which the

Environmental Protection Agency is the respondent: No.

79-1201, E. I. Du Pont De Nemours and Company; No. 79-

1222, American Petroleum Institute, et al.; No. 79-1290,

Chemical Manufacturers Association; No. 79-1335, The

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

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

34a

On Petitioners’ Motion to Correct the Record

Filed November 6, 1979

Edward W. Warren, Robert F. Van Voorheer, John S.

Hahn, Robert R. Bonzcek, Bernard J. Reilly, Carl B.

Everett, John H. Pickering, Andrew T. A. Macdonald and

David R. Johnson were on the motion to correct the

record, for petitioners American Petroleum Institute, et

al. in Nos. 79-1104, 79-1201, 79-1222, 79-1290, 79-1359

and 79-1370 and intervenors in Nos. 79-1335, 79-1356 and

79-1362.

Patrick J. Cafferty, Attorney, Department of Justice,

was on the opposition to motion to correct the record, for

respondent, Environmental Protection Agency.

Richard E. Ayres, Peter J. Herzberg and David D.

Doniger were on the opposition to motion to correct the

record, for intervenor National Resources Defense Coun-

cil, et al. in No. 79-1104 and petitioner in Nos. 79-1335

and 79-1362.

Also Joseph J. Brecher and Peter J. Herzberg entered

appearances, for petitioner Sierra Club in No. 79-1356.

Also Frederick S. Fisher, James E. Ryan, Jr. and

Roger L. Chaffe entered appearances for petitioner Com-

monwealth of Virginia, et al. in No. 79-1365.

Natural Resources Defense Council, Inc., et al.; No. 79-1356,

Sierra Club; No. 79-1359, Chemical Manufacturers Associa-

tion, et al.; No. 79-1362, The Connecticut Lung Association,

Inc.; No. 79-1365, Commonwealth of Virginia, ex rel., The

State Air Pollution Control Board; No. 79-1367, City of

Houston, Texas; No. 79-1370, American Petroleum Institute,

et al.

35a

Also Daniel Joseph and Courtenay Ellis entered ap-

pearances, for petitioner City of Houston, Texas, in No.

79-1367.

Also Jeffrey O. Cerar, Attorney, Environmental Pro-

tection Agency, entered an appearance for respondents.

Also Christopher S. Bond and Charles A. Blackmar

entered appearances for intervenor The St. Louis Re-

gional Commerce, et al. in No. 79-1104.

Also Charles S. Rogers, Assistant Attorney General for

the State of Oklahoma entered an appearance for inter-

venor, State of Oklahoma ex rel George Nigh, etc. in

No. 79-1104.

Before: MCGOWAN,* LEVENTHAL and WALD, Circuit

Judges. Opinion per curiam.

Per curiam: This motion to correct the record is part

of an action challenging the primary and secondary na-

tional ambient air quality standards for ozone, recently

promulgated by the Environmental Protection Agency

(EPA) and published at 44 Fep. Rec. 8202, February 8,

1979. The standards are challenged by a group of in-

dustry petitioners, who contend that the standards are

unrealistically strict, and by a group of environmentalist

and health petitioners,? who contend that they are not

strict enough. This opinion concerns one of several mo-

* Circuit Judge McGowan did not participate in this

decision.

1 The industry petitioners are American Petroleum Insti-

tute and its member companies, Manufacturing Chemists

Association and its member companies, and E. I. duPont de

Nemours & Co.

?The environmentalist petitioners are the National Re-

sources Defense Council, Sierra Club, American Lung Asso-

ciation, Delaware Valley Citizens’ Committee for Clean Air,

and Connecticut Lung Association.

36a

tions by the parties to supplement or correct the record.

We do not intimate any views as to the merits of the

case.

I. BACKGROUND

The industry petitioners have moved that this court

order the EPA to remove from the record for judicial

review certain documents placed in the record after the

Administrator publicly signed and announced the ozone

standards on January 26, 1979, but before they were

published in the Federal Register on February 8, 1979.

They contend that these materials* were included in the

record in contravention of the record-compilation require-

ments of Section 305(a) of the Clean Air Act Amend-

ments of 1977, Pus. L. No. 95-95, 91 STaT. 685, 772-776.

These amendments added a new Section 307(d) to the

Clean Air Act, 42 U.S.C. § 7607(d) (Supp. I 1977).

The purpose of the amendments was to facilitate ju-

dicial review by defining “what the record for a rule

consists of, and how and when material must be placed

in the record.” H.R. Rep. No. 294, 95th Cong., 1st Sess.

318, 319 (1977). The statute requires the inclusion of

some materials, and the exclusion of others, so that the

record for judicial review will comprise only those ma-

’The documents at issue are: document Nos. IIA-B-1

through 5 (“Studies or Contractor Reports” prepared on

various dates, placed in docket on February 6, 1979, concern-

in’ health effects or eye irritation from ozone, photochemical

» ‘ten after the comment period by Roger Randolph of

the Tulsa City-County Health Dept. concerning the calibra-

tion issue, one of many comments on the subject, placed in

docket on January 31, 1979); and IV-G-40 through 55, and

58 through 61 (comments from the public on the ozone stand-

ards, written after the close of the comment period, and

docketed after January 25, 1979). The EPA neither referred

to nor apparently relied upon those documents in reaching

its decision.

37a

terials directly pertinent to the agency’s decision. In

summary, it requires the EPA to compile a docket on or

before the date a proposed rule is published in the Federal

public inspection until the final rule is promulgated, and,

with one exception,‘ they become the record for judicial

review after such promulgation. The docket must include

the proposed rule, a statement of its basis and purpose

(including a summary of the factual data on which the

proposed rule is based, the methodology used with the

respect to those data, and the major legal interpreta-

tions and policy considerations underlying the rule), all

comments written by the public and submitted during

the comment period, a transcript of any public hearing on

the proposed rule, the text of the final rule, a statement

of the basis and purpose of the final rule, an explanation

of major changes from the proposed rule, and a response

to every major comment, criticism, and new datum sub-

mitted during the comment period.

In addition, the EPA may supplement the docket with

any public comments received after the comment period

or other document that becomes available after publica-

tion of the proposed rule. These additional materials may

be added to the docket if the Administrator determines

they are “of central relevance to the rulemaking.” The

statute requires that such materials, as well as comments

submitted during the comment period, be placed in the

docket ‘“‘as soon as possible after their availability.” Sec-

tion 307(d) (4) (B) (i), 42 U.S.C. § 7607(d) (4) (B) (i)

(Supp. I 1977).

‘Documents generated by the review of the rule by the

Office of Management and Budget and other federal agencies

must be available to the public in the rulemaking docket, but

they are excluded from the record for judicial review. Section

607 (d) (7) (A), 42 U.S.C. § 7607(d) (7) (A) (Supp. I 1977).

38a

In addition, the statute provides: “The promulgated

rule may not be based (in part or whole) on any informa-

tion or data which has not been placed in the docket as

of the date of such promulgation.” Section 307 (d) (6) (C),

42 U.S.C. § 7607(d)(6)(C) (Supp. I 1977). All the

parties to this case agree that this means that no ad-

ditional materials—other than those required by the

statute and wrongfully omitted by the EPA—may be

added to the docket after the rule is promulgated. The

record presented to the court on a petition for review

thus consists of materials required by the statute to be

included in the docket supplemented by materials “of

central importance to the rulemaking” placed in the

docket prior to promulgation of the rule.

We do not decide in this opinion whether other ma-

terials not specified by the statute to be included in the

record, but necessary for the court to make a complete

review of the decision, may be included in a supplemental

record for judicial review. All we decide today is when

the “date of such promulgation” occurs for purposes of

the record cut-off of Section 307 (d) (6) (C).

II. ANALYSIS

The issue in this case is whether the “date of such

promulgation” means the date that the rule is signed and

distributed to the press and public, or the date that the

rule is published in the Federal Register. The word

“promulgation” is not defined in the statute, nor is there

an explicit definition in the legislative history. Both sides

seek to bolster their arguments by reference to a 1977.

amendment to another section of the Clean Air Act,

Section 307(b) (1). The 1970 version read:

Any such petition [for review] shall be filed within

30 days from the date of such promulgation or ap-

proval, or after such date if such petition is based

solely on grounds arising after such 30th day.

39a

As amended, Section 307(b) (1)° reads:

Any petition for review under this subsection shall

be filed within sixty days from the date notice of

such promulgation, approval, or action appears in

the Federal Register * * *.

The House Report concerning amendmerts to this section,

H.R. Rep. No. 294, 95th Cong., 1st Sess. 322 (1977),

explains that this change was intended to make clear

that the time for filing a petition for review begins to

run from the time of publication in the Federai Register,

rather than from the date the Administrator signs the

rule and transmits it for publication.

The EPA and the environmentalist petitioners contend

that this change shows that Congress meant by “date of

such promulgation” the date of publication in the Regis-

ter. In contrast, the industry petitioners contend that

Congress has deliberately created a distinction between

the date of “promulgation” and the date of publication

in the Register. Although the industry petitioners’ argu-

ment seems somewhat the stronger, we are not willing to

decide this issue on so flimsy an indication of congres-

sional intent.

The statute must be interpreted in accordance with its

context and purpose. This has been the course followed

by this court in the past in deciding when “promulga-

tion” or “issuance” of a rule occurs. See, ¢.g., Industrial

Union Dept. v. Bingham, 570 F.2d 965 (D.C. Cir. 1977) ;

Microwave Communications, Inc. v. FCC, 515 F.2d 385

(D.C. Cir. 1974) ; Saturn Airways, Inc. v. CAB, 476 F.2d

907 (D.C. Cir. 1973). The main purpose of the record

cut-off provision of Section 307(d) (6) (C) was to ensure

that the rulemaking process would be reviewed on the

basis of data and reasoning that were available to EPA

5 Now codified at 42 U.S.C. § 7607(b) (1) (Supp. I 1977).

40a

at the time the decision was being made and that were

deemed important at that time. Pederson, Formal Records

and Informal Rulemaking, 85 YALE LJ. 38, 74-78

(1975).°

By requiring that the record be in final form when the

rule is promulgated, the statute promotes policies that are

vital to effective judicial review and long recognized by

this and other courts. If all materials relevant to the

decision are placed in a publicly available docket promptly

upon their receipt by the EPA—rather than assembled

after the decisionmaking process is completed—then in-

terested parties will be able to examine them and respond

to them. See Portland Cement Association v. Ruckleshaus,

486 F.2d 375 (D.C. Cir. 1973), cert. denied, 417 U.S. 921

(1974). Moreover, the creation of a precisely defined and

closed administrative record makes it more likely that

the agency’s decision will be based on the materials in

that record, and explained by the agency at the time of

promulgation. See Burlington Truck Lines, Inc. v. United

States, 371 U.S. 156, 168-169 (1962); International

Harvestor Co. v. Ruckleshaus, 478 F.2d 615, 632 (D.C.

Cir. 1973) ; Pederson, supra, at 73-74. The agency will

not be tempted to shore up inadequately justified positions

by adding post hoc rationalizations to the record, nor will

it assume at the time it promulgates a rule that there

will be an opportunity afterwards to improve the record.

In sum, the statute promotes public participation in rule-

making, reasoned decisionmaking based on the record, and

*The article by William F. Pederson, Jr., an attorney

in the Office of General Counsel of the EPA, may be taken

as an authoritative guide to congressional intent in enacting

the record provisions of Section 307(d). The House Report

on the 1977 amendments to the Clean Air Act states: “By

and large, this section [307(d)] represents a legislative

adoption of the suggestions for a rulemaking record set forth

in a law review article dealing with EPA [citing Pederson].”

H.R. Rep. No. 294, 95th Cong., Ist Sess. 319 (1977).

4la

judicial review of the agency decision based on the data

and reasoning before the agency at the time the decision

was made.

These considerations lead to the conclusion that “the

date of such promulgation” in Section 307(d) (6) (C)

means the date that the rule is signed and released to

the public. At that time, the agency’s decision is fixed,

and no additional data or arguments will change it.’

After that date, no materials added to the docket could be

examined by any members of the public; there would

be no opportunity for agency lawyers to insert supportive

documents into the record.

The EPA has argued that adoption of the date of

publication in the Federal Register as the date of promul-

gation would “allow[] EPA flexibility to review the

documents that were placed in the docket to ensure that

all documents which are required by statute to be in the

docket have in fact been placed there.” Memorandum of

Respondents in Opposition to Motion to Correct Record

and Motion to Supplement Record at 21. This argument

must be rejected. As to documents required by the

statute to be included in the record, EPA may—indeed,

must—place them in the record when they are available.®

As to other documents, the purpose of the statute is to

eliminate the flexibility of the EPA to add such docu-

ments after the decision has been made. If EPA wants

a document to be considered on judicial review, it must

7™In this case, the ozone standards were announced to the

press and public, and widely distributed in written form

to any interested parties. If, as in Jndustrial Union Dept. v.

Bingham, 570 F.2d 965 (D.C. Cir. 1977), the decision, after

being signed, were released only to a few selected members

of the public, other considerations might be present.

SIf they are erroneously omitted, the agency may follow

a reasonable procedure to supplement the record.

42a

place the document in the rulemaking docket, open to

the public, before the rule is signed and announced.

The industry petitioners’ motion to correct the record

by the removal from the record of document Nos. IIA-

B-1 through 5, IIB-E-7, [V-G-40 through 55, and IV-G-

58 through 61, is granted.

So ordered.

43a

APPENDIX C

Environmental Protection Agency

Promulgation of NAAQS for Ozone

(44 Fed. Reg. 8202, Feb. 8, 1979)

Title 40 — Protection Of Environment

Chapter I — Environmental

Protection Agency

Subchapter C — Air Programs

[FRL 1018-2]

Part 50 — National Primary and Secondary Ambient Air Quality

Standards

Revisions to the National Ambient Air Quality Standards for

Photochemical Oxidants

Acency: Environmental Protection Agency.

AcTION: Final rulemaking.

SUMMARY: In accordance with the provisions of Sections 108 and

109 of the Clean Air Act as amended, EPA has reviewed and revised

the criteria upon which the existing primary and secondary photoche-

mical oxidant standards are based. These standards were prom-

ulgated in 1971 (36 FR 8186) and were both set at an hourly average

level of 0.08 part per million (ppm) not to be exceeded more than |

hour per year. On June 22, 1978, EPA proposed changes in the

standard (43 FR 26962) based on the findings of the revised criteria.

The proposed changes included (1) raising the primary standard to

0.10 ppm, (2) retaining the 0.08 ppm secondary standard, (3) chang-

ing the chemical designation of the standard from photochemical

oxidants to ozone, and (4) changing to a standard with a statistical

rather than deterministic form. The final rulemaking will make three

further changes in the standard: (1) Raising the primary standard to

0.12 ppm, (2) raising the secondary standard to 0.12 ppm, and (3)

changing the definition of the point at which the standard is attained to

“when the expected number of days per calendar year with maximum

hourly average concentrations above 0.12 ppm is equal to or less than

one.”

44a

Errective Date: This revision is effective immediately upon publica-

tion. The normal 30-day delay in effectiveness is not required, when,

as in this case, a restriction is eased.

For FURTHER [INFORMATION CONTACT:

Mr. Joseph Padgett, Director (MD-i2), Strategies and Air Stan-

dards Division, Office of Air Quality Planning and Standards,

U.S. Environmental Protection Agency, Research Triangle

Park, NC 27711, Telephone: 919-541-5264 (FTS 629-5204).

AVAILABILITY OF RELATED LINFORMATION: A docket (Number OAQPS

78-8) containing information used by EPA in revising the standards is

available for public inspection and copying between 8:00 a.m. and

4:30 p.m. Monday through Friday, at EPA’s Central Docket Section,

Room 2903 Waterside Mall, 401 M Street, SW, Washington DC

20460. These materials include the “Air Quality Criteria for Ozone

and Other Photochemical Oxidants” and “Control Techniques for

Volatile Organic Emissions from Stationary Sources,” both of which

were issued simultaneously when this standard was proposed. The

control techniques document and staff papers pertaining to the form

of the ozone standard, risk assessment method, secondary standard,

and health panel assessment are available upon request from Mr.

Joseph Padgett. Statements of the environmental, economic, and

energy impacts of implementing this standard revision are also avail-

able upon request from Mr. Joseph Padgett, at the address shown

above. The air quality criteria document can be obtained from: Mr.

Michael Berry (MD-52), Environmental Criteria and Assessment

Office, Office of Research and Development, U.S. Environmental

Protection Agency, Research Triangle Park, NC 27711, Telephone:

919-541-2266 (FTS 629-2266).

This preamble describes revisions to 40 CFR Part 50, Appendix H,

“Interpretation of the National Ambient Air Quality Standards for

Ozone,” and Appendix D, “Measurement Principle and Calibration

Procedure for the Measurement of Photochemical Oxidants Cor-

rected for Interferences Due to Nitrogen Oxides and Sulfur Dioxide,”

that are related to the revision of the air quality standard for ozone. In

addition, elsewhere in this issue of the FeperaL Recister EPA is

promulgating revisions to 40 CFR Part 50, Appendix D, replacing

(superseding) the current calibration procedure with a new, superior

calibration procedure based on ultraviolet photometry.

45a

Revisions to 40 CFR Part 51, substituting the word “ozone” for

“photochemical oxidants” throughout that part, and to Section 51.14,

pertaining to control strategies, are being promulgated by EPA else-

where in this issue of the FepeRAL REGISTER.

SUPPLEMENTARY INFORMATION:

BACKGROUND

On April 30, 1971, the Environmental Protection Agency prom-

ulgated in the FEDERAL REGISTER (36 FR 8186) National Ambient Air

Quality Standards for photochemical oxidants. The scientific, tech-

nical, and medical bases for these standards are contained in the air

quality criteria document for photochemical oxidants, published by

the U.S. Department of Health, Education, and Welfare in March

1970. Both the primary and secondary standards were set at an hourly

average level of 0.08 ppm not to be exceeded more than once per

year. The asthma study cited as evidence for the original standard is

based on work by Schoettlin and Landau (1961). As discussed in the

June 22, 1978, proposed revision to the original standard, EPA has

reassessed its conclusions regarding this study. This reassessment,

plus the evaluation of medical evidence accumulated since 1970, led

EPA to propose, on June 22, 1978, a revised primary standard of 0.10

ppm (43 FR 26962). EPA did not propose a change in the secondary

welfare standard at that time. The proposal was accompanied by

publication of revised criteria and control techniques documents, as

well as various staff papers relating to the standard itself and to

implementation of the standard. EPA solicited written comments on

the propsed standard and, to accept oral testimony, sponsored four

public hearings (Washington, D.C. — July 18; Atlanta, Ga. —

August 17; Dallas, Tex. — August 22; Los Angeles, Calif. — August

24).

Oxidants are strongly oxidizing compounds, which are the primary

constituents of photochemical smog. The oxidant found in largest

amounts is ozone (O,), a very reactive form of oxygen. Oxidants also

include the group of compounds referred to collectively as peroxy-

acylnitrates (PANs) and other compounds, all produced in much

smaller quantities than ozone.

46a

Most of these materials are not emitted directly into the atmosphere

but result primarily from a series of chemical reactions between

oxidant precursors (nitrogen oxides and organic compounds) in the

presence of sunlight. The principal sources of organic compounds are

the hydrocarbon emissions from automobile and truck exhausts,

gasoline vapors, paint solvent evaporation, open burning, dry clean-

ing fluids, chemical plants and other industrial operations. Nitrogen

oxides are emitted primarily from combustion sources such as electric

power generation units, gas and oil-fired space heaters, and auto-

mobile, diesel and jet engines.

The reductions in emissions of nitrogen oxides and organic com-

pounds are achieved through lederal and State programs that have

been formalized in regulations promulgated under the Clean Air Act.

The Federal programs provide for reduction in emissions nationwide

through the Federal Motor Vehicle Control Program, the Federal

program for control of aircraft emissions, National Emission Stan-

dards for Hazardous Air Pollutants, and the development of New

Source Performance Standards. The State programs provide for addi-

tional control measures through State Implementation Plans in those

areas of the country where the Federal programs are not sufficiently

stringent to permit attainment of air quality standards.

LEGISLATIVE REQUIREMENTS AFFECTING

THIS PROMULGATION

Two sections of the Clean Air Act govern the development of a

National Ambient Air Quality Standard. Section 108 instructs EPA to

document the scientific basis (criteria) for the standard, and Section

109 provides guidance on establishing standards and reviewing the

criteria.

Air quality criteria are required by Section 108(a)(2) to reflect

accurately the latest scientific information useful in indicating the

kind and extent of all identifiable effects on public health or welfare

that may be expected from the presence of the pollutant in the ambient

air.

The Administrator is required to propose, simultaneously with the

issuance of these criteria, primary and secondary ambient air quality

standards based upon such criteria. The primary standard is defined in

47a

Section 109(b)(1) as the ambient air quality standard the attainment

and maintenance of which in the Administrator's judgment, based on

such criteria and allowing an adequate margin of safety, are requisite

to protect the public health. The secondary standard (Section

109(b)(2) must specify a level the attainment and maintenance of

which in the Administrator's judgment, based on such criteria, are

requisite to protect the public welfare from any known or anticipated

adverse effects associated with the presence of the pollutant in the

ambient air, These adverse welfare effects, which are discussed in

Section 302(h) of the Act, include effects on soils, water, crops,

vegetation, man-made materials, animals, weather, visibility,

hazards to transportation, economic values, personal comfort and

well-being, and other factors.

The Clean Air Act specifies that primary National Ambient Air

Quality Standards are to be based on scientific criteria relating to the

level that should be attained to protect public health adequately.

Considerations of cost of achieving those standards or the existence

of technology to bring about needed reductions of emissions are not

germane to such a determination, as the words of the Act and its

legislative history clearly indicate. Section 109(d) directs the Admi-

nistrator to complete a review of all existing standards and criteria

before the end of 1980 and at 5-year intervals thereafter and to revise

them in whatever manner that review reveals is necessary. This

promulgation is the result of such a review.

Assuring attainment and maintenance of ambient air quality stan-

dards is the responsibility of the States. Under section 110 of the Act,

they are to submit to EPA for approval State Implementation Plans

(SIPs) that provide for the necessary legal requirements for sources of

the relevant pollutant so as to demonstrate attainment and mainte-

nance of the standards by certain deadlines. In many areas of the

country the ambient air quality standards are not being attained,

despite the fact that the deadline for attainment has long since passed.

As a remedy, Part D of the Act requires states with violations of

ambient air quality standards to submit revised SIPs to ensure attain-

ment of the standards and to meet certain new requirements of Part D

by January 1, 1979. (Section 129%c), Pub. L. 95-95, note under 42

U.S.C. 7502.) The Act does not authorize the Administrator to

48a

extend that deadline, and consequently this revision of the photo-

chemical oxidant standard does not affect the deadline for submittal

of SIP revisions.

Section 1 10(a)(1) requires that SIP revisions be submitted within 9

months after a stendard is revised. However, this provision refers to

situations where a standard is tightened with the result that existing

SIPs are no longer adequate to attain and maintain the standard in

question. Where a standard is relaxed, no SIP revision is required by

the law, since states may have more stringent controls than necessary

if they choose.

Furthermore, the change in the chemical species designation of the

standard from photochemical oxidants to ozone does not make this

standard subject to the provision of section 110(a)(1) cited above.

The intent of the standard (total oxidant reduction), the control

strategies, and the index of progress toward attainment (measured

ozone levels) remain unchanged.

SUMMARY OF GENERAL FINDINGS FROM AIR QUALITY CRITERIA FOR

OZONE AND PHOTOCHEMICAL OXIDANTS

On April 20, 1977, EPA announced (42 FR 20493) that it was

reviewing and updating the 1970 criteria document for photochemi-

cal oxidants in accordance with provisions of section 109(d)( 1) of the

Clear Air Act as amended. The notice called for information and data

that would be helpful in revising the document. In preparing the

criteria document, EPA provided a number of opportunities for

external review and comment. Two drafts of the document have been

made available for external review, and EPA received more than 50

written comments on the first draft and approximately 20 on the

second draft. The American Petroleum Institute has submitted exten-

sive information that EPA considered in this standard review. The

criteria document was the subject of two meetings of the Subcommit-

tee on Scientific Criteria for Photochemical Oxidants of EPA's Scien-

ce Advisory Board. Each of these meetings was open to the public,

and a number of individuals presented both critical review and new

information for EPA's consideration. A full discussion of comments

received during the review process, as well as EPA’s disposition of

these comments, can be found in the docket (OAQPS 78-8) assem-

bled for this rulemaking.

49a

From EPA’s review of the scientific information presented in the

criteria document, several key areas with particular relevance to

setting the ozone standard have emerged:

1. Threshold concept — Although the concept of an adverse health

effect threshold has utility in setting ambient air quality standards, the

adverse health effect threshold concentration cannot be identified

with certainty. The lowest concentration which causes measured

health effects in a scientific experiment depends on the particular

subjers, who have been studied because sensitivity to pollutants

varies among different members of the population. Only limited

studies can be performed on groups of unusually sensitive persons.

Most experimental studies of human subjects are performed on small

numbers of relatively healthy persons who do not fully reflect the

range of human sensitivity. Also, the air to which the subjects are

exposed does not include the full mix of chemicals other than the

pollutant being studied which are in the ambient air. Some of these

chemicals may be additive with the given pollutant in causing the

adverse health effect, so that lower levels of the pollutant will result in

the effect. Animal exposure studies cannot provide precise models of

sensitive human populations. Thus, adverse health effect thresholds

for sensitive persons are difficult or impossible to determine ex-

perimentally, while the threshold for healthy persons or animals is not

likely to be predictive of the response of more sensitive groups. In this

notice of rulemaking EPA uses the terminology “probable effects

level” to refer to the level that in its best judgment is most likely to be

the adverse health effect threshold concentration. It is the fact that the

adverse health effect threshold concentration is actually unknown

that necessitates the margin of safety required by the Act.

2. Ozone health effects — Ozone is a pulmonary irritant that affects

the respiratory mucous membranes, other lung tissues and respiratory

functions. Clinical and epidemiological studies have demonstrated

that ozone impairs the normal mechanical function of the human lung

and causes clinical symptoms such as chest tightness, coughing and

wheezing. These effects may occur in sensitive individuals, as well as

in healthy exercising persons, at short-term ozone concentrations

between 0.15 and 0.25 ppm. The clinical studies data base for these

effects is far more extensive than that which was available in 1970,

50a

and these effects have now been demonstrated at lower levels than

those cited in the 1970 criteria document.

3. Effects on Asthmatics — The best available evidence suggests

that an elevated proportion of asthmatics experience attacks on days

when the peak hourly oxidant concentrations reach about 0.25 ppm.

This finding is based on a reevaluation of the study by Schoettlin and

Landau (1961).

4. Toxicologic findings — The key finding from toxicologic stu-

dies is the increased susceptibility to bacterial infection in laboratory

animals exposed to 0.10 ppm ozone and a bacterial challenge. Infec-

tion rates are lower for animals exposed only to the bacterial chal-

lenge. Other effects such as biochemical changes, morphological

abnormalities, and genetic changes have been found in some studies

of animals exposed to ozone concentrations as low as 0.1 to 0.3 ppm.

While the data from animal studies cannot be directly extrapolated to

man, they can be taken as indicators of the full range of effects that

may occur in humans. The epidemiology study by Durham (1974)

that reported increased rates of iliness in college students following

periods of elevated air pollution levels (with peak oxidant being the

pollution variable most strongly associated with illness) further in-

creases our concern regarding the implications for man of ihe animal

study findings.

5. Ozone effects on aging processes — A limited amount of data

suggests that ozone may accelerate the aging process in living organ-

isms. Exposure of rabbits to unspecified concentrations of ozone for |

hour per week for a year has been reported to induce premature aging

symptoms such as premature cartilage calcification, severe depletion

of body fat, and the general signs of aging (Stokinger, 1963).

6. Pollutant interactions — The fact that ozone exposure is fre-

quently accompanied by exposure to other pollutants, such as sulfur

dioxide (SO.), has prompted several investigators to conduct labora-

tory evaluations of exposure of human subjects to combinations of O;

and other pollutants. Simultaneous exposures to 0.37 ppm O. and

0.37 ppm SO. were reported to produce larger changes in pulmonary

function than exposure to either pollutant alone. No obvious effects

were observed in other simultaneous exposure tests using 0.25 ppm

Sla

O. and 0.3 ppm nitrogen dioxide (NO:;), as well as O., NO:, and 30

ppm carbon monoxide (CO). Nevertheless, the SO, - O; synergism

findings support the need for an adequate margin — of safety in the

ozone standard.

7. Mortality studies — No studies have conclusively linked expo-

sure to ozone or photochemical oxidants with an increase in human

mortality. A number of epidemiologic studies have been designed

and conducted to demonstrate this effect, but in each case the results

have been negative or inconclusive.

8. Welfare effects — Ozone accelerates the aging of many mate-

rials, resulting in rubber cracking, dye fading and paint erosion.

These effects are linearly related to the total dose of ozone and can

occur at very low levels. given long-duration exposures. Damage to

vegetation, as expressed by decreased growth and yield, is related to

the long-term (growing season) mean of the daily maximum 6- to

8-hour-average ozone concentrations.

9. Causes and control of oxidant pollution — All presently avail-

able evidence indicates that around urban centers with severe oxidant

problems, the major concern is the formation of photochemical

oxidants from man-made organic and nitrogen oxide emissions.

Control of these emissions will result in significant reductions in

ambient ozone, peroxyacetylnitrate (PAN), aldehydes and photo-

cheinical aerosol.

As is the case with most standard-setting activities, the data base on

ozone will continue to expand after the standard is set. EPA will

continue to inform itself of new research results and also will acceler-

ate the schedule for its own research on the health effects of ozone and

other photochemical oxidants at low exposure levels. The Agency

plans to make the results of these studies available as they are

completed and to issue an interim report on all new research results in

two years.

RULEMAKING PETITIONS

The Agency was petitioned by the American Petroleum Institute

(API) and 29 member companies on December 9, 1976, and by the

City of Houston on July 11, 1977, to revise the criteria, standards and

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control strategy guidelines for photochemical oxidants. EPA had

already begun such a revision when both petitions were filed. and the

Agency responded that it was deferring decision on these petitions

until the rulemaking was completed. EPA considers this final rule-

making and the accompanying one on control strategy guidelines to

be the Agency’s final action on these petitions. A summary of the two

petitions and EPA’s response is given below.

The API petition requested that EPA revise the air quality criteria

document for photochemical oxidants in light of new information

regarding the causes, effects, and extent of air pollution attributed to

ozone and other oxidants. EPA has published a revised air quality

criteria document for photochemical oxidants; in the Agency's judg-

ment, this document accurately reflects the latest scientific informa-

tion regarding the causes, effects, and extent of air pollution attri-

buted to ozone and other oxidants.

The second request in the API petition was that EPA establish a

national primary ambient air quality standard based on new studies

that allegedly demonstrate no significant adverse human health

effects at or below ozone levels of 0.25 ppm for 2-hour exposures. As

requested by API and as required under the Clean Air Act, the Agency

has considered all new studies published since 1971 that are relevant

to setting a revised primary standard the attainment and maintenance

of which would, in the Administrator's judgment, protect the public

health with an adequate margin of safety. EPA disagrees with API's

conclusion that new studies conducted since 1971 demonstrate no

significant adverse human-health effects at or below 0.25 ppm.

A more detailed discussion of EPA’s judgments regarding reported

or probable health consequences at concentrations below 0.25 ppm is

presented in the rationale for revising the primary standard and in the

response to comments, which appear elsewhere in this notice.

The third request by API was that the national secondary ambient

air quality standard be based on adverse effects on public welfare as

indicated by studies using ozone-specific measurement methods. In

addition, API concluded that Congress intended that EPA weight the

overall economic and social impact of a lower secondary standard

against adverse effects of a pollutant. EPA has reviewed the data

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presented in the criteria document and conlcuded that there is current-

ly no evidence of a significant decrease in yield or growth to commer-

cially important crops for short-term exposures to ozone concentra-

tions below 0.12 ppm. EPA believes a secondary standard more

stringent than the primary standard is unnecessary and that a cost-

benefit analysis is not required.

In their petitions, both API and Houston requested EPA to state the

primary and secondary standards so as to permit reliable assessments

of compliance. EPA agrees that the present deterministic form of the

oxidant standard has several limitations and has made reliable assess-

ment of compliance difficult. The revised ozone air quality standards

are stated in a statistical form that will more accurately reflect the air

quality problems in various regions of the country and allow more

reliable assessment of compliance with the standards.

The API and Houston petitions requested that EPA specify the use

of an appropriate measurement method for monitoring ambient con-

centrations of ozone. API suggested the use of ethylene chemilumin-

escence calibrated by either gas phase titration (GPT) or ultraviolet

(UV) photometry. As a result of EPA’s continuing evauation of

several calibration techniques, the Agency has defined the reference

method to be ethylene chemiluminescence calibrated by UV photo-

metry. (See the amendment to Appendix D of 40 CFR Part 50

elsewhere in this edition of the FEDERAL REGISTER. ) EPA is allowing

the use of a modified version of the current calibration method

(acidified KI) as an interim measure to avoid problems that would

result from immediate conversion to UV photometry.

Both the API and Houston petitions requested revision of the State

Implementation Plan (SIP) requirements (1) to delete the assumption

of no background concentration of photochemical oxidants and (2) to

specify more reliable, alternative oxidant prediction relationships to

replace Appendix J of 40 CFR Part 51 for determining the degree of

necessary precursor emission reductions.

With respect to the first point, EPA recognizes that background

concentrations and transport of ozone from upwind locations can

contribute to high levels of ozone in or near an urban area during the

afternoon hours. Therefore, several revisions are being made in

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control strategy and implementation guidelines for ozone. The re-

vised guidelines set forth procedures for consideration of both up-

wind transport and irreducible natural background by the States in

calculating the necessary reductions in hydrocarbon emissions. In

response to the second request, EPA has determined that Appendix J

of 40 CFR Part 51 no longer represents an acceptable analytical

relationship between hydrocarbons and ozone. Appendix J is, there-

fore, being deleted. EPA will now allow States to use any of four

analytical techniques to determine the amount of hydrocarbon reduc-

tion necessary to demonstrate attainment of the national ozone air

quality standards: (1) Photochemical dispersion models, (2) Empiric-

al Kinetics Modeling Approach (EKMA), (3) Empirical and statistic-

al models, and (4) Proportional rollback. These four techniques are

discussed further in the revision of Part 51, which appears elsewhere

in this edition of the FepeRAL REGIST

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