Reply Brief — American Trucking Assns., Inc. v. Browner

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No. 99-1426 OCT 05 apo0

IN THE | CLERK |

Supreme Court of the United States

AMERICAN TRUCKING ASSOCIATIONS, INC., CHAMBER OF

COMMERCE OF THE UNITED STATES, et al.,

Petitioners,

CAROL M. BROWNER, ADMINISTRATOR OF THE

ENVIRONMENTAL PROTECTION AGENCY, et al.,

Respondents.

On a Writ of Certiorari to the

United States Court of Appeals

For the District of Columbia Circuit

REPLY BRIEF

DAVID E. MENOTTI HENRY V. NICKEL

WILLIAM F. PEDERSEN F. WILLIAM BROWNELL

JEFFREY A. KNIGHT (Counsel of Record)

SHAWPITTMAN JAMES N. CHRISTMAN

2300 N Street, N.W. LUCINDA MINTON LANGWORTHY

Washington, D.C. 20037 HUNTON & WILLIAMS

(202) 663-8675 1900 K Street, N.W.

Counsel for American Washington, D.C. 20006

Forest & Paper (202) 955-1500

Association and American __ Counsel for Appalachian Power

Tron & Steel Institute Co., et al., American Public

Power Association, and

National Association of

October 5, 2000 Home Builders

[Additional Counsel Listed Inside]

WILSON-EPES PRINTING CO., INC. — (202) 789-0096 - WASHINGTON, D. C. 20001

G. WILLIAM FRICK

M. ELIZABETH COX

AMERICAN PETROLEUM

INSTITUTE

1220 L Street, N.W.

Washington, D.C. 20005

(202) 682-8250

Counsel for American

Petroleum Institute

RUSSEL S. FRYE

COLLIER, SHANNON, RILL &

ScoTT, PLLC

3050 K Street, N.W., Suite 400

Washington, D.C. 20007

(202) 342-8878

and

RICHARD WASSERSTROM

AMERICAN FOREST & PAPER

ASSOCIATION, INC.

1111 19th Street, N.W.

8th Floor

Washington, D.C. 20036

(202) 463-2582

Counsel for American Forest

& Paper Association, Inc.

GRANT CRANDALL

General Counsel

UNITED MINE WORKERS OF

AMERICA, AFL-CIO

8315 Lee Highway

Fairfax, VA 22031

(703) 208-7200

and

EUGENE M. TRISKO

P.O. Box 596

Berkeley Springs, WV 25411

(304) 258-1977

Counsel for United Mine

Workers of America, AFL-CIO

NEWMAN R. PORTER

LEWIS AND ROCA

40 N. Central Avenue

Phoenix, AZ 85004

(602) 262-5786

Counsel for Nevada Mining

Association, Newmont Gold

Company, and Meridian Gold

Company

HAROLD P. QUINN, JR.

NATIONAL MINING

ASSOCIATION

1130 17th Street, N.W.

Washington, D.C. 20036

(202) 463-2652

Counsel for National Mining

Association

MARCELLE SHOOP

Associate General Counsel

KENNECOTT UTAH COPPER

CORPORATION

8315 West 3595 South

P.O. Box 6001

Magna, Utah 84044-6001

(801) 252-3000

Counsel for Kennecott Holdings

Corporation, Kennecott

Energy and Coal Company

and Kennecott Services

Company

PETER S. GLASER

SHOOK, HARDY & BACON

600 14th Street, N.W.

Suite 800

Washington, D.C. 20005

(202) 639-5627

Counsel for Western Fuels

Association, Inc.

DAVID F. ZOLL

ALEXANDRA DAPOLITO DUNN

AMERICAN CHEMISTRY COUNCIL

1300 Wilson Boulevard

Arlington, VA 22209

(703) 741-5165

Counsel for American Chemistry

Council

DAVID M. FLANNERY

JACKSON & KELLY

P.O. Box 553

1600 Laidley Tower

Charleston, WV 25322

(304) 340-1017

Counsel for Midwest Ozone

Group and West Virginia

Chamber of Commerce

KURT E. BLASE

O’ CONNOR & HANNAN

Suite 500

1666 K Street, N.W.

Washington, D.C. 20006-2803

(202) 887-1400

Counsel for Kennecott Holdings

Corporation, Kennecott Energy

and Coal Company, Kennecott

Services Company, and

National Stone Association

DUANE J. DESIDERIO

NATIONAL ASSOCIATION OF

HOME BUILDERS

1201 15th Street, N.W.

Washington, D.C. 20005

(202) 861-2146

Counsel for National Association

of Home Builders

MAURICE H. MCBRIDE |

NATIONAL PETROCHEMICAL &

REFINERS ASSOCIATION

1899 L Street, N.W.

Washington, D.C. 20036

(202) 457-0480

Counsel for National

Petrochemical & Refiners

Association

TIMOTHY L. HARKER

THE HARKER LAW FIRM

9500 Accord Drive

Potomac, MD 20854

(301) 983-0964

and

THOMAS J. GRAVES

NATIONAL PAINT AND

COATINGS ASSOCIATION, INC.

1500 Rhode Island Ave., N.W.

Washington, D.C. 20005

(202) 462-6272

Counsel for National Paint and

Coatings Association

DAVID M. FRIEDLAND

BEVERIDGE & DIAMOND

1350 I Street, N.W.

Suite 700

Washington, D.C. 20005

(202) 789-6000

Counsel for Phoenix Cement

Company.

AMENDED DISCLOSURE STATEMENT

Pursuant to Supreme Court Rule 29.6, the following list

amends the corporate disclosure statement filed in the Brief

for Respondents Appalachian Power Co., ef al., In Support of

Petitioners on July 20, 2000.

Baltimore Gas and Electric Co.

(now referred to as Constellation Power Source

Generation, Inc.)

Carolina Power & LightCo.

(a subsidiary of CP&L Energy, Inc.)

(State Street Bank & Trust Company Boston is no

longer a 10% or greater owner)

Illinois Power Co.

(a subsidiary of Dynegy, Inc.)

PacifiCorp

(a subsidiary of Scottish Power plc)

TABLE OF CONTENTS

Page

AMENDED DISCLOSURE STATEMENT...................0000000+ i

ee Ca erinccicensccnnentsesnnesannasenbinmaaviiiie Vv

EE TTEIIT seicsvstioccensvnsliesesnmnesmunsticictnanenennetimamesniiianmasemestd x

aT Occinrremsecctimenetencendecenniinmaibinensenininiaipentataetitie l

SEE ccnnsnrsicuntenesturncmncinnnnteriatininenaiminianinianiiees 4

Il. EPA BASED ITS NAAQS DECISIONS ON

RISK PREDICTIONS, WITHOUT DEFINING

ANY PRINCIPLE FOR DETERMINING HOW

MUCH RISK IS ACCEPTABLE ..................ccccccsocerseseees 5

Il. THE CLEAN AIR ACT PROVIDES

GUIDANCE FOR PUBLIC HEALTH RISK

MANAGEMENT JUDGMENT.......00.0.....:ccccsccesseeeeeseenees 8

A. The Language of Section 109 .00..........cccccccceeeeeeee 8

C. The Requirement to Protect “Public

Health” and the Statutory Purposes

Language of the Act Must Guide EPA’s

Exercise of Discretion in Revising

De nnncentensenennesustusmesemnennnntimeniennasenees 17

ll. THIS COURT CAN IDENTIFY PRINCIPLES

THAT GUIDE EPA’S EXERCISE OF PUBLIC

HEALTH RISK MANAGEMENT JUDGMENT.......... 19

TABLE OF CONTENTS — Continued

CORE GIS cxcccecccssesescsscersnasinnecensssnscscsnesssnermnsusesenteeenneeee

APPENDIX

1 Presidential/Congressional Commission on Risk

Assessment and Risk Management, Framework

for Environmental Health Risk Management

CB I cccsensesecensesenecemencersscssmammmasssnesesnenverss

NAS/NRC, Risk Assessment in the Federal

Government: Managing the Process (1983)

Science Advisory Board, EPA, Toward Integrated

Environmental Decisionmaking (August 2000)

———

TABLE OF AUTHORITIES

CASES Page

American Textile Manufacturers Institute, Inc. v.

Donovan, 452 U.S. 490 (1981)........ccccccccceeeseeeeeeeeeeneenees 12

American Trucking Ass'ns v. EPA, 175 F.3d 1027

(D.C. Cir. 1999), modified, 195 F.3d 4 (D.C. Cir.

Sra isciicietitinniiiteicielaidinateatiaticinceni diaeidinnetilcntaniees 5, 10, 20

Chemical Manufacturers Association v. EPA, 899

NII, CII niece teiatinaaearenianas 12

Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (Sth

i Sat acrciceneidninsteueebeieiitenieiiciaseneneannansiadatetigmintaretmataitiaiatisinians 12

Forester v. CPSC, 559 F.2d 774 (D.C. Cir. 1977) .........00000. 12

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

I, SI aicncicertaii tienes teaaartaltaiartaieedidie 12

Lead Industries Association v. EPA, 647 F.2d 1130

erie CNL RIT hcnitenidaiiibaeaceeirirnaiatiaei iinet ciatsianeananiness 4

Mistretta v. United States, 488 U.S. 361 (1989) .................. 19

NRDC v. EPA, 824 F.2d 1146 (D.C. Cir. 1987).....cccccccsee00e: 12

NRDC v. Train, 421 U.S. 60 (1975)........ccccccccceesseeeeeeeeeeeeees 15

Union Electric Co. v. EPA, 427 U.S. 246 (1976)....... 3, 10, 15

STATUTES

Air Quality Act of 1967 § 108(a), Pub. L. No. 90-148,

81 Stat. 485 (1967) ....ccccccccccccsssececcssssuesssssssuecsesssueesesesnees 16

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

(1994 & Supp. III 1997)

CAA § 101(b), 42 U.S.C. § T401(B) -ccccses.cccsssueesssssseeesessevees 18

TABLE OF AUTHORITIES — Continued

Page

CAA § 101(b)(1), 42 U.S.C. § 7401 (b)(1) coccsccccsseesssessssessees 17

CAA § 108, 42 U.S.C. § 7408 ....ccccccssseessseessseeeen 2, 12, 13, 18

CAA § 108(a)(1), 42 U.S.C. § 7408(a)(1)..ccccceccsseesseeseeees 2,19

CAA § 108(a)(2), 42 U.S.C. § 7408(a)(2)...cccccccsseesseeesseeseees 13

8 ee passim

CAA § 109(a), 42 U.S.C. § 7409(a) ...ccccccccseecssessseessvesssueesees 16

CAA § 109(b), 42 U.S.C. § 7409(D) ....cccccecsseeen 10, 12, 13, 14

CAA § 109(b)(1), 42 U.S.C. § 7409(b)(1) ...cceccseesseees 2, 13, 19

CAA § 109(d), 42 U.S.C. § 7409(d) ..ccccccccscccssecsssesssesssnesenes 12

CAA § 109(d)(2), 42 U.S.C. § 7409(d)(2) .ecccccccssecsssessseesnees 12

CAA § 110, 42 U.S.C. § 7410 ..cccccccccsescsseesseccsnessseesseceen 14, 16

CAA § 110(a), 42 U.S.C. § 7410(€) ..cccccccccsecsssesssesssscssseesnees 15

CAA §§ 160-169B, 42 U.S.C. §§ 7470-7492 ....ccccsssesssseeenes 17

CAA §§ 181-185A, 42 U.S.C. §§ 7511-75116 vecccccsccssseessees 16

FEDERAL REGISTER

39 Fed. Reg. 31000 (1974) ....cccccccccssssssessssessseessucsssesssveesneeen 18

44 Fed. Reg. 8215-16 (1979)....cccccccsssscssesssucsssesssuesssessseeesnecen 5

52 Fed. Reg. 25641-44 (1987)....ccccccccccssessssesssssesssscessecessvessnes 5

55 Fed. Reg. 41211-12 (1990)....cccccccccsssessssessssessseecssseessneeen 18

62 Fed. Reg. 38653 (1997) ...cc.ccccccsscsssesssesssvessssesssesssscesneessvee 8

62 Fed. Reg. 38657 (1997) .....ssssssssssssssssssssssssssssesessesesesessese 9

——e— ee

= — — ae ee

Vii

TABLE OF AUTHORITIES — Continued

Page

62 Fed. Reg. 38664-65 (1997)..0........ccccccccscssscesserseeesesseeseenees 9

G2 FOG. Rag: SESES (1997) ..cccvcssceccccccccccccoscsscsscssocssccssossscoecees 8

G2 FOG. ROG, SEED (1997) ..cccccccccecccceccccccocsosccccssoscsocsssscoccceees 8

ee I Ce aiicciccrenciinsencntienibecintnietmicsianiniiuiuins 8

a eC Bee Ce Pncccncernsscsenteniecncstesnintntessesnstecnnsaaness 8

Se FR BE BO CIO Prcvccccrcccsccsncenccsssscescessecasissnsensensstines 5

ee ee cicricecnniescsenasentinsinttetatanidenssstesessasesi 8

a ee Be Ce Riccicerenscenasenscscsccnectnsseseciccnatsienentinent 8

G2 FOG. FARR, TEBE (IDI T cccccccscccdecccesccccccsccssccsscesesessescoocessses 6

ae ey Sy Se IY Picicccecenicncesnsentntnsseccenssnesttenccsieetinsen 8

Se ee Ss Se CO Piccicancnssenccensnnsenconinsnenteuntennencmeds 5,8

G2 Fed. Raw, SEBGZ (1997) ...ccccccccecccccsccsescoscecsoccccssocovcosssccscese 8

62 Fed. Reg, 38863 (1997) .....cececcccccscsscsecsvososssscsesescsessocoossoees 8

62 Fed. Reg. 38864-65 (1997) .00.......cccccccccssessessesseeseeereeeeeeeees 5

ae Ss Ee Ce Ricicteciccicccccscesentenssitcntereniatninmanteinecnia 8

nn SEP UII sinstndsseneicncccinnaicniniiiicisisesiiininianiaiiatiin 8

Vill

TABLE OF AUTHORITIES — Continued

Page

LEGISLATIVE HISTORY

S. Rep. No. 91-1196 (1970), reprinted in 1 Sen.

Comm. on Pub. Works, A Legislative History of

the Clean Air Amendments of 1970 (Comm. Print

Tipe iscdannivlepibetandoniedideituninemiadiatinctiestiiindineiimeiiinies 3, 11,17

Air Pollution—1970: Hearings on S. 3229, S. 3466,

S. 3546, Before the Subcomm. on Air and Water

Pollution of the Sen. Comm. on Pub. Works, 91st

Cong., pt. 4 (1970), reprinted in 2 Sen. Comm. on

Pub. Works, A Legislative History of the Clean

Air Amendments of 1970 (Comm. Print 1974)........... 1, 16

H.R. Rep. No. 95-294 (1977), reprinted in 4 Sen.

Comm. on Env’t and Pub. Works, A Legislative

History of the Clean Air Act Amendments of 1977

I Te er ccannstniedicctssecnieseniineuniumnanninnes 1, 10,17

Clean Air Act: Ozone and Particulate Matter

Standards: Hearings Before the Subcomm. on

Clean Air, Wetlands, Private Property and

Nuclear Safety and the Sen. Comm. on Env't and

Pub. Works, 105th Cong., pt. 1 (1997) .........cccccccceeeeeeeeees 7

MISCELLANEOUS

Clean Air Scientific Advisory Committee Transcript

SID, Bile Celie i rrvcccessnsacesceversannssasasenenenvensecemansanscanensmsceene 2

Clean Air Scientific Advisory Committee Transcript

GD. FE, FID ccccecensscesssnecstsssssecstensneomenneesnorsevennsouenssneia 9

TABLE OF AUTHORITIES — Continued

Page

EPA, Regulatory Impact Analyses for Particulate

Matter and Ozone National Ambient Air Quality

Standards and Proposed Regional Haze Rule

SEAR nr IANO re Ss a OO eI 11,15

EPA, Review of the National Ambient Air Quality

Standards for Ozone (1996) ........ccccccccccseseeesseeeeees 2, 5, 6,9

EPA, Review of the National Ambient Air Quality

Standards for Particulate Matter (1996)............ccccc000000000- 9

Letter from Dr. George T. Wolff, Chair, CASAC, to

Hon. Carol M. Browner (Nov. 30, 1995) ..........cccccccccceeeee 6

Letter from Dr. George T. Wolff, Chair, CASAC, to

Hon. Carol M. Browner (Mar. 15, 1996) .............ccccccce00e 7

Letter from Dr. George T. Wolff, Chair, CASAC, to

Hon. Carol M. Browner (June 13, 1996).................. 6, 7,8

NAS/NRC, Risk Assessment in the Federal

Government: Managing the Process (1983) ............:0+++ 2

| Presidential/Congressional Comm’n on Risk

Assessment and Risk Management, Framework

for Environmental Health Risk Management

ETE TTTED wstnnicaneoupedesinianenabininstiacenmpinineanenteusensisindiitiaianiaiaeuneien 10

Science Advisory Board, EPA, Toward Integrated

Environmental Decisionmaking (August 2000) ...2, 11, 20

1 The New Shorter Oxford English Dictionary (1993) ........ 13

Winston Harrington, ef al, On the Accuracy of

Regulatory Cost Estimates, 19 J. Pol. Analysis &

SEI TITET UTE cnincnicintnsniibibiiipeienipansiabatmaanieiantatiiietaialiss 15

GLOSSARY

The following is a glossary of acronyms and abbreviations

used in this brief.

Act

Administrator

Agency

App.

CAA

CASAC

EPA

NAAQS

OJA

OSP

Clean Air Act

Administrator of the United

States Environmental

Protection Agency

United States Environmental

Protection Agency

Appendix to Brief for

Respondents Appalachian

Power Company, ef al., in

Support of Petitioners (99-

1426)

Clean Air Act

Clean Air Scientific

Advisory Committee

United States Environmental

Protection Agency

National Ambient Air

Quality Standards

Joint Appendix in D.C. Cir.

Case No. 97-1441

Ozone Staff Paper (1996)

PMio

PM?

PMJA

PPM

Reply App.

RIA

Particulate Matter

Particulate Matter with an

aerodynamic diameter less

than or equal to 10 microns

Particulate Matter with an

aerodynamic diameter less

than or equal to 2.5 microns

Joint Appendix in D.C. Cir.

Case No. 97-1440

Parts Per Million

Appendix to Reply Brief of

Appalachian Power

Company, ef al. (99-1426)

Regulatory Impact Analyses

INTRODUCTION!

EPA and its supporters assert that a federal agency

directed by Congress to protect the public health must blind

itself to factors showing that its decisions would not benefit

the public. This Court should reject EPA’s remarkable

abandonment of the mission given it by Congress.

Appalachian Power Co., ef al. (“APC”) do not question

that EPA may regulate to protect the “public health” when

confronted with uncertain science. Rather APC asks this

Court to address whether the Clean Air Act (“CAA”)

constrains EPA’s exercise of policy judgment to manage

uncertain public health risks and, if so, what are the

constraints. This question is critically important because if

Congress has provided no legal standards to guide how EPA

manages such risks, then § 109 is an unconstitutional

delegation of lawmaking power. .

In order to answer this question, it is necessary to

understand the nature of the regulatory action required under

the NAAQS program. For most air pollutants, as for those at

issue here, science has not identified a threshold below which

health effects might not be predicted to occur.’ In other

words, unless there is a proven threshold below which there

are no demonstrated effects from a pollutant, EPA assumes

' This brief is filed in support of American Trucking Ass’ns, ef al.

? See, e.g., Air Pollution—1970: Hearings on S. 3229, S. 3466, S. 3546,

Before the Subcomm. on Air and Water Pollution of the Sen. Comm. on

Pub. Works, 91st Cong., pt. 4, at 1489 (1970) [hereinafter 1970 Hrg.],

reprinted in 2 Sen. Comm. on Pub. Works, A Legislative History of the

Clean Air Amendments of 1970, at 1184 (Comm. Print 1974) [hereinafter

1970 Legis. Hist.] (testimony of Dr. Middleton) (“To identify a no-

known-effects level is . . . very likely not possible.”); H.R. Rep. No. 95-

294, at 127 (1977), reprinted in 4 Sen. Comm. on Env’t and Pub. Works,

A Legislative History of the Clean Air Act Amendments of 1977, at 2594

(Comm. Print 1978) [hereinafter 1977 Legis. Hist.}.

effects will become fewer, but continue, down to a “zero”

concentration level.

As a result, with large populations, an assessment of

health risk will always predict effects, even when

concentrations of a pollutant approach or fall below naturally

occurring background concentrations.’ This is a “potential”

health risk driven by an assumption that, because science

cannot prove a threshold, no threshold exists. In

circumstances of ever-diminishing risk of harm, agencies

must exercise “risk management” judgment unless the statute

calls for elimination of all potential health risk.‘

In §§ 108 and 109 of the Act, Congress directed EPA to

regulate where pollution “endanger[s]” public health, CAA

§ 108(a)(1), and then to set air quality standards that are

“requisite” to protect “public health,” allowing an “adequate

margin of safety.” CAA § 109(b)(1). This is not a “zero

risk” mandate. Rather, in exercising its § 109 regulatory

authority, EPA must make two types of policy judgments.

First, it must determine what level of predicted health risk

* In this case, for example, EPA’s science advisers recognized that the

level of the revised ozone NAAQS (0.08 ppm) approaches background

concentrations in pristine areas. Clean Air Scientific Advisory Committee

(“CASAC”) Tr. (3/22/95) 296, OJA 278; EPA, Review of the National

Ambient Air Quality Standards for Ozone 20 (1996) [hereinafter OSP},

OJA 1830 (noting annual average hourly values at “clean” sites may be

0.075 ppm). Yet, EPA’s risk assessment predicts health effects at levels

as low as 0.04 ppm. /d. 116, OJA 1926.

* See Science Advisory Board, EPA, Toward Integrated Environmental

Decisionmaking 13 (August 2000) [hereinafter SAB] (Risk management

involves selection of a preferred option after “explicit consideration of the

trade-offs involved . . . .”), Reply App. 9a; NAS/NRC, Risk Assessment in

the Federal Government: Managing the Process 18-19 (1983)

(describing risk assessment as “characterization of the potential adverse

health effects of human exposures” and risk management as “the process

of evaluating alternative regulatory actions and selecting among them”),

Reply App. 6a-7a.

———

constitutes a potential “public health” problem (i.e., what

level presents a “significant” adverse public health risk).

Second, EPA must determine what regulatory response is

“requisite” to address that potential public health problem,

allowing an “adequate” margin of safety. As described by

Congress, in defining an “adequate” margin of safety, EPA

must provide a “reasonable degree of protection” in response

to scientific uncertainty. S. Rep. No. 91-1196, at 10 (1970),

reprinted in | 1970 Legis. Hist., supra note 2, at 410, OJA

3687; see EPA Br. (99-1426), at 33.

EPA argues strenuously that CAA § 109 “unambiguously”

requires that primary air quality standards be based solely on

the direct inhalation health effects of a pollutant, regardless

of other considerations. EPA Br. (99-1426), at 18, 19. But if

this were true, how does EPA determine what constitutes a

potential “public health” problem? Is 50,000 predicted

coughs in a population of fifty million a public health

problem? Is it twice that amount, or one-half that amount?

How are uncertainties inherent in such predictions to be

accounted for in determining whether predicted effects might

constitute a potential “public health” problem?

Once EPA determines that there is a significant adverse

public health risk, how does EPA determine a “reasonable

degree of protection” (i.e., an “adequate” margin of safety) in

response to that problem? Does a standard that is predicted

to reduce that risk in the affected population by 10 percent (or

2 percent or 20 percent) afford a “reasonable degree of

protection” for the “public health”? And what if there is

great uncertainty whether the “sensitive population” actually

experiences the effect? What if the revised standard is

predicted to deprive those with lower earnings of affordable

electricity, affordable health care, or affordable heating fuel,

thereby imposing adverse health and welfare consequences?

* See Union Elec. Co. v. EPA, 427 U.S. 246, 271-72 (1976) (Powell, J.,

concurring).

Finally, what if the Administrator's science advisers

conclude there is no significant difference in potential public

health protection afforded by existing and revised standards,

but the revised standard will impose additional costs on

society of $9 billion annually with associated adverse public

health risks flowing from those costs?

These are questions that can be addressed in a manner that

promotes the “public health” only after considering the

potential adverse impacts of the proposed regulatory action.

For the reasons discussed below, and contrary to the court of

appeals holding based on Lead Industries Ass'n v. EPA, 647

F.2d 1130 (D.C. Cir. 1980), Congress did not prohibit EPA

from considering factors essential to the exercise of sound

judgment in making NAAQS decisions that require the

management of uncertain health risks.

ARGUMENT

In its brief, EPA claims that the Court need not look at the

record, EPA Br. (99-1426), at 8, but then argues that the

record shows that the NAAQS decisions here were not the

product of risk management judgment. According to EPA,

its decisions were based on “real and significant effects, not

merely hypothetical risks.” /d. 8, 10.

Both courts and commentators have counseled caution

where agencies attempt to disguise policy judgment as

science, and EPA’s argument here presents a striking

example of this problem. EPA’s claim that the

Administrator’s decision was driven by demonstrated effects,

not risk predictions, is both implausible and inconsistent with

the record. More fundamentally, EPA’s argument fails to

appreciate the difference between a demonstrated public

health effect (e.g., “asthma”) and a predicted cause of that

effect (e.g., a particular type and level of pollution), which

requires judgment as to how to manage uncertain risks.

Based on Lead Industries, the lower court held that the

Administrator had no authority to consider the impacts of her

decision on society in exercising judgment as to whether

predicted health risk requires regulation as a potential public

health problem and, if so, what is a “reasonable degree of

protection” in response. 175 F.3d 1027, 1040-41; App. 18a-

21a. For the following reasons, the CAA does not constrain

the Administrator’s authority in that fashion, and the court of

appeals holding to the contrary in this case and in Lead

Industries must be overruled.

I. EPA BASED ITS NAAQS DECISIONS ON RISK

PREDICTIONS, WITHOUT DEFINING ANY

PRINCIPLE FOR DETERMINING HOW MUCH

RISK IS ACCEPTABLE.

These rulemakings addressed the potential risk of harm,

not demonstrated health effects. As EPA explains, the

rulemaking records for the NAAQS included new studies not

considered in prior standard reviews. EPA Br. (99-1426), at

10. These studies, however, addressed the same types of

health effects that EPA has long considered when regulating

these pollutants. For ozone, for example, these include

predicted respiratory symptoms (e.g., coughs) and

physiological changes (e.g., changes in airway resistance).°

For PM, they include predicted excess mortality, bronchitis,

lung function and symptom responses. ’

Reflecting this science, EPA’s exposure and risk analyses

for ozone addressed the same health effects for all of the

standards under consideration, including the existing 1-hour

standard.’ And, EPA concluded that these health effects

could be addressed by either a 1-hour or 8-hour standard.”

38864-65, OJA 9-10.

” Compare 52 Fed. Reg. 25641-44, PMJA 215-18, with 62 Fed. Reg.

38676, PMJA 26.

* See OSP, supra note 3, at 86, 123-24, 128, OJA 1896, 1933-34, 1938.

* 62 Fed. Reg. 38861, OJA 6.

Furthermore, as EPA observes, “CASAC clearly

understood” that the ozone record “showed a continuum of

risk,” with statistically significant decreases in risk for more

stringent standards. EPA Br. (99-1426), at 12. Nevertheless,

CASAC disagreed with EPA’s assertion that these decreases

in risk also reflected “corresponding increases in public

health protection.” /d.'°

Instead, CASAC concluded, the science does not allow

one to “distinguish{] any of the proposed [ozone] standards

. . . aS being significantly more protective of public health.” ''

While EPA claims that CASAC meant only that ozone is a

non-threshold pollutant, EPA Br. (99-1426), at 11-12, EPA is

wrong. CASAC explained that it reached its conclusion

because “the difference in percent of outdoor children [the

sensitive population] . . . responding [to ozone] between the

present [i.e., |-hour] standard and the most stringent proposal

are small and their ranges overlap for ali health endpoints.”

Id. Even the EPA staff observed that an 8-hour standard

equivalent to the existing ozone standard provided some

“margin of safety” for these ozone-related health risks. '?

As a result, CASAC concluded that any decision on ozone

NAAQS revision would be driven not by science, but by

“policy judgment.”'* In other words, because the current

standards provide a “margin of safety,” the Administrator

would have to determine that the existing “margin” was not

“adequate” and some other “margin” was.

'° Compare Letter from Dr. George T. Wolff, Chair, CASAC, to Hon.

Carol M. Browner 3 (Nov. 30, 1995) [hereinafter CASAC Ozone Letter],

OJA 238, with EPA Br. (99-1426), at 12.

'' CASAC Ozone Letter, supra note 10, at 3, OJA 238.

OSP, supra note 3, at 167, OJA 1977; 62 Fed. Reg. 38858, OJA 3.

'’ CASAC Ozone Letter, supra note 10, at 3, OJA 238; see also Letter

from Dr. George T. Wolff, Chair, CASAC, to Hon. Carol M. Browner 4

(June 13, 1996) [hereinafter CASAC PM Letter], PMJA 3164.

For PM, EPA “concluded that the available evidence

‘provide[s] ample reason to be concerned that there are

detectable human health effects attributable to PM at levels

below the current NAAQS.” EPA Br. (99-1426), at 10 n.6."*

But a “concern{]” that there may be health effects below a

given level does not by itself establish a “public health”

problem. Nor does it establish what regulatory response will

provide a “reasonable degree of protection” for that problem.

Thus, while CASAC concluded that the PM;p NAAQS

should be revised, it also observed that there remained “many

unanswered questions and uncertainties associated with

establishing causality” of health effects by PM2>s, which

prevented any consensus on what PM2; standard would be

necessary (i.¢., “requisite”) to protect public health.’

CASAC therefore concluded that the decision on PM

'* CASAC agreed that the Criteria Document from which the statement is

drawn would, after revision, provide “an adequate scientific basis for

regulatory decisions on PM,” see Letter from Dr. George T. Wolff, Chair,

CASAC, to Hon. Carol M. Browner 3 (Mar. 15, 1996), PMJA 3151, but

did not endorse any specific statements such as this one. Clean Air Act:

Ozone and Particulate Matter Standards: Hearings Before the Subcomm.

on Clean Air, Wetlands, Private Property and Nuclear Safety and the

Sen. Comm. on Env't and Pub. Works, 105th Cong., pt. 1, at 104 (1997)

(Responses by Dr. Wolff).

'S CASAC PM Letter, supra note 13, at 2-3, PMJA 3162-63. EPA

characterizes its PM standards as “toward the mid-portion of the range of

protection afforded by . . . the CASAC panel members who chose to

express individual views.” EPA Br. (99-1426), at 11 n.7. In fact,

CASAC did not endorse the EPA Staff's recommended ranges for PM; s

standards, see CASAC PM Letter, supra note 13, at 2, 5, PMJA 3162,

3165, and thirteen CASAC panel members recommended either no

annual standard or one /ess stringent than the one adopted by EPA as the

controlling standard (including five who favored a standard higher than

the top of EPA’s range). /d 5-6, PMJA 3165-66. Only two of the 21

panel members supported an annual standard as stringent as the one EPA

adopted. /d.

standard revision required “policy” judgment by the

Administrator to address a potential public health problem. '®

The Administrator confirmed that her decisions here called

for “policy” judgment.'’ This policy judgment addressed

whether more “margin of safety” was appropriate in response

to uncertain health risks, which the Administrator explained

“may not be amenable to quantification in terms of what. . .

is ‘acceptable’ or any other metric.”'* While EPA would

now like to avoid discussing how it exercises risk

management judgment in the face of uncertain science

regarding the cause of a predicted health effect, the nature of

EPA’s risk management authority in revising NAAQS,

therefore, is the critical issue in this case.

II. THE CLEAN AIR ACT PROVIDES GUIDANCE

FOR PUBLIC HEALTH RISK MANAGEMENT

JUDGMENT.

EPA argues that the language of § 109 “unambiguously”

requires it to base NAAQS decisions “solely on the health

and welfare effects” of the pollutant, and not on “other

considerations.” EPA Br. (99-1426), at 14, 18, 19. To the

contrary, EPA’s response brief, as well as the statute’s

language, legislative history, and purposes, confirm that

Congress did not tell EPA to ignore the consequences of its

public health policy decisions. |

A. The Language of Section 109

EPA argues that “[s]ection 109’s command that NAAQS

be set at levels ‘requisite’ to protect public health and welfare

unambiguously directs that the levels be set to achieve that

objective ....” EPA Br. (99-1426), at 19 (emphasis added).

But this tells us nothing, for the “objective” to which EPA

'© Id 4, PMJA 3164.

” 62 Fed. Reg. 38857, 38859, 38861, 38862, 38863, 38867, OJA 2, 4, 6,

7, 8, 12; id. 38653, 38668, 38669, 38671, 38672, PMJA 3, 18, 19, 21, 22.

'* 62 Fed. Reg: 38883, OJA 28; id. 38688, PMJA 38.

refers is protecting the “public health.” While EPA asserts

elsewhere that it regulates in response to a “risk of adverse

effects” or “medically significant risks,” EPA Br. (99-1426),

at 14, 33, EPA never explains what standards guide its

“public health” decisions when confronted with, at most, a

potential public health risk.

For example, in the case of ozone, a cough or a tightening

of the chest on inhalation (a symptom one might experience

by stepping out-of-doors on a cold morning) was observed

during prolonged exercise under controlled laboratory

conditions.'? Based on these studies, EPA predicted that

coughs would occur in a population (exercising children) that

did mot experience these symptoms when studied.””

Furthermore, EPA’s risk assessment predicted, based on a

no-threshold assumption, that such undemonstrated effects

would occur at levels below the lowest level tested in the

controlled studies (i.e., below 0.08 ppm).”!

EPA concedes that the statutory “public health” language

requires that it focus on the “‘health of the community at

large.” EPA Br. (99-1426), at 36 n.28. But how severe,

how frequent or how certain must the risk of an effect be

before it constitutes a potential “adverse” public health

effect? The “endangerment” standard of the statute requires

'? See OSP, supra note 3, at 28, 107-110, OJA 1838, 1917-20.

[ozone] . . . albeit without symptoms [e.g., coughs].”).

2! See CASAC Tr. (9/19/95) 109, OJA 298 (noting exposures between

0.06 ppm and 0.08 ppm contribute the most risk); EPA Br. (99-1257), at

13-14. In the case of PM,;, EPA’s risk assessment assumed a causal

association between PM,,; and effects to “background” levels of PM.

EPA, Review of the National Ambient Air Quality Standards for

Particulate Matter V1-1, Vi-3 (1996), PMJA 2051, 2053. The Agency

acknowledges, however, that both the causal mechanism and the existence

of an effects threshold are unknown. See 62 Fed. Reg. 38657, 38664-65,

PMJA 7, 14-15.

that EPA make a policy judgment as to what constitutes a

“significant risk” to public health.” This policy judgment

requires EPA to address explicitly the uncertainties inherent

in its risk predictions and then to put those predictions in

context, for example, of the risks federal agencies or the

public have found acceptable, and of the public health risks

that might be increased by regulation.”

Once it has articulated its basis for concluding that there is

a potential public health problem (which EPA failed to do

here), EPA may then set a standard at a level “requisite to

protect” the public health, allowing an “adequate margin of

safety.” As EPA explained after the lower court’s decision,

the “requisite to protect” standard of § 109(b) contemplates

air quality standards that are “neither more nor less stringent

than necessary” to protect the public health.”*

Even if this were EPA’s position on remand,”> how does

EPA select an option that is neither more nor less stringent

than “necessary” to protect “public health” where risk

management options reflect similar levels of health

22 See H.R. Rep. No. 95-294, at 3, 48-49, reprinted in 4 1977 Legis. Hist.,

supra note 2, at 2470, 2515-16; APC Br. (99-1426), at 37 n.87; ALA Br.

(99-1257), at 20-21.

3 See APC Br. (99-1426), at 30-32; GE Br. (99-1426), at 22-25; Mfrs.

Alliance/MAPI, ef al, Br. (99-1257), at 15-20; 1 Presidential/

Congressional Comm’n on Risk Assessment and Risk Management,

Framework for Environmental Health Risk Management 5, 35 (1997)

(Risk management requires putting problems into real world context and

considering “the potential . . . to increase one type of risk while reducing

the risk of concern.”), Reply App. Sa.

%* See 195 F.3d at 6, App. 71a; cf Union Elec., 427 U.S. at 263 (“[T])he

most natural reading of the ‘as may be necessary’ phrase in context is

simply that the Administrator must assure that the minimal, or

‘necessary,’ requirements are met... .”).

*> EPA’s proffered “intelligible principle” at rehearing was, of course, a

post hoc rationalization that only confirms the correctness of the lower

court’s decision. See APC Br. (99-1257), at 26 n.60.

protection (as in the case of ozone)?*° When a pollutant is

associated with but not necessarily the cause of the effect (as

with PM2>s), how can EPA identify the NAAQS that is no

more stringent than “necessary” to protect “public health?’

As risk becomes more certain and differences between risk

management options more apparent, more health protection

may be “necessary.” Where uncertainty is large and

differences in risk small, a different judgment might result.

In either case, what is necessary to protect the public health

depends on an evaluation of whether marginal reductions in

predicted risk are worth the collateral adverse health,

environmental or economic costs of those reductions.

Congress also emphasized that the “adequate margin of

safety” language of §109 is intended to provide a

“reasonable degree of protection” in response to uncertain

science and unknown hazards.” Providing a “reasonable”

degree of protection contemplates more than tallying

predictions of uncertain health effects.” As this Court has

°° For example, is a revised ozone NAAQS that imposes an estimated

$9.6 billion in annual costs on society on top of the cost of attaining the

l-hour standard, see EPA, Regulatory Impact Analyses for Particulate

Matter and Ozone National Ambient Air Quality Standards and Proposed

Regional Haze Rule ES-12 (1997) [hereinafter R/A], OJA 2919, for no

significant improvement in public health protection, “requisite” to protect

“public health’?

”” For example, is a revised NAAQS that is estimated to cause between

1,600 and 27,000 premature deaths, see APC Br. (99-1426), at 18, while

preventing 3,700 to 16,600 predicted premature deaths (based on an

uncertain, “assumed” causal relationship), R/JA, supra note 26, at ES-18,

OJA 2925, “requisite” to protect the “public health”?

8S. Rep. No. 91-1196, at 10, reprinted in | 1970 Legis. Hist., supra note

2, at 410, OJA 3687; see also EPA Br. (99-1426), at 33-34 (describing

margin of safety requirement in terms of a “reasonable degree of

protection”); Mass/NJ Br. (99-1426), at 21 n.39.

*? See SAB, supra note 4, at 14, 20 (“{T]echnical risk rankings, in

isolation, offer{] insufficient guidance for policy decisions.” What is

needed is “open and comprehensive examination of environmental

observed, the concept of reasonableness contemplates a

“balancing of costs and benefits.””°

Finally, where there is a NAAQS in place, and the States

have put in place (or are putting in place) a program to meet

that standard, EPA must determine whether a change in its

earlier NAAQS risk management decision is “appropriate” in

light of new information.”' EPA argues that § 109(d)’s

requirement that the Administrator revise NAAQS “as may

be appropriate in accordance with [§§ 108 and 109(b)}”

(emphasis added) adds nothing to § 109(b)’s requirement that

NAAQS be set at levels “requisite” to protect “public health”

with an “adequate margin of safety.”

But whether additional “margin of safety” is an

“appropriate” response to uncertain risk, or whether existing

control programs should remain in place while additional

scientific investigations are completed, can be resolved only

based on the advice that CASAC must give to “the

Administrator” (not the States) on the need for and adverse

impacts of standard revision. CAA § 109(d)(2). Only with

that information can the Administrator determine whether

standard revisions are “appropriate.” To ignore this

problems.”); cf Chemical Mfrs. Ass'n v. EPA, 899 F.2d 344, 359 (5th

Cir. 1990) (“{Q]uantity . . . without more, is . . . of little help in

understanding what is meant by ‘substantial.””).

(1981); see also Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 1222

(Sth Cir. 1991) (citing Forester v. CPSC, 559 F.2d 774, 789 (D.C. Cir.

1977)); International Harvester Co. v. Ruckelshaus, 478 F.2d 615, 642

(D.C. Cir. 1973) (Regulation in the face of uncertainty requires weighing

the “nature and consequences of risk of error.”). Indeed, the D.C. Circuit

has acknowledged such balancing by EPA when setting standards to

protect the public health with an “ample margin of safety.” See NRDC v.

EPA (“Vinyl Chloride”), 824 F.2d 1146, 1165 (D.C. Cir. 1987) (en banc).

*' This is an especially important question here, in light of the statutory

program for ozone reductions that would be disrupted by EPA’s standard

revision. APC Br. (99-1257), at 42-50.

information, as EPA and its supporters urge, could result in

decisions that disrupt control programs under an existing

NAAQS with no significant improvement in (or perhaps

reduction in) public health protection. See APC Br. (99-

1257), at 47-48.

B. The Structure of the Act and Its Legislative

History

Section 109(b)(1) requires that NAAQS be “based on” the

air quality “criteria” document that EPA issues under § 108.

See EPA Br. (99-1426), at 19. The § 108 criteria document is

to contain scientific information on the effects “which may

be expected to result from the presence of such pollutant in

the ambient air.” CAA§ 108(a)(2). Based on this language

of §§ 108 and 109, EPA argues that it is precluded, in setting

NAAQS, from considering factors not addressed in the

criteria document. EPA Br. (99-1426), at 19.

As EPA and its supporters explain, however, the criteria

are “descriptive; that is, they describe the effects that have

been observed to occur when the ambient air level of a

pollutant has reached or exceeded specific figures... .”*”

The criteria in fact “stress[] the difficulties of drawing a

bright line between pollution that is harmful and pollution

that is not.”*?

In revising NAAQS, however, the Administrator must

exercise judgment in light of uncertain risk predictions. The

words “based on” in § 109(b) therefore cannot suggest that

the information in the § 108 criteria document is the

exclusive record upon which NAAQS may be based. Rather,

consistent with their plain meaning,” the words “based on”

CBT Br. (99-1426), at 21 (emphasis added) (citations omitted); see

Mass/NJ Br. (99-1426), at 18-19; EPA Br. (99-1426), at 24.

** Mass/NJ Br. (99-1426), at 9 (emphasis added); see id. 20 (“air quality

criteria cannot be interpreted as threshold values”).

** See 1 The New Shorter Oxford English Dictionary 187 (1993) (“act as

a foundation for’).

merely call for consideration of the information in the criteria

document in determining what potential risks should be

regulated, and to what level.

Indeed, if the language in § 109(b) means that standards

must be “based on” the criteria document exclusively, there

would be no need for notice and comment rulemaking on the

standard. Under EPA’s interpretation, all the Administrator

would have to do is announce a NAAQS “based on” the

criteria document and go home. CASAC advice, necessary

information not included in the criteria document (e.g., EPA

and others’ risk and exposure analyses, and EPA’s “staff

paper”), and public comments would be irrelevant.

EPA next turns to the legislative history, arguing that it

confirms that “Congress made a policy choice [in 1970] not

to base NAAQS on consideration of the technological

feasibility ‘or cost-effectiveness of pollution control

measures.” EPA Br. (99-1426), at 21. But all this legislative

history shows is that Congress, in § 110 of the Act, (1)

authorized the States in 1970 to consider cost and feasibility

of pollution controls in implementing the NAAQS, so long as

the State’s “control strategy” program would bring about

timely attainment of the NAAQS, and (2) prohibited EPA

from overriding the State’s control program on cost or

feasibility grounds. See id. at 20.

This says nothing about what EPA is required to consider,

or prohibited from considering, when exercising judgment

under § 109 on how potential public health risks should be

managed in setting NAAQS. Indeed, because EPA claims it

is prohibited from considering cost and feasibility at the

implementation stage, and because States may often have to

ignore these factors to achieve expeditious attainment, unless

EPA’s public health policy judgment under § 109 reflects

consideration of the overall societal impacts, those impacts

might never be considered. See Ohio, et al., Br. (99-1426), at

EPA also argues that the legislative history shows that

Congress made “a deliberate policy judgment that the

NAAQS would have a ‘technology-forcing character.”” EPA

Br. (99-1426), at 25, quoting Union Elec. Co., 427 U.S. at

257. The Union Electric Court observed, however, that the

NAAQS program is “technology forcing” because, under

§ 110(a), States must develop programs to attain the NAAQS

in three years or sooner regardless of cost or feasibility. See

427 U.S. at 258. As the Court noted, “so long as the national

standards are being attained and maintained, there is no basis

in the present Clean Air Act for forcing further technological

developments.” /d. at 257; see also id. at 261.°°

Union Electric therefore does not say that EPA must

ignore real world impacts when evaluating risk management

options under § 109.°” Nevertheless, further developing its

** The records here indicate that EPA could not identify technologically

feasible measures for attaining these NAAQS. RIA, supra note 26, at ES-

11 to ES-12, OJA 2918-19. When EPA assumed the existence of cost-

effective measures to bring about national attainment, contrary to EPA’s

characterization of the RIA, EPA Br. (99-1426), at 46 n.41, costs

exceeded the quantifiable benefits of the ozone NAAQS while the range

of quantifiable benefits for the PM NAAQS fell within the estimated cost

range. RIA, supra note 26, at ES-20, OJA 2927. Historically, EPA has

sometimes overestimated and sometimes underestimated control costs,

although accuracy has improved over time. See Winston Harringon, ef

al., On the Accuracy of Regulatory Cost Estimates, 19 J. Pol. Analysis &

Mgmt. 297, 307, 309 (2000).

“technology forcing if the NAAQS adopted requires this result.”’).

*” Similarly, Congress’ statement in 1990 that primary NAAQS are to

protect the public health “without regard to the economic or technical

feasibility of attainment,” EPA Br. (99-1426), at 30 (citation omitted),

must be understood, if relevant at all, see APC Br. (99-1426), at 48-49;

Inhofe, et al., Br. (99-1426), at 17-30, as a reaffirmation that once EPA

sets a NAAQS, that NAAQS must be met.

§ 110 non sequitur, EPA argues that Congress has changed

§ 110 attainment deadlines, and asserts that this confirms that

EPA must ignore the consequences of its § 109 NAAQS

decisions. EPA Br. (99-1426), at 27-30.

That Congress has acted to give States more flexibility in

implementing NAAQS under § 110 says nothing about how

EPA sets the NAAQS under § 109. To the contrary, that

Congress in 1990 enacted a comprehensive ozone risk

management program in Subpart 2, CAA §§ 181-185A,

shows that Congress decided to override EPA’s failed ozone

risk management program and, in so doing, to preclude EPA

from establishing a more stringent ozone NAAQS.”

Regarding whether and how the Act constrains EPA’s

authority to manage potential public health risks, the

legislative history tells a different story than that told by

EPA. Congress in 1970 adopted statutory language to protect

the “public health” as opposed to “the health . . . of any

persons.” At the same time, Congress understood that EPA

would have to draw a line “between the point of no known

effects and the maximum effects.*° Congress therefore

authorized EPA to regulate in response to “significant”

public health risk, see supra note 22, and required EPA to

make practical judgments in drawing lines in order to provide

a “reasonable degree of protection” in responding to such

*® APC Br. (99-1257), at 42-50; Ohio, ef al., Br. (99-1257), at 10-31. As

EPA’s supporters recognize, Congress in Subpart 2 “itself has balanced

the public health and welfare goals of the statute against the economic and

technological challenges posed by meeting these goals.” Mass/NJ Br.

(99-1426), at 28.

°° Compare Air Quality Act of 1967 § 108(a), Pub. L. No. 90-148, 81

Stat. 485, 491 (1967), with CAA § 109(a); see Mass/NJ Br. (99-1257), at

13 (In 1970, “Congress instructed EPA to target health effects in

populations rather than in single individuals.”’).

” See 1970 Hrg., supra note 2, at-1487, reprinted in 2 1970 Legis. Hist.,

supra note 2, at 1182 (Sen. Muskie).

potential public health problems.*' In enacting the

“Prevention of Significant Deterioration” program in 1977,

CAA §§ 160-169B, Congress confirmed that the NAAQS

program requires judgments as to when predicted health risks

become a public health problem. See APC Br. (99-1426), at

43-45.

As a result, while protecting public health is the end that

implementation of the NAAQS must achieve, the Act does

not restrict the factors relevant to the Agency’s exercise of

risk management judgment in achieving that endpoint.

C. The Requirement to Protect “Public Health”

and the Statutory Purposes Language of the Act

Must Guide EPA’s Exercise of Discretion in

Revising NAAQS.

As discussed above, protecting the “public health”

contemplates balancing to ensure that EPA’s NAAQS

decisions promote society’s health and well-being. See APC

Br. (99-1426), at 27-31.** As EPA recognizes, this statutory

provision must be read “with due regard for the Act’s

purpose.” EPA Br. (99-1257), at 22.

Congress explained that the Act is intended to “ensure the

protection of the public health and the environment . . . while

at the same time considering the energy and economic needs

of this Nation.” Congress codified that intent in

§ 101(b)(1), which emphasizes in statutory language the

importance of balancing to promote the “public health” and

the “productive capacity” of the Nation. EPA has interpreted

*''S. Rep. No. 91-1196, at 10, reprinted in | 1970 Legis. Hist., supra note

2, at 410, OJA 3687; see also H.R. Rep. No. 95-294, at 127, reprinted in

4 1977 Legis. Hist., supra note 2, at 2594, OJA 3678.

* See also ATA Reply Br. (99-1426), Arg. § Il; ALA Br. (99-1257), at

19 (“public health disciplines . . . furnish a detailed context for

§ 109(b)(1)’s ‘public health’ mandate.”’).

Hist., supra note 2, at 2501-02.

this provision as calling for a “balancing of the social and

economic considerations with the environmental

implications” of its decisions. 39 Fed. Reg. 31000 (1974).

EPA responds that the statutory purposes have no

relevance here, because they cannot “take precedence over

the CAA’s specific language in Sections 108 and 109.” EPA

Br. (99-1426), at 42. But, as discussed above, nothing in the

language of §§ 108 or 109 restricts the factors that EPA is to

consider when exercising judgment as to what “margin of

safety” is “adequate” in selecting from a range of health

protective options. The statutory language of § 101(b) is

therefore blindingly relevant to defining the factors that will

govern the exercise of such judgments.

EPA argues next that the reference in § 101(b) to

promoting the public health and welfare and the “productive

capacity” of the Nation’s population means only that

improved air quality will “reduc[e] the harm that air pollution

causes.” EPA Br. (99-1426), at 43. But EPA counsel’s

characterization of congressional purpose as “less pollution is

better” is inconsistent with both Congress’ understanding and

the Agency’s prior interpretations of this language.

As EPA has explained, under § 101(b), “[iJt would be

counterproductive if, in protecting public health through

clearing the air, EPA were to create or exacerbate conditions

that endangered public health or safety. [According to EPA,

ijn its major regulatory rulemakings, EPA has carefully

weighed any potential adverse environmental and public

safety impacts against the benefits from its actions.””*

Because §§ 108 and 109 do not “unambiguously” restrict

factors relevant to managing risks, the Agency must turn to

the statutory purposes to inform its exercise of discretion, and

exercise that discretion in a way that achieves the balance

contemplated by Congress in § 101(b).

“ 55 Fed. Reg. 41204, 4121 1-12 (1990).

Ill. THIS COURT CAN IDENTIFY PRINCIPLES

THAT GUIDE EPA’S EXERCISE OF PUBLIC

HEALTH RISK MANAGEMENT JUDGMENT.

EPA argues that “[t}he principle that a statute must be

construed so as to avoid doubts as to its constitutionality

applies only when the statute’s meaning is unclear.” EPA Br.

(99-1426), at 48 n43. Here, EPA views the statute as

“unmistakably clear,” id, and argues that requiring the

Agency to consider more factors would compound the

nondelegation problem by giving EPA too much to consider.

Merely characterizing a range of risk and picking a point

from the spectrum while reciting risk characterization factors,

however, sheds no light on why there is a public health

problem, and what is a “reasonable” degree of protection. As

the Court observed in Mistretta, to avoid a nondelegation

problem, Congress must not only have “clearly delineate{d]

the general policy” of the statute but also “the boundaries of

th{e] delegated authority.” 488 U.S. 361, 372-73 (1989).

The constitutional problem perceived by the lower court

arose precisely out of EPA’s refusal to define the boundaries

of its public health authority under § 109. See APC Br. (99-

1257), at 25-31. If Congress provided no standards for

EPA’s public health decisions, then the Act would present a

clear nondelegation problem. See GE Br. (99-1257), at 21-

23, 29-30.

What then are the legal standards that flow from the Act’s

language, including the purposes section, and that can

provide “reasonable coherence” for selecting a NAAQS?

As discussed above, the focus of the NAAQS program is

on pollution that “endangers” the “public health,” CAA

§ 108(a)(1), and its goal is establishing air quality levels that

are “requisite to protect the public health.” CAA § 109(b)(1).

This language requires a determination whether the health

risks at issue create a potential “public health” problem (i.c.,

a significant.risk of adverse public health impacts). To make

this determination, EPA must specifically address whether

the estimated risks are of sufficient magnitude and certainty

to affect adversely the health of the community in light of,

inter alia, other risks that EPA has found worthy of

regulation, or that society is willing to accept.

If the Agency finds a potential public health problem, the

Agency must then address what is a “reasonable” degree of

protection. In exercising this judgment, EPA must address,

inter alia, how differing risk management options compare

with the status quo, and with the cost to society (e.g., health,

environmental or economic costs) of any additional margin of

safety. The balancing required by these risk management

judgments is no secret; relevant factors have been described

repeatedly by EPA and its science advisers. **

A balancing approach to risk management that assures

protection of “public health and welfare” and the “productive

capacity” of the Nation, backed up by a reasoned explanation

of how the balance was struck, avoids the nondelegation

problem perceived by the lower court. Furthermore, it

assures the “reasonable coherence” necessary to avoid

“arbitrary and capricious” decisionmaking and to enable

judicial review. 175 F.3d at 1038-40, App. 13a-18a. Finally,

because Lead Industries stands for the proposition that the

overall costs to society of risk management options may play

no role in NAAQS decisions, that decision must be

overruled. See APC Br. (99-1426), at 45-49.

CONCLUSION

For the reasons discussed above, the revised PM and

ozone NAAQS must be vacated, because EPA has failed to

consider factors relevant to the exercise of its public health

risk management judgment under § 109 of the Act.

** See, eg., SAB, supra note 4, at 13 (Relevant factors for risk

management decisions include “the societal values that both influence and

are affected by the decision, including values relating to economic

efficiency, sustainability, equity, and quality of life.”), Reply App. 9a; see

generally supra note 4; Marchant, ef al., Br. (99-1257), at 6-8. The

balancing, of course, need not be strictly quantitative.

DAVID E. MENOTTI

WILLIAM F. PEDERSEN

JEFFREY A. KNIGHT

SHAWPITTMAN

2300 N Street, N.W.

Washington, D.C. 20037

(202) 663-8675

Counsel for American Forest

& Paper Association, and

American Iron & Steel

Institute

G. WILLIAM FRICK

M. ELIZABETH COX

AMERICAN PETROLEUM

INSTITUTE

1220 L Street, N.W.

Washington, D.C. 20005

(202) 682-8250

. Counsel for American

Petroleum Institute

MAURICE H. MCBRIDE

NATIONAL PETROCHEMICAL &

REFINERS ASSOCIATION

1899 L Street, N.W.

Washington, D.C. 20036

(202) 457-0480

Counsel for National

Petrochemical & Refiners

Association

Respectfully submitted,

HENRY V. NICKEL

F. WILLIAM BROWNELL

(Counsel of Record)

JAMES N. CHRISTMAN

LUCINDA M. LANGWORTHY

HUNTON & WILLIAMS

1900 K Street, N.W.

Washington, D.C. 20006

(202) 955-1500

Counsel for Appalachian

Power Co., et al., American

Public Power Association,

and National Association of

Home Builders

NEWMAN R. PORTER

LEWIS AND ROCA

40 N. Central Avenue

Phoenix, AZ 85004

(602) 262-5786

Counsel for Nevada Mining

Association, Newmont Gold

Company, and Meridian Gold

Company

DAVID F. ZOLL

ALEXANDRA DAPOLITO DUNN

AMERICAN CHEMISTRY

COUNCIL

1300 Wilson Boulevard

Arlington, VA 22209

(703) 741-5165

Counsel for American

Chemistry Council

DAVID M. FLANNERY

JACKSON & KELLY

P.O. Box 553

1600 Laidley Tower

Charleston, WV 25322

(304) 340-1017

Counsel for Midwest Ozone

Group; and West Virginia

Chamber of Commerce

KURT BLASE

O’CONNOR & HANNAN

Suite 500

1666 K Street, N.W.

Washington, D.C. 20006-2803

(202) 887-1400

Counsel for Kennecott

Holdings Corporation,

Kennecott Energy and

Coal Company, Kennecott

Services Company, and

National Stone Association

PETER S. GLASER

SHOOK, HARDY & BACON

600 14" Street, N.W.

Suite 800

Washington, D.C. 20005

(202) 639-5627

Counsel for Western Fuels

Association, Inc.

HAROLD P. QUINN, JR.

NATIONAL MINING

ASSOCIATION

1130 17" Street, N.W.

Washington, D.C. 20036

(202) 463-2652

Counsel for National Mining

Association

MARCELLE SHOOP

Associate General Counsel

KENNECOTT UTAH COPPER

CORPORATION

8315 West 3595 South

P.O. Box 6001

Magna, Utah 84044-6001

(801) 252-3000

Counsel for Kennecott Holdings

Corporation, Kennecott

Energy and Coal Company,

and Kennecott Services

Company

DUANE J. DESIDERIO

NATIONAL ASSOCIATION OF

HOME BUILDERS

1201 15th Street, N.W.

Washington, D.C. 20005

(202) 861-2146

Counsel for National

Association of Home Builders

RUSSELL S. FRYE

COLLIER, SHANNON, RILL &

Scott, PLLC

3050 K Street, N.W.

Suite 400

Washington, D.C. 20007

(202) 342-8878

and

RICHARD WASSERSTROM

AMERICAN FOREST & PAPER

ASSOCIATION, INC.

1111 19th Street, N.W.

8" Floor

Washington, D.C. 20036

(202) 463-2582

Counsel for American Forest

& Paper Association, Inc.

GRANT CRANDALL

General Counsel

UNITED MINE WORKERS OF

AMERICA, AFL-CIO

8315 Lee Highway

Fairfax, VA 22031

(703) 208-7200

and

EUGENE M. TRISKO

P.O. Box 596

Berkeley Springs, WV 25411

(304) 258-1977

Counsel for United Mine

Workers of America, AFL-CIO

October 5, 2000

TIMOTHY L. HARKER

THE HARKER LAW FIRM

9500 Accord Drive

Potomac, MD 20854

(301) 983-0964

and

THOMAS J. GRAVES

NATIONAL PAINT AND

COATINGS ASSOCIATION,

INC.

1500 Rhode Island Ave., N.W.

Washington, D.C. 20005

(202) 462-6272

Counsel for National Paint and

Coatings Association

DAVID M. FRIEDLAND

BEVERIDGE & DIAMOND

1350 I Street, N.W.

Suite 700

Washington, D.C. 20005

(202) 789-6000

Counsel for Phoenix Cement

Company

APPENDIX

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Framework for Environmental Health Risk Management

The Presidential/Congressional Commission on Risk

Assessment and Risk Management

Final Report

Volume |

1997

The Commission’s Risk Management Framework

The Framework is general enough to work in a wide

variety of situations. The level of effort and resources

invested in using the Framework can be scaled to the

importance of the problem, potential severity and economic

impact of the risk, level of controversy surrounding it, and

resource constraints. The Framework is primarily intended

for risk decisions related to setting standards, controlling

pollution, protecting health, and cleaning up the environment.

It is useful for addressing these types of decisions at a local

community level (e.g., siting an incinerator or cleaning up a

hazardous waste site) or a national level (e.g., developing a

national program for controlling motor vehicle emissions).

The Framework need not be invoked for risk situations that

are routinely and expeditiously managed—for example, by

hazardous materials response teams, emergency room

| physicians, firefighter rescue teams, and voluntary product

, recalls.

Every stage of the Framework relies on three key

principles:

Broader centexts. Instead of evaluating single risks

associated with single chemicals in single environmental

media, the Framework puts health and environmental

problems in their larger, real-world contexts. Evaluating

problems in context involves evaluating different sources of a

particular chemical or chemical exposure, considering other

chemicals that could affect a particular risk or pose additional

risks, assessing other similar risks, and evaluating the extent

to which different exposures contribute to a particular health

effect of concern. The goal of considering problems in their

context is to clarify the impact that individual risk

management actions are likely to have on public health or the

environment and to help direct actions and resources where

they will do the most good.

Stakeholder participation. Involvement of stakeholders—

parties who are concerned about or affected by the risk

management problem—is critical to making and successfully

implementing sound, cost-effective, informed __ risk

management decisions. For this reason, the Framework

encourages stakeholder involvement to the extent appropriate

and feasible during all stages of the risk management process.

“Lstablish a Process for Engaging Stakeholders” on page 15

discusses in depth the value of and approaches to involving

stakeholders.

Iteration. Valuable information or perspective may

emerge during any stage of the risk management process.

This Framework is designed so that parts of it may be

repeated, giving risk managers and stakeholders the

flexibility to revisit early stages of the process when new

findings made during later stages shed sufficiently important

light on earlier deliberations and decisions. (“The Importance

of Iteration” on page 47 provides more information. )

Principles for Risk Management Decision-Making

A good risk management decision...

e Addresses a clearly articulated problem in its public

health and ecological context.

e Emerges from a decision-making process that elicits the

views of those affected by the decision, so that differing

technical assessments, public values, knowledge, and

perceptions are considered.

e ls based on a careful analysis of the weight of scientific

evidence that supports conclusions about a problem’s

potential risks to human health and the environment.

e Is made after examining a range of regulatory and

nonregulatory risk management options.

e Reduces or eliminates risks in ways that:

— Are based on the best available scientific,

economic, and other technical information.

— Account for their multisource, multimedia,

multichemical, and multirisk contexts.

— Are feasible, with benefits reasonably related to

their costs.

~ Give priority to preventing risks, not just

controlling them.

— Use alternatives to command-and-control

regulation, where applicable.

— Are sensitive to political, social, legal, and

cultural considerations.

— Include incentives for innovation, evaluation, and

research.

e Can be implemented effectively, expeditiously, flexibly,

and with stakeholder support.

e Can be shown to have a significant impact on the risks of

concer.

e Can be revised and changed when significant new

information becomes available, while avoiding “paralysis

by analysis.”

Advantages of the Commission’s

Risk Management Framework

Traditionally, risk management has relied on command-

and-control approaches that often require environmental

protection standards to be met using specific technologies.

Risk management has generally focused on controlling

single hazards in single environmental media. Many risk

management failures can be traced to not including

stakeholders in decision-making at the earliest possible

time and not considering risks in their broader contexts. In

contrast, the Commission’s Risk Management Framework

is intended to:

Provide an integrated, holistic approach to solving

public health and environmental problems in

context.

Ensure that decisions about the use of risk

assessment and economic analysis rely on the best

scientific evidence and are made in the context of

risk management alternatives.

' Emphasize the importance of collaboration,

communication, and negotiation among

stakeholders so that public values can influence risk

management strategies.

Produce risk management decisions that are more

likely to be successful than decisions made without

adequate and early stakeholder involvement.

Accommodate critical new information that may

emerge at any stage of the process.

aro oF

Potential Adverse Consequences

Analysis must consider whether an option may cause any

adverse consequences. One of the most important is the

potential for an option to increase one type of risk while

reducing the risk of concern:

e While reducing pollutant concentrations in one

environmental medium, the option may increase

pollutants in another medium. For example, using

aeration reduces pollutants in drinking water by

releasing them to the air. (Of course, if exposure to

air is considerably less than exposure to drinking

water, this tradeoff may be worthwhile.)

e While reducing long-term health risks for community

members, an option may produce short-term health

risks and injury for workers, as can happen during

cleanup of sites contaminated with hazardous

chemical and radioactive wastes.

e Banning one pesticide because it might cause cancer

may increase the use of another pesticide that is

known to cause birth defects or to harm wildlife, or

whose health effects are not known.

Thus, tradeoffs among different risks must be identified

and considered.

Other adverse consequences may be cultural, ethical,

political, social, or economic, such as:

e Economic impacts on a community, including

reduced property values or loss of jobs.

e Environmental justice issues, such as inequitable

distribution of costs and benefits as mentioned above;

disregard for a particular population group’s dietary

needs, preferences, or nutritional status; or giving

priority to site cleanup efforts in more affluent areas.

e Harming the social fabric of a town or tribe by

relocating the people away from a_ highly

contaminated area.

Risk Assessment in the Federal Government: Managing

the Process

Committee on the Institutional Means for Assessment of

Risks to Public Health

Commission on Life Sciences

National Research Council

National Academy Press

Washington, D.C. 1983

* * *

Risk Assessment and Risk Management

We use risk assessment to mean the characterization of the

potential adverse health effects of human exposures to

environmental hazards. Risk assessments include several

elements: description of the potential adverse health effects

based on an evaluation of results of epidemiologic, clinical,

toxicologic, and environmental research; extrapolation from

those results to predict the type and estimate the extent of

health effects in humans under given conditions of exposure;

judgments as to the number and characteristics of persons

exposed at various intensities and durations; and summary

judgments on the existence and overall magnitude of the

public-health problem. Risk assessment also includes

characterization of the uncertainties inherent in the process of

inferring risk.

The term risk assessment is often given narrower and

broader meanings than we have adopted here. For some

observers, the term is synonymous with quantitative risk

assessment and emphasizes reliance on numerical results.

Our broader definition includes quantification, but also

includes qualitative expressions of risk. Quantitative

estimates of risk are not always feasible, and they may be

eschewed by agencies for policy reasons. Broader uses of the

term than ours also embrace analysis of perceived risks,

comparisons of risks associated with different regulatory

strategies, and occasionally analysis of the economic and

social implications of regulatory decisions--functions that we

assign to risk management.

The Committee uses the term risk management to describe

the process of evaluating alternative regulatory actions and

selecting among them. Risk management, which is carried

out by regulatory agencies under various legislative

mandates, is an agency decision-making process that entails

consideration of political, social, economic, and engineering

information with risk-related information to develop, analyze,

and compare regulatory options and to select the appropriate

regulatory response to a potential chronic health hazard. The

selection process necessarily requires the use of value

judgments on such issues as the acceptability of risk and the

reasonableness of the costs of control.

* * *

Toward Integrated Environmental Decision-Making

United States Environmental Protection Agency

Science Advisory Board

(1400A)

Washington, DC

EPA-SAB-EC-00-01 1

August 2000

www.epa.gov/SAB

* * *

2.3 Analysis and Decision-Making (Phase II)

In Phase II of the IED Framework, the analysts take the

information and general directions gained in Phase | and

generate more detailed, more fully supported assessments of

risks and risk reduction options. For integrated decision-

making, options analysis should include consideration of risk

reduction opportunities with regard to their technical

feasibility, aggregate risk reduction to be obtained (e.g.,

reductions in “target” risks and collateral reduction in all

affected risks), full economic consequences of various risk

reduction scenarios, and so forth. Decision-makers also

should request analysis of potential options with regard to

sustainability, equity, and other potential decision criteria.

Options analysis generally is more “analytic” than

“deliberative” (NRC, 1996) although a continued level of

interaction between the participants in the overall process

(scientists, risk managers, and interested and affected parties)

is important. Options Analysis is also more resource-

intensive than Problem Formulation.

In the decision-making portion of Phase II, the Agency or

other decision-makers should a) utilize outputs from the

analyses of risk and risk reduction options, b) consider

widely-held public values, as well as the views of

participating stakeholders, c) consider the legal, economic,

and institutional constraints, and d) ultimately, make the

decision. Clearly, this process is not totally scientific.

However, the best science should inform and contribute to

decision-making. Developments in the social and decision

sciences, for example, are providing improved methods for

value elicitation and multi-attribute decision-making. The

documentation supporting the decision should make explicit

a) the implications of the chosen management option(s) to the

health of ecological or human systems, b) the economic costs

and benefits associated with the selected option, and c) the

societal values that both influence and are affected by the

decision, including values relating to economic efficiency,

sustainability, equity, and quality of life. Integrated decision-

making requires explicit consideration of the trade-offs

involved in pursuing multiple environmental goals and/or in

simultaneously pursuing environmental and _non-

environmental goals. In some cases, analysis may indicate

that a particular management option is not worth doing

because of the greater good that might be achieved by

investing those resources toward the achievement of another

goal.

It is important that the scientific and technical analyses

prepared during Phase II articulate clearly the uncertainties

associated with the estimates of risk, the estimates of risk

reduction that may be achieved by different management

options, and the economic assessments of various risk

management scenarios. Integrated decision-making does not

eliminate the uncertainties associated with making decisions.

However, by encouraging an open and comprehensive

examination of environmental problems, integrated decision-

making should lead to a clearer identification of the nature,

extent, and consequences of the uncertainties associated with

the available information. In any event, environmental

decision-making must proceed in the presence of

10a

uncertainties, and nothing in the proposed Framework should

be construed as precluding environmental decisions simply

because uncertainties remain.

* * *

3.1.2 What We Need

During the design of the Framework, the SAB participants

acknowledged that technical risk rankings, in isolation,

offered insufficient guidance for policy decisions. Given the

multitude of problems and issues to be addressed, a more

comprehensive and systematic framework for analyzing and

reducing environmental health, ecological, and quality of life

risks appeared necessary. During Problem Formulation, the

Agency needs methods for comparing risks that are robust,

transparent, effective, and inexpensive. As noted, some

initial steps have been taken for ranking risks within

categories; e.g., human health, quality of life. or ecosystem

risks.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.