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

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IN THE

Supreme Court of the United States

AMERICAN TRUCKING ASSOCIATIONS, INC., CHAMBER OF

COMMERCE OF THE UNITED STATES, et al.,

Petitioners,

Vv.

CAROL M. BROWNER, ADMINISTRATOR OF THE

ENVIRONMENTAL PROTECTION AGENCY, et ail.,

Respondents.

On a Writ of Certiorari to the

United States Court of Appeals

For the District of Columbia Circuit

BRIEF FOR RESPONDENTS

APPALACHIAN POWER COMPANY, et al.,

IN SUPPORT OF PETITIONERS

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

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

Power Association, and

National Association of

July 20, 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 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 Luilders

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.

QUESTION PRESENTED

Whether Sections 101, 108, and 109 of the Clean Air Act

require that the Environmental Protection Agency, in

evaluating the adequacy of nationwide ambient air quality

standards that address predicted “risks” to health, consider

the overall societal consequences of managing such risks in

determining whether and how to revise such standards?

l.

ii

PARTIES TO THE PROCEEDINGS

The parties joining in this brief were petitioners in

American Trucking Ass'ns, Inc. v. United States

Environmental Protection Agency, D.C. Cir. No. 97-1440

(and consolidated cases), and American Trucking Ass ‘ns,

Inc. v. United States Environmental Protection Agency,

D.C. Cir. No. 97-1441 (and consolidated cases), and are

listed below.

Appalachian Power Co.

Baltimore Gas and Electric Company

Carolina Power & Light Company

Central and South West Services, Inc.

Central Power and Light Company

Public Service Company of Oklahoma

Southwestern Electric Power Company

West Texas Utilities Company

Central Illinois Public Service Company

CINergy Corp.

Columbus Southern Power Company

Conectiv (petitioned as Delmarva Power & Light Co.

and intervened as Atlantic City Electric Co. in the

cases below)

Consumers Energy Company

Dayton Power and Light Company, The

Detroit Edison Company, The

Duke Energy Co.

FirstEnergy (petitioned as Ohio Edison Co. and

Centerior Energy Co., (with Centerior Energy

Co. subsidiaries Cleveland Electric

Illuminating Co. & Toledo Edison Co.) in the

cases below)

Florida Power Corporation

iii

Illinois Power Company

Indiana Michigan Power Company

Indianapolis Power & Light Company

Jacksonville Electric Authority

Kansas City Power & Light Company

Kentucky Power Company

LGE Energy Corp. (petitioned as Kentucky

Utilities Company and Louisville Gas &

Electric Co. in the cases below)

Madison Gas and Electric Company

Minnesota Power Company

| Monongahela Power Company,

dba Allegheny Power System, Inc.

Northern Indiana Public Service Company

Oglethorpe Power Corporation

Ohio Power Company

Ohio Valley Electric Corporation

Otter Tail Power Company

PacifiCorp

PPL Electric Utilities Corporation

dba PPL Utilities (petitioned as

Pennsylvania Power & Light Corp.)

Plains Electric Generation & Transmission

Cooperative, Inc.

Potomac Edison Company, The

dba Allegheny Power System, Inc.

Potomac Electric Power Company

Public Service Company of New Mexico

Salt River Project

South Carolina Electric & Gas Company

Southern Company

Alabama Power Company

Georgia Power Company

iv

Gulf Power Company

Mississippi Power Company

Savannah Electric & Power Company

Tampa Electric Company

Union Electric Company

Virginia Power

West Penn Power Company

dba Allegheny Power System, Inc.

Wisconsin Electric Power Company

Edison Electric Institute

National Rural Electric Cooperative Association

American Chemistry Council (petitioned as Chemical

Manufacturers Association in cases below and for

a writ of certiorari)

American Forest & Paper Association

American Iron & Steel Institute

American Petroleum Institute

American Public Power Association

Kennecott Energy and Coal Company

Kennecott Holdings Corporation

Kennecott Services Company

Meridian Gold Company

Midwest Ozone Group

National Association of Home Builders

National Mining Association

National Paint and Coatings Association

National Petrochemical & Refiners Association

(petitioned as National Petroleum Refiners

Association in the case below)

National Stone Association

Nevada Mining Association

Newmont Gold Co.

Phoenix Cement Company

v

United Mine Workers of America, AFL-CIO

West Virginia Chamber of Commerce

Western Fuels Association, Inc.

2. The following parties were petitioners in the cases whose

judgment is under review, but have not joined in filing

this brief.

Alliance of Automobile Manufacturers (petitioned as

American Automobile Manufacturers Association

in the cases below)

American Farm Bureau Federation

American Portland Cement Alliance

American Trucking Associations, Inc.

James Bassage

Burns Motor Freight, Inc.

Central Illinois Light Co.

Chamber of Commerce of the United States of

America

Citizens for Balanced Transportation

Commonwealth Edison

Duquesne Light Co.

Equipment Manufacturers Institute

Garner Trucking, Inc.

Genie Trucking Line, Inc.

Gloucester Company, Inc.

Michael Gregory

Idaho Mining Association

Judy’s Bakery, Inc.

David Matusow

Brian McCarthy

National Association of Manufacturers

National Automobile Dealers Association

National Coalition of Petroleum Retailers

vi

National Indian Business Association

vii

National Small Business United DISCLOSURE STATEMENT

Non-Ferrous Founders’ Society 1. Pursuant to Supreme Court Rules 24.1(b) and 29.6, the

Oklahoma Gas & Electric following list discloses the parent companies, and any

Richard Romero publicly held company that owns 10% or more, of any

Small Business Survival Association party joining in this brief.

State of Michigan

State of Ohio Alabama Power Company

State of West Virginia (a subsidiary of Southern Company)

Appalachian Power Company

3. Respondents Carol M. Browner, Administrator of the (a subsidiary of American Electric Power

United States Environmental Protection Agency, and the Company, Inc.) .

United States Environmental Protection Agency were the Baltimore Gas and Electric Company

respondents in all of the proceedings below. (a subsidiary of Constellation Energy Group, Inc.)

Carolina Power & Light Co.

4. The following parties were intervenors in the cases whose (10% or greater owner: State Street Bank &

judgment is under review. Trust Co. Boston)

American Lung Association Central and South West Services, Inc.

American Road and Transportation Builders

Association

Atlantic City Electric Company

Commonwealth of Massachusetts

State of New Jersey

. The following parties appeared as amici curiae in the

cases whose judgment is under review.

Representative Tom Bliley

Senator Orrin G. Hatch

State of Connecticut

State of New Hampshire

State of New York

State of Vermont

(a subsidiary of Central and South West

Corporation)

Central Illinois Public Service Company

(a subsidiary of Ameren Corporation)

Central Power and Light Company

(a subsidiary of Central and Southwest

Corporation)

Columbus Southern Power Company

(a subsidiary of American Electric Power Company,

Inc.)

Consumers Energy Company

(a subsidiary of CMS Energy Corporation)

Dayton Power & Light Company, The

(a subsidiary of DPL Inc.)

Detroit Edison Co., The

viii

(a subsidiary of DTE Energy Co.)

Florida Power Corporation

(a subsidiary of Florida Progress

Corporation)

Georgia Power Company

(a subsidiary of Southern Company)

Gulf Power Company

(a subsidiary of Southern Company)

Illinois Power

(a subsidiary of Dynergy, Inc.)

Indiana Michigan Power Company

(a subsidiary of American Electric Power

Company, Inc.)

Indianapolis Power & Light Company

(a subsidiary of IPALCO Enterprises, Inc.)

Kennecott Energy and Coal Co.

(an indirect subsidiary of Rio Tinto PLC)

Kennecott Holdings Corporation

(an indirect subsidiary of Rio Tinto PLC)

Kennecott Services Company

(an indirect subsidiary of Rio Tinto PLC)

Kentucky Power Company

(a subsidiary of American Electric Power Company,

Inc.)

Meridian Gold Co.

(a wholly-owned subsidiary of Meridian Gold, Inc.)

Mississippi Power Company

(a subsidiary of Southern Company)

Monongahela Power Company

(a subsidiary of Allegheny Energy, Inc.)

Newmont Gold Co.

(10% or greater owner: Newmont Mining

Corporation)

ix

Northern Indiana Public Service Company

(a subsidiary of NiSource Inc.)

Ohio Power Company

(a subsidiary of American Electric Power

Company, Inc.)

Otter Tail Power Co.

(10% or greater owner: Otter Tail Power Co.

ESOP)

Potomac Edison Company, The

(a subsidiary of Allegheny Energy, Inc.)

Public Service Company of Oklahoma

(a subsidiary of Central and Southwest

Corporation)

Savannah Electric & Power Company

(a subsidiary of Southern Company)

South Carolina Electric & Gas Company

(a subsidiary of SCANA Corporation)

Southwestern Electric Power Company

(a subsidiary of Central and Southwest

Corporation)

Tampa Electric Company

(a subsidiary of TECO Energy, Inc.)

Union Electric Co.

(a subsidiary of Ameren Corp.)

Virginia Power

(a subsidiary of Dominion Resources, Inc.)

West Penn Power Company

(a subsidiary of Allegheny Energy, Inc.)

West Texas Utilities Company

(a subsidiary of Central and South West

Corporation)

Wisconsin Electric Power Company

(a subsidiary of Wisconsin Energy Corporation)

x

xi

2. The following parties joining this brief have no parent

Association (formerly National Petroleum Refiners

Association)

National Rural Electric Cooperative Association

National Stone Association

Nevada Mining Association

Oglethorpe Power Corp.

Ohio Valley Electric Corp.

PacifiCorp

corporations, and no publicly-held companies have a 10% eee ao Corporation

or greater ownership interest in these parties. Phoenix Cement Company

American Chemistry Council (formerly Chemical — Electric Generation & Transmission

Pes ooperative, Inc.

Manufactwers Association) Potomac Electric Power C

American Forest & Paper Association Pubs Garvin Ca ened on salad

American Iron & Steel Institute a

American Petroleum Institute Southern C J

American Public Power Association : we

CINergy Corp. United Mine Workers of America, AFL-CIO

Conextiv West Virginia Chamber of Commerce

Duke Energy Corp. Western Fuels Association, Inc.

Edison Electric Institute

FirstEnergy Corp.

Jacksonville Electric Authority

Kansas City Power & Light Co.

LGE Energy Corp.

Madison Gas and Electric Co.

Midwest Ozone Group

Minnesota Power Company

National Association of Home Builders

National Mining Association

National Paint and Coatings Association

National Petrochemical & Refiners

Page

crt tcrersncensnsenencnsscenensesenest i

PARTIES TO THE PROCEEDINGS ..............:ccccccccceseeseeeeeees ii

DISCLOSURE STATEMENT ............:c-ccccsscccssccssscesscesesersees vii

ee XV

cia aciiicerinae crctncensaeentnsnnessennsentensest XXV

ee l

iliac teren ce nensnemennesamesenesceemmeceseess l

RELEVANT CONSTITUTIONAL, STATUTORY

AND REGULATORY PROVISIONS .............:cccccccceeeeeeneeees I

eae 2

TTT cercneniersenanenetenpensensesecnesnescscnescosseceees 5

ae 5

Il. EPA’S POLICY DECISION TO REVISE THE

OZONE AND PM NAAQS. ....0:ccsscccssssccccsscorsssecescssscesees 8

Ill. THE D.C. CIRCUIT’S DECISION ...000.......cccccceeeeeeeees 20

SUMMARY OF ARGUMENT................::cccccceseesseeeeseeeeeenees 21

i Serra tereasnenenetncsnnnnnsenssencesecssscesees 25

xiv

|. THE STATUTORY PURPOSES MUST INFORM

AN AGENCY’S IMPLEMENTATION OF A

BROAD CONGRESSIONAL DELEGATION................. 27

Il. CONGRESS IN § 109 CONTEMPLATED THAT

EPA WOULD CONSIDER THE BROAD

IMPACTS ON SOCIETY OF ITS PUBLIC

HEALTH RISK MANAGEMENT DECISIONS

CONSISTENT WITH THE aces OF THE

| 32

A. Sections 108 and 10%b) Do Not Mandate

Uninformed Public Health Risk Management

EE a 33

B. Section 109(d) Confirms The Need For

Consideration of the Impacts on Society of

Decisions on Whether to Revise NAAQS. ...... 39

C. The Legislative History Confirms the Need For

Balancing to Promote the Purposes of the Act. ..43

Ill. LEAD INDUSTRIES, WHICH THE LOWER

COURT CITES AS THE BASIS FOR ITS

DECISION, SHOULD BE OVERRULED.................-. 45

CONCLUSION ....cccecccsscscccseossovsssccssersonsscnsensssssesssssssssosssssees 49

XV

TABLE OF AUTHORITIES

CASES Page

Asgrow Seed Co. v. Winterboer, 513 U.S. 179

SEI EETITTnteiuietiichnichapeiinieinininamnattattaeinataaaliadbaciaaaiiatiatatimias 27

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

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

er a ee passim

AT&T Corp. v. lowa Utilities Board, 525 U.S. 366

eae ensiasbiisinasniitensnnnipcnsiciiineiiaiinaiinhinbiaibiguusttitusian 28, 31

American Petroleum Institute v. Costle, 665 F.2d

Ee 34, 46

Central Bank, N.A. v. First Interstate Bank, N.A.,

ee BITTE ccciccnsitasistnctiadintiaaeninstatiticaaiaiaees 48, 49

Chevron, USA, Inc. v. NRDC, 467 U.S. 837

Salt serissetianenpeeenenandtuntianiedesnesamenitaaiians 24, 32, 35, 49

Chrysler Corp. v. EPA, 631 F.2d 865 (D.C. Cir.

Saat hetsercersienneinneninnteneineencaeniattantaianiiniatabiaisiaemsansees 29

Ethyl Corp. v. EPA, 541 F.2d 1 (D.C. Cir. 1976).......3, 37

FDA v. Brown & Williamson Tobacco Corp., 120

ee Ce I cilicadiathtictasitiitesihiiiiaicatimartaciinclncactiatas 45

General Motors Corp. v. Ruckelshaus, 742 F.2d

KS 29

George E. Warren Corp. v. EPA, 159 F.3d 616

SND GUI UIEcniicteieectiineaitiesistediitadeceaeinenl penittnie 47

Grand Canyon Tour Coalition v. FAA, 154 F.3d

ENED SIDE cereieienscinieneneheetiniaiotnisnatiteamniegs 47

Immigration and Naturalization Service v.

Chadha, 462 U.S. 919 (1983)........ccccccccccscseseeeeseeeeees 49

Industrial Union Department, AFL-CIO vy.

American Petroleum Institute, 448 U.S. 607

AP ial 31, 36

xvi

International Harvester Co. v. Ruckelshaus, 478

Pf (ff 7. 41, 42

International Union, UAW vy. OSHA, 938 F.2d

N(R , 31

Johnson v. United States, 120 S.Ct. 1795 (2000).....28, 32

Jones v. United States, 120 S.Ct. 1904 (2000)............... 28

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

Oy passim

Michigan v. EPA, No. 98-1497, 2000 WL 180650

I 47

Mississippi Band of Choctaw Indians v. Holyfield,

a s ccitecerecirtiemnrnmenne 28

Mistretta v. United States, 488 U.S. 361 (1989) ............ 28

Motor Vehicle Manufacturers Association v. State

Farm Mutual Automobile Insurance Co., 463

Rls Sa cnctcncepencrnescemmemmnsmennneaiaveniinanmeste 35, 42

Natural Resources Defense Council v. EPA,

(“Vinyl Chloride”), 824 F.2d 1146 (D.C. Cir.

Fe crecesesensensesnrinensennesemmneienenalenmten 36, 47, 48

Natural Resources Defense Council, 902 F.2d 962

ek > ee 34, 38, 46

Phelps Dodge Corp. v. NLRB, 313 U.S. 177

ETT ncrecsssesininentintnnsntdenzecateiiammnenaittdianmmemieepnaenniancil 45

Public Lands Council v. Babbitt, 120 S.Ct. 1815

GET IE sccnssccntineneniunesaseineniintnnaemmemminneneencne 42

SEC v. Chenery Corp., 332 U.S. 194 (1947)........c.cc0000 34

Sierra Club v. EPA, 540 F.2d 1114 (D.C. Cir.

1976) , vacated sub nom. Montana Power Co.

v. EPA, 434 U.S. 809 (1977) .......ccccccccceseeeereeeeeeeenes 30

xvii

Sierra Club v. Ruckelshaus, 344 F.Supp. 253

(D.D.C.), aff'd per curiam, 4 E.R.C. 1815

(D.C. Cir. 1972), aff'd by an equally divided

Court, sub nom. Fri v. Sierra Club, 412 U.S.

i atitiaiehhcetitainnien icteric tinea iatiatsees 30

Smiley v. Citibank (South Dakota), N.A., 517 U.S.

a eee ae aan 35, 46

South Dakota v. Yankton Sioux Tribe, 522 U.S.

ERR se a en 48

Union Electric Co. v. EPA, 427 U.S. 246 (1976)........... 31

West v. Gibson, 527 U.S. 212 (1998) ........cccccccccccceeeseeee 40

Whirlpool Corp. v. Marshall, 445 U.S. 1 (1980)........... 28

CONSTITUTION AND STATUTES

8 8 | Re en eer en eT Te 2

ne 49

SE l

Air Quality Act, Pub. L. No. 90-148, 81 Stat. 485

rear cerenniecresecnenenietTiiecsmuiinintiadiantecaatintineniaiinsaaieeni 28

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

(1994 & Supp. III 1997)

CAA § 101, 42 U.S.C. § 7401 ...cccssssecsccssssessscssssessesssseesen 2

CAA § 101(b), 42 U.S.C. § 7401(b) -cccccsececccsssseesee passim

CAA § 101(b)(1), 42 U.S.C. § 7401(B)(1) cccccssseesce passim

CAA § 108, 42 U.S.C. § 7408 ..ccccccccccsssecsssssssesesssees passim

CAA § 108(a), 42 U.S.C. § 7408(a) ..ccccccccccccesscssseeoee 7,37

CAA § 108(a)(2), 42 U.S.C. § 7408(€)(2).cccccseeceecsve 6, 38

CAA § 108(a)(2)(A), 42 U.S.C. § 7408(a)2)(A) cosecssveeee. 6

CAA § 108(b), 42 U.S.C. § 7408(b) -..cccccccccsesecsssseeee 7, 40

CAA § 108(b)(1), 42 U.S.C. § 7408(B)(1) -ecccecccessssees 6, 39

CAA § 109, 42 U.S.C. § 7409 .....cccccccccsssssesessssseeeee passim

XViil

CAA § 109(b), 42 U.S.C. § 7409(b) ......ssscsseeessenen passim

CAA § 109(b)(1), 42 U.S.C. § 7409(D)(1) ..-....00 5, 23, 42

CAA § 109(b)(2), 42 U.S.C. § 7409(0)(2) ....sssssssseceseeeee .3

CAA § 109(d), 42 U.S.C. § 7409(d) ........ssccceessseeee passim

CAA § 109(d)(1), 42 U.S.C. § 109(d)(1) ........0000 6, 24, 39

CAA § 109(d)(2)(C), 42 U.S.C. § 7409(d)(2)(C)......e000 7

CAA § 109(d)(2)(C)(i), 42 U.S.C. § 7409(d)(C){i).. 41, 42

CAA § 109(d\(2)(C\iv), 42 U.S.C. § 7409

(9) (6) () eens 41

CAA § 112, 42 U.S.C. § 7412 ...ccccccceceeeeeereeneeeneenenennnens 35

CAA § 160(1), 42 U.S.C. § 747001) ......ccccccceeeeeeeeeeeneens 44

CAA §§ 160-169, 42 U.S.C. §§ 7470-7479 .........ccceeee 43

CAA §§ 171-179B 42 U.S.C. §§ 7501-7509 ..........0000 15

CAA §§ 181-185B, 42 U.S.C. §§ 7511-7511f............... 15

CAA § 302(h), 42 U.S.C. § 7602(f) ........ccceceereereennnes 38

Transportation Equity Act for the 21st Century

Pub. L. No. 105-178, 112 Stat. 463 § 6101

(en 2, 13, 17, 33

Transportation Equity Act for the 21st Century

Pub. L. No. 105-178, 112 Stat. 463 § 6102

OS TEES ADA ICE 2

FEDERAL REGULATIONS

40 CFR. § 50.7 (1999) csscccccccccccsnvsssscvccssseesceersnssssssssesess 2

40 CLF.R. § 50.9 (1999)....cccccccsssssssssssesseseeseeeeesssssnnnvesssees 2

40 C.F.R. § 50.10 (1999)....ccccccsssssssssssssesessssssnseessseeceessnee 2

1-Hour Ozone Standard: Reinstatement: Final

Rule (visited July 19, 2000)

<http://www.epa.gov/ttn/oarpg/t1/fr_notices/re

in8ss8.pdf> (reached through

<http://www.epa.gov/ttn/oarpg/t! pfpr.html>)......2, 15

xix

FEDERAL REGISTER

39 Fed. Reg. 31000 (1974) .........ccccccccceseseeseseeees 23, 29, 30

44 Fed. Reg. 8212 (1979) .0.........cccccesessessssesescessseesencneenees 9

GE FUG. Tae, GEES CIDTI) 2.xececcesccccscscsesecssesovsesescecesesceesie 10

58 Fed. Reg. 13011 (1993) .........ccccccscesesseseeseseeeevees 10, 26

58 Fed. Reg. 13015 (1993) ..........ccccccccsseseseeseseeneseeee 10, 26

61 Fed. Reg. 65641-42 (1996)...........cccccccscscsseseseeseeeseeees 25

62 Fed. Reg. 38421 (1997) ..........cccccccsessseseseeseeeseseens 13,17

62 Fed. Reg. 38653 (1997) ..........ccccccccsssseseseeseeeeeenes passim

62 Fed. Reg. 38666 (1997) ..........cccccscsessseseseseseseeeeseseneees 16

62 Fed. Reg. 38667 (1997) ..........ccccccssesesesescseseeseeeeescerees 17

62 Fed. Reg. 38668 (1997) ..0.........ccccccesessscsseeeseseseeeseeeees 14

62 Fed. Reg. 38669 (1997) ..0.........ccccccsseseseseseseeseseeeseseens 14

62 Fed. Reg. 38671 (1997)...........ccccccesssssseseseseesesssceeeeens 14

G2 Fed. Reg. 38672 (1997)............sscsressssesesscsesessecesererees 14

G2 Fed. Reg. 38675 (1997)...........cccrssscssscsesssssserereerererers 17

62 Fed. Reg. 38677 (1997) ..........ccccccssssssseseeseseeseneeees 8, 26

62 Fed. Reg. 38679 (1997) ..........cccccccessssssescesesesseneseeseneees 8

62 Fed. Reg. 38683-88 (1997)...0........ccccccccsssesseseeseeeseeees 20

62 Fed. Reg. 38688 (1997) ...........cccccccsecseseeeeseseeenees 14, 22

62 Fed. Reg. 38857 (1997) ...........ccccccssseseseseesesrssenseens 3,14

62 Fed. Reg. 38859 (1997) ...........cccccssessesesessessssessseeeeees 14

62 Fed. Reg. 38861 (1997) ..0........cccccccssesesescessseseeeesenenees 14

62 Fed. Reg. 38862 (1997) .........cccccccesssseseesessseeseeeeseneees 14

62 Fed. Reg. 38863 (1997) ...........ccccccecssseseeceseseesseeeseneees 14

62 Fed. Reg. 38867 (1997) ............cccccccseseseseeseseseseeeeecnees 14

62 Fed. Reg. 38869 (1997) ...........ccccccccsssesssseseseseseesenenees 14

62 Fed. Reg. 38873 (1997) ..........cccccccssesseseseeseseeeeees passim

62 Fed. Reg. 38878-80 (1997)...........cccccccsssessseeseseeeeeseees 15

62 Fed. Reg. 38878-85 (1997).........cccccccscsssseseseseseesesenees 20

62 Fed. Reg. 38882 (1997) ...........ccscsssesssseseseseessseseseseeseees 3

XX

62 Fed. Reg. 38883 (1997) .....ccccscvssssssssseeeeeesssee 14, 15, 22

62 Fed. Reg. 38894 (1997) .....ccccccsssssssssssssssesseseceeessssssseee .

LEGISLATIVE HISTORY

S. Rep. No. 90-403 (1967) ....ccccccscccsssssssssssssssseeseseeseensee 29

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

Comm. on Pub. Works, 93d Cong., 2d Sess.,

A Legislative History of the Clean Air

Amendments of 1970 (Comm. Print 1974).....7, 34, 43

Hearings on S. 251, S. 252 and S. 253, Before the

Subcomm. on Environmental Pollution of the

Sen. Comm. on Env't and Public Works, 95"

Came, tat Bane. (IGT 7) ncccecccecesecccscrssesccssvscssccesesssesees 43

123 Cong. Rec. 18458 (June 10, 1977), reprinted

in 3 Sen. Comm. on Env't and Pub. Works,

95th Cong., 2d Sess., A Legislative History of

the Clean Air Act Amendments of 1977

8 8 ee 7, 25, 34, 44

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

Comm. on Env't and Pub. Works, 95th Cong.,

2d Sess., A Legislative History of the Clean

Air Act Amendments of 1977 (Comm. Print

136 Cong. Rec. H12867 (daily ed. Oct. 26, 1990),

reprinted in 1 Sen. Comm. on Env’t & Pub.

Works, A Legislative History of the Clean Air

Act Amendments of 1990 (Comm. Print 1993)......... 16

H.R. Rep. No. 101-490, pt. 1, 101st Cong., 2d

Sess. (1990), reprinted in 2 Sen. Comm. on

Env’t & Pub. Works, A Legislative History of

xxi

the Clean Air Act Amendments of 1990

hs Ni 33

Clean Air Act: Ozone Particulate and 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, S. Hrg. No. 105-50, pt. 2

rea asia cieilddeiiiariaactainareniciaataidetatitiicieiiaaaliataeniaes 18

Hearings on Conformity Under the Clean Air Act

Before Sen. Comm. on Env’t and Pub. Works,

a 18

MISCELLANEOUS

eS a ae l

American Farm Bureau Federation, Comments

REE eee ae a ITE 19

American Petroleum Institute, Comments on

Proposed NAAQS for Ozone,

SUI aliiiesschdiesibcieecmcpsieiblcitaeie eich 19

Anne E. Smith, et al., Costs, Economic Impacts,

and Benefits of EPA's Ozone & Particulate

ERS a eee eee ey 4,17

Ben Miller & Claire Brackman Keane,

Encyclopedia and Dictionary of Medicine and

ae 26

Black's Medical Dictionary (Gordon Macpherson,

tS TIE NE 25, 26

Clean Air Scientific Advisory Committee

Transcript (March 22, 1995)....0....cccccccccccscecseseeeeseees 16

Dorland’s Illustrated Medical Dictionary (L.R.C.

Agnew ef all, 24 ed. 1965) ............ccccccccscccceccsccsesseses 26

xxii

EPA, Regulatory Analyses for the Particulate

Matter and Ozone National Ambient Air

Impact Quality Standards and Proposed

Regional Haze Rulle ..............cccssceeeseeeees 16, 17, 19, 32

EPA, Responses to Significant Comments on the

1996 Proposed Rule on the National Ambient

Air Quality Standards for Ozone (1997).............. 9,15

EPA, Review of the National Ambient Air Quality

Standards for Ozone (1996) ............:0-+++ 9,11, 12, 16

EPA, Review of the National Ambient Air Quality

Standards for Particulate Matter (1996)........ 8, 13, 25

Institute of Medicine, The Future of Public Health

ITI tenputnrnsuticitesindsteienditadteasdiiitinienidanincoupiaiaiiiiniataaiaabinnai 27

K. Arrow, et al., Is There a Role for Benefit-Cost

Analysis in Environmental Health and Safety

Regulation?, 272 Science 221 (1996) .............::.0000 37

Lawerence O. Gostin, et al., The Law and The

Public's Health: A Study of Infectious Disease

Law in the United States, 99 Colum. L. Rev.

TE cintceshansieitierciiiniaiiniuntaesitiailiial aria itiidaicaiaas 26, 27

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

to Hon. Carol M. Browner (Nov. 30, 1995)........ 8,13

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

to Hon. Carol M. Browner (Jun. 13, 1996) .............. 13

Mark Shere, The Myth of Meaningful

Environmental Risk Assessment, 19 Harv.

Envtl. L. Rev. 409 (Winter 1995)..................00008 30-31

Memorandum from Harvey M. Richmond to

Karen Martin (Feb. 11, 1997) ..............ccccccceesseeeeeeeeee 12

R.G. Whitfield, et al., A Probabilistic Assessment

of Health Risks Associated With Short-Term

Exposure To Tropospheric Ozone (1996) .............++. 12

RNa Ae STE RN RTI

xxiii

R.G. Whitfield, A Probabilistic Assessment of

Health Risks Associated with Short-term

Exposure to Tropospheric Ozone: A

ee ritrcentensnienesicniniteiniancctcementenaien 11

R. Morgenstern, ed., Economic Analyses at EPA

(Resources for the Future, Washington, D.C.)

Sara isicsitieciecientniintntenanitintiiminaeniantideminbiipnineetedene 37

Ralph L. Keeney, Mortality Risks Induced By

Economic Expenditures, 10 Risk Analysis

(EEE alEcnsscsiscprneniieenionentanepnnamentauapiensiiaiibentapeneiiniiendenn 18

Ralph L. Keeney & Kenneth Green, Estimating

Fatalities Induced By Economic Impacts of

EPA's Ozone and Particulate Standards

[EEPar art sicniuhinnenicesbinianinbdeshieddideainemiianadaapmamnintiieiatinineti 18

Randall Lutter & Christopher Wolz, UV-B

Screening by Tropospheric Ozone:

Implications for the National Ambient Air

Quality Standards, 31 Env. Sci. & Tech. 141

TTI eivicnstinninsinastnbeninsienenannuemnmiemeatiinnninbsietesiinen 19

Roger Detels & Lester Breslow, Current Scope

and Concerns In Public Health in 1 Oxford

Textbook of Public Health 3 (R. Detels et al.,

ins ee See iciiaieiidehieiaiciaiihiencaitiaptareiaatiaiiatchiccianic 26

Stephen Breyer, Breaking the Vicious Circle

Sarai dartitnntshinncinetipiecieniinemmtenineninnnintel 8, 10, 18, 31, 36

Stephen Breyer & Richard Stewart,

Administrative Law & Reg. Policy (3d ed.

Si teictesssettiietibnieipaeirientaesiiiniatestialiciatabiastiatiatiiincianinmiitiies 37

Tennessee Valley Authority, Detailed Comments

SEITE Sia, HET iasontedbitinieintiniiiabmsincntiiaiintatndahbddeeiesiiniy 19

U.S. Dept. of Commerce, Statistical Abstract of

the United States (119th ed. 1999) .............ccccccceeeeeeees 4

XXIV

W. Kip Viscusi, The Value of Life in Legal

Contexts: Survey and Critique, 2 Am. L. &

Bs Ss SP tcicctecisenibameesinesensitntsiunienii 18, 31

Webster's Third New International Dictionary of

the English Language (1993) .............:ssssseeseeeeeee 34

XXV

GLOSSARY

The following is a glossary of acronyms and abbreviations

used in this brief.

Act Clean Air Act

Administrator Administrator of the United

States Environmental

Protection Agency

Agency United States Environmental

Protection Agency

CAA Clean Air Act

CASAC Clean Air Scientific

Advisory Committee

EPA United States Environmental

Protection Agency

JA Joint Appendix

NAAQS National Ambient Air

Quality Standards

OJA Joint Appendix in D.C. Cir.

Case No. 97-1441

ORTC Response to Comments on

the Proposed Ozone Rule

OSP

PM

PMio

PM? 5

PMJA

PPM

PMSP

RIA

Subpart |

Subpart 2

UVB

XXVi

Ozone Staff Paper (1996)

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

Particulate Matter Staff Paper

Regulatory Impact Analyses

Subpart | of Part D of Title I

of the Clean Air Act

Subpart 2 of Part D of Title I

of the Clean Air Act

Solar Ultraviolet “B”

Radiation

BRIEF OF RESPONDENTS APPALACHIAN POWER

COMPANY, ET AL.

This brief of Respondents Appalachian Power Company,

et al., is being filed in support of Petitioners American

Trucking Associations, Inc., ef al.

OPINIONS BELOW

The opinion of the United States Court of Appeals for the

District of Columbia Circuit is reported at 175 F.3d 1027,

App. la. The opinions on the petitions for panel rehearing

and suggestions for en banc rehearing are reported at 195

F.3d 4, App. 68a.

JURISDICTION

The court of appeals entered its judgment on May 14, 1999.

Petitions for panel rehearing were granted in part and denied

in part, and suggestions for en banc rehearing were denied on

October 29, 1999. The petitions for certiorari were docketed

on January 27 and 28, 2000. Conditional cross-petitions for

certiorari were docketed on February 28, 2000, in accordance

with S. Ct. R. 12.5. On May 22, 2000, the Supreme Court

granted a writ of certiorari in Case No. 99-1257, and on May

30, 2000, the Supreme Court granted a writ of certiorari in

Case No. 99-1426, ordering that these cases be argued “in

tandem.” This Court has jurisdiction under 28 U.S.C.

§ 1254(1).

RELEVANT CONSTITUTIONAL, STATUTORY AND

REGULATORY PROVISIONS

Listed below are citations to the constitutional, statutory

and regulatory provisions involved in this case. Their text is

either set forth below, or in an Appendix (App. ___ ) to this

Brief. On June 26, 2000, the Court granted the Solicitor

2

General’s motion to dispense with printing a joint appendix

in Case No. 99-1426.'

Article I, Section 1 of the United States Constitution

provides in pertinent part that “All legislative Powers herein

granted shall be vested in a Congress of the United States....”

The statutory provisions are: the Clean Air Act §§ 101, 42

U.S.C. 7401, App. 105a; 108, 42 U.S.C. 7408, App. 105a-

108a; and 109, 42 U.S.C. 7409, App. 108a-11la; and the

Transportation Equity Act for the 21st Century, Pub. L. No.

105-178, 112 Stat. 463, §§ 6101, 6102, App. 11 1a-115a.

The regulatory provisions are: 40 C.F.R. §§ 50.7, 50.9 and

50.10 (1999), App. 100a-103a.

INTRODUCTION

Respondents Appalachian Power Company, ef a/., do not

question the importance of the Clean Air Act or the public

health and environmental goals of that Act. As the

Environmental Protection Agency (“EPA” or “Agency”)

continues to regulate air pollution to ever more stringent

levels in response to uncertain predictions of health risk,

however, the incremental health benefits of these regulations

become harder to ascertain and the costs of erroneous or

unnecessary regulations — including the risk of indirect health

effects and excessive compliance costs — increase. We are

concerned that, in such situations, failure to consider all of

' Copies of the Joint Appendix filed with the D.C. Circuit are available to

the Court, and are referred to in this brief as “PMJA” (D.C. Cir. Case No.

97-1440) and “OJA” (D.C. Cir. Case No. 97-1441).

* On July 5, 2000, the Environmental Protection Agency promulgated a

revision to 40 C.F.R. § 50.9%(b). The revised language is found in the

Appendix to this Brief at App. 104a.

ee ee

3

the impacts of a regulatory decision on society may result in

standards that do more harm than good for the public health.

This case concerns one such situation: the EPA

Administrator’s revision of National Ambient Air Quality

Standards (“NAAQS”) for ozone and particulate matter

(“PM”) under § 109 of the Clean Air Act (“CAA” or “Act”).

In this case, EPA revised the existing NAAQS for ozone and

PM, standards that EPA previously issued as “requisite to

protect the public health” with an “adequate margin of

safety” against the same health risks for which the Agency

now believes more stringent standards are needed. CAA §

109(b). In both rulemakings, the Administrator was faced

not with “demonstrated adverse effects” on the public, but

rather with a range of uncertain predictions of “health risk.”

Based on this record, the Administrator made a public health

“policy” judgment that “uncertainties associated with

inconclusive scientific and technical information” and

“hazards that research has not yet identified” justified revised

standards reflecting greater margins of safety. See, e.g., 62

Fed. Reg. 38857, OJA 2; id 38653, PMJA 3.

In making this decision, the Administrator concluded that

the Act forbade her from considering factors that would

allow her to make a reasoned public health policy judgment

when confronted with the “uncertainties” and “inconclusive”

information concededly at issue here. These prohibited

factors include the indirect health, environmental and

economic impacts of her decision. See 62 Fed. Reg. 38882,

> Cf Ethyl Corp. v. EPA, 541 F.2d 1, 13-15 (D.C. Cir. 1976) (en banc)

(comparing the “adverse effects” language of pre-1977 § 108(a), which

“require[d] proof of demonstrable harm,” with a “will endanger” standard

comparable to that added to § 108(a) in 1977, which authorizes regulation

in response to “significant risk of harm’”’).

4

OJA 27; Brief For Respondent EPA, at 49-51 (D.C. Cir. No.

97-1441).

The Administrator’s policy judgment, made with blinders

to the overall consequences of those decisions, resulted in

some of the most costly regulatory decisions ever made by a

federal agency. The record indicates monetary costs to meet

the new standards may be up to $150 billion each year,"

almost an order of magnitude greater than the $18 billion

total spent on medical research in the United States the year

these standards were promulgated.’ Equally important,

efforts to attain these standards have potentially adverse

public health and environmental effects, including an

increased risk of premature mortality.

These tradeoffs are part of any sound risk management

decision that promotes the public health. Based on a flawed

interpretation of the CAA grounded in D.C. Circuit

precedent, however, the lower court concluded that the

Administrator must ignore these impacts on society when

managing public health risk under § 109 of the Act. See

American Trucking Ass'ns v. EPA, 175 F.3d at 1040, App.

18a (citing Lead Industries Ass'n v. EPA, 647 F.2d 1130,

1148 (D.C. Cir. 1980)).

For the following reasons, this Court should reverse the

D.C. Circuit’s interpretation of the CAA in this case. The

lower court’s decision improperly prohibits EPA from

exercising sound risk management judgment under CAA

§ 109 that will promote the public health. Furthermore, the

Court should instruct EPA that it must consider the broad

* Anne E. Smith, et al., Costs, Economic Impacts, and Benefits of EPA's

Ozone & Particulate Standards 9 (1997), OJA 3323.

* See U.S. Dept. of Commerce, Statistical Abstract of the United States

118, Table 163 (119th ed. 1999).

5

impacts on society of its regulatory decisions managi

health “risks” through the NAAQS program, so that the

Agency’s NAAQS decisions will maximize the public good.

We do not advocate that consideration of costs be substituted

for te paper of health effects, but rather that EPA be

required to consider all factors relevant to managing public

health risk, in order that NAAQS decisions aaa. the

public health consistent with the statutory purposes of the

Clean Air Act.

STATEMENT

I. THE NAAQS PROGRAM

The purpose of the Act, as set forth in § 101(b)(1), is “to

protect and enhance the quality of the Nation’s air resources

so as to promote the public health and welfare and productive

capacity of its population.” This statutory language reflects

congressional intent that Clean Air Act programs achieve a

balance of social, economic and _ environmental

considerations.

In CAA §§ 108 and 109, the operative regulatory

provisions at issue here, Congress called for the

establishment of NAAQS for air pollutants that may

reasonably be anticipated to “endanger” public health or

welfare. Under § 109(b)(1), primary NAAQS are to reflect a

level of air quality “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.”

* Secondary NAAQS are to be set at a level that, in the Administrator’s

judgment, protects the public welfare from “known or anticipated adverse

effects.” CAA § 109(b)(2). In this case, EPA set secondary NAAQS at

the same level as the primary NAAQS. Judicial review of both the

6

The “criteria” to which § 109(b) refers is an informational

document that must “accurately reflect the latest scientific

knowledge useful in indicating 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.” CAA § 108(a)(2) (emphasis

added). While the effects on “public health or welfare”

addressed by the air quality criteria document must be related

to the “presence of such pollutant in the ambient air,” there

are otherwise no other limits on the nature of the effects

addressed by the criteria document. Rather, this document is

to cover “all identifiable effects” on the “public health or

welfare.” Jd. (emphasis added).

The criteria document is also to “include information on

... those variable factors (including atmospheric conditions)

which ... may alter the effects on public health or welfare of

such air pollutant.” /d § 108(a)(2)(A). Furthermore,

§ 108(b)(1) provides that “/s]imultaneously with the issuance

of [the] criteria” document, EPA must issue information on

the “cost of installation and operation, energy requirements,

emission reduction benefits, and environmental impact” of

methods for pollution control or prevention. CAA

§ 108(b)(1) (emphasis added). All of this information is to

be made available before EPA undertakes a NAAQS

rulemaking.

Once NAAQS are set, the Administrator must review

them and the underlying criteria document every five years

and revise them “as may be appropriate” in accordance with

§§ 108 and 109(b). CAA § 109(d)(1). To help with standard

primary and secondary NAAQS was sought. The lower court remanded

the secondary NAAQS to EPA along with the primary NAAQS. 175 F.3d

at 1040, App. 18a.

—

7

revision, the Administrator appoints “an independent

scientific review committee” to provide advice on the

scientific basis for setting and revising NAAQS. This

committee is to advise the Administrator on, among other

things, additional knowledge required to determine the

“adequacy” of existing standards and the “basis” for any

revisions to them, and on “any adverse public health,

welfare, social, economic, or energy effects which may result

from various strategies for attainment and maintenance” of

revised NAAQS. CAA § 109(d)(2)(C) (emphasis added).

When the air quality standards program was initially

enacted in 1970, the Senate Report described the NAAQS as

reflecting a “reasonable degree of protection” in the face of

uncertain science, rather than reflecting absolute protection

from any and all predicted risks.’ When it amended the Act

in 1977, Congress emphasized the importance of protecting

public health, but made clear that “public health” protection

does not embrace a “no-risk philosophy” because that

“ignores all economic and social consequences and is

impractical.”* In 1990, Congress extensively amended the

Act, but did not amend § 109, § 108(a) or § 108(b).

” S. Rep. No. 91-1196, at 10 (1970), reprinted in 1 Sen. Comm. on Pub.

Works, 93d Cong., 2d Sess., A Legislative History of The Clean Air

Amendments of 1970, at 410 (Comm. Print 1974) [hereinafter /970 Legis.

Hist.}, OJA 3687.

* H.R. Rep. No. 95-294, at 127 (1977), reprinted in 4 Sen. Comm. on

Env’t and Pub. Works, 95th Cong., 2d Sess., A Legislative History of the

Clean Air Act Amendments of 1977, at 2594 (Comm. Print 1978)

[hereinafter 1/977 Legis. Hist.], OJA 3678; cf 123 Cong. Rec. 18458,

18463 (June 10, 1977), reprinted in 3 1977 Legis. Hist., at 1038, OJA

3671 (Sen. Muskie) (When there is “no threshold on health effects ... it

[is] very difficult then to apply absolute health protection.”).

Il. EPA’S POLICY DECISION TO REVISE THE

OZONE AND PM NAAQS

In the rulemakings at issue in this case, EPA replaced the

existing 1-hour ozone NAAQS with a more stringent 8-hour

standard.” EPA also replaced the existing particulate matter

NAAQS based on a PMjo size indicator with standards for

both fine particles (PM2 5) and for coarse particles (PMjo)."°

As the lower court explained, “EPA regards ozone

definitely, and PM likely, as non-threshold pollutants, i.e.,

[pollutants] ... that have some possibility of some adverse

health impact (however slight) at any exposure level above

zero.”'' For each of these asserted non-threshold pollutants,

EPA was presented with a choice among alternative standard

levels characterized by uncertain estimates of health risk, a

choice calling for the exercise of judgment regarding how to

manage these predicted risks.'* This is dramatically

* 62 Fed. Reg. 38873, 38894, OJA 18, 39.

'° 62 Fed. Reg. 38677, 38679, PMJA 27, 29. The previous PMjo standard

controlled both coarse and fine PM. The court of appeals vacated the

coarse particle standard as arbitrary and capricious, see 175 F.3d at 1054-

55, App. 52a, because the PMyo indicator included a variable amount of

fine particulate matter. EPA has sought no further review of this ruling.

'' 175 F.3d at 1034, App. 5a; see also Letter from Dr. George T. Wolff,

Chair, CASAC, to Hon. Carol M. Browner 2 (Nov. 30, 1995) [hereinafter

CASAC Ozone Letter], OJA 237 (“[{T]here is no threshold concentration

for the onset of biological responses due to exposure to ozone above

background concentrations.”); EPA, Review of the National Ambient Air

Quality Standards for Particulate Matter V\-16 (1996) [hereinafter

PMSP), PMJA 2068.

'? Risk management requires a regulator to consider predictions of risk

and other information to decide on the need for and extent of risk

reduction. See Stephen Breyer, Breaking the Vicious Circle 10 (1993).

9

illustrated by EPA’s rulemaking addressing revision of the

ozone NAAQS.

Ozone is a constituent of smog produced by complex

chemical reactions in the atmosphere between volatile

organic compounds (“VOCs”) and nitrogen oxides (“NO,”)

emitted by numerous sources over broad areas. The reactions

that produce ozone take place over periods of days or longer,

through a process influenced by sunlight and other changing

atmospheric and meteorological conditions.

Further complicating ozone regulation, NO, and VOCs

that contribute to ozone formation are produced by natural as

well as human sources. As a result, short-term (e.g., 1-to-8

hour) ambient ozone concentrations average about 0.03 to

0.05 ppm even at remote and rural sites, such as Denali,

Glacier and Yellowstone National Parks, which are relatively

uninfluenced by mobile and stationary sources. The upper

range of short-term readings can exceed 0.07 ppm in such

remote areas.’

Promulgation of the 1-Hour Ozone NAAQS — The ozone

NAAQS that EPA revised in this rulemaking specified an

ozone concentration level of 0.12 ppm, based on a 1-hour

average, and allowed an average of one exceedance per year

over a three-year period. When EPA set this standard in

1979, it did so based on its judgment that “there is no clear

threshold... of adverse health effects,” and __ that

'° See EPA, Review of National Ambient Air Quality Standards for Ozone

20-21 (1996) [hereinafter OSP], OJA 1830-31; EPA, Responses to

Significant Comments on the 1996 Proposed Rule on the National Ambient

Air Quality Standards for Ozone 94, 96 (1997) [hereinafter ORTC], OJA

176, 178. See also 44 Fed. Reg. 8212, OJA 3490 (“Field measurements at

some remote sites, where man-caused ozone is likely to be negligible, have

shown low — but not insignificant — rates of exceedances of the 0.08 ppm

level.”).

10

“physiological responses probably occur in extremely

sensitive persons at very low levels.”'*

In 1993, EPA affirmed the appropriateness of this 1-hour

NAAQS to address a broad range of predicted and theoretical

health risks. In this 1993 decision, EPA was called upon to

exercise risk management judgment in making a decision that

promotes the “public health.”

For example, the Administrator found that revision of the

primary 1-hour NAAQS was not appropriate because changes

in performance on lung function tests after ozone exposures

at a 0.12 to 0.15 ppm level (e.g., temporary decreases in lung

capacity of 9-16% accompanied by respiratory symptoms)

“did not constitute adverse effects for purposes of section

109” even for “sensitive individuals,” and health studies

suggesting “aggravation of asthma and pre-existing

respiratory disease” at 0.12 ppm were limited by

“uncertainties about individual exposure levels and the role

of other pollutants.”'* In other words, the Administrator

found that not every predicted health risk or possible

physiological effect associated with exposure to ozone was a

potential adverse public health effect.

The Record for Revision of the Existing NAAQS -—-

Following this 1993 decision to reaffirm the existing 1-hour

NAAQS as “requisite to protect the public health” with an

“adequate margin of safety,” EPA in 1995 issued a revised

ozone criteria document. In evaluating the new criteria

document, the EPA staff explained that the public health

'* 44 Fed. Reg. 8215, OJA 3493.

'S 58 Fed. Reg. 13011, 13015, OJA 3452, 3456. These types of

“uncertainties embedded in the regulatory process,” of course, are a

common feature of rulemaking and can lead to overly conservative or

“random” regulation. Breyer, supra note 12, at 42, 48.

11

consequences of ozone exposures at levels consistent with

the present 1-hour NAAQS remained highly ambiguous for

both “chronic” and “episodic” effects.’ Based on the revised

criteria document, the EPA staff concluded that there was an

“absence of discernible health effects thresholds and ... that

population risk [for respiratory symptoms, lung function

changes, and hospital admissions] varies little with small

changes in air quality.”’’ On this basis, the staff concluded

that a 0.09 ppm 8-hour standard (i.e., the 8-hour standard

level that EPA concluded was roughly equivalent to the 0.12

ppm 1|-hour NAAQS) “would reduce estimated exposures of

the at-risk population sufficiently to provide some margin of

safety.”"*

The staff concluded that the ranges of estimated risk were

little different for the existing 1-hour and alternative 8-hour

standards,’ and that these risk estimates did not even reflect

all of the uncertainties associated with the numerous

assumptions made to develop the estimates.” For example,

'® See, e.g., OSP, supra note 13, at 35, 39, 55, 61, 153, OJA 1845, 1849,

1865, 1871, 1963 (As the EPA staff observed, the database on ozone-

induced bronchial responsiveness is “limited and uncertain”; ozone’s

impact on urban asthmatic morbidity is “not well understood”; no

evidence was found that children exposed to low levels of ozone

experience respiratory symptoms; the evidence of permanent structural

changes in human lungs is “largely hypothetical”; and no association

between 6 to 8 hour ozone exposure and hospital admissions could be

assessed).

'" Id 141, OJA 1951.

'§ Id 167, OJA 1977.

' See id. 125, 130, OJA 1935, 1940.

° See id. 116, 129-33, OJA 1926, 1939-43. See also R.G. Whitfield, A

Probabilistic Assessment of Health Risks Associated with Short-term

Exposure to Tropospheric Ozone: A Supplement 32-33 (1997), OJA 2363-

12

EPA’s January 1997 revised risk assessment showed that the

median risk of “large lung function decrements” would be

higher under an 8-hour standard than under the existing 1-

hour NAAQS in 2 of the 9 cities modeled, containing about

one-third of the sensitive population,”’ and that risks of

coughs and moderate lung function decrements (health

“endpoints” considered by EPA) for the l-hour NAAQS

would be /ower than the risks EPA found acceptable in

December 1996, when it proposed a 0.08 ppm 8-hour

NAAQS.” This EPA risk assessment also reported that risks

“are not dramatically different ... among the alternative 1-

hour and 8-hour standards” (including the existing 1-hour

NAAQS).”

EPA’s independent Clean Air Scientific Advisory

Committee (“CASAC”) reviewed the 1995 criteria document

and related staff analyses. These independent science

advisers concluded (1) that “our understanding of the health

effects of ozone is far from complete”; (2) that there are

“many gaps” in the science and “large uncertainties” in

EPA’s risk estimates; and (3) that “there is no ‘bright line’

which distinguishes any of the proposed standards (either the

64 (discussing limitations of the modeling); R.G. Whitfield, ef al, A

Probabilistic Assessment of Health Risks Associated With Short-Term

Exposure To Tropospheric Ozone 73 (1996), OJA2312 (discussing

“assumptions that could have systematically biased the results”’).

2! See Memorandum from Harvey M. Richmond to Karen Martin 11 (Feb.

11, 1997) [hereinafter Richmond], OJA 2324; OSP, supra note 13, at 80,

OJA 1891 (about | million out of 3 million “outdoor children” in the risk

assessment live in Los Angeles or Houston).

” Richmond, supra note 21, at 10, OJA 2323.

Id. 5, OJA 2318 (“{C]onsidering the uncertainties ... [any] differences [in

risk estimates] are not large.”’).

13

level or the number of allowable exceedances) as being

significantly more protective of public health.””*

Like the record for the ozone rulemaking, the record for

review of the PM NAAQS was characterized by uncertainty

about the magnitude and cause of any health risks. For

example, the EPA staff “emphasize{d] the unusually large

uncertainties associated with establishing standards for PM

relative to other single component pollutants for which

NAAQS have been set.””> CASAC members could form no

consensus regarding the level, averaging time, or form of a

revised standard because of the many unceriainties regarding

both the existence and nature of any causal relationship

between public health and the PM2; indicator.’ Reflecting

concerns with the lack of air quality data and uncertainty

regarding the constituents of PM25 that should be regulated,

the President directed EPA to postpone implementation of the

revised PM); NAAQS until adequate air quality data were

collected and a further review of the standards was

completed.”’ Congress subsequently ratified that directive.”*

** CASAC Ozone Letter, supra note 11, at 1, 3, 4, OJA 236, 238, 239

(emphasis added).

?° PMSP, supra note 11, at VII-41, PMJA 2153 (emphasis added). For

further description of the uncertainties in the PM rulemaking record, see

generally, Brief of Petitioners American Trucking Associations, Inc., et al.,

11-19 (No. 99-1426), and see also Brief in Response for Respondents

National Stone Association, ef al, at 2-4 (Nos. 99-1257, 99-1263, 99-

1265).

© Letter from George T. Wolff, Chair, CASAC, to Hon. Carol M.

Browner 2-3 (June 13, 1996), PMJA 3162-63. Moreover, only 2 of the

21 members of the CASAC panel, specifically supported the stringent

annual PM; ; standard adopted by EPA. See id, Table 1, PMJA 3165.

”” 62 Fed. Reg. 38421, PMJA 195.

*® Transportation Equity Act for the 21st Century § 6101, Pub. L. No.

105-178, 112 Stat. 463 (1998), App. 11 1a-113a.

14

EPA's Decisions to Revise the NAAQS — EPA’s decisions

here were not driven by demonstrated health effects caused

by small exposures to the pollutants in question, but rather by

uncertain estimates of health risk. Reflecting these uncertain

risk estimates, the Administrator explained that her decisions

on revised NAAQS were the product of “policy” judgment.”’

According to the Administrator, these “policy” judgments

represented the degree of protection she declared was

“sufficient{]” in light of “[uJncertainties associated with

inconclusive scientific and technical information” and

“hazards that research has not yet identified.”*”

The Administrator explained that the level of public health

protection that she deemed sufficient for the revised NAAQS

was “largely judgmental in nature, particularly with respect to

non-threshold pollutants, and may not be amenable to

quantification in terms of what risk is ‘acceptable’ or any

other metric.”' In exercising this “judgment,” the

Administrator considered “the nature and severity” of

predicted health effects, “the size of the sensitive populations

at risk,” and the “kind and degree of uncertainties.”** Having

said this, the Administrator never explained how

consideration of these factors justified a change in the

management of predicted risks addressed by the then-current

standards, or how the revised standards would fulfill the

? See 62 Fed. Reg. 38857, 38859, 38861, 38862, 38863, 38867, 38869

n.23, OJA 2, 4, 6, 7, 8, 12, 14; id. 38653, 38668, 38669, 38671, 38672,

PMJA 3, 18, 19, 21, 22.

*° 62 Fed. Reg. 38857, OJA 2; see id. 38863, 38867, OJA 8, 12; id.

38653, PMJA 3.

*' 62 Fed. Reg. 38883, OJA 28; id. 38688, PMJA 38 (emphasis added).

*? See supra note 31.

15

purposes section of the Act. 175 F.3d at 1034-36, App. Sa-

9a; see also id. 1034-35, App. 6a-7a (citing 62 Fed. Reg.

38883, OJA 28). To the contrary, according to the

Administrator, “nothing in the statute requires her to make

any specific ‘findings,”” even a finding of “significant risk.”””

In contrast to the uncertain and inconclusive nature of the

Administrator’s predictions of health risk, the records for

these rulemakings made quite clear that EPA’s standards

would have profound impacts on society, and might be

impossible to attain. According to the Administrator,

however, her judgment regarding standard revision could not

be informed by consideration of any information related to

their collateral health, social or economic consequences.**

For example, as part of its decision adopting the revised 8-

hour NAAQS, EPA promulgated a rule requiring the

development of a new, more stringent ozone reduction

program under Subpart | of the Act, in place of the program

that Congress had adopted when it enacted Subpart 2 in

1990.°° Because the new Subpart | program based on the

* Brief of Respondent EPA, at 43 (D.C. Cir. No. 97-1441).

* 62 Fed. Reg. 38878-80, OJA 23-25; ORTC, supra note 13, at 123-24,

128-33, OJA 205-06, 210-15.

** 62 Fed. Reg. 38873, OJA 18, as revised in 1-Hour Ozone Standard:

Reinstatement: Final Rule (reinstating the |-hour ozone standard and

Subpart 2 requirements only until the legal status of the 8-hour standard is

resolved). App. 104a. Subpart | appears at CAA §§ 171-179B. The

Subpart 2 program that Congress added in 1990 spelled out a detailed and

comprehensive program addressing what could, and could not, be

required to reduce ozone to address the public health concerns associated

with the existing |-hour NAAQS. See CAA §§ 181-185B.

16

revised 8-hour NAAQS would “require significantly different

emission reduction targets” in some areas,”° it would disrupt

existing control programs and attainment deadlines

established in Subpart 2 of the Act — requirements that

Congress established to address the same _ uncertain

predictions of health risk that EPA would now address

through a Subpart | program based on the revised 8-hour

NAAQS.*’ Areas with severe nonattainment problems like

Los Angeles and Houston would be thrown back into the

failed pre-1990 paradigm where unrealistic planning

deadlines under Subpart | led to regulatory paralysis. ”*

Like the 1-hour ozone NAAQS, the existing PM NAAQS

was reducing particulate concentrations around the country.*”

*© See, e.g, EPA, Regulatory Analyses for the Particulate Matter and

Ozone National Ambient Air Impact Quality Standards and Proposed

Regional Haze Rule 7-2, 7-5, 9-3 [hereinafter RIA], OJA 2930-31, 2935.

”” Several of EPA’s science advisers recommended against having both |-

hour and 8-hour NAAQS because of the confusion it would cause for

achieving ozone reductions. See, e.g, CASAC Transcript of March 22,

1995, at 303, 308, OJA 280, 282 (remarks of James Price and George

Wolff). See also OSP, supra note 13, at 147, OJA 1957 (noting

“adequate reduction in risks” can be achieved with either a |-hour or 8-

hour standard).

** See, e.g, 136 Cong. Rec. H12867 (daily ed. Oct. 26, 1990) (Rep.

Fields) reprinted in | Sen. Comm. on Env’t & Pub. Works, A Legislative

History of the Clean Air Act Amendments of 1990, at 1236 (Comm. Print

1993) [hereinafter /990 Legis. Hist.], OJA 3543 (the Subpart 2 provisions

“address the failure of our nonattainment areas to achieve ambient air

quality deadlines in existing law.... We have not, however, simply

continued to tell the states to do a plan to clean the air. That did not

work.”).

*® See 62 Fed. Reg. 38666, PMJA 16 (noting the success of the earlier PM

NAAQS and “the continued improvement in air quality through the

current [PM, 9] standards”).

17

In contrast to this successful NAAQS program,

implementation of the revised PMzs; NAAQS would be

impeded by a lack of air quality data and uncertainty as to

what constituents of PM; should be regulated to reduce

predicted health risks.“° Reflecting these problems, the

President and Congress postponed implementation of the

revised NAAQS until after the next five-year review cycle,

and until after a decision was made on “whether to revise or

maintain the new standards.”*"

Besides threatening to disrupt ongoing pollution

reductions under the existing NAAQS, the record showed

that, by EPA’s own admission, the costs of full attainment of

the revised ozone NAAQS (estimated by EPA at an

additional $9.6 billion per year over the existing NAAQS)

would outweigh its benefits (estimated by EPA at $1.5 to 8.5

billion per year)” EPA’s own estimates showed the cost of

attaining the revised particulate standards was extraordinarily

high, as much as $37 billion each year.”

The record also showed that these costs would reduce

average real after tax incomes by 1-2% per person, with the

” See id. 38667, 38675 n.38, PMJA 17, 25 (noting the need for additional

research “to better identify which species are of concern for human health,

and the sources and relative magnitude of such species” and for additional

air quality monitoring).

*' 62 Fed. Reg. 38421, PMJA 195; Transportation Equity Act for the 21st

Century, § 6101, Pub. L. No. 105-178, 112 Stat. 463 (1998). App. I 1la-

113a.

” See RIA, supra note 36, at ES-11 to ES-12, ES-17, 9-1, OJA 2918-19,

2924, 2934.

® Id at 9-1, OJA 2934. Other estimates of the costs of the revised

NAAQS ranged up to $150 billion annually. Smith, et al., supra note 4,

at 9, OJA 3323.

18

impact falling disproportionately on lower income groups.

The increased costs and unemployment resulting from the

NAAQS therefore would themselves create public health

risk,“ with risk estimates ranging up to 27,000 premature

deaths.** The revised NAAQS would also prevent highway

improvements that were expected to save lives.“ Even at

these extraordinarily high costs, EPA was unable to identify

“ See Ralph L. Keeney, Mortality Risks Induced By Economic

Expenditures, 10 Risk Analysis 147, 157 (1990) (If the intent of an air

quality standard is avoiding adverse public health effects, it is “ridiculous

not to consider the potential mortality [and morbidity] implications of

implementing the regulation itself.”). See generally Breyer, supra note

12, at 20; W. Kip Viscusi, The Value of Life in Legal Contexts: Survey

and Critique, 2 Am. L. & Econ. Rev. 195, 200 (2000) (explaining that

regulations may create both direct and indirect health risks).

* Ralph L. Keeney & Kenneth Green, Estimating Fatalities Induced By

Economic Impacts of EPA's Ozone and Particulate Standards \3 (1997),

OJA 3328. This estimate is based on higher costs for attaining the

standards than EPA projects. Up to 1600 prelicted fatalities were

estimated even under EPA's artificially low cost estimates. /d; see also

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, S. Hrg. No.

105-50, pt. 2, at 162 (1997) (prepared statement of Susan E. Dudley, Vice

President and Director of Environmental Analysis, Economics, Inc.)

(attaining the proposed ozone NAAQS could increase deaths by 4250 to

5667 per year).

“ Cf Hearings on Conformity Under the Clean Air Act Before Sen.

Comm. on Env't and Pub. Works, 106th Cong. 29-30 (1999) (statement of

Jim L. Joyner, Chmn. Bd. of Commissioners, Henry County, Georgia)

(explaining that Clean Air Act transportation conformity requirements

related to implementation of NAAQS are impeding safety-related road

construction projects).

19

control techniques that would bring about nationwide

attainment.*’

Finally, the record showed that revising the existing ozone

NAAQS might also increase public health risk through

increased incidence of cataracts and cancers associated with

increased UVB radiation exposure.“* And more restrictive

NAAQS could increase unemployment, electricity rates, and

the costs of food and other consumer products.”

As a result, EPA’s decisions to revise the existing NAAQS

would (1) impose billions of dollars more in costs on society,

(2) increase indirect public health risk, (3) in the case of the

ozone NAAQS, be implemented in a manner rejected by

Congress, and (4) in the case of the PM NAAQS, not be

implemented at all until after the next 5 year review of that

NAAQS. The Administrator refused to consider any of these

consequences of her decision, however, on the grounds that

*” According to the Administrator, the expenditures assumed in EPA’s

regulatory analyses — up to $10,000 per ton for the removal of ozone

precursor pollutants and up to $1 billion/ug/m’ of ambient PM),

eliminated — were insufficient to provide attainment. R/A, supra note 36,

at ES-11 to ES-12, OJA 2918-19; see also American Petroleum Institute,

Comments on Proposed NAAQS for Ozone, Appendix B (1997), OJA

3293-3301.

“* Randall Lutter & Christopher Wolz, UV-B Screening by Tropospheric

Ozone: Implications for the National Ambient Air Quality Standards, 31

Env. Sci. & Tech. 141, 145 (1997), OJA 2764 (estimating an increase of

25-50 melanoma deaths, 2000 to 11000 skin cancers and 13000 to 28000

cataracts from a reduction in seasonal average ozone levels of 10 parts per

billion).

” See, e.g., American Farm Bureau Federation, Comments 1-3 (Mar. 12,

1997), OJA 3318-20 (impacts on agricultural sector and increased food

prices); Tennessee Valley Authority, Detailed Comments 10 (Mar. 11,

1997), OJA 3317 (11% increase in electric rates and job loss).

20

she had no statutory authority to consider them, even though

EPA purportedly was exercising “policy” judgment to protect

the “public health.” Indeed, according to the Administrator,

even information showing that implementation of a revised

NAAQS will be “difficult, counter-productive or confusin

dofes] not undermine EPA’s [NAAQS] revision authority.”

Ill. THE D.C. CIRCUIT’S DECISION

Because the Agency had interpreted the Act to authorize it

to exercise judgment with no guiding principle, the court

below remanded the revised standards to EPA for further

rulemaking. According to the court, the Agency is obligated

to interpret the Act to provide an “intelligible principle” for

her exercise of risk management judgment. 175 F.3d 1034,

App. 5a.

The lower court also held that EPA must consider all

effects of an air pollutant in the ambient air — whether

adverse or beneficent — when selecting an appropriate

NAAQS. /d. 1052-53, App. 47a-48a. At the same time,

however, the court briefly and emphatically rejected the

suggestion that, in developing an intelligible principle to

guide its risk management judgment, the Agency may

consider factors such as indirect public health and

environmental impacts and costs, factors that any rational

62 Fed. Reg. 38878-85, OJA 23-30; id. 38683-88, PMJA 33-38.

*' Brief of Respondent EPA, at 73 (D.C. Cir. No. 97-1441).

* Thus, the lower court directed EPA to consider the scientific evidence

that ozone in the ambient air protects against the effects of UVB

radiation. EPA did not petition this Court for review of that aspect of the

lower court’s decision.

21

person would consider relevant to determining the acceptable

level of public health risk.”

Quoting earlier decisions of the circuit, the court

concluded that this issue was resolved “in Chevron step one

terms,” because the CAA “on its face does not allow

consideration of technological or economic feasibility.” /d

1040, App. 19a. According to the court, this prohibition on

the factors the Administrator may consider in exercising

“public health” risk management judgment extends not only

to the costs and feasibility of control technologies, but to all

the indirect health, environmental and economic impacts that

might be caused by a decision to revise an existing NAAQS.

Although the court below made minor modifications to its

opinion on rehearing, 195 F.3d 10, App. 79a-80a, it did not

change its holding limiting the factors EPA can consider in

managing public health risk.

SUMMARY OF ARGUMENT

Section 109 of the Clean Air Act directs the EPA

Administrator to set NAAQS that are “requisite to protect the

public health” with an “adequate margin of safety,” and to

make such revisions to those standards as may be

“appropriate in accordance with [§§ 108 and 109(b)].” Such

standards must be supported by a sound scientific record. In

revising the NAAQS for ozone and PM, the Administrator

relied on uncertain predictions of health risk to adopt revised

standards that will set in motion two of the most costly and

* 175 F.3d at 1040, App. 18a-20a. The only example the court gave of

how EPA could develop a “principled structure” for setting NAAQS,

however, was Oregon’s Medicaid program, a program that relied on cost

considerations. /d. 1039, App. 15a-18a.

22

burdensome regulatory programs ever required by a federal

administrative agency.

Citing uncertain “risk” estimates and reflecting the

assumed lack of any level of exposure at which there is an

absence of health risk, the Administrator’s decisions to revise

the NAAQS were “largely judgmental in nature... and may

not be amenable to quantification in terms of what risk is

‘acceptable’ or any other metric.” 62 Fed. Reg. 38883, OJA

28 (emphasis added); id. 38688, PMJA 38 (emphasis added).

The costs of these standards, however, can be measured both

in the potential for adverse impacts on public health and the

environment, and in the dollars required to attain them (up to

$150 billion each year). EPA concedes that the revised

ozone NAAQS have costs that may exceed their benefits, and

that NAAQS will interfere with a separate congressional

program for reducing ozone to address the health risks at

issue here.

In revising these NAAQS, the Administrator concluded

that she was precluded from considering the indirect health,

environmental and economic effects of her policy decision to

provide additional margin of safety in response to uncertain

health risk — factors that would normally be relevant to sound

“public health” policy judgment. The United States Court of

Appeals for the District of Columbia Circuit agreed that the

Administrator had no authority to consider such factors,

relying on its own precedents with Lead IJndustries

Association v. EPA, 647 F.2d 1130 (D.C. Cir. 1980). This

decision should be reversed.

1. Broad delegations of regulatory authority must be

implemented to give effect to congressional purpose, absent

statutory language directing a different result. In the Clean

Air Act, Congress specified through explicit statutory

language that the goal of the Act is to promote the “public

23

health” which, by its very definition, includes consideration

of economic and social realities. The language of § 101(b)(1)

of the Act, according to EPA itself, calls for a “balancing of

the social and economic considerations with the

environmental implications” of a regulatory decision. 39

Fed. Reg. 31000. This Court’s precedents have long

recognized that the normal meaning of statutory terms as well

as the statutory purposes must be used to provide decisional

criteria where statutory terms are undefined, unless there is

clear statutory evidence requiring a different result. There is

no such evidence here.

2. Section 109(b)(1) of the Clean Air Act, directs the

Administrator to establish standards at a level “requisite” to

protect the “public health” with an “adequate margin of

safety.” When confronted with predicted but uncertain health

risk, as opposed to a demonstrated “adverse effect” on public

health, these terms call for the exercise of risk management

judgment that involves balancing a broad range of factors

consistent with the statutory purposes section of the Act.

a. None of this statutory language directs the

Administrator, in exercising this risk management judgment,

to ignore factors such as the total health, environmental, and

economic @onsequences of actions that are critical to

protecting and promoting the public health. Indeed,

consideration of these factors is consistent with the common

understanding of “public health” regulation, which

contemplates a balancing of factors to improve the conditions

wm which people live. Consideration of these factors also is

essential to fulfilling the Clean Air Act’s overriding statutory

purpose of protecting the public’s health in a way that also

promotes the “public welfare” and the “productive capacity”

of the people of this country. Finally, the common approach

to establishing am “adequate margin of safety” requires

24

considering both the costs and the benefits of the margin in

question.

b. Furthermore, § 109(d)(1) of the Act directs

EPA to revise NAAQS “as may be appropriate in accordance

with” §§ 108 and 109(b). Those sections then tell the

Administrator, as part of this standard revision process, to

obtain from her science advisors information on the overall

impacts on society of standard revisions. This is consistent

with congressional intent that the Agency exercise its

judgment to manage public health risk in a manner that

promotes the statutory purposes.

c. The Act’s legislative history confirms that

Congress expected the Administrator to consider practical

impacts including societal costs to determine whether the risk

posed by a pollutant such as ozone or PM is unacceptable or

whether standard revisions were “appropriate.” Congress

understood that NAAQS were not intended to be standards

which eliminate any and all health risk. Rather, Congress

observed in 1970 when it enacted §§ 108 and 109, and again

in 1977 when it amended §§ 108 and 109, that these

provisions do not contemplate “zero risk” regulation, but

rather a “reasonable degree of protection.”

3. Finally, review of the language, structure and

purposes of the Act shows that the circuit precedent on which

the lower court relied — Lead Industries — was wrongly

decided. There is no statutory language providing, as the

Lead Industries court concluded, that costs and other impacts

may “play no part in the promulgation of [NAAQS].” 647

F.2d at 1148. Rather, applying this Court’s subsequent

decision in Chevron, this Court should conclude that,

consistent with the congressional purposes stated in § 101(b)

of the Act, the statute on its face contemplates consideration

25

by EPA of the broad impacts on society of its NAAQS

decisions when it manages health risks under § 109.

ARGUMENT

The standards before the court are standards that protect

against predicted “risk” from pollution, not against pollution

that has been shown to cause an adverse public health

“effect” like the London “killer fog.”** Under the Act,

NAAQS must be set below the level at which such

demonstrated adverse public health effects occur. This case,

by contrast, involves pollution levels far below those at

which adverse public health effects have been demonstrated.

What is at issue here is how EPA manages health “risks.”

In making decisions to manage risks (as opposed to

eliminating known, adverse public health effects), EPA must

act like any other agency with “public health” risk

management responsibilities. A mandate to protect the

“public health” does not contemplate elimination of all health

risk, or absolute protection of any particular individual.*°

** Historically, increased mortality and morbidity has been observed

during episodes of extremely high levels of air pollution PMSP, supra

note 11, at V-11, PMJA 1962. With fine particles, for example, such

effects have been observed with levels reaching 500-1000 yg/m’ or more

daily. 61 Fed. Reg. 65641-42 & n.7, PMJA 122-23. This is at least an

order of magnitude higher than daily fine PM levels observed today in

this country. See PMSP, supra note 11, at IV-17a, PMJA 1943. By

contrast, the studies on which the new standards are based used statistical

techniques to predict the possibility that health effects might occur at

ambient concentrations extending down to background levels.

*® See H.R. Rep. No. 95-294, at 127, reprinted in 4 1977 Legis. Hist.,

supra note 8, at 2594, OJA 3678 (a “no-risk philosophy ... ignores all

economic and social consequences and is impractical”); 123 Cong. Rec.

at 18463 (Sen. Muskie), reprinted in 3 1977 Legis. Hist., supra note 8, at

1038, OJA 3671; see also Black's Medical Dictionary 454 (Gordon

26

Indeed, EPA agrees that not every predicted “health risk” is a

“public health” risk.

Rather, as traditionally understood by public health

professionals, “many factors such as the social, economic and

physical environment in which the people live” can affect the

public’s health.°’ Regulation that addresses public health

risk therefore “operates in a world of choices in the allocation

of limited resources,” and contemplates a focus on

Macpherson, ed., 39th ed. 1999) (“Central to understanding public health

is recognition that public-health practitioners are concerned not just with

individuals, but with whole populations and that improving health care

plays only a part of public-health improvement.”).

*© See 62 Fed. Reg. 38677, PMJA 27 (noting that the level of the new

daily PM, ; standard “is not risk free”); see also supra note 15 (discussing

1993 decision to reaffirm the |-hour NAAQS).

*” See, e.g., Ben Miller & Claire Brackman Keane, Encyclopedia and

Dictionary of Medicine and Nursing 410 (1972) (public health is the

“field of medicine that is concerned with... the physical, mental and

social well-being of the community as a whole”); Dorland’s Illustrated

Medical Dictionary 647 (L.R.C. Agnew ef al. eds., 24th ed. 1965)

(Health is “[a] state of complete physical, mental and social well-being,

and not merely the absence of disease and infirmity.”); Black's Medical

Dictionary, supra note 54, at 454; see also id. 242 (“Environment,

including living and working conditions, plays an important part in

determining a person’s health.”) (emphasis added); Roger Detels & Lester

Breslow, Current Scope and Concerns In Public Health in | Oxford

Textbook of Public Health 3, 3 (Roger Detels et al. eds., 3d ed. 1997)

(public health concerns dating back to the early twentieth century include

crowding and undernutrition as well as disease).

** Lawrence O. Gostin, et al., The Law and The Public's Health: A Study

of Infectious Disease Law in the United States, 99 Colum. L. Rev. 59, 68

(1999).

27

“fulfill[ing] society’s interest in assuring conditions in which

people can be healthy.”*”

As such, “public health, as both a goal and a practice, is as

inherently political (i.e., concerned with the allocation of

resources in society) as it is technological (i.e., concerned

with deployment of professional knowledge of illness).”™

Developing public health policy necessarily involves

tradeoffs in order to choose the risk management option that

produces th greatest value for society.

In this case, citing a flawed interpretation of the CAA in

the lower court’s 1980 Lead Industries decision, the D.C.

Circuit held that Congress prohibited the EPA from

considering factors that are necessary to sound public health

risk management judgment in setting or revising NAAQS.

For the following reasons, this result is neither consistent

with the Act nor logical, and may result in decisions that do

not promote the public health.

I. THE STATUTORY PURPOSES MUST INFORM

AN AGENCY’S IMPLEMENTATION OF A

BROAD CONGRESSIONAL DELEGATION.

Broad delegations of congressional authority must be

implemented in a manner consistent with the ordinary

meaning of undefined statutory terms,°! and in a manner that

furthers Congress’ overall purposes in enacting the

legislation. As the Court only recently explained, “in the

absence of a statutory definition,” courts should look to “both

the generally accepted meaning of the term and to the

® See Institute of Medicine, The Future of Public Health 7, 40 (1988).

= Gostin, supra note 58, at 68.

*' Asgrow Seed Co. v. Winterboer, 513 U.S. 179, 187 (1995).

28

purpose of the statute.” Furthermore, a court’s “obligation

is to give effect to congressional purpose so long as the

congressional language does not bar that result.”

Thus, where Congress has not provided detailed guidance

for implementation of a statutory provision, this Court has

analyzed the validity of an agency’s regulation by examining

its conformance with the “fundamental objective” of the

statute in question.” Only last term, in striking down a

regulatory program adopted by the FCC, this Court

emphasized that broad delegation of regulatory authority

requires the agency “to apply some limiting standard

rationally related to the goals of the Act.”** Indeed, the

failure to apply any limiting standard related to the goals of

the Act may raise concerns under the congressional

nondelegation doctrine.”

As early as 1967, in enacting the first Air Quality Act,

Pub. L. No. 90-148, 81 Stat. 485, Congress explained that the

development of air quality standards should “be influenced

* Mississippi Band of Choctaw Indians v. Holyfield, 490 U.S. 30, 47-48

(1989).

*? Johnson v. United States, 120 S.Ct. 1795, 1805 n.10 (2000) citations

omitted).

* See Whirlpool Corp. v. Marshall, 445 U.S. 1, 11-12 (1980).

** AT&T Corp. v. lowa Utils. Bd, 525 U.S. 366, 388 (1999) (emphasis

added).

Mistretta v. United States, 488 U.S. 361, 374 n.7 (1989) (“In recent

years, our application of the nondelegation doctrine principally has been

limited to the interpretation of statutory texts, and, more particularly, to

giving narrow constructions to statutory delegations that might otherwise

be thought to be unconstitutional.”); Jones v. United States, 120 S.Ct.

1904, 1911 (2000) (statute is to be construed to avoid constitutional

infirmity).

29

not only by a concern for the protection of health or welfare,

but also by economic, social and _ technological

considerations.””’ In amending the Act in 1977, Congress

again emphasized that the Act’s purpose was to “insure the

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

at the same time considering the energy and economic needs

of this Nation.”

Reflecting these principles, Congress has long recognized,

in explicit statutory language, that the fundamental objective

of the Act is to promote the “public health” consistent with

economic and social realities. Thus, Congress stated in

§ 101(b) of the Act that the purpose of the Act is “to protect

and enhance the quality of the Nation’s air resources so as to

promote the public health and welfare and the productive

capacity of its population.” CAA § 101(b)(1) (emphasis

added).

The Agency itself has explained the importance of

exercising its discretion in light of the Act’s stated goal “to

protect and enhance the quality of the nation’s air resources

so as to promote the public health and welfare and the

productive capacity of its population.” As EPA has

observed, this language contemplates “a balancing of the

social and economic considerations with the environmental

*’ S. Rep. No. 90-403, at 28 (1967).

“* H.R. Rep. No. 95-294, at 34-35 (1977), reprinted in 4 1977 Legis.

Hist., supra note 8, at 2501-02 (emphasis added).

* See 39 Fed. Reg. 31000; see also Lead Industries, 647 F.2d at 1152;

Chrysler Corp. v. EPA, 631 F.2d 865, 888 (D.C. Cir. 1980); General

Motors Corp. v. Ruckelshaus, 742 F.2d 1561, 1572 n.15 (D.C. Cir. 1984).

30

implications” of a decision in order “to fulfill the mandate”

of the Act.”°

Framing EPA’s responsibilities to accommodate these

statutory objectives does not call for the Administrator to

ignore the broad impacts on the public of alternative

approaches. Rather, it calls for balancing to ensure that the

Agency’s judgments reflect sound public health policy.

These statutory purposes have special relevance in the

context of a regulatory program calling on the Agency to

exercise “public health” risk management judgment, a term

which by its very definition contemplates sonsideration of the

social and economic realities of an age: -y's risk management

decision. Thus, for example, regulation that trades reduction

in some predicted health risks for increases in others may not

further the “public health.” Similarly, adopting a revised

NAAQS that makes implementation of an air quality standard

“difficult, counterproductive or confusing”’' may not

promote the “public health.” Anc imcreasing the costs of

regulation to society in an attempt to insure against

speculative risk may in fact impair, sot protect, the “public

health.”

” 39 Fed. Reg. 31000. Indeed, the court of a »eals itself illustrated the

overriding importance of the purposes section of the Clean Air Act by

ruling that section 101(b)(1) imposed upon the Administrator the

obligation to establish a regulatory program that was not mentioned in the

operative provisions of the Act. See Sierra Club y EPA, 540 F.2d 1114

(D.C. Cir. 1976), vacated sub nom. Montana Power Co. v. EPA, 434 U.S.

809 (1977); Sierra Club v. Ruckelshaus, 344 F. Supp. 253 (D.D.C.), aff'd

per curiam, 4 E.R.C. 1815 (D.C. Cir. 1972), aff'd hy an equailly divided

Court, sub nom. Fri v. Sierra Club, 412 U.S. 541 (1973).

”' Brief of Respondent EPA, at 73 (D.C. Cir. No. 97-1441).

™ Some studies suggest that $3 million to $7 million spent on regulatory

costs may lead to one additional premature death. See Mark Shere, The

31

A profligate commitment of money and technology to

guard against one set of uncertain health risks may result in

inadequate means to cope with other more serious

problems.” Indeed, without consideration of the unavoidable

relationship between the costs of goods produced and the

capacity of the public to purchase such goods, stringent

margins of safety designed to protect against hypothetical

risks that by their nature are uncertain could have the effect

of increasing the cost of — and perhaps even denying to the

poor and those on fixed incomes — products such as

electricity for heating and cooling that are essential to the

public’s health. As Justice Powell recognized in his

concurrence in Union Electric Co. v. EPA, for example, the

“shutdown of an urban area’s electrical service could have an

even more serious impact on the health of the public than that

created by a decline in ambient air quality.” 427 U.S. 246,

272 (1976).

In this case, EPA must construe the Act to apply “some

limiting standard, rationally related to the goals of the Act””*

to govern its exercise of public health risk judgment, unless

Myth of Meaningful Environmental Risk Assessment, \9 Harv. Envil. L.

Rev. 409, 472 nn. 271-72 (Winter 1995) ((citing International Union,

UAW v. OSHA, 938 F.2d 1310, 1326 (D.C. Cir. 1991) (Williams, J.,

concurring) (explaining that recent studies predict that “each $7.5 million

of costs generated by regulation may ... induce one [premature] fatality”

in the public through reduced availability of resources for medical care

and safety)).

™ See, e.g., Industrial Union Dep't, AFL-CIO v. American Petroleum

Inst., 448 U.S. 607, 669-70 (1980) (Powell, J., concurring); Stephen

Breyer, supra note 12, at 18-19; see also W. Kip Viscusi, The Value of

Life in Legal Contexts: Survey and Critique, 2 Am. L. & Econ. Rev. 195,

200-01 (2000).

™ AT&T Corp., 525 US. at 388.

32

this Court finds that Congress explicitly directed EPA to

ignore the statutory language defining the purposes of the

Act. Because, as discussed below, there is no such explicit

constraint on the Agency’s regulatory authority in § 109 of

the Act, the Agency must look to the concept of “public

health” as commonly understood by health professionals and

to the purposes section of the Act in formulating decisional

criteria to govern management of uncertain health risks under

CAA § 109.

Il. CONGRESS IN §109 CONTEMPLATED THAT

EPA WOULD CONSIDER THE BROAD IMPACTS

ON SOCIETY OF ITS PUBLIC HEALTH RISK

MANAGEMENT DECISIONS CONSISTENT

WITH THE PURPOSES OF THE ACT.

No one disputes that the NAAQS program has truly

extraordinary impacts on the Nation’s economy and on

society generally. EPA’s own analyses show that the revised

standards at issue represent perhaps the most costly

regulatory decision ever made by that agency.”° In addition

to these very high implementation and control costs, the types

of impacts include adverse health impacts associated with

increased UVB radiation exposure; increased unemployment;

the higher cost of essential products; disruption in the

implementation of the congressional ozone reduction

program; and disruption of highway safety programs. See

supra pp. 15-18. Furthermore, EPA has explained that the

” See Johnson, 120 S.Ct. at 1805 n.10; Chevron, USA, Inc. v. NRDC, 467

U.S. 837, 842-43 (1984) (The first inquiry for a reviewing court is

whether “Congress has directly spoken to the precise question at issue.”).

%

See RIA, supra note 36, at ES-13, ES-19, 7-11, 9-1 (1997), OJA 29

2926, 2932, 2934. oe

anes ea |

33

revised NAAQS may simply be impossible to achieve in

some areas.

These, of course, are the types of concerns that led

Congress in 1990 to amend the Act to establish the Subpart 2

program for managing the uncertain public health risks

addressed by the 1l-hour ozone NAAQS.”’ And concerns

about implementation and efficacy of the revised standards

also caused Congress to delay implementation of the revised

PM25 NAAQS.

The lower court has held that EPA has no statutory

authority to consider any of these impacts when exercising

public health risk management judgment under § 109. But

there is nothing on the face of either §§ 108 and 109 that

prohibits the Administrator from balancing the broad range of

factors called for in § 101(b)(1) of the Act in exercising her

risk management judgment. To the contrary, the language of

§§ 108 and 109 supports the use of the statutory purposes to

derive decisional criteria for the Administrator’s exercise of

risk management judgment.

A. Sections 108 and 10%(b) Do Not Mandate

Uninformed Public Health Risk Management

Decisions.

Under § 109, NAAQS are to be set at a level that, in the

“judgment” of the Administrator, is “requisite to protect

public health” allowing an “adequate” margin of safety.

Nothing in this language tells the Administrator to exercise

”” H.R. Rep. No. 101-490, pt. 1, 101st Cong., 2d Sess., at 146-47 (1990),

reprinted in 2 1990 Legis. Hist., supra note 38, at 3170-71, OJA 3556-

$7.

™* See Transportation Equity Act for the 21st Century § 6101(b)(3), Pub.

L. No. 105-178, 112 Stat. 463 (1998). App. 113a.

34

her risk management judgment with blinders to the broad

consequences for society of her decisions.

The plain meaning of the word “requisite” is

“indispensable” or “necessary,” suggesting that the

Administrator must establish a need for the revised standard

to protect public health.” Furthermore, as discussed above,

the concept of “public health” calls on regulators to promote

the overall health of the population by reducing predicted

risks to acceptable levels. See supra pp. 24-27.

Whether a standard is “requisite” to protect the “public

health” in the face of uncertain predictions of health risk,

therefore, does not on its face limit the factors relevant to the

Agency’s exercise of risk management judgment. To the

contrary, a standard cannot be “requisite” to protect the

“public health” without some understanding of whether and

why predicted health risks are unacceptable under the

existing standard, and yet acceptable under the revised

standard.*'

”? Webster's Third New International Dictionary of the English Language

1929 (1993).

*° As the legislative history explains, this language means that standards

must be set at “the maximum permissible ambient air level” that will

protect sensitive subgroups in the population. S. Rep. No. 91-1196, at 10

(1970), reprinted in | 1970 Legis. Hist., supra note 7, at 410, OJA 3687;

see also H.R. Rep. No. 95-294, at 127, reprinted in 4 1977 Legis. Hist,

supra note 8, at 2594, OJA 3678; 123 Cong. Rec. 18460, reprinted in 3

1977 Legis. Hist., supra note 8, at 1030-31, OJA 3669-70 (NAAQS are

the “minimum necessary and the minimum reasonably attainable” for

achieving public health goals).

*' See SEC v. Chenery Corp., 332 U.S. 194, 196-97 (1947) (“{iJt will not

do for a court to be compelled to guess at the theory underlying the

agency's action....”); see also NRDC v. EPA, 902 F.2d 962, 969 (D.C. Cir.

1990) (NAAQS needed to avoid “an unacceptable risk” of premature

mortality); American Petroleum Inst. v. Costle, 665 F.2d 1176, 1187 (D.C.

35

As this Court has “frequently reiterated..., an agency must

cogently explain why it has exercised its discretion in a given

manner.” But, to use the ozone case as an example, where

there is no “bright line” distinguishing alternative standards

from a public health protection standpoint, see supra pp. 12-

13, how can the alternative that imposes the greatest overall

burdens on society be “requisite” to protect the public’s

health? How can a standard that imposes enormous costs on

society and that cannot be achieved in many areas, see supra

pp. 15-16, be “requisite” to protect the public’s health as

compared to a standard that imposes fewer burdens and is

being successfully implemented to reduce the same “public

health” risks? The Agency never answers these questions on

the grounds that Congress told it not to — an illogical and

implausible result under a statute whose purpose is to

promote the public health and welfare and the productive

capacity of the country’s population. CAA § 101(b)(1).

Similarly, the statutory direction that the Administrator

select a margin of safety that is “adequate” does not suggest

that she ignore the broad impacts of her decision on society

when exercising risk management judgment. To the

contrary, as the en banc D.C. Circuit observed in addressing

the similar language of CAA § 112, a finding that a level of

Cir. 1981) (Section 109 requires “a reasoned analysis and evidence of

risk.”’).

" Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 US.

29, 48 (1983); Smiley v. Citibank (South Dakota), N.A., 517 U.S. 735,

740-41 (1996) (explaining that deference accorded under Chevron is

based on “presumption that Congress, when it left ambiguity in a statute

meant for implementation by an agency, understood that the ambiguity

would be resolved, first and foremost, by the agency, and desired the

agency... t0 possess whatever degree of discretion the ambiguity

allows.” (emphasis added).

34

air quality is “safe” does not require that it be “risk free.”

Furthermore, even a requirement to provide an “ample”

margin of safety to protect public health does “nor ...

preclude consideration of any factor.”™*

The “adequaicy]” of a margin of safety cannot be

determined in the abstract. Like purchasing insurance to

protect against the possibility that a risk will become a

reality, how much margin is “adequate” will depend on a

broad range of factors including the certainty, size and nature

of the risk, and on the cost of providing that insurance (or

“margin” of safety) to protect against that predicted risk.*°

If insurance can be provided at little cost, it may be worth

the price. If insurance is so costly that it would impoverish

those to be protected, it should be rejected as doing “more

harm than good.””* Similarly, in the case of a non-threshold

pollutant where some health risk is assumed at any level

above “zero,” what margin of safety is “adequate” can be

informed only by striking the balance contemplated by the

purposes section of the Act.

Congress in 1977 also adopted a “significant risk”

standard as the threshold for regulation under the NAAQS

" NRDC v. EPA, (“Vinyl Chloride”), 824 F.2d 1146, 1164 (D.C. Cir.

1987) (en banc) (citing Industrial Union Dep't, 448 U.S. at 642).

“ Vinyl Chloride, 824 F.2d at 1155 (emphasis added).

** Cf id. at 1165 (in setting National Emission Standards for Hazardous

Air Pollutants, the Administrator “must ... decide what risks are

acceptable in the world in which we live.”) (citing Industrial Union

Dep't, 448 U.S. at 642 (“There are many activities that we engage in

every day ... that entail some risk of accident or material health

impairment [that] few people would consider ‘unsafe.’”’)).

* See Breyer, supra note 12, at 11; see also Vinyl Chloride, 824 F.2d at

1148.

37

87

program. A numer of commentators have explained that

the significance of risk cannot be determined in isolation

from the costs of eliminating that risk.™

In short, determining whether an existing NAAQS —

provides an “adequate” margin of safety, or whether a revised

NAAQS is “requisite” to protect the “public health,” are

quintessential risk management judgments that require a

baiancing of all factors relevant to promoting the public’s

health. This authorizing language does not call on the

Administrator fo ignore the consequences of her decisions;

rather, she can promote the public health only by considering

those consequences and striking the balance contemplated by

§ 101(b) of the Act.

This conclusion finds additional support in the language of

§ 108 describing the information that must be available for

NAAQS decisions. For example, § 108(a) provides that the

criteria document that is considered in making NAAQS

*” See H.R. Rep. No. 95-294, at 3, 48-49 (1977), reprinted in 4 1977

Legis. Hist., supra note 8, at 2470, 2515-16, OJA 3675, 3676-77

(adopting the endangerment standard as “the standard of proof which the

Administrator must meet before promulgating regulations controlling the

emissions of any air pollutant ... under this act.”) (emphasis added); Ethy/

Corp., 541 F.2d at 12, 16, 31-32 (The “will endanger” language has been

interpreted to require a finding of “significant risk of harm to the public

health.”).

** Stephen Breyer & Richard Stewart, Administrative Law & Reg. Policy

350 (3d ed. 1992); see also K. Arrow, et al., Is There a Role for Benefit-

Cost Analysis in Environmental, Health and Safety Regulation?, 272

Science 221 (1996) (advocating the use of cost benefit analyses in

regulatory decisions on environmental protection); R. Morgenstern, ed.,

Economic Analyses at EPA, ix-x (Resources for the Future, Washington,

D.C. 1997) (“[T}hough it should never be the only factor on which to base

a regulatory decision, economic analysis in its many forms should always

be one of the factors.”’).

38

decisions is to address “all identifiable effects on public

health or welfare expected from the presence of such

pollutant in the ambient air, in varying quantities,” as well as

“variable factors (including atmospheric conditions) which of

themselves or in combination with other factors may alter the

effects [of the pollutant] on public health or welfare.’ A

range of health risks might flow from the presence of a

pollutant in the ambient air, including both direct effects

associated with exposures to the pollutant (e.g., inhalation

health risks) and indirect health effects associated with how

programs for reducing the pollutant as it is present “in the

ambient air” are affected by NAAQS revision.

In other words, a standard that cannot be achieved, or that

will render pollutant reduction efforts more “difficult,

counter-productive, or confusing,” Brief of Respondent EPA,

at 73 (D.C. Cir. No. 97-1441), as compared to available

alternatives, has identifiable and adverse impacts on public

health. “[Ajll identifiable effects” of the pollutant as

influenced by such real world factors are appropriate topics

for consideration in the criteria document and by EPA during

the NAAQS rulemaking. Indeed, in a portion of its decision

not challenged by EPA, the lower court rejected EPA’s

refusal to construe the “all identifiable effects” language to

include the UVB radiation effects of ozone reduction. 175

F.3d at 1051-52, App. 43a-46a. Clearly, this language is not

limited to inhalation-related effects, as EPA has construed it.

Section 108 also directs EPA to address in its criteria “all

identifiable effects” on “public ... welfare,” CAA

§ 108(a)(2), a term that includes “economic values.” CAA

§ 302(h). EPA must also provide “simultaneously” with

issuance of the criteria document information on the “cost ...

® See NRDC, 902 F.2d at 973 (emphasis added) (citing CAA § 108(aX2)).

39

energy requirements, emission reduction benefit, and

environmental impact” of alternative control strategies. CAA

§ 108(b)(1). In view of this statutory language, EPA is

required to have available to it for any NAAQS rulemaking

all of the information it needs to exercise sound risk

management judgment. That Congress directed EPA to

develop this information under §108 in time for

consideration in NAAQS rulemakings does not mean that

EPA must ignore it, but rather supports the conclusion that

EPA should exercise its risk management judgment in light

of this information and consistent with the statutory purposes

of the Act.

In sum, Congress in §§ 108 and 109 did not tell EPA to

exercise public health risk management judgment by ignoring

the overall consequences of its action. Rather, Congress’

broad delegation of risk management authority must be

implemented by defining limiting standards that protect the

“public health” while promoting the statutory purposes of the

Act.

B. Section 109(d) Confirms The Need For

Consideration of the Impacts on Society of

Decisions on Whether to Revise NAAQS.

Once EPA has established a NAAQS for a pollutant, as it

has for both pollutants in this case, Congress directed that

EPA revise the standard periodically as “may be appropriate”

in accordance with §§ 108 and 109(b). CAA § 109(d)(1). In

the case of standard revision, there is by definition a standard

in place that the Agency previously determined was

“requisite to protect public health” with an “adequate margin

of safety.”

To establish that standard revision is “appropriate” in

accordance with §§ 108 and 109(b), the Agency must explain

40

why a change in the status quo is “requisite” to protect

“public health.” In other words, the agency must explain why

the existing standard is no longer “appropriate” in accordance

with §§ 108 and 109(b) and the revised standard is.

This analysis by definition recognizes the need to evaluate

a broad range of relevant factors. See West v. Gibson, 527

U.S. 212, 218 (1998) (“The meaning of the word

‘appropriate’ permits its scope to expand” as changes in the

law, or in the world, would require). In other words, the

“appropriate” language confirms the importance of the

ordinary meaning of “public health” and the statutory

purposes as a source of decisional criteria for the Agency’s

exercise of discretion regarding NAAQS revision.

Furthermore, as discussed above, the broad language of

§ 109(b) contemplates the exercise of risk management

judgment, and the information requirements of § 108 ensure

that the Administrator will have at her disposal all of the

information required for reasoned “public health” risk

management. In the context of standard revision, § 109(d)

specifically directs the Administrator to make any

“appropriate” revisions “in accordance with § 108” — a

provision that requires (under § 108(b)) development of

information on implementation impacts “simultaneously”

with public health information.

Whether standard revision is “appropriate in accordance

with” § 108 and § 109(b) therefore does not limit the factors

relevant to the exercise of risk management judgment.

Rather, it contemplates the balancing of a range of factors

consistent with the purposes of the Act.

In exercising her standard revision authority, Congress

also required the Administrator to obtain the advice of her

science advisers on a number of factors, including areas

where additional knowledge is needed to understand the

41

adequacy of existing and revised NAAQS, and on the “public

health, welfare, social, economic, or energy effects which

may result” from alternative implementation programs.”

CAA § 109(d)(2)(C){iv).

Some of this information goes to the evaluation of the

direct health risks of alternative air quality levels and

implementation approaches. Other information goes to the

risk management judgment on whether standard revision is

“requisite” to protect public health, on whether margins of

safety under existing and revised standards are “adequate,”

and on whether existing standards should be revised at all in

light of “areas in which additional knowledge is required to

appraise the adequacy” of existing standards. CAA

§ 109(d)(2)(C)(i).

The Administrator does not dispute that certain of the

information her science advisers must develop (e.g.,

information on the “adequacy” and “basis” of existing and

revised standards) is relevant to her decision on standard

revision. She has asserted, however, that other information

that must be developed (e.g., impacts resulting from

alternative attainment strategies) is irrelevant to revising the

standard.

The statute on its face does not direct the Administrator to

consider only some of these § 109(d) factors and not others in

determining what approach to managing uncertain health risk

is “appropriate” in accordance with the “adequate” margin of

safety and the “requisite” to protect “public health” language

of § 109(b). Indeed, it would be unreasonable to conclude

® See International Harvester Co. v. Ruckelshaus, 478 F.2d 615, 648

(D.C. Cir. 1973) (heightened standard of explanation required to override

science advisor’s advice).

42

that Congress wanted EPA to have all of this information

before it, but to consider only some of it.”!

Congress, of course, commented in legislative history that

the type of information identified in § 109(d) may be “of

interest and assistance to the States and Congress.””

Nevertheless, Congress directed CASAC in the statute “to

advise the Administrator with respect to any harmful effects”

of standard revision in the context of her consideration of

standard revision. CAA § 109(d)(2)(C)(i) (emphasis added).

As this Court has recognized, an agency has a heightened

burden to explain its decision to change an existing

regulatory program.’ In this case, where existing air quality

standards were in place that EPA had previously determined

were “requisite to protect the public health” with an

“adequate margin of safety,” CAA § 109(b)(1), the Agency

cannot fulfill its obligation of reasoned decisionmaking by

ignoring information that Congress told it to develop.

*" Cf id. at 642 (where data are uncertain or ambiguous, EPA must

consider the “nature and consequences of the risk of error” in making

regulatory decisions).

2 HR. Rep. No. 95-294, at 183 (1977), reprinted in 4 1977 Legis. Hist.,

supra note 8, at 2650, OJA 3680.

* See MVMA, 463 U.S. at 42 (“[AJn agency changing its course ... is

obligated to supply a reasoned analysis for the change beyond that which

may be required when an agency does not act in the first instance.”)

(emphasis added); see also Public Lands Council v. Babbitt, 120 S.Ct.

1815, 1828-29 (2000) (O’Connor, J., concurring) (“Under [MVMA vy.

State Farm), an agency that departs from its previous rules will be found

to have acted arbitrarily and capriciously, if it fails ‘to supply a reasoned

analysis for the change ....’”’).

43

C. The Legislative History Confirms the Need For

Balancing to Promote the Purposes of the Act.

The legislative history confirms the message of the

statutory language that Congress intended the Agency to

exercise sound public health risk management judgment in

light of the purposes of the Act and the commonly

understood meaning of “public health.”

In enacting the NAAQS program in 1970, the Senate

explained that the “primary” NAAQS were to set a “national

health minimum” standard which would provide a

“reasonable degree of protection.” See S. Rep. No. 91-1196,

at 10, reprinted in 1 1970 Legis. His:., supra note 7, at 410,

OJA 3687. With this understanding, Congress left States the

option to establish an ambient air quality standard “more

stringent” than the “national health minimum.” /d.

In 1977, when it amended the Act, Congress understood

that the NAAQS did not incorporate a “no risk philosophy”

and explained that NAAQS should reflect the principle that

“public [health] policy ... [be] wise policy.”* Further

reflecting Congress’ delegation of authority to EPA to

manage (not eliminate) health risk to achieve the Act’s

“public” health objective, Congress established in 1977 an

additional CAA prograin to prevent significant deterioration

(PSD) of air quality in areas where air quality is better than

the NAAQS.

™ See H.R. Rep. No. 95-294, at 127, reprinted in 4 1977 Legis. Hist.,

supra note 8, at 2594, OJA 3678; Hearings on S. 251, S. 252 and S. 253

Before the Subcomm. on Environmental Pollution of the Sen. Comm. on

Env't and Pub. Works, 95th Cong., Ist Sess., at 6-7 (1977) (Chmn.

Muskie); see also id. at 37.

* See CAA Title I, Part C, §§ 160-169.

44

In arguing for this “non-degradation” program, Senator

Muskie, the Clean Air Act’s chief sponsor, explained that

were set for dirty air areas as the minimum

necessary and the minimum reasonably

attainable in the dirty area areas.... Even at

the national primary standard level, which is

the health standard, there are health effects

that are not protected against.... At any level

between zero pollution and the pollution

permitted by national U primary standards,

there are health effects.

This PSD program is intended to address “any actual or

potential adverse effect,” CAA § 160(1) (emphasis added),

thereby addressing health risks not addressed by the “public

health” standards established under § 109. In other words,

Congress in 1977 recognized that not all predicted health

risks are public health risks, and Congress therefore

responded with a separate program to address those health

and welfare risks at levels of air pollution lower than

specified by the NAAQS. Given this statutory matrix,

Congress could not have intended that EPA ignore all of the

costs and practical impacts of the risk management

judgments required in setting the public health-based

NAAQS.

In 1990, Congress enacted extensive amendments to the

Clean Air Act, but did not amend the NAAQS program in

§§ 108 and 109. Thus, Congress left in place a program that

delegates to EPA authority to exercise public health risk

* See 123 Cong. Rec. 18460, reprinted in 3 1977 Legis. Hist., supra note

8, at 1030 (emphasis added), OJA 3669.

45

management judgment in setting and revising NAAQS.

Implicit in that delegation is the obligation for the Agency to

“give clear indication that it has exercised the discretion with

which Congress has empowered it.””’ Far from directing the

Agency to ignore factors that are relevant to the exercise of

reasoned risk management judgment, the legislative history

of the 1970 Act and the 1977 Amendments to § 109 confirms

that this discretion must be exercised in a manner that

furthers the statutory purposes of the Act.

* > * J

As the Court has said, judges “must be guided to a degree

by common sense as to the manner in which Congress is

likely to delegate a policy decision of such economic and

political magnitude to an administrative agency.” In this

case, there is nothing on the face of the Act that directs the

Administrator, in exercising her judgment to determine

whether a standard revision is appropriate, to ignore the

broad impacts of her decision on society. To the contrary, the

common understanding of “public health” regulation and the

explicit statutory language in § 101(b)(1) of the Act requires

the Agency to strike a balance considering all factors.

lll. LEAD INDUSTRIES, WHICH THE LOWER

COURT CITES AS THE BASIS FOR ITS

DECISION, SHOULD BE OVERRULED.

Without parsing the language of the statute or even

mentioning the purposes section of the Act, the lower court

has simply relied on Lead Industries, and subsequent cases

” Phelps Dodge Corp. v. NLRB, 313 U.S. 177, 197 (1941).

” FDA v. Brown & Williamson Tobacco Corp., 120 S.Ct. 1291, 1301

(2000).

46

citing Lead Industries,” for the proposition that the

Administrator is precluded from considering the broad

impacts of her decision on society in exercising her public

health risk management responsibilities. 175 F.3d at 1040-

41, App. 19a-2la. According to the court, this is a simple

matter of statutory construction that can be resolved under

“step one” of Chevron. See id. at 1040 (explaining that Lead

Industries was decided “in Chevron step one terms”’).

The Lead Industries case, however, was decided before

Chevron and found clarity of congressional expression in

§ 109 where none exists. Indeed, as discussed above, a

Chevron “step one” analysis of all of the relevant Clean Air

Act provisions, including the purposes section of the Act,

confirms that EPA has broad discretion to consider and to

balance all relevant factors in making “public health” risk

management decisions. Because Lead Industries as applied

by the lower court is at odds with the statute, it should be

overruled.

First, as discussed above, nothing on the face of the statute

directs EPA in exercising risk management judgment to

ignore the broad impacts of its decision on society. In fact, as

the D.C. Circuit observed in Lead Industries, “[s}ection

109(b) does not specify precisely what Congress had in mind

when it directed the Administrator to prescribe air quality

standards that are ‘requisite to protect the public health.””

647 F.2d at 1152.

Where Congress has delegated in broad terms, it is for the

agency to fill out the statutory provision “within the limits of

[the congressional] delegation.”'” Reflecting this

established principle, the D.C. Circuit has repeatedly held in

” American Petroleum Inst., 665 F.2d at 1148; NRDC, 902 F.2d at 973.

'° Chevron, 467 U.S. at 865; see also Smiley, 517 U.S. at 740-41.

47

the wake of this Court’s decision in Chevron that an agency

is free to consider costs when not expressly precluded from

doing so by statute.""' Indeed, as discussed above, a

determination that regulation is “requisite” to protect the

“public health” with an “adequate” margin of safety in

response to predicted and theoretical health risk cannot be

made without considering the overall impacts of the decision

on society, including the costs of that decision.

Second, while the Lead Industries court asserted that the

structure of the Act and legislative history supported its broad

statement that costs can play no role in the promulgation of

air quality standards, just the opposite conclusion is more

appropriate in cases where the Agency must exercise risk

management judgment to address uncertain and predicted

health risk. In this case, Congress explained that the NAAQS

program does not contemplate “zero risk” regulation.

Congress therefore called on EPA to exercise judgment as to

what risk is acceptable, in setting standards that are

“requisite” to protect the “public health” with an “adequate”

margin of safety. That judgment cannot be exercised without

an understanding of the overall consequences of the Agency’s

action.

Third, the Lead Industries court reasoned that the

“technology-forcing” nature of the CAA supports the

conclusion that Congress wanted EPA to ignore the costs and

feasibility of control technologies in setting NAAQS. 647

'*" See, e.g., Michigan v. EPA, No. 98-1497, 2000 WL 180650, at *12

(D.C. Cir. Mar. 3, 2000) (“{Ojnly where there is a ‘clear congressional

intent to preclude consideration of costs’ ... [do] we find agencies barred

from considering costs.”); see also, e.g, Vinyl Chloride, 824 F.2d at

1155; George E. Warren Corp. v. EPA, 159 F.3d 616, 622-23 (D.C. Cir.

1998); Grand Canyon Tour Coalition v. FAA, 154 F.3d 455, 475 (D.C.

Cir. 1998).

48

F.2d at 1149. However, this has little relevance to the

exercise of public health risk management judgment. In

other words, NAAQS that are set to reflect sound risk

management principles will still require industrial sources to

install whatever controls it takes to achieve those NAAQS.

Similarly, while the D.C. Circuit has pointed to congressional

statements that sources would have to shut down if they

could not meet the NAAQS as supporting its construction of

§ 109, see Vinyl Chloride, 824 F.2d at 1159, sources would

still have to shut down if they could not meet a NAAQS that

reflects the exercise of sound public health risk management

judgment.

Finally, Congress did not re-enact § 109 of the Clean Air

Act in 1990, nor did it amend § 109 to codify the lower

court’s interpretations of § 109. No changes were made to

§ 109 in 1990. As a result, isolated statements in the 1990

legislative history (which EPA has argued suggest

acquiescence to the D.C. Circuit’s earlier decisions'™) should

be treated with great skepticism. As this Court has

commented, “the views of a subsequent Congress form a

hazardous basis for inferring the intent of an earlier one.”'”

Indeed, where Congress has not been requested to act on a

statutory provision, and has taken no action, there is no basis

'? Brief for the Federal Cross-Respondents in Opposition, at 14-15 (Nos.

99-1426, 99-1431, 99-1442).

‘8 South Dakota v. Yankton Sioux Tribe, $22 U.S. 329, 355 (1998);

Central Bank, N.A. v. First Interstate Bank, N.A., 511 U.S. 164, 185-87

(1994) (rejecting application of the “acquiescence doctrine” where

Congress had amended other statutory provisions within the Act).

49

for concluding that Congress as a legislative body had any

intent on the matter.'™

In sum, when EPA regulates pollutant concentrations that

are below any known “adverse effects” threshold, there will

always be ranges of theoretical and uncertain predictions of

health risk. The Agency must examine this range and decide

whether standard revision is “appropriate” and will promote

the overall goals of the Act.

Congress’ delegation to EPA of authority to choose a

result that is “appropriate” does not forbid consideration of

any factor relevant to managing public health risks in a way

that promotes the purposes of the Act. Therefore, a judicial

interpretation of § 109 that precludes consideration of

societal costs and related factors must be rejected under any

sound Chevron “step one” analysis It is now time to resolve

the confusion that has been created by Lead Industries by

overturning that decision as inconsistent with the Act and the

principles enunciated by this Court in Chevron.

CONCLUSION

For the reasons stated above, the decision of the lower

court that EPA is precluded from considering the broad

impacts of its decision on society in exercising risk

management judgment under § 109 should be reversed,

'* See Central Bank N.A., 511 U.S. at 185-87; id. at 186 (citing U.S.

CONST. art. I, § 7, cl. 2). See also Immigration and Naturalization Serv.

v. Chadha, 462 U.S. 919, 954 (1983) (“Amendment and repeal of

statutes, no less than enforcement, must conform with Article !.”).

50

and the standards should be vacated because they were not

based on consideration of all relevant factors.

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

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 Counsel for Appalachian

Institute Power Co., et al., American

Public Power Association,

and National Association of

Home Builders

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

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.

MARCELLE SHOOP

Associate General Counsel

KENNECOTT 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 Co.

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

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

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

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

HAROLD P. QUINN, JR.

NATIONAL MINING

ASSOCIATION

1130 17" Street, N.W.

Washington, D.C. 20036

(202) 463-2652

Counsel for National Mining

Association

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

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

July 20, 2000

PETER S. GLASER

SHOOK, HARDY & BACON

600 14th Street, N.W.

Suite 800

Washington, D.C. 20005 z

(202) 639-5627

Counsel for Western Fuels

Association, Inc.

DAVID M. FRIEDLAND

BEVERIDGE & DIAMOND

1350 I Street, N.W.

Suite 700

Washington, D.C. 20005

(202) 789-6000

Counsel for Phoenix Cement Co.

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.

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