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SY Supreme Court, U.S.

FILED

IN THE

Supreme Court of the United OrkeK

CAROL M. BROWNER, ADMINISTRATOR OF THE

ENVIRONMENTAL PROTECTION AGENCY, et al.,

Petitioners,

Vv.

AMERICAN TRUCKING ASSOCIATIONS, INC., ef ai.,

Respondents.

On Writ of Certiorari to the

United States Court of Appeals Y

for the District of Columbia Circuit

BRIEF OF AMICI CURIAE SENATOR ORRIN HATCH

AND REPRESENTATIVE TOM BLILEY

IN SUPPORT OF RESPONDENTS

LLOYD N. CUTLER CARTER G. PHILLIPS

C. BOYDEN GRAY ALAN CHARLES RAUL *

WILMER, CUTLER & PICKERING STEPHEN B. KINNAIRD

2445 M Street, N.W. SIDLEY & AUSTIN

Washington, D.C. 20037 | 1722 Eye Street, N.W.

“e

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ye pace are *

Cy

QUESTION PRESENTED

Whether the Environmental Protection Agency’s interpreta-

tion of Section 109 of the Clean Air Act, in conformity with

Lead Industries Ass'n v. EPA, 647 F.2d 1130, 1148 (D.C. Cir.

1980), effects an unconstitutional delegation of legislative

power?

(i)

TABLE OF CONTENTS

Ey et. |) ||) a i

ee IIITIIED cccntccniccenscencreccsesecccecececnseses \

INTERES F OF ARGICT CURIAE ......cceccrecrerssersecsseseseees I

INTRODUCTION AND SUMMARY OF THE AR-

GUMENT

I.

NONDELEGATION IS A VITAL PRINCIPLE

OF SEPARATION OF POWERS THAT

GUARDS AGAINST GRANTS OF ARBI-

TRARY POWER TO THE EXECUTIVE.........

A.

Congress May Not Grant The Executive

Branch (And The Executive May Not Usurp)

Arbitrary Power Unbounded By Law ..........

. The Nondelegation Doctrine Has Emerged

As An Important Canon Of Statutory Con-

struction To Constrain Executive Power .....

The Arbitrariness Of A Grant Of Power De-

TTT tersseeetepesnenanenecenesszccssceseses

Whether Lead Industries 1s Inconsistent

With The Nondelegation Doctrine Must Be

Determined In Light Of The Statutory Con-

text Of Scientific Indeterminacy And Vast

Administrative Power .............c..csccceeseeeeeees

THE LEAD INDUSTRIES INTERPRETATION

OF SECTION 109 DOFS NOT PROVIDE AN

INTELLIGIBLE PRINCIPLE CONSTRAINING

THE ADMINISTRATOR'S POWER ...............

(iii)

iV

TABLE OF CONTENTS—Continued

A. Under A Proper Interpretation Of Section

..

109, The Principle Of Cost-Effectiveness

Constrains The Administrator’s Discretion

When The Scientific Evidence Is Indetermi-

. The Lead Industries Rule That EPA May

Only Rely Upon Scientific Factors Even

When Science Is Indeterminate Violates

Nondelegation Principles ................cccccceeeees

The Arbitrariness Of The Lead Industries

Rule Is Evident In The PM And Ozone

SIND ccnscseninnrcennctersicneianinsmennamnsensante

De FUR CaN scinsnsncstnininesieenenaiiennintaaigenies

2. Crome Resbomahineg..........sccccccosscescscescoeeses

Sa NITES cnrconnessentianesensteneneneninmnomenssanilensninenens

Page

17

V

TABLE OF AUTHORITIES

CASES Page

A.L.A. Schechter Poultry Corp. v. United States,

a hs Ga Cop errennssncesnnnntmnnnmeed 4,7, 8, 11

AT&T Corp. v. lowa Utils. Bd., 525 U.S. 366

nee 9, 22, 23, 25

American Power & Light Co. v. SEC, 329 U.S. 90

Gee csnsnssnnicsmsnsmnecsmesssemenmsennienmnmemmasnees passim

Arizona Grocery Co. v. Atchison T. F. & S. Ry.,

BO Gh FU Cee neni 13

Baltimore Gas & Elec. v. NRDC, 462 U.S. 87

GI cnsnensnsinicemsssnsensenpeeestinnnneniemnuaesinntatens 30

Buttfield v. Stranahan, 192 U.S. 470 (1904) ........ 7, 8, 12,

17, 20

Chemical Mfrs. Ass'n v. EPA, 28 F.3d 1259 (D.C.

SAR, FD vecisseremteenntensepennseniensemnemiienaenniinn 27

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

GO etrcnessnserennsnenementeemennnenniemnsenemenennnn 30

Chlorine Chemistry Council v. EPA, 206 F.3d

SA Gis Gat GRIND cxsnsesenssnssamessommeimesnentnienes 27

Clinton v. City of New York, 524 U.S. 417

(Fe asesscersesmesesevensessmensssssnstecomemnsennenss 7,9, 10, 11

Daubert v. Merrell Dow Pharms., Inc., 509 U.S.

i 13, 30

FDA v. Brown & Williamson Tobacco Corp., 120

ey eae eee 5, 30

Federal Power Comm'n v. Hope Natural Gas Co.,

FED Ca FOO (Oe p erncessecsssecsssssnsremecenmeeans 12

Federal Radio Comm'n v. Nelson Bros. Bond &

Mortgage Co., 289 US. 266 (1933) ....7, 10, 11, 12, 13

Field v. Clark, 143 U.S. 649 (1892) ........ccccccceeseees 6, 8, 12

Flue-Cured Tobacco Coop. Stabilization Corp. v.

EPA, 4 F. Supp. 2d 435 (M.D.N.C. 1998)........ 4 28

Hecht Co. v. Bowles, 321 U.S. 32T (1944).........4. 13

vi

TABLE OF AUTHORITIES—Continued

Page

Industrial Union Dep't, AFL-CIO v. American Pe-

troleum Inst., 448 U.S. 607 (1980) ........ 6,9, 10,11, 15

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

ey Mate Wee cncnicnneicieniniienduiiniatadtuanabiietin 20

Interstate Commerce Comm nv. Goodrich Transit

ee ae 12

J.W. Hampton, Jr., & Co. v. United States, 276

hs a ee ccnncnsssnitentabintinempeuiepesimenmegsineniies 10

Kent v. Dulles, 357 U.S. 116 (1958)... eee 9.11

Lead Indus. Ass'n v. EPA, 647 F.2d 1130 (D.C.

GR. FIED caseccenssatqecssesnssevensnsensosmnannsssnessessssesescees passim

Lichter v. United States, 334 U.S. 742 (1948).....7, 10, 11

Louisiana Pub. Serv. Comm'n v. FCC, 476 U.S.

Be Ce encmnstigemmemnminmmes 7

Loving v. United States, 517 U.S. 748

PF ncccsestnscspscenenenitinanmctemmnnnel 6, 7, 10, 24

Michigan v. EPA, 213 F.3d 663 (D.C. Cir.

SEITE cicncensstennensgsenemennninenneniaeniatienane 1]

Missouri v. Jenkins, 515 U.S. 70 (1995).............0.. 13

Mistretta v. United States, 488 U.S. 361 (1989)... 9

Motor Vehicle Mfrs. Ass'n of United States, Inc. v.

State Farm Mut. Auto. Ins. Co., 463 U.S. 29

SEP hceresnesnsvesmernsnnitnemmesemeeneneansamenasee 30

Natural Resources Defense Council, Inc. v. EPA,

902 F.2d 962 (D.C. Cir. 1990), vacated in part

on other grounds, 921 F.2d 326 (D.C. Cir.

Sia cinetrenanieninsenenssininniietiibiatennimesnnnaninimaueas 13

National Broad. Co. v. United States, 319 U.S. 190

ETI ctsennipniigienestnnenniiieesseiueninieeiaen »..10, 12, 23, 25, 29

National Cable Television Ass'n v. United States,

a Cs ee crerennencunsncnnsennaniintinnuiinsapees 8,9

New York Cent. Sec. Corp. v. United States, 287

2 ee ee 10, 12, 13

Vii

TABLE OF AUTHORITIES—Continued

Page

Opp Cotton Mills v. Administrator of Wage &

Hour Div. of Dep't of Labor, 312 U.S. 126

FU na ee iitniasaniaipenensceinintasteenaiinnnennniemnninunnsenmaniie 12

Skinner v. Mid-America Pipeline Co., 490 U.S.

Re Gee a iniitienatscsntentontennicncnveniinnenininaneniinie 8, 11

Sunshine Anthracite Coal Co. v. Adkins, 310 U.S.

Fe Cee ennintcsterinantemauntennasinaincaiiiibianianed 8, 12,24

Touby v. United States, 500 U.S. 160 (1991) ........ 8,9, 10

Union Bridge Co. v. United States, 204 U.S. 364

PRET Picissesennenensenmmesntessmnenmensaenneenmemeniten 7, 11, 12

Union Elec. Co. v. EPA, 427 U.S. 246 (1976)....... 24

United States v. Grimaud, 220 U.S. 506

(POO Pnsechesnsseninmentiennintetennmiemnemnmnanenent 10, 11, 12

United States v. Mazurie, 419 U.S. 544 (1975)..... 10

Vance v. Bradley, 440 U.S. 93 (1979) ..... ee eeeceeeeee 8

Wayman v. Southard, 23 U.S. (10 Wheat.) 1

EUIEI D hateunecenscnapionsenicentnntinpieeneenensinietebmenimneienane 8

Yakus v. United States, 321 U.S. 414 (1944).....11, 17, 29

CONSTITUTION AND STATUTES

FS ene 6

Transportation Equity Act for the 21st Century,

Pub. L. No. 105-178, 1998 U.S.C.C.A.N. (112

SUR.) GU CUR ORD cecccssssecsansscnesesensnnsanenescnpocsnmnes 14

2 ets 0) Cal netenenesnsnnsnsemninntenioenmenninentensamemenmens 16

Se ls 0) Pee ccerrresessssasrensensenemmnntnenaseneeninn 23

i Pia icnseuninnsnqsenesimmenenteneenemipennenennes 17, 18

Ee Foie cininennanencnpentenenegsmmmmnennaseneinies 3, 17, 18, 19

Bp Fee netarcecnnsnesensesstveemmmnnnssnenneneneets 16, 19

SD PEED snctervenesennnestanegenenensvetsenentente 19

FEDERAL REGULATIONS

National Ambient Air Quality Standards for

Ozone; Proposed Decision, 61 Fed. Reg. 65,715

Vill

TABLE OF AUTHORITIES—Continued

National Ambient Air Quality Standards for Par-

ticulate Matter; Final Rule, 62 Fed. Reg. 38,651

(FIFI D ccoccsnssacsssccunssnemnenpennnengonsocssnensinimmnmnene 15,

National Ambient Air Quality Standards for

Ozone; Final Rule, 62 Fed. Reg. 38,855

(FGI P ccsvensscasnmnsessnnsenessnsasovecensennsunvecteasnet 15, 19,

COURT RULES

GT vee a Ee ae

ET aS

LEGISLATIVE HISTORY

H.R. Rep. No. 95-294 (1977) .......cccceceeees - aR

SCHOLARLY AUTHORITIES

~ Stephen A. Breyer, The Vicious Cycle (1993) ...14,

Leonard M. Fleck, Just Health Care Rationing: A

Democratic Decisionmaking Approach, 140

Se FU Eee BRR. BET CEPI ccccccsnsescessesesopesscescsecs

Michael Gough & Steven Milloy, EPA's Cancer

Risk Guidelines: Guidance To Nowhere, Cato

Policy Analysis No. 263 (Nov. 12, 1996), avail-

able at http://www.cato.org/pubs/pas/pa-263.

TITIES sccccccenscensnssensessnenesenensnteevedheennmnatmenessnssenesenees

Sheila Jasanoff, The Fifth Branch: Science Advis-

ers as Policy Makers (1990) .............000000 13, 14, 15,

Douglas H. Johnson, The Insignificance of Statisti-

cal Significance Testing, 63 J. of Wildlife Mgmt.

763 (1999), available at http://www.npwrc.

usgs.gov/resource/1999/statsig/stathyp.htm.......

5

4»

-_

tl

i)

Page

2l,

l,

23

27

ix

TABLE OF AUTHORITIES—Continued

David H. Kaye & David A. Freedman, Reference

Guide on Statistics, in Federal Judical Ctr., Ref-

erence Manual on Scientific Evidence 331

Alon Rosenthal et al., Legislating Acceptable Can-

cer Risk from Exposure to Toxic Chemicals, 19

BOSIREY LAD. SEP (IDIS) covccccceccvesscosccccsesessssecees

Cass R. Sunstein, /s The Clean Air Act Unconstitu-

tional?, 98 Mich. L. Rev. 303 (1999) ............00

Wendy E. Wagner, The Science Charade in Toxic

Risk Regulation, 95 Colum. L. Rev. 1613

OTHER AUTHORITIES

Office of Air Quality Planning and Standards,

EPA, National Air Quality and Emissions

Trends Report, 1998, at http://www.

epa.gov/oar/agtmnd98 (last modified June 2,

SITE cenvsrecnscenscetocntanesenssinmesemmsssorrentsmennensenmenenets

R.G. Whitfield, A Probabilistic Assessment of

Health Risks Associated With Short-Term Expo-

sures to Tropospheric Ozone: A Supplement

GR, FEF Pocenssenssesnennsvensnecnsanssemeanscosssveesnsnssensents

Letter from George Wolff, Chair, CASAC, to

Carol Browner, Administrator, EPA (Nov. 30,

Page

27

22

23

14

14

28

15

INTEREST OF AMICI CURIAE '

Amicus Orrin Hatch is a Member of the United States

Senate from Utah, and amicus Tom Bliley is a Member of the

United States House of Representatives from Virginia. Amici

are both eoncerned that the Environmental Protection

Agency's (“EPA”) implementation of the Act is contrary to

congressional will, undermines the separation of powers, and

frustrates effective congressional and judicial oversight.

Because EPA has been hamstrung by an erroneous judicial

precedent that irrationally prevents the agency from

considering the cost effectiveness of its regulations, and that,

provides no other constitutionally required _ intelligible

principles to constrain the agency’s discretion, EPA engages

in a science charade wherein policy and economic judgments

are masked as scientific determinations.

INTRODUCTION AND SUMMARY OF THE .

ARGUMENT

This case involves a Statutory provision that confers

unusually broad administrative power. Under this Court’s

teaching, the statute—and the Agency’s interpretation of its

authority thereunder—must receive “separation of powers”

scrutiny commensurate with the potential impacts on society.

On petition for review of the revised national ambient-air

quality standards (“NAAQS”) for particulate matter (“PM”)

and ozone set by the EPA pursuant to section 109 of the

Clean Air Act (“Act”), the United States Court of Appeals for

the District of Columbia held that “the construction of the

Clean Air Act on which EPA relied in promulgating the

' Pursuant to Rule 37.6 of the Rules of this Court, amici state that no

counsel for any party authored this brief in whole or in part, and that

Citizens for a Sound Economy has made a monetary contribution to the

preparation and submission of this brief. The parties have consented to the z

filing of this brief. Letters evidencing such consent have been filed with

the Office of the Clerk of this Court. See Sup. Ct. R. 37.3.

2

NAAQS at issue here effects an unconstitutional delegation

of legislative power.” Pet. App. 4a. The court declared that it

was not enough that EPA had identified the factors it used in

determining standards, for “EPA appears to have articulated

no ‘intelligible principle’ to channel its application of these

factors; nor is one apparent from the statute.” /d. at Sa.

Noting that there is no threshold concentration below which

ozone and PM do not adversely affect health, that EPA has

declined to read section 109 to require it to eliminate all

health risks, and that the decisional factors listed by EPA “do

not themselves speak to the issue of degree,” id. at 7a, the

court of appeals correctly held that “EPA lacks . . . any

determinate criterion for drawing lines” and “has failed to

state intelligibly how much is too much.” /d. at 6a.

The court found no enlightenment in the agency preambles

for the final rules, which amounted to litthke more than a

showing “that EPA is applying the stated factors and that

larger public health harms (including increased probability of

such harms) are, as expected, associated with higher pollutant

concentrations.” /d. at 10a. The Agency’s identification of

relevant factors did not provide any intelligible principle

limiting agency discretion; EPA’s rationale “could as easily,

for any non-threshold pollutant, justify a standard of zero.”

Id. at 11a. Cost-benefit analysis, the Court observed, would

avoid such indeterminacy, but D.C. Circuit precedents “read

§ 109(b)(1) as barring EPA from considering any factor other

than ‘health effects relating to pollutants in the air.” Pet.

App. 15a (citing, inter alia, Lead Indus. Ass'n v. EPA, 647

F.2d 1130, 1148 (D.C. Cir. 1980)).”

> The Government suggests that the court of appeals wandered off into

the constitutional thicket on its own by stating that the court “[rjel{ied] on

a theory that the parties had not extensively briefed.” U.S. Br. 15. To the

contrary, the issue was amply briefed below. Not only was the issue

raised by the “Small Business Petitioners,” Pet. App. Sa, but amici curiae

Senator Hatch (in the PM case) and Representative Bliley (in the ozone

3

The court of appeals was thus forced to address the

constitutional issue of nondelegation only because it was

constrained to follow the erroneous circuit precedent of Lead

Industries. As demonstrated in the brief of amici curiae in

the companion case No. 99-1426 (“Hatch/Bliley Br.”), the

Clean Air Act does permit the EPA Administrator to consider

cost-benefit analysis in setting NAAQS. Where Congress has

not mandated a “zero risk” standard (as EPA concedes) and

scientific evidence of public-health dangers is not itself

determinative, cost-effectiveness (including cost-benefit

balancing) is a necessary risk-management principle that

guides and limits the Administrator’s choice of a NAAQS

that is “requisite to protect the public health” and “allow[s] an

adequate margin of safety,” 42 U.S.C. § 7409(b)(1). While

Congress has made the fundamental choices about environ-

mental regulation, it relies on the Administrator to determine

the precise level of NAAQS based on her expert consid-

eration of the best science, medical data, and all of the other

relevant factors requisite to assure the public health is

adequately protected.

Lead Industries’s exclusion of cost-benefit balancing

empowers the Administrator to. regulate without limits.

Unwilling to admit or surrender the unfettered discretion it

exercises, EPA engages in “science charades” that mask

inevitable cost-based decisions as science-based, and it

effectively abandons—on covert grounds—the core Clean Air

Act goal of NAAQS attainment. Hatch/Bliley Br. 25-30

(discussing negative implications for attainment of the

President’s $10,000 per ton cap on “implementation” costs).

case) each submitted full-length briefs devoted to the nondelegation

issue. In the ozone case, the Government moved to strike the Bliley brief,

but its motion was denied. Order, No. 97-1441 (D.C. Cir. May 19, 1998).

In the PM case, the Government requested, and was granted, additional

pages to brief the nondelegation issue in response to the Hatch brief.

Order, No. 97-1440 (D.C. Cir. June 25, 1998).

4

Not only is the error of Lead /ndustries manifest, but the

doctrine of avoidance of constitutional questions compels its

rejection by this Court. The prohibition against delegation of

legislative power committed exclusively to Congress by

Article I is an indispensable element of separation of powers.

In modern jurisprudence, the nondelegation doctrine plays a

vital role as a canon of statutory construction by which this

Court narrowly construes broad statutory grants of authority

to supply meaningful and _ constitutionally necessary

constraints on agency discretion. The decision below is thus

right in line with this Court’s application of the nondelegation

doctrine subsequent to the era that produced A.L.A. Schechter

Poultry Corp. v. United States, 295 U.S. 495, 537 (1935).

As this Court’s precedents make clear, whether a given

statutory delegation is an unconstitutional grant of arbitrary

power to an agency depends critically on context. The

Government and its supporters miss this point by

mechanically citing the language of statutory delegations

upheld by this Court in the past, without regard to the

statutory and factual contexts defining limits for those

delegations. The context for setting NAAQS under the Clean

Air Act is fundamentally different because of the conceded

indeterminacy of the relevant science and the unparalleled

power the Administrator wields under section 109 over states,

local governments, and the American public. The non-

delegation decisions of this Court require a narrowing

construction of administrative authority to ensure that such

power is properly circumscribed.

Lead Industries extinguished intelligible principles that

could constrain the Administrator’s judgment in this context.

The principle suggested by the Government and its

supporters—that the Administrator has a mandate to protect

the public health by setting NAAQS based only on scientific

or medical evidence of health risks suffered by sensitive

populations—does not in fact provide any decisional

5

principle to guide the Administrator in deciding which health

risks she will’ abate and which she will tolerate. The

Administrator has acknowledged that Congress did not intend

NAAQS to be set at a level to eliminate all health risks, for

that would be harmful to the country. Thus, EPA is

essentially rationing public health protections: it has set the

ozone and PM NAAQS at levels that will protect some

populations from health impairment, but not others.

The Administrator purports to rely exclusively on science-

based criteria in making those choices. But risk management,

which is what the NAAQS provisions of the Act require, is

not that simple. Under the Lead Industries regime, EPA is

denied the measuring stick necessary to make comparative

judgments about public-health impacts. As a result, EPA

cannot forthrightly justify where it has drawn the lines of

protection. Lead Industries thus leads to incoherence and

science charades, as these rulemakings demonstrate. See

infra at 26-29. Congress cannot be presumed to have

delegated to the Administrator such massive power over

American life without a rational principle to direct her

judgments. See FDA v. Brown & Williamson Tobacco

Corp., 120 S. Ct. 1291, 1301 (2000). Under such a reading,

the Administrator exercises an impermissible power,

legislative in nature, to allocate health protections based on

arbitrary (and not fully disclosed) factors.”

Section 109 is not unconstitutional simply because Lead

Industries does not supply an intelligible limiting principle;

rather, this Court’s nondelegation jurisprudence requires that

this Court, if at all possible, adopt an alternative construction

*EPA’s ozone rule fails to protect perhaps an additional 18,000

children from moderate or severe pain on inspiration without any basis in

the scientific evidence to differentiate them from children who are

protected. See infra at 28-29. If EPA has denied this protection on any

basis other than balancing the overall benefits and costs to the public, its

decisionmaking is illegitimate as well as arbitrary.

6

with limiting principles that deflect doubts about a statute’s

constitutionality. As the court below acknowledged, cost-

effectiveness is an intelligible principle to guide the

Administrator in allocating health care protection under the

Act—indeed, it is the universally accepted principle of

environmental risk management and line-drawing. Nothing

in the statute prohibits the Administrator from considering

cost-effectiveness, and, as argued in the’companion case, the

statutory text, structure, and history indicate that Congress

intended the Administrator to take such factors into account.

This Court should reject Lead Industries and hold that the

Administrator may consider the cost-effectiveness of alter-

native standards where the science is inconclusive.

I. NONDELEGATION IS A VITAL PRINCIPLE

OF SEPARATION OF POWERS’ THAT

GUARDS AGAINST GRANTS OF ARBITRARY

POWER TO THE EXECUTIVE.

A. Congress May Not Grant The Executive

Branch (And The Executive May Not Usurp)

Arbitrary Power Unbounded By Law.

Article I, section | of the Constitution grants “[alJll

legislative Powers” exclusively to Congress. See U.S. Const.

art. I, § 1. “That Congress cannot delegate legislative power

to the President is a principle universally recognized as vital

to the integrity and maintenance of the system of government

ordained by the Constitution.” Field v. Clark, 143 U.S. 649,

692 (1892). This principle “ensures to the extent consistent

with orderly governmental administration that important

choices of social policy are made by Congress, the branch of

our Government most responsive to the popular will.”

Industrial Union Dep't, AFL-CIO v. American Petroleum

Inst., 448 U.S. 607, 685 (1980) (Rehnquist, J., concurring in

the judgment); Loving v. United States, 517 U.S. 748, 757-58

(1996). The nondelegation doctrine thus “prevent|s]

Congress from forsaking its duties,” even when it does not

J

encroach upon the prerogatives or impair the functioning of a

coordinate branch. /d. at 758. “Abdication of responsibility

is not part of the constitutional design.” Clinton v. City of

New York, 524 U.S. 417, 452 (1998) (Kennedy, J.,

concurring).

Nondelegation is not, however, strictly a matter of pre-

venting one branch's exercise of functions properly belonging

to another. This doctrine applies not only to cir-

cumstances where the executive is given the power to issue

prospective rules with the force and e‘fect of law (although

such power is granted here), but also to the quintessentially

executive function of administering a statute in a specific

case.’ All federal executive authority not independ-

ently derived from the Constitution must be granted by

Congress, Louisiana Public Service Commission v. FCC,

476 U.S. 355, 374 (1986), and no officer may be given power

unbounded by law. The fundamental concern in any kind of

statutory delegation to the executive branch is whether it

grants “arbitrary discretion,” Buttfield v. Stranahan, 192 U.S.

470, 496 (1904); Union Bridge, 204 U.S. at 387; Federal

Radio Commission v. Nelson Brothers Bond & Mortgage Co..,

289 U.S. 266, 282 (1933); Schechter Poultry, 295 U.S. at

537, whereby the executive acts as a law unto itself. See

Clinton, 524 U.S. at 452 (Kennedy, J,, concurring) (non-

delegation is a vertical protection of the citizenry as well as a

horizontal protection of the division of power among the

* See, e.g., Lichter v. United States, 334 U.S. 742, 775-76 (1948)

(authorization of administrative officials to renegotiate a wartime contract

based on a determination that the contractor earned “excessive profits”);

American Power & Light Co. v. SEC, 329 U.S. 90, 96-97 (1946)

(authorization of SEC, after an opportunity for a hearing, to order a

holding company to adopt a corporate structure that equitably distributes

shareholder voting power); Union Bridge Co. v. United States, 204 U.S.

34, 367-68 (1907) (authorization of Secretary of War, after an

opportunity for a hearing, to order a bridge owner to remove unreasonable

obstructions to navigation).

8

branches). Congress has broad power to draw policy lines

subject to the minimal constraints of legislative rationality,

see Vance v. Bradley, 440 U.S. 93, 108 (1979) (permitting

Congress to set mandatory retirement age of 60 for foreign

service Officers); National Cable Television Ass'n v. United

States, 415 U.S. 336, 342 (1974), but the executive does not.

B. The Nondelegation Doctrine Has Emerged As

An Important Canon Of Statutory Construc-

tion To Constrain Executive Power.

The essential inquiry in this Court’s nondelegation juris-

prudence is to ascertain when the executive discretion granted

by Congress is arbitrary. Delegation of discretionary author-

ity has long been recognized as a legitimate attribute of

legislative power, see Wayman v. Southard, 23 U.S. (10

Wheat.) 1, 42 (1825); Field v. Clark, 143 U.S. 649, 693-94

(1892), and this Court has not hesitated to approve even “

‘broad’ standards for administrative action” that are “a

reflection of the necessities of modern legislation dealing

with complex economic and social problems.” American

Power & Light, 329 U.S. at 105 (“Necessity . . . fixes a point

beyond which it is unreasonable and impracticable to compel

Congress to prescribe detailed rules . . . .”); Sunshine

Anthracite Coal Co. v. Adkins, 310 U.S. 381, 398 (1940).

But even so, discretion, in Justice Cardozo’s famous words,

must be “canalized within banks that keep it from

overflowing” and not “unconfined and vagrant.” Schechter

Poultry, 295 U.S. at 551 (Cardozo, J., concurring); Touby v.

United States, 500 U.S. 160, 166 (1991) (the statute must

“meaningfully constrain{] the [officer's] discretion”).

Congress must fix the “primary standard,” Buttfield, 192 U.S.

at 496, against which executive action may be measured so

that a court may “ * “ascertain whether the will of Congress

has been obeyed.” *” Skinner v. Mid-America Pipeline Co.,

490 U.S. 212, 218 (1989) (quoting Mistretta v. United States,

488 U.S. 361, 379 (1989) (quoting Yakus v. United States,

9

321 U.S. 414, 426 (1944))); see also Clinton, 524 U.S. at 484

(Breyer, J., dissenting). In this Court’s classic formulation,

“[s]o long as Congress ‘lays down by legislative act an

intelligible principle to which the person or body authorized

to act is directed to conform, such legislative action is not a

forbidden delegation of legislative power.’ Touby, 500 U.S.

at 165 (brackets omitted) (quoting J.W. Hampton, Jr. & Co.

v. United States, 276 U.S. 394, 409 (1928)). Cf. AT&T Corp.

v.Jowa Utils. Bd., 525 U.S. 366, 388 (1999) (interpreting

statute to require agency “to apply some limiting standard,

rationally related to the goals of the Act”).

Although this Court has struck down statutes as violating

the nondelegation doctrine only in two 1935 decisions,

Panama Refining and Schechter Poultry, the doctrine remains

an important canon of interpretation employed to give

“narrow constructions to statutory delegations that might

otherwise be thought to be unconstitutional.” Mistretta v.

United States, 488 U.S. 361, 373 n.7 (1989). Thus, in Kent v.

Dulles, 357 U.S. 116, 128-29 (1958), this Court invoked

nondelegation principles to narrow a statute to deny the

Secretary of State “unbridled discretion” to restrict the right

of citizens to travel. See also National Cable, 415 U.S. at 342

(avoiding nondelegation problem by narrowing power of

agency to assess fees). And, in /ndustrial Union Department,

AFL-CIO vy. American Petroleum Institute, 448 U.S. 607

(1980), a case strikingly parallel to this one, the Occupational

Safety and Health Administration (OSHA) had interpreted its

organic statute to permit it to promulgate workplace standards

to regulate any health risks from dangerous substances.

Noting that OSHA’s construction suggested a grant of

“unprecedented power over American industry” to an admin-

istrative agency to engage in “pervasive regulation limited

only by the constraint of feasibility,” id. at 645, a plurality of

this Court narrowed the statute to empower OSHA to regulate

only “significant” risks to health and safety. Jd. at 642.

Otherwise, this Court held, “the statute would make such a

10

‘sweeping delegation of legislative power’ that it might be

unconstitutional under the [nondelegation doctrine]. <A

construction of the statute that avoids this kind of open-ended

grant should certainly be favored.” /d. at 646; see also id. at

672-76 (Rehnquist, J., concurring in the judgment) (voting to

invalidate the statute as an unconstitutional delegation of

legislative power).

C. The Arbitrariness Of A Grant Of Power De-

pends On Context.

As this Court’s nondelegation precedents make clear,

whether a statute delegates arbitrary power depends critically

on context. Lichter, 334 U.S. at 785 (“Standards prescribed

by Congress are to be read in light of the conditions to which

they are to be applied.”); American Power & Light, 329 US.

at 104 (statutory standards are not to “be tested in isolation,”

but “derive much meaningful content from the purpose of the

Act, its factual background and the statutory context in which

they appear’); Nelson Bros., 289 U.S. at 285; New York Cent.

Sec. Corp. v. United States, 287 U.S. 12, 24 (1932); National

Broad, Co. v. United States, 319 U.S. 190, 215-16, 219

(1943) (“NBC”); see also Clinton, 524 U.S. at 488 (Breyer, J.,

dissenting). The intelligible-principle rule is always the

same, but the sufficiency of a given standard under that rule

turns not just on the bare language of the statute, but on

numerous factors specific to the statutory scheme. Thus, the

arbitrariness of a delegation may depend upon the clarity of

Statutory purposes, American Power & Light, 329 U.S. at

105; New York Central, 287 U.S. at 24-25, the complexity of

the subject matter of regulation, NBC, 319 U.S. at 219, the

variability of factual conditions, J/.W. Hampton, Jr. & Co. v.

United States, 276 U.S. 394, 404-05 (1928); United States v.

Grimaud, 220 U.S. 506, 516 (1911), the exigency of

circumstances, Touby, 500 U.S. at 168; Lichter, 334 U.S. at

779-80, the nature of power being exercised and of the officer

exercising it, Loving, 517° US. at 772; United States v.

Mazurie, 419 U.S. 544, 556-67 (1975),° past administrative

practice, Kent, 357 U.S. at 127-28; Lichter, 334 U.S. at 777-

78, 783, the presence of procedural safeguards, Lichter, 334

U.S. at 786-87; Union Bridge, 204 U.S. at 387, whether the

regulation concerns government property or the public

domain, Grimaud, 220 U.S. at 521; Nelson Bros., 289 U.S. at

282, whether constitutionally protected rights are at stake,

Kent, 357 U.S. at 128-29, and whether unusually broad

administrative power is conferred, /ndustrial Union, 448 U.S.

at 645-46; Schechter Poultry, 295 U.S. at 542; Michigan v.

———_ EPA, 213 F.3d. 663, 680-81 (D.C. Cir. 2000).

The Government and its supporters disregard the crucial

element of context by mechanically citing broad language of

delegation in statutes that have been upheld by this Court;

they argue that, even under Lead Industries, the detailed

prescriptions of section 109 cannot be unconstitutional in

light of past decisions of this Court upholding standards such

as the “public interest,” “public convenience,” justice and

equity, and reasonableness. Cf. U.S. Br. at 22, 25; Mass Br.

at 29, 35; see also Pet. App. 59a-60a (Tatel, J., dissenting in

part). The cited cases, however, involved circumstances

where there were ascertainable historical facts that could be

found by the administrative or executive officer; the officer’s

judgment (whether embodied in an order or a generally

applicable regulation) could be applied to those facts and

tested by a court against reason and statutory purpose. The

broad standards at issue in those cases related to

administrative determinations based on the actual costs or

conditions of a particular company or industry,° on historical

> Cf. Clinton, 524 U.S. at 445 (noting special foreign-affairs context of

Field v. Clark).

* See Skinner, 490 U.S. at 219-20 (imposition of fees on pipeline

ies based on “reasonable relationship” to their specific volume-

miles, miles, and revenues); Lichter, 334 U.S. at 785-86 (determination of

“excessive profits” earned on a specific government contract based on

cost investigation); Yakus v. United States, 321 U.S. 414, 420-21 (1944)

a

12?

_

practices or exigencies of a specific industry,’ or on narrowly

defined and detailed factual investigation of a_ particular

subject matter.” Because the statutory standards at issue were

tethered to ascertainable facts and conditions, this Court has

repeatedly stated that even broad standards such as the

“public interest” are not “indefinite” given the context and the

(wartime fixing of maximum prices for commodities that are “just and

equitable” after ascertainment of “prevailing prices” with adjustments for

factors such as speculation, cost changes, and profit trends); Federal

Power Comm'n v. Hopé Natural Gas Co., 320 U.S. 591, 600-01 (1944)

(determination of “just and reasonable rate[s|” for a specific utility based

on its cost structure); Opp Cotton Mills v. Administrator of Wage Hour

Div. of Dep't of Labor, 312 U.S. 126, 144-46 (1941) (determination of

minimum wages for classes of industry based on factfinding regarding

competitive conditions and effect on employment); Sunshine Anthracite

Coal, 310 U.S. at 397-98 (determination of maximum and minimum

prices for coal based on prevailing costs-per-ton and market prices, with

exemptions to ensure “fair return” or “fair value” for every mine);

American Power & Light, 289 U.S. at 105 (determination of fairness of

distribution of voting power of shareholders of a specific corporation);

New York Cent., 287 U.S. at 24-25 (determination of whether a specific

railroad’s acquisition of control of another’s line is in the “public

interest’).

’ See NBC, 319 U.S. at 217 (regulation of radio licensees); Ne/son

Bros., 289 U.S. at 282 (same); Interstate Commerce Comm'n v. Goodrich

Transit Co., 224 U.S. 194, 214-15 (1912) (formulation of uniform systems

of accounts to monitor common carriers by water); Grimaud, 220 U.S. at

515-16, 521 (authorization of regulations of “occupancy and use” for

preservation of national forests, which persons use under an “implied

license” from the Government).

*See Union Bridge, 204 U.S. at 386-87 (determining after hearing

whether a particular bridge examined by the Army Corps of Engineers

was an unreasonable obsiruction to navigation); Buttfield, 192 U.S. at

494-95 (issuance of standards of “purity, quality, and fitness for

consumption” based on expert rankings of imported teas); Field, 143 U.S.

at 692-93 (suspension of free importation of articles after investigation as

to whether exporting country imposed duties that were “reciprocally

unequal and unreasonable”).

13

statutory purposes. See, ¢.g., Nelson Bros., 289 U.S. at 285;

New York Cent., 287 U.S. at 24.”

D. Whether Lead Industries Is Inconsistent With

The Nondelegation Doctrine Must Be Deter-

mined In Light Of The Statutory Context Of

Scientific Indeterminacy And Vast Adminis-

trative Power.

The context of the Clean Air Act is fundamentally different

from that of statutes reviewed in this Court’s prior

nondelegation decisions (except for /ndustrial Union) in two

important respects. The first is the inherently subjective

nature of regulatory science. As Sheila Jasanoff has

documented, there has been a profound shift in administrative

regulation from traditional factfinding and industry expertise

to the “new” administrative agencies such as EPA engaged in

“regulatory science.” Sheila Jasanoff, The Fifth Branch:

Science Advisers as Policy Makers 40-45 (1990),"°

Regulatory science is different from rigorous research

science; it is policymaking requiring “‘predictions ... at the

frontiers of science.’”” NRDC v. EPA, 902 F.2d 962, 968

(D.C. Cir. 1990), vacated in part on other grounds, 92\ F.2d

” Reasonableness, fairness, justice, equity, and the public interest are

not lawless standards for fact-specific judgments; they are the

foundational standards of the common law and equity. Cf. Missouri v. .

Jenkins, 515 U.S. 70, 129 (1995) (Thomas, J., concurring) (discussing

historical conception that principles of equity do not grant “ ‘arbitrary

discretion’ ” to the courts); Hecht v. Bowles, 321 U.S. 321, 329 (1944)

(equity is “the instrument for nice adjustment and reconciliation between

the public interest and private needs”). Such standards do not become

lawless when applied to fact-based administrative agency determinations.

See Arizona Grocery Co. v. Atchison T. F. & S. Ry., 284 U.S. 370, 384-85

(1932) (describing shift of determination of reasonableness of railroad

rates from courts to administrative agencies).

"’ Cf. Daubert v. Merrell Dow Pharms, Inc., 509 U.S. 579, 593 (1993)

(citing Jasanoff regarding issues of reliability of scientific evidence).

14

326 (D.C. Cir. 1991); Jasanoff, supra, at 94 (regulators draw

conclusions that “involve subjective judgment, and even

policy, to compensate for the absence of hard knowledge”).

When regulators issue rules, “[t}hough the answer may be

couched in technical terms, as a verdict about the adequacy of

evidence, it necessarily incorporates a socicpolitically colored

judgment about the acceptability of risk.” /d. at 232; see also

Wendy E. Wagner, The Science Charade in Toxic Risk

Regulation, 95 Colum. L. Rev. 1613, 1617 (1995). The

uncertainties inherent in regulatory science are particularly

acute as administrative agencies push for the “last 10 percent”

of environmental protection. See Stephen A. Breyer, The

Vicious Cycle 11 (1993).""

This case amply demonstrates that proposition. The mas-

sive scientific uncertainties about the existence of any health

effects from fine PM are uniformly acknowledged (by the

President, Congress, CASAC, the National Academy of

Sciences, and EPA itself), and Congress had appropriated

large sums for further research with the express intent that

EPA delay further rulemaking. Hatch/Bliley Br. 2-3; see also

Pub. L. No. 105-178, §§ 6101-6104, 1998 U.S.C.C.A.N. (112

Stat.) 107, 463-65 (1998) (codified at 42 U.S.C. § 7407 note)

'' The Lead Industries problem has thus become more important than

ever before. While the air has gotten much cleaner under existing and

past standards, Office of Air Quality Planning and Standards, EPA,

National Air Quality and Emissions Trends Report, 1998, at 1, at

http://www.epa.gov/oar/agtrnd98 (last modified June 2, 2000), the country

is still far from attaining the current NAAQS. Now, EPA is arrogating to

itself the power to make arbitrary policy choices imposing dramatic costs

on society without considering all relevant factors. This Court should not

be swayed by arguments that Congress’s enactment of procedural

improvements in the NAAQS process obviates the need for close scrutiny

of Lead Industries under the nondelegation doctrine. See Mass. Br. 36-38.

The issue here is to vindicate the congressional mandate that the

Administrator apply the full range of her expert judgment, based on ail

relevant circumstances, to set standards requisite to protect the public

health.

15

(delaying implementation of revised NAAQS to allow for

judicial review, and disclaiming ratification of those

standards). For ozone, CASAC has declared that no “bright

line” distinguishes any of the contemplated standards from

any others in terms of health protection provided. Letter from

George Wolff, Chair, CASAC, to Carol Browner,

Administrator, EPA 3 (Nov. 30, 1995) (regarding CASAC

closure on the primary standard portion of the Staff Paper for

ozone). See infra at 26-29 (discussing EPA’s reliance on in-

determinate science). Indeed, the Administrator admits she is

exercising “policy judgment,” National Ambient Air Quality

Standards for Particulate Matter; Final Rule, 62 Fed. Reg.

38,651, 38,668 (1997) (“PM Rule”); National Ambient Air

Quality Standards for Ozone; Final Rule, 62 Fed. Reg.

38,855, 38,863, 38,867 (1997) (“Ozone Rule’), but maintains

the fiction that her judgment is science-based, even though

the setting of standards “necessarily” involves (and his-

torically has involved) sociopolitical considerations such as

cost. Jasanoff, supra, at 104-06, 232. EPA’s stance aside,

the nondelegation doctrine demands that the statute be

interpreted in light of its context: i.e., to give EPA intellig-

ible principles by which to navigate extreme scientific

uncertainty.

The second critical element of context that distinguishes

other nondelegation cases is the sheer scope of the coercive

power in the Administrator’s hands here. The authority to set

NAAQS is the power to dictate massive regulation of multi-

tudinous sources by States and their political subdivisions in

devising implementation plans under section 110. It is also

undisputed, even by EPA’s conservative estimate, that many

billions of dollars in annual compliance costs, above and

beyond what is required to meet current NAAQS, turn on

every fractional change in the NAAQS. _ The plurality

decision in Industrial Union recognized that the grant of vast

power to an agency increases the risk of arbitrary action. 448

U.S. at 645-46. The court below likewise properly recog-

16

nized that such vast power demands a “ ‘more precise’ ”

standard to ensure against arbitrary administrative action.

Pet. App. 12a.

.

Thus, Judge Silberman, in his dissent from denial of

rehearing en banc, was wrong to dismiss the nondelegation

reasoning in /ndustrial Union as “a makeweight, tossed into

the analysis, ... to help justify the result.” Pet. App. 93a.

First, nondelegation was central to the outcome of that

decision, and justified the narrow construction adopted by the

plurality. Second, because it interpreted the statute to ensure

that the grant of power is not arbitrary in its context,

Industrial Union is squarely within the tradition of this

Court’s nondelegation jurisprudence. Although not so much

as mentioned in the Government’s brief, that decision

strongly supports rejecting Lead Industries in favor of a

narrower construction. Indeed, the reasoning of /ndustrial

Union applies a fortiori here, for EPA’s power over the States

and industrial sources under section 109 dwarfs that of OSHA

to regulate hazardous workplaces. '”

'* The Government is also wrong to fault the court of appeals for

allegedly misusing the nondelegation doctrine as an improper “additional

means, beyond the explicit judicial review provisions of the CAA, to

supervise the exercise of administrative discretion.” U.S. Br. at 26. The

Government (and Judge Silberman, Pet. App. 95a-96a) contend that the

court could do no more than undertake the arbitrary-and-capricious review

authorized by statute. See 5 U.S.C. § 706; 42 U.S.C. § 7607(d)(9)(A).

However, the constitutional prohibition on grants of arbitrary (i...

legislative) power to executive agencies is neither coextensive with, nor

satisfied by, arbitrary-and-capricious review. The former ensures that the

statute itself does not grant arbitrary power to an agency; the latter

addresses the narrow question of whether, in a specific instance, the

agency has acted arbitrarily in exercising properly delegated power. Here,

the court of appeals was thus not seeking “to supervise the exercise of

administrative discretion” in implementing the Act, but to ensure that the

constitutional limits on congressional allocation of federal power are

respected in the Act itself. This was a proper subject of review.

17

In short, the nondelegation doctrine requires this Court, if

possible, to adopt a constitutional construction of section 109

of the Clean Air Act that ensures that the EPA’s discretion is

not arbitrary, given the statutory context of deep scientific

uncertainty about health effects and unparalleled adminis-

trative power over the States and the national economy. Lead

Industries cannot fit that bill: it authorizes the Admin-

istrator to rely solely upon scientific evidence even when

science is indeterminate, thus leaving the Administrator free

to set risk levels without any constraining principle.

Il. THE LEAD INDUSTRIES INTERPRETATION

OF SECTION 109 DOES NOT PROVIDE AN

INTELLIGIBLE PRINCIPLE CONSTRAINING

THE ADMINISTRATOR’S POWER.

A. Under A Proper Interpretation Of Section 109,

The Principle Of Cost-Effectiveness Constrains

The Administrator’s Discretion When The

Scientific Evidence Is Indeterminate.

Properly interpreted, section 109 of the Clean Air Act is

clearly constitutional. As described more fully in our prior

brief, Congress legislated “as far as was reasonably

practicable,” Buttfield, 192 U.S. at 496, in a scientifically

complex area of environmental regulation, and channeled the

Administrator’s discretion by providing principled constraints

that permit the courts to “ascertain whether the will of

Congress has been obeyed,” Yakus, 321 U.S. at 426. For

pollutants emitted from numerous or diverse sources that

“cause or contribute to air pollution which may reasonably be

anticipated to endanger public health or welfare,” 42 U.S.C.

§ 7408(a)(1)(A), the Administrator, among other things, sets

primary NAAQS “the attainment and maintenance of which

in the judgment of the Administrator, based on [air quality]

criteria and allowing an adequate margin of safety, are

requisite to protect the public health.” /d. § 7409(b)(1).

18

Congress intended the Administrator’s judgment to be based

on science to the extent possible: not only does section 109

require the Administrator to base the standard on air-quality

criteria that “shall accurately reflect the latest scientific

knowledge” regarding pollution effects, id. § 7408(a)(2), but

it also authorizes “an independent scientific review com-

mittee,” CASAC, to advise the Administrator on the estab-

lishment and revision of NAAQS, id. § 7409(d)(2)(A)-(B).

As noted above, science cannot alone guide the Ad-

ministrator in her judgment. Recognizing the inherent inde-

terminacy of science about public health risks from pollution,

and intending standards that would be “preventative or

precautionary,” H.R. Rep. No. 95-294, at 49 (1977), Congress

directed the Administrator to “allow[] an adequate margin of

safety” to account for scientific uncertainty in making a

“judgment” about what is “requisite to protect the public

health.” 42 U.S.C. § 7409(b)(1). Congress did not forbid the

Administrator to consider any factor relevant to inform her

judgment as to what was “adequate” or “requisite’—and

certainly did not preclude consideration of cost/benefit

balancing, which is fundamental to traditional concepts of

environmental risk management, Hatch/Bliley Br. 20-23, and

of “protect{ing] the public health,” see Br. for Cross-Pet’rs

37-43. To the contrary, Congress directed the Administrator

to gather “information on air pollution techniques” that “shall

include data relating to the cost of installation and operation,

energy requirements, emission reduction benefits, and

environmental impact of the emission control technology,” 42

U.S.C. § 7408(b)(1), and to publish this information along

with the air-quality criteria prior to the proposal of a new or

revised NAAQS, id. § 7409(a)(2). Congress further required

CASAC to “advise the Administrator of any adverse public

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

may result from various strategies for attainment and

maintenance of such national ambient air quality standards,”

19

id. § 7409(d)(2)(C)(iv),'? and required the Administrator to

explain any significant departure from “pertinent findings,

recommendations, and comments” of CASAC and _ the

National Academy of Sciences, id. § 7607(d)(3). The

Administrator also must conduct cost-benefit analysis of the

NAAQS. /d. § 7612(a)(1)."*

The regulatory scheme essentially replicates that of the Air

Quality Act of 1967, except that the authority to set air-

quality standards is now vested in EPA rather than the States:

standards must be set at or below the level at which science

reflected in the air-quality criteria shows dangers to public

health, but, in the face of scientific uncertainty, the ultimate

standard would reflect a socioeconomic judgment as to what

risk levels are tolerable. See Hatch/Bliley Br. 15-18. Thus,

scientific evidence of a significant risk of danger to the public

health, and, to the extent science is uncertain, the cost-

effectiveness of alternative standards, are the intelligible

principles that constrain the Administrator’s discretion.

Bound by Lead Industries, the court of appeals could not

adopt this interpretation, Pet. App. 15a, and thus was

compelled to declare unconstitutional the Administrator’s

construction (which itself was tethered to Lead Industries).

'’ Despite the obvious intent of Congress, the court below accepted the

Government's argument that information gathered in section 109(d)(2)(C)

may not be used in setting NAAQS. Pet. App. 21a. Not only does that

argument have no basis in text, but EPA does not follow it. Indeed, it

explicitly relied on evidence gathered under subsection (C)(iii)—namely,

the proportion of pollutant concentrations that is anthropogenic—in

setting the ozone NAAQS. Ozone Rule, 62 Fed. Reg. at 38,868. Having

done so, it cannot plausibly argue that it is barred from considering the

cost data gathered under subsection (C)(iv) of that statute.

EPA also considers costs in apportioning burdens among states

pursuant to its authority to order upwind states to curtail emissions that

contribute significantly to nonattainment by downwind states—a risk-

management task that cannot be divorced from the setting of NAAQS.

See Hatch/Bliley Br. 24-25.

20

Id. at }la. The interpretation discussed above is not only the

most natural reading of the Act’s text, structure, and history,

but it is also compelled by the doctrine of avoidance of

constitutional questions: only cost-effectiveness and the

balancing of benefits and costs are intelligible principles to

guide the Administrator in choosing among alternatives that

protect the public in varying degrees. Cf. id. at 14a-15a (cost-

benefit analysis provides determinacy to avoid nondelegation

problems); /nternational Union, UAW v. OSHA, 938 F.2d

1310, 1319-21 (D.C. Cir. 1991) (same). By contrast, the

Government's approach of simply identifying evidentiary

factors for consideration does not provide any comparative

standard whatsoever, and thus arrogates to the Administrator

an impermissible power, legislative in nature, to draw lines

on an arbitrary basis.

B. The Lead Industries Rule That EPA May Only

Rely Upon Scientific Factors Even When

Science Is Indeterminate Violates Nondelega-

tion Principles.

Drawing on some of the same statutory provisions

discussed above, the Government and its supporters attempt

to defend Lead Industries by arguing that there are intelligible

principles that bind the Administrator, even if cost-

effectiveness may not be considered. Their view, sum-

marized, is that EPA has a statutory mandate to “protect the

public health” by setting standards, after consideration of air-

quality criteria and CASAC advice and adding a margin of

safety, that protect sensitive populations from adverse health

effects linked to the presence of a criteria pollutant in the

outside air. U.S. Br. 22-25; Mass. Br. 28-34. This, they

claim, is specific enough to pass constitutional muster.

Erroneous as a matter of statutory interpretation, this

construction cannot provide the “primary standard,” Buttfield,

192 U.S. at 496, against which EPA’s actions can be

21

measured. The reason is that EPA has acknowledged that

section 109 does not require the NAAQS to eliminate all

adverse health effects (i.e., achieve zero-risk). See, e.g., PM

Rule, 62 Fed. Reg. at 38,653; Ozone Rule, 62 Fed. Reg. at

38,857. In other words, the purported “primary standard” of

protecting against adverse health effects upon sensitive

populations does not suggest any intelligible principle to

guide the Administrator in deciding which adverse health

effects to prevent, or which populations to protect. Moreover,

all the statutory procedures on which their briefs rely only

relate to that part of the NAAQS process that is not in

controversy: namely, the congressional directive that NAAQS

be based on ine best science possible. The procedures do not

address the issue of how the Administrator makes the highly

consequential choice among alternative risk levels when the

science is indeterminate, and when adverse health effects

would still occur even under the alternatives selected. The

lengthy recounting of statutory procedures in the opposing

briefs thus should not deflect this Court’s attention from the

issue at hand: namely, as the court of appeals rightly

identified it, what “intelligible principle” controls. the

discretion of the Administrator in choosing any risk level

above zero when science does not provide the answer. Pet.

App. 6a.

On this score, the Administrator offers only a series of so-

called decisional factors, and it is un these factors that the

validity of Lead Industries turns. The Administrator iden-

tifies those factors as “the nature and severity of the health

effects involved, the size of the sensitive population(s) at risk,

the types of health information available, and the kind and

degree of uncertainties that must be addressed.” Ozone Rule,

62 Fed. Reg. at 38,883. But, those factors (though certainly

relevant) are not “determinate criteria for drawing lines” and

“do not themselves speak to the issue of degree.” Pet. App.

6a, 7a. More fundamentally, in simply identifying decisional

factors, the Administrator has failed in her obligation “to

22

apply some limiting standard, rationally related to the goals of

the Act.” Jowa Utils. Bd., 525 U.S. at 388.

The nub of the issue is this: Because Congress did not

expect NAAQS to eliminate all health risks, as EPA

acknowledges, the setting of NAAQS is essentially an

exercise in the allocation of environmental health protections

and the management of risk. See Pet. App. 16a-17a

(suggesting that EPA could derive intelligible principle from

Oregon plan for rationing health care); Breyer, supra, at 18-

19, 23 (discussing impact of finite resources on risk

regulation). Put another way, EPA has set standards at levels

that will protect some populations from health impairment,

but not others. The only reason for drawing such lines is

economic, in the broad sense of that word: namely, tighter

standards are progressively expensive, and approaching zero

risk is counter-productive because it diverts society's

resources away from other needs. See, e.g., H.R. Rep. No.

95-294, at 127 (1977) (rejecting argument that NAAQS could

be set at a zero-risk level because such an approach “ignores

all economic and social consequences and is impractical”).

Cost-effectiveness is an intelligible principle by which to

allocate health protection: if the scientific basis for choosing

among various standards is indeterminate, the Administrator

may select a standard because its benefits for the public are in

her judgment reasonably commensurate with the costs to

society.”

The medical-evidence decisional factors forwarded by the

Administrator, by contrast, provide no principled basis for

balancing and line-drawing. They are not rationally related to

any coherent standard for allocating public health protections,

nor do they fully “tak[e] into account the objectives of the

'S See Alon Rosenthal et al., “Legislating Acceptable Cancer Risk from

Exposure to Toxic Chemicals,” 19 Ecology L.Q. 269, 336 (1992) (cost-

effectiveness is a means “to maximize public health protection through the

rationing of finite resources”).

23

Act,” lowa Utilities Board, 525 U.S. at 392, which are to

induce “reasonable Federal, State, and local governmental

actions,” 42 U.S.C. § 7401(c), to “promote the public health

and welfare and the productive capacity of [the Nation’s]

population,” id. § 7401(b)(1). EPA’s exclusive reliance on

such factors is feckless when the judgment regarding

rationing of health protection is not merely technical, but

social, political, and economic, see Jasanoff, supra, at 232.

Indeed, no rational regulator would forbear from protecting

any population—or any individual—from even a health effect

of moderate severity, no matter the certainty of the evidence,

if the cost of doing so were comparatively trivial. Breyer,

supra, at 65; Cass R. Sunstein, /s The Clean Air Act

Unconstitutional? , 98 Mich. L. Rev. 303, 308 (1999). Thus,

in setting NAAQS at a certain level of protection above zero

(achievable) risk, the Administrator has necessarily

determined (without saying) that additional protections are

not worth it.

The Government will no doubt claim in reply that broad-

ening the factors EPA may consider to include costs

necessarily expands its discretion, and thus heightens any

nondelegation problems. That is not so, and this Court

directly rejected such an argument in the NBC case, where it

refused to narrow the Federal Communications Commission’s

authority under the “public interest” standard to the con-

sideration of “technological objections to the granting of a

license.” 319 U.S. at 216. Such factors, the Court held,

would be indeterminate in the context of radio regulation,

given the evident purposes of the Communications Act of

benefiting the public at large: “If the criterion of ‘public

interest’ were limited to such matters, how could the

Commission choose between two applicants for the same

facilities, each of whom is financially and technically

qualified to operate a station?” /d. at 216-17.

24

The same is true here; just as withdrawing relevant factors

from the FCC's consideration would thwart protection of

“public interest,” so too would withdrawing consideration of

costs and other regulatory effects of a NAAQS unduly limit

the Administrator in achieving her mandate of protecting the

public health.'® Permitting the Administrator to consider

costs does not increase her discretion; it simply prevents

arbitrariness, and administrative charades, in selecting among

alternative standards, and tethers her decisionmaking to

statutory purposes, which is the overriding purpose of the

nondelegation doctrine. And it promotes the accountability

that is the animating reason for the nondelegation doctrine,

see Loving, 517 U.S. at 757-58, by permitting meaningful

judicial, congressional and public scrutiny of these enorm-

ously important administrative decisions.

By identifying indeterminate decisional factors as the only

limits on its authority, EPA has arrogated to itself the

arbitrary power to drive health risks all the way down to zero,

' Because “requisite to protect the public health” is the ultimate

statutory standard, we emphasize that cost-effectiveness is not a strait-

jacket, and does not demand that the Administrator set the NAAQS at the

precise point where benefits exceed costs. As the Government rightly

contends, the nondelegation doctrine does not require quantitative “rules

of thumb,” American Power & Light, 329 U.S. at 106, and “|t}he

difficulty or impossibility of drawing a statutory line is one of the reasons

for supplying merely a statutory guide.” Sunshine Anthracite Coal, 310

U.S. at 399-400. Cost-effectiveness is a decisional principle that can be

weighed against the extent and uncertainty of health risks to ensure

administrative judgment that rationally protects public health, and that

would then be reviewable by courts under the arbitrary and capricious

standard. It is a more flexible standard than other possible constraining

principles: e.g., a mandate for the Administrator to reduce health risks to

the level of technological or economic feasibility. Here, the Administrator

has the latitude to go beyond feasibility constraints if the public health

benefits warrant, see Union Electric Co. v. EPA, 427 U.S. 246, 257 (1976)

(discussing technology-forcing character of Act), or to stop short of

feasibility if the anticipated health benefits are not worth the cost.

25

even if that would bring the entire economy to its knees. In

charging EPA with setting standards “requisite to protect the

public health,” Congress cannot be presumed to have given

EPA the unfettered power to impose mandates that may be

wholly inimical to the public interest.'’

Thus, just as this Court in /owa Utilities Board interpreted

the local competition provisions of the Telecommunications

Act of 1996 to “requir[e] the [FCC] to determine on a rational

basis which network elements must be made available [to

competitors], taking into account the objectives of the Act,”

525 U.S. at 391-92, so too this Court should interpret section

109 to require EPA to determine on a rational basis which

populations will be protected in setting NAAQS. Because the

allocation of public health protections in managing risks is, in

the face of scientific uncertainty, a socioeconomic and

political decision, the consideration of economic factors must

play some part in any rational decisionmaking by EPA. Lead

'’ This Court has recognized that the resources of American society for

achieving important social objectives “are limited, and therefore precious;

they cannot be left to wasteful use without detriment to the public

interest.” NBC, 319 U.S. at 216, 217. Finite resources are an inescapable

fact of environmental regulation, just as they are in the field of health

care, where priority-setting is inevitable. See, e.g., Leonard M. Fleck, Just

Health Care Rationing: A Democratic Decisionmaking Approach, 140 U.

Pa. L. Rev. 1597 (1992). The aggregate (i.e., “political”) level of

expenditures American citizens, governments, and businesses make

available toward public health is a precious resource. Accordingly,

“comparative considerations as to the [benefits] to be rendered,” NBC,

319 U.S. at 217 (emphasis added), must govern here. EPA thus sheds a

crucial limit on its administrative power by failing to compare the

significance of health risks—as in /ndustrial Union—and the relative

“wasteful[ness|” of regulatory options—as in NBC. The President un-

derstood this in issuing the cost limitations on implementation of the

NAAQS, but his effort to effect a cure was neither timely nor legally

sufficient. Hatch-Bliley Br. 27-30. EPA had to apply the requisite

limiting principles when it set the NAAQS.

26

Industries, by excluding such considerations, offers in their

place nothing but radical indeterminacy and unconstrained

discretion on the part of the Administrator.

C. The Arbitrariness Of The Lead Industries Rule

Is Evident In The PM And Ozone Rule-

makings.

The incoherence of the decisional factors that the Govern-

ment claims are “intelligible principles” is manifest in the PM

and ozone rulemakings. This incoherence is not the product

of the Administrator's abuse of a prope. discretion, but of a

statutory misconstruction of the Act that yields no standards

rationally related to the statutory task of setting NAAQS.

1. PM Rulemaking

In the PM rulemaking, the Administrator applied the

decisional factors and purported to have set the PM)

standard by relying on studies with “statistical significance to

the 95% confidence level.” U.S. Br. 32. According to the

Government, the Administrator picked the lowest concen-

tration at which an epidemiological study showed a statist-

ically significant correlation between PM and an adverse

health effect, and added a margin of safety. /d. at 32-33.

If this were so, it would be about as arbitrary an approach

to multibillion-dollar decisions regarding the public health as

could be imagined. As an initial matter, it is at least ironic

that EPA is trumpeting statistical significance as the dis-

positive factor even as it is criticized for downplaying that

factor in other risk-management contexts. See Michael

Gough & Steven Milloy, EPA’s Cancer Risk Guidelines:

Guidance To Nowhere, Cato Policy Analysis No. 263 (Nov.

12, 1996), available at http://www.cato.org/pubs/pas/pa-

263.html. Furthermore, even if lack of statistical significance

27

may be reasonable grounds for rejecting a study,'* it by no

means follows that statistical significance can reasonably be

the principal basis for regulatory action. First, statistical

significance indicates that the results are not the product of

chance, but it does not measure “the extent or importance of a

difference” detected by the study or “the strength or impor-

lance of an association” between two variables (e.g., a

pollutant exposure and a health effect). David H. Kaye &

David A. Freedman, Reference Guide on Statistics, in Federal

Judicial Ctr., Reference Manual on Scientific Evidence 331,

378-79 (1994). Second, statistical significance (which is

often simply a function of sample size, id. at 379) assumes

the validity of the study design and the randomness of the

sampling, among other factors; worthless studies may

generate statistically significant results. USGS Site, supra, at

|, 3-4. Finally, EPA’s reliance on this single factor is absurd

given its overall conclusion that the scientific evidence on

PM is rife with “significant uncertainties,” PM Rule, 62 Fed.

Reg. at 38,655— including the fundamental uncertainty as to

whether particles of a certain size are causing any health

effects, or whether those detected result instead from other

factors (such as a specific chemical agent). See Br. for Cross-

Pet’rs at 13-15. No regulator worth her salt would make

decisions on this basis, and it is doubtful the Administrator

did so here. This is more likely yet another science

charade—the invocation of technical jargon to support a

decision made on other, undisclosed factors.'”

'* But cf. Douglas H. Johnson, The Insignificance of Statistical

Significance Testing, 63 J. of Wildlife Mgmt. 763 (1999), available

at hitp://www.npwrc.usgs.gov/resource/1999/statsig/stathyp.him (“USGS

Site”) (discussing longstanding controversy among scientists over whether

Statistical significance has any utility in scientific research).

'’ It is noteworthy that EPA disregards good science when it conflicts

with the agency's preferred policy, see Chlorine Chemistry Council v.

EPA, 206 F.3d 1286, 1291 (D.C. Cir. 2000) (criticizing “EPA's disregard

of its own scientific findings”); Chemical Manufacturers Ass'n v. EPA, 28

28

2. Ozone Rulemaking

The Government defends the ozone rulemaking with the

ipse dixit that EPA “identified important and meaningful

differences in the character of the scientific evidence regard-

ing risks,” U.S. Br. 33, but it is clear that EPA engaged in

arbitrary linedrawing. For ozone, the evidence indicated that

41,000 children in nine urban areas would suffer moderate or

severe pain on deep inspiration once or more per year at a

concentration of .09 parts per million (“ppm”); 27,000

children would at the new NAAQS of .08 ppm; 22,000 would

at .O8 ppm with a slightly lower average daily maximum, and

approximately 9,000 would at .07 ppm. Similarly, 97,000

children would suffer large lung-function decreases of at least

20% at .09 ppm; 58,000 at the new NAAQS of .08 ppm;

43,000 at .08 ppm with a slightly lower average daily

maximum; and approximately 12,000 at .07 ppm.””

F.3d 1259, 1266 (D.C. Cir. 1994) (criticizing EPA’s scientific * ‘let-them-

eat-cake’ attitude” to the public it serves); Flue-Cured Tobacco

Cooperative Stabilization Corp. v. EPA, 4 F. Supp. 2d 435, 456, 460

(M.D.N.C. 1998) (criticizing EPA for cherry-picking data and altering

methodology to achieve statistical significance), but happily relies on bad

science that may support favored policy outcomes. See a/so Phillip K.

Howard, The Death of Common Sense 7 (1994) (noting instance where

EPA set a rule that maximized cost without any corresponding benefit,

and the counterproductive results of such regulation).

” Ozone Rule, 62 Fed. Reg. at 38,865; R.G. Whitfield, A Probabilistic

Assessment of Health Risks Associated With Short-Term Exposures to

Tropospheric Ozone: A Supplement 21-22 (Jan. 1997) (6 Ozone JA 2325,

2352-53) (prepared for EPA); National Ambient Air Quality Standards for

Ozone; Proposed Decision, 61 Fed. Reg. 65,716, 65,725 (1996) (0.07

ppm). The figures used for the .08 and .09 ppm standards are drawn from

EPA's final rule, which did not repeat the risk analysis for the 0.07 ppm

alternative standard that was included in the proposed rule. While the

original and final risk assessments used slightly different methodologies,

they show roughly similar disparities in health effects. See 61 Fed. Reg.

at 65,725.

29

On what basis did EPA decide to provide protection from

severe pain on inspiration to an incremental 14,000 children

by setting the NAAQS at 0.08 ppm, but not to another 18,000

by setting it one notch lower at 0.07 ppm? Why did EPA

protect an incremental 39,000 (but not an additional 46,000)

children from large lung-function decreases? EPA’s deci-

sional factors do not supply a standard—these are the same

populations suffering the same health effects, estimated from

the same data and models, with the same uncertainty for any

concentration. The only rational, moral, and democratic rea-

son why EPA would draw a line at .08 ppm and deny

improved health to many thousands of people is that the

massive expenditure of national resources required to drive

ozone concentrations that low would be counterproductive for

the overall health of the public.

Congress fully intended for the Administrator to consider

the cost-effectiveness of alternative standards in the face of

scientific uncertainty. “The language of the Act does not

withdraw such a [consideration] from the Administrator’s

judgment, “and there is no evidence that Congress did not

mean its broad language to carry the authority it expresses.”

NBC, 319 U.S. at 218. As the court below acknowledged,

Pet. App. 15a, cost-effectiveness of a precautionary standard

is an intelligible principle where the scientific evidence is

indeterminate—indeed, it is the generally accepted principle

of risk management and line-drawing in the face of scientific

uncertainty. See Hatch/Bliley Br. 7-8. Moreover, it is a

principle which the judiciary can enforce to determine

whether congressional will has been obeyed, Yakus, 321 U.S.

at 426, and such considerations must be out in the open for

the judiciary to determine whether the Administrator has

substantially complied with the statute.”'

*! Judicial review is an indispensable concomitant of broad delegations

by Congress, see American Power & Light, 329 U.S. at 105, and

necessary to the proper implementation of the Clean Air Act. Contrary to

30

Lead Industries offends nondelegation principles; it gives

EPA arbitrary unilateral power to overhaul the nation’s

environmental policy, and transform the nation’s economy

dramatically, without a congressional mandate or scientific

imperative to do so. This Court should construe section 109

to permit the Administrator to consider the cost-effectiveness

of alternative air-quality standards,” and this Court should

adopt that interpretation to avoid serious questions about the

statute’s constitutionality.

CONCLUSION

On the grounds set forth above, the judgment below should

be affirmed.

the Government's contentions, U.S. Br. 27, judicial review is more

important, not less, when the agency engages in regulatory science. The

principle of deference to agency scientific decisions established in

Baltimore Gas & Electric v. NRDC, 462 U.S. 87, 103 (1983), is not to the

contrary; it simply means that the court cannot substitute its judgment for

that of the agency. Courts nonetheless still have an important role to

ensure reliable regulatory science, similar to the gatekeeping function of

trial courts recognized in Daubert v. Merrell Dow Pharmaceuticals, Inc.,

509 U.S. 579 (1993). Here, if Lead Industries is set aside, a reviewing

court could prevent EPA from withholding its scientific assumptions,

papering over scientific uncertainties, and failing to consider all “the

relevant factors.” Motor Vehicle Mfrs. Ass'n of United States, Inc. v.

State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42 (1983). Courts must be

vigilant in unmasking science charades, wherein an agency dresses its

unadorned policy choices in scientific garb.

* It is the function of this Court, not EPA, to interpret the statute to

define intelligible principles. Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837

(1984), is inapposite to nondelegation issues. Chevron is premised on

congressional intent to delegate rulemaking power to the agency. See

FDA v. Brown & Williamson Tobacco Corp., 120 S. Ct. 1291, 1314

(2000); Chevron, 467 U.S. at 844-45. A delegated power cannot be

invoked to supply the principles that make the very delegation

constitutionally permissible. The Constitution requires that the limiting

principle must come from the statute itself, as construed by the judiciary.

Respectfully submitted,

LLOYD N. CUTLER CARTER G. PHILLIPS

C. BOYDEN GRAY ALAN CHARLES RAUL *

WILMER, CUTLER & PICKERING STEPHEN B. KINNAIRD

2445 M Street, N.W. SIDLEY & AUSTIN

Washington, D.C 20037 1722 Eye Street, N.W.

(202) 663-6000 Washington, D.C. 20006

(202) 736-8000

Counsel for Amici Curiae

September 11, 2000 * Counsel of Record