Reply Brief — Mallinckrodt, Inc. v. Maine People's Alliance (No. 06-1540)

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FILED

JUL 2- 2007

— OFFICE

OF THE CLERK

No. 06-1540 LU SUPREME COURT, U.S.

IN THE

Supreme Court of the United States

MALLINCKRODT INC.

Petitioner,

MAINE PEOPLE’S ALLIANCE AND NATURAL RESOURCES

DEFENSE COUNCIL, INC.

Respondents.

On Petition for a Writ of Certiorari

to the United States Court of Appeals

for the First Circuit

REPLY BRIEF OF PETITIONER

J. ANDREW SCHLICKMAN CARTER G. PHILLIPS*

JOHN M. HEYDE JOSEPH R. GUERRA

SIDLEY AUSTIN LLP NORINA |. EDELMAN

One South Dearborn SIDLEY AUSTIN LLP

Chicago, IL 60603 1501 K Street, N.W.

(312) 853-7000 Washington, D.C. 20005

(202) 736-8000

Counsel for Petitioner

July 2, 2007 * Counsel of Record

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WILSON-EPES PRINTING Co., INC. — (202) 789-0096 — WASHINGTON, D.C. 20002

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TABLE OF CONTENTS

Page

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TABLE OF AUTHORITIES

CASES Page

Acme Printing Ink Co. v. Menard, Inc., 812 F.

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Cox v. City of Dallas, 256 F.3d 281 (Sth Cir.

SD hidiiicsihie alagibid plnnstisclacecptpntadne ene 9

Dague v. City of Burlington, 935 F.2d 1343 (2d

Cir. 1991), rev'd in part on other grounds by

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Duke Power Co. v. Carolina Envt'l Study Group,

FE Re Ts GAO OF Pe as ists so ecadinchccsancbniouabiakistaise 3,4

Friends of the Earth, Inc. v. Laidlaw Envt'l

Servs.(TOC), Inc., 528 U.S. 167 (2000) .............. l

Interfaith Cmty. Org. v. Honeywell Int'l, Inc.. 399

F.3d 248 (3d Cir.), cert. denied. 545 U.S. 1129

I ais eetaaainicteds acntaeiiocaben cae ae 1, 2,9

LaFleur v. Whitman, 300 F.3d 256 (2d Cir.

ME isla cids Minidhcgabiba iced dada ccshcices causinatiomilopatstenkauce 2

Parker v. Scrap Metal Processors, Inc., 386 F.3d

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STATUTES

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REPLY BRIEF OF PETITIONER

Respondents do not, because they cannot, refute

petitioner’s showing that the decision below raises two

fundamentally important issues of federal law. The First

Circuit ruled that federal courts can determine that an

increased risk of potential harm is societally unacceptable,

then use that quintessentially legislative judgment as the

predicate for an exercise of judicial power under Article III.

The lower court also adopted a concededly ““sweeping’” and

“expansive reading” of § 7002(a)(1)(B) of the Resource

Conservation Recovery Act (RCRA), Pet. App. 18a, 31a, that

permits private citizens to second guess and override policy-

based risk assessments of the Environmental Protection

Agency (EPA). Respondents’ lengthy defense of these

rulings serves only to confirm the need for this Court’s

review.

1. As petitioner has explained, this case raises a question of

standing that this Court has not previously resolved: whether

a non-de minimis risk of future harm is a cognizable injury-in-

fact, when no expert and politically accountable agency has

deemed that risk unacceptable, and plaintiffs are not suing

under a statute that provides a right to judicial review of an

agency’s failure or refusal to address that risk. Respondents

deem it “radical” to challenge a finding of standing that is

based on risks of future harms outside these two recognized ©

categories of case. Opp’n 3. But the very cases they cite

simply underscore the deviant nature of the lower court’s

standing determination.

Respondents rely heavily on the decision in Friends of the

Earth, Inc. v. Laidlaw Environmental Services (TOC), Inc.,

528 U.S. 167 (2000). See Opp’n 5-6. But, in that case, the

Court found plaintiffs’ concerns reasonable given the

defendant’s “continuous and pervasive illegal discharges of

pollutants.” 528 U.S. at 184 (emphasis added). The Third

Circuit’s decision in Interfaith Community Organization v.

Honeywell International, Inc., 399 F.3d 248 (3d Cir.), cert

denied, 545 U.S. 1129 (2005), is similarly unhelpful, as the

court concluded that the discharge of one of the most toxic

carcinogens was illegal. Jd. at 252-53 & n.1, 255-56. These

cases simply illustrate that a risk of future harm is a

cognizable injury when a politically accountable body has

deemed that risk unacceptable. Because the First Circuit

found injury-in-fact in the absence of such a determination, its

decision represents an expansion of standing doctrine.’

Respondents’ reliance on LaFleur v. Whitman, 300 F.3d

256 (2d Cir. 2002), is likewise misplaced. That case involved

a challenge to agency action under the Administrative

Procedure Act, and standing was in part based upon a

procedural injury. /d. at 270-71. LaFleur thus illustrates the

second category of cases in which standing has been found

based on increased risks of future harm.

Unable to show that the finding of standing here fits within

either of these heretofore recognized categories of cases,

respondents misstate petitioner’s position, asserting that

petitioner sceks a ruling that “courts are powerless to find

injury-in-fact except as defined by a ‘politically accountable

entity.” Opp’n 3, 13. There are numerous injuries, however,

that suffice under Article III in the absence of agency action,

such as illness or actual environmental harm. The question

here is when can an increased risk of future, potential harm

suffice to satisfy Article II]. There are undoubtedly some

situations where a risk of potential future harm is so likely

' Recognizing this, respondents misleadingly claim that the district

court considered evidence from politically accountable agencies in finding

injury. Opp’n 12 n.8. But the state and federal officials did not testify

that the risk of potential harm at issue here was unacceptable. To the

contrary, they believed the media protection standards they ordered

protected the public health. Similarly, the district court did not rely on

evidence of sedimentary mercury in excess of National Oceanic and

Atmospheric Administration guidelines because the guidelines had a low

accuracy in predicting adverse effects of mercury. Pet. App. 55a n.13.

and/or so grave that it constitutes a cognizable injury. But it

is neither “radical,” nor a “‘no-holds-barred assault on the

federal’” judiciary, id. at 3, to argue that where, as in this

case, a finding of standing rests on a policy-laden judgment

that an increased risk of potential future harm may be

societally unacceptable, federal courts are improperly making

what are essentially legislative judgments to justify the

exercise of judicial power under Article III.

Respondents assert that courts are in fact competent to

make such policy judgments, id. at 3-7, 12-15, noting that

courts have the “traditional equitable authority” to address

risks in imminent and substantial endangerment cases. /d. at

6-7. But respondents have it exactly backwards. Standing

has nothing to do with a court’s equitable powers, but instead

determines whether the court has the constitutional authority

to exercise its equitable powers at all. Whether federal

jurisdiction exists is a threshold question, one that must be

answered before a court can engage the gears of equity.

Even more critically, courts are not, in actuality, competent

to make general determinations about societally acceptable

levels of risk absert guidance from an expert and politically

accountable agency. Such determinations do not turn on

factfinding, as respondents suggest. Rather, they are

fundamental policy choices, squarely within the province of

the political branches. Respondents would have this Court

disregard the significant case law cited in the petition, Pet. 15

& n.3, because the cases do not specifically address standing.

Opp’n 10 & n.6. But this is beside the point. The cases stand

for the principle that deciding when a non-grave risk is

societally acceptable falls outside the institutional competence

of the courts, which precisely supports the limitation of

Article III advanced by petitioner.

None of the cases respondents cite supports the idea that

courts can engage in such risk assessments to determine

standing. In Duke Power Co. v. Carolina Envii. amental

Study Group, Inc., 438 U.S. 59 (1978), this Court expressly

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declined to base standing on “present apprehension generated

by . . . future uncertainty,” finding that it “need not

determine” whether that injury was “sufficiently concrete to

satisfy constitutional requirements.” Jd. at 73. The Court

ultimately based standing on “environmental and aesthetic

consequences of the thermal pollution of the two lakes in the

vicinity of the disputed power plants” as well as the emission

of non-natural radiation into the environment. /d. at 73-74.”

This holding does not advance respondents’ cause, but

granting the petition here will allow the Court to decide the

issue it left open in Duke Power.

Respondents also argue that Congress authorized courts to

make the risk assessment required by the First Circuit’s inter-

pretation of standing. Opp’n 7-12. This argument, however,

simply begs the question of the scope of RCRA’s citizen-suit

provision. As petitioner explained, § 7002(a)(1)(B) does not

define a statutory injury so broadly as to sweep in all potential

risks of future harm except those that can be dismissed as not

serious.

In short, respondents have failed to refute petitioner’s

showing that the First Circuit has expanded standing doctrine

beyond any category previously recognized by this Court, and

that this expansion raises a profoundly important question

concerning the limits of judicial authority under Article II].

To the contrary, respondents’ defense of that ruling simply

underscores the importance of the issue, and the necessity of

review by this Court.

* The Court did find that the emission of non-natural radiation was a

present injury given “our generalized concem about exposure to radiation

and the apprehension flowing from the uncertainty about the health and

genetic consequences of even small emissions like those concededly

emitted by nuclear power plants.” Duke Power Co., 438 U.S. at 74. As

noted above, however, the Court declined to rest standing on this ground

alone.

2. Respondents likewise do not seriously dispute that the

lower courts’ “‘sweeping’” and “expansive reading” of

§ 7002(a)(1)(B), Pet. App. 18a, 31a, raises fundamentally

important questions concerning the role of private citizens in

enforcing federal environmental laws. Respondents admit

that, “among environmental statutes that provide for an

agency-implemented regulatory scheme,” RCRA is “[a]lone”

in permitting citizen suits “independent of agency-imposed

requirements.” Opp’n 7. And a broad interpretation of this

unique cause of action permits private citizens to second

guess policy-based risk assessments: in this case, EPA

ordered a downriver study and media protection standards it

deemed sufficient to prevent undue health and environmental

risks, but the lower courts’ lax liability standard allowed

respondents to override this policy judgment and compel a

multi-million dollar study to determine whether downriver

mercury “[iJs . . . posing an unacceptable risk.” JA0274-

0275. |

Unable to dispute the importance of a_ statutory

interpretation that affords private citizens such co-equal

policy-making authority, respondents argue at length that

Congress intended this extraordinary result.. The text,

structure and history of the statute, however, refute that claim.

As petitioner has shown, a lenient liability standard renders

§ 7002(a)’s bifurcation of citizen suits meaningless, allowing

citizens to enjoin (1) all risks EPA deems unacceptable and

(2) all other non-de minimis risks. Pet. 20-21. The First

Circuit conceded this anomaly, but dismissed it as the product

of congressional oversight. Pet. App. 26a-27a. Because

cardinal rules of interpretation do not permit such cavalier

acceptance of statutory redundancy, Pet. 21, respondents do

not defend this reasoning. But their alternative rationale fares

no better. They note that subsection (a)(1)(B) requires

“independent evidence of potential endangerment” while

subsection (a)(1)(A) does not, and that different government

actions bar suit under these provisions. Opp’n 23-24.°

Differences in evidentiary standards or suit-precluding

activities, however, do not eliminate the total redundancy in

the substantive scope of two distinct provisions that the

decision below produces: under the lower courts’ lenient

liability standard, subsection (a)(1)(B) provides a remedy for

all potential risks covered by subsection (a)(1)(A)—as well as

other risks. Indeed, respondents ultimately admit this. See id.

at 21 (“Congress conferred ‘imminent and_ substantial

endangerment’ authority to ensure complete protection

against threats from dangerous wastes, irrespective of other

remedies” in RCRA).

By contrast, giving “imminent and __ substantial

endangerment” its naturally restrictive meaning avoids this

redundancy. Subsection (a)(1)(B) prevents likely threats of

grave harm that are not otherwise governed by permits or

other regulatory measures. It thus serves as a limited adjunct

to the permitting regime. So construed, it does not allow

second-guessing of EPA risk assessments. EPA cannot,

consistent with its statutory duties, conclude that a likely risk

of grave harm is “acceptable.” If citizens can sue only to

prevent such risks, therefore, they will not override EPA

judgments that a particular risk is societally acceptable, but

will instead properly supplement EPA’s enforcement

authority, by addressing an unacceptable risk that the agency

has failed, for whatever reason, to address.‘

* A district court conclusion that civil penalties are not available under

§ 7002(a)(1)(B), Opp’n 24, is not evidence that the remedial scope of the

two subsections differs.

* Such supplementation accords with the legislative history respondents

quote, Opp’n 18. That history shows only that Congress thought EPA was

not enforcing its standards, not that EPA’s standards permitted undue risks

to health and safety. And while this construction requires courts to assess

some risks without EPA guidance, id. at 17, they would do so in far more

limited circumstances than under the lenient liability standard, which

Nor can RCRA’s hierarchy of risk standards and associated

remedies be dismissed as a “chimerical construct.” Opp’n 19.

Respondents claim that an “imminent and_ substantial

endangerment” is not necessarily the most significant risk,

because courts have discretion to respond with something

other than immediate injunctive relief. Jd. at 20. But the

critical fact is that only an “imminent and substantial

endangerment” can justify injunctive relief, whereas a

“substantial potential risk” and “substantial hazard” cannot.

These latter two standards, therefore, must specify risks less

significant than an “imminent and substantial endangerment.”

But, under the lower courts’ interpretation, only risks that are

not “serious,” or give rise to unreasonable medical concerns,

are less significant than those embraced by § 7002(a)(1)(B).

Respondents attempt to justify this textual absurdity by

arguing that Congress considered “a study to determine

appropriate remediation (well short of ‘immediate preventive

action” . . .) as a suitable response” to an imminent and -

substantial endangerment. Jd. at 21 (quoting Pet. 18). But

the provision they cite bars suits only if EPA requires a

remediation study “and is diligently proceeding with a

remedial action under” the Comprehensive Environmental

Response, Compensation and Liability Act. 42 U.S.C.

§ 6972(b)(2)(B)(iii) (emphasis added). See also Acme

Printing Ink Co. v. Menard, Inc., 812 F. Supp. 1498 (E.D.

Wis. 1992) (initiation of study does not bar citizen suit). A

“remedial action” is a “permanent remedy taken instead of or

in addition to removal actions . . . to prevent or minimize the

release of hazardous substances so that they do not migrate or

cause substantial danger.” 42 U.S.C. § 9601(24). Such an

EPA action thus involves the same type of actual remediation

as the other agency activities that bar suit under

§ 7002(a)(1)(B), ie., diligent prosecution of an injunctive

action under § 7003, a CERCLA removal action, or issuance

compels courts io make “medical and scientific conclusions that ‘clearly

lie on the frontiers of scientific knowledge.’” Pet. App. 53a.

; baie

ty,

of an administrative or court order compelling a removal

action. /d. § 6972(b)(2)(B\(i), (ii) & (iv).

The fact that a suit under § 7002(a)(1)(B) can be barred

only by permanent remedies—not the studies or monitoring

that a “substantial potential risk” or “substantial hazard”

trigger—confirms that RCRA does set forth a graduated scale

of risks and responses. The lower courts’ interpretation of an

imminent and substantial endangerment, however, affords no

rational, independent meaning to the statute’s two lesser risk

standards. Contrary to respondents’ claim, neither the phrase

“may present” nor the legislative history justifies this result.

By changing the phrase “may present” to “is presenting,”

Congress authorized relief based on potential, not just actual,

endangerments. But that phrase does not also reduce the

degree of the potential endangerment itself. Thus, the phrase

“js presenting an imminent and substantial endangerment”

meant an actual and very significant threat; the phrase “may

present an imminent and substantial endangerment,” in turn,

means a potential and very significant threat, not all potential

threats except non-serious ones that cause only unreasonable

medical concerns, as the courts below held.

Nor can the sentence from a Senate Report that respondents

and the First Circuit repeatedly quote, see Opp’n 2, 8, 16, 26;

Pet. App. 16a, 29a, bear the weight that they place on it.

Congress could have authorized relief whenever hazardous or

solid wastes “may present any risk.” The statute, however,

refers instead to an “imminent and substantial endangerment.”

The stringent meaning of this very different language cannot

be ignored based on an unenacted sentence in a Senate

Report, particularly where, as petitioner has shown, RCRA’s

hierarchy of risks and bifurcation of citizen suits confirm that

the enacted language is not a mere synonym for the

sweepingly broad phrase “any risk.”

In short, the language, structure and history of the statute do

not justify—and indeed, affirmatively refute—the lower

courts’ view that § 7002(a)(1)(B) authorizes private citizens

to second guess EPA risk analyses. They likewise refute the

lower court’s conclusion that the phrase “an imminent and

substantial endangerment” empowers federal courts to

undertake the same policy-laden risk: assessments that

Congress entrusted to an expert and politically accountable

agency through numerous detailed and far more explicit

grants of statutory authority. See Pet. 17. The extraordinary

ramifications of the First Circuit’s contrary conclusions are

themselves sufficient to warrant review of the decision below.

Contrary to respondents’ blithe assurances, moreover, the

First Circuit’s decision is more than a_ run-of-the-mill

application of a well-settled standard. Prior cases involved

violations of state or federal standards, /nterfaith Cmty. Org.,

399 F.3d at 259-61 (violations of state standards); Cox v. City

of Dallas, 256 F.3d 281, 300 (Sth Cir. 2001) (benzene levels

in excess of state standards in a dump accessible to children);

Parker v. Scrap Metal Processors, Inc., 386 F.3d 993, 1002

(11th Cir. 2004) (“PCB and lead levels above the legal

limits”); or evidence of current environmental harms, id. at

1015 (trees killed); Dague v. City of Burlington, 935 F.2d

1343, 1357-58 (2d Cir. 1991), rev'd in part on other grounds

by 505 U.S. 557 (1992) (leachate from landfill toxic to

aquatic life). The decision in this case makes clear for the

first time that the impermissibly expansive reading of

§ 7002(a)(1)(B) permits a finding of liability even where a

multi-year, multi-million dollar study is necessary to

determine whether wastes pose any unacceptable risk, and

where the plaintiffs’ own expert is unsure whether the wastes

pose any problem at all.

The impact of such an extraordinary ruling will not be lost

on plaintiffs, and the resulting costs on industry will be

significant. Properly construed, RCRA does not compel

businesses “to internalize the costs of” studies to determine

whether decades-old wastes pose an unacceptable threat to

human health or the environment. Opp’n 28. The financial

and competitive impacts of the First Circuit’s erroneous

construction simply underscore that this profoundly important

question of federal law should be resolved by this Court.

CONCLUSION

For the foregoing reasons, and those stated in the petition,

the petition for a writ of certiorari should be granted.

Respectfully submitted,