Appendix — Dow AgroSciences LLC v. Sleath

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APPENDIX A — OPINION OF THE SUPREME COURT

OF THE STATE OF MONTANA DATED, DECIDED

AND FILED DECEMBER 28, 2000

No. 99-185

IN THE SUPREME COURT OF THE

STATE OF MONTANA

2000 MT 381

LIBBY SLEATH, MARY ANN HAYES, GLENDA

TRUESDELL, and MARY OWEN,

Plaintiffs/Appellants,

Vv.

WEST MONT HOME HEALTH SERVICES, INC., WEST

MONT HOME MANAGEMENT SERVICES, INC., ORKIN

EXTERMINATION COMPANY, INC., and EP CO., INC.,

and ROFAN SERVICES, INC., d/b/a DOWELANCO,

Defendants/Respondents.

APPEAL FROM: District Court of the First Judicial District,

In and for the County of Lewis and Clark,

The Honorable Jeffrey M. Sherlock, Judge

presiding.

* * *

Heard January 11, 2000

Submitted February 15, 2000

Decided December 28, 2000

* * *

Appendix A

Justice James C. Nelson delivered the Opinion of the Court.

41 Appellants Libby Sleath, Mary Ann Hayes, Glenda

Truesdell, and Mary Owen brought this personal injury action

against Respondents West Mont Home Health Services, Inc.

and West Mont Home Management Services, Inc. (collectively

referred to as “West Mont”); Orkin Extermination Company,

Inc. (Orkin); and Ep Co., Inc. and Rofan Services, Inc.

d/b/a DowElanco (collectively referred to as “DowElanco”),

for injuries Appellants allegedly suffered when Orkin applied

a pesticide manufactured by DowElanco at the West Mont

building where plaintiffs worked. The District Court for the

First Judicial District, Lewis and Clark County, granted

summary judgment in favor of DowElanco on the basis that

Appellants’ claims are preempted by the Federal Insecticide,

Fungicide and Rodenticide Act (FIFRA). We reverse and

remand for further proceedings consistent with this opinion.

{2 Appellants present the following issues for review:

93 1. Whether Appellants’ failure to warn claims, pleaded

in negligence, strict liability, and breach of express warranty,

are preempted by FIFRA because they are based upon or

implicate the pesticide’s labels.

94 2. Whether the failure to warn claims in Appellants’

negligence and strict liability theories of liability are

preempted by FIFRA when Appellants were not purchasers

or users of the pesticide and were, instead, unwitting

bystanders who never saw the pesticide’s labels and who

suffered injury from the use of the pesticide by others.

Appendix A

45 3. Whether Appellants’ strict liability for design defect

theory of liability is preempted by FIFRA.

{6 Because we conclude that Issue 1 is dispositive, we do

not address Issues 2 and 3.

Factual and Procedural Background

{7 Appellants worked in a building in Helena owned by their

employer, West Mont. Sometime in 1991, West Mont ordered

that all windows in the building be closed and that the

operating cranks for the windows be removed, thereby

preventing fresh air ventilation of the building. Between 1991

and 1994, Orkin applied various pesticides, collectively

referred to here as Dursban, to the interior of the West Mont

building every three to six weeks without prior or subsequent

warnings to Appellants. These pesticides were manufactured

and sold by DowElanco.

48 Each of the Appellants began suffering from various

physical ailments and were forced to leave their employment

on advice of their physicians. Appellant Hayes worked in

the West Mont building until June 28, 1993; Appellant Owen

worked until July 12, 1993; Appellant Truesdell worked until

August 24, 1993; and Appellant Sleath worked until May

1994. Appellants first learned that they were routinely

exposed to Dursban in 1995 when they requested information

from West Mont about the pesticide applications. Prior to

1995, Appellants were unaware that they had been exposed

to Dursban.

9 Dursban is DowElanco’s registered trademark for a group

of insecticides developed, manufactured, and marketed by

Appendix A

DowElanco. The active ingredient in each of the Dursban

products is a synthetic chemical compound known as

chlorpyrifos which is one of a group of compounds known

as organophosphates. Organophosphates are synthetic

chemical relatives of the nerve gases used in World Wars I

and II. They are central and peripheral nervous

system poisons that inhibit the action of the enzyme

acetylcholinesterase.

410 Depending on exposure frequency and dosage levels,

the toxicity to the central and peripheral nervous systems

can cause symptoms such as headaches, dizziness, flu-like

malaise, urinary frequency, confusion and difficulties with

memory and concentration. Each of the Appellants exhibits

one or more of these symptoms, all of which are

toxicologically consistent with excessive exposure to

chlorpyrifos as contained in Dursban.

911 Dursban’s labels are registered in accordance with

FIFRA and its implementing regulations. Each of the

Dursban labels relevant to this case contains the following

statement:

DowElanco warrants that this product conforms

to the chemical description on the label and is

reasonably fit for the purposes stated on the label

when used in strict accordance with the directions,

subject to the inherent risks set forth below.

412 DowElanco markets and sells its Dursban products only

to professional applicators, distributors, and formulators.

It does not market or sell Dursban products to the general

Appendix A

public. In fact, Dursban’s labels require that it be applied

by, or under the direction of, commercial applicators.

{13 On January 5, 1996, Appellants filed a complaint against

West Mont, Orkin, and DowElanco. Thereafter, on October

9, 1996, Appellants, with leave of the District Court, filed

their Second Amended Complaint wherein they alleged that

West Mont was negligent for failing to ensure that the

building in which Appellants were working was free from

hazardous chemicals and for failing to warn Appellants and

other employees about the possible health risks of the

pesticides applied in the building. Appellants also alleged

that Orkin negligently and carelessly failed to give warning

or otherwise take steps to ensure that Appellants and others

would not be exposed to the pesticide’s adverse effects.

14 As to DowElanco, the complaint alleged negligent

design and manufacture of Dursban, strict products liability

for the design and manufacture of Dursban, and breach of

express and implied warranties. Moreover, the negligence

and strict liability theories contained allegations that

DowElanco failed to provide adequate warnings about the

dangers of Dursban.

415 During the course of discovery, DowElanco served each

Appellant with an identical set of 15 interrogatories.

Appellants’ answers to these interrogatories were nearly

identical. And, in response to many of these interrogatories,

Appellants referred to Dursban’s labels.

416 On February 24, 1998, DowElanco moved for summary

judgment on the basis that all of Appellants’ claims are

Appendix A

preempted by FIFRA because Appellants’ complaint and

interrogatory answers show that Appellants’ theories of

liability are all based solely upon inclusions in or omissions

from Dursban’s labels. The specific provision in FIFRA to

which DowElanco refers is 7 U.S.C. § 136v(b); which

provides:

(b) Uniformity

Such State shall not impose or continue in

effect any requirements for labeling or packaging

in addition to or different from those required

under this subchapter.

417 Appellants responded to DowElanco’s motion for

summary judgment by redacting their interrogatory answers

to exclude specific references to Dursban’s labels. Appellants

also submitted a supplemental affidavit from Robert K.

Smith, Ph.D., one of Appellants’ proposed expert witnesses,

setting forth his opinion that Dursban is defective and

unreasonably dangerous “in the context of interior workplace

application of those products.”

418 DowElanco moved to strike this supplemental affidavit,

but the District Court denied the motion. The court

determined, however, that even considering the supplemental

affidavit and excluding references to Dursban’s labels in

Appellants’ interrogatory answers, all of Appellants’ claims

are based on Dursban’s labels. Hence, the District Court

concluded that pursuant to this Court’s opinion in McAlpine

v. Rhone-Poulenc Ag. Co. (1997), 285 Mont. 224, 947 P.2d

474, all of Appellants’ claims against DowElanco are

Appendix A

preempted by FIFRA. Accordingly, the District Court

granted summary judgment in favor of DowElanco.

Standard of Review

419 Our standard of review in appeals from summary

judgment rulings is de novo. Oliver v. Stimson Lumber Co.,

1999 MT 328, 9 21, 297 Mont. 336, 9 21, 993 P.2d 11, J 21

(citing Motarie v. N. Mont. Joint Refuse Disposal (1995),

274 Mont. 239, 242, 907 P.2d 154, 156; Mead v. M.S.B.,

Inc. (1994), 264 Mont. 465, 470, 872 P.2d 782, 785). When

we review a district court’s grant of summary judgment, we

apply the same evaluation as the district court based on Rule

56, M.R.Civ.P. Oliver, § 21 (citing Bruner v. Yellowstone

County (1995), 272 Mont. 261, 264, 900 P.2d 901, 903). We

set forth our inquiry in Bruner as follows:

The movant must demonstrate that no genuine

issues of material fact exist. Once this has been

accomplished, the burden then shifts to the non-

moving party to prove, by more than mere denial

and speculation, that a genuine issue does exist.

Having determined that genuine issues of fact do

not exist, the court must then determine whether

the moving party is entitled to judgment as a

matter of law. We review the legal] determinations

made by a district court as to whether the court

erred.

Oliver, ¥ 21 (quoting Bruner, 272 Mont. at 264-65, 900 P.2d

at 903).

Appendix A

420 Moreover, in a summary judgment proceeding, the

evidence must be viewed in the light most favorable to the

nonmoving party, and all reasonable inferences will be drawn

therefrom in favor of the party opposing summary judgment.

Oliver, § 22 (citing Joyce v. Garnaas, 1999 MT 170, 4 8,

295 Mont. 198, J 8, 983 P.2d 369, 4 8). Consequently, we

will view the evidence in the light most favorable to the

Appellants and all reasonable inferences will be drawn in

their favor.

Issue 1.

21 Whether Appellants’ failure to warn claims, pleaded in

negligence, strict liability, and breach of express warranty,

are preempted by FIFRA because they are based upon or

implicate the pesticide’s labels.

422 The United States Constitution provides that “[t]his

Constitution, and the Laws of the United States which shall

be made in Pursuance thereof. . . shall be the supreme Law

of the Land; ... any Thing in the Constitution or Laws of

any State to the Contrary notwithstanding.” U.S. Const. art.

VI, cl. 2. “It is basic to this constitutional command that all

conflicting state provisions be without effect.” Maryland v.

Louisiana (1981), 451 U.S. 725, 746, 101 S.Ct. 2114, 2128-

29, 68 L.Ed.2d 576 (citing McCulloch v. Maryland (1819),

17 U.S. 316, 427, 4 Wheat. 316, 4 L.Ed. 579; Hines v.

Davidowitz (1941), 312 U.S. 52, 61 S.Ct. 399, 85 L.Ed. 581).

423 This preemptive power is not to be found carelessly,

however.

Appendix A

[B]ecause the States are independent sovereigns

in our federal system, we have long presumed that

Congress does not cavalierly pre-empt state-law

causes of action. In all pre-emption cases, and

particularly in those in which Congress has

“legislated ... in a field which the States have

traditionally occupied,” ... we “start with the

assumption that the historic police powers of the

States were not to be superseded by the Federal

Act unless that was the clear and manifest purpose

of Congress.”

Medtronic, Inc. v. Lohr (1996), 518 U.S. 470, 485, 116 S.Ct.

2240, 2250, 135 L.Ed.2d 700 (quoting Rice v. Santa Fe

Elevator Corp. (1947), 331 U.S. 218, 230, 67 S.Ct. 1146,

1152, 91 L.Ed. 1447). See also Cipollone v. Liggett Group,

Inc. (1992), 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120

L.Ed.2d 407. Thus, the purpose of Congress “‘is the ultimate

touchstone” in every preemption case. Medtronic, 518 U.S.

at 485, 116 S.Ct. at 2250 (quoting Retail Clerks v.

Schermerhorn (1963), 375 U.S. 96, 103, 84 S.Ct. 219, 223,

11 L.Ed.2d 179).

{24 Congress’s intent may be “explicitly stated in the

statute’s language or implicitly contained in its structure and

purpose.” Cipollone, 505 U.S. at 516, 112 S.Ct. at 2617

(quoting Jones v. Rath Packing Co. (1977), 430 U.S. 519,

525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604). Furthermore,

[i]n the absence of an express congressional

command, state law is pre-empted if that law

actually conflicts with federal law, or if federal

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Appendix A

law so thoroughly occupies a legislative field as

to make reasonable the inference that Congress

left no room for the States to supplement it.

Cipollone, 505 U.S. at 516, 112 S.Ct. at 2617 (internal

quotations and citations omitted).

425 FIFRA was first enacted by Congress in 1947 to regulate

pesticides. The 1947 Act required pesticide manufacturers

to register pesticides with the Secretary of Agriculture, to

display poison warnings on the labels of highly toxic

pesticides, and to include other warning statements to prevent

injury to people, animals and plants. In 1949, the Secretary

of Agriculture, under the authority of FIFRA, issued

substantial pesticide labeling requirements. In 1970, the

authority for pesticide regulation was transferred to the newly

created Environmental Protection Agency (EPA), which now

administers the pesticide labeling requirements imposed by

the Department of Agriculture.

426 In 1972, Congress enacted sweeping amendments to

FIFRA, largely in response to public concerns over the

health risks of the pesticide DDT. The 1972 amendments

established that the primary purpose of federal pesticide

regulation is the protection of human health and the

environment from the risks posed by pesticides. While

FIFRA had previously regulated pesticides primarily through

labeling requirements, the 1972 amendments established

federal regulation of pesticide use, an area previously

regulated exclusively by the states.

927 The 1972 amendments established a program of federal-

state cooperation in regulating pesticides. Under this

1 acti Sad aban, oe Be

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Appendix A

program, the EPA registers pesticides for a particular use

and approves pesticide labels. In doing so, FIFRA requires

that the EPA must determine whether the pesticide’s

composition is such as to warrant the proposed claims for it;

whether the labeling and other materials comply with FIFRA;

whether the pesticide will perform its intended function

without unreasonable adverse effects on the environment;

and whether the pesticide will have unreasonable adverse

effects on the environment when used in accordance with

widespread and commonly recognized practices. Pursuant

to a 1978 amendment, the EPA does not evaluate pesticide

label claims regarding efficacy or otherwise regulate efficacy

in approving pesticide labels.

28 States retain broad authority to regulate the sale and

use of pesticides. Under 7 U.S.C. § 136v(a), states may

regulate pesticide sales or use more strictly than the federal

government. Under 7 U.S.C. § 136v(c) and its accompanying

regulations, states may register pesticides for local uses in

addition to those approved by the EPA and may impose

supplemental labeling requirements regarding those

additional uses.

29 The term “label” means “the written, printed, or graphic

matter on, or attached to, the pesticide ... or any of its

containers or wrappers.” 7 U.S.C. § 136(p)(1). The term

“labeling” means “all labels and all other written, printed,

or graphic matter — (A) accompanying the pesticide . . . at

any time; or (B) to which reference is made on the label or

in literature accompanying the pesticide... .” 7 U.S.C.

§ 136(p)(2). The EPA has specific regulations concerning

content, placement, type size, and prominence of warnings

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Appendix A

and precautionary statements on a label. See 40 C.F.R.

§ 156.10. The final form of the printed labeling for a pesticide

must be submitted to and accepted by the EPA before

registration. 40 C.F.R. § 156.10(a)(6). Once the EPA

approves a label, the manufacturer may not change it without

the EPA’s approval. Worm v. American Cyanamid Co.

(4th Cir. 1993), 5 F.3d 744, 747.

430 In the case sub judice, Appellants ask this Court to

revisit its decision in McAlpine v. Rhone-Poulenc Ag. Co.

(1997), 285 Mont. 224, 947 P.2d 474, insofar as it holds that

state law claims based on a failure to warn are preempted by

FIFRA to the extent that they expressly or implicitly

challenge the adequacy of the warnings 1n a pesticide’s label.

Appellants maintain that this Court reached its conclusion

in McAlpine by following the decisions holding that the

preemption language of FIFRA should be given the same

effect as the statute governing cigarette advertising that the

United States Supreme Court construed in Cipollone v.

Liggett Group, Inc. (1992), 505 U.S. 504, 112 S.Ct. 2608,

120 L.Ed.2d-407.

431 Appellants present three reasons why we should revisit

our decision in McAlpine. First, Appellants argue that a plain

reading of the parties’ briefs in McAlpine confirms that all

parties to that appeal simply assumed that Cipollone was

controlling on the question of FIFRA’s preemption language

and never examined the validity of that proposition.

432 Second, Appellants point out that none of the parties’

briefs in McAlpine mentioned Medtronic, Inc. v. Lohr (1996),

518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700, wherein the

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Appendix A

Supreme Court stated that the preemption language of the

Medical Device Amendments of 1976 (the MDA), which is

similar to FIFRA’s preemption section, does not preempt

state law failure to warn claims regarding medical devices

even though they are properly labeled pursuant to the MDA.

Medtronic, 518 U.S. at 501-02, 116 S.Ct. at 2258. Appellants

argue that Medtronic demonstrates that when a federal

regulatory statute consistently uses the term “requirement”

to mean positive legislative or administrative enactments,

and there is no indication in the statute’s legislative history

that Congress intended to preempt state common law, the

term “requirements” does not include common law damage

actions.

433 Third, Appellants point out that the United States

Department of Justice, representing the EPA, filed an amicus

curiae brief in Etcheverry v. Tri-Ag Service, Inc. (Cal. 2000),

993 P.2d 366, articulating the Government’s position that

FIFRA does not preempt any state law theories of liability,

including failure to warn claims that implicate pesticide

labels. Appellants argue that the EPA’s view of the scope of

FIFRA’s preemptive effect is entitled to substantial weight

because the EPA is charged by Congress with overseeing

the primary enforcement responsibility of the states under

FIFRA, and thus the EPA is uniquely qualified to determine

whether a particular form of state law should be preempted.

Appellants also argue that the EPA’s brief is a record of the

California Supreme Court within the meaning of Rule

202(b)(6), M.R.Evid., and that this Court may take judicial

notice of it pursuant to Rules 202(d)(2) and (f)(2), M.R.Evid.

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Appendix A

434 DowElanco argues on the other hand, that Congress

expressly stated its intent to preempt state law under FIFRA

when it amended § 136v(b) in 1972 to read:

[A] State shall not impose or continue in effect

any requirements for labeling or packaging in

addition to or different from those required under

this Act.

In addition, DowElanco maintains that Appellants’ argument

that this Court was inadequately advised when it decided

McAlpine has been waived by Appellants’ failure to raise

the argument in the District Court and that, even so,

Appellants’ argument is without merit. DowElanco argues

that the United States Supreme Court’s decision in

Medtronic, wherein the Supreme Court construed a different

statute, does not alter preemption analysis under FIFRA.

Moreover, DowElanco argues that even though Medtronic

was decided nearly two years before Appellants filed their

response to DowElanco’s motion for summary judgment,

Appellants did not make any argument to the District Court

based on Medtronic or even cite to Medtronic in their

response to DowElanco’s motion for summary judgment.

Hence, DowElanco contends that Appellants waived their

Medtronic argument.

935 DowElanco correctly points out that this Court has

repeatedly held that we will not address either an issue raised

for the first time on appeal or a party’s change in legal theory.

Unified Industries, Inc. v. Easley, 1998 MT 145, 4 15, 289

Mont. 255, J 15, 961 P.2d 100, 4 15. However, this Court

has never applied this rule to cases. Indeed, we have decided

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Appendix A

issues based on cases neither side cited. See DeTienne

Associates v. Montana Rail Link, (1993), 261 Mont. 238,

241, 862 P.2d 1106, 1107-08. Medtronic does not raise an

issue for the first time on appeal or raise a new theory of

liability. It simply represents further legal support for the

preemption issue. “In our de novo review of a district court

ruling on summary judgment, we are not bound by the legal

authority presented in the district court.” Thomas v.

Northwestern Nat. Ins. Co., 1998 MT 343, § 22, 292 Mont.

357, | 22, 973 P.2d 804, ¥ 22.

436 DowElanco also objects to Appellants’ contention that

this Court should consider and give deference to the EPA’s

brief in Etcheverry. DowElanco maintains that courts do not

give deference to an agency’s statutory interpretation which

is contrary to the plain language of a statute, as determined

by the courts. DowElanco argues that Appellants have put

the cart before the horse because the initial question is

whether Congressional intent can be ascertained by the

language of the statute and traditional tools of statutory

interpretation. Moreover, DowElanco argues that the rule of

deference to agency statutory interpretations does not apply

to an agency’s litigation position.

{37 In Chevron, U.S.A., Inc. v. Natural Resources Defense

Council, Inc. (1984), 467 U.S. 837, 844, 104 S.Ct. 2778,

2782, 81 L.Ed.2d 694, the United States Supreme Court

stated: “We have long recognized that considerable weight

should be accorded to an executive department’s construction

of a statutory scheme it is entrusted to administer... .” In

this case, because the EPA is the agency charged with

administering FIFRA, we agree with Appellants that we

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should consider the EPA’s brief in Etcheverry and that the

EPA’s interpretation of FIFRA should receive deference.

438 Moreover, the EPA was not a party in any of the

previous actions regarding FIFRA and had not previously

expressed an opinion in court on whether FIFRA preempts

state-law damages actions. As a result, we did not have the

benefit of the EPA’s position on FIFRA preemption when

we decided McAlpine. Nor did we have the benefit of the

United States Supreme Court’s decision in Medtronic.

Consequently, we take this opportunity to revisit our decision

in McAlpine insofar as it holds that state law claims based

on a failure to warn are preempted by FIFRA.

939 In McAlpine, several farmers brought a products liability

action against the manufacturer and distributor of a herbicide

alleging that they suffered damage as a result of defendants’

failure to warn them that the herbicide could damage their

crops if applied in cool weather. We held in McAlpine, that

because the plaintiffs’ negligence claim was based solely

on the insufficiencies in the product’s warning label, that

claim was preempted by FIFRA. McAlpine, 285 Mont. at

231-32, 947 P.2d at 478. We also held that FIFRA did not

preempt plaintiffs’ breach of warranty and strict liability

claims to the extent that those claims did not rely on

representations made on the product’s label. McAlpine, 285

Mont. at 232-33, 947 P.2d at 478-79.

940 We predicated our decision in McAlpine on the United

States Supreme Court’s decision in Cipollone wherein the

Supreme Court interpreted a portion of the Public Health

Cigarette Smoking Act of 1969 that provided:

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Appendix A

(b) No requirement or prohibition based on

smoking and health shall be imposed under State

law with respect to the advertising or promotion

of any cigarettes the packages of which are labeled

in conformity with the provisions of this Act.

Cipollone, 505 U.S. at 515, 112 S.Ct. at 2617 (quoting

15 U.S.C. § 1334(b)).

41 The plaintiff in Cipollone claimed that the defendant

tobacco company caused his mother’s death by failing to

provide adequate warnings on its cigarettes and by

misrepresenting the dangers of smoking to the public.

Cipollone, 505 U.S. at 508, 112 S.Ct. at 2613. The Supreme

Court determined in Cipollone that:

The phrase “[n]o requirement or prohibition”

sweeps broadly and suggests no distinction

between positive enactments and common law:

to the contrary, those words easily encompass

obligations that take the form of common-law

rules.

Cipollone, 505 U.S. at 521, 112 S.Ct. at 2620. On that basis,

the Supreme Court held that state law failure to warn claims

are preempted insofar as they require a showing that a

defendant’s cigarette advertising “should have included

additional, or more clearly stated, warnings.” Cipollone, 505

U.S. at 524, 112 S.Ct. at 2621.

42 In our discussion of Cipollone in McAlpine, we noted

that

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[a]ll of the circuit courts, and several state

supreme courts, that have considered the effect

of FIFRA’s preemption clause have concluded |

that it should be given the same effect as the |

preemption clause interpreted in Cipollone... .

Thus, for purposes of determining the scope of |

FIFRA preemption, Cipollone provides the

appropriate framework for our analysis.

McAlpine, 285 Mont. at 229-30, 947 P.2d at 477 (citations

omitted). Hence, we determined in McAlpine that, as in the

cigarette labeling statute at issue in Cipollone, the phrase

“requirement” in § 136v(b) of FIFRA includes state common

law damage actions. McAlpine, 285 Mont. at 230, 947 P.2d

at 477. Consequently, we concluded that FIFRA preempts

state tort claims to the extent that they arise from an omission

or inclusion in a product’s label, but that claims alleging a

product, manufacturing, or design defect; claims alleging

negligent design, testing, or manufacturing; or claims

alleging breach of warranty that do not rely on such an

omission or inclusion in the product’s label, are not

preempted. McAlpine, 285 Mont. at 230, 947 P.2d at 477.

943 However, as pointed out by Appellants in their brief on

appeal and as we noted earlier in this opinion, we did not

have the benefit of the Supreme Court’s decision in

Medtronic in making our determination in McAlpine. The

Supreme Court held in Medtronic that in spite of its earlier

decision in Cipollone, the preemption provision at issue in

Medtronic did not preempt state common law damage

actions.

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Appendix A

44 In Medtronic, a pacemaker recipient’s pacemaker failed

resulting in a “complete heart block” that required her to

undergo emergency surgery. According to her physician, the

likely cause of the failure was a defect in the lead that

transmits the heartbeat-steadying electrical signal from the

“pulse generator” to the heart itself. The pacemaker recipient

brought an action against the pacemaker manufacturer

asserting claims of negligence and strict liability. Medtronic,

518 U.S. at 480-81, 116 S.Ct. at 2248.

45 The preemption statute at issue in Medtronic provided:

State and local requirements respecting devices

(a) General rule

Except as provided in subsection (b) of this

section, no State or political subdivision of a

State may establish or continue in effect with

respect to a device intended for human use any

. requirement —

(1) which is different from, or in addition to,

any requirement applicable under this chapter to

the device, and

(2) which relates to the safety or

effectiveness of the device or to any other matter

included in a requirement applicable to the device

under this chapter.

Medtronic, 518 U.S. at 481-82, 116 S.Ct. at 2248-49 (quoting

21 U.S.C. § 360k(a)).

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446 A four-Justice plurality held in Medtronic that distinct

features of the MDA mandated the conclusion that Congress

intended only to preempt states from imposing positive law

“requirements” on medical devices in the form of regulations

or laws and did not intend to preempt common law damage

actions. Medtronic, 518 U.S. at 488-89, 116 S.Ct. at 2252.

The Medtronic plurality found five key differences in the

statutory schemes of the 1969 Cigarette Act and the MDA

that mandated the conclusion that Congress did not intend

the word “requirements” to mean the same thing in both

statutes.

{47 First, the preemption of state authority resulting from

the 1969 Cigarette Act prevented only “a limited set of state

requirements” — requirements imposed on advertising

regarding the health effects of cigarettes, while preemption

of common law actions as a result of the MDA would

extinguish all state law design defect claims regarding all

medical devices. Second, the MDA provided no private

damages action that would replace state common law actions.

Third, the MDA’s preemption provision, unlike the 1969

Cigarette Act’s, expressed congressional concern “with the

problem of specific, conflicting state statutes and regulations

rather than the general duties enforced by common-law

actions.” Fourth, unlike the 1969 Cigarette Act, the MDA

uses the word “requirements” in numerous provisions, and

each use clearly refers only to statutory and regulatory law,

not common law. Fifth, the legislative history of the MDA

reveals no reference in the hearings, committee reports, or

debates that suggests a congressional intent to preempt all

common- law remedies. Medtronic, 518 U.S. at 487-91, 116

S.Ct. at 2251-53.

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448 In the same way, while the term “requirements” may

encompass common law duties in some contexts, the text,

legislative history, and purposes of FIFRA demonstrate that

Congress had no intent that the use of the term

“requirements” in § 136v(b) would extinguish state common

law damage actions. As the EPA noted in its amicus brief in

Etcheverry:

When § 136v(b) was enacted in 1972, state law

actions against pesticide manufacturers for failure

to warn were a commonplace and uncontroversial

feature of the legal landscape. No evidence from

the text or legislative history of FIFRA suggests

that Congress had any intent to extinguish those

actions or that Congress even considered doing

so. Indeed, Congress amended FIFRA in 1972 out

of increasing concern for the human health and

the environmental effects of pesticides such as

DDT. Given that FIFRA establishes no private

damages remedy for those injured by pesticides,

it would be astonishing that, without any

discussion, Congress could have intended to

deprive injured persons of all means of relief.

949 FIFRA’s text demonstrates that Congress had no intent

to extinguish damages remedies under state common law.

For example, in § 136v, Congress used the term

“requirements” to mean “regulation,” a term connoting

positive commands of law, not court orders to pay damages

for the harms caused by pesticides. Section 136v(a) provides

that “[a] State may regulate” the sales or use of pesticides as

long as the state “regulation” does not permit a sale or use

22a

Appendix A

prohibited by FIFRA. Section 136v(b) forbids “[s]uch

state” from regulating labeling by imposing labeling

“requirements” in addition to or different from those required

under FIFRA. The plainest reading of the two subsections is

that a state may “regulate” pesticide sales or use, but in doing

so may not impose labeling “requirements.” In other words,

§ 136v(b)’s prohibition on state labeling “requirements”

represents an exception to § 136v(a)’s general grant of state

authority to “regulate” pesticide sales and use.

9450 The Medtronic plurality interpreted the term

“requirements” in the MDA’s preemption provision by

examining its usages throughout the MDA. In doing so, the

plurality adhered to “the normal rule of statutory construction

that identical words used in different parts of the same act

are intended to have the same meaning.” Sullivan v. Stroop

(1990), 496 U.S. 478, 484, 110 S.Ct. 2499, 2504, 110 L.Ed.2d

438 (internal quotations and citations omitted).

451 The term “requirements” appears in FIFRA 75 times.

No court considering preemption under FIFRA ever

addressed the meaning of “requirements” in the entire context

of FIFRA; courts only looked at it in terms of § 136v(b).

However, in each instance other than § 136v(b), Congress

intended the term “requirements” to mean enactments of

positive law by legislative or administrative bodies. It is

inconceivable that Congress intended that § 136v(b) would

be the only section of FIFRA in which the term

“requirements” includes the application of general rules of

common law by judges and juries.

452 Throughout FIFRA, the term “requirements” refers

exclusively to positive enactments of statutory and regulatory

23a

Appendix A

law. Accordingly, the term “requirements” should be given

the same reading in § 136v(b). Simply because the term

“requirement” was found in Cipollone to encompass common

law actions for damage, does not preclude this Court from

reaching a contrary result in this case. “Only mischief can

result if [the same words appearing in different statutes] are

given one meaning regardless of the statutory context.”

Lee v. Madigan (1959), 358 U.S. 228, 231, 79 S.Ct. 276,

278, 3 L.Ed.2d 260.

53 Moreover, subsections (a) and (c) of § 136v demonstrate

that Congress intended to authorize states to take actions

that may indirectly prompt pesticide manufacturers to change

their labels. Indirect pressure on pesticide manufacturers to

change their labels, which may result from liability in damage

actions, cannot be characterized as labeling “requirements.”

A state court award of damages for failure to warn does not

mandate any change in labeling. Rather, it merely requires

that a pesticide manufacturer pay money to an injured person.

While a damage award may prompt a pesticide manufacturer

to seek the EPA’s approval for a change in labeling, it does

not directly command such a change. As the EPA points out,

such indirect pressure cannot reasonably be characterized

as imposing labeling requirements.

54 Indeed, indirect pressure to change a pesticide label does

not frustrate Congress’s purpose of establishing nationally

uniform pesticide labels. The EPA approves only one label

per pesticide. In approving a labeling change, the EPA

substitutes a new nationally uniform label. This process is

the same whether the labeling change is prompted by state

damage liability or state regulation authorized by FIFRA.

24a

Appendix A

455 In addition, FIFRA’s legislative history does not

demonstrate a Congressional intent to extinguish actions for

damages. As the EPA noted in its amicus brief, when

§ 136v(b) was enacted, common law actions against pesticide

manufacturers for failure to warn were a “well-recognized

and uncontroversial feature of the legal landscape.” Common

law actions for inadequate, misleading, or false

representations regarding pesticides were available as early

as 1884. And, in the first part of this century, dozens of

reported decisions recognized the availability of actions for

false or inadequate representations regarding pesticides,

including actions based on pesticide labels. After FIFRA was

enacted in 1947, the federal government issued substantial

labeling regulations, but state and federal courts uniformly

concluded that the federal pesticide labeling regulations did

not alter the availability of state law damage actions for

inadequate labeling. By 1972, when § 136v(b) was enacted,

nearly every state and federal jurisdiction recognized

pesticide manufacturer and dealer liability both for personal

injuries and crop damage resulting from the failure to provide

adequate warnings.

56 FIFRA’s legislative history reveals no intent to alter

the availability of common law remedies. In 1971 and 1972,

three House and Senate committees devoted 25 days to

hearings on proposed pesticide legislation. In the thousands

of pages of transcripts of the hearings and floor debates, there

is no suggestion that the 1972 amendments to FIFRA would

preempt state tort law.

457 For instance, in the committee hearings, testifying on

behalf of the Administration and the EPA, which drafted the

;

25a

Appendix A

bill that formed the basis of the 1972 amendments, the EPA’s

General Counsel, John Quarles, testified as follows:

I would like to emphasize that the States have

played a major and continuing role in pesticides

regulation. ... We wish to encourage and not

supplant these efforts by providing that States may

prohibit the use of a particular pesticide within

their jurisdiction even if the pesticide is registered

under the Federal authority. States thus are not

precluded from imposing stricter standards or

added requirements, but they may not permit any

sale or use of a pesticide which is prohibited under

the authority of the Act.

The EPA’s brief in Etcheverry at 24-25 (quoting the Federal

Pesticide Control Act of 1971: Hearings Before the House

Committee on Agriculture, 92d Congress (1971) at 8).

458 These hearings reveal that Congress had no intent to

preempt state tort law. Quarles testified as the first witness

in the first hearing, stating unequivocally: “The bill does

not affect tort liability.” EPA’s brief at 28 (quoting House

Ag. Comm. Hearing at 42). No one disagreed and no witness

or member of Congress suggested that FIFRA would alter

common law duties or affect the availability of tort damages.

459 In addition, the four House and Senate Committee

reports describe in detail the changes that the 1972

amendments would bring to federal pesticide regulation.

Each report summarizes the changes made by the bill, but

none mentions any intent to preempt state damage actions.

26a

Appendix A

460 Furthermore, the House and Senate debated the 1972

FIFRA amendments over 5 days. Like the committee

hearings and reports, the floor debates reveal no suggestion

of a Congressional intent to preempt state tort law. The

preemption provision was not mentioned on the floor of the

Senate. The preemption provision was debated at length on

the floor of the House, but nowhere in the debate is there a

suggestion that the preemption provision would affect state

tort law.

461 Therefore, as pointed out by EPA, rather than reveal an

intent to extinguish state common law damage remedies, the

legislative history of the 1972 FIFRA amendments is replete

with evidence that Congress understood and intended that

state damage actions would remain available. Moreover,

there is a presumption against preemption of common law

remedies. Medtronic, 518 U.S. at 485-86, 116 S.Ct. at 2250;

Cipollone, 505 U.S. at 518, 523, 112 S.Ct. at 2618, 2621.

That long standing presumption can only be overcome by

evidence of a “clear and manifest” intent of Congress to

preempt state law. See Wisconsin Public Intervenor v.

Mortier (1991), 501 U.S. 597, 610, 111 S.Ct. 2476, 2484,

115 L.Ed.2d 532. In the absence of evidence that Congress

intended to alter then existing law, FIFRA should not be

interpreted to do so.

62 Furthermore, preemption of state tort law would conflict

with FIFRA’s purposes. The 1972 FIFRA amendments were

enacted to address growing public concern with the

environmental and public health effects of pesticides such

as DDT. The fact that there is no federal private damage

remedy, that Congress was aware of state damage remedies,

27a

Appendix A

and that Congress decided to give the states the primary

enforcement authority under FIFRA, all strongly imply that

Congress did not intend to preempt state common law

damage remedies. Given that the 1972 amendments to FIFRA

were intended to provide increased public protection against

the harms caused by pesticides, it would make no sense to

infer that Congress intended to close off all avenues of

judicial relief for those injured by pesticides.

63 The Medtronic plurality adopted similar arguments in

interpreting the MDA. Absent a federal private cause of

action, preemption of state common law damage actions

would effectively bar relief to persons injured by defective

medical devices and “have the perverse effect of granting

complete immunity from design defect liability to an entire

industry that, in the judgment of Congress, needed more

stringent regulation. . . .” Medtronic, 518 U.S. at 487, 116

S.Ct. at 2251. “It is to say the least, ‘difficult to believe that

Congress would, without comment, remove all means of

judicial recourse for those injured by illegal conduct,’ and it

would take language much plainer than the text of § 360k to

convince us that Congress intended that result.” Medtronic,

518 U.S. at 487, 116 S.Ct. at 2251 (quoting Silkwood v. Kerr-

McGee Corp. (1984), 464 U.S. 238, 251, 104 S.Ct. 615, 623,

78 L.Ed.2d 443). In the same way, FIFRA’s preemptive force

should not be interpreted to undermine the statutory purpose

to provide increased protection from harmful pesticides.

164 We conclude that Congress intended the term

“requirements” in § 136v(b) of FIFRA to mean enactments

of positive law by legislative or administrative bodies, not

State law damage actions. Consequently, we overrule our

prior decision in McAlpine for holding otherwise.

28a

Appendix A

465 Accordingly, we hold that Appellants’ claims are not

preempted by FIFRA and that the District Court erred in

granting summary judgment in favor of DowElanco on that

basis.

466 Reversed and remanded for further proceedings

consistent with this opinion.

s/ James C. Nelson

Justice

s/ J.A. Turnage

Chief Justice

s/ William E. Hunt, Sr.

s/ Jim Regnier

s/ Terry N. Trieweiler

Justices

Hon. Thomas M. McKittrick, District Judge

sitting for Justice W. William Leaphart

s/ Thomas M. McKittrick

District Judge

29a

Appendix A

Justice Karla M. Gray, dissenting.

67 I dissent from the Court’s opinion. We resolved the

dispositive issue in this case, whether failure to warn claims

— pleaded in negligence, strict liability and breach of express

warranty — are preempted by FIFRA, a scant three years

ago in McAlpine, holding such claims are preempted to the

extent they expressly or implicitly challenge the adequacy

of the warnings in a pesticide’s label. 1 would hold that

McAlpine is controlling and affirm the District Court.

168 Stare decisis, which means to abide by or adhere to

decided cases, is of fundamental and central importance to

the rule of law. State v. Gatts (1996), 279 Mont. 42, 51, 928

P.2d 114, 119 (citations omitted). It is a “ ‘fundamental

doctrine which reflects our concerns for stability,

predictability and equal treatment... .’”” Gatts, 279 Mont.

at 51,928 P.2d at 119 (quoting Formicove, Inc. v. Burlington

Northern, Inc. (1983), 207 Mont. 189, 194, 673 P.2d 469,

472). The doctrine is meant to keep courts from lightly

overruling past decisions, in order to heed the necessity for

stability and predictability in the law. See Gatts, 279 Mont.

at 51, 928 P.2d at 119 (citing Morayne v. States Marine Lines

(1970), 398 U.S. 375, 403, 90 S.Ct. 1772, 1789, 26 L.Ed.2d

339, 358). At the same time, stare decisis is not a mechanical

adherence to the latest decision and, of course, court

decisions are not sacrosanct. Gatts, 279 Mont. at 51, 928

P.2d at 119 (citation omitted). A decision which is manifestly

wrong need not be followed. Gatts, 279 Mont. at 51, 928

P.2d at 119 (citation omitted). It is my view that, in overruling

McAlpine, the Court is merely substituting a result it finds

preferable to that announced in our well-reasoned McA lpine

30a

Appendix A

decision. The Court makes no showing of manifest

incorrectness here and, indeed, neither the EPA’s amicus

brief in Etcheverry nor the United States Supreme Court’s

decision in Medtronic provides an appropriate basis on which

to resolve the present case by overruling McAlpine.

469 Starting with the U.S. Department of Justice’s brief on

behalf of EPA in the recent California Etcheverry case,

I would give it no deference. This is not an internal policy

or regulatory statement of the EPA regarding its

administration of FIFRA of the type to which courts give

deference. It is a brief prepared for litigation, part of the

government’s litigation strategy. Moreover, as the California

Supreme Court observed,

[e]ven though the question presented in this case

has been addressed by nine of the federal circuit

courts of appeals, the United States failed to file

amicus curiae briefs in any of the cases and

permitted those courts to proceed upon a

fundamental assumption that it now characterizes

as mistaken.

Etcheverry, 993 P.2d at 374. In addition, the matter on which

the EPA rests its contention that FIFRA does not preempt

failure to warn claims relates to its waiver of review of

pesticide efficacy claims. As was the situation in Etcheverry,

however, the case before us does not relate to pesticide

efficacy, that is, whether the pesticide will control the target

pest(s). See Etcheverry, 993 P.2d at 374. The case before us

involves the indoor application of Dursban without

ventilation. Thus, as in Etcheverry, the EPA’s argument is

3la

Appendix A

irrelevant to the case before us. See Etcheverry, 993 P.2d at

375. Under these circumstances, the Court’s decision to give

this johnny-come-lately litigation brief significant weight is

a perilously slim basis on which to premise overruling our

well-reasoned decision in McAlpine.

470 Nor dol find Medtronic either useful or persuasive here

and this no doubt explains why it was not called to our

attention in McAlpine. As the Court notes several times, the

portion of Medtronic on which it relies is a four-Justice

plurality, clearly not controlling authority even if the MDA

and FIFRA contained more similar preemption language.

Indeed, it is my view, as it was the view of the California

Supreme Court in Etcheverry, that Medtronic is

distinguishable on the basis that Congress gave the Food

and Drug Administration a unique role in determining the

scope of preemption under the MDA. Congress did not give

the EPA an analogous role in implementing FIFRA.

See Etcheverry, 993 P.2d at 373 (citations omitted).

971 I would hold that Medtronic does not undermine our

conclusion in McAlpine that FIFRA preempts state failure

to warn claims. In doing so, I would join the overwhelming

majority of courts which have examined the question in the

wake of Medtronic. See, e.g., Grenier v. Vermont Log Bidgs.,

Inc. (1* Cir. 1999), 96 F.3d 559; Oliver v. Reckitt & Colman.

Inc. (M.D. Fla. 1998), 12 F.Supp.2d 1287; Hawkins v.

Leslie's Poolmart (D.N.J. 1997), 965 F.Supp. 566; Kuiper

v. American Cyanamid Co. (E.D. Wis. 1997), 960 F.Supp.

1378; Koch v. Shell Oil Co. (D. Kan. 1997), 173 F.R.D. 288;

Etcheverry, 993 P.2d at 373; Ackerman v. American

Cyanamid Co. (lowa 1998), 586 N.W.2d 208; Ackles v.

32a

Appendix A

Luttrell (Neb. 1997), 561 N.W.2d 573, cert. denied, 522 U.S.

928 (1997); Didier v. Drexel Chemical Co. (Wash. App.

1997), 938 P.2d 364; Lewis v. American Cyanamid Co. (N.J.

1998), 715 A.2d 967; Sherman v. Claire Mfg. Co. (N.Y. App.

Div. 1997), 657 N.Y.S.2d 453.

472 In my view, no showing has been made that McAipine

is “manifestly wrong.” See Gatts, 279 Mont. at 51, 928 P.2d

at 119. Therefore, | would apply stare decisis here, reaffirm

McAlpine and affirm the District Court. I dissent from the

Court’s failure to do so.

s/ Karla M. Gray

Justice

33a

APPENDIX B — ORDER OF THE MONTANA FIRST

JUDICIAL DISTRICT COURT, LEWIS AND CLARK

COUNTY ON MOTION FOR SUMMARY JUDGMENT

DATED JANUARY 8, 1999

MONTANA FIRST JUDICIAL DISTRICT COURT

LEWIS AND CLARK COUNTY

Cause No. BDV 96-18

LIBBY SLEATH, MARY ANN HAYES, GLENDA

TRUESDELL, and MARY OWEN,

Plaintiffs,

Vv.

WEST MONT HOME HEALTH SERVICES, INC., WEST

MONT HOME MANAGEMENT SERVICES, INC., ORKIN

EXTERMINATION COMPANY, INC., and EP CO., INC.,

and ROFAN SERVICES, INC., d/b/a DOW ELANCO,

Defendants.

ORDER ON MOTION FOR

SUMMARY JUDGMENT

This matter is before the Court on the motion of Ep Co.,

Inc., and Rofan Services, Inc., d/b/a Dow Elanco, (hereinafter

Dow) for summary judgment. The crux of Plaintiffs’

complaint against Dow is that Dow manufactured various

formulations of Dursban insecticides that were applied

between 1991 and 1994 by Orkin Extermination Company

at the office building of West Mont Home Health Services

34a

Appendix B

in Helena, Montana. During that period of time, Plaintiffs

worked in the West Mont building.

Plaintiffs, in their second amended complaint, allege

three causes of action against Dow. The first is a cause of

action for negligence; the second is a breach of warranty;

and the final one is a claim of strict liability.

The issue currently before the Court is whether or not

Plaintiffs’ claims are barred by the Federal Insecticide,

Fungicide and Rodenticide Act (hereinafter FIFRA) found

at U.S.C. § 136, et seq.

STANDARD OF REVIEW

Summary judgment is proper only when no genuine issue

of material fact exists and the moving party is entitled to

judgment as a matter of law. Rule 56(c), M.R.Civ.P. It

encourages judicial economy through the elimination of

unnecessary trial, delay, and expense. Bonawitz v. Bourke,

173 Mont. 179, 182, 567 P.2d 32, 33 (1977). However,

summary judgment is not to be utilized to deny the parties

an opportunity to try their cases before a jury. Brohman v.

State, 230 Mont. 198, 202, 749 P.2d 67, 70 (1988).

The movant has the initial burden to show that there is a

complete absence of any genuine issue of material fact. To

satisfy this burden, the movant must make a clear showing

as to what the truth is so as to exclude any real doubt as to

the existence of any genuine issue of material fact. Minnie

v. City of Roundup, 257 Mont. 429, 431, 849 P.2d 212, 214

(1993). The burden then shifts to the party opposing the

35a

Appendix B

motion to show that there are genuine issues for trial.

Brinkman and Lenon v. P & D Land Enter., 263 Mont. 238,

242, 867 P.2d 1112, 1114 (1994). The party Opposing the

summary judgment is entitled to have any inferences drawn

from the factual record resolved in his or her favor. Rule

56(c), M.R.Civ.P. Rule 56(c) permits the court to render

judgment if the pleadings, admissions, and any affidavits

filed show that there is no genuine issue as to any material

fact and that the moving party is entitled to a judgment as a

matter of law. Poulsen’s, Inc. y. Wood, 232 Mont. 4] 1, 415,

756 P.2d 1162, 1165 (1988).

DISCUSSION

Four products manufactured by Dow were applied at the

West Mont facility; Dursban 4E, Dursban LO, Empire 20

and Dursban granules. Each of these products is registered

with the Environmental Protection Agency (EPA) as directed

by FIFRA. See Robert F. Bischoff Aff.

The labels for the assorted Dursban products contain

various instructions on the manner in which the individual

products should be used. See Bischoff Aff. Exs. A, B and C.

All parties agree that the Montana Supreme Court’s decision

in McAlpine v. Rhone-Poulenc Ag. Co., 285 Mont. 224, 947

P.2d 474 (1997), governs the case at bar. In McAlpine, the

Montana Supreme Court held:

Under FIFRA, “a State shall not impose or

continue in effect any requirements for labeling

or packaging in addition to or different from those

required under this subchapter.” 7 U.S.C.

36a

Appendix B

§ 136v(b). We determine that, as in the cigarette

labeling statute, the phrase “requirement” in

7 U.S.C. § 136v(b) includes state common law

damage actions. Therefore, FIFRA preempts state

tort claims to the extent they arise from an

omission or inclusion in the product’s label.

Claims alleging a product, manufacturing or

design defect, claims alleging negligent design,

testing or manufacturing, or claims alleging [a]

breach of warranty that do not rely on such an

omission or inclusion in the product’s label are

not preempted.

285 Mont. at 230, 947 P.2d at 477.

The McAlpine decision is in accord with what one legal

analyst has called a “tsunami of authority.” See, e.g.

Louisiana-Pacific Corp. v. Koppers Co., 32 Cal. App. 4th

599, 38 Cal. Rptr. 2d 257 (1995); Taylor AG Industries vy.

Pure-Gro, 54 F.3d 555 (9th Cir. 1995); MacDonald v.

Monsanto Co., 27 F.3d 1021 (Sth Cir. 1994); Worm vy.

American Cyanamid Co., 5 F.3d 744 (4th Cir. 1993); King

v. EJ. DuPont de Nemours & Co., 996 F.2d 1346 (1st Cir.

1993); Shaw v. Dow Brands, Inc., 994 F.2d 364 (7th Cir.

1993); Papas v. Upjohn Co., 985 F.2d 516 (11th Cir. 1993)

(Papas II); Arkansas-Platte & Gulf v. Van Waters & Rogers,

Inc., 981 F.2d 1177 (10th Cir. 1993) (Arkansas-Platte II);

Kuiper v. American Cyanamid Co., 131 F.3d 656 (1997).

Plaintiffs’ admission that their express warranty claim

is preempted by FIFRA eases this Court’s burden somewhat.

See Pls’ Resp. at 3. However, the Court still must consider

37a

Appendix B

Plaintiffs’ complaint, interrogatory answers and affidavits

on file to determine if Plaintiffs’ remaining claims are based

upon an omission or inclusion in the products’ labels.

Prior to addressing these remaining claims, the Court

needs to consider two disputes that have arisen between the

parties. First, Dow submitted contention interrogatories to

Plaintiffs, many of which were answered with reference to

the products’ labels. Plaintiffs now suggest that the Court

should read these interrogatories and omit any reference to

the products’ labels. Plaintiffs note that these interrogatories

were submitted prior to the Montana Supreme Court’s

decision in McAlpine and were in response to Dow’s request

that Plaintiffs set forth any and all grounds for liability.

Contrarily, Dow suggests that the Court’s modification to

Plaintiffs’ answers to the interrogatories not be allowed.

However, for purposes of this motion, the Court feels it

appropriate to eliminate any specific references to the

products’ labels that were contained in Plaintiffs’ answers

to the interrogatories.

Second, Dow contends Dr. Robert K. Simon’s

supplemental affidavit should be stricken. Dow’s contention

is that Dr. Simon changed his opinion in his second affidavit,

and that this change violates the expert disclosure rule. The

Court rejects this argument, holding that Dr. Simon’s

supplemental affidavit was a necessary response for Plaintiffs

to counter the affidavits filed by Dow pursuant to their motion

for summary judgment.

At the hearing on the motion for summary judgment,

Plaintiffs’ attorney indicated that, in essence, his clients’

38a

Appendix B

claim against Dow was a design defect strict liability case.

This seemly abandons Plaintiffs’ claims against Dow for

negligence and breach of implied warranty. However, since

nothing is in writing on this particular issue, the Court feels

it prudent to address the negligence and implied warranty

arguments.

Negligence

Plaintiffs’ negligence claim is contained in Count IV of

the complaint at paragraph 31. The following allegation is

made: “Defendants EP Co., Inc., and Rofan Services, d/b/a

DOW ELANCO, and its agents or employees were negligent

in failing to provide adequate warning of the known, harmful

and inherently dangerous properties of Chlorpyrifos

[Dursban] to the public. .. .” If, as Plaintiffs’ suggest, Dow

was negligent in that it had knowledge of the harmful effects

of its products, but failed to provide a warning, this claim

must be classified as a failure to warn claim. How, we must

ask ourselves, could Dow protect itself from liability for this

allegedly negligent activity? Clearly, what Dow would have

to do would be to place some warning on its label. As

previously noted, a multitude of courts, including the

Montana Supreme Court, have held that FIFRA does preempt

state law causes of action predicated on a failure to warn.

This comes about, primarily, because the failure to warn is

an attack on the EPA-approved label for the product.

Breach of Implied Warranty

The interrogatories expanding on Plaintiffs’ claim of

breach of implied warranty start with Interrogatory No. 2.

In Plaintiffs’ Answer No. 2c, they aver that Dursban is:

39a

Appendix B

“not fit to be used in unventilated areas or without

limits on the applications. . .. When used according

to Defendant DowElanco’s instructions, Dursban

and/or Chlorpyrifos exposed plaintiff to manufac-

turing impurities and caused cholinesterase

inhibition in plaintiff which may have been

avoided by proper warnings and instructions.”

The omitted language from Interrogatory No. 2 was the

specific mention of the label. However, the remaining

information clearly shows that Plaintiffs’ complaint deals

with the use and application instructions on the product. The

labels for all of the Dursban products do have limits on the

application and use of the products. Therefore, Plaintiffs are

once again, pursuant to their answer to Interrogatory No. 2,

challenging the label. Reference can also be made to

Interrogatories No. 10 and 12 which refer to “inadequate

warnings on its Dursban/Chlorpyrifos products” and

“application and use standards.” Again, these issues are dealt

with on the label. Such being the case, Plaintiffs’ claim for

breach of implied warranty is, in reality, an attack on the

instructions contained on the EPA-approved label.

Dow should be granted summary judgment on both the

claim of negligence and breach of implied warranty.

Strict Liability

At oral argument, Plaintiffs Suggested that their real

claim against Dow was one for a design defect. Strict liability

claims, as other common law tort claims, may be preempted

by FIFRA. See McAlpine, 285 Mont. at 230, 947 P.2d at

40a

Appendix B

477; Quest Chem. Corp. v. Elam, 898 S.W.2d 819, 821 (Tex.

1995); Worm v. America Cyanamid Co., 5 F.3d 744 (4th Cir.

1993); Grenier v. Vermont Log Bldgs, Inc., 96 F.3d 559 (1st

Cir. 1996); Shaw v. Dow Brands, Inc., 994 F.2d 364 (7th

Cir. 1993). However, this area of FIFRA preemption does

prove problematic for the Court. The courts have dropped

hints as to the type of strict liability claims that could survive

FIFRA preemption. For example, a claim that the product

was unfit for any use might survive the present motion.

Grenier, 96 F.3d at 564. Also, if a plaintiff can assert factual

grounds for a strict liability claim other than those based on

inadequate warnings, FIFRA would not preempt his claim.

See Quest, 898 S.W.2d at 821.

The Worm court noted that “the line between a claim

for mislabeling and a claim for a defective product may not

always be clear.” 5 F.3d at 747. However, the distinction

may become less blurred by considering, zs one factor,

whether it was reasonably foreseeable that the manufacturer,

in seeking to avoid liability, would choose to alter the product

or the label. Jd.

The labels on the various products involved here discuss

the type of buildings in which the Dursban products may be

applied and also discuss the frequency of application of the

products. See Bischoff Aff. Exs. A, B and C. At issue here is

that Plaintiffs’ answer to Interrogatory No. 4, which alleges

that Dursban causes health problems in humans when used

without adequate ventilation and without appropriate limits

on applications. Notably, Defendants’ labels provide no such

instruction. Plaintiffs’ answer goes on to state that there are

no warnings on the label for the dangers of Dursban and that

4la

Appendix B

repeated use of Dursban in a closed building without

adequate ventilation can cause a toxic buildup of the product.

Even in omitting the word “label” in the aforementioned

answer, it seems clear that the answer to Interrogatory No. 4

is questioning the label instructions for the various Dursban

products that are shown on the attachment to Bischoff’s

affidavit. The label instructions discuss the type of buildings

in which Dursban can be applied, and also mention

reapplication rates. Thus, at least as far as the interrogatory

answer goes, it appears that Plaintiffs’ strict liability claim

against Dow is, in reality, a label-based claim.

Finally, the Court must review the affidavits of Dr.

Simon. Specifically, we must refer to his supplemental

affidavit that is attached to Plaintiffs’ reply brief in

Opposition to Dow’s motion for summary judgment. In

paragraph 3, Dr. Simon states that the design defect making

Dursban products unreasonably dangevous to the ultimate

consumer in the context of interior workplace application of

those products. In paragraph 5 of his supplemental affidavit,

Dr. Simon indicates that the known impurities, degradation

products and impurities in Dursban cause the products to be

unreasonably dangerous, again, in the context of interior

workplace application. Again and again in his supplemental

affidavit, Dr. Simon refers to the “context of interior

workplace application.” In his original affidavit, Dr. Simon

discusses air flow and ventilation in the West Mont building

as being a factor in this problem. See Simon Aff., J 8.2. Also

in his original affidavit, paragraph 8.5 again talks about the

“excessive application of pesticides.” All of what Dr. Simon

Says may well be true. However, underlying his conclusion

that these products are unreasonably dangerous is their

42a

Appendix B

application “in the context of interior workplaces” and at

the reapplication rate and ventilation rate in those interior

areas. These are all topics that are discussed on the various

labels of these products. See Bischoff Aff. Exs. A, B and C.

Plaintiffs must, therefore, be contesting the label directions

and warnings related to interior workplace application,

ventilation and reapplication of the products. Consequently,

their strict liability claim must also be preempted under

McAlpine.

CONCLUSION

Therefore, based on the above, IT IS HEREBY

ORDERED, ADJUDGED AND DECREED that the motion

for summary judgment filed by Dow is GRANTED.

DATED this 8 day of Jan. 1999.

s/ Jeffrey M. Sherlock

JEFFREY M. SHERLOCK

District Court Judge

43a

APPENDIX C — FINAL JUDGMENT OF THE

MONTANA FIRST JUDICIAL DISTRICT COURT,

LEWIS AND CLARK COUNTY PURSUANT TO

RULE 54(b) M.R.C.P. DATED FEBRUARY 22, 1999

MONTANA FIRST JUDICIAL DISTRICT COURT

LEWIS AND CLARK COUNTY

Cause No. BDV 96-018

LIBBY SLEATH, MARY ANN HAYES, GLENDA

TRUESDELL, and MARY OWEN,

Plaintiffs,

WEST MONT HOME HEALTH SERVICES, WEST MONT

HOME MANAGEMENT SERVICES, INC., ORKIN

EXTERMINATION COMPANY, and EPCO, INC., and

ROFAN SERVICES INC., d/b/a DOWELANCO,

Defendants.

FINAL JUDGMENT PURSUANT TO

RULE 54(b) M.R.C.P.

Based upon Plaintiffs and Defendant EPCO, Inc. and

Rofan Services, Inc., d/b/a DowElanco (hereinafter

DowElanco) motion and the lack of objection by the

remaining Defendants and for good cause shown, the

Court, pursuant to Rule 54(b), M.R.Civ.P., enters this

Final Judgment in this matter, in favor of Defendant

44a

Appendix C

DOWELANCO, and makes the following findings in support

of this certification and entry of a Final Judgment:

A. The District Court’s Order makes a final ruling as to

DowElanco in this proceeding. The claims of Plaintiffs

against the other Defendants are not final, indeed none of

the other claims are in a status where a definitive ruling will

be reached with regard to any of the other non-DowElanco

Defendants in the near future and there is no reason to delay

entry of a final judgment in favor of DowElanco.

B. The claims against DowElanco are based upon

product liability law, and relate to manufacture of DowElanco

products, whereas the claims against the remaining

Defendants are upon different theories of liability relating

to the application of DowElanco products. Thus the claims

are distinct and a ruling as to the one class of the Defendants

represented by DowElanco will not affect the proceedings

against the remaining Defendants. To the contrary, no result

of appellate review of the claims against DowElanco will

have any effect on the claims or proceedings against

remaining Defendants. Finally, there are no claims or

counterclaims which could result in a setoff of this judgment.

C. There is no reason to delay the entry of a final

judgment in favor of DowElanco and entry of a final judgment

will facilitate further handling of the issues in this litigation.

DATED this 22nd day of February, 1999.

s/ JEFFREY M. SHERLOCK

District Judge

45a

APPENDIX D — ORDER OF THE SUPREME COURT

OF THE STATE OF MONTANA DENYING

PETITION FOR REHEARING DATED

AND FILED FEBRUARY 1, 2001

IN THE SUPREME COURT OF THE

STATE OF MONTANA

No. 99-185

LIBBY SLEATH, MARY ANN HAYES, GLENDA

TRUESDELL, and MARY OWEN,

Plaintiffs and Appellants,

WEST MONT HOME HEALTH SERVICES, INC., WEST

MONT HOME MANAGEMENT SERVICES, INC., ORKIN

EXTERMINATION COMPANY, INC., and EP CO., INC.,

and ROFAN SERVICES, INC., d/b/a DOW ELANCO,

Defendants and Respondents.

ORDER

IT IS ORDERED that the Petition for Rehearing filed

with this Court by respondents EP CO, Inc., and Rofan

Services, Inc., d/b/a Dow Elanco, is DENIED.

46a

Appendix D

DATED this Ist day of February, 2001.

s/ Karla M. Gray

Chief Justice

s/ James C. Nelson

s/ Jim Regnier

s/ W. William Leaphart

Justices

Justice Terry N. Trieweiler would also deny the petition for

rehearing.

47a

APPENDIX E — BRIEF AMICUS CURIAE FOR THE

UNITED STATES IN ETCHEVERRY, et al. v. TRI-AG

SERVICE, INC., et al., SUPREME COURT OF

CALIFORNIA, NO. S072524 DATED MARCH, 1999

No. S072524

IN THE SUPREME COURT OF CALIFORNIA

MONIQUE ETCHEVERRY, et al.,

Plaintiffs-Appellants,

¥.

TRI-AG SERVICE, INC., BAYER CORP., et al.,

Defendants-Respondents.

ON APPEAL FROM THE COURT OF APPEAL,

THIRD APPELLATE DISTRICT

BRIEF AMICUS CURIAE FOR THE UNITED STATES

IN SUPPORT OF PLAINTIFFS-APPELLANTS

OF COUNSEL: LOIS J. SCHIFFER

GARY S. GUZY Assistant Attorney General

Acting General Counsel

JARED A. GOLDSTEIN

ROBERT G. DREHER ANNE R. TRAUM

Deputy General Counsel Attorneys

: Environment and Natural

JONATHAN J. FLEUCHAUS Resources Division

Attorney U.S. Department of Justice

United States Environmental Washington, D.C. 20530

Protection Agency (202) 514-5316

Washington, D.C. 20044

48a

Appendix E

TABLE OF CONTENTS

QUES TIN PREGOINEGD oa iviccewewencccsees

INTEREST OF THE UNITED STATES......... :

FIFRA’S STATUTORY AND REGULATORY

et | errr errr rey eee eer e

SUMMARY OF ARGUMENT ................

PRION oo So tahoe nbd iu nbbeeadineinees |

I. FIFRA DOES NOT PREEMPT STATE

COMMON LAW DAMAGES ACTIONS

“ee 6 688 6 6 6 06.680 8 € 6. 629 F.8O OR 2 6.44 2 6 4 2. 2 Oo

A. As the Supreme Court’s Decisions in

Cipollone and Medtronic Demonstrate,

FIFRA’s Preemption Provision Must Be

Read in its Statutory Context ........

B. The Text of FIFRA Demonstrates That

Congress Did Not Intend to Preempt

Common Law Actions .............

1. Under section 136v, the term

“requirements” refers to state

commands regarding labeling

enn ar CS et

[70a]

[72a]

[75a]

49a

Appendix E

FIFRA’s other references to

“requirements” all refer to direct

commands imposed by law, not the

indirect pressure resulting from tort

liebility soi 63 iee ei k ee

Section 136v addresses state

commands regarding labeling, not

state actions that indirectly pressure

pesticide manufacturers to change

Sg ROOT ees Pee

C. The History of FIFRA Demonstrates No

Congressional Intent to Extinguish

Actions for Damages...............

When section 136v(b) was enacted,

common law actions against

pesticide manufacturers for failure

to warn were a well-recognized and

uncontroversial feature of the legal

MMIII ig fk Fig dau dees dares

FIFRA’s legislative history reveais

no intent to alter the availability of

common law remedies. .........

a. The committee hearings-....

b. The committee reports .....

c. The floor debates..........

[77a]

[82a]

[84a]

[85a]

[89a]

[91a]

50a

Appendix E

D. Preemption of State Tort Law Would

Conflict with the Purposes of the 1972

FIFRA Amendments ............... [101la]

II. SECTION 136V(B) DOES NOT PREEMPT "

COMMON LAW ACTIONS ADDRESSING

MATTERS SUCH AS PESTICIDE

EFFICACY UNREGULATED BY EPA... [104a]

A. EPA Does Not Evaluate Pesticide

SOY i ccc ise tee [107a]

B. Congress Did Not Intend to Leave

Pesticide Efficacy Unregulated ...... [114a]}

II. FIFRA DOES NOT PREEMPT STATE

DAMAGES ACTIONS CHALLENGING

OFF-LABEL STATEMENTS ........... [115a]

CONMCIIIIN oo e are [117a]

CERTIFICATE OF SERVICE................. [118a]

ADDENDUM: Pesticide Regulation (PR) Notice 96-4

S5la

Appendix E

TABLE OF AUTHORITIES

CASES

American Airlines, Inc. v. Wolens,

SES TB. 2 eee ba veciecieeviwiws [103a]

Arkansas Electric Cooperative Corp. v. Arkansas

Public Service Comm'n,

461 08 SIS GOED 67s) hexoses. [1143]

Arkansas-Platte & Gulf Partnership v. Van Waters

& Rogers, Inc.,

961: F.26 1177 (10s Car. 1993) 2.5. ec ccecene [107a]

Arkansas-Platte & Gulf v. Van Waters & Rogers, Inc.,

ie Se Bees fe |: ) [71a]

Bean v. Diamond Alkali Co..,

Be |) re [89a]

Burke v. Dow Chemical Co.,

797 F. Supp. 1128 (E.D.N.Y. 1992) .......... [64a]

Cipollone v. Liggett Group, Inc.,

A UES GW ol bw av kvic pccecwcvaces passim

Corprew v. Geigy Chemical Corp.,

ROP et WU Ere EOE hs Sh eee c i ceceees [89a]

Daniels v. Atlantic Refining Co.,

295 F. Supp. 125 (D. Del. 1968) ............. [89a]

52a

Appendix E

Diamond Alkali Co. v. Godwin,

112 S.E.2d 365 (Ga. Ct. App. 1959) .......... [89a]

Dole v. Dow Chemical Co.,

316 N.Y.S.2d 348 (N.Y. Sup. Ct. 1970) ....... ~ [89a]

Eaton Fruit Co. v. California Spray-Chemical Corp.,

445 P26: 457 (Aris, 19GE) dsc ie csi ec ss [89a]

Ebers v. General Chemical Co.,

17. WA FPO CR, IDG o's vc cen cdvnecs [86a]

Gonzalez v. Virginia-Carolina Chemical Co.,

239 F. Supp. 567 (D.S.C. 1965)........... [88a, 89a]

Goodyear Atomic Corp. v. Miller,

SOG US: TP CIRO 6 isc adaiads ikexees - [85a]

Grenier v. Vermont Log Buildings, Inc.,

G6 F356 S50 Ci Cae Pe ooo ene lasaeess [71a]

Grey v. Hayes-Sammons Chemical Co.,

S10 FG ore Cet CE: BE 6 od Sn eeiieends [89a]

Griffin v. Planters Chemical Corp.,

302 F. Sepp. 937 (DSA. TSG 665i civ wees [88a]

Hubbard-Hall Chemical Co. v. Silverman,

340 F.2d 402 (Ist Cir. 1965) ............. [88a, 89a]

Ingersoll-Rand Co. v. McClendon,

O56 US. 155 COGN cal eniiandiiies ere [103a]

53a

Appendix E

International Association of Machinists v. Wisconsin

Employment Relations Comm'n,

427 U.S. 132 (1976). oo sv ocasi stcesereee [114a]

Jones v. George,

Gi Tom, SO9 CIT: oon cckiccaskessecewes {86a}

King v. E.J. DuPont de Nemours,

996 F.2d 1346 (ist Cir. 1993) ............... [107a]

Lee v. Madigan,

SOS UI Ca CRO Sika vn ne chk cadet ed ia [75a]

McClanahan v. California Spray-Chemical Co.,

To Gee TEA OCG: BOO in ce SiR eae ee [88a, 89a]

McCrossin v. Noyes Brothers & Cutler,

SFm Ee. Seer Ce, TBI So 6 ics ns tia sens [86a]

Medtronic v. Lohr,

gh k Bey | ere er Ae eee passim

Mossrud v. Lee,

7g 8 ge, Yi. Bh. | Aes yp nee [86a]

Muncy v. Magnolia Chemical Co.,

437 S.W.2d 15 (Tex. Ct. App. 1968).......... [88a]

Oneida County, N.Y. v. Oneida Indian Nation,

gp gl Mee Fh...) Baran pra ero ae [103a]

54a

Appendix E

Oubre v. Entergy Operations, Inc.,

118 S. Cr B38 Ce i hie ews [85a]

Papas v. Upjohn Co.,

985 F.2d 316 (11th Cir. 1993) ...........006. [71a]

Perry Creek Cranberry Corp. v. Hopkins Ag.

Chemical Co., ,

139 N.W.2d 96 (Wisc. 1966) ............. [88a, 89a]

Retail Clerks v. Schemerhorn,

37S US. FOCI) koe cee ae [71a]

Rice v. Santa Fe Elevator Corp.,

S31 02.5. ZI CST) os vaste cd sek ceeeasee [70a]

Rose v. Buffalo Air Service,

104 N.W.2d 431 (Neb. 1960)............055. [89a]

Rumsey v. Freeway Manor Minimax,

423 S.W.2d 387 (Tex. Ct. App. 1968)......... [88a]

Silkwood v. Kerr-McGee Corp.,

464 U.S. 238 (1984) ....... Seveea bee ks Cees [104a]

Stull’s Chemicals, Inc. v. Davis,

263 S.W.2d 806 (Tex. Ct. App. 1953)......... [89a]

Sullivan v. Stroop,

496 U.S. 478 (1990)

55a

Appendix E

Taylor AG Industrial v. Pure-Gro,

54 F.3d 555 (9th Cir. 1995) ............. [7la, 107a]

United States National Bank of Ore. v. Independent

Insurance Agents of America, Inc.,

SOB US. 499.(1993) ... ccsccsedsahitetnda [72a]

United States v. Texas,

FOl Us SAMENOOE) veectictiddcidiavesedes [85a]

Weichert v. American Cyanamid Inc.,

~ Eo a) er eer rere [71a]

West Disinfecting Co. v. Plummer,

44 App. D.C. 345 (D.C. Cir. 1916) ........... [86a]

White v. National Bank of Commerce,

278 P. 915 (Cal. D. Ct. App. 1929) ........... [86a]

Wisconsin Public Intervenor v. Mortier,

ts | BP eee ee eee [64a]

Wise v. Hayes,

ee aE BPS COPE EPOED cievcvuccscavetees [89a]

Worm v. American Cyanamid Co.,

Prades Fe CE GMs CPHOP cvienieesivévece [7la, 107a]

56a

Appendix E

STATUTES, RULES AND REGULATIONS

Federal Insecticide, Fungicide and Rodenticide

Act (FIFRA):

7 Us BEE ode cd oct cacesinswsle eee [86a]

7 Ueda: RHMIEEDS wn ccnbcnssbbidennesstas [77a]

peif Soe 0 | Rr erre rer rer rer passim

paik tem: os; |) rarer ree [78a]

7 UA. TIO 6 oa chert ccdcnceedn [78a]

7 U.S.C. 136a(c)(2)(B)(vili)(I)(A) .:.......... [78a]

7 U.S.C. 136a(c)(2)(B)(vitip(II]) ............. [78a]

7 Ue SE ob 608 ccs chawligides bee [78a]

4 Rs RII 8 oie nc aksutatncdednae [78a]

7 Un SE i heUSb6 ae os connecayasl [78a]

F Us MEE 6 60 5 cdleeccasa cones [78a, 81a]

7 Mes CN 6 hub dee Nase dNnkn bacee [78a, 80a]

7 UBL. EAGAN avin cba ddveecesawsis [78a]

FULDA. SEs 6 cick eccnuvecevens [78a]

F Gees SEE cn hb ods dua nedeveduens [78a]

7 Ul SD 6 8p :8 Kiba cravadasenin [78a]

pps Fae rer perce ys oy [78a]

FU es RE ck ov cus nusndaceeusas [78a, 79a]

peak op rr rer rrr oe [78a, 79a]

pei Fame ON Pere re or rrr ey [78a]

F ses ED n.b.n kd do eeein ceushes [78a]

F OBA, TARR oo 6:0:k0 640 sn btetivxes [78a]

pRi ek eer rer we Pr [78a]

Aik fee Ul rere err [78a] -

7 U.S.C. 136a-1(eK4KAMiv) ........222000. [78a]

F Sb MIE ia nes eedenaveseone (78a, 79a]

pees Food TL Ur rae [78a]

FURL, CS sooo odes [78a]

7 US.C.

7 U.S.C.

7US.C.

7 U.S.C.

7 USS.C.

7 U.S.C.

7 USS.C.

7 U.S.C.

7 US.C.

7 U.S.C.

7 USS.C.

7 U.S.C.

7 US.C.

7 U.S.C.

7 US.C.

7 U.S.C.

57a

Appendix E ree,

136a-1(g)(2)(E)(ii). «2. eee eee eee eee [78a]

136a-1(§) 6. cec sc cives seu ebares [78a]

1S6AQO M2). ice vn cas [79a, 80a, 113a]}

1960(IMSMD) «0a sii eee ens [79a]

196Q(1NE) 25005 eo ETA [79a]

SORES os hhcs ie esdasceeeee [79a, 80a]

IS6QfOM A) i... 6 ike REI. [79a]

SOO kc vk es ieee eee [79a]

CGA ios sess 6 SAS [79a, 80a]

SOOT ick os on ce aes [79a, 80a]

kg rr er ee Poe ree re [79a]

RMD s a'0c cccv abyss eedabd beta) [79a]

SDGetOMIMA) 5 5. 5 is GS: [79a]

LN os i 6 6 ERE E EES oe . [79a]

EIGER o:-v.0 C4 VG Be [79a, 81a]

RD 68 obs Leeks [79a, 80a]

fo || ans eae wee [79a, 80a]

+ «| sy RESO ee a ater Ya [79a, 80a]

Tn 8} eee yer errr re ee [79a, 80a]

RU ik oikn cs ki eeeiea [79a, 80a]

SED GR aos 05 ie SEEs Kees [79a, 80a]

TFIIB) 6 obs es [79a, 80a]

Se) 8 6 isk hades dee esersa [79a]

SD a5 stan ei tabad ea eek [79a]

ee rere ee me ee [79a, 80a]

SAEED chi 3 bed os se Kara [77a, 81a]

Ley ae ne SIA [77a, 81a]

eer Tf ner e Meee een [65a]

Ses kis Soe PRE eda Ts ees passim

RPE Ci buch Wevehae bake peed [79a]

5 RGR er ee Pe we ee mT 7 ery [79a]

SEE Sc wac canon ceeeekeaaesd [80a]

58a

Appendix E

7 USBG. 19GWERIGED oc dcteskscdiaesta [79a, 80a]

0 BK. SIONS si ccacnscoaceseuges [65a, 79a, 102a]

7 UBL. SIGH oc co cvvecsdcvcssseubusees [79a]

F OA BIE oc ccccccévudeaseseveveen [79a]

O Cake ERS oi ccccccccccebunsbeaser [79a, 80a]

FIFRA Regulations:

F CPB. BEBE CII c kee cncccccedcwinssaet [87a]

pets B® RG. | Br, ee [87a]

T Gate CGR CEE é cvicdenccssdiseeabecass [87a]

7 CBee. HERBS CRD oc cccccccnssstoboces [87a]

TCH. SERRE CID 0c cccccsswvessscesan [87a]

F Cite COR OENOTED s cc ccccavbsvedcocess [87a]

T Cae SERRE CR 0 oc ocbcccdvadecseses [87a]

het s Rot, | err rrr [87a]

7 CHa. CGR AED CRP ccc cccccdcctdeoccese [87a]

7 CHR. BGR AOG Gi e boc kc dcckddéddcaseus [87a]

40 C.F.R. 1SG.1QEMAMEMC) 2 occcccccccssecs [112a}

BOC Fs RE aed cvcvsscssvai {[104a,110a,113a} —

GO CF Be ISSUED sc cccccccescs [104a, 110a, 111la}

SOC ks TREE 0c cccccacdicdévecenes [110a]

pet A ee Rl, ee [113a]

pe sk err rr [66a, 82a, 99a]

Other:

44 Fed. Reg. 27932 (May 11, 1979) .......... [110a}

47 Fed. Reg. 40659, 40661 (Sept. 15, 1982).... [110a]

47 Fed. Reg. 53192 (Nov. 24, 1982) .......... [110a]

49 Fed. Reg. 42856 42873-42874 (1984) ...... [112a]

59a |

Appendix E

LEGISLATIVE HISTORY

Bills:

H.R. 10729, 92d Cong., 2d Sess. § 24(1972)... [95a]

H.R. 4152, 92d Cong., Ist Sess. (1971) ....... [92a]

S. 660, 92d Cong., Ist Sess. (1971)........... [92a]

Hearings:

Federal Environmental! Pesticide Control Act:

Hearings Before the Subcomm. on Ag.

Research of the Sen. Comm. on Ag. and

Forestry, 92d Cong., 1* Sess. (1971) [1971

Sen. Ag. Comm. hearing]............... passim

Federal Pesticide Control Act of 1971: Hearings

Before the House Comm. On Ag., 92d Cong.,

1* Sess (1971) [House Ag. Comm. hearings]

“e*eeeeeneeeeeeeneeneneeeeneeneeneneneeneeneeeneeenene

Federal Environmental Pesticide Control Act of

1971: Hearings Before the Subcomm. on the

Environment of the House Comm. on

commerce, 92d Cong., 2d Sess. (1972)

[Sen. Commerce Comm. hearing] ........

eo eve ewww eeneeneneenenwn err eee eh eh eh eh

60a

Appendix E

Federal Environmental Pesticide Control Act:

Hearings Before the Subcomm. on Ag.

Research of the Sen. Comm. on Ag. and

Forestry, 92d Cong., 2d Sess. (1972)

[1972 Sen. Ag. Comm. hearing]... [90a, 95a, 96a]

Committee Reports:

H.R. Conf. Rep. No. 1540, 92d Cong., 2d Sess.

tigre) a> ae [90a, 98a]

S. Rep. No. 838, 92d Cong., 2d Sess. 3 (1972)

a Rs PPT e reer ee passim

S. Rep. No. 970, 92d Cong., 2d Sess. 9 (1972)

[Sen. Commerce Comm.]........ [64a, 90a, 97a]

H.R. Rep. No. 511, 92d Cong., Ist Sess. (1971)

[House Ag. Comm.] ............ [64a, 97a, 98a]

Floor Debates:

117 Cong. Rec. 39,975-39,981 (Nov. 8, 1971)

(House debate)................ [90a, 99a, 100a]

117 Cong. Rec. 40,020-40,068 (Nov. 9, 1971)

(House debate and passage) ...... ear per

118 Cong. Rec. 32,448-32,263 (Sept. 26, 1972)

(Sen. debate and passage)............ [90a, 99a]

6la

Appendix E

118 Cong. Rec. 33,920-33,924 (Oct. 5, 1972)

(Sen. passage of conference report).... [90a, 99a]

118 Cong. Rec. 35,543-35547 (Oct. 12, 1972)

(House passage of conference report) .. [90a, 99a]

MISCELLANEOUS

“Liability of Manufacturer or Seller for Injury

Caused by Animal Feed or Medicine, Crop Sprays,

Fertilizers, Insecticides, Rodenticides, and Similar

Products,” 81 A.L.R. 2d 147 (1962) .......... [87a]

Restatement (Second) of Torts §§ 286-288C ..... [83a]

Robert L. Rabin, “A Sociolegal History of the

Tobacco Tort Litigation,” 44 Stan. L. Rev. 853

(PR hae sacedkks fh eswksapayediehatcidss [85a]

62a

Appendix E

No. 8072524

IN THE SUPREME COURT OF CALIFORNIA

MONIQUE ETCHEVERRY, et al.,

Plaintiffs-Appellants,

TRI-AG SERVICE, INC., BAYER CORP., et al.,

Defendants-Respondents.

ON APPEAL FROM THE COURT OF APPEAL,

THIRD APPELLATE DISTRICT

BRIEF AMICUS CURIAE FOR THE UNITED STATES

IN SUPPORT OF PLAINTIFFS-APPELLANTS

INTEREST OF THE UNITED STATES

This appeal addresses the preemptive effect of 7 U.S.C.

136v, the provision of the Federal Insecticide, Fungicide and

Rodenticide Act (FIFRA) that establishes the authority of

state governments to regulate pesticides. The preemptive

effect of FIFRA implicates at least two important federal

interests. First, the United States has a general interest in

the preemptive force of federal statutes and in properly

delineating the regulatory authorities of the state and federal

governments. Pursuant to that interest, the United States

seeks to ensure that federal law does not deprive individuals

63a

Appendix E

of otherwise available state-law remedies unless Congress

clearly manifested an intent to do so. Second, the United

States Environmental Protection Agency (EPA) is the

primary agency charged by Congress with the administration

of FIFRA. Because FIFRA establishes a broad program of

joint federal-state regulation, EPA’s authority over pesticides

is necessarily affected by the scope of state authority.

Believing that state tort law would be available as a check

on inadequate or false manufacturer statements regarding

pesticide efficacy, EPA approves pesticide labels without

evaluating those claims. Accordingly, the United States has

institutional and programmatic interests in the resolution of

this appeal.

FIFRA’S STATUTORY AND REGULATORY

FRAMEWORK

First enacted in 1947, P.L. 80-103, 61 Stat. 163, FIFRA

established a federal program for the regulation of pesticides.

The 1947 Act required the registration of pesticides with the

Secretary of Agriculture, the display of poison warnings on

the labels of highly toxic pesticides, and the inclusion of

other warning statements to prevent injury to people, animals,

and plants. In 1949, pursuant to his authority under FIFRA,

the Secretary issued substantial pesticide labeling

requirements. See 7 C.F.R. Part 162 (1949). In 1970,

authority for pesticide regulation was transferred to the

newly-created EPA,' which administered the pesticide

labeling requirements imposed by the Department of

Agriculture. See 7 C.F.R. Part 2762 (1971).

1. See Reorganization Plan No. 3 of 1970, section 2(8)(i),

5 U.S.C. Appendix at 610 (1970).

64a

Appendix E

In 1972, largely in response to public concerns over the

pesticide DDT,” Congress enacted sweeping amendments to

FIFRA. Those amendments establish that the primary

purpose of federal pesticide regulation is the protection of

human health and the environment from the risks posed by

pesticides.’ While FIFRA had previously regulated pesticides

primarily through labeling requirements, the 1972 amendments

established federal regulation of pesticide use, an area

previously regulated exclusively by states.‘

As amended by the 1972 amendments, FIFRA

establishes a broad program of federal-state cooperation in

2. See, e.g., Burke v. Dow Chemical Co., 797 F. Supp. 1128,

1134 (E.D.N.Y. 1992) (“The statute was completely overhauled in

1972 * * * in light of concerns over the health risks of DDT and

other chemical pesticides.”); 118 Cong. Rec. 32,259 (statement of

Sen. Neson) (Sept. 26, 1972); id. at 32,262 (statement of Sen.

Tunney); 118 Cong. Rec. 40,038 (statement of Rep. Dow) (Nov. 9,

1971); S. Rep. No. 970, 92d Cong., 2d Sess. 9 (1972); Federal

Environmental Pesticide Control Act: Hearings Before the

Subcomm. on Ag. Research of the Sen. Comm. on Ag. and Forestry,

92d Cong., Ist Sess. 141 (statement of Sen. Nelson) (1971).

3. See Wisconsin Public Intervenor v. Mortier, 501 U.S. 597,

601 (1991) (“In 1972, growing environmental and safety concerns

led Congress to undertake a comprehensive revision of FIFRA.”);

S. Rep. No. 838, 92d Cong., 2d Sess. 3 (1972) (“This bill provides

for the more complete regulation of pesticides in order to provide

for the protection of man and his environment and the enhancement

of the beauty of the world around him.”).

4. See Mortier, 501 U.S. at 601; H. Rep. No. 511, 92d Cong.,

Ist Sess. 4 (1972).

65a

Appendix E

regulating pesticides. Under this program, EPA registers

pesticides for particular uses and approves pesticides labels.

7 U.S.C. 136a(5). FIFRA requires that, in registering

pesticides and approving their labels, EPA must determine

(a) that the pesticide’s “composition is such as to warrant

the proposed claims for it,” (b) that the labeling and other

materials “comply with the requirements” of FIFRA, (c) that

the pesticide “will perform its intended function without

unreasonable adverse effects on the environment,” and

(d) that “when used in accordance with widespread and

commonly recognized practice” the pesticide will not have

unreasonable adverse effects on the environment. /bid.

Pursuant to a 1978 amendment, EPA does not evaluate

pesticide label claims regarding efficacy or otherwise

regulate efficacy in approving pesticide labels. bid.

Under FIFRA, state governments have a substantial role

in regulating pesticides. As the Supreme Court stated, FIFRA

“leaves ample room for States and localities to supplement

federal efforts.” Mortier, 501 U.S. at 613. FIFRA gives states

the lead role in enforcing pesticide use restrictions. 7 U.S.C.

136w-1; see also 7 U.S.C. 136u.

States further retain broad authority to regulate the sale

and use of pesticides:

(a) In general. A state may regulate the sale or

use of any federally registered pesticide or device

in the State, but only if and to the extent the

regulation does not permit any sale or use

prohibited by this subchapter.

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Appendix E

(b) Uniformity. Such State shall not impose or

continue in effect any requirements for labeling

or packaging in addition to or different from those

required under this subchapter.

registration for additional uses of federally

registered pesticides formulated for distribution

and use within that State to meet special local

needs in accord with the purposes of this

subchapter and if registration for such use has not

previously been denied, disapproved, or canceled

by the Administrator.

7 U.S.C. 136(v). Under subsection (a), states may regulate

pesticide sales or use more strictly than the federal

government. Under subsection (c) and accompanying

regulations, states may register pesticides for local uses in

addition to those approved by EPA and may impose

supplemental labeling requirements regarding those

additional uses. See 40 C.F.R. 162.153(e). Under subsection

(b), which is at issue in this appeal, states may not impose

pesticide labeling “requirements” that are “in addition to or

different from” requirements imposed under FIFRA.

SUMMARY OF ARGUMENT

The majority of courts that have examined the question

presented by this case have concluded that FIFRA preempts

all state-law failure to warn actions and all other state-law

tort actions that implicate federally approved pesticide labels.

The United States was not a party in any of those actions

67a

Appendix E

and has not previously expressed an opinion in court on

whether FIFRA preempts state-law damages actions.’ In June

1996, recognizing that the decisions holding that FIFRA

preempts state tort law reflect a widespread misunderstanding

of EPA’s role in regulating pesticides, EPA issued Pesticide

Regulation Notice 96-4 (PR 96-4), which details the process

for registering pesticides under FIFRA. See Addendum. As

PR 96-4 explains, EPA’s approval of a pesticide does not

involve evaluation of pesticide label statements regarding

the product’s efficacy. EPA waived review of efficacy

statements pursuant to express authorization by Congress,

7 U.S.C. 136a(c)(5), and it did so based on its conclusion

that state tort law provides an effective means of ensuring

the adequacy of statements regarding efficacy. Having

published PR 96-4, the United States submits this brief to

more fully inform the Court of its views on the preemptive

force of FIFRA.

FIFRA does not preempt state-law actions for damages.

Section 136v(b) prohibits states from imposing labeling

“requirements” in addition to, or different from, those

imposed under FIFRA. While the term “requirements” may

encompass common law duties in some contexts, the text,

legislative history, and purposes of FIFRA demonstrate

that Congress had no intent that the use of the term

“requirements” in section 136v(b) would extinguish state law

5. The United States’ brief in Mortier stated that “Congress

clearly preempted all but federal regulation of labels.” Brief for the

United States as Amicus Curiae, Wisconsin Public Intervenor v.

Mortier, No. 89-1950 (Oct. Term 1990). The brief did not, however,

take any position on whether state damages actions impose

“requirements” under section 136v(b).

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Appendix E

damages actions. When section 136v(b) was enacted in 1972,

state law actions against pesticide manufacturers for failure

to warn were a commonplace and uncontroversial feature of

the legal landscape. No evidence from the text or legislative

history of FIFRA suggests that Congress had any intent to

extinguish those actions or that Congress even considered

doing so. Indeed, Congress amended FIFRA in 1972 out

of increasing concern for the human health and the

environmental effects of pesticides such as DDT. Given that

FIFRA establishes no private damages remedy for those

injured by pesticides, it would be astonishing that, without

any discussion, Congress could have intended to deprive

injured persons of all means of relief.

Even if FIFRA could be read to preempt some state

damages actions, it cannot be read to preempt tort actions

addressing the efficacy of pesticides. Pursuant to express

congressional authorization, EPA has waived review of

pesticide label statements regarding the efficacy of

pesticides. Congress encouraged EPA to waive efficacy

review in order to streamline the process for federal approval

of pesticides. In authorizing the waiver, Congress anticipated

that the states would fill the regulatory gap. No evidence

suggests that Congress intended to leave the subject of

pesticide efficacy unregulated by both the state and federal

governments. A finding that FIFRA preempts state damages

actions for efficacy-related claims would have a consequence

unintended by Congress: in the area of pesticide efficacy,

there would be not only an absence of federal labeling

regulation but also preemption of state damages claims.

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Appendix E

Even if FIFRA could be read to preempt state damages

actions challenging the claims on pesticide labels regarding

efficacy, it does not preempt damages claims challenging

off-label statements. FIFRA only prohibits states from

imposing “labeling” requirements; damages actions alleging

harm from pesticide advertising, or from oral statements of

pesticide manufacturers, do not impose any “labeling”

requirements. The Supreme Court has repeatedly instructed

that express preemption provisions like section 136v(b) must

be interpreted narrowly and should not be interpreted to

preempt traditional areas of state regulation uniess Congress

manifested a clear intent to effect such preemption. Here,

Congress has only preempted state labeling requirements; it

has not expressed any intent to regulate pesticide

manufacturer statements that do not appear on the label.

The courts that have concluded that FIFRA preempts

state-law damages actions have done so, we respectfully

submit, without fully examining the text, regulatory

background, legislative history, and purposes of FIFRA.

Many important factors not considered by the courts persuade

the United States that FIFRA was not intended to preempt

state-law actions for damages: (1) that Congress did not

establish a federal damages remedy to replace state damages

remedies and that preemption would thus leave individuals

injured by pesticides largely, or entirely, without a remedy;

(2) that Congress drafted section 136v(b) against the existing

regulatory background of FIFRA, which, since 1949, has

included a well-developed body of federal pesticide labeling

requirements, suggesting that Congress only intended to

prevent states from imposing similar labeling requirements;

(3) that Congress drafted section 136v(b) against the existing

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Appendix E

common law background, which, since 1884, has authorized

the imposition of damages for false or inadequate statements

regarding pesticides; (4) that the voluminous legislative

history of section 136v(b) overwhelmingly demonstrates that

Congress was exclusively concerned with preventing

conflicting state regulations of pesticide labeling by state

administrative agencies and that no member of Congress ever

mentioned an intent to preempt state damages actions;

(5) that Congress gave EPA authority to waive review of

pesticide efficacy based on its expectation that states would

fill the regulatory gap; and (6) that, pursuant to congressional

authorization, EPA has waived regulatory review of pesticide

label claims regarding product efficacy when it approves

pesticide labels. Because no court has examined those

factors, the United States believes that its views will assist

this Court in determining FIFRA’s preemptive force.

ARGUMENT

I. FIFRA DOES NOT PREEMPT STATE COMMON

LAW DAMAGES ACTIONS

The Supreme Court has repeatedly emphasized that there

is a “presumption against the pre-emption of state police

power,” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 518

(1992), and that the determination of whether federal law

preempts traditional areas of state authority must therefore

“start with the assumption that the historic police powers of

the States [are] not to be superseded by * * * Federal Act

unless that [is] the clear and manifest purpose of Congress.”

Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).

The presumption against preemption derives from core

principles of federalism, which guarantee states the freedom

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Appendix E

to regulate as independent sovereigns within their traditional

spheres. Medtronic v. Lohr, 518 U.S. 470, 485 (1996).

Moreover, in every preemption case, “[t]he purpose of

Congress is the ultimate touchstone.” /bid. (quoting Retail

Clerks v. Schemerhorn, 375 U.S. 96, 103 (1963)).

The text and history of FIFRA reveal no “clear and

manifest” congressional intent to extinguish state-law actions

for damages.® On the contrary, the text and history

demonstrate that Congress intended only to prevent state

administrative bodies from issuing labeling regulations that

conflicted with federal requirements. No evidence suggests

that Congress ever intended to deprive injured persons of

state-law damages remedies. Moreover, given that FIFRA

establishes no federal damages remedy, preemption of state

tort law would strongly conflict with the central purpose of

the 1972 FIFRA amendments — providing increased public

protection against pesticides.

6. While this case addresses pesticide manufacturers’ liability

for failure to warn, other courts have held that FIFRA preempts any

claim that challenges the adequacy of a pesticide label, including

implied breach of warranty, see, e.g., Worm v. American Cyanimid

Co., 5 F.3d 744, 748 (4th Cir. 1993), Papas v. Upjohn Co., 985

F.2d 516, 518 (11th Cir. 1993); express breach of warranty, see,

e.g., Grenier v. Vermont Log Buildings, Inc., 96 F.3d 559, 563-565

(1st Cir. 1996); Welchert v. American Cyanamid Inc., 59 F.3d 69,

71-73 (8th Cir. 1995); Taylor AG Indus. v. Pure-Gro, 54 F.3d 555,

561 (9th Cir. 1995); strict liability, see, e.g., Papas, 985 F.2d at

518, Arkansas-Platte & Gulf v. Van Waters & Rogers, Inc., 981

F.2d 1177 (10th Cir. 1993); negligence, see, e.g., Papas, 985 F.2d

at 518; Arkansas-Platte, 981 F.2d 1177; design defect, see, e.g.,

Grenier, 96 F.3d at 563-565, Worm, 5 F.3d at 748; and negligent

testing, see, e.g., Taylor, 54 F.3d at 563; Worm, 5 F.3d at 748.

72a

Appendix E

A. As the Supreme Court’s Decisions in Cipollone

and Medtronic Demonstrate, FIFRA’s Preemption

Provision Must Be Read in Its Statutory Context

FIFRA prohibits states from imposing “requirements”

on pesticide labels in addition to those imposed under the

Act. 7 U.S.C. 136v(b). The central issue here is whether the

term “requirements” under section 136v(b) includes state

common law damages actions. The United States does not

dispute the contention that in some contexts the word

“requirements” may encompass obligations imposed through

common law damages actions. The text, legislative history,

and purposes of FIFRA demonstrate, however, that, as it is

used in section 136v(b), the term “requirements” means

direct commands imposed by law regarding the contents of

labels. In this context, the term “requirements” does not

include state damages actions because such actions do not

mandate any changes in labeling.

The Supreme Court has long recognized that the terms

of federal statutes must not be read in isolation but must be

understood in their statutory context.’ In Cipollone v. Liggett

Group. Inc., 505 U.S. 504 (1992), and Medtronic v. Lohr,

518 U.S. 470 (1996), the Supreme Court interpreted two

express preemption provisions that prohibited states from

imposing certain types of “requirements.” Examining the

7. See United States Nat. Bank of Ore. v. Independent Ins.

Agents of America, Inc., 508 U.S. 439, 455 (1993) (quoting United

States v. Heirs of Boisdore, 49 U.S. (8 How.) 113, 122 (1849))

(“ ‘In expounding a statute, we must not be guided by a single

sentence or member of a sentence, but look to the provisions of the

whole law, and to its object and policy.’ ”).

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Appendix E

different statutory contexts, the Court reached different

conclusions as to whether Congress intended the term

“requirements” to encompass state damages actions.

In Cipollone, the Court found that the Public Health

Cigarette Smoking Act of 1969 (the 1969 Cigarette Act)

preempted state common law damages actions for inadequate

labeling. The 1969 Cigarette Act barred states from imposing

any “ requirement or prohibition based on smoking and health

* ** with respect to the advertising or promotion of any

cigarettes.” That provision superseded the preemption

provision of the 1965 Federal Cigarette Labeling and

Advertising Act (the 1965 Cigarette Act), which barred states

from mandating that any “statement” appear on cigarette

advertising. The Court held that the 1965 Cigarette Act’s

bar on promotional “statements” did not preempt state

damages actions. 505 U.S. at 518-520. A four-Justice

plurality concluded that the 1969 Cigarette Act, which

expanded the bar to include promotional “requirements,” did

preempt certain obligations imposed by state common law.

In reaching its conclusion, the plurality credited the

broadening of the statutory language with expressing a

congressional intent to expand the preemptive force of federal

cigarette laws.

In contrast, in Medtronic, the Court found that the

Medical Devices Amendments of 1976 (MDA) did not

preempt state common law damages actions. Like the

preemption provision of the 1969 Cigarette Act, the MDA

prohibited states from imposing “requirements” on medical

devices in addition to federal requirements imposed under

the Act. 21 U.S.C. 360k(a). The Court ruled, however, that

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Appendix E

the MDA did not preempt state common law damages

actions. A four-Justice plurality found that distinct features

of the MDA mandated the conclusion that Congress intended

only to preempt states from imposing positive law

“requirements” on medical devices in the form of regulations

or laws and did not intend to preempt common law damage

actions.* 518 U.S. at 488-89.°

8. The Medtronic plurality found five key differences in the

statutory schemes of the 1969 Cigarette Act and the MDA that

mandated the conclusion that Congress did not intend the word

“requirements” to mean the same thing in both statutes. First, the

preemption of state authority resulting from the 1969 Cigarette Act

prevented only “a limited set of state requirements” — requirements

imposed on advertising regarding the health effects of cigarettes,

while preemption of common law actions as a result of the MDA

would extinguish all state law design defect claims regarding all

medical devices. /d. at 488. Second, the MDA provided no private

damages action that would replace state common law actions. Third,

the MDA’s preemption provision, unlike the 1969 Cigarette Act’s,

expressed congressional concern “with the problem of specific,

conflicting State statutes and regulations rather than the general duties

enforced by common-law actions.” /d. at 489. Fourth, unlike the 1969

Cigarette Act, the MDA uses the word “requirements” in numerous

provisions, and each use clearly refers only to statutory and regulatory

law, not common law. Fifth, the legislative history of the MDA

reveals no reference in the hearings, committee reports, or debates that

suggests a congressional intent to preempt all common-law remedies.

9. Agreeing that the meaning of the term “requirements”

depends on the statutory context, Justice Breyer concurred on the

ground that, as used in the MDA, the word “requirements” is

ambiguous and therefore the Food and Drug Administration, which

administers the MDA, is entitled to deference for its view that state

law is not preempted. 518 U.S. at 503-508.

75a

Appendix E

Cipollone and Medtronic may appear to be in some |

tension but in fact teach the same lesson: that the term

“requirements” must be interpreted in its statutory context.

As the Supreme Court has said, “Only mischief can result if

[the same words appearing in different statutes] are given

one meaning regardless of the statutory context.” Lee v.

Madigan, 358 U.S. 228, 231 (1959). An examination of the

text, legislative history, and purposes of the 1972 FIFRA

amendments reveals that, by preempting state labeling

“requirements,” Congress did not intend to preempt

traditional state damages actions against pesticide

manufacturers for failure to warn.

B. The Text of FIFRA Demonstrates that-Congress

Did Not Intend to Preempt Common Law Actions

FIFRA’s text demonstrates that Congress had no intent

to extinguish damages remedies under state common law.

First, in section 136v, Congress used the term “requirements”

to mean “regulation,” a term connoting positive commands

of law, not court orders to pay damages for the harms caused

by pesticides. Second, the term “requirements” appears in

FIFRA 75 times, and each time refers to direct commands

of law, which state damages actions do not impose. Third,

subsections 136v(a) and (c) demonstrate that Congress

intended to authorize states to take actions that may indirectly

prompt pesticide manufacturers to change their labels;

indirect pressure on pesticide manufacturers to change their

labels, which may result from liability in damages actions,

cannot be characterized as labeling “requirements.”

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Appendix E

1. Under section 136v, the term “requirements”

refers to state commands regarding labeling

content.

Section 136v(b)’s bar on state-imposed labeling

“requirements” must be interpreted in its context as a

subsection of section 136v, the provision of the 1972

amendments entitled “Authority of States.” Without section

136v, state regulation of pesticide use might have been

eliminated by the 1972 amendments. Prior to 1972, the

federal government regulated pesticides primarily through a

registration process requiring federal approval of pesticide

labels. S. Rep. No. 838, 92d Cong., 2d Sess. 3 (1972). The

1972 amendments expanded federal regulation to include

pesticide use, an area previously regulated exclusively by

states. Ibid.

Section 136v clarifies the continuing role of state

governments in pesticide regulation, authorizing states to

regulate pesticides more stringently than EPA. Section

136v(a) thus provides that “[a] State may regulate” the sales

or use of pesticides as long as the state “regulation” does

not permit a sale or use prohibited by FIFRA. Section 136v(b)

forbids “[s]uch state” from regulating labeling by imposing

labeling “requirements” in addition to or different from those

required under FIFRA. The plainest reading of the two

subsections is that a state may “regulate” pesticide sales or

use, but in doing so may not impose labeling “requirements.”

In other words, section 136v(b)’s prohibition on state labeling

“requirements” represents an exception to section 136v(a)’s

general grant of state authority to “regulate” pesticide sales

and use. Congress could only have intended that the term

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Appendix E

“requirements” in section 136v(b) refers to a subset of state

“regulation” in section 136v(a). As a majority of the Court

held in Cipollone, “the term ‘regulation’ most naturally refers

to positive enactments by those bodies, not to common-law

damages actions.” 505 U.S. at 519. Section 136v clearly

preempts state labeling commands, but suggests no

congressional intent to preempt state damages actions.

2. FIFRA’s other references to “requirements”

all refer to direct commands imposed by law,

not the indirect pressure resulting from tort

liability.

The Medtronic plurality interpreted the term

“requirements” in the MDA’s preemption provision by

examining its usages throughout the MDA. In doing so, the

plurality adhered to “the normal rule of statutory construction

that identical words used in different parts of the same act

are intended to have the same meaning.” Sullivan v. Stroop,

496 U.S. 478, 484 (1990) (internal quotation marks omitted).

Throughout FIFRA, the term “requirements” refers

exclusively to positive commands of law. Accordingly, the

term “requirements” should be given the same reading in

section 136v(b).

The term “requirements” appears seventy-five times in

FIFRA, and each time refers only to positive law requirements."

10. See 7 U.S.C. 136(q)(1)(F) (a pesticide is “misbranded” if

its label does not contain “requirements” imposed under FIFRA);

7 U.S.C. 136(q)(1)(G) (same); 7 U.S.C. 136a(b)(2) (unregistered

pesticides may be transferred in accordance with “the requirements

(Cont’d)

78a

Appendix E

(Cont'd)

of an experimental use permit”); 7 U.S.C. 136a(c)(2)(A) (EPA may

establish “standards for data requirements for the registration of

pesticides with respect to minor uses”); 7 U.S.C. 136a(c)(2)(B)(iv)

(suspended pesticide shall be reinstated upon a showing that the

registrant “has complied fully with the requirements that served as

a basis for the notice of intent to suspend”); 7 U.S.C.

136a(c)(2)(B)(viii)(I)(A) (“data requirements” imposed by federal

and state authorities); 7 U.S.C. 136a(c)(2)(B)(vili)(IIL) (“the

Administrator shall develop a process to identify and assist in

alleviating future disparities between Federal and State data

requirements.”); 7 U.S.C. 136a(c)(2)(E) (criteria under which EPA

“may waive otherwise applicable data requirements”); 7 U.S.C.

136a(c)(5)(B) (EPA shall register pesticides if, inter alia, “its labeling

and other material required to be submitted comply with the

requirements of this subchapter”); 7 U.S.C. 136a(c)(6) (denial of

registration for failing to satisfy FIFRA’s “requirements”);

7 U.S.C. 136a(c)(9)(B) (labeling “requirements”); 7 U.S.C.

136a(g)(1)(A) (EPA must follow “the procedures and substantive

requirements of section 136d”); 7 U.S.C. 136a(h) (imposing

“{rjegistration requirements for antimicrobial pesticides”); 7 U.S.C.

136a(h)(3)(A)(ii) (establishing “requirements” for proposed

regulations addressing antimicrobial pesticides); 7 U.S.C.

136a(h)(3)(B)(iii) (establishing “requirements” for final regulations);

7 U.S.C. 136a(h)(3)(C); 7 U.S.C. 136a(h)(4)(B) (data requirements);

7 U.S.C. 136a-1(a)(1) (data requirements); 7 U.S.C. 136a-1(a)(2)

(“requirements of section 136a(c)(5)”); 7 U.S.C. 136a-1(b)(4) (data

requirements); 7 U.S.C. 136a-1(c)(1)(C) (data requirements);

7 U.S.C. 136a-1(e)(1)(A) (“requirements of section 136a”); 7 U.S.C.

136a-1(e)(1)(B) (same); 7 U.S.C. 136a-1(e)(1)(D) (same); 7 U.S.C.

136a-1(e)(4)(A)(iv) (same); 7 U.S.C. 136a-1(f)(1) (data

requirements); 7 U.S.C. 136a-1(f)(1)(B) (same); 7 U.S.C.

136a-1(g)(2)(C) (“requirements of section 136a(c)(5)”); 7 U.S.C.

136a-1(g)(2)(E)(ii) (requirements of the Federal Food, Drug, and

Cosmetic Act); 7 U.S.C. 136a-1(j) (exemption from “the requirements

(Cont'd)

79a

Appendix E

FIFRA establishes “data requirements,”'' “time

(Cont'd)

of subsections (d), (e), (f), and (i)”); 7 U.S.C. 136d(b)(2) (time

requirements); 7 U.S.C. 136d(f)(3)(D) (“data and other requirements”);

7: U.S.C. 136d(f)(4) (data requirements); 7 U.S.C. 136f(a)

(recordkeeping requirements); 7 U.S.C. 136g(c)(1) (civil and

criminal proceedings for failing to comply with requirements of

subchapter); 7 U.S.C. 136i(a)(1) (requirements on state certification

of pest applicators); 7 U.S.C. 136i-1(a) recordkeeping requirements

for certified applicators); 7 U.S.C. 136i-1(e) (requirements of this

section do not affect state or federal laws); 7 U.S.C. 136j(b)(1)

(exemption from penalties for certain persons who comply with

requirements of this subchapter); 7 U.S.C. 136k(b)(3) (seizure of

pesticides that cause harm but comply with requirements of this

subchapter); 7 U.S.C. 136m(a)(2)(A) (indemnity unless registrant

should have known pesticide did not meet requirements for

registration); 7 U.S.C. 136q(a)(1) (data requirements); 7 U.S.C.

136q(a)(1)(B) (label requirements for transportation); 7 U.S.C.

136q(a)(2)(A) (EPA authority to issue regulatory requirements;

7 U.S.C. 136q(a)(2)(B) (same); 7 U.S.C. 136q(a)(2)(C) (same);

7 U.S.C. 136q(a)(3)(A) (same); 7 U.S.C. 136q(a)(3)(B) (same);

7 U.S.C. 136q(a)(3)(C) (same); 7 U.S.C. 136q(f)(1)(B)(iv)

(requirements under Solid Waste Disposal Act); 7 U.S.C.

136q(f)(1)(C) (exemptions from requirements of this subchapter);

7 U.S.C. 136q(f)(3) (requirements of Solid Waste Disposal Act);

7 U.S.C. 136q(h) (same); 7 U.S.C. 136v(b) (state labeling requirements);

7 U.S.C. 136w(a)(2)(C) (time requirements) 7 U.S.C. 136w(b)

(exemption from requirements of this subchapter); 7 U.S.C. 136w(d)

(time requirements); 7 U.S.C. 136w-1(b) (requirements of section

136i); 7 U.S.C. 136w-2(a) (referral to state officials for investigation

consistent with requirements of this subchapter); 7 U.S.C. 136w-5

(state minimum requirements for training applicators).

11. See, e.g., 7 U.S.C. 136a-1(a)(1); 7 U.S.C. 136a-1(b)(4);

7 U.S.C. 136a-1(f)(1); 7 U.S.C. 136d(f)(4); 7 U.S.C. 136q(a)(1).

80a

Appendix E

9912 6

requirements, registration requirements,”'? and

“recordkeeping requirements.”'* FIFRA refers to

“requirements” imposed under other federal and state laws.'°

All of these references to “requirements” clearly encompass

commands imposed by statute or regulation.

FIFRA’s many usages of the term “requirements,”

including section 136v, demonstrate that Congress

understood “requirements” to be a subset of “regulations.”

For example, EPA “may by regulation * * * issue

requirements” regarding pesticide storage and

transportation.'® EPA may “by regulation * * * issue

requirements” for disposing of certain pesticides,'’ pesticide

containers,'* and pesticide container rinsing agents.'°

12. See, e.g., 7 U.S.C. 136d(b)(2); 7 U.S.C. 136w(a)(2)(C);

7 U.S.C. 136w(d)(1).

13. See, e.g., 7 U.S.C. 136a(h).

14. See, e.g., 7 U.S.C. 136f(a); 7 U.S.C. 136i-1(a).

15. See, e.g., 7 U.S.C. 136a-1(g)Z2)E); 7 U.S.C.

136q(f)(1)(B)(iv); 7 U.S.C. 136i-1(e); 7 U.S.C. 136q(h); 7 U.S.C.

136w-5.

16. 7 U.S.C. 136q(a)(2)(A) (emphasis added). See also

7 U.S.C. 136q(a)(3)(A).

17. 7 U.S.C. 136q(a)(2)(B), (C) (emphasis added).

18. 7 U.S.C. 136q(a)(3)(B).

19. 7 U.S.C. 136q(a)(3)(C).

8la

Appendix E

Furthermore, each reference to labeling “requirements”

refers to statutory or regulatory commands. For example,

FIFRA mandates that EPA register a pesticide only if its

labeling complies with the labeling “requirements” imposed

under FIFRA.” FIFRA defines a pesticide to be

“misbranded” if its label does not meet the various

“requirements” imposed under FIFRA.”' Since FIFRA refers

exclusively to labeling “requirements” imposed by regulation,

section 136v(b) cannot be read to encompass voluntary

labeling changes resulting from a state damages action.

As the Medtronic plurality concluded with respect to

the uses of the term “requirements” in the MDA, the uses of

the term “requirements” throughout FIFRA demonstrate that

“its focus is * * * positive law by legislative or administrative

bodies, not the application of general rules of common law

by judges and juries.” 518 U.S. at 489. Specifically, FIFRA’s

usage of the term “requirements” demonstrates (1) that

Congress used the term “requirements” to denote a subset

of “regulations,” a term connoting positive commands of law,

and (2) that Congress understood labeling “requirements”

to refer to labeling con:mands imposed by statute and regulation.

20. 7 U.S.C. 136a(c)(5).

21. 7 U.S.C. 136(q)(1)(F),(G). See also, e.g., 7 U.S.C.

136a(c)(9)(B) (entitled “Requirements,” establishes that pesticide

labels must not “conflict with or detract from any statement required

by law or the Administrator as a condition of registration”) 7 U.S.C.

136a(c)(9)(B); 7 U.S.C. 136q(a)(1)(B) (the Administrator may

impose regulations mandating that “the labeling of a pesticide

contain requirements and procedures for the transportation, storage,

and disposal of the pesticide”).

82a

Appendix E

3. Section 136v addresses state commands

regarding labeling, not state actions that

indirectly pressure pesticide manufacturers

to change their labels.

A state court award of damages for failure to warn does

not mandate any change in labeling. Rather, it merely

requires that a pesticide manufacturer pay money to an

injured person. While a damages award may prompt a

pesticide manufacturer to seek EPA approval for a change

in labeling, it does not directly command such a change.” In

several provisions of FIFRA, Congress authorized states to

apply indirect pressure on pesticide manufacturers to change

their labels. For instance, pursuant to section 136v(a), a state

may prohibit pesticide use or restrict Pesticide sales for any

reason, including the adequacy of warnings. Pesticide use

or sales restrictions may pressure pesticide manufacturers

to seek EPA approval to alter a pesticide label. Alternatively,

a pesticide manufacturer may request EPA approval to

change a pesticide label in order to promote additional

pesticide uses approved by states under section 136v(c) that

have not been approved by EPA pursuant to section

136a(c)(5).7? Damages awards, like use or sale prohibitions,

22. In contrast, an injunction imposed against a manufacturer

to change its label would represent a state-mandated labeling

requirement and would therefore be preempted.

23. Pursuant to their authority under section 136v(c), states

may directly impose supplemental labeling requirements regarding

state-approved local uses. 40 C.F.R. 162.153(e). If the pesticide

manufacturer seeks to alter the label nationally, however, it must

obtain EPA approval.

83a

Appendix E

and state-approved additional uses, may indirectly pressure

pesticide manufacturers to change their labels. But such

indirect pressure cannot reasonably be characterized as

imposing labeling requirements.

Moreover, indirect pressure to change a pesticide label

does not frustrate Congress’s purpose of establishing

nationally uniform pesticide labels. EPA approves only one

label per pesticide. In approving a labeling change, EPA

substitutes a new nationally uniform label. This process is

the same whether the labeling change is prompted by state

damages liability or state regulation authorized by FIFRA.

The concern that state damages awards would impose

requirements that conflict with EPA’s determinations is

unfounded. Damages awards do not impose labeling

“requirements” as that term is used in FIFRA. Furthermore,

in state-law damages actions, EPA’s evaluation and approval

of pesticide label statements may be evidence of the adequacy

of the label or a pesticide manufacturer’s conduct. For

example, where a pesticide manufacturer shows that it

requested EPA approval of a particular label statement and

EPA rejected the request, tort law ordinarily will preclude

the imposition of liability for failing to include the statement.

See Restatement (Second) of Torts §§ 286-288C.** Because

pesticide manufacturers remain free to seek alterations of

their labels, however, EPA approval of a pesticide label

should not completely shield a pesticide manufacturer from

state law liability.

24. In addition, a state judgment imposing liability for failing

to include a label statement that EPA rejected may result in an actual

conflict between state and federal law and may therefore be

precluded as a result of implied preemption analysis.

seer ae

84a

Appendix E

C. The History of FIFRA Demonstrates No

Congressional Intent to Extinguish Actions for

Damages

When section 136v(b) was enacted in 1972, common

law actions against pesticide manufacturers for failure to

warn were widely available and had been held not to conflict

with federal labeling requirements. The legislative history

of the 1972 FIFRA amendments include no suggestion of an

intent to extinguish common law damages actions.”* Indeed,

the legislative history overwhelmingly demonstrates that

Congress enacted section 136v(b) to preclude state

administrative bodies from imposing commands on the

content of pesticide labels, not to alter existing tort remedies.

25. In Medtronic the plurality refused to accept that Congress

intended to preempt common-law damages actions where the

legislative history was devoid of such intent:

There is, to the best of our knowledge, nothing in the

hearings, the committee reports, or the debates

suggesting that any proponent of the legislation intended

a sweeping pre-emption of traditional common-law

remedies against manufacturers and distributors of

defective devices. If Congress intended such a result,

its failure even to hint at it is spectacularly odd.

Medtronic, 518 U.S. at 491. That Congress could intend FIFRA

preemptive force to be so sweeping is no less incredible, given the

total absence of legislative history evincing such intent.

85a

Appendix E

1. When section 136v(b) was enacted, common

law actions against pesticide manufacturers

for failure to warn were a well-recognized

and uncontroversial feature of the legal

landscape.

Section 136v cannot be understood without an

appreciation for the common law in 1972. A court must

“presume that Congress is knowledgeable about existing law

pertinent to the legislation it enacts.” Goodyear Atomic Corp.

v. Miller, 486 U.S. 174, 185 (1988). A court should interpret

a statute to alter existing law only if Congress intended that

result.” Because common law actions for failure to warn

about pesticides were widely available in 1972 and no

evidence hints that Congress intended to eliminate those

actions, a court should not read section 136v to do so.?’

26. See United States v. Texas, 507 U.S. 529, 540-541 (1993)

(Stevens, J., dissenting) (“We presume that Congress understands

the legal terrain in which it operates, * * * and we therefore expect

Congress to state clearly any intent to reshape that terrain.”);

cf. Oubre v. Entergy Operations, Inc., 118 S. Ct. 838, 845-846

(1998) (“[C]ommon-law doctrines ‘ought not to be deemed repealed,

unless the language of a statute be clear and explicit for this

purpose.” ”) (quoting Fairfax’s Devisee v. Hunter’s Lessee, 11 U.S.

(7 Cranch) 603, 623 (1812)).

27. The widespread availability of failure to warn actions

against pesticide manufacturers at the time section 136v was enacted

contrasts sharply with the unavailability of damages actions against

cigarette manufacturers at the time of the enactment of the federal

cigarette labeling statutes at issue in Cipollone. See Robert L. Rabin,

“A Sociolegal History of the Tobacco Tort Litigation,” 44 Stan. L.

Rev. 853 (1992).

86a

Appendix E

Common law actions for inadequate, misleading, or false

representations regarding pesticides were available at least

as early as 1884.”* In the first part of this century, dozens of

reported decisions recognized the availability of actions for

false or inadequate representations regarding pesticides,

including actions based on pesticide labels.”” After FIFRA

was enacted in 1947, the federal government issued

substantial labeling regulations,” but state and federal courts

28. See Jones v. George, 61 Tex. 345 (1884) (action against

the seller of “Royall’s Patent or Receipt for Killing Worms,” which

was represented as effective against cotton worms but which failed

to control the worms).

29. See, e.g., White v. National Bank of Commerce, 278

P. 915 (Cal. D. Ct. App. 1929) (crop damage action against seller

of “Volck Concentrate,” falsely represented to control pests without

harming citrus trees); West Disinfecting Co. v. Plummer, 44 App.

D.C. 345 (D.C. Cir. 1916) (personal injury action against maker of

“Kil-Bug” for allegedly inadequate label); Ebers v. General Chem.

Co., 17 N.W.2d 176 (Mich. 1945) (action for crop damage caused

by inadequately labeled ethylene dichloride emulsion sold to control

peach tree borers); McCrossin v. Noyes Bros. & Cutler, 173 N.W.

566 (Minn. 1919) (wrongful death action against dealer of “Roach

Doom” based on allegedly inadequate label); Mossrud v. Lee, 157

N.W. 758 (Wis. 1916) (action for harm caused by inadequately

labeled “Quack Grass Destroyer”).

30. 7 C.F.R. Part 162 (1949). Those regulations, issued by the

Secretary of Agriculture pursuant to 7 U.S.C. 135d, established that

every pesticide label must prominently contain certain features,

including the name and address of the manufacturer, the net contents

of the pesticide, an “ingredient statement” providing the names and

percentages of active and inert ingredients, directions for use, and

(Cont'd)

87a

Appendix E

uniformly concluded that the federal pesticide labeling

regulations did not alter the availability of state law damages

actions for inadequate labeling. A 1962 annotation of cases

addressing the liability of agricultural chemical

manufacturers stretches over 80 pages and restates the

prevailing rule: “It is patent that a manufacturer of animal

feed or medicine, or of an insecticide, or of other similar

products, may, in some circumstances be held to a duty to

give warning regarding his product.”

Case law uniformly recognized that FIFRA’s labeling

requirements did not conflict with the obligation to pay

(Cont'd)

certain cautionary or warning statements. 7 C.F.R. 162.6, 162.7,

162.103 (1949). The regulations included requirements specifying

the size, typeface, and position of the required pesticide label features.

See, e.g., 7 C.F.R. 162.102 (1949) (product name); 7 C.F.R. 162.103

(1949) (ingredient statement); 7 C.F.R. 162.104 (1949) (net contents);

7 C.F.R. 162.105 (1949) (directions for use). Pesticides found to be

highly toxic under 7 C.F.R. 162.8 (1949) were required to bear a label

with the skull and crossbones symbols, the word “poison” in red lettering

against a contrasting background, and provide emergency precautions.

7 C.F.R. 162.6, 162.9 (1949). The regulations further established

pesticide-specific warning statements. See, e.g., 7 C.F.R. 162.112

(1949) (benzene hexachloride); 7 C.F.R. 162.113 (1949) (household

fly sprays); 7 C.F.R. 162.114 (1949) (DDT). With various additions,

those labeling requirements continued in force at the time that

Congress enacted section 136v(b) and continue in force today.

See 7 C.F.R. Part 2762 (1971); 7 C.F.R. Part 156 (1998).

31. Annotation, “Liability of Manufacturer or Seller for Injury

Caused by Animal Feed or Medicine, Crop Sprays, Fertilizers,

Insecticides, Rodenticides, and Similar Products,” 81 A.L.R.2d 147

(1962).

88a

Appendix E

damages in tort law for failure to warn. Thus, in a wrongful

death action against an insecticide manufacturer, the First

Circuit concluded that federal labeling approval “merely

satisfied” federal law, but did not certify that defendant had

met the standard of due care imposed by the state law.

Hubbard-Hall Chem. Co. v. Silverman, 340 F.2d 402, 405

(1st Cir. 1965). The court plainly recognized that FIFRA

did not occupy the field of pesticide regulation. /bid. Far

from preempting state tort law, FIFRA’s labeling

requirements were widely understood to set minimum

standards of care without otherwise altering state common

law.*?

By 1972, when section 136v(b) was enacted, nearly

every state and federal jurisdiction recognized pesticide

32. See, e.g., Griffin v. Planters Chem. Corp., 302 F. Supp.

937, 944 (D.S.C. 1969) (“Aside from the requirements set forth for

the label by the Secretary of Agriculture, he had a duty to use a

label, or furnish a warning commensurate with the danger.”);

Gonzalez v. Virginia-Carolina Chem. Co., 239 F. Supp. 567, 572

(D.S.C. 1965) (“Even had the defendant not failed to warn the public

as it was required to do by the Federal and State law, it is my opinion

that the manufacturer of a hazardous material is under a common

law duty to * * * give adequate warning.”); Muncy v. Magnolia

Chem. Co., 437 S.W.2d 15, 19 (Tex. Ct. App. 1968) (“The statutes

and regulations set minimum standards for those marketing economic

poisons.”) Rumsey v. Freeway Manor Minimax, 423 S.W.2d 387,

394 (Tex. Ct. App. 1968) (FIFRA does not “purport[ ] to change

the common law duty to warn. * * * We are of the view that [FIFRA

and its regulations] merely set minimum standards.”); McClanahan

v. California Spray-Chem. Co., 75 $.E.2d 712 (Va. 1953) (violation

of FIFRA is negligence per se in state common law tort action);

Perry Creek Cranberry Corp. v. Hopkins Ag. Chem. Co., 139

N.W.2d 96, 102 (Wisc. 1966) (same).

89a

Appendix E

manufacturer and dealer liability both for personal injuries

and crop damage resulting from the failure to provide

adequate warnings.” Courts uniformly agreed that such

actions did not conflict with federal labeling requirements.

In the absence of evidence that Congress intended to alter

then-existing law, FIFRA should not be interpreted to do so.

2. FIFRA’s legislative history reveals no intent

to alter the availability of common law

remedies. 3

Section 136v was enacted to delineate state regulatory

authority, not to preempt existing state tort law. In 1971 and

1972, three House and Senate committees devoted 25 days

to hearings on proposed pesticide legislation, the transcripts

33. See, e.g., Hubbard-Hall Chem. Co. v. Silverman, 340 F.2d

402 (1st Cir. 1965) (applying Mass. law); Grey v. Hayes-Sammons

Chem. Co., 310 F.2d 291 (Sth Cir. 1962) {applying Miss. law);

Daniels v. Atlantic Refining Co., 295 F. Supp. 125 (D. Del. 1968)

(applying Delaware law); Gonzalez v. Virginia-Carolina Chem. Co.,

239 F. Supp. 567 (E.D. S.C. 1965) (applying South Carolina law);

Eaton Fruit Co. v. California Spray-Chem. Corp., 445 P.2d 437

(Ariz. 1968); Diamond Alkali Co. v. Godwin, 112 S.E.2d 365 (Ga.

Ct. App. 1959); Bean v. Diamond Alkali Co., 454 P.2d 69 (Idaho

1969); Rose v. Buffalo Air Service, 104 N.W.2d 431 (Neb. 1960);

Dole v. Dow Chem. Co., 316 N.Y.S.2d 348 (N.Y. Sup. Ct. 1970);

Corprew v. Geigy Chem. Corp., 157 8.E.2d 98 (N.C. 1967); Stull’s

Chems., Inc. v. Davis, 263 S.W.2d 806 (Tex. Ct. App. 1953);

McClanahan v. California Spray-Chem Corp., 75 S.E.2d 712 (Va.

1953); Wise v. Hayes, 361 P.2d 171 (Wash. 1961); Perry Creek

Cranberry Corp. v. Hopkins Ag. Chem. Co., 139 N.W.2d 96 (Wisc.

1966).

90a

Appendix E

of which fill over 2,300 pages.** Each committee issued a

report, filling over 275 pages.**> A conference committee

issued a 34-page report.*® Floor debates occurred over five

days, the transcript of which fills over 150 pages in the

Congressional Record.*’ In those thousands of pages of

34. Federal Pesticide Control Act of 1971: Hearings Before

the House Comm. on Ag., 92d Cong., Ist Sess (1971) [hereinafter

House Ag. Comm. hearing]; Federal Environmental Pesticide

Control Act: Hearings Before the Subcomm. on Ag. Research of

the Sen. Comm. on Ag. and Forestry, 92d Cong., Ist Sess. (1971)

{hereinafter 1971 Sen. Ag. Comm. hearing]; Federal Environmental

Pesticide Control Act: Hearings Before the Subcomm. on Ag.

Research of the Sen. Comm. on Ag. and Forestry, 92d Cong., 2d

Sess. (1972) [hereinafter 1972 Sen. Ag. Comm. hearing]; Federal

Environmental Pesticide Control Act of 1971: Hearings Before the

Subcomm. on the Environment of the House Comm. on Commerce,

92d Cong., 2d Sess. (1972) [hereinafter Sen. Commerce Comm.

hearing].

35. H.R. Rep. No. 511, 92d Cong., Ist Sess. (1971) [hereinafter

House Ag. Comm. report]; S. Rep. No. 838, 92d Cong., 2d Sess.

(1972) [hereinafter Sen Ag. Comm. report]; S. Rep. No. 838

(Supplemental Report), 92d Cong., 2d Sess. (1972) [hereinafter

Supplemental Sen. Ag. Comm. report]; S. Rep. No. 970, 92d Cong.,

2d Sess. (1972) [hereinafter Sen. Commerce Comm. report}.

36. H.R. Conf. Rep. No. 1540, 92d Cong., 2d Sess. (1972).

37. 117 Cong. Rec. 39,975-39,981 (Nov. 8, 1971) (House

debate); 117 Cong. Rec. 40,020-40,068 (House debate and passage);

118 Cong. Rec. 32,448-32,263 (Sept. 26, 1972) (Sen. debate and

passage); 118 Cong. Rec. 33,920-33,924 (Oct. 5, 1972) (Sen. passage

of conference report); 118 Cong. Rec. 35,543-35,547 (Oct. 12, 1972)

(House passage of conference report).

9la

Appendix E

hearings, reports, and floor debates, there is no suggestion

that the 1972 amendments to FIFRA would preempt state

tort law.

a. The committee hearings. The most extensive

discussion of what became section 136v occurred in the

committee hearings, when the provision was first drafted.

Testifying on behalf of the Administration and EPA, which

drafted the bill that formed the basis of the 1972 amendments,”*

EPA’s General Counsel emphasized that the bill was intended

to authorize state agencies to continue to regulate pesticide

use more strictly than the federal government:

I would like to emphasize that the States have

played a major and continuing role in pesticides

regulation. * * * We wish to encourage and not

supplant these efforts by providing that States may

prohibit the use of a particular pesticide within

their jurisdiction even if the pesticide is registered

under the Federal authority. States thus are not

precluded from imposing stricter standards or

added requirements, but they may not permit any

sale or use of a pesticide which is prohibited under

the authority of the Act.

House Ag. Comm. hearing at 8 (statement of EPA General

Counsel John Quarles).*?

38. See Sen. Ag. Comm. report at 9.

39. See also id. at 740 (statement of EPA Administrator

William D. Ruckelshaus) (“I think [the federal government] ought

(Cont'd)

92a

Appendix E

As originally drafted, the Administration’s bill did not

include an express provision addressing the continuing

regulatory authority of the states.*° Representatives of state

agencies feared, however, that the absence of a provision

expressly preserving state authority might be construed

to oust them completely from any regulatory role,

notwithstanding a contrary congressional intent. The

representative of the National Association of State

Departments of Agriculture thus stated: “It is our feeling

that it will be better for Congress to clearly indicate its

intentions in this bill rather than leaving this area a glaring

omission and have a battery of fellow lawyers and courts

trying to answer these questions later on.””*!

(Cont’d)

to set certain base levels of use for the pesticides * * * and the States

can set stricter limits if they so desire.”); 1971 Sen. Ag. Comm.

hearing at 293 (statement of EPA Administrator Ruckelshaus).

40. See S. 660, 92d Cong., Ist Sess. (1971), reprinted in 1971

Sen. Ag. Comm. hearing at 7-110; H.R. 4152, 92 Cong., Ist Sess.

(1971), reprinted in House Ag. comm. hearing at 859-904.

41. 1971 Sen. Ag. Comm. hearing at 338. See also House Ag.

Comm. hearing at 517 (statement of Dr. Charles P. Ellington) (unless

the states’ role is clarified “I can almost predict with certainty that

in a matter of a few years, there will be no State registration programs

at all”); id. at 851 (letter from H.L. Bruer, Tennessee Dept. of Ag.)

(“[W]e do not believe that the pre-emption of the field of pesticide

registration and management is either necessary or desirable.”’); 1971

Sen. Ag. Comm. hearing at 336 (statement of Dr. Ellington) (without

amendment the bill “would completely preempt State registration

and if enacted and enforced as written there would no longer be any

(Cont'd)

93a

Appendix E

Representatives of the pesticide manufacturers also

advocated the inclusion of an express provision clarifying

the role of the state agencies.“* They were concerned that

state authority to regulate pesticide sales and use more strictly

than the federal government might be construed to authorize

state agencies to impose labeling regulations. One witness

described the problems that might result from conflicting

state regulations: “Some states might want the word

‘flammable,’ some ‘inflammable.’ * * * Some States might

want red lettering; others orange, another yellow, and so

(Cont'd)

need for State registration laws”); id. at 486 (statement of W.A.

Ruffin, Alabama Dept. of Ag.) (expressing concern that the

“implication” of the bill is that the “Federal Government is the only

agency in the Nation competent to handle” pesticide regulation);

id. at 494 (statement of John Kirkpatrick, Alabama Dept. of Ag.)

(stating that the bill should be clarified to give states the right to

enact stricter regulations than the minimum federal standard); id. at

498 (statement of J.R. Conley, Georgia Dept. of Ag.) (expressing

concern about the implication of federal preemption of state

regulation).

42. See House Ag. Comm. hearings at 334 (statement of Parke

C. Brinkley, President, National Agricultural Chemicals Assn.)

(“[T]here should also be included in the bill a determination that it

preempts the field of pesticide regulations.”); id. at 355 (stating that

a preemption provision would clarify that FIFRA establishes “a

minimum standard” and that “some States will want greater

enforcement”); 1971 Sen. Ag. Comm. hearing at 418 (statement of

Parke C. Brinkley, President, National Agricultural Chemicals

Assn.) (“Congress should find that this system preempts the field of

pesticide regulation subject to * * * authorizing State officials to

impose additional regulatory requirements.”).

94a

Appendix E

forth.”* In other testimony, pesticide manufacturers asserted

that uniform labeling would alleviate the expense of

producing multiple labels.“ EPA agreed that there was a need

for uniformity.*

Representatives of both the pesticide manufacturers and

the state agriculture agencies submitted proposed preemption

43. House Ag. Comm. hearing at 282-283 (statement of Robert

L. Ackley); 1971 Sen. Ag. Comm. hearing at 510 (statement of

Arthur B. Chivvis, President of Chemical Specialties Manufacturers

Assn.); id. at 509 (same).

44. 1971 Sen. Ag. Comm. hearing at 509 (statement of Arthur

B. Chivvis) (“The next portion of this bill that we would like to

consider with the committee is the need for uniformity in the labeling

and registration of household pesticides. Aerosol cans are usually

lithographed, a rather expensive process * * *. To invite States to

ignore the Federal registration and impose their own separate

requirements on the label of these products would create a

nightmare.”).

45. EPA Administrator William D. Ruckelshaus testified:

A number of States are strengthening their [pesticide]

programs * * *. If the Federal Government does not

move ahead and modernize its pesticide legislation,

there is a possibility that there will be a large number

of differing pesticide regulatory programs in the

country, causing problems for consumers and industry

alike, because of the lack of uniform requirements in

various jurisdictions.

1971 Sen. Ag. Comm. hearing at 297.

95a

Appendix E

provisions.** Characterized by EPA as specifying “the

pesticide regulatory authority retained by the States,”*’ the

preemption provision enacted as 7 U.S.C. 136v represented

a compromise acceptable to the pesticide manufacturers, the

state regulators, and the Administration.** Section (a)

effectuates EPA’s intent to authorize states to regulate the

sale and use of pesticides more strictly than the federal

government. Section (b) effectuates the pesticide

manufacturers’ desire to prohibit states from imposing

labeling requirements in addition to, or different from, those

imposed by EPA. And section (c) carries forth the state

regulatory agencies’ desire for authority to register pesticides

for local uses not authorized by EPA.”

46. See House Ag. Comm. hearing at 344 (amendment

submitted by the National Agricultural Chemicals Assn.); id. at 829

(amendment submitted by Errett Deck, Wash. Dept. of Ag.).

See also id. at 796 (amendment submitted by the American Frozen

Food Institute).

47. 1972 Sen. Ag. Comm. hearing at 93.

48. See 1972 Sen. Ag. Comm. hearing at 93 (statement of

David D. Dominick, EPA Assistant Administrator); id. at 153-154

(statement of Charles H. Frommer, New York Dept. of Environmental

Conservation) (“We very strongly favor the provision of section

24(b) which provides for uniform labeling.”); Sen. Commerce

Comm. hearing at 135 (statement of David A. Phillipson, Vice

President, National Agricultural Chemicals Assn.).

49. See H.R. 10729, 92d Cong., 2d Sess. § 24 (1972), reprinted

in 1972 Sen. Ag. Comm. hearing at 69-70.

96a

Appendix E

The hearings reveal that Congress had no intent to

preempt state tort law. EPA’s General Counsel, testifying

as the first witness in the first hearing, stated unequivocally:

“The bill does not affect tort liability.”°° No one disagreed.

No witness or Member of Congress suggested that FIFRA

would alter common law duties or affect the availability of

tort damages. In three other instances, pesticide industry

representatives mentioned, offhandedly, that product liability

lawsuits had been brought against their companies,*' but none

of the 250 witnesses, including the 36 pesticide industry

witnesses, or any Member of Congress, suggested that

Congress should protect the pesticide industry from such

actions. Thus, in 2,389 pages of committee hearing

transcripts, the subject of common law tort actions was raised

exactly five times, and not once in the context of preemption.

The discussion of preemption, in contrast, exclusively

50. House Ag. Comm. hearing at 42. The statement responded

to a question posed by House Agriculture Committee Chairman W.R.

Poage, which Mr. Quarles understood as being directed at state tort

law but which Rep. Poage clarified was addressed to FIFRA’s

statutory civil penalties.

51. See House Ag. Comm. hearing at 415 (statement of John

G. Kuniholm, Senior Counsel for Hercules, Inc.); 1971 Sen. Ag.

Comm. hearing at 467 (statement of William L. Brehm, President,

United Pesticide Formulators & Distributors Assn.); id. at 505

(statement of Ralph E. Heal, Executive Secretary, National Pest

Control Assn.). In addition, a witness appearing on behalf of migrant

farmers suggested that EPA regulations “facilitate the conduct of

law suits” by providing “some evidence of what the standard of

care is.” 1971 Sen. Ag. Comm. hearing at 314 (statement of Kevin

Carey, Deputy Director, Migrant Legal Program).

97a

Appendix E

addressed the ongoing regulatory authority of state

administrative agencies.

b. The committee reports. The four House and Senate

Committee reports describe in detail the changes that the

1972 amendments would bring to federal pesticide

regulation. The reports agree that “[t]he thrust of these

amendments is to change FIFRA from a labeling law into a

comprehensive regulatory statute that will henceforth more

carefully control the manufacture, distribution, and use of

pesticides.”*? The reports discuss the continuing authority

of state agencies to regulate pesticide use* and emphasize

that the amendments establish a “coordinated Federal-State

administrative system to carry out the new program.”™ In

this scheme, states have prime enforcement responsibility

and “the Federal Government sets the program standards.”**

52. House Ag. Comm. report at 1. See also Sen. Ag. Comm.

report at 1-2; Sen. Commerce Comm. report at 8.

53. See House Ag. Comm. report at 1-2, 16, 28; Sen. Ag.

Comm. report at 2, 30; Supplemental Report of the Comm. on Ag.

and Forestry, 92d Cong., 2d Sess. 51-52 (1972); Sen. Commerce

Comm. report at 7, 29-30, 44.

54. House Ag. Comm. report at 1. See also Sen. Ag. Comm.

report at 2, 29-30; Sen Commerce Comm. report at 44.

55. House Ag. Comm. report at 1. See also id. at 16 (“[T]}he

States would also be precluded from adopting programs which are

less stringent than the Federal standards.”); id. at 28 (“Generally,

the intent of the provision is to leave the States the authority to

impose stricter regulation on pesticides use than that required under

the Act.”); Sen. Ag. Comm. report at 30; Sen. Commerce Comm.

report at 7, 29, 44.

98a

Appendix E

Each report summarizes the changes made by the bill, but

none mentions any intent to preempt state damages actions.*°

The reports barely touch on the preemption of state

authority to impose additional or different labeling

requirements. Each of the Senate reports contains only a

single sentence on the subject: “Subsection (b) preempts any

State labeling or packaging requirement differing from such

requirements under the Act.”*’ The House Agriculture

Committee report contains two additional sentences: “State

authority to change Federal labeling and packaging is

completely preempted. * * * [T]he Committee has adopted

language which is intended to completely preempt State

authority in regard to labeling and packaging.””**

The House Agriculture Committee’s intention to

“completely preempt” state labeling authority cannot

reasonably be read to express a congressional intent to

extinguish damages actions. First, the committee’s

preemption discussion exclusively addressed the preemption

of state regulatory authority without remotely addressing the

56. See House Ag. Comm. report at 1-2, 12-13; Sen. Ag.

Comm. report at 1-2, 5-6; Sen. Commerce Comm. report at 8.

57. Sen Ag. Comm. report at 30; Sen. Commerce Comm. report

at 44.

58. House Ag. Comm. report at 1-2, 16. The Conference

Committee Report to the 1972 amendments contains no mention of

state authority under the amendments, the preemption provision, or

state common law. H.R. Conf. Rep. No. 1540, 92d Cong., 2d Sess.

(1972).

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Appendix E

preemption of damages actions. Second, under the case law

in 1972, state common law damages actions were not

interpreted to impose labeling requirements. Third, as discussed

below, Congress ultimately rejected the preemption provision

written by the House Agriculture Committee that would have

diminished the states’ authority to regulate pesticide sales

and use. The preemption provision adopted as section 136v

is the Senate’s, not the House committee’s. Furthermore,

pursuant to the preemption provision enacted by Congress,

states may approve local uses of pesticides in addition to

those approved by EPA and may impose supplementary

labeling requirements regarding those additional uses.

See 40 C.F.R. 162.153(e). Thus, it is simply not true that

FIFRA completely preempts state labeling authority.

c. The floor debates. The House and Senate debated

the 1972 FIFRA amendments over five days.*® Like the

committee hearings and reports, the floor debates reveal no

suggestion of a congressional intent to preempt state tort law.

The preemption provision was not mentioned on the floor

of the Senate. Summarizing the amendments,” no Senator

59. See 117 Cong. Rec. 39,975-39,981 (Nov. 8, 1971) (House

debate); 117 Cong. Rec. 40,020-40,068 (House debate and passage);

118 Cong. Rec. 32,448-32,263 (Sept. 26, 1972) (Sen. debate and

passage); 118 Cong. Rec. 33,920-33,924 (Oct. 5, 1972) (Sen. passage

of conference report); 118 Cong. Rec. 35,543-35,547 (Oct. 12, 1972)

(House passage of conference report).

60. See 118 Cong. Rec. 32,256 (Sept. 26, 1972) (statement of

Sen. Allen) (“Mr. President, this bill does two things. First, it

(Cont’d)

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Appendix E

mentioned the preemption of state tort law. The preemption

provision was, however, debated at length on the floor of

the House. Unlike the Senate bill, the House bill would have

prohibited states from regulating certain pesticides more

strictly than EPA.*' An amendment was adopted eliminating

the restriction.” Nowhere in the debate on the amendment

is there a suggestion that the preemption provision would

affect state tort law.

The House debate on another provision, section 136m,

demonstrates that Congress anticipated the availability of

state damages actions for the harms caused by pesticides.

Section 136m requires the government, upon canceling

pesticide registration, to indemnify pesticide manufacturers,

dealers, and users, for the cost of purchasing pesticides made

unusable by the cancellation. Several House Members feared

that the indemnity provision would transform the United

(Cont'd)

provides for regulating the use of pesticides, as distinguished from

their labeling and interstate distribution. Second, it extends pesticide

regulation to interstate commerce.”). See also 117 Cong. Rec. 39,975

(Nov. 8, 1971) (statement of Rep. Sisk); ibid. (statement of Rep.

Latta); 117 Cong. Rec. 39,976-39,977 (Nov. 8, 1971) (statement of

Rep. Poage); 117 Cong. Rec. 40,067 (Nov. 9, 1971) (statement of

Rep. Mizell); 118 Cong. Rec. 32,256 (Sept. 26, 1972) (statement of

Sen. Allen); id. at 32,260; 118 Cong. Rec. 35,545 (Oct. 12, 1972)

(statement of Rep. Ky).

61. See 117 Cong. Rec. 40,027 (Nov. 9, 1971) (reprinting

committee bill).

62. 117 Cong. Rec. 40,065 (Nov. 9, 1971).

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Appendix E

States into an insurer of pesticides.® Proponents of the indemnity

provision assuaged this fear by explaining that the indemnity

payment would cover only the costs of owning unusable

products™ and would not insure against common law tort

actions: “It has nothing to do with losses they might have

suffered because of any damage done by the pesticides through

food and fiber to their neighbors or someone down the street.”

Rather than reveal an intent to extinguish existing

state-law damages remedies, the legislative history of the

1972 FIFRA amendments is replete with evidence that

Congress understood and intended that state damages actions

would remain available.

D. Preemption of State Tort Law Would Conflict

with the Purposes of the 1972 FIFRA

Amendments

The 1972 FIFRA amendments were enacted to address

growing public concern with the environmental and public

63. See 117 Cong. Rec. 40,046 (Nov. 9, 1971) (statement of

Rep. Evans); 117 Cong. Rec. 40,050 (Nov. 9, 1971) (statement of

Rep. Dickinson); 117 Cong. Rec. 40,055 (Nov. 9, 1971) (statement

of Rep. Brasco).

64. 117 Cong. Rec. 40,051 (Nov. 9, 1971) (statement of

Rep. Poage); 117 Cong. Rec. 40,052 (Nov. 9, 1971) (statement of

Rep. Teague); 117 Cong. Rec. 40,053 (Nov. 9, 1971) (statement of

Rep. Abernathy);

65. 117 Cong. Rec. 40,052 (Nov. 9, 1971) (statement of

Rep. Teague).

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Appendix E

health effects of pesticides such as DDT. As the Senate

Agriculture Committee report explains, “The bill provides

for the more complete regulation of pesticides in order to

provide for the protection of man and his environment and

the enhancement of the beauty of the world around him.”®

Congress knew of the harms caused by pesticides: the

committees heard different estimates of the number of deaths

and injuries attributable to pesticides, ranging from 200 to

800 deaths per year, and 60,000 to 80,000 injuries.°’ Congress

was also aware that state damages actions provided a remedy

for those injuries, meaning that FIFRA need not provide a

private cause of action for damages. Likewise, FIFRA does

not establish an exclusive federal enforcement scheme.

Instead, FIFRA delegates to the states primary enforcement

responsibilities. See 7 U.S.C. 136w-1.

66. Sen. Ag. Comm. report at 3. See also Sen. Commerce

Comm. report at 9 (“[S]ociety has become increasingly sensitive to

the abuses certain pesticides have inflicted upon man and the

environment.”)

67. See House Ag. Comm. hearing at 708 (statement of Russell

Train, Chairman, President’s Council on Environmental Quality)

(estimating that pesticides were involved in 200 deaths and 60,000

injuries a year); Sen. Ag. Comm. hearing at 161 (same); id. at

168-171 (reprinting Wayland J. Hayes, “Occurrence of Poisoning

by Pesticides”); id. at 172-186 (reprinting Wayland J. Hayes,

“Mortality from Pesticides in 1961”); id. at 506 (National Pest

Control Association analysis of pesticide-related accidents);

Sen. Commerce Comm. hearing at 87 (statement of A.V. Krebs,

Agribusiness Accountability Project) (discussing harms caused by

parathion); id. at 96 (statement of Sen. Nelson) (discussing pesticide

poisoning case); id. at 170 (statement of Sen. Inouye) (discussing

studies of nerve damage caused by pesticides).

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Appendix E

These three facts — the absence of a federal private

damages remedy, Congress’s awareness of state damages

remedies, and Congress’s decision to give the states the

primary enforcement authority under FIFRA — strongly

imply that Congress did not intend to preempt state common

law damages remedies.“ Given that the 1972 amendments

to FIFRA were intended to provide increased public

protection against the harms caused by pesticides, it would

make no sense to infer that Congress intended to close off

all avenues of judicial relief for those injured by pesticides.

The Medtronic plurality rejected similar arguments in

interpreting the MDA. Absent a federal private cause of

action, preemption of state damages actions would effectively

bar relief to persons injured by defective medical devices

and “have the perverse effect of granting complete immunity

from design defect liability to an entire industry that, in the

judgment of Congress, needed more stringent regulation

** * "518 U.S. at 487. Such an interpretation contravened

Congress’s purpose and intent:

It is to say the least, “difficult to believe that

Congress would, without comment, remove all

68. Compare American Airlines, Inc. v. Wolens, 513 U.S. 219

(1995) (finding that, because the Airline Deregulation Act does not

establish exclusive federal remedies, state common law actions are

not preempted) with /ngersoll-Rand Co. v. McClendon, 498 U.S.

133, 143-145 (1990) (finding that ERISA’s comprehensive civil

enforcement scheme supports preemption of common-law wrongful

discharge claims). Cf. Oneida County, N.Y. v. Oneida Indian Nation,

470 U.S. 226, 236-237 (1985) (federal statutes do not extinguish

federal common law unless “the statute speaks directly to the

question otherwise answered by federal common law’).

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Appendix E

means of judicial recourse for those injured by

illegal conduct.” Silkwood v. Kerr-McGee Corp.,

464 U.S. 238, 251 (1984), and it would take

language much plainer than the text of § 360k to

convince us that Congress intended that result.

518 U.S. at 487. Similarly, Congress did not anticipate that

FIFRA would eliminate relief for persons harmed by

pesticides. FIFRA’s preemptive force should not be

interpreted to undermine the statutory purpose to provide

increased protection from harmful pesticides.

Il. SECTION 136v(b) DOES NOT PREEMPT

COMMON LAW ACTIONS ADDRESSING

MATTERS SUCH AS PESTICIDE EFFICACY

UNREGULATED BY EPA

Even if FIFRA’s prohibition on state labeling

“requirements” can be read to preempt some state damages

actions, it cannot be read to preempt damages actions

regarding pesticide efficacy? because such actions do not

impose labeling requirements “in addition to or different

from” those imposed by FIFRA. FIFRA contains a general

prohibition against “misbranding” of pesticide labels, which

establishes that a label violates FIFRA if it 1s “false or

misleading,” contains inadequate “directions for use,” or

omits a necessary “warning or caution statement.” 7 U.S.C.

69. The efficacy of pesticides depends on two variables:

(1) whether the pesticide controls the target pest and (2) whether

the pesticide does no harm to the target crop. EPA refers to the first

aspect of efficacy as “product performance,” 40 C.F.R. 158.640(b),

and the second aspect as “phytotoxicity.” 40 C.F.R. 158.540.

10Sa

Appendix E

136(q). In registering pesticides, EPA evaluates whether label

statements addressing human health and the environment

comply with the misbranding prohibition. With express

congressional approval, however, EPA registers pesticides

without evaluating the truthfulness or adequacy of label

statements addressing pesticide efficacy, including any

warnings that address potential crop damage. In the absence

of federal evaluation of efficacy statements, the only

applicable federal “requirement” governing such statements

is the general prohibition against misbranding. Because the

common law duty to warn imposes nearly identical

obligations,” the common law duty is not “in addition to or

different from” a federal requirement and thus is not

preempted by FIFRA.

In Medtronic, the Supreme Court unanimously agreed

that, when state law parallels federal law, state law is not

“different from, or in addition to” federal law and therefore

is not preempted under the MDA. As the plurality stated,

the MDA does not preempt state authority “to provide a

traditional damages remedy for violations of common-law

duties when those duties parallel federal requirements.” 518

U.S. at 495. The dissent similarly concluded that “[t]o be

sure, the threat of a damages remedy will give manufacturers

an additional cause to comply, but the requirements imposed

70. See Restatement (Third) of Torts § 2 (1998) (“A product

*** is defective because of inadequate instructions or warnings

when the foreseeable risks of harm posed by the product could have

been reduced or avoided by the provision of reasonable instructions

or warnings by the seller or other distributor, or a predecessor in the

commercial chain of distribution, and the omission of the instructions

or warnings renders the product not reasonably safe.”).

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Appendix E

on them under state and federal law do not differ.” Jd. at 513

(O’Connor, J., dissenting). See also id. at 505 (Breyer, J.,

concurring).”' Applying the Medtronic Court’s unanimous

conclusion here, when state law parallels the requirements

imposed under FIFRA, state law cannot be characterized as

imposing requirements “in addition to or different from”

federal requirements. Because the state duty to warn parallels

the federal misbranding prohibition, it is not preempted by

section 136v(b).

Furthermore, because EPA registers pesticides without

evaluating efficacy claims, preemption of state damages

71. In his concurrence in Medtronic, Justice Breyer concluded

that the MDA’s preemption of state authority to impose requirements

“different from, or in addition to” requirements imposed under the

MDA only precludes states from imposing requirements on the same

subjects as federal requirements:

The words “any [state] requirement” and “any [federal]

requirement,” for example, do not tell us which

requirements are at issue, for every state requirement

that is not identical to even one federal requirement is

“different from, or in addition to” that single federal

requirement; yet, Congress could not have intended that

the existence of one single federal rule, say, about a

2-inch hearing aid wire, would pre-empt every state law

hearing aid rule, even a set of rules related only to the

packaging or shipping of hearing aids. Thus, Congress

must have intended that courts look elsewhere for help

as to just which federal requirements pre-empt just

which state requirements, as well as just how they might

do so.

518 U.S. at 505 (bracketed material supplied by Justice Breyer).

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Appendix E

actions challenging pesticide efficacy statements would leave

such statements largely, or entirely, unregulated. That result

would contravene congressional intent. In authorizing EPA

to waive the review of pesticide efficacy claims, Congress

anticipated that the states would regulate pesticide efficacy.

Following Congress’s lead, EPA waived its review of

pesticide efficacy claims, finding that state tort law

adequately polices pesticide claims of efficacy. No evidence

suggests that Congress or EPA had any intent to leave the

area of pesticide efficacy unregulated.

A. EPA Does Not Evaluate Pesticide Efficacy

The conclusion by some courts that FIFRA preempts all

damages actions challenging the adequacy of pesticide

warnings relies on the mistaken notion that FIFRA regulates

all aspects of pesticide labeling.” The same mistake is

repeated by many amici in their briefs to this Court.” In fact,

72. See, e.g., Taylor AG Industries v. Pure-Gro, 54 F.3d 555,

560 (9th Cir. 1995) (finding preemption given FIFRA’s “rigorous

label-approval process”); Worm v. American Cyanamid Co., 5 F.3d

744, 747 (4th Cir. 1993) (finding that preemption is necessary

“{g]iven the comprehensive nature of the FIFRA labeling process”);

Arkansas-Platte & Gulf Partnership v. Van Waters & Rogers, Inc.,

981 F.2d 1177, 1179 (10th Cir. 1993) (“We believe Congress

circumscribed the area of labeling and packaging and preserved it

only for federal law.”); King v. E.J. DuPont de Nemours, 996 F.2d

1346, 1347 (ist Cir. 1993) (“The EPA has promulgated comprehensive

labeling requirements governing the scope, content, wording and

format of herbicide labeling.”).

73. See, e.g., Brief of American Crop Protection Assn. at 8

(“The EPA Administrator then undertakes a comprehensive review

of all pertinent data * * *.”).

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Appendix E

with few exceptions, EPA has not regulated pesticide efficacy

claims for almost 20 years.

Although the 1972 amendments to FIFRA required EPA

to evaluate all claims made on a pesticide label, a 1978

amendment allows EPA to limit the scope of its review. The

1972 amendments mandated that EPA register a pesticide

only upon evaluating a proposed pesticide label and

determining that the pesticide’s “composition is such as to

warrant the proposed claims for it.” 7 U.S.C. 136a(5)(A).

After the enactment of the 1972 amendments, however, it

immediately became clear that the pesticide approval process

was overly cumbersome. As the House Agriculture

Committee stated, “The

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