Amicus Curiae Brief — Bates v. Dow Agrosciences LLC

No. 03-388 | OFF f ee Cle

IN THE

Supreme Court of the United States

DENNIS BATES, ET AL.,

Petitioners,

v.

Dow AGROSCIENCES LLC,

Respondent.

On Writ of Certiorari

to the United States Court of Appeals

for the Fifth Circuit

BRIEF OF AMICI CURIAE

NATURAL RESOURCES DEFENSE COUNCIL, ET AL.

IN SUPPORT OF PETITIONERS

Brian Wolfman Patti Goldman

Public Citizen Litigation Group (Counsel of Record)

1600 20th Street, NW Grant Cope

Washington, D.C. 20009 Earthjustice

(202) 588-1000 705 Second Avenue,

Suite 203

Leslie Brueckner Seattle, WA 98104

Trial Lawyers for Public (206) 343-7340

Justice, P.C.

1717 Massachusetts, N.W..,

Suite 800

Washington, D.C. 20036

(202) 797-8600

Counsel for Amici

September 13, 2004

TABLE OF CONTENTS

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INTRODUCTION AND INTEREST OF AMICI ........ l

8S 4 ge Fc 8 |.) ar 3

cogeh tadbcandeded bane and cediaseasess 4

I. FIFRA ESTABLISHES A FLUID

REGULATORY SCHEME IN WHICH

PESTICIDE REGISTRATIONS AND

EPA-APPROVED LABELS MUST

CHANGE TO CONFORM TO UPGRADED

HEALTH AND ENVIRONMENTAL

STANDARDS AND NEW EVIDENCE OF

ENVIRONMENTAL AND SAFETY RISKS. .... 4

A. FIFRA Imposes a Duty on Pesticide

Registrants to Avoid Unreasonable Adverse

B. FIFRA Imposes an Ongoing Obligation on

Registrants To Draft Pesticide Labels That

Adequately Protect Health and The

TL sce ecuuaneueesceesaeases 9

od FIFRA's Preemption Provision ......... 11

———

il

II. STATE COMMON-LAW OBLIGATIONS

PARALLEL MANUFACTURERS' DUTIES

UNDER

FIFRA, ENCOURAGE SPEEDIER FIFRA

COMPLIANCE, AND PROMOTE FIFRA'S GOAL

OF PROTECTING HEALTH AND THE

ENVIRONMENTE: ..cccssccscosessustsenens 13

A. FIFRA's Express Recognition of State

Authority to Regulate Pesticide Sale and Use

Supports the Availability of State Damages

Actions That Would Lead to Sale and Use

ReswietiOMS. .. oc cccncvssensseeee 14

B. Failure-to-Warn Actions Reinforce the

Registrant's Duties to Ensure that Pesticide

Labels Meet FIFRA's Standards. ........ 18

C. State Damages Actions Complement and

Fill Gaps in the FIFRA Regulatory Scheme. 23

l.

tl

CONCLUSION

ADDENDUM

FIFRA Allows Temporary

Authorizations of Pesticide Uses that

Lack FIFRA Registrations. ...... 24

EPA-Approved Labels Are Not

Intended To Provide Warnings To The

Public, As Opposed to the Purchaser

or User, About the Risks Posed by

Wee 25

eeseoae uve ee Oeseeeeseeseeea ese OCC eee ss. 2 22 2 aS

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TABLE OF AUTHORITIES

CASES

Banks v. ICI Americas, Inc.,

i eweeues 17

Castillo v. EJ. DuPont de Nemours, Co.,

854 So. 2d 1264 (Fla. 2003)............... 23,27

Chemical Manufacturers Specialties Association v. Allenby,

958 F.2d 941 (9th Cir.), cert. denied,

i tc ceeteeecnscesess 27-28

Cipollone v. Liggett,

a 12, 21

Environmental Defense Fund v. EPA,

$10 F.26 1292 (D.C. Cir. 1975) .............. 7-8

Goodyear Atomic Corp. v. Miller,

Ee 15, 21

Henderson v. Department of Agriculture,

875 P.2d 487 (Or. App. 1994) ................ 27

Jenkins v. James B. Day & Co.,

634 N.E.2d 998 (Ohio 1994) ................. 19

Macias v. State of California,

en cdc rcceedncccceceses 25

Medtronic, Inc. v. Lohr,

ee ic ceuenee 19

IV

New York State Pesticide Coalition v. Jorling,

874 F.2d 115 (2d Cir. 1989).............-2--- 28

Ruiz-Guzman v. Amvac Chemical Corp.,

2000 WL 1763212 (9th Cir. 2000) ............ 16

Ruiz-Guzman v. Amvac Chemical Corp.,

AA b, |). > errs 16

Rumsey v. Freeway Manor Minimax,

423 S.W.2d 387 (Tex. App. 1968) ............. 22

Silkwood v. Kerr-McGee Corp.,

GEOG Bee Ce a oc ctncccescnseswendonns 21

Sprietsma v. Mercury Marine,

Se Ue SE 6 vce vncnsessnnenssctuucal 21

Washington Toxics Coalition v. EPA,

PO, Cee CUP WOUND wc cccccceccetscee’s 7

Wisconsin Public Intervenor v. Mortier,

Fee Wa BOE GE ok os cekwescesecsaes 13, 14,27

FEDERAL STATUTES

F hs OO SON an ok ccccancaescctcsckessiaes 1,11

Fie © ED 6c ncectanceccedcedveccensnhusndwexnet 7

7 ULI. B TPEREEIEAD 5 cc ccccctcccceveccesssees 7,11

7 UBL. © TREES cv cccccaccccccecsecocuvssees 1]

‘

RN eee air Ae 7 11

Re ee Ne TNS pe te eee 5

NR OR ee ata see aeseaereeaes 5

7 US.C. § 136a(CMIMC) . 00... c cece cece eee eeeee ees 9

7 US.C. § 136a(CM5) 0... 0c cee ec ee ec eee eee: 5, 10, 23

7 US.C. § 136a(d\ IMC) 0... c ccc cece ccc eee ceeeees 5

TUS.C. § 1360(fM1) . 2... 2. ccc e cece ccc ceeeceeeees 8

7 US.C. § 136a(f)( 2)... 2. cece cece cc eeeceeeeeeeees 1

7 US.C. § 136a-1(gX2MAMii) .. 00. eee ee eee eee eee 6

7 US.C. § 136d(aX2). 0... ee ccc cece cence eee ceeeees 7

OR ec. ocuncoasseescesuavansusinns 8

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7 US.C. § 136j(aI ME) 2... cece cece eee cence neers 7.

TUBL. B IDGGREINE) «2.0.0... cccccncccccsscccees 7

7 US.C. § 136)(aX2MG) 2.2... c cece cece eee eeeeeees 6

TUS.C. § 19GMAMIMIE) 2... cece cece cceecceeees 7

IN RIO |. cacsnsdensudscssenueeaseee 8

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Pee et Son aaechdudck wares a eetadenenaouenl 8

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PR ED cc unouuveseseusesayuabeuwe 5,11, 14

Fs OF awh nccenevcsaaesacanen 11, 18, 19, 20

PRR DE ca tantentedhubaGeuanaeetenaenny 24

tn cient ackencheddhasennese newer en 20

SPD theca bee 6nenuseanscabensesesunee 9

SP se Ds canecnknsesdaneaseoseanvasues 9

ee Sn onn6cbadnégneuasoesaenuness 7

ee Ghee OOD. newcneccvcusectessecuad 6

Be Seis OS PEED os ccc cevacsccevivececs 6

Pub. L. No. 92-516, 86 Stat. 996 (1972) ............... +

FEDERAL REGULATIONS AND

ADMINISTRATIVE MATERIALS

ol ees 9

I se 5

I OS i occ uvidceusdnnncccncecdh 27

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40 CF.R. § 152.46(a) . 2.00. cece cece cece eee eeee 10

40 C.F.R. § 152.50(e) o.oo cece cece ccueceuees 9

40 C.F.R. §152.50(f)(3) 00. c cc cece ccc cece eceuees 5

40 C.F.R. § 152.130(b) 0... cece ccc cece ee eeeee 10

40 C-F.R. § 152.130(c)........... cece ceeecceeceees 10

40 C.F.R. § 152.132(d)(5) ... 0... c ccc eeecceeeeuees 10

40 C.F.R. § 158.640(b) 2.00. occ ccc cece eee eeee 24

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I oo isc dcécnciinvidancentetas 17

42 Fed. Reg. 61,788 (Dec. 6, 1977) .. 0... cece ee eeuees 22

44 Fed. Reg. 51,166 (Aug. 30, 1979) ............000. 22

47 Fed. Reg. 46,747 (Oct. 20, 1982) ........ 000.0000. 22

49 Fed. Reg. 28,666 (July 13, 1984) .............008. 18

49 Fed. Reg. 37,960 (Sept. 26, 1984) .. 0.0.0... .000. i

52 Fed. Reg. 1334 (Jan. 10, 1986) .... 2.0... cece eeu ee 18

53 Fed. Reg. 15,956 (May 4, 1988) ..............005. 10

Er SE I AS oe

Vill IX

59 Fed. Reg. 38,973 (August 1, 1994)... 00... .....05. 16 STATE STATUES AND REGULATIONS

60 Fed. Reg. 17,357 (April $, 1995) 2.2.0.0. 6 eee. 16 Cal. Health & Safety Code § 111246 .......... 0.055. 14

66 Fed. Reg. 44,141 (Aug. 22, 2001)............ ee Se CD AG, BAUS cccccvcccccsscoseccecsess 15

67 Fed. Reg. 1919 (Jan. 15, 2002) .............-.005. 23 La. Admin. Code tit. 7, § 149(B) «2.6... eee eee eee 29

67 Fed. Reg. 8244 (Feb. 22, 2002)... 1... 2. cece eee 18 Mass. Amn. Laws Gh. 94,6 192 ....cccvecccccssvcces 14

67 Fed. Reg. 46,900 (July 17, 2002) ................. 23 Md. Code Ann. Agric. § 5-210.5 2.0... . ce eee ee eee 15

7 Fed. Reg. 79,611 (Dec. 30, 2002) ... 2... cece eenees 6 Riles Beet. B UGB.TES 2. ccccsccccccvcvcesesccccess 15

69 Fed. Reg. 39,927 (July 1, 2004) .................. 22 Wis. Stat. § 94.707(1m) .. 0.0.6.0 cece cece eee ee eens 14

FEDERAL LEGISLATIVE HISTORY , &§ Fh .) BPTI ITITTTTrrr rrr 15

H.R. Rep. No. 511, 92d Cong., Ist Sess. (1971) ......... 4 _, © 3). % ) BPPTTTTTTOTTICTrrTeeri eee 15

S. Rep. No. 511, 97th Cong., 2d Sess. (1982) .......... 13 Wry. Stat: § 3S-7-3SO on ccccccvcveccvccccesevcees 29

S. Rep. No. 92-970, 92d Cong., 2d Sess. (1972), 9 Cal. Cade. Ram, 66608 ...cccvvcccvcccscesscccees 14

reprinted in 1972 U.S.C.C.A.N. 4092 .. 0-7... . (14

302 Ky. Admin. Regs. 29:050, § 12... ........5 50 eeeee 29

128 Comm, Ras. SAAGS CIFEE) «ww cc cvevccccseccccens 12

La. Admin. Code tit. 7, § 149(B) ........ 0.00 e ee ee eee 29

Testimony of John A. Todhunter,

Reauthorization of the Federal Insecticide, N.H. Code Admin. R. Pes 506.04 .......... 56.4 e eee 29

Fungicide, and Rodenticide Act: Hearings on S. .

2245, S. 2620 and S. 2621 Before the Senate N.J. Admin. Code § 7:30-10.6(q) ........ 050 e eee ees 29

Committee on Agriculture, Nutrition and Forestry,

97th Cong., 2d Sess. (1982) ............55. 12-13 Wash. Admin. Code 16-228-1231(e) ......... 6.600005 15

x

MISCELLANEOUS

DePalma, “When Pest Killers Make Mistakes,”

New York Times, Sept. 1, 2004 ..........0005. 27

Environmental Working Group and Healthy Building

Network, Poisoned Playgrounds (2001) ........ 18

Fenske er al.,““Strategies for Assessing Children’s

Organophosphorous Pesticide Exposures in

Agricultural Communities,”

10 J. Expos. Anal. Envt’l Epid. 662 (2000) ...... 26

General Accounting Office,

Pesticides: EPA's Formidable Task to Assess and

Regulate Their Risks (1986) ...........0 04 eee 6

Liptak, “The Poison is Arsenic, and the Suspect Wood,”

The New York Times, June 26,2002 ........... 18

Natural Resources Defense Council,

Trouble on the Farm: Growing up with

Pesticides in Agricultural Communities,

Oct. 1998 (available athttp://www.nrdc.org/health

kids/farm/farminx.asp) ..........eceeeeeeees 26

Thompson, ef al, “Pesticide Take-Home Pathway Among

Children of Agricultural Workers,”

45 J. Occ. Envt’] Med. 42 (2003,.............. 26

l

INTRODUCTION AND INTEREST OF AMICI'

This brief addresses the issue of whether the Federal

Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7

U.S.C. § 136 et seq., preempts state damages actions arising out

of personal injuries caused by exposure to federally registered

pesticides. Amici are non-profit organizations dedicated to

protecting individuals from harm relating to dangerous

consumer products, including pesticides, and many have

participated in regulatory proceedings concerning federal

pesticide registration. Amici believe that FIFRA and state

damages actions complement one another in a constructive way

that strengthens the public health protection derived from

pesticide regulation.

Natural Resources Defense Council is an environmental

organization with more than 465,000 members nationwide. Its

membership and staff of scientists, lawyers, and other

environmental specialists have a longstanding interest in

improving the regulation of pesticides and other toxic chemical

residues in food, air, and water. NRDC has actively

participated in the development, enforcement, and reform of

pesticide laws and pesticide regulation for over two decades.

Public Citizen is an advocacy, lobbying, and litigating

organization with 160,000 members nationwide. It has a

longstanding interest in limiting the reach of the federal

preemption doctrine to situations in which Congress clearly

intends to oust state law in order to serve important federal

objectives. Public Citizen’s lawyers have represented parties

and amici before this Court in many cases that posed the

‘In blanket letters of consent filed with the Clerk, the parties have

consented to the filing of amicus briefs in this case. Pursuant to this

Court’s Rule 37.6, amici state that this brief was not authored in

whole or in part by counsel for a party and that no one other than

amici made a monetary contribution to the preparation or submission

of this brief.

2

question whether federal law preempts state-law remedies

intended to compensate those harmed by tortious conduct.

Trial Lawyers for Public Justice is a national public

interest law firm dedicated to pursuing justice for the victims of

corporate and governmental abuses. It seeks to ensure that tort

law fully serves its dual purposes — compensating those injured

by wrongful conduct and deterring similar conduct in the

future. TLPJ is gravely concerned that, if the tort system is

closed to innocent victims of improperly labeled pesticides

through application of the preemption doctrine in this case,

neither of these purposes will be served.

The Sierra Club is an environmental organization with

over 700.000 members nationwide. It was one of the first

organizations to advocate for laws protecting human health,

wildlife. and the environment from the damage caused by

pesticides.

Bevond Pesticides National Coalition Against the

Misuse of Pesticides has approximately 1,200 members

nationwide. It promotes public and worker protection from

pesticide hazards and the adoption of alternative pest

management strategies that reduce or eliminate dependency on

toxic chemicals. Beyond Pesticides has been an active

participant in the regulatory process under FIFRA since its

founding in 1981.

Defenders of Wildlife has over 450,000 members and

supporters nationwide. It is dedicated to the protection of all

native wild animals and plants in their natural communities.

Defenders’ programs focus on three serious threats to the

planet: the accelerating rate of extinction of species; the

associated loss of biodiversity; and the alteration and

destruction of habitat. :

Physicians for Social Responsibility is a national

organization whose 30,000 members are physicians, other

healthcare and public health professionals, and citizens

concerned about threats to human health. It educates the

medical community and the public about the links between

3

environmental exposures and human health and promotes

preventive, precautionary policy solutions to protect public

health. PSR has been an active participant in the regulatory

proceedings under FIFRA.

The Farmworker Justice Fund, Inc. is an advocacy and

education organization based in Washington, D.C. Its purpose

is to empower migrant and seasonal farmworkers to improve

their wages, working conditions, occupational safety, health,

immigration status, and access to justice through litigation,

advocacy, public awareness, capacity building, coalition

building, and support for union organizing. For more than two

decades, FJF has fought for improved protections for

farmworkers and their families exposed to pesticides at home

and on the job.

SUMMARY OF ARGUMENT

FIFRA charges registrants with ensuring that their

pesticides will not have unreasonable adverse health and

environmental effects and with writing pesticide labels that

achieve this result. Once the Environmental Protection Agency

(“EPA”) approves a pesticide use under this standard, the

pesticide may then be sold and used in the United States.

EPA’s past approval of a pesticide label, however,

affords no guarantee that the pesticide use will comply with

FIFRA’s “unreasonable adverse effects” standard over time as

regulatory standards change and new evidence emerges.

FIFRA commands the registrant to keep EPA apprised of any

information documenting adverse effects from a pesticide use

and to seek changes in the registration and EPA-approved label

when warranted by such new information or changing

conditions. A pesticide is misbranded and subject to FIFRA

enforcement measures if its label, even if federally approved,

does not provide adequate health and environmental protection.

_ This potential misbranding liability evinces Congress’s intent

that FIFRA would be a fluid scheme, obligating registrants to

4

provide EPA adverse effects information and to update their

labels to reflect such information and current standards.

Common-law liability similarly imposes obligations to

ensure that product design and labeling will avoid unreasonable

adverse health and environmental effects. State damages

actions can identify shortcomings in previously approved

FIFRA registrations and labels and prompt registrants to remain

vigilant in ensuring that their products can be used without

harming human health and the environment. Such actions

create an incentive to avoid unreasonable harm and serve as a

catalyst for registrants to modify their pesticide products and

labels when warranted by evolving legal standards, emerging

science, and evidence of harm from existing uses.

ARGUMENT

I. FIFRA ESTABLISHES A FLUID REGULATORY

SCHEME IN WHICH PESTICIDE

REGISTRATIONS AND EPA-APPROVED

LABELS MUST CHANGE TO CONFORM TO

UPGRADED HEALTH AND ENVIRONMENTAL

STANDARDS AND NEW EVIDENCE OF

ENVIRONMENTAL AND SAFETY RISKS.

A. FIFRA Imposes a Duty on Pesticide Registrants

to Avoid Unreasonable Adverse Health and

Environmental Effects At All Times.

Congress enacted FIFRA in 1947 to protect farmers

from adulterated and ineffective pesticides. For over three

decades, FIFRA had no health or environmental protections. In

1972 in the wake of Rachel Carson’s Silent Spring and the

controversy over DDT, Congress adopted a sweeping overhaul

of FIFRA that made health and environmental protections its

centerpiece. See Pub. L. No. 92-516, 86 Stat. 996 (1972); H.R.

Rep. No. 511, 92d Cong., 1" Sess. (1971). The amended

5

FIFRA required EPA to determine allowable pesticide use

based on the increasing body of scientific evidence indicating

that pesticides pose risks to human health and the environment.

As amended, FIFRA establishes a _ federal-state

partnership with minimum federal standards that states and

their subdivisions can supplement and make more stringent but

cannot undercut. See 7 U.S.C. § 136v(a). A pesticide may

generally not be sold or used in the United States unless it has

an EPA registration for a specific use of the pesticide. /d. §

136a(a). EPA registers a pesticide upon determining that the

labeling complies with FIFRA’s requirements, that composition

claims are warranted, that the pesticide will perform its

intended function, and that the pesticide use will not cause

unreasonable adverse effects on health or the environment. /d.

§ 136a(c)(5).

EPA must classify pesticides as general or restricted use

pesticides, depending on the risks posed to human health and

the environment. Where necessary to prevent unreasonable

adverse health or environmental effects, EPA must classify a

pesticide as restricted use. /d. § 136a(d)(1)(C). Restricted use

pesticides are subject to additional regulatory restrictions,

particularly concerning application of the pesticide. /d.

FIFRA requires a person seeking to register a pesticide

to demonstrate that the proposed pesticide meets FIFRA’s

standards. /d. §§ 136a(a), (c). The proponent bears the burden

of proof and must present sufficient supporting scientific

evidence of the pesticide’s safety and impact on health and the

environment. 40 C.F.R. § 152.50(f)(3). EPA has established

standards for the data required to support a pesticide

registration. See generally 40 C.F.R. Part 152. The company

seeking the registration (the “registrant”’) generates and submits

the scientific studies on which EPA will base its determination.

Id.

An EPA registration is a license to market and use a

pesticide that conforms to a specified formulation and the use

restrictions approved by EPA. The use restrictions are set out

6

on the EPA-approved label affixed to the product as it moves

through interstate commerce. A pesticide may not be used in

a manner inconsistent with the label. 7 U.S.C. § 136j(a)(2)(G).

The 1972 amendments left existing registrations in

place until the registrants submitted newly required data and,

based on its assessment of such data, EPA either canceled or

reregistered the pesticide uses with modifications to meet the

new health and environmental standard. As of 1986, EPA had

reregistered none of the 50,000 pesticides subject to

reregistration, and had completed its reassessment of none of

the 600 pre-1972 active pesticide ingredients. General

Accounting Office, Pesticides: EPA's Formidable Task to

Assess and Regulate Their Risks at 3 (1986).

Congress amended FIFRA in 1988 and again in 1996 to

impose deadlines on the reregistration process. Under the

statutory timetable, EPA is not scheduled to complete the

reregistration of all the old pesticides until fiscal year 2008.

See 7 U.S.C. § 136a-1(g)(2)(A)(ii).. Even when this initial

reregistration process is complete, EPA will regularly need to

revisit existing reregistrations to assess new data. It is common

for a registration to identify gaps in data that the registrant must

fill over time. For example, in 2000, EPA issued a conditional

registration for Strongarm, the pesticide at issue in this case,

that required the registrant to submit neurotoxicity,

mutagenicity, and residue chemistry studies.

http://www.epa.gov/opprd001/factsheets/diclosulam.pdf.

While the studies were due in 2001, EPA has yet to complete

its assessment and make revisions to the conditional

registration. Similarly, under the 1996 Food Quality Protection

Act, EPA must assess a food-use pesticide’s potential to cause

endocrine disruption effects and the cumulative effects of

exposures to pesticides that have a common mechanism of

toxicity, 21 U.S.C. § 3462(b)(2)(D)(v) & (viii), yet EPA is still

in the process of developing protocols for assessing such

effects. 67 Fed. Reg. 79,611 (Dec. 30, 2002) (requesting

comment on EPA’s proposed approach for screening for an

:

initial group of chemicals for effects on endocrine system).

Likewise, EPA typically reregisters pesticides without first

engaging in required consultations with the Fish and Wildlife

Service and National Marine Fisheries Service to determine

whether the pesticide use will jeopardize the survival of

endangered species, as required under the Endangered Species

Act (“ESA”), 16 U.S.C. § 1536(a)(2). See Washington Toxics

Coalition v. EPA, No. C01-132C, Orders (W.D. Wash. July 2,

2002 & Aug. 8, 2003) (declaring EPA in violation of ESA for

failing to consult on its pesticide registrations’ impacts on

threatened and endangered salmon and ordering injunctive

relief). Once EPA completes the ESA consultations, it will

need to make changes to the registrations required to ensure

that the pesticides will not cause jeopardy to endangered

species’ survival.

Because EPA depends almost entirely on manufacturer

submissions, and EPA does not itself conduct testing on the

pesticides’ health and environmental effects, FIFRA imposes

stringent and continuing obligations on registrants to submit

complete, up-to-date information to EPA. First, a registrant

may not knowingly falsify any part of an application for

registration or other information required to be submitted under

FIFRA and may not make any false or misleading statement or

representation in a pesticide's labeling. 7 U.S.C. §§

136j(a)(1(E), 136j(ay2(C) & (M); 136(q)(1)(A). Second,

even after EPA issues a registration based on the registrant’s

submissions, the registrant has an ongoing obligation to provide

EPA with all factual information that they have regarding

unreasonable adverse health and environmental effects. /d. §

136d(a)(2); 40 C.F.R. Part 159.

Third, and of critical importance, registrants have a

continuing obligation to ensure that the registration and label

complies with FIFRA's requirements. /d. §§ 136j(a)(1)(E),

136(q). Under FIFRA, “the burden is on the registrant to

establish that continued registration poses no safety threat.”

Environmental Defense Fund v. EPA, 510 F.2d 1292, 1302

(D.C. Cir. 1975).

To satisfy this burden, registrants must make changes to

the registration and labels whenever necessary to protect health

and the environment. In tum, FIFRA mandates that “the

registration shall be amended to reflect such change if the

Administrator determines that the change will not violate any

provision of this subchapter.” 7 U.S.C. § 136a(f)(1) (emphasis

added).

If EPA determines that the pesticide registration does

not comply with FIFRA, EPA may commence administrative

proceedings to cancel the pesticide’s registration. /d. §

136d(b). EPA may also seize or bar the use or sale of

pesticides that violate FIFRA. /d. §§ 136) & 136k; see also id.

$ 136/ (authorizing civil and criminal penalties for FIFRA

violations). None of these mechanisms for enforcing FIFRA

provides compensation to individuals who suffer injuries as a

result of FIFRA violations; nor does any other federal cause of

action provide such compensation. Traditional state-law

damages actions thus have historically provided the only means

for compensating people who have been injured by unsafe or

mislabeled pesticides.

Because cancellation proceedings are time-consuming

and expensive, EPA rarely brings them to compel label

changes. Rather, EPA leaves most use and label changes to its

ongoing process of reregistering pesticides. However, as noted

above, EPA has yet to reregister thousands of pesticides that

were initially registered before Congress, in 1972, imposed

stringent data requirements pertaining to human health and

environmental harm. Because EPA waits until the culmination

of the reregistration process to impose most product and label

changes on the registrant, EPA is not currently ensuring that the

pesticide registrations and labels for thousands of pesticides

comply with FIFRA. EPA’s reregistration backlog makes it all

the more critical that pesticide registrants have strong

incentives to comply with their obligation to make whatever

product and label changes are necessary to meet FIFRA’s

9

requirements. For this reason, the Assistant Administrator of

EPA for Pesticides and Toxic Substances took the position in

1994 that:

After reviewing the legal framework and the

policy considerations, I conclude that EPA

would clearly prefer the legal interpretation that

FIFRA does not preempt state tort actions.. . .

With the limited government resources

available to regulate a growing number of

pesticide products, we believe that tort litigation

can be an effective tool and ally to the

regulatory process. If tort actions are not

preempted by FIFRA, manufacturers’ concern

about possible tort liability may well lead them

to take additional steps to provide users with

information about their products. Such

information could, in turn, enable users to

choose and use pesticides in ways that are safer

for themselves, others, and the environment.

Letter from Lynn R. Goldman, Assistant Administrator for

Pesticides and Toxic Substances (Jan. 7, 1994) (reproduced in

addendum to this brief).

B. FIFRA Imposes an Ongoing Obligation on

Registrants To Draft Pesticide Labels That

Adequately Protect Health and _ The

Environment.

Unlike federal statutes governing cigarettes and

smokeless tobacco, FIFRA does not mandate the precise

wording for pesticide labels, see 15 U.S.C. §§ 1333, 4402(a)(1).

Nor do EPA’s regulations dictate the specific language to be

used for the bulk of each label, as some regulations do. See 21

C.F.R. § 801.430(c) (specific tampon warning).

Rather, FIFRA leaves the drafting of the label to the

registrant. 7 U.S.C. § 136a(c)(1(C); 40 C.F.R. § 152.50(e). It

10

charges the registrant, not the government, with devising

pesticide labels that convey adequate information to prevent

“unreasonable adverse effects” to health and the environment.

As a result, labels for similar pesticides produced and marketed

by different registrants may differ significantly from one

another. Such differences are permissible as long as the

registrant writes a label that ensures against “unreasonable

adverse effects.” As EPA has made clear, “[t]he registrant must

take responsibility for quality control of the product's

composition and for adequate labeling describing the product,

its hazards and uses.” 53 Fed. Reg. 15,952 (May 4, 1988).

FIFRA and EPA’s regulations establish certain

minimum requirements for pesticide labels, such as the

inclusion of certain terms to reflect acute poison risks.

Inclusion of such FIFRA mandated statements, however, does

not satisfy the registrant's FIFRA obligations. The label must

also contain directions for use that guard against unreasonable

adverse effects. Moreover, FIFRA allows labels to contain

information that goes beyond those requirements, and EPA

never assesses whether a label complies with other legal

obligations.

A registrant has a duty to submit revised labels for EPA

approval whenever the existing label falls short of meeting

FIFRA’s requirements. Many label revisions require only EPA

notification, not agency approval, 40 C.F.R. § 152.46(a), and

some revisions, such as changes in nonmandatory label

statements, additions required by other federal laws, or changes

in the label format, do not even require EPA notification. 40

C.F.R. § 152.46; see also id. §§ 152.130(b) & (c),

152.132(d)(5). As such, it is the registrant who decides that a

label change is necessary and who drafts a revised label. EPA

must allow the label change to be made unless it would violate

FIFRA. 7 U.S.C. § 136a(c)(5).

A pesticide is misbranded if, notwithstanding EPA’s

registration of the pesticide and acceptance of the label, it fails

to contain whatever additional warnings are necessary to

protect against unreasonable adverse health and environmental

effects. Jd. § 136(q)(1)(F)-(G). The fact that EPA has

approved a label is no defense to a claim under FIFRA that the

product is misbranded. /d. §§ 136(q)(1)(A), 136a(f)(2). In

other words, the fact that a pesticide label has been approved

does not immunize the registrant from liability for violating its

FIFRA obligations. Indeed, EPA has recognized that “(flor

liability reasons, companies often voluntarily provide additional

information on the label, particularly in the area of

precautionary statements.” 49 Fed. Reg. 37,960, 37,971 (Sept.

26, 1984). Nothing in FIFRA or EPA’s regulations prohibits

including such label warnings, provided that they do not violate

any specific requirement imposed by FIFRA or its

implementing regulations. /d.

Cc. FIFRA’s Preemption Provision

FIFRA contains a section, entitled “Authority of

States,” which affirms state authority to supplement federal

pesticide regulation:

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.

7 US.C. § 136v(a). Through this provision, Congress

expressly left room for state regulation that affords more, but

not less, health and environmental protection.

Immediately following this subsection is FIFRA’s label

preemption provision, which provides:

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.

Id. § 136v(b). This provision does not pertain to state damages

actions at all, since “[s]uch State” refers back to the preceding

12

provision, which refers to states that “regulate” pesticide sale

or use through “regulation.” The reference to state

requirements is therefore limited to regulations, which are

generally understood to embody statutes or legislative-type

rules. See Cipollone v. Liggett, 505 U.S. 504, 519, 523 (1992)

(preemption provision’s reference to “regulation” most

naturally refers to positive enactments of regulatory bodies, not

to common law damages remedies). Even if it is construed to

apply to state damages actions, the preemption provision is

limited to those labeling or packaging requirements that are “in

addition to or different from” those required under FIFRA. The

linchpin would, therefore, be whether state law obligations

create duties in addition to or different from FIFRA’s

unreasonable adverse effects standard. As explained below,

state common-law obligations generally do no such thing.

None of FIFRA’s state authority provisions directly

addresses the viability of state damage actions. The only

explicit legislative discussion of FIFRA's preemptive effect on

state damage actions came in 1982 during congressional

debates over an amendment that would have provided federal

injunctive relief for persons injured by pesticides. In the course

of these debates, several House Members and EPA indicated

their belief that state tort remedies were generally available.

128 Cong. Rec. 20,498, 20,504 (1982) (Representative

Wampler stated he knew of no case “where a private citizen

had not been able to sue in state courts for redress of

grievances.”’); id. at 20,502 (Representative Panetta explained

that the amendment would provide federal injunctive relief but

leave individuals harmed by pesticides state court remedies for

money damages); id. at 20,500 (Representative Thomas

explained that, without the amendment, individuals would

merely have “State rights in terms of suing for damages,

negligence, nuisance”); Testimony of John A. Todhunter,

Reauthorization of the Federal Insecticide, Fungicide, and

Rodenticide Act: Hearings on S. 2245, S. 2620 and S. 2621

_ Before the Senate Committee on Agriculture, Nutrition and

13

Forestry, 97th Cong., 2d Sess. (1982) (testimony of EPA

official explaining that EPA believed the amendment was

unnecessary because “it is something we feel people have under

existing laws other than FIFRA and our preference would be

not to see FIFRA cluttered up with additional amendments

putting those particular things in FIFRA”).’ Therefore, the only

evidence directly on point reveals that Congress believed that

individuals harmed by pesticides continue to have recourse to

state damage actions under the FIFRA scheme.

II. STATE COMMON-LAW OBLIGATIONS

PARALLEL MANUFACTURERS’ DUTIES

UNDER FIFRA, ENCOURAGE SPEEDIER FIFRA

COMPLIANCE, AND PROMOTE FIFRA’S GOAL

OF PROTECTING HEALTH AND THE

ENVIRONMENT.

In Wisconsin Public Intervenor v. Mortier, 501 U.S. 597

(1991), this Court held that FIFRA does not preempt local

regulation of pesticide use. Although the Court stated that “the

1972 amendments turned FIFRA into a ‘comprehensive

regulatory statute,” id. at 613 (quoting Ruckelshaus vy.

Monsanto, 467 U.S. 986, 991 (1984)), it recognized that

“FIFRA nonetheless leaves substantial portions of the field

vacant. ... FIFRA nowhere seeks to establish an affirmative

permit scheme for the actual use of pesticides. It certainly does

not equate registration and labeling requirements with a general

approval to apply pesticides throughout the Nation without

regard to regional and local factors like climate, population,

geography, and water supply.” Jd. at 613-14. The Court

concluded that FIFRA’s specific grant of authority to states to

*The House passed the amendment offered by Representative Panetta, but

the substitute measure that passed the Senate Forestry and Agriculture

Committee did not contain that amendment. S. Rep. No. 511, 97th Ceng.,

2d Sess. (1982).

14

regulate pesticide sale and use “acts to ensure that the States

could continue to regulate use and sales even where, such as

with regard to the banning of mislabeled products, a narrow

pre-emptive overlap might occur.” /d. at 614.

Just as local pesticide regulation may complement and

fill gaps in federal regulation under FIFRA, state damages

actions likewise further the state’s preserved authority to

regulate pesticide sale and use. The common-law duty to warn

users and the public of pesticide hazards reinforces the

registrants’ duty to ensure that their labels guard against

unreasonable adverse effects. Mcreover, some state legal

obligations also buttress the registrants’ duties to provide EPA

up-to-date information about pesticide hazards so that EPA can

ensure that previously issued registrations continue to protect

the public.

A. FIFRA’s Express Recognition of State

Authority to Regulate Pesticide Sale and Use

Supports the Availability of State Damages

Actions That Would Lead to Sale and Use

Restrictions.

Under 7 U.S.C. § 136v(a), a state may ban the sale or

use of a federally registered pesticide or may impose

restrictions on its use beyond what EPA has imposed. See S.

Rep. No. 92-970, 92d Cong., 2d Sess. (1972), reprinted in 1972

U.S.C.C.A.N. 4092, 4111-12 (“Local governments could,

however, prohibit or restrict the sale or use of pesticides within

their jurisdiction.”). For example, the States of Massachusetts

and Wisconsin imposed restrictions on the use of daminozide

on apples after EPA determined that it was a carcinogen, but

before EPA took action to restrict its use. See Mass. Ann. Laws

ch. 94, § 192; Wis. Stat. § 94.707(1m). Similarly, states have

banned or restricted the use of other pesticides that EPA had

permitted to be used. See, e.g., Gal. Health & Safety Code §

111246 (lindane); 3 Cal. Code. Reg. § 6400 (restricted use

15

pesticides); Wash. Admin. Code 16-228-1231(e) (restricting the

use of numerous pesticides to protect groundwater); Iowa Code

Ann. § 206.32 (chlordane); Md. Code Ann. Agric. § 5-210.5

(chlordane, heptachlor, aldrin and dieldrin); Minn. Stat. §

18B.115 (chlordane and heptachlor); Wis. Stat. § 94.707(a)-(b)

(2-4-5 trichlorophenoxyacetic acid and silvex).

State authority to ban or restrict pesticide use in a

regulatory capacity is similar to many types of state damages

actions. Although a regulatory ban directly prevents harm

before the fact, state damages actions allow individuals harmed

by pesticide use to sue for damages to compensate for their

losses. The underlying legal duty in such-a case may require

the pesticide manufacturer to avoid designing, marketing, or

selling a pesticide for a use that causes the same type of harm

an affirmative state regulation may seek to prevent. Ifa state

can affirmatively ban a pesticide to prevent harm to its citizens,

as it can under the FIFRA scheme, it also can allow its citizens

to enforce and seek redress for violations of legal duties in

lawsuits that may indirectly produce the same result. See

Goodyear Atomic Corp. v. Miller, 486 U.S. 174, 185 (1988)

(“The effects of direct regulation on the operation of federal

projects are significantly more intrusive than the incidental

regulatory effects of such an additional award provision.

Appellant may choose to disregard Ohio safety regulations and

simply pay an additional workers’ compensation award if an

employee's injury is caused by a safety violation. We believe

Congress may reasonably determine that incidental regulatory

pressure is acceptable, whereas direct regulatory authority is

not.”’) (citation omitted).

An apt example is provided by litigation over the

pesticide phosdrin, a highly toxic nerve-agent, which caused

acute poisonings of farmworkers. In the summer of 1993,

Amvac Corp. marketed phosdrin for the first time in

Washington state, even though more than 600 suspected

poisonings of workers, including three deaths, were reported in

California from 1982 through 1989. Amvac had acknowledged

16

that the existing FIFRA registration and label did not

adequately protect workers, EPA had directed Amvac to

develop and implement restrictions on phosdrin use to protect

workers, and California had already imposed some such

restrictions. Upon finding the FIFRA requirements inadequate,

the Washington Department of Agriculture adopted an

emergency regulation requiring worker training, wind

restrictions to lessen drift, and safeguards to protect workers

who mix and apply the pesticide. Tragically, however,

throughout the summer of 1993, 29 workers reported acute

pesticide poisoning from exposure to phosdrin. The

Washington Department of Agriculture banned all phosdrin use

before the end of the summer to stop the stream of worker

poisoning incidents. The following year, EPA, which had-been

conducting a review of phosdrin’s worker impacts, concluded

that phosdrin caused unreasonable adverse effects to workers.

In the summer of 1994, shortly after EPA announced its intent

to take steps to suspend phosdrin’s registration, Amvac

requested a voluntary cancellation of its FIFRA registration for

phosdrin. 59 Fed. Reg. 38,973 (August 1, 1994); 60 Fed. Reg.

17,357 (Apmil 5, 1995).

The workers became casualties of EPA’s delays in

canceling registrations of pesticides that do not meet FIFRA’s

unreasonable adverse effects standard. Three of the workers

sued both Amvac and the distributor for marketing and

distributing a defectively designed product. The Washington

Supreme Court upheld their right to bring such a claim under

state law, Ruiz-Guzman yv. Amvac Chemical Corp., 7 P.3d 795

(Wash. 2000), and the Ninth Circuit held that FIFRA did not

preempt the workers’ design defect claims. Ruiz-Guzman v.

Amvac Chemical Corp., 2000 WL 1763212 (9th Cir. 2000).

Ultimately, the cases resulted in a settlement. The injured

workers’ ability to seek damages promoted FIFRA’s purpose

of protecting workers against unreasonable adverse effects from

pesticides.

A similar situation occurred in connection with a rat

—_———"

17

poison that tasted sweet and looked like candy. Although the

label cautioned to keep the rat poison out of reach of children

and that the poison might be harmful if swallowed, a nine-year-

old boy ate some of the poison when he found it at a boys’ club

and ultimately died as a result. A jury awarded his family

compensatory and punitive damages upon finding that the

registrant withheld adverse incidents of human exposure from

EPA and that the product could have been designed with a

bittering agent to avoid being mistaken for candy and with a

substance that would induce vomiting. The Georgia Supreme

Court held that FIFRA preempted the failure-to-warn claim and

remanded the design defect claim for a new trial under a newly

announced risk-utility test. Banks v. ICI Americas, Inc., 450

S.E.2d 671, 673 (Ga. 1994),

State damages actions play a particularly important role

in promoting FIFRA’s health and safety goals given the

backlog in EPA reregistrations discussed above. And EPA is

continually upgrading registration requirements to address

emerging evidence of adverse effects. For example, for years,

workers have been exposed to harmful and sometimes lethal

doses of pesticides when they re-enter sprayed areas. Although

pesticide registrations establish prohibitions on worker re-entry

during specified periods, the specified periods have often

proved to be insufficient to protect the workers from acute

poisonings. As part of its implementation of a worker

protection standard promulgated in 1992, 40 C.F.R. § 170.112,

and its reregistration process, EPA is reviewing and expanding

the re-entry periods. However, workers have been subjected to

excessive exposures to acutely toxic pesticides in the meantime

and rely on state-law compensation systems to make them

whole.

Not only is the reregistration process plagued by delay,

but EPA is sometimes unwilling to take action that would

constrain certain pesticide uses, particularly where the scientific

basis for the constraint is questioned by the registrant. For

example, in 1984, after finding that arsenic-treated wood

18

products posed excessive cancer and birth defect risks, EPA

announced its intent to cancel registrations of arsenic products

used to treat wood unless consumer warnings and precautionary

information were provided to wholesalers, distributors, and

retailers to be passed along to consumers. 49 Fed. Reg. 28,666

(July 13, 1984). Two years later, EPA accepted a voluntary

industry-sponsored consumer awareness program, in lieu of

mandatory warnings. 52 Fed. Reg. 1334 (Jan. 10, 1986). After

acceptance of this voluntary program, reports of people being

poisoned and playground structures and decks being

contaminated by arsenic-treated wood continued to surface,

precipitating dozens of lawsuits against the makers and

distributors of arsenic-treated wood. Liptak, “The Poison is

Arsenic, and the Suspect Wood,” New York Times, at Al, June

26. 2002; Environmental Working Group and Healthy Building

Network, Poisoned Playgrounds 13-14 (2001). In response, the

industry and EPA agreed to a phase-out of arsenic-treated wood

for residential uses. 67 Fed. Reg. 8244 (Feb. 22, 2002);

http://www.epa.gov/pesticides/factsheets/chemicals/cca_tran

sition. htm.

State damages actions, like those seeking redress for

poisonings and contamination from arsenic-treated wood,

promote FIFRA’s goal of preventing adverse health and

environmental effects from pesticide use. Since FIFRA

expressly authorizes states to regulate pesticide sale and use

directly, it must also be read to preserve state damages actions

that indirectly further this goal.

B. Failure-to-Warn Actions Reinforce the

Registrant’s Duties to Ensure that Pesticide

Labels Meet FIFRA’s Standards.

If FIFRA preemption extends to state damages actions

at all, it preempts only those failure-to-warn claims that require

a label that is “in addition to or different from” that required

under FIFRA. 7 U.S.C. § 136v(b). Since FIFRA requires

19

labels to ensure that the pesticide use will not cause

unreasonable adverse health or environmental effects, state

failure-to-warn duties reinforce FIFRA’s label requirements.

Few, if any, state tort claims allege that manufacturers

should have required different label warnings from those

required under FIFRA, because most state duty-to-warn

obligations are subsumed within FIFRA’s unreasonable adverse

effects standard and its misbranding mandate, i.e., they

challenge a failure to provide sufficient warnings to prevent

unreasonable adverse effects. Where plaintiffs are seeking

redress for a failure to relay critical warnings to the public, state

damage actions do not impose any labeling requirements that

are “in addition to or different from those required under”

FIFRA. /d. Instead, they provide a means for individuals who

are harmed by misbranded pesticides to obtain compensation

for that harm. The remedial measures that the registrant would

take to avoid such liability would either consist of label

changes that would be required under FIFRA in any event, or

other means of conveying information — such as pamphlets,

advertisements, and notices in publications — which are not

subject to FIFRA's labeling requirements. The common-law

duties on which those allegations were based thus mimic the

manufacturer’s duties under FIFRA, which places the burden

of testing, identifying, and labeling as to risks to people and the

environment on the registrant.

Thus, the plaintiffs’ claims arising from pesticide-

related injuries are based on state-law duties that parallel

requirements imposed under FIFRA. Like the “parallel” state

claims held not preempted by the federal Medical Device

Amendments, see Medtronic, Inc. v. Lohr, 518 U.S. 470, 496-

97 (1996), they are not “in addition to or different from”

FIFRA’s requirements within the meaning of 7 U.S.C. §

136v(b), and, therefore, are not preempted.

In Jenkins v. James B. Day & Co., 634 N.E.2d 998

(Ohio 1994), the Ohio Supreme Court reached the same

conclusion with respect to the Federal Hazardous Substances

20

Act (“FHSA”), which preempts state cautionary labeling

requirements that are not identical to applicable federal labeling

requirements. 15 U.S.C. § 1261. The court held that FHSA

labeling requirements do not preempt state duty-to-warn claims

because they are identical; both require the manufacturer to

design product labels that “protect against the [] risk of illness

or injury.” 634 N.E.2d at 1002.

The possibility of state tort liability creates additional

incentives for manufacturers to ensure that their labels contain

the most complete and accurate information available to protect

health and the environment consistent with FIFRA. It is

particularly important to maintain strong incentives for

registrants to make necessary labeling changes, given that it

will be many years before EPA completes its assessment of

existing labels as part of the pesticide reregistration process and

that EPA will continue to assess and require revised labels after

that. A contrary reading would permit a manufacturer, who

knew of dangers from use of the pesticide as directed on the

label, to refrain from informing EPA of needed label changes

and then to hide behind the very label it knew to be inadequate.

Such a result was never contemplated by Congress and should

not be countenanced by the courts.

It makes sense for Congress to preempt state regulatory

labeling requirements, while allowing state damage actions that

challenge the adequacy of pesticide warnings. In order to guard

against duplicative label approval schemes burdening interstate

commerce, Congress sought to ensure that manufacturers would

have one label nationwide, rather than different ones in each

state. A reading of 7 U.S.C. § 136v(b) to encompass state label

regulations, but not damage actions, accomplishes that result.

No state can establish a label approval scheme. Since the

registrant must use an EPA-approved label, pesticide labels for

particular products will be uniform throughout the United

States.

Indeed, this Court has repeatedly noted, in rejecting

preemption of state damages claims, that Congress can

21

rationally preempt state regulatory efforts that conflict with the

federal regulatory scheme regarding a particular product or

industry, while allowing state damages actions arising from

those regulated activities to go forward. See Sprietsma v.

Mercury Marine, 537 U.S. 51, 64 (2002) (preemption of state

positive law, but not state common law “does not produce

anomalous results. It would have been perfectly rational for

Congress not to pre-empt common-law claims, which — unlike

most administrative and legislative regulations—necessarily

perform an important remedial role in compensating accident

victims.”’) (citing Si/kwood v. Kerr-McGee Corp., 464 U.S. 238,

251 (1984)); Cipollone, 505 U.S. at 518 (“there is no general,

inherent conflict between [express] federal preemption of state

[regulatory] warning requirements and the continued vitality of

state common-law damages actions”); Goodyear Atomic, 486

U.S. at 185-86 (“The effects of direct regulation ... are

significantly more intrusive than the incidental regulatory

effects of such an award provision. ...Congress may reasonably

determine that incidental regulatory pressure is acceptable,

whereas direct regulatory authority is not.”); Silkwood, 464

U.S. at 256 (despite federal preemption of state regulatory

authority, state-law punitive damages awards not preempted

even though “regulatory in the sense that a nuclear plant will be

threatened with damages liability if it does not conform to state

standards”).

State damages actions serve to highlight defects in the

EPA-approved labels. It is hard to imagine state damage

actions leading to conflicting labels because the manufacturer

retains the ability to draft the label to meet all its obligations.

‘nstead, state damage actions create an incentive for registrants

to submit more complete and informative labels to EPA for

approval and to ensure that pesticides are not misbranded by

virtue of inadequate warnings of health and environmental

effects. Compliance with any such state common law

obligation to provide warnings and precautionary information

on the pesticide label promotes the overall FIFRA goal of

22

protecting the public from the adverse effects of pesticide use,

without creating any conflict between a manufacturer's FIFRA

obligations and compliance with that duty.

For example, Rumsey v. Freeway Manor Minimax, 423

S.W.2d 387 (Tex. App. 1968), involved a three-year-old boy’s

ingestion of a roach poison, which led to his death. The court

held that the evidence could support a finding of negligence

because the label identified an antidote when, in fact, there was

no antidote for the insecticide. Such a finding would likely

spur the registram: ‘o modify the label to disclose the lack of an

antidote and the full risks of ingestion of the poison.

Likewise, in 1999, crawfish farmers brought a class

action alleging fraudulent and negligent misrepresentation for

marketing the insecticide fipronil for use on rice crops in

Louisiana. Fipronil is highly toxic to aquatic invertebrates,

including crawfish, and in Louisiana, rice and crawfish farms

occur in close proximity, often in the same pond. The farmers

used fipronil on rice seed to combat the rice water weevil, but \

suffered significant declines in crawfish production in adjacent

areas. The class action resulted in a $45 million settlement in

March 2004. A few months later, the registrant asked EPA to

cancel registration of its pesticide products containing fipronil

for use on rice. 69 Fed. Reg. 39,927 (July 1, 2004).

Similarly, in 1977, EPA found that the fungicide

benomy!] caused unreasonable adverse effects based on, among

other things, evidence of birth defects, including rats born

without eyes or with very small eyes after in utero exposure to

benomyl. 42 Fed. Reg. 61,788 (Dec. 6, 1977). Initially, EPA

proposed to cancel benomy! registrations unless the labeling

warned that “benomy! causes birth defects and reduced sperm

production in laboratory animals. Exposures to benomyl during

pregnancy should be avoided.” 44 Fed. Reg. 51,166, 51,169

(Aug. 30, 1979). In its final determination, EPA backtracked

and required that the label state only: “Harmful if inhaled.

Wear a cloth or disposable paper dust mask during handling

and mixing.” 47 Fed. Reg. 46,747, 46,750 (Oct. 20, 1982).

23

Over the years since, dozens of children in rural areas have

been born with no or tiny eyes after their mothers were exposed

to benomyl during pregnancy. A jury awarded $4 million to the

family of one such child whose mother was exposed by

applications at a nearby farm. Castillo v. E.l. DuPont de

Nemours, Co., 854 So.2d 1264 (Fla. 2003).

Although EPA initially addressed the potential for birth

defects from benomyl through label warnings, Dupont

ultimately requested cancellation of all of its registrations and

ceased production of benomyl in 2001, 67 Fed. Reg. 1919 (Jan.

15, 2002), and EPA thereafter issued a notice phasing out

remaining uses of benomyl. 67 Fed. Reg. 46,900 (July 17,

2002). Under FIFRA, the states had the authority to ban use of

benomyl on the ground that it could not be used, even with

extensive warnings, without causing unreasonable adverse

effects, such as birth defects. Thus, the states plainly had the

lesser authority to provide damages awards on the ground that

benomy] was misbranded.

c. State Damages Actions Complement and Fill

Gaps in the FIFRA Regulatory Scheme.

Many courts holding that FIFRA preempts state

damages actions have assumed that EPA has made a finding

that predetermines the outcome of the state law question that

would be presented to a jury in such a case. While FIFRA’s

nreasonable adverse effects standard resembles the legal duty

underlying some state law duties, EPA does not even purport to

guard against unreasonable adverse effects in certain contexts.

This case concerns such a gap in that EPA neither

reviews nor makes finding concerning the efficacy of most

pesticides. A 1978 FIFRA amendment expressly authorized

EPA to waive data requirements pertaining to a product's

efficacy and to register such pesticides without determining that

the composition warrants proposed claims of efficacy. 7 U.S.C.

§ 136a(c)(5). Pursuant to this authority, EPA waived review of

24

efficacy claims for most pesticides. 40 C.F.R. § 158.640(b).

Accordingly, EPA _ registers most pesticides without

determining whether their composition warrants the efficacy

claims made by the registrant, such as the claims made by

respondent that led to damage to petitioners’ crops.

Efficacy claims are not alone. EPA never passes on the

unreasonable adverse effects of many pesticides either because

the registrant has concealed information needed to make such

an assessment or because FIFRA authorizes the pesticide use

without such a finding. Even where EPA makes such a

determination, it never purports to require notice to members of

the public who unwittingly may find themselves exposed to

pesticides wafting away from their targets and into unwelcome

locations.

1. FIFRA Allows Temporary Authorizations of

Pesticide Uses that Lack FIFRA Registrations.

Under FIFRA, some pesticide uses may be authorized

even though the particular pesticide use has not passed muster

under FIFRA’s “unreasonable adverse effects” standard. First,

states may register federally registered pesticides for additional

uses that are not permitted on the pesticide label. 7 U.S.C. §

136v(c). Such state registrations, known as special local need

registrations, become effective upon state approval and remain

effective until rescinded by the state or by EPA. As part of the

state approval, the state prescribes directions for use, including

the information that must be provided to users or the public.

No EPA approval is required for a state local needs permit to

become effective.

Second, FIFRA authorizes EPA to exempt state or

federal agencies from FIFRA requirements in emergency

conditions. /d. § 136p. Under this authority, EPA grants

temporary exemptions from EPA registration requirements for

particular uses of pesticides that are not permitted under FIFRA

registrations. Typically, a state requests an emergency

25

exemption and submits to EPA proposed conditions for the

pesticide. Upon obtaining EPA approval, the state then

authorizes and imposes the agreed-upon conditions on the

pesticide use. While EPA makes an unreasonable adverse

effects determination for an emergency exemption, it does so

based on an expedited review of far more limited information

than required for a registration and focusing on the impacts of

the use for only one year, even though emergency exemptions

may be sought for successive years. 40 C.F.R. § 166.25(b).

For example, in Macias v. State of California, 897 P.2d

530 (Cal. 1995), a boy who became blind after being sprayed

by malathion as part of California’s medfly eradication program

brought a failure-to-warn claim. The California Department of

Food and Agriculture had issued a special local need

registration and obtained an emergency exemption to allow use

of malathion for an unregistered use. The case challenged the

manufacturer’s and the state’s failure to warn the public of the

health hazards posed by the aerial spraying. While the

California Supreme Court did not allow the boy to challenge

the manufacturer’s failure to provide warnings in connection

with a state-administered emergency program, it did not find

the claim against the state to be barred. /d. at 538-40. Nothing

in FIFRA precluded the state from requiring public notification

of the health risks of the aerial spraying, particularly since the

state established the parameters of the spraying program

embodied in its special local needs permit and medfly

eradication program.

2. EPA-Approved Labels Are Not Intended To

Provide Warnings To The Public, As Opposed

to the Purchaser or User, About the Risks Posed

by Pesticides.

Although some failure to warn claims might spur the

registrant to strengthen the warnings on the EPA-approved

label, others such claims seek warnings that cannot be provided

26

through the product label. FIFRA labels are attached to the

pesticide product as it moves through the streams of commerce.

Although they may convey warnings and directions for use to

the direct purchaser or user, labels do not reach members of the

public who may be unwittingly exposed to pesticides.

For example, spray drift is a key mechanism through

which pesticides migrate away from their target and cause harm

to the public. States receive about 2500 complaints of drift

each year, and many =~=more’- go __ unreported.

http://www.epa.gov/opppmsd1/PR_Notices/prdraft-

spraydrift801.htm, at 3. Many pesticide labels include a

general direction, such as “Do not allow drift,” but EPA has

recently proposed to require clearer and more specific

directions for preventing spray drift, which establish no-spray

buffer zones, maximum wind speeds, and aerial equipment

limitations. 66 Fed. Reg. 44,141 (Aug. 22, 2001);

http: (www.epa.gov opppmsd1/PR_Notices/prdraft-

spraydrift801.htm.

Ordinarily, the pesticide purchaser or applicator will see

the pesticide label. Pesticide drift, however, can reach

neighboring homes and farms, schools in the vicinity, and the

public at large. There is a growing body of evidence, for

example, that the children of farmworkers are exposed to

pesticide residues in their homes both as a result of drift and

residues on their parents’ clothing. See, e.g., Thompson, et al.,

“Pesticide Take-Home Pathway Among Children of

Agricultural Workers,” 45 J. Occ. Envt’] Med. 42 (2003) (take-

home exposure and drift present increased risk for farmworker

children); Fenske, et al., “Strategies for Assessing Children’s

Organophosphorous Pesticide Exposures in Agricultural

Communities,” 10 J. Expos. Anal. Envt’l Epid. 662 (2000)

(levels of pesticides in farmworker children from drift and take

home exposures exceed EPA safe levels in substantial fraction

of farmworker children); Natural Resources Defense Council,

Trouble on the Farm: Growing up with Pesticides in

Agricultural Communities, Oct. 1998 (available at

27

http://www.nrdc.org/health/kids/farm/farminx.asp). | Many

lawsuits have been brought by such innocent bystanders who

did not choose to use the pesticide but were nonetheless

exposed and harmed, see, e.g., Castillo v. E.l. DuPont de

Nemours, 854 So.2d 1264 (Fla. 2003), including cases

involving school children mistakenly sprayed by pesticides.

See, e.g., Henderson v. Dept. of Agriculture, 875 P.2d 487, 488

(Or. App. 1994); DePalma, “When Pest Killers Make

Mistakes,” New York Times, at B1, Sept. 1, 2004. In none of

these instances would a pesticide label warning have reached

the injured party to allow them to avoid being in harm’s way,

and, indeed, EPA does not regulate the relationship between

pesticide registrants and members of the general public, who

may be unwittingly exposed to pesticides applied in public

places or that drift away from their intended site.

FIFRA’s preemption provision is limited to “labeling or

packaging,” which FIFRA defines as the material intended to

accompany the pesticide through the streams of commerce.

Pesticide labeling does not encompass all communications

made by a manufacturer in connection with the sale or

marketing of a pesticide product. FIFRA, therefore, leaves the

registrants other means to convey information to pesticide

purchasers and users, none of which needs to be submitted to

EPA as part of the approval process. See, e.g., 40 C.F.R. §

152.168(b).

The local ordinance at issue in Wisconsin Public

Intervenor required the posting of placards on sprayed areas

notifying the public of the pesticide application and any

applicable re-entry periods. 501 U.S. at 603. This Court never

suggested that such a public notice requirement might be barred

by FIFRA’s express preemption provision.

In addition, two federal courts of appeals have explicitly

distinguished between preempted pesticide labels, which go to

the purchaser of the pesticide, and other permissible

communications designed to warn the general public of risks of

pesticide uses. In Chemical Mfrs. Specialties Ass'n v. Allenby,

28

958 F.2d 941, 946 (9th Cir.), cert. denied, 506 U.S. 825 (1992),

the Ninth Circuit held that FIFRA does not preempt point-of-

sale warnings on products containing carcinogens and

reproductive toxins mandated by California's Proposition 65

because:

FIFRA’s definition of labeling cannot

encompass every type of written material

accompanying the pesticide at any time. If this

were true, then price stickers affixed to shelves,

sheets indicating that a product is on sale, and

even the logo on the exterminator’s hat would

all constitute impermissible labeling.

Although there was no question that Proposition 65, as

an affirmative enactment, is a state regulation within the

meaning of FIFRA’s preemption provision, the court held that

Proposition 65 warnings do not constitute labeling requirements

under FIFRA. /d. at 946-47.

Similarly, in New York State Pesticide Coalition v.

Jorling, 874 F.2d 115 (2d Cir. 1989), the Second Circuit

refused to construe the term “labeling” in § 136v(b) to include

warnings given to customers who contract for pesticide services

or public notification of pesticide applications. Because a

construction of “labeling” to include anything that could be said

to “accompany” a pesticide would literally include “the logo on

the applicator's hat and the license plate on the vehicle in which

the pesticide is transported,” the court limited that definition to

material attached to the immediate container or otherwise

expected to remain with the pesticide during the period of use.

Id. at 119-20 (quoting letter from EPA's general counsel).

These decisions effectuate Congress’ purpose to have

uniform labels on pesticides sold in interstate commerce, see

Allenby, 958 F.2d at 944, without embracing broad preemption

of a whole range of state regulation that was never

contemplated by Congress. Both Allenby and Jorling

distinguished between FIFRA labels, which are designed to

reach the purchaser and often the end user, from warnings that

29

are directed to the general public or others who may encounter

pesticides during or after their application.’ Given that nothing

in FIFRA requires or prohibits such public or innocent

bystander warnings, and FIFRA’s preemption is limited to

“labeling,” states remain free to require such public notice as a

condition of pesticide sale or use. Similarly, FIFRA cannot be

read to preempt state failure-to-warn claims brought by such

innocent bystanders.

Exercising their authority to regulate pesticide use,

several states have adopted protective safeguards constraining

pesticide applications around schools. Some states have

required notification of students, teachers, and staff before

pesticides are applied on school grounds. See, e.g., Wyo. Stat.

§ 35-7-350; 302 Ky. Admin. Regs. 29:050, § 12; N.H. Code

Admin. R. Pes 506.04. Other states have established a buffer

zone around schools and other public buildings where aerial

pesticide applications are prohibited. N.J. Admin. Code § 7:30-

10.6(q); La. Admin. Code tit. 7, § 149(B).

Such state regulation fills gaps in federal regulation of

pesticide sale and use through EPA registration of pesticides.

FIFRA expressly authorizes such state supplementation through

affirmative state regulation. State damages actions similarly fill

gaps left by FIFRA, albeit indirectly. Because the registrant

retains full authority and legal duties under FIFRA to ensure

that its registrations and pesticide labels prevent unreasonable

adverse health and environmental effects, state damages action

promote the FIFRA scheme.

‘Allenby and Jorling involved both the provision of information to

purchasers and public notice. The point-of-sale warnings in Allenby and

the customer disclosures in Jorling would reach the purchaser of the

pesticide products or services, while point-of-sale warnings and public

notices on places where pesticides had been applied would notify the

general public. The courts of appeals did not distinguish between the

recipients in holding that FIFRA does not preempt such off-label warnings.

30

CONCLUSION

The decision below should be reversed.

September 13, 2004

Respectfully submitted,

Patti Goldman

(Counsel of Record)

Grant Cope

Earthjustice

705 Second Avenue, Suite 203

Seattle, WA 98104

(206) 343-7340

Brian Wolfman

Public Citizen Litigation Group

1600 20" Street, N.W.

Washington, D.C. 20009

(202) 588-1000

Leslie Brueckner

Trial Lawyers for Public Justice, P.C.

1717 Massachusetts, N.W., Suite 800

Washington, D.C. 20036

(202) 797-8600

Attorneys for Amici Natural

Resources Defense Council, et al.

UNITED STATES ENVIRONMENTAL

PROTECTION AGENCY

Washington, D.C. 20460

Office of Prevention, Pesticides and Toxic Substances

Jan 7 1994

Ms. Patti A. Goldman

Public Citizen Litigation Group

Suite 700

2000 P Street, NW

Washington, DC 20036

Dear Ms. Goldman:

Thank you for your letter of November 5 urging the

Environmental Protection Agency (EPA) to support the

position that the Federal Insecticide, Fungicide and

Rodenticide Act (FIFRA) does not preempt state tort actions.

There appear to be reasonable legal arguments for the

position that FIFRA does not preempt such lawsuits. After

reviewing the legal framework and the policy considerations,

I conclude that EPA would clearly prefer the legal

interpretation that FIFRA does not preempt state tort actions.

As you know, under FIFRA, EPA is responsible for

registering pesticides on the basis of scientific data adequate

to demonstrate that their use in accordance with label

directions will not result in unreasonable adverse effects on

people or the environment. The Agency carefully reviews

product labels to ensure that they provide users with

adequate information on the proper use of a pesticide. There

are currently many pesticide products on the market that have

not been reviewed according to modern standards. We are

currently directing much of our resources toward the

reregistration program for reviewing large amounts of data

on these older pesticides. This effort, however, is clearly

costly and time consuming.

With limited government resources available to

regulate a growing number of pesticide products,-we believe

that tort litigation can be an effective tool and ally to the

regulatory process. If tort actions are not preempted by

FIFRA, manufacturers’ concern about possible tort liability

may well lead then to take additional steps to provide users

with information about their products. Such information

could, in turn, enable users to choose and use pesticides in

ways that are safer for themselves, others, and the °

environment.

Accordingly, the Agency will consider opportunities

to participate in ongoing litigation where FIFRA tort

preemption is an issue. | hope this information is useful.

Please let me know if I may be of further assistance.

Sincerely yours,

Lynn R. Geldman

Assistant Administrator