Amicus Curiae Brief — Bates v. Dow Agrosciences LLC

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No. 03-388

————=—=K==_=_—_==Zq{x——[=S=[=S[={7_{_zz=z_Z*====

IN THE

Supreme Court of the Anited 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 CROPLIFE AMERICA AND

NATIONAL PEST MANAGEMENT ASSOCIATION

AS AMICI CURIAE IN SUPPORT OF RESPONDENT

DOUGLAS T. NELSON LAWRENCE S. EBNER *

SEEMA MAHINI MCKENNA LONG &

CROPLIFE AMERICA ALDRIDGE LLP

1156 15th Street, N.W. 1900 K Street, N.W.

Suite 400 Washington, D.C. 20006

Washington, D.C. 20005 (202) 496-7500

(202) 296-1585

* Counsel of Record

Attorneys for Amici Curiae

SS Sa a LEESON

WILSON-EPES PRINTING CO., INC. — (202) 789-0096 — WASHINGTON, D.C. 20001

TABLE OF CONTENTS

PEA ONIITS cxsemnssnsessrssnsemmcaesceesseecsnomemmsennapianesiaan

Il.

SECTION 136v(b) OF FIFRA NEITHER

PREEMPTS ALL DAMAGES CLAIMS

AGAINST PESTICIDE MANUFACTURERS

NOR PRECLUDES FARMERS FROM

OBTAINING COMPENSATION FOR CROP

A. The Lower Courts Have Consistently Held

That Only Labeling-Related Damages

Claims Are Preempted By § 136v(b)..........

B. Agricultural Pesticide Manufacturers Are

Conscientious Product Stewards Which

Strive To Maintain Good Will With Farm-

ers Through Prompt Resolution Of Crop

I Cn werenscenssnsnnsscctssemeniarenniencinentinians

FIFRA PREEMPTION OF LABELING-

RELATED DAMAGES CLAIMS _ PRE-

SERVES THE SIGNIFICANT HEALTH,

SAFETY, ENVIRONMENTAL, AND PROD-

UCT PERFORMANCE BENEFITS OF EPA-

REGULATED, NATIONALLY UNIFORM

PRODUCT LABELING.............ccccsscssscessseesesees

A. Nationally Uniform Product Labeling

Plays A Crucial Role In The Coordinated

Federal/State Regulatory Partnership Es-

tablished By Congress ...............:ccsseeeeeeeeees

(i)

11

13

TABLE OF CONTENTS—Continued TABLE OF AUTHORITIES

Page CASES Page

B. Labeling-Related Damages Claims Would Akee v. Dow Chem. Co., 272 F.Supp.2d 1112

Impair—Not Promote—FIFRA’s Goals ..... 20 a inate aaasimetciaariieeiniatie 9

Ill. CONGRESS DID NOT INTEND TO “an on dg hebes gg hg ge

EXCLUDE FROM FIFRA cee mye (2003) , F was 3.29

TION LABELING-RELATED DAMA (2003).......-000 seeessnsnnnsneeeecnnecensnnnnnnenenceneeensnsnse ,

CLAIMS THAT INVOLVE AGRICUL- A eget Grp, Me. 3 US.

TURAL CROP INJURY oc....ccccccssccccosssescooo 24 ( er 4, 21, 22, 24, 26

CSX Transp., Inc. v. Easterwood, 507 U.S.

—— TTT TE 30 TEST rENern ene Tere NNe EE 4

Etcheverry v. Tri-Ag Service, Inc., 993 P.2d 366

EC ene ene passim

Geier v. American Honda Motor Co., Inc., 529

BET TTITTTET cstnrtecunnimepicacennennsnssesentinnemineen 24

Grenier v. Vermont Log Bldgs., Inc., 96 F.3d 559

acetal laiiaicctaiertatinniaateaes 8

In re DuPont-Benlate Litigation, 859 F Supp 619

(D.P.R. 1994)............ sjqngag»ereecesesecscecscscessnsesecseees &

In re Starlink Corn Products Liability Litigation,

212 F.Supp.2d 828 (N.D. Ill. 2002)................... 9,10

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

ERE e 9, 29

Lescs v. William R. Hughes, Inc., 168 F.3d 482

(Table), No. 97-2278, 1999 WL 12913

(4th Cir. Jan. 14, 1999) (Text) ..........ccccccccceeeees 10

Lowe vv. Sporicidin Int'l, 47 F.3d 124

SEI, [IIIT siscnsrnsesstenaienemusnapmemnnensiignsnesnneenemsces 10

MacDonald v. Monsanto Co., 27 F.3d 1021

I, CI cniceeastaienitreenaneernnemmeamemenmenmeegen 22

Medtronic v. Lohr, 518 U.S. 470 (1996) ............... 4,22

Nathan Kimmel, Inc. v. DowElanco, 275 F.3d

I TE ncn snsrenienetemememenenminnimmenss 7

National Agric. Chem. Ass'n v. Rominger, 500 F.

Supp. 465 (E.D. Cal. 1980) ............ccccsccsscesceseees 13

iv

TABLE OF AUTHORITIES—Continued

Nat'l Bank of Commerce v. Dow Chem. Co., 165

Pee Ge GG Ce ccccssscenseserenmmnennnmeensen

Netland v. Hess & Clark, Inc., 284 F.3d 895

(8th Cir.), cert. denied, 537 U.S. 949 (2002).....

New York State Pesticide Coalition v. Jorling,

874 F.2d 115 (2d Cir. 1989) ..0.......cccccesseseeesseees

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

Papas v. Upjohn Co., 926 F.2d 1019 (11th Cir.

1991), vacated and remanded sub nom. Papas

v. Zoecon Corp., 505 U.S. 1215 (1992) (vacat-

ing and remanding for further consideration in

light of Cipollone v. Liggett Group, Inc., 505

U.S. 504 (1992)), aff'd sub nom. Papas v.

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

Ruckelshaus v. Monsanto Co., 467 U.S. 986

14, 16

23

(BBE ccccccccnceevssssezsssssessensncsssessvensnsesensnssenssquen 13, 14, 26

Taylor AG Indus. v. Pure-Gro, 54 F.3d 555

CBE COR. BEGG D cccsccscnsscessszecsssnssnsssesssessnssersnssesee 9, 22, 29

Welchert v. American Cyanamid, Inc., 59 F.3d 69

ee

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

| 3, 13, 14

Worm v. American Cyanamid Co., 5 F.3d 744

CSE GRE, SEED ccrcccsseccsssczsecszsenssssssssvmscvsnensennssen 8, 20, 29

Worm v. American Cyanamid Co., 970 F.2d 1301

GREG, GE cnercneneneninnnetcenmmnesenemennn

STATUTES AND REGULATIONS

Federal Insecticide, Fungicide and Rodenticide

Act,

7 U.S.C. §§ 136-136y (2000) ......ccccccccecsseeeseseee

7 U.S.C. § 136j(a(2)M(G)...cccecccccescvecssssessesveeeesees

\

TABLE OF AUTHORITIES—Continued

Page

7 U.S.C. § 136W-1(8)....cccccesssesssessseesseessessveesseen 20

RIE: passim

iii scicienebienitieinieeisie 16, 18

40 C.F.R. § 156.10(i)(2)(ii) .....eccccccsesssessvessveesveesees 16

|. rs 19

40 C.F.R. § 158.640(b)(1) ...ccccccscssseccsesseessesseesvee 28

LEGISLATIVE MATERIALS

Federal Env. Pesticide Control Act: Hearings

Before the Subcomm. on Agric. Research &

Gen'l Legis. of the Sen. Comm. on Agric. &

Forestry, 92d Cong. 416 (Mar. 9, 1971)........... 15

Federal Env. Pesticide Control Act: Hearings

Before the Subcomm. on Agric. Research &

Gen'l Legis. of the Sen. Comm. on Agric. &

Forestry, 92d Cong. 87 (Mar. 7-8, 1972)........... 15

H.R. Rep. No. 313 (1947), reprinted in 1947

eee 14

H.R. Rep. No. 92-511 (1971), reprinted in 1972

2 eee nn 15, 21

H.R. Rep. No. 95-343 (1977), reprinted in 1978

A ees 25, 26

H.R. Rep. No. 95-663 (1977), reprinted in 1978

See 27, 28

S. Rep. No. 92-838 (1972), reprinted in 1972

i eee 16

S. Rep. No. 95-1188 (1978).............c.0sscsscssssesreesees 26

ne 16, 25, 27

14 Weekly Comp. Pres. Doc. 1696 (Oct. 2, 1978)... 26

Conf. Rpt. on S. 1678 (Sept. 18, 1978), Sen.

Comm. on Agric., Nutrition & Forestry, 95th

Cong. (Comm. Print 1979) .............cccccsceceeeeeees 26

vi

TABLE OF AUTHORITIES—Continued

MISCELLANEOUS Page

44 Fed. Reg. 27,932 (May 11, 1979)...........cccccesees 26, 29

48 Fed. Reg. 24,000 (July 26, 1983) ...........cccessees 27

69 Fed. Reg. 23,200 (Apr. 28, 2004).............cccceees 18

AAPCO Mission Statement, available at http://

aapco.ceris.purdue.edu/htm/mission.htm .......... 20

Draft Pesticide Registration (PR) Notice 2004-

XX (Apr. 28, 2004), available at http://

www.epa.gov/PR_Notices/draftpr2004-X.pdf.. 19

Pesticide Registration (PR) Notice 2001-1 (Jan.

2, 2001), available at http://www.epa.gov/

opppmsd1/PR_Notices/pr2001-1 .pdf................ 18

Pesticide Registration (PR) Notice 2001-3 (Jan.

16, 2001), available at http://www.epa.gov/

opppmsd1/PR_Notices/pr2001-3.pdf................. 19

Pesticide Registration (PR) Notice 2001-6

(Sept. 7, 2001), available at http://www.

epa.gov/opppmsd1/PR_Notices/pr2001 -6.pdf... 19

Pesticide Registration (PR) Notice 96-6 (Oct. 1,

1996), available at http://www.epa.gov/

opppmsd1/PR_Notices/pr96-6.html .................. 19

Pesticide Registration (PR) Notice 96-7 (Oct. 1,

1996), available at http://www.epa.gov/

opppmsd1/PR_Notices/pr96-7.html .................. 19

Pesticide Registration (PR) Notice 97-8 (Sept.

25, 1997), available at http://www.epa.gov/

opppmsd1/PR_Notices/pr97-8.html .................. 19

EPA, Label Review Manual, available at

http://www.epa.gov/oppfead | /labeling/Irmail ... 17

EPA, “Read the Label First,” available at

http://www.epa.gov/pesticides/label.................. 17

Northeastern Regional Pesticide Coordinators,

Pesticide Applicator Training Manual, Ch.

XIV-3 (2d ed., revised 1998) .00.......ccccccceeneeenees 16

vii

TABLE OF AUTHORITIES—Continued

Viet D.. Dinh, “Reassessing the Law of

Preemption,” 88 Geo. L.J. 2085 (2000).............

Amicus Br. for United States, American

Cyanamid Co. v. Geye, No. 02-367 (U.S. filed

Be Ce Mae censircneerinennecinisitatnineinnmnnesinntintes

Amicus Br. for United States, Wisconsin Pub.

Intervenor v. Mortier, No. 89-1905 (U.S. filed

EE Se a instensttsnnsteenennennnizensniamneenmisienenemennuein

Page

22

INTEREST OF THE AMICI CURIAE'

Amici curiae CropLife America and National Pest

Management Association have a substantial interest in the

subject of this appeal—the preemptive reach of § 136v(b) of

the Federal Insecticide, Fungicide, and Rodenticide Act

(“FIFRA”), 7 U.S.C. §§ 136-136y. The members of these

nationally prominent trade associations are the types of

companies (pesticide manufacturers, formulators, and

distributors, and structural pest control firms) that most

frequently are subjected to agricultural crop damage,

homeowner property damage, and personal injury suits

involving the use of pesticides. The associations are

submitting this amicus curiae brief for three principal

reasons:

(i) To rebut Petitioners’ insinuations that affirming the

Fifth Circuit’s opinion below somehow would shield

agricultural pesticide manufacturers from all state law

damages remedies for pesticide-related crop injury, and

leave aggrieved farmers with no means of obtaining

compensation;

(ii) To explain why federal preemption of failure-to-

warn and other /abeling-related damages claims pro-

motes FIFRA’s goals and is essential for maintaining

the important health, safety, environmental, and product

performance benefits provided by nationally uniform

pesticide product labeling that is regulated solely by

the United States Environmental Protection Agency

(EPA); and

' The parties have lodged with the Clerk blanket consents to the filing

of amicus curiae briefs. Pursuant to Sup. Ct. R. 37.6, amici curiae

CropLife America and National Pest Management Association state that

no counsel for a party has written this brief in whole or in part, and that

no person or entity, other than amici curiae, its members, or its counsel,

has made a monetary contribution to the preparation or submission of

this brief.

2

(iii) To highlight the implausibility of Petitioners’ con-

tention that by enacting FIFRA’s so-called efficacy data

waiver, Congress intended to create a gaping exception

to preemption for labeling-related damages claims that

involve agricultural crop injury.

CropLife America, a national, not-for-profit trade associa-

tion, represents the American plant science industry on a

broad range of legislative, regulatory, legal, scientific, and

product stewardship issues. Its members serve farmers and

consumers by developing, manufacturing, and distributing

virtually all of the agricultural crop protection pesticides and

biotechnology products used to produce safe, high-quality,

affordable, and abundant food, fiber, and other crops.

For the past 57 years, CropLife America (formerly known

as the American Crop Protection Association, and before that,

the National Agricultural Chemicals Association) has been

industry’s foremost voice on enactment, amendment, and

implementation of FIFRA, the nation’s primary pesticide

regulatory statute. CropLife America and its members con-

sider FIFRA’s carefully balanced allocation of pesticide

regulatory authority between EPA and the states, especially

the system of federally regulated, nationally uniform product

labeling mandated by § 136v(b), to be a subject of paramount

importance. For this reason, CropLife America has an abiding

interest in ensuring that courts, when confronted with state

law liability claims that directly or indirectly attack the ade-

quacy of the warnings, precautionary measures, directions for

use, or other information on a pesticide’s federally regulated

product labeling, properly apply § 136v(b), which expressly

preempts the states from imposing “any requirements for

labeling” that are “in addition to or different from” those

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

On numerous occasions during the past 12 years, CropLife

America has successfully argued in amicus curiae briefs

submitted to federal courts of appeals and state appellate

3

courts that § 136v(b) encompasses requirements imposed

through state damages claims for inadequate labeling or

failure to warn. In addition, last year CropLife America filed

an amicus curiae brief urging review of the Texas Supreme

Court’s opinion in American Cyanamid Co. v. Geye, 79

S.W.3d 21 (Tex. 2002), cert. denied, 539 U.S. 969 (2003),

which contrary to the Fifth Circuit’s opinion here,

erroneously held that all agricultural crop damage claims

(including those that are labeling-related) are excluded from

preemption.

The National Pest Management Association (“NPMA”)

is a national, not-for-profit, trade association representing

more than 5,000 pest control companies throughout the

United States. The association’s members help protect food,

health, property and the environment with a broad range of

pest management services such as control of termites, insects,

and rodents in residential, commerrial, and institutional

settings; control of mosquitoes and wildlife that transmit

West Nile Virus or other life-threatening diseases; and control

of stored product pests in food handling and agricultural

surroundings. NPMA, which was established in 1933,

supports its members through technical, educational,

business, public relations, and government affairs programs.

Since pest management professionals are both required and

trained to apply pesticides in a manner consistent with their

nationally uniform, EPA-approved product labeling, NPMA

participates as amicus curiae in appeals involving important

issues arising under FIFRA, including the statute's

preemptive effect. For example, NPMA and _ other

associations (including CropLife America) jointly filed an

amicus curiae brief in W. consin Public Intervenor v.

Mortier, 501 U.S. 597 (1991) (involving FIFRA preemption

of a local government pesticide use ordinance), in which the

Court confirmed (id. at 615) that “labeling . . . fall[s] within

an area thet FIFRA’s ‘program’ pre-empts.” NPMA has

4

joined CropLife America here because the categorical anti-

preemption position that Petitioners and most of their amici

are advocating would severely undermine the congressionally

mandated system of nationally uniform pesticide product

labeling, which greatly facilitates applicator training and

safety, and helps to protect consumers and the public.

SUMMARY OF ARGUMENT

The scope of FIFRA’s express preemption provision,

§ 136v(b), is defined by its own plain, broad, language.

States are unequivocally prohibited from imposing “any

requirements for /abeliig” which are “in addition to or

different from” those required under FIFRA. 7 U.S.C.

§ 136v(b) (“Uniformity”) (emphasis added). This Court’s

preemption jurisprudeiice establishes that a federal statutory

prohibition against imposition of state requirements easily

encompasses requirements imposed through state damages

actions. See Cipollone v. Liggett Group, Inc., 505 U.S. 504,

521 (1992); see also Medtronic v. Lohr, 518 U.S. 470, 504,

509 (1996); CSX Transp., Inc. v. Easterwood, 507 U.S. 658,

664 (1993). Therefore, as numerous federal courts of appeals

and state appellate courts have held, § 136v(b) expressly

preempts any state damages claim, such as a claim based on

failure to warn, that would have the effect of imposing state

requirements for labeling which are in addition to or different

from those that have been imposed under FIFRA. The same

courts have been equally clear, however, that § 136v(b) does

not preempt non-labeling related claims. Petitioners’ over-

blown assertions implying that § 136v(b) immunizes pesti-

cide manufacturers from all “damages actions” (rather than

merely preempting labeling-related claims), and leaves farm-

ers with no means of obtaining compensation for crop injury,

are unfounded both as a matter of law and fact. Pesticide

manufacturers are excellent product stewards, and have

strong economic incentives for resolving crop injury pro-

5

blems before they turn into litigation. This is why crop

damage litigation is the exception, not the norm.

Nationally uniform product labeling that is regulated solely

by EPA plays a critical role in achieving FIFRA’s fundamen-

tal goal of protecting health and the environment. For

example, such labeling is an essential component of educa-

tional and training programs for pesticide applicators, and

enormously aids applicator comprehension of, and compli-

ance with, label wamings, precautionary measures, and

directions for use. Only EPA (and certainly not a lay juror)

has the expertise, experience, and other resources to deter-

mine, on a product-by-product, category-by-category, or

across-the-board basis, what specific warnings, precautionary

measures, and other information should or should not be

included on nationally uniform pesticide labeling. Rather

than having a salutary effect, the nationwide epidemic of

labeling-related damages suits that Petitioners and their amici

are urging this Court to trigger would clash with FIFRA’s

health and environmental goals by drastically undermining

the integrity of EPA’s labeling determinations, and for all

practical purposes, destroying national labeling uniformity.

Section 136v(b), enacted in 1972, contains no exception to

preemption for labeling-related damages claims that involve

agricultural crop injury. Nor did Congress intend to amend

§ 136v(b), or otherwise affect that provision’s self-executing

operation, when in 1978 at EPA’s request, it streamlined

FIFRA’s federal registration procedures, including by en-

acting the efficacy data waiver authorization found in

§ 136a(c)(5). Congress authorized EPA to selectively waive

submission of efficacy data to support a registration because

of the high level of efficacy-related expertise within the

agricultural community, not the courtroom. Lay juries would

not have the type of expertise that Congress had in mind if

called upon in a crop injury suit to second-guess the adequacy

of EPA’s labeling determinations.

6

ARGUMENT

I. SECTION 136v(b) OF FIFRA NEITHER PRE-

EMPTS ALL DAMAGES CLAIMS AGAINST

PESTICIDE MANUFACTURERS NOR PRE-

CLUDES FARMERS FROM OBTAINING

COMPENSATION FOR CROP INJURY

A. The Lower Courts Have Consistently Held

That Only Labeling-Related Damages Claims

Are Preempted By § 136v(b)

By its own express terms, § 136v(b) of FIFRA is limited to

preemption of “any requirements for labeling . . . in addition

to or different from those required under [the Act].” 7 U.S.C.

§ 136v(b) (emphasis added). As a result, only /abeling-

related damages claims, such as failure-to-warn claims

(which necessarily impose state law requirements for “ade-

quate” label warnings), are expressly preempted. This is the

fixed, statutorily defined scope of tort preemption under

§ 136v(b). Nevertheless, in an effort to bolster their extreme

position that § 136v(b) does not preempt any damages claims,

Petitioners, in the first 29 pages of their brief, attempt to

transform FIFRA preemption into an all-or-nothing proposi-

tion. They erect and then take aim at an easy but illusory

target, namely that Congress did not intend § 136v(b) to

immunize pesticide manufacturers from all state law liability

or deprive farmers of all state law damages remedies. See,

e.g., Pet. Br. at 2 (“it is unthinkable that Congress ... in-

tended to exonerate manufacturers from traditional state-law

remedies”); at 14 (“State damages actions are not preempted

by FIFRA”); at 16 (“Nothing ... indicates that Congress

intended to ... preclud{e] farmers from seeking redress for

the damages caused to them by pesticide manufacturers.”’); at

25 (“FIFRA’s Legislative History And Purposes Reveal No

Intent To Preempt Damages Actions”); at 26 (“no witness or

Member of Congress ever suggested that the proposed [1972]

legislation would shield pesticide manufacturers from product

7

liability tort suits”); at 29 (“it does not follow that all such

claims are barred”).

Unlike virtually every lower court that has opined on the

scope of FIFRA tort preemption, Petitioners and their amici

somehow overlook the clearly circumscribed preemptive

boundary of § 136v(b) (i.e., preemption of additional or

different requirements for /abeling) and that provision’s

resultant limitation to /abeling-related damages claims, such

as Claims for failure to warn.” To be sure, “[t]he federal court

decisions holding that FIFRA preempts siate law failure-to-

warn claims are numerous, consistent, pragmatic and power-

fully reasoned.” Etcheverry v. Tri-Ag Service, Inc., 993 P.2d

366, 368 (Cal. 2000).’ But as the Fifth Circuit reconfirmed in

its opinion below, “FIFRA does not preempt common law

that is unconcerned with [pesticide] labeling.” Pet. App. 10a

(citing Andrus v. AgrEvo USA Co., 178 F.3d 395, 398 (Sth

Cir. 1999)); see also id. at 11a (quoting Hart v. Bayer Corp.,

199 F.3d 239, 245 (Sth Cir. 2000) (“FIFRA preemption does

not extend to non-labeling state common-law causes of

action”). Indeed, “courts have rejected preemption chal-

lenges with regard to a wide variety of claims where they did

? Section 136v(b) also preempts “an.’ requirements for . . . packaging in

addition to or different from those required under [FIFRA].” Nothing in

this brief is intended to imply that § 136v(b) does not also encompass

packaging-related claims.

* The California Supreme Court squarely rejected all of the arguments,

many of which are repeated by Petitioners here, in what Petitioners

nevertheless describe as the “powerful brief” (Pet. Br. at 28) filed by the

government as amicus curiae in Etcheverry. See Nathan Kimmel, Inc. v.

DowElanco, 275 F.3d 1199, 1207 (9th Cir. 2002) (“The California Su-

preme Court found the EPA’s position [in Etcheverry] both unsupported

by the relevant law and unpersuasive in its substance, noting that the

EPA’s views went against the holdings of eight federal circuit courts of

appeal.”). Last term the government advised this Court that it has “reex-

amined the position that it urged in Etcheverry [and] concluded that [it] is

incorrect.” U.S. Br. at 17, American Cyanamid Co. v. Geye (No. 02-367).

8

not implicate requirements for labeling.” Etcheverry, 993

P.2d at 377 (collecting cases).

For example, in Netland v. Hess & Clark, Inc., 284 F.3d

895, 900 (8th Cir.), cert. denied, 537 U.S. 949 (2002), the

court of appeals reaffirmed that “ ‘if the state law claim is

premised on inadequate labeling or a failure to warn,’ which

results in the imposition of additional or different labeling

requirements, the claim is nonetheless preempted regardless

of the guise under which the claim is presented” (quoting

Nat'l Bank of Commerce v. Dow Chem. Co., 165 F.3d 602,

608 (8th Cir. 1999)); see, e.g., Grenier v. Vermont Log

Blidgs., Inc., 96 F.3d 559, 565 (Ist Cir. 1996) (§ 136v(b)

preempts a purported design or manufacturing defect claim if

it actually is a “disguised labeling claim”). But “[t}he line

between a claim for mislabeling and a claim for a defective

product may not always be clear.” Worm v. American

Cyanamid Co., 5 F.3d 744, 747 (4th Cir. 1993). The court of

appeals agreed with the plaintiff in Netland “that detectively

manufactured or designed products properly labeled under

FIFRA remain subject to state regulation, in the form of

common law or other claims.” 284 F.3d at 900. Thus,

§ 136v(b) would not preempt a farmer’s claim tkat his crops

were destroyed by a herbicide which, due to a manufacturing

error, contained substantially more active ingredient than

allowed by its FIFRA registration. Nor would § 136v(b)

preempt a claim that a herbicide was ineffective in killing

weeds because it contained substantially less active ingredient

than approved by EPA. Along the same lines, a claim that

“particular lots” of herbicide caused crop damage because

they were “negligently contaminated” with another herbicide

has been held not preempted. /n re DuPont-Benlate

Litigation, 859 F.Supp 619, 622, 623 (D.P.R. 1994); see also

Nat'l Bank of Comm., 165 F.3d at 608-09 (§ 136v(b) does not

preempt a claim based on the presence of a “toxic impurity”

in a pesticide product). And a district court recently ruled

9

that § 136v(b) does not preempt a negligent distribution claim

alleging that a bulk container of an agricultural pesticide

“erupted” and caused environmental contamination. See Akee

v. Dow Chem. Co., 272 F.Supp.2d 1112, 1127 (D. Hawaii

2003) (“the court does not see anything in the record before it

suggesting that this claim is in any way a labeling or warning

based claim”).

The lower courts have been virtually unanimous in holding

that “[w]hen a claim, however couched, boils down to an

assertion that a pesticide’s label failed to warn of the damage

plaintiff allegedly suffered, the claim is preempted by

FIFRA.” Etcheverry, 993 P.2d at 376 (collecting cases). For

example, § 136v(b) preempts claims alleging that a pesticide

is “misbranded” (which § 2(q)(1)(G) defines to include labels

that do not contain adequate warnings). See, e.g., Kuiper v.

American Cyanamid Co., 131 F.3d 656, 666 (7th Cir. 1997);

Papas v. Upjohn Co., 985 F.2d 516, 518-19 (11th Cir. 1993).

But a claim alleging that the manufacturer of corn seed which

was genetically modified to be resistant to certain insects

failed to comply with the terms of a FIFRA conditional

registration, such as selling the seeds without the label

required by EPA, has been held not to impose an additional or

different requirement for labeling, and thus, not preempted.

See In re Starlink Corn Products Liability Litigation, 212

F.Supp.2d 828, 836 (N.D. Ill. 2002).

Further, the lower courts have consistently held that

§ 136v(b) preempts claims for misrepresentation or breach of

express warranty based on so-called “off-label” statements

(e.g., advertising statements; oral statements) “if they merely

repeat information in the label itself.” Kuiper, 131 F.3d

at 662; see also Pet. App. 17a (farmers’ fraud and breach

of warranty claims are preempted “[bJecause no evidence

was presented demonstrating that the retailer statements

deviated from the contents of the Scepter label”); Taylor AG

Indus. v. Pure-Gro, 54 F.3d 555, 563 (9th Cir. 1995) (FIFRA

10

preempts claim based on distributor’s oral representation

regarding crop safety where there was “no evidence establish-

ing that [it] made any statements that were inconsistent with

or went beyond the labels”); Lowe v. Sporicidin Int'l, 47 F.3d

124, 127-30 (4th Cir. 1995) (§ 136v(b) preempts claims based

on “off-label” representations which do not “substantially

differ” from the label). As the California Supreme Court

indicated in Etcheverry, however, “[w]here off-label state-

ments address matters outside the scope of the label, an action

may well lie.” 993 P.2d at 378; see, e.g., In re Starlink, 212

F.Supp.2d at 836-37 (“Claims based on off-label represen-

tations . . . are not preempted . . . to the extent the represen-

tations substantially differ from the label.”); id. at 837

(holding that oral statements to farmers that genetically

modified corn “was safe for human consumption . . . directly

contradict the approved label”). Thus, if a herbicide were

registered only for use on peanuts, but the manufacturer

advertised that it also works well on cotton, § 136v(b) would

not preempt a cotton crop injury claim based on that off-label

statement, since it substantially differs from, rather than

repeats the information on, the EPA-approved label.

Therefore, affirming the principle adopted by numerous

federal and state appellate courts that § 136v(b) preempts

only failure-to-warn and other labeling-related claims would

not, aS Petitioners claim, give “sweeping effect to the pre-

emption provision.” Pet. Br. at 1. Preemption of such claims

benefits farmers and the public by preserving the national

labeling uniformity mandated by Congress (see discussion

infra), but contrary to the hyperbolic advocacy of Petitioners

and their amici, in no way precludes farmers or other plain-

tiffs from pursuing non-labeling related damages actions

against pesticide manufacturers. See Lescs v. William R.

Hughes, Inc., 168 F.3d 482 (Table), No. 97-2278, 1999 WL

12913, at *7 (4th Cir. Jan. 14, 1999) (Text) (“FIFRA’s

language does not suggest some extraordinarily broad scope

of preemption that extends beyond the statutory scheme. Nor

does it work to destroy all means of redress for plaintiffs

under the common law of a state.”’).

B. Agricultural Pesticide Manufacturers Are Con-

scientious Product Stewards Which Strive To

Maintain Good Will With Farmers Through

Prompt Resolution Of Crop Injury Claims

According to Petitioners, “[bJecause nothing in FIFRA

affords compensation to parties injured by pesticides, state-

law damages claims properly fill the void left by Congress.”

Pet. Br. at 14. This facile logic erroneously implies that

litigation is the only way that farmers can obtain compensa-

tion from pesticide manufacturers for crop injury. Like most

farmers, these Petitioners, to whom Respondent offered the

opportunity to obtain reasonable compensation without litiga-

tion (see J.A. 143-45), know better.

In reality, pesticide manufacturers are an integral, well

respected part cf the agricultural community. Along with

university researchers, agricultural extension agents, private

crop consultants, seed suppliers, farm store retailers, and

custom applicators, pesticide manufacturers and their dis-

tributors serve as an important informational resource to

farmers. For example, manufacturers provide farmers, either

directly or through distributors and retailers, with abundant

technical information regarding their products and how they

can be used safely and effectively on particular crops. In

addition, manufacturers continualiy interact with farmers to

better learn how their products perform in specific geographic

locations or under particular environmental conditions. Such

information can lead to more finely tuned directions for use,

and when necessary, use restrictions.

Moreover, R&D-oriented pesticide innovators invest hun-

dreds of millions of dollars in screening, testing, and register-

ing highly efficacious new products that benefit farmers, the

12

agricultural economy, and consumers throughout the United

States and world. These include, for example, low dose, less

toxic products which break down rapidly after application to

food crops; products applied with advanced delivery systems

that reduce applicator and environmental exposure; and bio-

technology products, such as genetically engineered seed that

grows into insect-resistant crops. Prior to obtaining a FIFRA

registration for a new agricultural pesticide, a manufacturer

may conduct more than 250 health, safety, environmental,

and efficacy studies. In addition to their individual activities,

pesticide manufacturers, through CropLife America, partici-

pate in industry-wide product stewardship programs, such as

the Ag Container Recycling Council, which helps farmers

reduce disposal costs and avoid environmental contamination.

Petitioners’ contention that a multitude of lay jurors, who

know nothing about crop production or pesticides, should

have free reign to find that pesticide manufacturers’ EPA-

approved labeling is inadequate, and on that basis, render

huge damages awards in order to fill a FIFRA compensation

“void,” fails to take into account the highly collegial and

cooperative relationship between agricultural pesticide manu-

facturers and farmers. As a matter of good product steward-

ship and sound business sense, manufacturers’ regional and

local field representatives, who typically have considerable

agronomic expertise, work closely with farmers to promptly

investigate and resolve product performance and/or crop

injury problems without litigation. Most pesticide manu-

facturers have well established customer satisfaction policies.

When circumstances warrant, and depending on the nature of

the problem, remedies provided by manufacturers may range

from re-application of pesticides at the manufacturer’s

expense, to reimbursement of the cost of unsatisfactorily

performing products, to replacement of seed or monetary

compensation for injured crops. Upon the infrequent event of

widespread crop injury problems with a product, manu-

13

facturers have established formal claims settlement pro-

cedures (such as the Strongarm mediation program initiated

by Respondent here) in order to maintain the company’s

reputation and good will, treat farmers fairly, and avoid

lawsuits.

If FIFRA tort preemption were the all-encompassing prod-

uct liability defense that Petitioners and their amici pretend to

fear, manufacturers, aside from their excellent product stew-

ardship and strong economic incentives for satisfying farm-

ers’ needs, would have little reason to resolve crop injury

claims. Instead, manufacturers invest substantial financial

resources to resolve any crop injury problems that farmers

encounter. As a result, and contrary to the impression that

Petitioners try to create, the need to file crop damage suits for

the purpose of obtaining compensation from pesticide

manufacturers is the exception, and certainly not, as

Petitioners assert, a reason to hold that § 136v(b) is limited to

positive enactments.

Il. FIFRA PREEMPTION OF LABELING-RE-

LATED DAMAGES CLAIMS PRESERVES THE

SIGNIFICANT HEALTH, SAFETY, ENVIRON-

MENTAL, AND PRODUCT PERFORMANCE

BENEFITS OF EPA-REGULATED, NATION-

ALLY UNIFORM PRODUCT LABELING

A. Nationally Uniform Product Labeling Plays A

Crucial Role In The Coordinated Federal/State

Regulatory Partnership Established By Con-

gress

“FIFRA’s historic focus [is] on labeling.” Wisconsin Pub.

Intervenor v. Mortier, 501 U.S. at 613. When FIFRA was

first enacted in 1947, it was intended to supplement existing

regulation of pesticides by the states. See Ruckelshaus v.

Monsanto Co., 467 U.S. 986, 990 n.2 (1984); National Agric.

Chem. Ass'n v. Rominger, 500 F. Supp. 465, 468 (E.D. Cal.

14

1980). But even back then, Congress was concerned about the

need for promoting national uniformity in pesticide labeling.

See H.R. Rep. No. 313, at 3 (1947) (noting that the 1947

FIFRA “is in accord” with the Uniform State Insecticide,

Fungicide, and Rodenticide Act; that enactment of the federal

legislation “will greatly facilitate the coordination of work in

this field among the States and with the Federal Govern-

ment;” and that “[ijt is highly desirable that laws governing

[pesticides] be as nearly uniform as possible . . . so that

manufacturers may have Nation-wide distribution with a

minimum of conflict between the labeling requirements of the

various laws.) (emphasis added). To this end, “[t}he 1947

legislation ... contained general standards setting forth the

types of information necessary for proper labeling of a

registered pesticide, including directions for use; warnings to

prevent harm to people, animals, and plants; and claims made

about the efficacy of the product.” Ruckelshaus, 467 U.S. at

991. There was, however, no express preemption provision

regarding state regulation of labeling.

“In 1972, growing environmental and safety concerns led

Congress to undertake a comprehensive revision of FIFRA.”

Mortier, 501 U.S. at 601. Congress transformed the Act into

a “comprehensive regulatory statute” (Ruckelshaus, 467 U.S.

at 991) and “significantly strengthened [its] registration and

labeling standards.” Mortier, 501 U.S. at 601. During its

extensive deliberations, Congress carefully considered the

allocation of pesticide regulatory authority between the newly

created EPA and the states in order to establish “a

coordinated Federal-State administrative system to carry out

the new program.” /d. at 615 (quoting H.R. Rep. No. 92-511,

at 1). Under that “regulatory partnership” the states share

responsibility with EPA for regulating the sale and use of

pesticides, but pesticide “labeling . . . fall[s] within an area

that FIFRA’s ‘program’ pre-empts.” /d.; see also New York

State Pesticide Coalition v. Jorling, 874 F.2d 115, 118 (2d

15

Cir. 1989) (“The states have joint control with the federal

government in regulating the use of pesticides . . . with the

exception of the EPA’s exclusive supervision of labeling.”’).

More specifically, the 1972 FIFRA amendments added

§ 136v(b) (“Uniformity”), which Congress intended “to com-

pletely preempt State authority in regard to labeling.” H.R.

Rep. No. 92-511, at 16 (1971). Representatives of both the

pesticide industry and agriculture testified in support of the

need for national labeling uniformity. See, e.g. Fed. Env.

Pesticide Control Act: Hearings Before the Subcomm. on

Agric. Research & Gen'l Legis. of the Sen. Comm. on Agric.

& Forestry, 92d Cong. 416 (Mar. 9, 1971) (Stmnt. of Parke

C. Brinkley, President, Nat’! Agric. Chem. Ass’n) (EPA has

“sufficient scientific expertise [for] the determination of the

proper labeling . .. of each product. There is no need for this

process to be duplicated in each of the 50 States.”); id. at 354

(Stmnt. of Clifford G. McIntyre, Director, Natural Resources

Dept., and Ass’t Legis. Dir., Am. Farm Bureau Fed.) (“In

labeling the manufacturers have a real problem with the

whole diversified requirements in 48 States. We accept the

concept of some uniformity.”). EPA and state pesticide regu-

lators also supported national uniformity. See id., 92d Cong.

87 (Mar. 7-8, 1972) (Stmnt. of David D. Dominick, Ass’t

Admin. for Categorical Programs, EPA) (“I think that the

basic thrust that is needed in new legislation is uniformity [of]

registration.”); id. at 153 (Stmnt. of Charles H. Frommer,

Dir., Bureau of Pesticide Control, N.Y. State Dep’t of Env’!

Conservation) (“We very strongly favor the provision of

[§ 136(b)] which provides for uniform labeling. We have en-

dorsed uniform labeling and we intend to continue to endorse

uniform labeling.”’).

As the Solicitor General explained to the Court in Mortier,

“an exclusively federal approach is necessary in certain areas

of pesticide regulation. One such area is labeling.” U.S. Br.

at 22, Wisconsin Pub. Intervenor v. Mortier (No. 89-1905).

16

Thus, as amended, “FIFRA placed the ‘labeling’ of pesticides

within the singular province of the EPA.” Jorling, 874 F.2d at

117. Indeed, Congress intended a pesticide’s nationally

uniform, EPA-approved product labeling not to be merely a

“guide,” but instead, “the final authority” governing applica-

tion of a pesticide. S. Rep. No. 95-334, at 4 (1977). Further,

prior to 1972, FIFRA contained “no prohibition ... against

the misuse of a registered pesticide.” S. Rep. No. 92-838, at

4 (1972). In order to correct this deficiency, Congress added

§ 136j(a)(2)(G), which makes it “unlawful for any person . . .

to use any registered pesticide in a manner inconsistent with

its labeling.” 7 U.S.C. § 136j(a)(2)(G). To underscore the

importance of this federal statutory prohibition, EPA requires

every pesticide label to caution applicators that “It is a

violation of Federal law to use this product in a manner

inconsistent with its labeling.” 40 C.F.R. § 156.10(i)(2)(ii).

In fact, FIFRA’s fundamental precept that “The Label Is The

Law” is a prominent feature of the basic training provided in

virtually every state-sponsored pesticide applicator training

program. See, e.g., Northeastern Regional Pesticide Coordi-

nators, Pesticide Applicator Training Manual (commonly

referred to as the multi-state “Core Manual”), Ch. XIV-3 (2d

ed., revised 1998).

Pesticide labeling is different from the ordinary labels

placed on most types of products. It is the principal means by

which EPA ensures that all necessary warnings, safety

precautions, personal protective equipment requirements,

directions for use, and other essential information is commu-

nicated from a pesticide’s manufacturer through the chain of

distribution to the individuals who actually handle and use the

product. See 40 C.F.R. Part 156 (Labeling Requirements for

Pesticides); see also Jorling, 874 F.2d at 119 (‘FIFRA

labeling’ is designed to be read and followed by the end

user.”). EPA continually stresses the importance of reading

and complying with all pesticide labeling requirements. See,

17

e.g., “Read the Labe! First” (http://www. epa.gov/pesticides/

label). It is difficult to overstate the substantial health, safety,

environmental, and product performance benefits that nation-

ally uniform, EPA-regulated product labeling affords to

farmers, professional pesticide applicators, and the public:

First, EPA has the necessary personnel, expertise, experi-

ence, institutional policies, funding, and national perspective,

and possesses (or has access to) the registration data (e.g.,

product chemistry data; toxicity data; environmental fate

data; fish and wildlife data; and efficacy data) required to

comprehensively regulate the warnings, precautionary mea-

sures, directions for use, and other information on a product’s

labeling before and/or after the product is registered.

Needless to say, review and regulation of product labeling is

a responsibility which EPA takes very seriously. See, e.g.,

EPA, Label Review Manual, available at http://www.epa.

gov/oppfead 1 /labeling/Irmail. No state agency, much less a

court or jury, has resources or expertise which approach

EPA’s capability to scrutinize or regulate pesticide labeling.

Second, distribution of a FIFRA-registered product with its

own, EPA-approved, nationally uniform labeling is essential

for applying or using it in a safe and effective manner. As

part of their product stewardship and marketing activities,

manufacturers of agricultural, structural pest control, public

health, and other types of pesticides provide written infor-

mation to farmers, professional applicators, and other users

regarding how to apply or use particular products safely and

effectively in accordance with their EPA-approved labeling.

Manufacturers, often in conjunction with distributors, univer-

sity and extension personnel, state regulators, and national,

state and local trade associations, also conduct educational

and training sessions on a local, regional, or national level.

Label review and comprehension is the cornerstone of

such programs. Without nationally uniform labeling for a

pesticide product, detailed application information and appro-

18

priate training would be difficult if not impossible to provide.

Further, if pesticide manufacturers were confronted with the

economic burden and logistical nightmare of distributing the

same product for the same uses with different labeling re-

quired by different states (or inexpert juries), they could be

forced to make their products available only in the states with

the largest potential markets. That would deprive farmers in

other states of the beneficial, cost-effective products that they

need.

Third, across-the-board national labeling uniformity for all

FIFRA-registered products with respect to format (e.g., the

listing of active ingredients), and the utilization of toxicity

signal words (e.g., “DANGER;” “WARNING”) and precau-

tionary statements for physical and chemical hazards (e.g.,

“Corrosive, causes eye or skin damage;” “Extremely flamma-

ble’), facilitates applicator training and label comprehension.

See 40 C.F.R. Part 156. Uniformity also is critical for first

aid and the operations of the National Pesticide Information

Center (http://www.npic.orst.edu) and other poison control

centers. See, e.g., Pesticide Registration (“PR”) Notice 2001-

1 (“First Aid Statements on Pesticide Product Labels”) (EPA

PR notices can be accessed through http://www.epa.gov/

PR_Notices).

Fourth, to the extent feasible and appropriate, EPA also

strives to achieve labeling uniformity for various categories

of products in order to promote their safe and effective use.

For example, in April 2004 EPA issued for comment draft

uniform labeling statements for professionally applied, wide-

area adult mosquito control products. See 69 Fed. Reg.

23,200 (Apr. 28, 2004). These labeling requirements, which

EPA developed with input from state regulators, set forth

certain specific language to be included on-the labeling of

such products. EPA’s “purpose [is] to improve consistency in

the labeling of this group of products [to] better serve the

needs of users, regulators and the public.” Draft PR Notice

19

2004-XX at 3. Among other things, the draft PR notice in-

cludes uniform mosquito product label language “to ensure

use or supervision by trained applicators” and “to protect

bodies of water and aquatic life.” /d. at 4,6. Along the same

lines, EPA has adopted uniform requirements for certain

aspects of the labeling of other categories of pesticide prod-

ucts. These include flammable total release room foggers, (40

C.F.R. § 156.78(d)), non-antimicrobial residential/household

use insecticides (PR Notice 2001-6), insect repellents (PR

Notice 2001-3), soil applied termiticides (PR Notice 96-7),

and pet care pesticide products (PR Notice 96-6). The

purpose of these and similar EPA labeling requirements for

categories of products is to “bring uniformity” to pesticide

labeling. See PR Notice 97-8.

Fifth, there are numerous national and regional structural

termite and pest control companies and lawn care companies

which apply pesticides in multiple states. Such firms develop

and conduct their own extensive technician (i.e., pesticide

applicator) training, often with the assistance of product

manufacturers and distributors. The same is true for the

companies that protect public health through wide-scale

mosquito and vector control. Applicator training would be

exceedingly difficult to develop and conduct if a particular

pesticide product used by a pest control company had differ-

ent labels (with different warnings, personal protective

equipment requirements, directions for use, etc.) in different

states. To say the least, such disparate labels would be

confusing and difficult to follow for individual pest control

technicians, many of whom routinely cross state lines in a

day’s work.

Sixth, nationally uniform product labeling not only pro-

motes applicator compliance, but also, state enforcement

activities. Although § 136v(b) reserves to EPA alone the

authority to regulate the content and format of pesticide

labeling, Congress has assigned to the states the “primary

20

enforcement responsibility for pesticide use violations.” 7

U.S.C. § 136w-I(a). This means that the states have the

principal responsibility for ensuring that pesticides are

applied or used in accordance with their nationally uniform

labeling. Because of national labeling uniformity, state pesti-

cide enforcement officia are able to interact with each other

to address compliance issues relating to particular labeling

requirements for specific products or categories of products.

For example, the Association of Structural Pest Control

Regulatory Officials (“ASPCRO”) is a professional associa-

tion whose members often comment to EPA as a group

regarding labeling issues relating to specific termite control

and other structural pesticide products. See http://www.

aspcro.org. Another organization, the Association of Ameri-

can Pesticide Control Officials (*“AAPCO”) is comprised of

state and federal pesticide regulatory officials. AAPCO’s

primary mission is “to encourage uniformity among the states

in their pesticide regulatory programs,” such as “uniform

and effective . . . enforcement,” including with regard to “safe

use of pesticides.” See AAPCO Mission Statement, avail-

able at http://aapco.ceris.purdue.edu/htm/mission.htm. AAPCO

could not fulfill its mission without nationally uniform

pesticide labeling.

The foregoing are only some of the reasons why Congress,

in enacting § 136v(b), mandated nationally uniform pesticide

labeling, which more than ever remains a crucial mechanism

for achieving FIFRA’s goals, especially protection of health

and the environment.

B. Labeling-Related Damages Claims Would

Impair—Not Promote—FIFRA’s Goals

“The objectives and purposes of FIFRA include . . . com-

prehensive and uniform regulation of . . . labeling.” Worm, 5

F.3d at 747. According to Petitioners, however, preemption

of state damages actions that attack the adequacy of the

wamings and other information on EPA-approved, nationally

21

uniform product labeling somehow conflicts with FIFRA’s

goals. See, e.g., Pet. Br. at 14 (“To construe § 136v(b) as

preempting the farmers’ suits would be contrary to

Congress’s central aim. . . .”). One of the amicus briefs filed

in support of Petitioners even argues that “FIFRA and state

damages actions complement one another in a constructive

way.” Br. of Natural Resources Defense Council, et al. at 1.

But exactly the opposite is true. Labeling-related damages

claims would seriously undermine EPA’s exclusive authority

to regulate pesticide labeling, severely thwart national

labeling uniformity, and substantially diminish the health,

safety, environmental, and product performance benefits that

only nationally uniform labeling can provide. Petitioners’

argument (Pet. Br. at 25-26) that FIFRA did not preempt

failure-to-warn suits prior to the pesticide regulatory sea

change which Congress effected in 1972—in other words,

before Congress’ mandate for national labeling uniformity—

proves nothing regarding the preemptive purpose, nature, and

effect of § 136v(b), or the deleterious effects that labeling-

related damages claims would have on the federal pesticide

regulatory scheme today.

“(T]he purpose of Congress is the ultimate touchstone of

pre-emption analysis.” Cipollone v. Liggett Group, Inc., 505

U.S. 504, 516 (1992) (internal quotation omitted). Congress’

purpose in enacting § 136v(b), which is entitled “Unifor-

mity,” is absolutely clear: “In dividing the responsibility be-

tween the States and the Federal Government for the manage-

ment of an effective pesticide program, the Committee has

adopted language which is intended to completely preempt

State authority in regard to labeling... .” H.R. Rep. No. 92-

511, at 16 (1971) (emphasis added). It is simply implausible

that Congress, utilizing the broad and unambiguous language

of § 136v(b), would have so clearly intended to preempt the

states from imposing their own additional or different

requirements for labeling, but simultaneously intended to

22

allow the states, “through the back door by means of tort

suits,” to impose precisely such additional or different label-

ing requirements. Etcheverry, 993 P.2d at 376.

There can be no doubt that “[t]he effects of . . . the state

tort suit are identical” to those of a “state agency regulation.”

Medtronic, 518 U.S. at 504 (Breyer, J., concurring in part and

concurring in the judgment); see also Cipollone, 505 U.S. at

521 (“The obligation to pay compensation can be, indeed is

designed to be, a potent method of governing conduct and

controlling policy.”) (internal quotation omitted); Taylor, 54

F.3d at 560 (“Awarding damages on the Appellants’ claim

would therefore be tantamount to allowing the state ... to

regulate pesticide labeling indirectly, an action which is

specifically prohibited by § 136v(b).”); Worm v. American

Cyanamid Co., 970 F.2d 1301, 1307 (4th Cir. 1992) (“surely

a jury verdict resulting from a pesticide manufacturer's

failure to warn of the dangers of the product has an effect no

different from a legislatively enacted state regulation

requiring the insertion of a specific warning on the pesticide

label”); see generally Viet D. Dinh, “Reassessing the Law of

Preemption,” 88 Geo. L.J. 2085, 2114 (2000) (“the effect of

tort liability on primary conduct is the same as a statutory

prescription or regulatory standard”’).

As a result, without preemption of labeling-related dam-

ages claims, nationally uniform labeling would become

a mockery, or at the very least exceedingly difficult to

achieve or maintain. The “undeniable practical effect” of

such damages claims “would be that state law requires

additional labeling standards not mandated by FIFRA; it

cannot be presumed that businesses wish to bring about their

own economic suicide.” MacDonald v. Monsanto Co., 27

F.3d 1021, 1025 (Sth Cir. 1994). To avoid state tort liability

for inadequate labeling, pesticide manufacturers would be

compelled by the vagaries of each adverse jury verdict to

seek EPA’s permission to add more and more additional,

23

different, inconsistent and/or conflicting warnings, precau-

tionary measures, directions for use, etc. to their “nationally

uniform” labeling. “Such a change, if permitted by the EPA,

would destroy the uniformity that Congress and the EPA

seeks to achieve in pesticide labeling . . . case-by-case, state-

by-state outside pressure on the regulatory process would

hinder the development of an orderly, systematic, and uni-

form nationwide labeling scheme.” Papas v. Upjohn Co.,

926 F.2d 1019, 1025-26 (11th Cir. 1991).

Furthermore, unlike EPA, common-law juries lack the

expertise, experience, resources, and national perspective to

review a pesticide’s labeling for accuracy and adequacy,

much less impose their own additional or different labeling

requirements. Nevertheiess, Petitioners’ proposal to allow

individual juries around the nation “to sit, in effect, as super-

EPA review boards that could question the adequacy of the

EPA’s [labeling] determination[s]” would, as a practical

matter, destroy national labeling uniformity. Welchert v.

American Cyanamid, Inc., 59 F.3d 69, 73 (8th Cir. 1995).

More specifically, the resultant jumble of differing or

conflicting, jury-imposed warnings, precautionary méasures,

directions for use, etc. would compel manufacturers to try to

devise “patchwork” labeling, which if approved by EPA,

would be lengthy, confusing, contradictory, and challenging

or impossible to follow. That in turn, would interfere with

safe and effective use of pesticides.

Therefore, rather than promoting FIFRA’s objectives,

including the important goal of national labeling uniformity,

damages claims for failure to warn or inadequate labeling

would make them exceedingly difficult to accomplish, if not

unattainable. As a result, FIFRA’s “policy [of uniformity] by

itself favors pre-emption of state tort suits, for the rules of law

that judges and juries create or apply in such suits may

themselves similarly create uncertainty and even conflict, say,

when different juries in different States reach different deci-

24

sions on similar facts.” Geier v. American Honda Motor Co..,

Inc., 529 U.S. 861, 871 (2000). Rather than “complement-

ing” EPA’s regulation of pesticides and their labeling, such

suits “would take from those who would enforce a federal law

the very ability to achieve the law’s congressionally man-

dated objectives that the Constitution, through the operation

of ordinary pre-emption principles, seeks to protect.” /d.

at 872.

III. CONGRESS DID NOT INTEND TO EXCLUDE

FROM FIFRA PREEMPTION LABELING-

RELATED DAMAGES CLAIMS THAT IN-

VOLVE AGRICULTURAL CROP INJURY

Petitioners contend that even if § 136v(b) reaches damages

claims, it does not apply to labeling-related claims which

directly or indirectly allege that an agricultural pesticide’s

labeling was inadequate to prevent crop injury. See Pet. Br. at

29. Nothing in the plain, broad, preemptive language of

§ 136v(b), however, excludes state-imposed labeling require-

ments that involve agricultural crop injury or product

efficacy. “When Congress has considered the issue of pre-

emption and has included in the enacted legislation a provi-

sion explicitly addressing that issue, and what that provision

provides a ‘reliable indicium of congressional intent with

respect to state authority,” Malone v. White Motor Corp., 435

U.S., at 505, ‘there is no need to infer congressional intent to

pre-empt state laws from the substantive provisions’ of the

legislation.” Cipollone, SOS U.S. at 517 (emphasis added).

Nevertheless, Petitioners erroneously infer from one of

FIFRA’s substantive provisions, the efficacy data waiver

authorization contained in § 136a(c\(5) of the statute's

pesticide registration section, that Congress intended to create

a gaping exception to preemption under § 136v(b) for

labeling-related damages claims that involve efficacy-related

agricultural crop injury. To the contrary, there is no basis for

assuming that by enacting the 1978 efficacy data waiver

25

authorization as one of many federal registration refinements

requested by EPA, Congress intended to upset the fundamen-

tal allocation of regulatory authority between EPA and the

states, and specifically EPA’s exclusive authority to regulate

nationally uniform pesticide labeling, which was so carefully

considered only six years earlier when Congress rewrote

FIFRA and enacted § 136v(b). If Petitioners’ unfounded

view of the (nonexistent) relationship between the efficacy

data waiver authorization and § 136v(b) were correct, it

would follow a fortiori that for more than 25 years the states

have been free to enact statutes or issue agency rules that

regulate pesticide labeling to prevent efficacy-related crop

injury. Not surprisingly, despite the supposed “regulatory

gap” created by EPA's efficacy data waiver policy (Br. for

Natural Resources Defense Council at 23), neither Petitioners

nor their amici have pointed to any such state positive

enactments.

There is no indication in the legislative history of the

Federal Pesticide Act of 1978 that Congress intended the

efficacy data waiver authorization of § 136c(5)(a) to amend

or otherwise affect § 136v(b) in any manner. Instead, the

efficacy data waiver authorization was one of a number of

pesticide registration-related amendments which EPA

requested during 1977-78 because under the 1972 Act, the

federal “registration and reregistration process has ground to

a virtual halt.” S. Rep. No. 95-334, at 3 (July 6, 1977); see

H.R. Rep. No. 95-343, at 6 (May 16, 1977) (Stmnt. of

Douglas M. Costle, Admin., EPA) (discussing “specifics

about correcting the difficulties which currently beset the

pesticides regulatory program”). “The [1978] amendments

[were] designed to improve the operation of the Federal

pesticide registration program and facilitate the imple-

mentation of the major changes in that program made by the

1972 amendments to the Act.” S. Rep. No. 95-334, at 1; see

also Stmnt. of Sen. Leahy on Consideration of the Conf. Rpt.

26

on S. 1678, September 18, 1978, at 1-2, Sen. Comm. on

Agric., Nutrition & Forestry, 95th Cong. (Comm. Print 1979)

(“This bill will break the logjam in the reregistration

process”). The 1978 amendments to FIFRA’s registration

and reregistration provisions included changes to the data

consideration, data compensation, and trade secrets provi-

sions with regard to the granting of “generic” (/.e., me-too)

pesticide registrations (see Ruckelshaus, 467 U.S. at 993-94);

expedited registration procedures for “formulator” products

containing registered active ingredients purchased from

another company; provisions for the granting of “conditional”

registrations prior to submission of all data required for

registration or reregistration; provisions relating to registra-

tion of pesticides for “minor” agricultural uses; extension of

the period for reregistering previously registered pesticides;

and the efficacy data waiver authorization. See S. Rep. No.

95-1188 (Sept. 12, 1978). Upon signing the Federal Pesticide

Act of 1978, President Carter stated that “[w]ith these

amendments, the important task of registering pesticides may

move forward in a more streamlined and efficient manner.”

14 Weekly Comp. Pres. Doc. 1696 (Oct. 2, 1978).

As to the specific need for the efficacy data waiver authori-

zation, EPA Administrator Costle testified in April 1977 “we

feel that far too much Agency time is currently being spent in

reviewing efficacy data while shortages abound in the

reregistration data validation areas.” H.R. Rep. No. 95-343,

at 9 (May 16, 1977) (emphasis added); see also 44 Fed. Reg.

27,932, 27,938 (May 11, 1979) (“The decision to pursue

efficacy waiver as an Agency policy stemmed from a need to

reduce the amount of resources devoted to reviewing product

performance so that additional effort could be devoted to

the evaluation of health and safety data, and from a desire

to reduce regulatory burdens in pesticide registration.”)

(emphasis added). Therefore, “the purpose of Congress”

(Cipollone, SOS U.S. at 516) in enacting the efficacy data

27

waiver authorization had nothing whatsoever to do with

preemption of state law. Instead, “Congress intended to give

EPA broad discretion to determine how best to expend its

limited resources reviewing pesticides.” 48 Fed. Reg. 34,000,

34,001 (July 26, 1983); see also S. Rep. No. 95-334, at 3

(“The expenditure of resources by the [EPA] in reviewing

efficacy data is not the best use of resources since a pesticide

manufacturer is not likely to expend the substantial invest-

ment in time and money needed to obtain registration of a

pesticide on a non-efficacious product.”). Petitioners’ theory

that § 136v(b) only applies when manufacturers submit to

EPA for review, data on a particular subject (e.g., efficacy)

defeats the very purpose of the waiver, which is to afford

EPA flexibility to efficiently allocate its limited scientific re-

sources by requiring submission of efficacy data only when

and if crop damage problems develop after a product is

registered and in use.

Mor-over, the labeling-related crop injury claims which

Petitioners incorrectly assert the efficacy data waiver authori-

zation excludes from preemption, would conflict with how

Congress intended review of product efficacy to work. The

provision’s legislative history explains that if “the Admin-

istrator found that some other procedure for assuring the

efficacy of pesticide products appeared to be sufficient [he]

could register or reregister products without requiring sub-

mission or citation of some or all of the efficacy data that

otherwise would be required under FIFRA.” H.R. Rep. No.

95-663, at 27 (1977) (emphasis added).

This authority would be used most commonly with

respect to agricultural pesticides, due to the high level of

knowledge concerning pesticidal efficacy which prevails

in the agricultural community, the existence of means

for communicating efficacy information to users, the

organizational expertise of the Department of Agricul-

28

ture, the Extension Services, and the universities in this

area, and the stake the industry has in marketing prod-

ucts that are efficacious.

Id. (emphasis added). Along the same lines, when EPA

adopted its efficacy data waiver policy pursuant to § 3a(c)(5),

the Agency indicated that “the efficacy of agricultural pesti-

cides can be effectively regulated by the marketplace (in

conjunction with extension services and university research

personnel). 44 Fed. Reg. at 27,938 (emphasis added). Thus,

both Congress and EPA indicated that waiving submission

of efficacy data was possible because of the considerable,

efficacy-related knowledge and expertise present within the

agricultural community. Regulation of labeling by lay jurors,

who lack the high level of knowledge and expertise contem-

plated by Congress, would be incompatible with, and

seriously undermine, the type of expert “marketplace regula-

tion”’—not courtroom regulation—that Congress and EPA

envisioned.

Unless preempted, labeling-related claims involving agri-

cultural crop injury would wreak the same havoc with

national labeling uniformity as labeling-related damages

claims involving any other subject. Petitioners’ premise that

there are no pertinent labeling “requirements” because EPA

has abandoned regulation of labeling in connection with

product efficacy and crop injury prevention is belied by the

actual language of the Agency's efficacy data waiver. See 40

C.F.R. § 158.640(b)(1) (“The Agency has waived all require-

ments to submit efficacy data. ... However, each registrant

must ensure through testing that his products are efficacious

when used in accordance with label directions and commonly

accepted pest control practices. The Agency reserves the

right to require, on a case-by-case basis, submission of

efficacy data for any pesticide product”) (emphasis added).

Thus, for most products (but not including the Strongarm

product at issue here) EPA merely has waived the automatic

29

submission of efficacy data at the time a product is first

registered. When EPA adopted this policy, it explained that

“(t]he Administrator reserves the right to request submission

of efficacy data in support of label claims for any registered

product. A request may be made for any product for which a

pattern of inadequate performance has been reported.” 44

Fed. Reg. at 27,939 (emphasis added). Accordingly, when

and if efficacy-related problems develop after a pesticide

product has been registered and used by farmers, EPA has the

authority, both under FIFRA and its own efficacy data waiver

regulation, to require submission of efficacy data and regulate

the product’s nationally uniform labeling to prevent crop

injury. Nothing about the efficacy data waiver authorization

or the selective manner in which EPA has implemented it

changes the fact that any requirements for labeling imposed

through state damages claims for crop injury necessarily

would be “in addition to or different from” the requirements

for labeling imposed by EPA under FIFRA, and therefore,

expressly preempted by § 136v(b).

The Texas Supreme Court in American Cyanamid v. Geye,

which involved the same FIFRA preemption issue, got it

wrong. The court acknowledged that “[t}his is an express

preemption case,” but instead of focusing on the language of

§ 136v(b), erroneously indicated that “EPA regulations define

‘the domain expressly pre-empted.’” 79 S.W.3d at 24 (quot-

ing Cipollone, 505 U.S. at 517) (emphasis added). The court

then mistakenly assumed that EPA’s efficacy data policy

means that the Agency never regulates labeling to prevent

crop injury. /d. at 25. The federal courts of appeals

have reached the opposite and correct conclusion. See, é.g.,

Kuiper, Welchert, Taylor, Worm. As the Fifth Circuit

explained in its opinion below,

We find Geye unhelpful because it did not address the

principal issue: whether the scope of FIFRA’s express

preemption clause includes product effectiveness claims

30

which relate to product labeling. Geye holds only that

the specific Texas state-law claims for crop damage did

not present a problem of conflict preemption. . . . The

scope of FIFRA’s express preemption clause is defined

by the simple text of § 136v. That the EPA has not

elected to impose labeling regulations concerning prod-

uct effectiveness does not alter the plain meaning of

§ 136v(b) nor avoid preemption of a claim that has the

effect of imposing labeling requirements.

Pet. App. 14a-15a (emphasis added).

CONCLUSION

The Fifth Circuit’s opinion should be affirmed.

Respectfully submitted,

DOUGLAS T. NELSON LAWRENCE S. EBNER *

SEEMA MAHINI MCKENNA LONG &

CROPLIFE AMERICA ALDRIDGE LLP

1156 15th Street, N.W. 1900 K Street, N.W.

Suite 400 Washington, D.C. 2 0006

Washington, D.C. 20005 (202) 496-7500

(202) 296-1585 Attorneys for Amici Curiae

* Counsel of Record

November 2004