# Amicus Curiae Brief — Bates v. Dow Agrosciences LLC

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 2005
- **Citation:** 544 U.S. 431

## Text

gf
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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385014_0709%3A16. Public record. Not legal advice.