Amicus Curiae Brief — Bates v. Dow Agrosciences LLC

(22) “a

3n The

Supreme Court of the Anited States

o

DENNIS BATES, et al.,

Petitioners,

v.

DOW AGROSCIENCES LLC,

Respondent.

BRIEF FOR HERBERT SAMUEL HARRISON AS

AMICUS CURIAE SUPPORTING PETITIONERS

®

ALEX M. MILLER MIKAL C. WATTS

Watts Law Firm, L.L.P. Counsel of Record

300 Convent, Suite 100 Watts Law Firs, L.L.P.

San Antonio, Texas 78205 Tower II Building, 14th Floor

(210) 527-0500 555 North Carancahua Street

Corpus Christi, Texas 78478

(361) 997-0500

Attorneys for Amicus Curiae

Herbert Samuel Harrison

COCKLE LAW BRIEF PRINTING CO (800) 225-6964

OR CALL COLLECT (402) 342-2831

ct eR. ore

QUESTION PRESENTED

Which, if any, state law crop injury claims are pre-

empted by the Federal Insecticide, Fungicide, and Roden-

ticide Act, 7 U.S.C. §§136-137?

ii

TABLE OF CONTENTS

Page

Crrsstion PrOSGROG ..ccccescusesccesssesesssnsnmemnnenanane i

Table of Cemtenttt .1ccccccccccsssenscocssesssassneniseueaaen ii

Talebe of Assinar tthe ..ccccsccccsscesesssinteumamememan iv

Identity and Interest of Amicus Curiae..................... 1

Summary of the Argument.................ccccseeeeeeeeeeeeeeeees 3

pO En eee 3

I. Federal Pesticide Regulation Has Evolved

Away From Evaluating Product Efficacy........ 3

II. Under FIFRA, The EPA Does Not Evaluate

Efficacy Of Agricultural Pesticides................. 6

A. EPA Does Not Evaluate Efficacy When

Granting Emergency Exemptions. ............ 7

B. EPA Considers Product Efficacy In A

Limited Manner Under The Reduced-

Risk Initiative, But Not In Registering

FD FUGREGEED ccccccccscssevednesetiiesetnsaienmiadinien 8

1. Pesticides Are Not Registered Under

The Reduced-Risk Initiative............... ll

2. EPA Waives Efficacy Review In Reg-

istering Agricultural Pesticides .......... ll

C. Efficacy Is Irrelevant In Granting “Me

Too” Registrations. ..............:cccceseeeeeeeeeeeees 14

D. EPA Waives Efficacy Review For “Fast

Track” Conditional Registrations............. 15

E. The EPA Evaluates Efficacy In Only Two

Situations, Neither Of Which Are Pre-

sented In This Case ..............cccccecececeseeeees 16

ee —

ill

TABLE OF CONTENTS - Continued

Page

F. Post-Registration Reporting Of Ineffec-

tive Products Falls Short Of Efficacy

ee 17

Ill. Although Applicants May Submit It, The

EPA Does Not Consider Efficacy Data In

PRIORI FOGRIGIEOD ..0000cccccccccsccccsccsscccsccceses 18

EES ELE 20

iv

TABLE OF AUTHORITIES

- Page

CASES

Am. Cyanamid Co. v. Geye, 79 S.W.3d 21 (Tex.

Sn 20

Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)....... 20

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ................... 20

Ruckelshaus v. Monsanto, 467 U.S. 986 (1984).................. 4

Wis. Pub. Intervenor v. Mortier, 501 U.S. 597 (1991) ......... 4

STATUTES AND REGULATIONS

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ee BD ccnccccsssecnesnsnscscsncsesssensnsnssscemenesnsses 11

I) OU en 14, 15, 16

GF a © Re cenccscnncscnnsnsesentsnsenemeeenesmess 4,5

OU 14, 15

Be) OI 15

Fe © Be ccnesensnscssvenssnsssensssssesssnsnsemnessnsvesenssmnenensseemmesen 7

GG © Sa resnnsscesssnsemesteeensmmmenmen 14

tg) | ee 17

GO Ga 0 Bi cccecssnsssnanssseenqeenssemmememnsem 13

GG Ob ee cressemsscssremenmmnmmns 13

TD) Oe 5, 17, 19

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CQ) OU 17

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TABLE OF AUTHORITIES -— Continued

Page

en RE 7

TE SR en mOT 7

I ai ania aerate iat 7

TT nnstncriteiatnersicimsirimnatinaieaiianiaeadnetiiaatiamieaeantes 7

OTHER AUTHORITIES

H. R. Rep. No. 91-637, 91st Cong., Ist Sess. (1969)........... 4

H. R. REP. No. 95-663, 95th Cong., 1st Sess. (1977),

reprinted in 1978 U.S.C.C.A.N. 1992 ....0.......cccccceeees 5,17

H. R. REP. No. 95-343, 95th Cong., 1st Sess. (1977),

reprinted in 1978 U.S.C.C.A.N. 1974 ..........cccccccceesceeeeeees 5

57 Fed. Reg. 32140 (July 20, 1992) ..0.....0......ccccccccceceeeeeees 11

64 Fed. Reg. 9152 (Feb. 24, 1999) ...0.........ccccccccccseceeeeeeeeeeees 8

es I airclhainirinrsiittertnrriencnerrcnieiinatsasisimtniin 8

Brief of Amicus Curiae the United States on Peti-

tion for a Writ of Certiorari, Bates v. Dow Agro-

Sciences LLC, 332 F.3d 323 (5th Cir. 2002), cert.

granted, 124 S. Ct. 2903 (No. 03-388)..................... 17, 19

Donald T. Hornstein, Lessons from Federal Pesti-

cide Regulation on the Paradigms and Politics of

Environmental Law Reform, 10 Yale J. on Reg.

Ee ee 3

William H. Rodgers, Jr., Environmental Law:

Pesticides and Toxic Substances (1988) .....................--++. 4

Fred Whitford, et al., Pesticides and Ecological Risk

Na i eaten elidel 6, 7

vi

TABLE OF AUTHORITIES - Continued

OFFICE OF PESTICIDE PROGRAMS, U.S. EvTL. PROT.

AGENCY, PESTICIDE REGULATION NOTICE 96-4 (June

3, 1996), available at http://www.epa.gov/oppmsd 1/

Oe 18, 19

OFFICE OF PESTICIDE PROGRAMS, U.S. EvTL. PROT.

AGENCY, PESTICIDE REGULATION NOTICE 97-3 (Sept.

4, 1997), available at http:’//www.epa.gov/oppmsd 1/

PR Feather EERIE ccccccscccccccsccccssccccsssccscsesceeens passim

1

IDENTITY AND INTEREST OF AMICUS CURIAE

Herbert Samuel Harrison respectfully submits this

brief as amicus curiae in this case.’

Harrison earned a Bachelor of Science in Professional

Agriculture from Berea College in 1955 and a Masters of

Agriculture from the University of Florida in 1958. He

served as a Program Specialist in the United States

Department of Agriculture (““UDSA”) Pesticide Registra-

tion Divisions Office of Pesticide Programs (“OPP”) from

1967 until 1970. In that position, he coordinated scientific

and regulatory review of applications for pesticides under

the Federal Insecticide, Fungicide, and Rodenticide Act

(“FIFRA”). After creation of the United States Environ-

mental Protection Agency (“EPA”) by executive order in

1970, regulatory oversight of pesticides was transferred

from the USDA to the EPA.

From 1970 to 1971, Harrison was the Chief of the

Ecological Investigations Branch of the EPA where he

developed a program to investigate the adverse effects of

pesticides. In 1971, he was promoted to Chief of the

Insecticide and Rodenticide Branch of the EPA where he

review of applications for pesticide registration, reregistra-

tion, amended registration, and experimental use permits.

He served in that capacity for 21 years, after which he

became Special Assistant to the Director, responsible for

* Pursuant to Rule 37.6, amicus curiae discloses that no counsel for

a party authored any part of this brief, nor did any person or entity

other than amicus curiae make a monetary contribution to the prepara-

tion or submission of this brief. Letters from Petitioners and Respon-

dent granting consent to the filing of this amicus curiae brief have been

filed with this Court.

2

training the new EPA Director in the details of pesticide

registration and regulation.

One of Harrison’s more important duties while in the

Insecticide and Rodenticide Branch was to create and edit

the EPA instruction manual “General Information on

Applying for Registration of Pesticides in the United

States.” That manual informed pesticide manufacturers

and other prospective applicants how to fulfill the registra-

tion requirements of FIFRA and the Federal Food, Drug,

and Cosmetic Act. That manual details the EPA pesticide

registration process, regulations, and policies, and specifies

the requirements for data compensation and labeling.

During his career, Harrison was awarded five EPA

Bronze Medals for his work in pesticide regulation. He

retired from government service in 1993, having spent the

previous 27 years overseeing the registration of pesticides

for the federal government. Upon his retirement and in

recognition..of his exceptional career service, he was

awarded the EPA's Distinguished Career Gold Medal, the

highest honor the Agency awards.

After retiring, Harrison began a pesticide consulting

business to advise pesticide companies on the various

aspects of pesticide regulation by the federal government.

He has therefore kept abreast of pesticide registration

developments. Due to his background and experience, he

is intimately familiar with the EPA pesticide registration

and label approval process, including the policy decisions

involved with implementing virtually every nuance of the

program. He submits this brief to demystify the pesticide

registration process and to aid the Court in assessing the

importance of how pesticides are registered.

S

3

SUMMARY OF THE ARGUMENT

The majority of courts to consider this issue have

concluded that EPA waiver of regulation in the area of

pesticide efficacy is “beside the point” and “irrelevant.” By

so superficially dismissing this crucial fact, those courts

have exposed their fundamental lack of understanding of

the EPA pesticide registration process. Analysis of the

question before this Court should begin and end by recog-

nizing the absence of EPA regulation of pesticide efficacy.

Simply put, the EPA does not approve herbicide label

claims regarding how well a product works. The EPA does

not review whether the product actually injures the crops

it was intended to assist. Without EPA review of pesticide

efficacy or approval of its label-based efficacy claims, there

simply is no federal regulation of pesticide efficacy. With-

out federal regulation, there can be no preemption.

¢

ARGUMENT

I. Federal Pesticide Regulation Has Evolved

Away From Evaluating Product Efficacy.

In its early years, pesticide regulation in this country

was weak at best. Donald T. Hornstein, Lessons from

Federal Pesticide Regulation on the Paradigms and Poli-

tics of Environmental Law Reform, 10 Yale J. on Reg. 369,

423 (1993). By the end of the 1960's, a House of Represen-

tatives subcommittee investigation concluded:

Pesticide products had been approved for use

without compliance with interdepartmental pro-

cedures for resolving safety questions; that they

had been approved for uses practically certain to

result in the illegal adulteration of food; that

4

some labels approved for registration failed to in-

form users of possible hazards and provide accu-

rate directions; that actions to cancel registered

products were long delayed; that, despite comple-

tion of uncontested cancellation proceedings,

hazardous products lingered in the marketing

channels for years; and that conflicts of interest

had clouded administrative decisions.

William H. Rodgers, Jr., Environmental Law: Pesticides

and Toxic Substances 31 (1988) (citing H. R. REP. No. 91-

637, 91st Cong., 1st Sess. (1969)). These disclosures

contributed in no small way to a 1970 government reor-

ganization plan that stripped the United States Depart-

ment of Agriculture of its authority to regulate chemical

pesticides and transferred that power to the newly-

established Environmental Protection Agency (“EPA”). Id.

Federal regulation of pesticides has grown more

stringent on the EPA’s watch. In 1972, Congress responded

to “growing environmental and safety concerns” by “sig-

nificantly strengthen[ing] FIFRA’s registration and label-

ing standards.” Wis. Pub. Intervenor v. Mortier, 501 U.S.

597, 601 (1991). These amendments “transformed FIFRA

from a labeling law into a comprehensive regulatory

statute.” Id. (quoting Ruckelshaus v. Monsanto, 467 U.S.

986, 991 (1984)). Under the 1972 amendments, Congress

instructed the EPA to register a pesticide after evaluating

its proposed label and determining that its “composition is

such as to warrant the proposed claims for it.” 7 U.S.C.

§ 136a(c)(5)(A). Pesticide manufacturers were therefore

required to submit massive quantities of documents so the

EPA could substantiate the claims made on a proposed

label. By 1977, the requirement that the EPA evaluate and

——

5

approve pesticide efficacy’ claims had so thoroughly

overburdened the Agency that Administrator Douglas M.

Costle requested that Congress eliminate the requirement

that the Agency review pesticide efficacy during the

registration process. H. R. REP. No. 95-343 (1977), re-

printed in 1978 U.S.C.C.A.N. 1974. On behalf of the EPA,

Costle complained that “[t]he registration and reregistra-

tion process, which is the foundation of the program, has

come to a virtual halt.” H. R. Rep. No. 95-663 (1977),

reprinted in 1978 U.S.C.C.A.N. 1991.

In 1978, Congress reacted to the EPA’s predicament by

amending FIFRA and permitting the EPA to forego the

time-consuming and resource-intensive evaluation of

product efficacy. See 7 U.S.C. § 136a(c)(5) (“[iJn considering

an application for the registration of a pesticide, the

Administrator may waive data requirements pertaining to

efficacy, in which event the Administrator may register the

pesticide without determining that the pesticide’s composi-

tion is such as to warrant proposed claims of efficacy”).

Congress expected this efficacy waiver authority “to be

used, in particular with respect to agricultural chemicals.”

H. R. Rep. No. 95-663, 95th Cong., lst Sess. 19 (1977),

reprinted in 1978 U.S.C.C.A.N. 1992. For the past 26

years, the EPA “has waived all requirements to submit

efficacy data unless the pesticide product bears a claim to

control pest microorganisms that pose a threat to human

health and whose presence cannot be readily observed by

the user... .” 40 C.F.R. §§ 158.640(b)(1); 158.540. Therefore,

* As defined by the EPA, “efficacy” has two discrete components:

product performance (whether the product controls the target pest) and

target area phytotoxicity (whether the product harms the target crop).

U:S. Inv. Br. 4, 13 (citing 40 C.F.R. §§158.540, 158.640).

6

although FIFRA still requires the EPA to register a pesti-

cide after determining that “its composition is such as to

warrant the proposed claims for it,” the EPA no longer

evaluates the efficacy of agricultural pesticides.

II. Under FIFRA, The EPA Does Not Evaluate

Efficacy Of Agricultural Pesticides.

FIFRA charges the EPA with conducting four distinct

registration reviews: initial registration; reregistration;

experimental use permits; and special review. Fred Whit-

ford, et al., Pesticides and Ecological Risk Assessment 11

(2003).° Initial registration of a pesticide is a two-step

process and the same process applies to all applicants. See

7 U.S.C. §136a(c). In the first step, the EPA decides

whether a product meets the criteria for expedited review.

If the product qualifies for expedited review, it reaches the

second level of EPA analysis — the actual registration

review — more quickly. If the product does not qualify, the

manufacturer simply submits the product for conventional

registration. Regardless of whether a product has qualified

for expedited review, the second level of EPA review is the

exact same for all products; the only difference is that

products that do not qualify for expedited review have to

wait longer in line.

The EPA publishes scientific testing regulations to

ensure that when a product reaches the front of the line

and its registration is decided by the EPA, the studies

supporting its registration are complete and employ

* Because the pesticide at issue faced EPA scrutiny during the

initial registration review process, this brief will address the EPA's

waiver of efficacy data specific to that process.

premier scientific tests and methods. See, e.g., 40 C.F.R.

Part 160. Those regulations detail the testing required and

how the studies are to be performed. See id. Advances in

science and new experimental tools have yielded more

complex and voluminous data for review, and the data

commonly submitted for an initial pesticide registration

frequently exceeds 10,000 pages. Whitford at 8. Those

increased review responsibilities have understandably

delayed the registration process and created a paradox

under which the EPA is expected to conduct more inten-

sive reviews and more quickly respond to an increased

number of applications. See id. The EPA has attempted to

alleviate the bottleneck of initial registration applications

by developing several expedited review programs under

which select products advance more quickly to the front of

the line.

A. EPA Does Not Evaluate Efficacy When

Granting Emergency Exemptions.

In emergency situations, the EPA may authorize the

use of a previously unregistered pesticide. See 7 U.S.C.

§ 136p. This exemption, however, is limited in several

ways. First, a federal or state agency must request the

exemption. See 40 C.F.R. § 166.20(a). Second, the EPA

must determine that emergency pest conditions exist, that

is, a threat of significant economic loss, significant risk to

the environment or a significant risk to endangered or

threatened species or beneficial organisms. See 40 C.F.R.

§ 166.2. Third, the EPA must be able to establish a formal

tolerance or limit on the amount of pesticide residues left

on the treated area, especially if the pesticide residue

could affect the food supply. See 40 C.F.R. § 166.25(a)(2).

Fourth, the emergency exemption may be authorized for

8

“only as long as is necessary to control the pest or condi-

tions causing the emergency.” 40 C.F.R. § 166.45.

On February 24, 1999, the Texas Department of

Agriculture submitted an application for an emergency

exemption to permit Strongarm “to treat up to 184,000

acres of peanuts, to control broadleaf weeds” in Texas. 64

Fed. Reg. 9152 (Feb. 24, 1999). This application proposed

the use of diclosulam, the active ingredient in Strongarm,

a chemical that had not been previously registered by the

EPA. Id. The EPA denied that emergency application on

March 9, 1999, and Dow was forced to pursue an alternate

method of expedited registration review. See 65 Fed. Reg.

3691, 3707 (2000) (“[t]his request was denied because

adequate alternatives are available to control the weeds

specified in this request.”)

B. EPA Considers Product Efficacy In A Lim-

ited Manner Under The Reduced-Risk Ini-

tiative, But Not In Registering The

Pesticide.

The EPA’s most notable expedited review program, the

“Reduced-Risk Initiative,” went into effect on an interim

basis in July 1993 and was finalized in September 1997.

OFFICE OF PESTICIDE PROGRAMS, U.S. EvVTL. PROT. AGENCY,

PESTICIDE REGULATION NOTICE 97-3 § 4 (Sept. 4, 1997),

available at http://www.epa.gov/oppmsd1/PR_Notices/pr97-3.

html. Under this program, “lower-risk pesticide products

which would result in reduced risks to human health and

the environment when compared to existing alternatives”

are guided through the backlog of registration applications

and receive expedited review. Jd. at § 1. Products that

meet the reduced-risk criteria receive a registration deci-

sion from the EPA in an average of 14 months, compared to

9 a

38 months for conventional pesticides that do not qualify. Jd.

at §4. During the 50 months the EPA applied the interim

reduced-risk criteria, applicants sent 39 submissions to the

EPA for consideration as reduced-risk pesticides. Jd. Of that

number, 22 were accepted as reduced-risk candidates* and 16

* In descending order, the factors that contributed most signifi-

cantly to the EPA’s decision to grant an application reduced-risk status

during that 50-month period were:

° Human Health Effects

- very low mammalian toxicity

- toxicity generally lower than alternatives

- displaces chemicals that pose potential human health concerns

- reduces exposure to mixers, loaders, applicators, and reentry

workers

° Non-Target Organism Effects (Birds)

- very low toxicity to birds

- very low toxicity to honeybees

- significantly less toxicity/risk to birds than alternatives

- not harmful to beneficial insects, highly selective pest impacts

° Non-Target Organism Effects (Fish)

- verylow toxicity to fish

- less toxicity/risk to fish than alternatives

- potential toxicity/risk to fish mitigatable

- similar toxicity to fish as alternatives but significantly less expo-

sure

° Groundwater

- low potential for groundwater contamination

- low drift, runoff potential

- runoff mitigatable

° Lower Use Rates Than Alternatives, Fewer Applications

° Low Pest Resistance Potential

° Highly Compatible With IPM (Integrated Pest Management)

° Efficacy -

Id. at § 5.

10

were rejected.* Jd. Out of the 22 accepted reduced-risk

submissions, 14 were eventually registered. Jd.

Strongarm was not approved for expedited review

under the Reduced-Risk Initiative. Stephen Schaible, the

conventional reduced-risk pesticide program coordinator,

advised amicus curiae that Strongarm was originally

submitted under the Reduced-Risk Initiative, but its

application was denied because it did not meet the reduced-

risk criteria. The requirements of submitting efficacy

information under the Reduced-Risk Initiative may be

misleading, and understanding exactly what is reviewed

under the Reduced-Risk Initiative and why is complicated.

Amicus curiae was one of the initial proponents of the

reduced-risk criteria and has personal experience with its

practical applications. To avoid potential confusion, this

brief will attempt to explain the Reduced-Risk Initiative

* Also in descending order, the factors that contributed most

significantly to the EPA’s decision to deny an application reduced-risk

status during that time were:

° Human Health Effects

- inadequate/inappropriate comparisons with alternatives

- inadequate documentation of effects

- human health risk reduction case weak

° Non-Target Organism Effects (Birds and Fish)

- toxic to birds

- toxic to fish

- risk reduction case inadequate when compared to alternatives

° Potential Groundwater Problems .

° Unlikely To Displace Higher Risk Alternatives

° Lack Of Efficacy Data

° Phytotoxicity

Id. at § 5.

11

even though Strongarm was not approved under that

process.

1. Pesticides Are Not Registered Under

The Reduced-Risk Initiative.

All chemical pesticide applications ultimately face the

same registration review regardless of whether they are

submitted under the Reduced-Risk Initiative, a different

“fast track” program in effect for registration of conven-

tional pesticides, or the conventional registration program.

7 U.S.C. § 136a(c\2)A). The only benefit of the Reduced-

Risk Initiative is expedited review and the possibility of

accelerated registration. P.R. Notice 97-3 § 6 (noting that if

the EPA “decides that a pesticide qualifies for reduced-risk

status, then it will further expedite review of the remain-

der of the application for registration”). Regardless of the

process by which an application reaches the front of the

line, all applications are treated the same in the second

step of EPA review — the registration process.

2. EPA Waives Efficacy Review In Regis-

tering Agricultural Pesticides.

One of the objectives of the Reduced-Risk Initiative is

to displace more harmful pesticides. See id. at §1. To

evaluate whether consumers will purchase a new, safer

product and thereby displace a more harmful one, the EPA

is required to perform some review of whether the product

will in fact work. See 57 Fed. Reg. 32140 (July 20, 1992)

(stating that the “specific goal of such [reduced-risk]

policies would be to encourage the registration of lower

risk substitutes for existing high-risk pesticides”). In order

12

to decide whether an applicant qualifies for the benefits of

the Reduced-Risk Initiative, the EPA requires the appli-

cant to submit a summary of comparative performance or

efficacy data — but not the supporting data itself.” PR.

Notice 97-3 § 7(G). The results of an applicant’s efficacy

studies, as represented by the summary of comparative

performance data, affect whether that applicant qualifies

for the benefit of expedited review under the Reduced-Risk

Initiative. See id. at §5. However, once the applicant

passes the first step of qualifying for the Reduced-Risk

Initiative, the EPA has no further use for the efficacy

summaries and does not use that information in the

registration process. See id.

As with any scientific data, much of the data that is

required to be submitted for registration may be read in

more than one way. The EPA requires applicants to submit

data generated by standard testing against a collection of

generic plants and plant families intended to generally

represent plants found in the environment. See, e.g., id. at

§ 7(G). This data may, in some instances, be read to

express an applicant’s findings on product efficacy. See id.

However, the EPA uses these generic tests now, as in the

past, only to assess whether a new pesticide will pose an

unreasonable risk to humans, non-target plants and

organisms, or the environment in general. Jd. at §1.

Although the data compiled in some of these studies may

also be read to express findings as to product performance

or target area phytotoxicity, the EPA does not, and due to

* For several years, if an applicant submitted the data supporting

its summary in addition to the summary itself, the EPA’s practice was

to send that material back to the applicant.

Tn —

13

insufficient funding, cannot examine those studies for that

result during the registration review process.

Importantly, the EPA provides a great deal of “flexibil-

ity in requiring (or not requiring) data” and expressly

offers to “waive data requirements on a case-by-case basis

in response to specific written requests by applicants.” 40

C.F.R. §§ 158.35, 158.45. Under the Reduced-Risk Initia-

tive, the EPA specifically permits an applicant to substi-

tute “reasoning as to why [required data] should not be

considered in the Agency’s decision” for the data itself. P.R.

Notice 97-3 §7. An applicant may, therefore, “provide a

short rationale describing” the reasons it should not have

to provide information required by the Reduced-Risk

Initiative, including, presumably, the summary of com-

parative performance or efficacy data. See id. These

provisions illustrate that the absence of information

required by the Reduced-Risk Initiative may not serve as a

bar to registration and even without all the required

information, an applicant may still be considered for

expedited review. See id. For that reason, applying for

expedited review under the Reduced-Risk Initiative does

not constitute a regulation of efficacy.

The benefits of expedited review under the Reduced-

Risk Initiative are available only for those products that

demonstrate a reduced risk to human health and the

environment than existing alternatives. See id. at § 1.

Requiring applicants under the Reduced-Risk Initiative to

submit a summary of efficacy data but not the data them-

selves is the only way the resource-limited EPA can ensure

that applicants can substantiate their claim to have

produced a safer pesticide and their entitlement to expe-

dited review. If the EPA did not require applicants to

produce a summary of this data, then it would have no

14

way of knowing whether the applicant had even tested the

product and would lack the ability to gauge the applicant’s

entitlement to the benefits of the Reduced-Risk Initiative.

An applicant who claims that applying for the purely

voluntary Reduced-Risk Initiative constitutes some EPA

regulation of product efficacy demonstrates a lack of

understanding of the Reduced-Risk Initiative and its

process.

C. Efficacy Is Irrelevant In Granting “Me

Too” Registrations.

Under FIFRA, the EPA may conditionally register a

pesticide if it determines that “the pesticide and proposed

use are identical or substantially similar to any currently

registered pesticide and use thereof or differ only in ways

that would not significantly increase the risk of unreason-

able adverse effects of the environment.” 7 U.S.C.

§ 136a(c)(7)(A). This conditional registration, also called

“me too” registration, is designed for products that are

identical to a product previously registered by the EPA.

See 40 C.F.R. § 152.113(b). To qualify for “me too” registra-

tion, an applicant “shall submit such data as would be

required to obtain registration of a similar pesticide under

paragraph (5).” Jd. Paragraph 5 waives the requirement of

submitting efficacy data. See 7 U.S.C. § 136a(c)(5).

When the EPA issued its March 8, 2000 registration of

Strongarm, it stated that Strongarm was conditionally

registered under the “me too” program. However, Stron-

garm’s active ingredient, diclosulam, was neither identical

to any currently registered pesticide, nor was it different

from a currently registered pesticide only in ways that

would not significantly increase the risk of unreasonable

15

adverse effects on the environment. That confusion

prompted amicus curiae to contact Jim Tompkins, a

Product Manager in the Herbicide Branch of the EPA’s

Registration Division and the signatory of Strongarm’s

notice of pesticide registration. Tompkins explained that

Strongarm was actually registered under the “fast track”

conditional registration provisions of 7 U.S.C. § 136a(c)\(7\(C)

and not the “me too” provisions of 7 U.S.C. § 136a(c)(7)(A).

Even if Strongarm had been registered under the “me too”

program, however, the EPA would not have reviewed any

efficacy data Dow submitted. See 7 U.S.C. § 136a(c)(5).

D. EPA Waives Efficacy Review For “Fast

Track” Conditional Registrations.

On March 8, 2000, Strongarm was registered under the

conditional registration provisions of 7 U.S.C. § 136a(c)(7\(C).

Under that statute, the EPA:

may conditionally register a pesticide containing

an active ingredient not contained in any cur-

rently registered pesticide for a period reasona-

bly sufficient for the generation and submission

of required data (which are lacking because a pe-

riod reasonably sufficient for generation of the

data has not elapsed since the Administrator

first imposed the data requirement) on the condi-

tion that by the end of such period the Adminis-

trator receives such data and the data do not

meet or exceed risk criteria enumerated in regu-

lations issued under this subchapter, and on

other such conditions as the Administrator may

prescribe.

7 U.S.C. § 136a(cX7C). This “fast track” program for

registering conventional pesticides is premised upon a

16

determination “that use of the pesticide during such period

will not cause any unreasonable effects on the environ-

ment, and that use of the pesticide is in the public inter-

est.” Id. The conditions of Dow’s registration of Strongarm

required Dow to “submit and/or cite all data required for

registration reregistration of your product under FIFRA

sec. 3(c)(5).” Section 3(c)(5) specifically provides:

In considering an application for the registration

of a pesticide, the Administrator may waive data

requirements pertaining to efficacy, in which

event the Administrator may register the pesti-

cide without determining that the pesticide’s

composition is such as to warrant proposed

claims of efficacy. If a pesticide is found to be effi-

cacious by any State under section 136v(c) of this

title, a presumption is established that the Ad-

ministrator shall waive data requirements per-

taining to efficacy for use of the pesticide in such

State.

7 U.S.C. § 136a(c)(5). Under this “fast track” program for

registering conventional pesticides, as for all registration

of chemical pesticides, the EPA has waived the evaluation

of product performance and target area phytotoxicity.

E. The EPA Evaluates Efficacy In Only Two

Situations, Neither Of Which Are Pre-

sented In This Case.

The EPA continues to evaluate efficacy data in two

limited areas, neither of which are presented in this case.

First, if the EPA considers canceling, denying, or reclassi-

fying “registration of a pesticide product because uses of

that product may cause unreasonable adverse effects on

the environment,” then it will initiate special review

17

procedures under 40 C.F.R. Part 154. 40 C.F.R. § 154.1.

Because the EPA did not initiate special review proceed-

ings against Strongarm, it did not evaluate the product’s

efficacy claims. Second, the EPA evaluates efficacy data in

certain public health situations if it is reported that the

pesticide poses some unusual risk of harm to human

health or the environment. 40 C.F.R. § 158.640(b)(1). This

exception applies to products such as hospital disinfec-

tants, where a lack of efficacy might allow proliferation of

microorganisms that affect public health. H. R. Rep. No.

95-663, 95th Cong., 1st Sess. 19 (1977), reprinted in 1978

U.S.C.C.A.N. 1992. Strongarm was not found to affect

public health or pose an unusual risk of harm to human

health or the environment, so the EPA was not obligated

to, and in fact did not, evaluate its efficacy claims.

F. Post-Registration Reporting Of Ineffec-

tive Products Falls Short Of Efficacy

Regulation.

In its invitation brief on petition for writ of certiorari,

the United States argued that the EPA has not abandoned

all regulation of product efficacy. Brief of Amicus Curiae

the United States on Petition for a Writ of Certiorari, 13

n.2, Bates v. Dow AgroSciences LLC, 332 F.3d 323 (5th Cir.

2002), cert. granted, 124 S. Ct. 2903 (No. 03-388). The

United States argued that the EPA regulates product

efficacy because manufacturers must “report to EPA when

they learn that their products have harmed non-target

organisms such as crops or persons, if the label does not

provide adequate notice of the risk of such harm.” 40

C.F.R. 159.184(a)(1). Logically, however, post-registration

and post-injury reporting of efficacy problems does not act

as government approval of efficacy claims during the

registration process. This regulation does not require the

18

EPA to evaluate product efficacy before the label is ap-

proved or the product is registered. For those reasons, the

post-registration obligation to report efficacy complaints

does not equate government evaluation of product efficacy.

III. Although Applicants May Submit It, The EPA

Does Not Consider Efficacy Data In Register-

ing Pesticides.

In 1996, the EPA explained its “procedures in approv-

ing pesticide labels relating to the efficacy of agricultural

pesticides .. . to correct a misunderstanding regarding the

FIFRA label approval process that is reflected in a series

of court decisions concerning the preemptive effect of

FIFRA.” OFFICE OF PESTICIDE PROGRAMS, U.S. EVTL. PROT.

AGENCY, PESTICIDE REGULATION NOTICE 96-4 § 1 (June 3,

1996), available at http://www.epa.gov/oppmsd1/PR_Notices/

pr96-4.html. In that notice, the EPA’s Office of Pesticide

Programs stated “[b]ecause efficacy data is not reviewed as

part of the registration of agricultural pesticides, it would

be incorrect to contend that the label approval process

involves an examination of the efficacy of the pesticide.”

Id. at 3. The EPA went a step further and clarified:

[T]hese registration requirement should not be

read as reintroducing efficacy concerns into the

label approval process. Having directly given

EPA the authority to disregard efficacy issues,

Congress could not have intended that, once EPA

exercised this authority, the same efficiency issues

would come in through the back door of the label

approval process. Under the statute and its regu-

lations, EPA still must determine in registering a

pesticide if the pesticide’s label complies with FI-

FRA or is misbranded but, unless EPA reinstates

the requirement to submit efficacy data (either

ec nee +

19

generally or with regard to a particular pesticide),

that compliance and misbranding inquiry will gen-

erally not extend to the evaluation of the efficacy

of the pesticide.

PESTICIDE REGULATION 96-4 § 3 (emphasis added).

Under C.F.R. §§ 158.540 and 158.640(b)(1), the EPA

requires all manufacturers to develop and maintain data

supporting their efficacy claims. However, even the United

States recognized that [glenerally, EPA does not independ-

ently evaluate a registrant’s product efficacy claims

pertaining to agricultural pesticides.” U.S. Inv. Br. 13 n.2.

The only agricultural pesticides for which the EPA takes

efficacy into account in the registration process are those

that “claim to control pest microorganisms that pose a

threat to human health and whose presence cannot readily

be observed by the user....” 40 C.F.R. § 158.640(b)(1).

These regulations require pesticide manufacturers to

compile and maintain efficacy data, but they do not

require the EPA to evaluate the efficacy data before

registering the pesticide or approving the label.

Many manufacturers have argued that because they

voluntarily submitted efficacy data to the EPA during the

registration process, the EPA reviewed their claims of

product efficacy. Plainly, that argument misses the point

that the EPA is under no obligation to review these docu-

ments and lacks the resources to evaluate them. If such an

argument were embraced by this Court, it would give

applicants an incentive to automatically deluge the EPA

with data it does not want, need, or have the ability to

review. The EPA’s term for such production of data, “mali-

cious compliance,” describes its view of applicants who

flood it with data in an effort to gain an advantage in the

registration process. Such a construction “would have the

perverse effect of granting complete immunity ... to an

20

industry that, in the judgment of Congress, needed more

stringent regulation.” Medtronic, Inc. v. Lohr, 51% '.S.

470, 486 (1996). Logically, therefore, it cannot be said that

submission of efficacy data equates to EPA review and

approval of a product’s efficacy claims.

¢

CONCLUSION

“EPA regulations define ‘the domain expressly pre-

empted.’” Am. Cyanamid Co. v. Geye, 79 S.W.3d 21, 24

(Tex. 2002) (quoting Cipollone v. Liggett Group, Inc., 505

U.S. 504, 517 (1992)). In 1978, Congress waived the

requirement that the EPA determine pesticide efficacy

before registering that pesticide. That waiver was specifi-

cally intended for agricultural pesticides because the EPA

recognized that the registrant, the user, and the USDA

which insures agricultural crops are in a superior position

to judge product efficacy. For more than a quarter century,

the federal government has not regulated pesticide effi-

cacy — not by registering a product, not by approving a

label, and certainly not by receiving post-registration

complaints. No federal agency examines whether a pesti-

cide will control a target pest without injuring the crop to

which it is applied. For those reasons, there is no federal

regulation of agricultural pesticide efficacy. There can be

no requirement in addition to or different from the federal

regulation if there is no federal regulation. Without federal

regulation, there can be no preemption.

Amicus curiae therefore urges this Court to reverse

the judgment of the United States Court of Appeals for the

Fifth Circuit and hold that the state law crop injury claims

21

pursued in this case are not preempted by the Federal

Insecticide, Fungicide, and Rodenticide Act.

Respectfully submitted,

ALEX M. MILLER MIKAL C. WATTS

Watts LAW Fir, L.L.P. Counsel of Record

300 Convent, Suite 100 Watts LAw Fir, L.L.P.

San Antonio, Texas 78205 Tower II Building, 14th Floor

(210) 527-0500 555 North Carancahua Street

Corpus Christi, Texas 78478

(361) 997-0500

Attorneys for Amicus Curiae

Herbert Samuel Harrison