Amicus Curiae Brief — Clark v. Southern Oregon Citizens Against Toxic Sprays, Inc.

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No. 84-267”

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OEE 98 1934

In the Supreme Court of the United-States, . STEVAS,

October Term, 1984

CLERK

Court, U.S,

WILLIAM P. CLARK, ET AL.,

Petitioners,

vs.

SOUTHERN OREGON CITIZENS AGAINST

TOXIC SPRAYS, INC.,

Respondent.

On PETITION FOR WRIT OF CERTIORARI TO THE UNITED STATES

Court or APPEALS FOR THE NINTH CIRCUIT

BRIEF OF AMICUS CURIAE MONSANTO COMPANY

IN SUPPORT OF THE PETITION OF WILLIAM P.

CLARK, ET AL., FOR A WRIT OF CERTIORARI

G. WILLIAM FRIcK*

Joun T. MAUGHMER

LATHROP, Koontz, RIGHTER, CLAGETT

& NorquistT

2345 Grand Avenue, Suite 2600

Kansas City, Missouri 64108

(816) 842-0820

Counsel to Amicus Curiae

Of Counsel:

FREDERICK A. PROVORNY

Monsanto Company

800 N. Lindbergh Blvd.

St. Louis, Missouri 63167

(314) 694-2857

A. RAYMOND RANDOLPH

RANDOLPH & TRUITT

4801 Massachusetts Ave., N.W.

Washington, D.C. 20016

(202) 363-0800

*Counsel of Record

E. L. Mewpewnmatt, Inc., 926 Cherry Street, Kansas City, Mo. 64106, (816) 421-3030

ail

TABLE OF CONTENTS

CRS TEL AT OL Iy ree OO REED 1

SSNS SATE a a ee Re 1

SELL ALOE 2

I a striction 2

Reasons for Granting the Writ 20020000000.000000.ccceeeeeeteeeeeeees 4

I a added cceenieripondenebbectanenninbetin 11

TABLE OF AUTHORITIES

Cases

Calvert Cliffs Coordinating Committee, Inc. v. AEC,

Re ee Cr ay ED ccecceterinciccesittscnnicnsinvcvsnne 8

Citizens Against Toxic Sprays, Inc. v. Bergland, 428

PS ED Me Is PED eictcetecicccentetcreccenpentimesecnedacenaese 8

Conservation Council of North Carolina v. Froehlke,

Ga Fee. TIS (BED. NC, IGTT) neccccccccsccccecsececsensseser 10

Merrell v. Block, No. 83-3908, slip op. (9th Cir. Jan.

ie IEE ssscelaanehscisciess nancies ice etinahcinindenkcnabiinnesblctinniilidantnanbditn 5,7

Metropolitan Edison Co. v. PANE, 460 U.S. 766

I cael ice candid danni tesmeshnceineliadiabendonatsliinniatateind 5, 10

Northwest Coalition for Alternatives to Pesticides v.

Block, Civ. No. 82-6272, slip op. (D. Or. Jan. 6,

1984), appeal pending, No. 84-3821 (9th Cir.) ........... 7

Ruckelshaus v. Monsanto Company, ........ | ;

I een ies rencsieeichavansiieornmneanictnnsties 3, 4,5

Save Our Ecosystems v. Watt, No. 83-3908, slip op.

Nn I Gt TIN consort cccestnencncteastbieiadibclesecceptionntss 7

United States v. Goodman, 486 F.2d 847 (7th Cir. 1973) 5

Warm Springs Dam Task Force v. Gribble, 621 F.2d

I oR 10

Statutes and Regulations

Clean Air Act, 42 U.S.C. 7401 et seq. .............-.-cccccceceereoes 7

Federal Insecticide, Fungicide and Rodenticide Act, 7

TO TEE OR OOD. neetenteietstnesctcrsciceeonbtreaneatciiatiaam passim

thom: BE FT TE NY sccctinccecniccsnentciernnicapaiictie 6

Section 6(b), 7 U.S.C. 136d (DD) .....2.20..-..0cceccocoecenceecsoee- 6

Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq. ........ 7

National Environmental Policy Act, 42 U.S.C. 4321

OE: cericiecieinscnsicciniececsinentccsiorisieclbaitieiiaiiaainalsl passim

GD Clie BBE iecnnicncninmiiiokeeeed 6

OD Ge I cecaiisnisinsscicmnigatnieiidleainaaiehimananinnaa 9

CD Cie OD dincsitrrsissictsihnsteeiihipeaenitbictaiceicnceatiieanaigedeaeeinian 10

Miscellaneous

Proposed Regulation, 47 Fed. Reg. 53192 et seq. ........... 4

No. 84-267

In the Supreme Court of the United States

October Term, 1984

WILLIAM P. CLARK, ET AL.,

Petitioners,

Vs.

SOUTHERN OREGON CITIZENS AGAINST

TOXIC SPRAYS, INC.,

Respondent.

On PETITION FOR WRIT OF CERTIORARI TO THE UNITED STATES

CourT OF APPEALS FOR THE NINTH CIRCUIT

BRIEF OF AMICUS CURIAE MONSANTO COMPANY

IN SUPPORT OF THE PETITION OF WILLIAM P.

CLARK, ET AL., FOR A WRIT OF CERTIORARI

OPINIONS BELOW

The opinion of the Court of Appeals, Southern Oregon

Citizens Against Toxic Sprays, Inc. v. Clark, is reported

at 720 F.2d 1475. The opinion of the district court,

Southern Oregon Citizens Against Toxic Sprays v. Watt,

is unreported. (See Petitioners’ Appendix, 13a-24a).

JURISDICTION

The judgment of the Court of Appeals was entered

on December 2, 1983. A petition for rehearing was denied

on March 21, 1984. On June 8, 1984, Justice Rehnquist

extended the time for filing a petition for writ of certiorari

to and including August 1, 1984. On July 24, 1984, Justice

Rehnquist further extended the time for filing a petition

for writ of certiorari to and including August 18, 1984.

On or before August 18, 1984 petitioners William P. Clark,

et al., filed their petition for writ of certiorari to the

United States Court of Appeals for the Ninth Circuit.

Respondent sought and was granted an extension of time

to and including October 22, 1984 for filing its opposition.

The jurisdiction of this Court is invoked under 28 U.S.C.

1254(1). Letters from counsel] for petitioners and respon-

dent granting consent to the filing of this Brief have

been filed with the Clerk of the Court.

STATUTES INVOLVED

Section 102 of the National Environmental Policy Act

of 1969, (“NEPA”) 42 U.S.C. (& Supp. V) 4321, and

relevant provisions of the Federal Insecticide, Fungicide

and Rodenticide Act, (“FIFRA”) 7 U.S.C. 136 et seq.,

are reprinted at 27a-33a of Petitioners’ Appendix.

INTEREST OF AMICUS CURIAE

Monsanto Company is a developer, manufacturer, and

marketer of pesticides’ including Roundup,* one of the

herbicides the Bureau of Land Management (“BLM”)

proposed to utilize for its vegetation contro] spraying

program. The decision of the Court of Appeals prevented |

BLM from purchasing and using Monsanto’s product pend- |

ing preparation of the court-ordered NEPA review. No |

pesticide may be marketed unless it has been registered

by the Environmental Protection Agency (“EPA”) after |

extensive testing pursuant to FIFRA. Although Congress

has charged EPA with the duty of providing pesticides will

1. As used in FIFRA and in this Brief, the term “pesticides”

includes herbicides as well as a variety of other products such

as insecticides and fungicides.

*A registered trademark of Monsanto Company.

Re ne rn EA

not cause unreasonable adverse effects on the environ-

ment, the Court of Appeals ruled BLM and any other

federal agency using pesticides cannot rely on EPA but

must instead independently conduct a scientific analysis

of each pesticide the agency proposes to use. This court-

ordered analysis will take place totally outside the care-

fully constructed congressional scheme embodied in

FIFRA. Pesticide producers which sell their products to

federal agencies will be subjected to still further layers

of federal regulations as each federal agency devises its

own testing and research requirements under NEPA.

Data submitted to agencies other than EPA will not carry

with it the protections, both procedural and substantive,

that FIFRA demands and which this Court considered

the past Term. See Ruckelshaus v. Monsanto Company,

sell US. ........, 104 S.Ct. 2862 (1984).

Because of Monsanto’s concern about the debilitating

and contradictory effects of such a duplicative regulatory

system, the Company participated in this case as amicus

curiae in the Court of Appeals. This Brief addresses the

opinion below from the viewpoint of pesticide manufac-

turers already subject to the comprehensive regulatory

scheme of FIFRA.

REASONS FOR GRANTING THE WRIT

1. The tasks assigned to BLM by the Court of

Appeals duplicate EPA’s responsibilities under FIFRA.

FIFRA’s comprehensive scheme includes an extensive data

review process which EPA undertakes as part of its

decision to register a pesticide or to cancel or suspend

an existing registration. See, e.g., Ruckelshaus v. Mon-

santo Company, ........ 8 Sea , 104 S.Ct. 2862, 2866-70

(1984). All of the products BLM sought to use in its

forest spraying program are currently registered by EPA,

pursuant to FIFRA, for those very uses. According to

the Court of Appeals, BLM cannot rely on EPA’s deter-

minations regarding these pesticides. NEPA, the Court

ruled, requires each federal agency to conduct an inde-

pendent scientific evaluation of the potential harmful ef-

fects of each pesticide it seeks to use whenever any

question is raised about the product’s safety. The Court

of Appeals did not find defects in EPA’s implementation

of FIFRA. Instead, it determined as a procedural matter

that one agency cannot rely upon the decisions of another

in carrying out its NEPA responsibilities. The implica-

tions of that determination are far-reaching.

a. Notwithstanding the substantial data required

of registrants, and EPA’s thorough analysis of that informa-

tion preceding FIFRA registration, pesticide manufacturers

now face entirely new review processes, processes with

no data guidelines, standards or consistency in approach.

The research and test data now required by EPA to support

registration under FIFRA is extensive and costly. EPA’s

data requirements published in proposed form on No-

vember 24, 1982 (47 Fed. Reg. 53192 et seq.) reflect the

broad range of complex studies EPA requires of registrants.

iar eeeieenneiiailiiliamaaiiinal

These include efficacy technical information, phytotoxicity

studies, metabolism and residue studies, environmental

chemistry studies, toxicology studies, fish and wildlife

studies and manufacturing studies. A single long-term

animal feeding study to assess chronic toxicity can itself

cost several hundred thousand dollars and can take 4

years. These research and test data, and the trade secrets

contained in them, must be furnished to EPA to register

a product under FIFRA. Ruckelshaus v. Monsanto Com-

pany, supra, 104 S.Ct. at 2870-71. Under the Court of

Appeals’ decision, as subsequently explained in Merrell

v. Block, No. 83-3908, slip op. 10-11, 14 (9th Cir. Jan. 27,

1984), all federal agencies using pesticides must now an-

alyze this complex data package by undertaking research

activities themselves or by requiring registrants which have

satisfied EPA to develop even more data.

FIFRA establishes EPA as the “congressionally desig-

nated expert on pesticides.” United States v. Goodman,

486 F.2d 847, 849 (7th Cir. 1973). It is incongruous, and

inconsistent with the rule of reason governing NEPA’s

procedural requirements, for the Court of Appeals to

conclude that after enacting FIFRA Congress intended

other federal agencies, regardless of their lack of exper-

tise, to stand in EPA’s stead. This result threatens pesti-

cide producers with the extraordinary burden of con-

ducting years of additional research and testing whenever

a federal agency needs to compile an environmental impact

statement (“EIS”) before using their product. See Metro-

politan Edison Company v. PANE, 460 U.S. 766, 776 (1983).?

b. Respondent has ignored FIFRA and the deci-

sion below encourages it to do so. If any individual

2. Federal agencies may find it difficult to obtain vuppliers

for their pesticide needs when these are the consequences.

believes there is a human health risk associated with

the use of a pesticide, they may formally request, pursuant

to the provisions of FIFRA, that EPA revise or cancel

the registration; if the Administrator refuses to do so,

they may obtain judicial review. 7 U.S.C. 136n(a). In-

stead of utilizing the procedures established by Congress,

respondent sought to delay use of these products through

the creation of a new NEPA-based review process con-

ducted by federal agencies which use the products. Any

concerns respondent has about a particular pesticide can

and should be addressed to EPA pursuant to FIFRA.

The decision below also deprives registrants such as

Monsanto of their rights under FIFRA. Section 6(b)

of FIFRA, 7 U.S.C. 136d(b), and EPA’s registration reg-

ulations in 40 C.F.R. 162.11, ensure that issues regarding

the safety of the product are thoroughly considered before

a registration is cancelled. Under the NEPA program

devised by the Court of Appeals there are no procedural

safeguards and thus no assurances that an agency’s deci-

sion to preclude use of an EPA-registered product was

based on a full, accurate understanding of the data. Fur-

thermore, the provisions in FIFRA carefully regulating

the use and disclosure of registrants’ trade secret data,

which Congress developed to protect the interests of regis-

trants within the overall goals of FIFRA, would no longer

be applicable.

c. Virtually any pesticide use by a federal agency

can be enjoined because no agency other than EPA has

conducted the broad-ranging, complex scientific analysis

involved in registration of a pesticide. The Court of Ap-

peals’ decision has produced precisely that result. Govern-

ment spraying programs have been enjoined in BLM’s

Eugene Oregon District, in the Siuslaw National Forest,

end in the remainder of the BLM and U.S. Forest Service

areas in Oregon and Washington, as well as portions of

Idaho and Northern California. See Merrell v. Block,

No. 83-3908, slip op. (9th Cir. Jan. 27, 1984); Save Our

Ecosystems v. Watt, No. 83-3908, slip op. (9th Cir. Jan. 27,

1984); Northwest Coalition for Alternatives to Pesticides

v. Block, Civ. No. 82-6272, slip op. (D, Or. Jan. 6, 1984),

appeal pending, No. 84-3821 (9th Cir.). In light of the

Court of Appeals’ interpretation of NEPA, the spraying

of thousands of acres of federal lands will come to a halt,

with serious potential adverse impact on timber produc-

tion, while a redundant scientific review of the pesticides

is conducted, possibly taking many years.

d. The principle that NEPA can prevent an

agency from utilizing another agency’s decision made in

accordance with a congressionally-mandated review would

not be limited tc pesticides. Disagreements over the

safety of drugs often accompany Food and Drug Admin-

istration (“FDA”) implementation of the Food, Drug and

Cosmetic Act, 21 U.S.C. 301 et seq. For example, oppo-

nents of use of a particular drug could require that the

Veterans Administration or a military installation conduct

an independent review of the safety of that drug before

allowing it to be used, notwithstanding FDA registration.

Products reviewed by other agencies, such as the Con-

sumer Product Safety Commission or the National High-

way Traffic Safety Administration, could similarly be

subject to duplicate analysis by federal users. Even EPA’s

establishment of health-based restrictions on emissions

from motor vehicles or additives to fuel, pursuant to the

Clean Air Act, 42 U.S.C. 7401 et seq., would not be con-

trolling on other government agencies which purchase

those products. Such a circumvention of congressional-

mandated duties, and a duplication of expertise among

agencies, was never contemplated by Congress, or sanc-

tioned by previous courts, as part of the review obligations

imposed by NEPA.*

2. The problems presented by the Court of Appeals’

decision are particularly acute due to the Court’s addi-

tional misapplication of NEPA in requiring BLM to ex-

amine mere possibilities, however remote, of an adverse

health effect. The district court found that any “po-

tential harmful effect on human health” must be con-

sidered a significant adverse effect requiring further re-

view by the agency, including a “worst case” analysis.

Southern Oregon Citizens Against Toxic Sprays v. Watt,

No. 79-1098FR, slip op. 8 (D. Or. Sept. 9, 1982). The

Court of Appeals agreed that the “uncertainty” about the

“possibility” of significant adverse effects requires a worst

case analysis. Southern Oregon Citizens Against Toxic

Sprays, Inc. v. Clark, 720 F.2d 1475, 1479 (9th Cir. 1983).*

3. In directing BLM to ignore EPA’s determinations under

FIFRA, the Court of Appeals misapplied earlier court decisions

which caution that an agency may not abdicate its responsibil-

ities under NEPA on the basis of decisions made by other agencies.

See, e.g., Citizens Against Toxic Sprays, Inc. v. Bergland, 428

F.Supp. 908 (D. Or. 1977) and Calvert Cliffs Coordinating Com-

mittee, Inc. v. AEC, 449 F.2d 1109 (D.C. Cir. 1971). Those cases

merely hold that an agency may not let another agency’s decision

relieve it of the responsibility to apply NEPA’s deliberative

process and determine its own course of conduct. This does

not mean, however, that the agency may not consider - and

rely upon - the conclusions of the other agency. The agency

subject to NEPA still must make its own determination whether

and how to proceed, weighing its proposed action against the

foreseeable environmental effects associated with that action.

For example, BLM might decide not to use a particular pesticide,

even though it is registered EPA, because of particular site

factors or because EPA may have pending possible changes to

the registration. EPA’s determination regarding the register-

ability of these pesticides, however, is one of the factors available

to BLM in assessing its actions, and BLM must be allowed to

rely upon that determination.

4. The regulations of the Council on Environmental Quality

(“CEQ”) do not require worst case analyses to examine every

possible uncertainty about an action. They specifically provide

(Continued on following page)

Uncertainty about ultimate effects can accompany

virtually any federal action; such a criterion for review

dramatically increases the number of situations where an

EIS can be ordered and greatly expands the research

which must be conducted. No amount of empirical data

can ever provide 100% assurance that any substance is

totally “safe.” Thus, by insisting that the only way to

avoid independent review or worst case analysis is to

prove a negative, the Court of Appeals has ensured there

will always be “potential” for harm and “uncertainty”

which can be used to compel federal agencies to comply

with the new substantive obligations which the Court

of Appeals has created.°

By requiring federal agencies to undertake such an

intensive analysis of speculative risks associated with

product safety, the Court of Appeals has burdened federal

agencies and has legislated a new layer of regulatory

requirements on manufacturers of products such as pesti-

cides and drugs used by those agencies. The research

obligation imposed on these agencies by the Court of Ap-

Footnote continued—

that the worst case analysis is required only when an agency is

evaluating significant adverse effects on the human environment in

an EIS. 40 C.F.R. 1502.22. “Uncertainty” about the “potential” of

human health effects cannot meet the threshold test of “effect” as

defined in the CEQ regulations because it cannot be reasonably

foreseeable, so the worst case regulation does not come into

play. Only when a foreseeable effect exists would a worst case

analysis be relevant to ensure data gaps or scientific uncertainty

do not leave review of that effect uncompleted. The Court of

Appeals has improperly interpreted this limited intent of the

worst case regulation to create a procedure for requiring review

of speculative events which do not meet the definition of “effect.”

5. Even though respondent presented information raising

uncertainty about potential health effects of 44 one (2,4-D)

of the 13 herbicides under consideration by BLM, the district

court enjoined the spraying of all herbicides pending their review

in a worst case analysis.

peals directs them to develop data to resolve the uncer-

tainties, not merely to identify the information which

has been developed on a particular product and reveal

the scientific disagreements so that the decision-maker

may consider this information, which is all that NEPA

requires. See Conservation Council of North Carolina

v. Froehlke, 435 F.Supp. 775, 793 (M.D. N.C. 1977).

To avoid such an unbounded expansion of NEPA, it

has been consistently held that federal agencies should

limit their inquiry to probable effects, avoiding unproduc-

tive examinations of remote or highly speculative events.

Warm Springs Dam Task Force v. Gribble, 621 F.2d 1017,

1026 (9th Cir. 1980). The Council on Environmental

Quality (“CEQ”) codified this essential limitation by de-

fining the unreasonable adverse “effects” which an agency

must examine in an EIS as those consequences which

will directly occur or which are “reasonably forseeable.”

40 C.F.R. 1508.8. If there is uncertainty about even the

possibility of an event, such a possibility cannot be an

“effect” which federal agencies must examine. Disre-

garding this fundamental principle of NEPA led the Court

of Appeals into a direct confrontation with FIFRA’s con-

gressional scheme, which specifically addresses such issues.

In complying with NEPA, federal agencies should build

on FIFRA, not be charged with recreating it. “Time

and resources are simply too limited . . . to believe that

Congress intended to extend NEPA as far as the Court

of Appeals has taken it.” Metropolitan Edison Company

v. PANE, supra, 460 US. at 776.

CONCLUSION

For the reasons set forth above, this Court should

grant the Solicitor General’s Petition for a Writ of Cer-

tiorari to the United States Court of Appeals for the

Ninth Circuit.

Respectfully submitted,

G. WiLL1aM Frick*

Joun T. MaucHMer

LATHROP, Koontz, RiGHTER, CLAGETT

& Norquist