Amicus Curiae Brief — CropLife America v. Baykeeper

Supreme Court, U.S.

(Z FILED

DEC 4- 2c09

nme fH

Nos. 09-533 & 7

IN THE

Supreme Court of the United States

CROPLIFE AMERICA, et al.,

Petitioners,

v.

BAYKEEPER, et al.

Respondents.

AMERICAN FARM BUREAU FEDERATION, et al.,

Petitioners,

Vv.

BAYKEEPER, et al.

Respondents.

On Petitions for a Writ of Certiorari

to the United States Court of Appeals

for the Sixth Circuit

BRIEF OF VALENT BIOSCIENCES

CORPORATION AS AMICUS CURIAE

IN SUPPORT OF PETITIONERS

Of Counsel LAWRENCE S. EBNER

j Counsel of Record

ROBIN M. DEMOUTH

DUGAL S. SICKERT JOHN D. CONNER, JR.

VALENT BIOSCIENCES DANIEL E. JOHNSON

CORPO MCKENNA LONG &

ae ALDRIDGE LLP

870 Technology Way

1900 K Street, NW

Libertyville, IL 60048 Washington, D.C. 20006

(202) 496-7500

Attorneys for Amicus Curiae

December 4, 2009

WiLSON-EPES PRINTING Co., INC. — (202) 789-0096 -— WASHINGTON, D. C. 20002

TABLE OF CONTENTS

TABLE OF AUTHORITIES ..............cscccccsserseees

INTEREST OF AMICUS CURIAE..............:00006

REASONS FOR GRANTING THE PETITIONS

I.

IT.

THIS CASE IS EXCEPTIONALLY

IMPORTANT TO PUBLIC HEALTH AND

THE PROTECTION OF FORESTS

BECAUSE UNLESS THE SIXTH CIR-

CUIT’S DECISION IS REVERSED, THE

AVAILABILITY AND EFFECTIVE USE

OF STATE-OF-THE-ART, NATURALLY

OCCURRING BIOLOGICAL PESTICIDES

WILL BE SERIOUSLY CURTAILED, IF

ieee se ih ae i PO.) en

A. The Sixth Circuit’s Decision Vacating

EPA’s Final Rule and Requiring

NPDES Permits for Biological Pesti-

cides Will Frustrate If Not Altogether

Prevent Their Timely and Effective Use

B. Bt Larvicides Are Critical for Effective

| eee

C. Bt Larvicides Also Are Important for

ee Bg.) aes

D. EPA Has Recognized That Biological

Pesticides Pose Lower Risks Than Most

Conventional Pesticides..........................

THE SIXTH CIRCUIT’S DECISION IS

PREMISED IN PART ON FUNDA-

MENTAL ERRORS REGARDING BIO-

LOGICAL PESTICIDES. ...........cssessecsssrosesssees

(i)

11

il

TABLE OF CONTENTS—Continued

Page

A. Biopesticides Are Not “Biological

Material” Pollutants Under the Clean

WR a iced rhtsonesccssccesecesce: 12

B. Biopesticides Do Not “Undeniably Alter

the Physical Integrity of the Waters’..... 18

CON CL USaGIaY caccsacseesta ne nUnntabhicatevescessccscccsse 20

iii

TABLE OF AUTHORITIES

CASES Page

Association to Protect Hammersley, Eld, &

Totten Inlets v. Taylor Resources, Inc., 299

FOG TOOT CREE Ge, Bi) vvsecsssesssesescerenessssscnses 16

Brown v. Gardner, 513 U.S. 115 (1994).............. 15

Chevron, U.S.A., Inc. v. Natural Res. Def.

Council, 467 U.S. 837 (1984) ............ccccecceesecees 14, 15

Concerned Area Residents for the Env’t v.

Southview Farm, 34 F.3d 114 (2d Cir. 1994).. 17

FDA v. Brown & Williamson Tobacco Corp.,

BO Cle Re I attneskassincusatnensecacccercebrnsienss 14

Grand Traverse Band of Ottawa & Chippewa

Indians v. Office of U.S. Attorney, 369 F.3d

ee Ce I SE eccabrastekicenadictnaeccenietiacaen 13

Natl Ass’n of Home Builders v. Defenders of

Wildlife, 551 U.S. 644 (2007)............. ccc eeeseeees 14

National Wildlife Federation v. Consumers

Power Co., 862 F.2d 580 (6th Cir. 1988)......... 17

United States Public Interest Research Group

uv. Atlantic Salmon of Maine, 215 F. Supp. 2d

SOP CE Bs WINE cstadciticniencaoaenenn 17

United States v. Frezzo Bros., 461 F. Supp. 266

(E.D. Pa. 1978), affd, 602 F.2d 1123 (3d Cir.

RF? svsssedssccsecevonennnanasnacienaseaaneneanaee 18

United States v. Plaza Health Laboratories,

Inc., 3 F.3d 643 (2d Cir. 1993), cert. denied,

CIS U.S, Rae Ce iivciitasetase ae 17-18

Zuni Pub. School Dist. No. 89 v. Dep’t of Educ.,

CB U2. BE Ce iictasicecsnttnsecnccapecnsvceiaen 15

lV

TABLE OF AUTHORITIES—Continued

STATUTES Page

Fhe MIRED vecsesienesisxssdnsevnccccceeszctencsoves 11

Be ee OE vac ccccceccsccacevstsssacdentncedvonsenseiane 2

ee ee ic scccssinisenssivesancicsbonsineesenicuins 2

ee re I coc crcvevica bes oiacsnsxbnssnethsxsteesaesees 18

OTHER AUTHORITIES

BD GF ie ee eR icitteccennccvescncccccsasonsvese 11

40 C.F.R. §§ 158.2100-158.2174............. eee eee ee 11

71 Fed. Reg. 68,483 (Nov. 27, 2006).................... 9

71 Fed. Reg. 68,486 (Nov. 27, 2006)................006 15

71 Fed. Reg. 68,487 (Nov. 27, 2006)................000 15, 18

72 Fed. Reg. 60,988, 60,989 (Oct. 26, 2007)........ 11

American Mosquito Control Association, Mos-

quito-Borne Diseases, availabie at http://

Www.mosquito.org/mosquito-information/mos

raises nciosisnnidcanisscssineDawstseresesdess 7

American Mosquito Control Association, Con-

trol, available at http://www.mosquito.org/

mosquito-information/control.aspx ................. 8

Centers for Disease Control and Prevention,

West Nile Virus, Statistics, Surveillance, and

Control, available at http://www.cdc.gov/

ncidod/dvbid/westnile/surv&controlCaseCou

nt09_detailed.htm#MeningitisEnc.................. 8

Centers for Disease Control and Prevention,

The Impact of Malaria, A Leading Cause of

Death Worldwide, available at http://www.

cdc.gov/malaria/index.htm.................sceeseeeeeeees 8

Vv

TABLE OF AUTHORITIES—Continued

CNN, Study: Saving Forests Best Way To

Cheap, Clean Water, available at http://

www.cnn.com/2003/TECH/science/09/03/fore

sts.water.reut/index.html ....................ssseesseeees 10

EPA, Biological Integrity, available at http://

www.epa.gov/bioiwebl/htm)/biointeg.html..... 19

EPA, Clean Water Act Permitting of Discharges

from Pesticide Applications (Webinar) (Oct.

7, 2009), available at http://www.epa.gov/

pesticides/ppdc/2009/october/session-1.pd ...... 5-6, 7

EPA, Larvicides for Mosquito Control, avail-

able at http://www.epa.gov/opp0000 l/health/

mosquitoes/larvicides4mosquitoes.htm....4, 8, 9, 15, 19

EPA NPDES Application Estimates and

Information Sources (draft) (Sept. 23, 2009)

available at http://www.epa.gov/pesticides/

ppdc/2009/october/session1-npdes. pdf............. 6, 10

EPA, Pesticide Registration Notice 97-3 at

XI(B), available at http://epa.gov/PR_Noti

I iinisissnadcnenisuavatialentaniaeecadeneieceess 12

EPA Pesticides Glossary, available at http://

www.epa.gov/pesticides/glossary/#b................ 13, 16

EPA, What Are Biopesticides?, available at

http://www.epa.gov/pesticides/Diopesticides/

whatarebiopesticides.htm..................eeccseeeeeeees 11,19

vi

TABLE OF AUTHORITIES—Continued

National Research Council, Committee on the

Future Role of Pesticides in US Agriculture,

The Future Role of Pesticides in US

Agriculture (2000) at 251-52, available at

http://books.nap.edu/openbook.php?record_id

IE asaivnessntesecesessnesecsnsansactsisssniccsvace

North Carolina State University, Pesticide

Resistance Management, available at http://

ipm.ncsu.edu/apple/orchardguide/Resistance.

© SEEEERRARPTETSS SERED MOAI ER SDD ree NO ODADAS AE AEA AA ROI

Russell S. Jones, The Biochemical Classi-

fication Committee and the Classification of:

Biochemical Active Ingredients, available at

http://www.Pharmsolutions.com/doc5s/Classi

ficationBioChemicalActiveIngredients.htm....

USDA, Forest Service, Control / Eradication

Agents for the Gypsy Moth Human Health

and Ecological Risk Assessment for Bacillus

thuringiensis var. kurstaki (B.t.k.), available

at http://www. fs.fed.us/foresthealth/pesticide

I I nscnccccanesseascnanasseciacuninenvess

USDA Forest Service, Northeastern Area,

Gypsy Moth Digest—Defoliation, available

at http://na.fs.fed.us/fhp/gm/defoliation/index.

SN 0kti2 iain Cannel sak eaaenone ran inasaiencaaemeanaie

World Health $ Organization, Bacillus

Thuringiensis, Summary, available at http://

apps. who.int/bookorders/anglais/detart1.jsp?

sesslan=1&codlan=1&codcol=16&codcech=21

Page

12

10

INTEREST OF AMICUS CURIAE'

Valent BioSciences Corporation (“VBC”) manufac-

tures a unique class of FIFRA-registered pesticides

known as “biological pesticides,” which consist of

naturally occurring microorganisms. They are

applied to water to control mosquito larvae before

they grow into adults capable of transmitting disease;

to the canopy of forests to control caterpillars that

defoliate and destroy trees; and also to agricultural

crops.

Biological pesticides are environmentally beneficial

and play an important role in integrated pest and

mosquito management programs. Their application

to or near water, including the application of a sub-

species of the naturally occurring soil bacterium

Bacillus thuringiensis (“Bt”), does not produce

biological wastes. Nor do biological pesticides alter

the chemical, physical or biological integrity of the

waters of the United States. The World Health

Organization has concluded that “Bt products are

unlikely to pose any hazard to humans or other

vertebrates or to the great majority of non-target

invertebrates. . . .””

* VBC states under Supreme Court Rule 37.6 that no counsel

for a party authored this brief in whole or in part, and that no

person or entity, other than VBC and its counsel, made a mone-

tary contribution intended to fund the preparation or submis-

sion of this brief. Under Supreme Court Rule 37.2, on

November 19 and 20, 2009, VBC provided counsel of record

listed then on the Court docket with notice of its intention to file

this brief. All of those parties have consented to the filing of the

brief; their letters of consent are lodged with the Clerk.

? World Health Organization, Bacillus Thuringiensis,

Summary, available at http://apps.who.int/bookorders/anglais/

detart1.jsp?sesslan=1&codlan=1&codcol=16&codcch=217.

2

VBC devotes a substantial portion of its resources

to the research and development, FIFRA registration,

and commercialization of biological pesticides,

including Bt larvicides. The industry that discovers

and commercializes biological pesticides is comprised

of many small or medium size businesses, such as

VBC.

VBC respectfully submits that the Sixth Circuit’s

conclusion that a biological pesticide is always a

Clean Water Act (“CWA”) “pollutant” is wrong. See

33 U.S.C. § 1362(6). If allowed to stand, the lower

court’s decision will discourage, and in most cases

prevent, the timely and effective use of biological

pesticides, and also needlessly subject users of

biological pesticides to CWA citizen suits. Losing the

timely use of biological pesticides would be especially

unfortunate because the CWA’s goal is “to restore

and maintain the chemical, physical and biological

integrity” of waters, 33 U.S.C. § 1251(a), not to regu-

late as CWA pollutants environmentally beneficial

biological pesticides, which help to protect public

health and the natural environment.

VBC, which also submitted an amicus curiae brief

below, is filing this brief in support of both certiorari

petitions in order to urge the Court to review and

correct the Sixth Circuit’s decision, including specifi-

cally with respect to biological pesticides.

3

REASONS FOR GRANTING THE PETITIONS

Review should be granted in order to correct the

lower court’s erroneous hoiding that biological pesti-

cides are CWA “pollutants.” They are instead a

unique and invaluable class of EPA-approved pesti-

cides, comprised of naturally occurring microorgan-

isms, including the soil bacterium Bacillus thurin-

giensis (“Bt”). Bt biological pesticides, also called Bt

larvicides because they control insect larvae, are

applied to water to control the larval form of the

mosquito, an insect that causes more death and

disease than any non-human animal. They also are

applied to forests to control caterpillars that annually

destroy millions of acres of trees. Bt larvicides not

only are highly effective in controlling mosquito

larvae and caterpillars, but also benefit the aquatic

environment because they do not affect nontarget

aquatic organisms. Bt biological pesticides provide

significant net environmental, economic and public

health benefits.

The CWA’s illustrative “pollutant” example—

“biological materials’—means biological wastes, not

any and all material of a biological nature, such as Bt

larvicides. And because they do not alter the integr-

ity of the waters to which they are applied, Bt larvi-

cides do not meet the CWA’s definition of “pollution.”

Unless reversed, the Sixth Circuit’s decision requir-

ing compliance with time-consuming NPDES permit

requirements will delay or prevent the timely and

effective application of Bt biological pesticides to con-

trol disease-carrying mosquitoes and other target

pests.

4

I. THIS CASE IS EXCEPTIONALLY IMPOR-

TANT TO PUBLIC HEALTH AND THE

PROTECTION OF FORESTS BECAUSE

UNLESS THE SIXTH CIRCUIT’S DECI-

SION IS REVERSED, THE AVAILABILITY

AND EFFECTIVE USE OF STATE-OF-

THE-ART, NATURALLY OCCURRING

BIOLOGICAL PESTICIDES WILL BE

SERIOUSLY CURTAILED, IF NOT COM-

PLETELY LOST

Bt biological pesticides benefit the environment

while controlling insects. Bt larvicides are inherently

less toxic to man and the environment than conven-

tional chemical pesticides. In contrast with most

conventional chemical pesticides, which may affect a

large spectrum of organisms, including adversely

affecting non-target organisms, Bt larvicides affect

only the biology of the larva of a particular insect

pest, and they decompose quickly in the water.

Indeed, EPA has stated that “[e]xtensive testing

shows that microbial [i.e., biological] larvicides do not

pose risks to wildlife, nontarget species, or the envi-

ronment, when used according to label directions.”’

For these reasons, Bt biological pesticides provide

significant net environmental, economic and social

benefits. They protect public health. They also

reduce forest defoliation and thereby maintain the

capacity of forests to capture carbon and offset

greenhouse gas emissions and control insects that

jeopardize wildlife.

® EPA, Larvicides for Mosquito Control, available at http://

www.epa.gov/opp0000 l/health/mosquitoes/iarvicides4mosquitoes.

htm (hereinafter “EPA, Larvicides for Mosquito Control”)

(emphasis added).

5

The National Research Council, whose members

are drawn from the Councils of the National Acad-

emy of Sciences, reported in 2000 that while conven-

tional pesticides will continue to play an important

role in pest control technology, there remains the

need for pest controls that are consistent with

ecologically-based pest management.‘ Biological

pesticides are consistent with ecologically-based pest

management. The Sixth Circuit’s holding that

biological pesticides are CWA “pollutants” will dis-

courage their continued development and use. By

subjecting these highly beneficial and time-sensitive

products (which EPA has repeatedly determined are

safer for the environment than conventional pesti-

cides) to a lengthy permitting process, the Sixth Cir-

cuit decision will sharply curtail and reverse efforts

to control harmful and life-threatening diseases and

the adverse effects associated with deforestation.

A. The Sixth Circuit’s Decision Vacating

EPA’s Final Rule and Requiring

NPDES Permits for Biological Pesti-

cides Will Frustrate If Not Altogether

Prevent Their Timely and Effective

Use

To initiate the process of complying with the lower

ccurt’s decision, EPA, on October 7, 2009, released for

comment draft conditions for applying pesticides

under an National Pollutant Discharge Elimination

System (“NPDES”) pesticide general permit (“PGP”).°

* National Research Council, Committee on the Future Role

of Pesticides in US Agriculture, The Future Role of Pesticides in

US Agriculture (2000) at 251-52, available at http://books.nap

edu/openbook.php?record_id=9598&page=R1.

® EPA, Clean Water Act Permitting of Discharges from Pesti-

cide Applications (Webinar) (Oct. 7, 2009), available at http://

6

In particular, under the draft conditions, applicators

of all pesticides to or near water must hold, as of

April 10, 2011, an individual NPDES permit or

comply with the conditions of a PGP. The PGP will

impose a myriad of conditions and restrictions on

pesticide applicators, including the requirement to

file a Notice of Intent (“NOI”) before applying pesti-

cides, technology and water quality-based effluent

limits, and monitoring and reporting requirements.

Governmental and private entities charged with

controlling nuisance and disease-carrying mosquitoes

face severe budgetary constraints in the current

economy. They can ill afford the additional costs of

complying with the conditions of PGP, especially

when, in the case of biological pesticides, compliance

will not bring any additional benefits to man or the

environment.

The use of larvicides for mosquito control is wide-

spread: they are applied to treat four million acres

of water annually.® The application of Bt for larval

control also is extremely time-sensitive. For mos-

quito control, Bt biological pesticides must be applied

while the larvae are in their feeding stage and before

they enter the pupae phase, a narrow and time

critical window of several days. Moreover, mosquito

larvae populations can increase as a result of

unexpected rains and high tides.

www.epa.gov/pesticides/ppdc/2009/october/session-1.pdf (herein-

after “EPA, CWA Permitting of Discharges from Pesticide

Applications”).

* EPA, NPDES Application Estimates and Information Sources

(draft) (Sept. 23, 2009) available at http://www.epa.gov/pes

ticides/ppdc/2009/october/sessionl-npdes.pdf. (hereinafter “EPA

NPDES Application Estimates”).

7

The Sixth Circuit’s decision will prevent the timely

and effective application of Bt biological pesticides.

EPA has stated that “[a] person filing an NOI would

be covered starting 10 days after receipt of a complete

and accurate NOI form by the appropriate permitting

authority (provided the permitting authority does not

delay authorization to further assess the NOJ).”’

Requiring applicators to wait ten days before using

the Bt larvicides likely will force them to miss the

critical larvae feeding stage. While pesticides may be

applied in emergency situations before the submis-

sion of a NOI, the purpose of mosquito larviciding is

to avoid an emergency. Because the Sixth Circuit

decision will, as a practical matter, prevent the

timely use of Bt larvicides, the decision will have

a significant adverse impact on the use of these

beneficial pest control products.

B. Bt Larvicides Are Critical for Effective

Mosquito Control

The mosquito is a very efficient carrier of disease.

It causes more human suffering and death than any

non-human animal.® The mosquito transmits more

than 100 pathogens that cause protozoan diseases

such as malaria, filarial diseases such as heartworm,

and viral diseases such as yellow fever, dengue fever,

encephalitis, and West Nile virus. Each year there

are 300 to 500 million cases of malaria reported

worldwide, resulting in at least one million deaths

7 EPA, CWA Permitting of Discharges from Pesticide Applica-

tions (slide 45) (emphasis added).

® American Mosquito Control Association, Mosquito-Borne

Diseases, available at http//www.mosquito.org/mosquito-

information/mosquito-borne.aspx.

8

every year.” CDC already has reported 608 cases of

mosquito-transmitted West Nile Virus, and 28

deaths, in 2009."°

All mosquitoes begin life in stagnant or standing

water and develop through four stages of meta-

morphous: egg, larva, pupa, and adult. The female’s

eggs hatch within a day or two, releasing larvae that

only live in water from four to fourteen days, after

which they change to pupae before becoming adult

mosquitoes that take flight. Public and private mos-

quito control programs practice Integrated Mosquito

Management, which seeks to control mosquitoes by

reducing aquatic breeding sites for the larvae. When

monitoring and surveillance programs confirm the

need to control mosquito larvae with pesticides, the

FIFRA-registered choices include biological pesticides

such as Bt larvicides, biochemical pesticides such as

methoprene (an insect growth regulator), and con-

ventional organophosphate chemical insecticides.”

Unlike the more limited and precise application of

larvicides, the control of adult mosquitoes requires

the ground and aerial spraying of conventional

organophosphate chemical pesticides over much

larger areas.”

® Centers for Disease Control and Prevention, The Impact of

Malaria, A Leading Cause of Death Worldwide, available at

http://www.cdc.gov/malaria/index.htm.

Centers for Disease Control and Prevention, West Nile

Virus, Statistics, Surveillance, and Control, available at http://

www.cdc.gov/ncidod/dvbid/westnile/surv&controlCaseCount09_d

etailed.htm#MeningitisEnc.

" American Mosquito Control Association, Control, available

at http://www.mosquito.org/mosquito-information/control.aspx.

" EPA, Larvicides for Mosquito Control (“Killing mosquito

larvae before they emerge as adults can reduce or eliminate the

9

The most widely used biological pesticide applied to

water to control mosquito larvae are two subspecies

of Bt: Bacillus thuringiensis israelensis (“Bti”) and

Bacillus sphaericus (“B. sphaericus”). Mosquito larvae

consume the dormant Bt bacterium spores and an

associated Bt toxin that binds to receptor cells in the

mosquito larva’s gut, thereby causing the larva to

starve. These receptor cells are not present in fish or

mammals. Bti and B. sphaericus therefore benefit

the environment because they control only the

mosquito larvae and do not affect other nontarget

aquatic organisms.’ Bt biological pesticides serve as

an important tool in managing the mosquito’s devel-

opment of resistance to traditional chemical larvi-

cides and adulticides. “*

C. Bt Larvicides Also Are Important for

Protecting Forests

EPA’s Final Rule, 71 Fed. Reg. 68,483 (Nov. 27,

2006), cited, as an example of pesticides that are

applied “near” water, insecticides that are applied

aerially to the forest canopy to control foliage-feeding

caterpillars where waters of the United States may

be present below the canopy. Pet. App. 7a. In 2008,

the Gypsy Moth alone defoliated 1,593,649 acres of

trees in the northeastern United States." There are

need for ground or aerial application of pesticides to kill adult

mosquitoes.”).

* id.

‘* North Carolina State University, Pesticide Resistance Man-

agement, avaiable at http/Apm.ncsu.edu/apple/orchardguide/Res

istance.pdf.

"* USDA, Forest Service, Northeastern Area, Gypsy Moth

Digest—Defoliation, available at http//na.fs.fed.us/fhp/gm/

defoliation/index.shtm.

10

2.7 million acres of forests that are treated every year

to control caterpillars."° The Sixth Circuit’s decision

will also preclude the timely and effective use of

these biological pesticides to control caterpillars that

kill trees. Preserving forests through the application

of biological pesticides contributes to clean water

because forests serve to filter pollutants. *”

Commercial formulations of Bacillus thuringiensis

subspecies kurstaki (“Btk”) have been used to control

forest caterpillar pests since the mid-1970’s. More

than a million pounds of Btk are applied annually in

the United States to control the destructive gypsy

moth. A total of 2,743,816 acres were treated with

Btk formulations between 1995 and 2002." As with

other subspecies of Bt, Btk is considered “friendly” to

humans and the environment. It controls only

susceptible caterpillars by the mechanism described

above. “U.S. EPA (1998) classifies Btk as virtually

non-toxic to fish, based on an assessment of several

acute toxicity studies in trout and one study in

bluegills.”®

‘© EPA NPDES Application Estimates.

'' CNN, Study: Saving Forests Best Way To Cheap, Clean Wa-

ter, available at http://www.cnn.com/2003/TECH/science/09/03/

forests.water.reut/index html.

'8 USDA, Forest Service, Control/Eradication Agents for the

Gypsy Moth Human Health and Ecological Risk Assessment for

Bacillus thuringiensis var. kurstaki (B.t.k.), available at http://

www.fs.fed.us/foresthealth/pesticide/pdfs/060804_btk.pdf.

'8 Td. at 4-8.

11

D. EPA Has Recognized That Biological

Pesticides Pose Lower Risks Than

Most Conventional Pesticides

EPA is responsible for registration of the following

categories of pesticides under FIFRA: conventional

(chemical) pesticides, biological pesticides (or micro-

bials or biopesticides), biochemical pesticides, plant-

incorporated protectants (plants that genetically

produce their own pesticides), and antimicrobial pes-

ticides (e.g., disinfectants). See 72 Fed. Reg. 60,988,

60,989 (Oct. 26, 2007). The Agency has stated that

“[t]hese pesticides, although regulated under the

same statutory standards under FIFRA and FFDCA,

pose different levels of risk and exposure... .” Id.

Because they consist of naturally occurring micro-

organisms, EPA has stated that “[bliopesticides are

usually inherently less toxic than conventional pesti-

cides.”*” The Agency requires all pesticide applicants

to submit toxicology and environmental studies,

which the Agency reviews to determine whether a

pesticide meets FIFRA’s “no unreasonable adverse

effects on the environment” standard for registration.

See 7 U.S.C. § 136a(c)(5)(D). But because biological

pesticides are inherently less toxic than conventional

pesticides, EPA requires applicants for biological

pesticide registrations to submit much less data than

applicants seeking to register conventional pesticides.

Compare 40 C.F.R. §§ 158.1—158.1410 (data re-

quirements for conventional pesticides) with 40

C.F.R. §§ 158.2100—158.2174 (data requirements for

microbial pesticides).

20 EPA, What Are Biopesticides?, available at http:/Awww.

epa.gov/pesticides/biopesticides/whatarebiopesticides.htm.

(hereinafter “EPA, What are Biopesticides?”).

12

In 1995, EPA created the Biopesticides and Pollu-

tion Prevention Division to bring “safer pesticides

products into the market place and to encourage the

adoption of these safer, reduced risk products and

related integrated pest management (IPM)

practices.”** EPA Guidelines for expedited review of

conventional and biological pesticides explain that

“EPA believes that biological pesticides generally

pose less risk than most conventional pesticides.”™

The Sixth Circuit’s decision would require all users

of these beneficial and efficacious biological pesticides

to submit to the time-consuming NPDES permitting

process, which will hamper, if not largely prevent,

the use of these products to control disease and

deforestation.

Il. THE SIXTH CIRCUIT'S DECISION IS

PREMISED IN PART ON FUNDAMENTAL

ERRORS REGARDING BIOLOGICAL

PESTICIDES

A. Biopesticides Are Not “Biological Ma-

terial” Pollutants Under the Clean

Water Act

Biological pesticides are not CWA pollutants

because they are not biological wastes. The Sixth

Circuit’s decision that biological pesticides, which

benefit public health and the environment, are CWA

pollutants because they may superficially “fit into the

ordinary meaning of ‘biological materials,” Pet. App.

*1 Russell S. Jones, The Biochemical Classification Committee

and the Classification of Biochemical Active Ingredients, avail-

able at http://www.pharmsolutions.com/docs/ClassificationBioChe

micalActiveIngredients.htm.

22 EPA, Pesticide Registration Notice 97-3 at XI(B), available

at http://epa.gov/PR_Notices/pr97-3.html.

13

19a, is wrong. That conclusion produces absurd

results and is at odds with basic principles of statu-

tory construction and established case law holding

that “biological materials” means biological wastes.

The Sixth Circuit cited no legislative history

remotely suggesting that when Congress passed the

CWA in 1972, it intended that any and all “matter of

a biological nature” introduced into the waters of

the United States would constitute the prohibited

discharge of a pollutant. Pet. App. 2la. If that were

true, then Congress intended that the state game

warden who stocks the local trout stream in the

Spring with “artificial concentrations” of young trout,

or the fisherman who casts upon the waters the

sacrificial worm, must first obtain a NPDES permit.

Under the Sixth Circuit’s decision, both the trout and

the worm would squarely qualify as “biological

materials” within the “ordinary, contemporary, [and]

common meaning” of the term, thus requiring an

NPDES permit. See id. at 20a-2la, citing Grand

Traverse Band of Ottawa & Chippewa Indians v.

Office of U.S. Attorney, 369 F.3d 960, 967 (6th Cir.

2004).

“Biological materials” as used in the CWA defini-

tion of “pollutants,” however, means biological

wastes. Bt larvicides are not biological wastes. They

are applied to or near waters of the United States to

protect the environment, public health and natural

forestry resources. After serving their intended bene-

ficial purpose they do not leave a residue or waste in

the waters because they consist of naturally occur-

ring bacteria.”

% EPA Pesticides Glossary, available at http:/Awww.epa.gov/

pesticides/glossary/#b (hereinafter “EPA Pesticides Glossary”).

14

The “precise question at issue” is whether, when

Congress enacted the CWA in 1972, it clearly

intended that a “biological pesticide” applied to water

to control a pest was a prohibited “pollutant.” See

Chevron, U.S.A., Inc. v. Natural Res. Def. Council,

467 U.S. 837, 837-38 (1984). The Sixth Circuit

committed clear error when, instead of ascertaining

“whether Congress has directly spoken to the precise

question at issue,” it quoted two dictionary defini-

tions of “material” and summarily declared that the

“plain, unambiguous nature of” biological materials

compels the conclusion that biological pesticides are

CWA pollutants. Pet. App 20a-21a. Chevron requires

more.

A court must assess the clarity or lack of clarity of

statutory language by employing all of the traditional

tools of statutory construction. Chevron, 467 U.S. at

843, n.9 (“If a court, employing traditional tools of

statutory construction, ascertains that Congress had

an intention on the precise question at issue, that

intention is the law and must be given effect.”).

Thus, the clarity or ambiguity of the statutory term

“biological materials” must not be assessed in a

vacuum, or merely by reference to general dictionary

definitions, but instead must be assessed within the

context of whether Congress intended “biological ma-

terials” to encompass beneficial biological pesticides.

See generally Nat'l Ass’n of Home Builders v. De-

fenders of Wildlife, 551 U.S. 644, 666 (2007) (“[T]he

meaning—or ambiguity—of certain words or phrases

may only become evident when placed in context... .

It is a fundamental canon of statutory construction

that the words of a statute must be read in their con-

text and with a view to their place in the overall sta-

tutory scheme.” (citing FDA v. Brown & Williamson

Tobacco Corp., 529 U.S. 120, 132-33 (2000)) (internal

15

quotation marks omitted); Zuni Pub. School Dist. No.

89 v. Dep't of Educ., 550 U.S. 81, 98 (2007) (statutory

“(ajmbiguity is a creature not [just] of definitional

possibilities but [also] of statutory context.”) (quoting

Brown v. Gardner, 513 U.S. 115, 118 (1994)).

The context of the CWA demonstrates that

Congress did not intend “biological materials” to

include biological pesticides. EPA did not register

the first aquatic Bt biological larvicide, Bti, for the

control of mosquito larvae until 1983. It did not

register the second Bt mosquito larvicide, B. sphaeri-

cus, until 1991.% As EPA’s Final Rule noted, “(t]he

fact that more biological pesticides have been devel-

oped since passage of the [Clean Water] Act in 1972

does not justify expanding the reach of the NPDES

permit requirement when there is no evidence that

Congress intended the CWA to regulate biological

pesticides in a manner different from chemical pesti-

cides.” Final Rule, 71 Fed. Reg. at 68,486. Because

Congress could not have directly addressed whether

“biological materials” includes “biological pesticides,”

the Sixth Circuit should have afforded Chevron defe-

rence to EPA’s Final Rule, which concluded that “it

would not make sense, and would be inconsistent

with the goals of the Clean Water Act, to discourage

the use of biological pesticides by requiring applica-

tors of these products to obtain an NPDES permit

when chemical pesticides have no such requirement.”

Id. at 68,486-87.

Ironically, to bolster its conclusion that “biological

materials” includes biological pesticides, the Sixth

Circuit looked at an EPA definition of the term “bio-

logical pesticides.” Pet. App. 22a-23a. The Sixth

4 EPA, Larvicides for Mosquito Control.

16

Circuit, however, materially misstated EPA’s defini-

tion. According to the Sixth Circuit, EPA defines

“biological pesticides” to include “other biological

materials.” Jd. In fact, the EPA definition of “bio-

logical pesticides” does not include “other biological

materials,” but only “certain microorganisms, includ-

ing bacteria, fungi, viruses, and protozoa that are

effective in controlling target pests.”*

The Sixth Circuit also erred when it assumed that

biological pesticides are wastes. Bt biological pesti-

cides are not wastes: they leave no residue in the wa-

ter after serving their intended purpose of controlling

mosquito larva.” Courts treat “biological materials”

as pollutants only if they are biological wastes.

In each of the “biological materials” cases cited by

the Sixth Circuit, the court specifically found that

human activity generated a biological waste. For

example, in Association to Protect Hammersley, Eld,

& Totten Inlets v. Taylor Resources, Inc., 299 F.3d

1007, 1016 (9th Cir. 2002), the Ninth Circuit found

the CWA to be “ambiguous on whether ‘iological

materials’ means all biological matter regardless of

quantum and nature.” The court held that mussel

shells, mussel feces, and other biological materials

emitted from mussel-harvesting facilities were not

“biological materials” because “the shells and natural

byproduct of living mussels released ... are the

result of the natural biological processes of the

mussels, not the waste product of a transforming

human process.” Jd. at 1017 (emphasis added).

Applying the doctrine of ejusdem generis, the court

found that the “more specific items in the illustrative

5 EPA Pesticides Glossary.

* id.

17

list of pollutants . . . support an understanding of the

more general statutory term, ‘biological materials,’ as

waste material of a human or industrial process.” Id.

at 1016 (emphasis added).

In the second case cited by the Sixth Circuit,

National Wildlife Federation v. Consumers Power

Co., 862 F.2d 580 (6th Cir. 1988), the court found

that fish remains discharged from a hydroelectric

facility are pollutants since they are “biological mate-

rials.” That the biological materials—dead fish and

fish parts—remain in the water after the human

activity attests to their characterization as “biological

materials” wastes. In the third case, relied upon but

not analyzed by the Sixth Circuit, United States

Public Interest Research Group v. Atlantic Salmon of

Maine, 215 F. Supp. 2d 239 (D. Me. 2002), the district

court went no further than to hold that non-North

American salmon that escape from an aquaculture

facility are “biological materials” because the fish do

not occur naturally in that water and that salmon

feces and urine that escape the facility’s nets are

either “biological materials” or “agricultural wastes.”

Id. at 247-49. Animal feces and urine are biological

materials, but more importantly they are wastes—

the useless byproducts of metabolism.

Other courts have confirmed that biological mate-

rials means biological wastes. See, e.g., Concerned

Area Residents for the Env’t v. Southview Farm, 34

F.3d 114, 117 (2d Cir. 1994) (liquid manure spread on

farm fields met definition of pollutant as it was “solid

waste, .. . sewage, .. . biological materials, . . . and

agricultural waste discharged into water”); United

States v. Plaza Health Laboratories, Inc., 3 F.3d 643,

645 (2d Cir. 1993), cert. denied, 512 U.S. 1245 (1994)

(discarded vials of human blood are “biological mate-

18

rials”); United States v. Frezzo Bros., 461 F. Supp.

266, 269-70 (E.D. Pa. 1978), affd, 602 F.2d 1123 (3d

Cir. 1979) (runoff from pile of “mushroom compost”

was discharge of “sewage” and “biological materials”).

EPA’s Final Rule relied upon and cited most of

these cases for the Agency’s well supported conclu-

sion that “[iJn cases in which courts have found

specific biological materials to be ‘pollutants’ under

section 502(6) the substances at issue were waste

materials discharged from a point source.” 71 Fed.

Reg. at 68,487. The Sixth Circuit found a conven-

tional pesticide to be a “chemical waste” only if it

leaves an excess portion in the water “after perform-

ing its intended purpose.” Pet. App. 18a. For this

reason, a Bt bacterium is a biological waste only

when it too leaves an excess portion in the water

after performing its intended purpose. But because

they are naturally occurring, Bt bacterium do not

leave an excess portion in the water after performing

their intended purpose. Therefore, Bt larvicides are

not pollutants under the Clean Water Act.

B. Biopesticides Do Not “Undeniably

Alter the Physical Integrity of the

Waters”

After mistakenly concluding that biological pesti-

cides are CWA “pollutants” because they fit within

the ordinary meaning of “biological materials,” the

Sixth Circuit then mistakenly concluded that a bio-

logical pesticide must meet the CWA’s definition

of “pollution,” 33 U.S.C. § 1362(19), because, when

added to water, they “undeniably alter its biological

integrity.” Pet. App. 23a. There is no evidence even

remotely suggesting, however, that the addition of

naturally occurring Bt biological pesticides alters the

biological integrity of the waters of the United States.

19

Instead, EPA has concluded that biological pesti-

cides do not alter the water integrity. The Agency

defines “biological integrity” of water as “the capabil-

ity of supporting and maintaining a balanced, inte-

grated, adaptive community of organisms having a

species composition, diversity, and functional organi-

zation comparable to that of the natural habitat of

the region.”” The application of Bti and B. sphaeri-

cus to aquatic environments to control mosquito

larvae, as well as the application of Btk near water to

control caterpillars that defoliate trees, meet EPA’s

criteria for preserving the water’s biological integrity.

Because they are naturally occurring, they degrade

quickly.” EPA has expressly stated that “[e]xtensive

testing shows that microbial larvicides do not pose

risks to wildlife, nontarget species, or the environ-

ment, when used according to label directions.””

Similarly, EPA has classified Btk as nontoxic to fish

and aquatic invertebrate. Because EPA has deter-

mined that biological pesticides do not pose risks to

nontarget aquatic species, the Sixth Circuit erred

when it concluded that it is “undeniable” that biologi-

cal pesticides alter the biological integrity of waters

of the United States.

The Sixth Circuit incorrectly concluded that the

CWA’s definitions of “pollutant” and “pollution” are

unambiguous and include biological pesticides. In so

doing, the court unnecessarily subjected users of

beneficial biological pesticides to a costly and time-

*' EPA, Biological Integrity, available at http://www.epa.gov/

bioiweb l/htmVbiointeg. html.

“EPA, What are Biopesticides? (“Biopesticides . . . often

decompose quickly . . .”).

*® EPA, Larvicides for Mosquito Control. (Emphasis added.)

20

consuming NPDES permitting process that will

hinder the timely use of these products for important

public health and environmental uses.

CONCLUSION

The petitions for a writ of certiorari should be

granted.

Respectfully submitted,

Of Counsel LAWRENCE S. EBNER

Counsel of Record

ROBIN M. DEMOUTH

DUGAL S. SICKERT JOHN D. CONNER, JR.

DANIEL E. JOHNSON

VALENT BIOSCIENCES

CORPORATION MCKENNA LONG &

870 Technology Way ALDRIDGE LLP

, , 1900 K Street, NW

Libertyville, IL 60048 Washington, D.C. 20006

(202) 496-7500

Attorneys for Amicus Curiae

December 4, 2009