AAA No

BEFORE THE

AMERICAN

ARBITRATION ASSOCIATION

North American

CourtofArbitration forSportPanel

UnitedStatesAnti-Doping

Agency,

Claimant,

Floyd

Landis, Respondent.

RESPONDENT

LANDIS'

PRE-TRIAL BRIEF

AAA

No. 30

190

00847 06

L

INTRODUCTION

Thiscaseisabout

one

thingonly

-

whether

theUnitedStates

Anti-Doping

Agency

("US

ADA")

has

proven

toacomfortablesatisfactionofthepanelthat

Floyd

Landis

committed

a dopingviolationduringStage 17ofthe

2006 Tour

de France("Tour").

The

comfortablesatisfactionstandardisa sliding scale that

depends

on

the seriousnessofthe allegationbeing

made.

Thisinquirythusbeginswiththeseriousness

of

theallegation,

which

standsatthecrossroadsofthe

most

prestigious professional bicyclerace,an

important junctureinanti-doping

and

a turningpointin

Mr.

Landis'life

and

career.

The

Tour

isthe

crown

jewel

of

professional cycling.

The Tour

is

one of

the

most watched

sportingevents

on

earth.

Never

beforehasa

winner

ofthe

Tour been

accusedof

violating adopingoffenseduringtheTour.

Never

beforehasthe anti-dopingsystem

been

subject to as

much comment

and

review.

The

result

of

thisinquiry

means

everythingto

Mr.

Landis,

whose

reputation, livelihood

and

yearsof

work

to

become

Tour

Champion

are

on

theline. Thisinquirythus

demands

a standard of proof veryclose to the

"beyond

a reasonable doubt"standard.

USADA

does not

meet

thishigh

burden

becauseitcannot.

The

analytic

and

procedurallaboratory errors inthiscase violate the International

StandardforLaboratories("ISL"),applicable

World Anti-Doping

Agency

("WADA")

Technical

Documents,

InternationalStandardsOrganization("ISO"),Standard Operating

Proceduresof

LNDD

and

other standardsofbest practices.

Taken

individually,

and

in

combination, they bar

USADA

from

establishing that

Mr.

Landis

committed

any

doping

violation.

They

include:

°

Violations

of

rulesregardingchain

of

custody; °

Violations

of

rulesregardingthepreparation

of

laboratory

documents

;

°

Violations

of

rulesrequiring

more

stringentproceduresbe usedin

GC-MS

confirmation than

GC-MS

screening; °

Violations

of

rulespreventingwrongfullyidentifying

compounds

inthe

GC-MS

process; °

Violations

of

rulesregardingrunningcalibrationcontrols

and

verifying calibrationcurvesin

GC-MS

testing;

°

Violations

of

rulesregardingrunningtests

on

degradedurinesamples;

°

Violations

of

rulesprohibitingmatrixinterferencein

chromatograms

inthe

°

Violations

of

rules requiringthe validationofpositivitycriteriafor

GC-C-IRMS

testing;

°

Proceduresthat create theabsurdresult thattheallegedadverseanalytic finding in the

GC-C-IRMS

testing

would

bepositiveatLabaratorie Nationalde Depistage

du

Dopage ("LNDD")

butnotpositiveat

many

other

WAD

A-accreditedlaboratories;and,

°

Violations

of

other rulesregardinglinearity,maintenance

and

operationof

testingequipment,stability

and

performance oftesting.

It iscriticaltorecognizethatthiswealth

of

errorspresentsacohesivepictureofa dysfunctional laboratory operating inaincompetent

manner

overall.1

One

or

two

errors,

oreventhreeorfour errors

may

indicatethekindsof mistakesthatare explainable.

What

makes

thiscase deeplytroublingisthebreadth

and

scopeof mistakesthatrenderallofits laboratory resultswithrespect to

Mr.

Landis'performance

on

Stage 17utterly

meaningless.

Adding

totheweight

of

thelaboratoryerrors,

USADA's

and

LNDD's

ultimate accusation

-

that

Mr.

Landis tooktestosteroneduringthe

Tour

- makes

no

senseatall.

Testosteronehas

no

shorttermbenefit,

and Mr.

Landis

knew

it. Hisperformance

on

Stage 17

was

the result

of

a carefully crafted strategy to

win back

theleadershipofthe

Tour

-

at

which

point

he

knew

he

would be

subject todopingtests.

Mr.

Landis'total

1

The

exhibits inthiscaseareorganizedas follows. Discovery pages providedto

Mr.

Landisthatbegin withthe

USADA,

WADA,

LNDD

and

AFLD

bate-stamp

numbers

will

be

referred to

by

the prefix

and

number

(forexample,

USADA0001

is referred to asExhibit

USADA0001).

Additional

documents and

exhibits willbegin withtheprefix

GDC

followed

by

a

number.

Thisexhibit

numbering

sequencewill

testosterone leveldid not exceedthe

amount

normalfor

Mr.

Landis over

many

times

he

has

been

tested

-

his testosteronereadings

were

completely normal.

Mr.

Landis'

performance

on

Stage 17

was

entirelywithinhisathletic abilities

-

as

shown

by

his

historicaltraining

and power

data. Lastly,

and

perhaps

most

inlinewith

common

sense,

inorderfor

Mr.

Landisto

have committed

adopingoffensewith a drugthat

would

not

help

him

inan

amount

too smallto matter,

he

would have

violatedthe principlesof honesthard

work

and

sacrificethatput

him

insecond placeinthe

Union

Cycliste International

Rankings

atthestart

of

the

2006

Tour.

Inresponse,

USADA

struggles toshoveasquare

peg

intoa

round

hole

by

pointing

toareas

where

LNDD

actuallydidthings properly.

Many

ofthesearguments,as will

be

shown,aresimply nottrue.

For

example,

USADA

contendsthat

Mr.

Landis'adverse

analyticfindings

would be

positive

by any

criteria. See

USADA's

PretrialHearingBrief,

at58.

Not

true.

UCLA's

anti-dopinglaboratory, Australia'santi-doping laboratory

and

Cologne'santi-doping laboratory

would

notconclude

Mr.

Landis'confirmationcarbon

isotoperatio test

was

an adverseanalytic finding. Othersareunsupported

by any

authority. Seeid.at32-48(citingtoevidenceinviolation

of

the Panel'sprocedural

orders). Appropriate motionstostrikewillbefiled.

At

other places,ithas simply ignored

where

LNDD

grossly erred

-

and

failstoaccountfortheholistic

incompetence

describedabove. Seeid.at

66

(attemptingtojustify,withoutbasis,the rulesprohibiting testing inthepresence

of

degredation

of

sample). Indoingso,

USADA

missesthe

mark

-

ithastheburden of proving comfortablesatisfactiontovery high standardfor

LNDD's

results.

Simply

defendingitself

by

pointing to alleged areas

where

LNDD

performed

work

properly(or criticizing portionsof

Mr.

Landis1

briefdesignedtoalertthepanelof

issues that justify additional discovery)simply

do

not,

and

should notsuffice.2

Pursuantto thetelephonicstatusconferenceofApril 24,2007,

Mr.

Landiswill

furthersupplementthisbrief

upon

thereviewoftheStandardOperatingProcedures

and

thedata

from

theforthcomingelectronicdatafiles.

Even

withoutsuch supplementation,

US

ADA

has demonstratedthatithasfaileditsburden of persuasion becauseitcan not

meet

it.

Mr.

Landis

won

the

2006 Tour

fair

and

square, as will

be

proven

atthearbitral

hearing.

II.

STATEMENT OF

FACTS

A.

FACTUAL

OVERVIEW

Floyd Landis

was

born

and

raised in Farmersville,Pennsylvania

and

was

raised as

a

Mennonite

inan areathatwas,

and

still is,a predominately

Mennonite

community.

Traditional

Mennonite

values

of

modesty, devotiontofaith,honesthard

work

and

selflessness

were

instilledin

him

and

his fivesiblings.

Mr.

Landisfirstlearnedto ridea bicycle forsimpletransportation

and

recreation,buthe soon displayed

enormous

natural

talent.

He won

thefirst

mountain

bikerace

he

entered,

and

in1993,

was

crowned

junior

nationalchampion.

Soon

afterwards,hestated that

he

would win

the

Tour de

France

one

day.

He

continuedtorace

from

thattimeuntilhis resultsattractedthe attention

of

the

UnitedStates Postalteam,

where he

helped

Lance Armstrong

win

three straight

Tour

de

Francevictories,

from 2002

to2004. Hisnativetalentforclimbing mountains

-

apure

indicator

of

strength

and power

-

led the

Phonak team

tosign

him

asaleader inJanuary 2006.

By

July2006,

Mr.

Landis

was

experiencingthebestseason

of

his career,eachrace

showing

a steady progression

of

skill

and

strength,built

upon

theathletic

prowess

built

while with UnitedStates Postal

team and team

Discovery.

By

thetime helined

up

to

startthe

2006 Tour

deFrance("Tour"),he

had

already

won

the

2006

Amgen

Tour of

California,the

2006

Paris-Nice

and

the

2006 Tour

de Georgia.

He

stoodinsecond place inthe

UCI

ProTour

standings.

On

July 23,2006,

Mr.

Landisfinishedthe

20

thstageofthe

2006 Tour

deFranceas theyellowjerseyholder3

and

leader

of

theGeneralClassification

by

57seconds.

During

theTour,

Mr.

Landis providedurinesamplestothe

UCI

on

thefollowingdates: July4,

11,13, 14,18,20,22

and

23,2006.4 SeeExhibits

USADA

0412, 0419, 0426, 0433,

0440,0447, 0458, 0465. All

of

theurinesamples provided

by Mr.

Landis duringthis

period

were

testedat

LNDD.

SeeExhibits

USADA

415, 422,429, 436, 443, 451,461,

and

468.

On

July 25,2006,

LNDD

notified

CPLD

and

the

UCI

thatitstest

of

the

A

3

The

yellowjerseyisgiventothe cyclistinfirstplaceinthegeneralclassification.

4

Sample from

the

specimen

taken

from Mr.

Landis

on

July

20

("Stage17Sample")

displayed an

Adverse

Analytic Finding ("AAF"). SeeExhibits

USADA

188, 199.

On

July 27,2006,

USADA

notified

Mr.

Landisofthe

AAF

and assumed

prosecution ofthismatter. SeeExhibits

GDC000

1-0003. Inits

communication

to

Mr.

Landis,

USADA

indicated that

he

couldeither request the testingofthe

B

Sample

or

simply acceptthe

AAF

from

the

A

Sample of

theStage 17 Sample.

Mr.

Landis refused

toacceptthe

AAF

from

the

A

Sample and

elected to

have

the

B

Sample

tested. See

Exhibits

GDC0004-0005.

Between August

3and5,2006,

LNDD

conducteditstesting

of

the

B

Sample from

theStage 17 specimen. SeeExhibits

USADA

0365, 0366.

LNDD

eventuallyconcludedthat the

B

Sample

confirmedthe

AAF,

usingits

Gas

Chromotography/Combustion/Isotope Ratio

Mass

Spectrometry

("GC/C/IRMS"

or

simply

"IRMS")

instrument. SeeExhibits0365, 0366.

On

August

5,2006,

LNDD

notified

Mr.

Landis,

USADA,

the

AFLD,

the

UCI

and

the

media of

itsfindings. See Exhibit

GDC0006.

On

September

11,2006,

Mr.

Landisfiledpleadings before

USADA's

Anti-Doping Review

boardinorderto

have

thiscase dismissed. SeeExhibits

GDC0007-0022.

On

September

18,2006,the

Anti-Doping Review

boardrejected

Mr.

Landis'

petition,

and

the instantlitigationbegan. See Exhibit

GDC0023.

B.

STAGE

17

SAMPLE

TESTING

CHRONOLOGY

USADA's

Briefcontainsadetailed descriptionconcerningthe collection

and

transportationoftheStage 17 Sample, withspecificdetail

on

the collection

and

however,isacorrespondinglydetailed descriptionofthechronologyoftheStage17

A

and

B

samplesonce theyarrivedat

LNDD.

1. July20,

2006

Mr.

Landis'Stage17

A

and

B

samples

was

received

by

LNDD

at21:35. See

Exhibits

22 and

24.

According

to

LNDD

records,at22:15the

A

bottle

was

placedinthe

refrigerator

and

the

B

bottle

was

placedinthe freezer. See Exhibit

USADA0253.

2. July21,

2006

At

7:35, L.Martin("Martin")

removed

the

A

bottle

from

therefrigerator.

At

8:10,

Martin preparedthe aliquot for the

EPO

test. See Exhibit

US

ADA025

3.

Between

8:10

and

9:10,

LNDD

has

no

documentation concerningthe intra-laboratory transfer

of

the

A

bottlethatoccurred

between

Martin

and

Garcia.

At

9:10,Garcia preparedanaliquot for

the

T/E

test. See Exhibit

USADA0253.

At

9:25, the

A

bottle

was

placedinthe

refrigerator. See Exhibit

USADA0253.

At

9:40, the

T/E

aliquot

was

sent toachemistry

laboratory. See Exhibit

USADA0255.

The T/E

chemistry

workup,

describedlater,lasted

from

9:40to 14:45. SeeExhibits

USADA0037-0039,

0043.

The T/E

or

GC/MS

test

(describedbelow)

was

preformedat19:36

by

Galatola,

and

was

monitored

by

Cerpolini.

Exhibit

USADA0255.

At

an

unknown

time,Cerpolinireadthe

T/E

data. Exhibit 0054.

3. July22,

2006

At

9:25, Cerpolini

removed

the

A

bottle

from

therefrigerator. Exhibit

USADA0253.

At

10:50,Cerpolini created thefirstconfirmation

T/E

aliquot. Exhibit

USADA

0253.

At

11:02,thefirstconfirmationaliquot

was

sent to chemistry. Exhibit

was

performed

by

Cerpolini. Exhibit

USADA0200.

At

1 1:20,

Mongongu

prepareda

GC-C-IRMS

(describedbelow)aliquotusingthe

A

bottle.

Once

again,

LNDD

has

no

documentation concerningthe intra-laboratory transferofthe

A

bottle

between

Cerpolini

and

Mongongu

thatoccurred

between

10:50to11:20.

At

1 1:25,the

IRMS

aliquotis

takento thechemistrylaboratory

by

Mongongu.

Exhibits119-120.

The

IRMS

aliquot

was

atchemistry

from

11:25 to 19:40,

which

is

performed

by

Mongongu.

Exhibits

USADA01

19-0120.

At

12:40, Cerpoliniplacesthe

much

traveled

A

bottleinthe

refrigerator. Exhibit

USADA0253.

At

18:02, thefirst

A

confirmation

T/E

testis

conducted. Exhibits

USADA020

1-0205.

4. July23,

2006

From

9:05 to 14:25, the

IRMS

aliquot

was

inchemistry,

which

was

performed

by

Mongongu.

Exhibits

USADA0

120-0121.

At

14:30, the

A

bottle

was

removed from

the refrigerator

by

Cariou,

and

at15:00the

second

A

confirmation

T/E

aliquotis

made

by

Cariou. Exhibits

USADA0253,

0256.

Yet

again,

LNDD

has

no

documentation concerningthe location orhandler

of

the

A

bottle

from

15:00to 17:00.

From

15:10to

17:25thesecond confirmation

T/E

aliquotisinchemistry,

which

was

performed

by

Cariou. Exhibit

USADA0079.

At

17:00,while Cariou

performed

thechemistry

on

the

second

T/E

aliquot,Cariou returnedthe

A

bottle to therefrigerator. Exhibit

USADA0253.

At

21:23

Mongongu

readthedata

from

the

IRMS

test. Exhibits

USADA0

155,0185-0186.

5. July24,

2006

Sometime

before8:20, Cerpolini

removed

the

A

bottle

from

therefrigerator.

Exhibit

USADA0253

.

At

8:20, Cerpoliniplacedthe

A

bottle in thefreezer. Exhibit

USADA0253.

From

9:10to 10:54,chemistry continued

on

thesecond

T/E

confirmation test

by

Cariou. Exhibit

USADA0079.

Sometime

after12:54, Cerpolinireadthedata

from

thefirstconfirmation

T/E

test. Exhibits

USADA02

12-0215,0223.

At

13:28, the

second

T/E

confirmationtest

was

conducted. Exhibit

USADA0256,

0080-0084.

At

17:15, thesecond confirmationdata

was

read

by

Cerpolini. Exhibits

USADA0092-0093,

0101.

6. July25,

2006

At

atime

unknown

based

on

thedocumentation, Buissiou re-conductedeither the firstorsecond

A

T/E

confirmationaliquotusingthescreen method. Exhibits

USADA

0057-0059.

7. July28,

2006

Thereis

no

documentation concerning

when

the

B

bottle

was removed from

freezer3,

by

whom

the bottle

was

removed,

and where

the bottle

was

locatedafterit

was

removed.

At

15:45, the

unknown

operatorreplacedthe

B

bottle in freezer5. Exhibit

USADA

0254.

8.

August

3,

2006

At

9:12, the

B

bottle

was

removed from

the freezer

by

Cerpolini. Exhibit

USADA025

1.

At

11:03,Frelat creates the

B IRMS

aliquot. Exhibit

USADA0254.

LNDD

has

no

documentation concerningthe intra-laboratorv transferofthe

B

bottle

from

Cerpolini to Frelat

which

occurred

sometime between

9:12and11:03.

At

11:05,

Barlagnecreatesanaliquot for the

B

T/E

test. Exhibit

USADA0254.

LNDD

has

no

documentation concerningthe intra-laboratory transferofthe

B

bottle

between

Frelat

and

Barlagne.

From

11:26 to 18:05, the

B IRMS

aliquotisin chemistry,

which

isperformed

by

Frelat. Exhibits

US

ADA0299-03

00,0106-0109.

From

11:45 to 16:25, the

B

T/E

aliquotisatchemistry,

which

is

performed

by

Barlagne. Exhibits

USADA0264,

0074-0076.

At

19:45, the

B

T/E

testisconducted. Exhibits

USADA0256,

0265-0268, 0272.

9.

August

4,

2006

At

7:39, the

B

T/E

testdata

was

read

by

Barlagne

and

Cerpolini. Exhibits

USADA0269-0271,

0277-0284, 0288. Frelatcontinuedtoperform chemistry

on

the

B

IRMS

aliquot

from

9:16to 16:40.

At

17:00Frelatconductedthe

IRMS

test. Exhibit

USADA0302.

At

a time

unknown,

Frelatreadthe

IRMS

data. Exhibits

USADA035

1-0352.

III.

TESTOSTERONE

DID

NOT

AID

MR.

LANDIS

IV.DURING

STAGE

17

A.

TESTOSTERONE

1. Testosterone

Generally

Testosteroneisa steroid

hormone

withinthe

human

body

naturallyoccurringin both

men

and

women.

In

men,

testosteroneis

produced

by Leydig

cells,

and

primarily secreted

by

thetestes. Exhibits

GDC0034-0053.

Testosteroneperforms

many

critical

bone

and

muscle

mass and

secondary sexualcharacteristicsTestosteroneisderived

from

cholesterolthrough aseriesof enzyme-regulatedsteps. SeeJ.

Kraemer

and A.

D.

Rogol,

The

Endocrine

System

in Sports

and

Exercise,at526-28. Aftersynthesis,testosteroneis secreted into thebloodstream.

The

effectsoftestosteroneafterbeingsecretedinthebloodarecomplicated. See

id.

2.

Short-Term

Testosterone

Use

Has

No

Effect

On

A

Cyclist's

Performance

Acute

orshort-termadministration

of

testosteronehas

no

known

effect

on

athletic performance. Dr.

Gary

Wadler, a

member

of

the

World

Anti-Doping

Agency, and

a

member

ofthatorganization's"prohibitedlists

and methods"

committee,aswellasa

spokesman

forthe

American

CollegeofSports

Medicine

opinedinaninterview that

LNDD's

Stage 17results

do

not"addup." SeeExhibits

GDC0054-0055;

GDC0056-0061.

According

toWadler, one-time use

of

steroidscouldresult inan

abnormal

test,but

would

have

had

no

effect

on performance and

could not accountforLandis'

win of

the

Tour

orof Stage 17 oftheTour:

Steroidscanincrease strength

and improve

recovery time

and

preventthe

breakdown of

muscle,

maybe make him more

assertive

and

aggressive.All ofthosecould

have

some

positiveattribute.

But

most

steroidsaregivenin cycles [6-12

weeks] and

incontext

of

working

outina

gym

withweights.

It

makes

no

senseto

me why

an

athlete

would

take testosterone the

day

of a race

when

itdoesn't

work

that

way.

Itdoesn't

make

sensein

terms

of the

pharmacology

of the drug,

and

itreallydoesn't

have

the

attributesthat

would

be

attractivetoacyclist

~

particularlyone running

The

performance-enhancingeffects

of

testosterone areerroneously

assumed

tobe

well-established;however, sucheffectsare,infact,controversialinpopulationsof

normal

men.

SeeExhibits

GDC0062-0063.

In1996, a studyfoundthatthe

common

perceptions that testosteronepromotes endurance

was

foundtobeunsubstantiated. See

Exhibits

GDC0272-0278. More

recentreviewsreiterate thispoint: testosterone'seffects, ifany, are

most

likelytobe observedinpopulationsofhighly trained athletesperforming

strength taskslikeweightlifting,not

endurance

taskslikecycling,

and

only thenafter

supraphysiologicdosesovera period

of

weeks. Exhibits

GDC0249-0271.

Further,thereissignificantliteraturethat inaddition to testosteronebeinga dose-dependentsteroid,thereisathreshold

amount

that

must

be administeredinorderto

observeanyeffectatall. Indeed,a studypublishedin

2001

foundthat50

mg

of

testosterone,thoughtatthetimetobe doublethe naturalreplacementlevel,administered

over a

20

week

perioddidnotresult in

any

meaningfuleffect. See Exhibit

GDC0279-0288.

A

2004

study

found

thattheconclusionsinthe

2001

study

had

not

be

contradicted

by

anylaterstudy.

Although

thereisliteraturethatsupportsthecontention that testosteronecan

increaselean

muscle

mass,therehas

been

no

studythathasfoundthese effectswithless thansix

weeks

of high dosetestosteroneadministration. Notably,

no

increasesineither

body

weightorlean

muscle

mass

was

seen

where

testosterone

was

only takenforthree

weeks. Also,

even

with prolongedadministration, thereis

no

guaranteetosee

meaningfuleffects.

One

studyfailedtonote

an

increaseinmuscle circumference even

Most

importantly, the

2004

study againconcludedthatthere

was no

evidencetosupport

thecontentionthat testosteroneuse hasany impact

on

endurance

and

recovery.

3.

Floyd

Landis'Testosterone

Was

Normal

USADA

attempts todemonstratethat

Mr.

Landislongitudinal

GC/MS

values

show

adopingviolations. See

USADA

Pre-HearingBrief,at125.

Without

conceding

the validity

of

thisflawedstudy,allitreally

shows

isthat

Mr.

Landis' testosterone

on

Stage 17

was

verysimilar to his testosterone levels

on

other stages.

B.

STAGE

17

WAS

NOT

A SUPERHUMAN PERFORMANCE FOR

FLOYD

LANDIS

During and

afterthe

2006

Tour,

commentators

opinedthat

Mr.

Landis'

performance

on

Stage 17

would

not

have been

possiblebutfortheuseofa

performance-enhancingdrug. Aside

from

thefacta singleuse oftestosteroneisnotperformance enhancingand, contrary to those allegations,

Mr.

Landis'

performance

during Stage17

was

notatallunusualfor

Mr.

Landis.

Not

onlydidhe enjoyspectacularsuccessthrough

2005 and

thefirsthalfof 2006,

Mr.

Landis rode

many

of those eventsin

2005 and

2006

witha

power

meter.

The

data

from

that

power

meter demonstratesthat

from

astatistical

perspective, hisperformance

on

Stage 17

was

entirelyconsistentwithhispast

achievements.

1.

How's

Power Measured?

Beginning

in2003,intraining

and

incompetition,

Mr.

Landis usedadevicecalled

the

"PowerTap."

The PowerTap

devicereplaces the rear

hub and

axleofthe bicycle,

and

from

the

PowerTap

issent wirelessly

from

the rear

hub

toan output device

mounted on

the handlebars. Afterthe riderhas completedhis orhertraining or race, the data

on

the

output device caneasilybe

downloaded

ontoa

computer

for analysis.

2.

What

Does

Power

Data

Mean

toa Cyclist

Power

dataisan importantconsideration in training

and

competition because

power

isafunctionof

how

hard

and

fastacyclist pedals. Further,

power

dataisan

objective

measure

ofexercise intensity

and

adirectdeterminant

of

physical performance.

Once

theinformation

from

the

PowerTap

deviceis

downloaded,

several metricscan

be

analyzed.

These

metrics includeintensity,

5

totalenergy expended,6distributionof

intensity,7

and peak power

outputforany given

segment of

time.

Mr.

Landis usedthe

PowerTap

device during Stage 17

and

thefollowingdata

was

measured: Intensity

was

281 watts; Total

Energy Expended

was

5,456kilojoules;

Time

at lactatethreshold9

was

162 minutes;

Time

above

lactatethreshold

was

43 minutes; Five

5 6

Intensityistheaverage

power

used duringthe ride

measured

inWatts.

Totalenergy

expended

is

synonymous

withthe

amount of

work

performed by

the

cyclist,

and

is

measured

in Kilojoules.

7

The amount of

timespentbelow,at,

and above

thelactatethreshold.

8

The

highest

power measurement

for either a5, 10,or

30 minute

period. 9

Lactateisaby-product of anaerobic metabolism.

During

light

and

moderate-intensity exercise, theblood concentration oflactateremains low,

and

the

body

isable to

absorblactate fasterthanthe

muscle

cellsareproducingit.

However,

as exercise

intensity increases, there

comes

a pointat

which

lactate

removal

failstokeep

up

with

the rate

of

lactateproduction.Thispointisreferred to as thelactatethreshold (LT).

Excessive bloodlactate

and hydrogen

ion concentrations

combine

tointerferewith [Footnote continued

on

next page]

Minute Peak

Power

was

451watts;

Ten Minute Peak

Power

was

431watts;

and

Thirty

Minute Peak

Power

was

401watts. This

power

data

from

Stage 17 appearsasfollows:

previouslyduplicated or betteredintraining

and

racing. Indeed,foreachindividual

metric,there are severalpreviousraces in

which Mr.

Landis

exceeded

thedata

from

Stage17.

Mr.

Landis

began

usingthe

PowerTap

devicein2003.

Mr.

Landis,

and

his

coaches,however,didnot

download

thedata

from

thedeviceonto a computer. It

was

not

until2005,after

Mr.

Landisleft

Team

Discovery

and

hiredaspecific

power

coach, that

Mr.

Landis'

power

data

was downloaded from

the

PowerTap

deviceintothecomputer.

There

areeighty-oneotherdata points

from

variousraces in

2005 and 2006

thatcanbe

compared

to theStage17data.

Comparing

thesedata points to thedata

from

Stage17,itisevidentthatthereis

nothing remarkableaboutthe

power

exerted

by Mr.

Landis during Stage17.

Out

ofthe

eighty-onedata points

Mr.

Landis

had

an averageintensity

of

more

than281wattsinsix

rides. In otherwords,seven percentof

Mr.

Landis' rides

were

more

intensethan Stage

17. Further,

Mr.

Landisexerted

more

totalenergy than

he

didduring Stage17

on

eight

otherrides. That

means

that intenpercent

of

Mr.

Landis' rides in

2005 and

2006,

Mr.

Landis exerted

more

totalenergy thanhedidduringStage17.

Comparing

the

peak

power

outputforany given

segment measurements

followa

similar pattern.

Mr.

Landis has elevenrides,or fifteen percent, in

which

his fiveminute

peak

power

outputisgreaterthan during Stage 17.

And, Mr.

Landis hassixrides,or

sevenpercent,in

which

histenminute

peak

power

isgreaterthan during Stage17.

The

most

telling

comparison between Mr.

Landis'pervious

power

data

and

Stage

the

amount

of timeat lactatethreshold

was

greaterthaninStage17.

And, most

critically,

in

20

otherrides,

Mr.

Landisspent

more

time

above

hislactatethreshold levelthanin

Stage17. Indeed,intwenty-nine of

Mr.

Landis'otherrecordedrides,hespent

more

time

above

hislactatethresholdlevel.

Accordinglythesecomparisonsestablish that

Mr.

Landis'performance during

Stage 17

was

not superhuman.

C.

PURE

POWER

DOES

NOT WIN

RACES

Innon-timedevents

and

steep climbs, thereisastrong disassociation

between

power

output

and

race placing. Inthesetypes

of

races,overallracetacticsplayavital

role.

For

instance,theprotected

team

captainexpendstheleast

amount

of energy but

places thehighestatthe

end

ofthe day.

Thisisfurtherexemplified

by comparing

the

power

data

and

race finish

between

Mr.

Landis

and

anotherrider,WillFrischkorn,duringthe

Brasstown Bald

Stageofthe

Tour of

Georgia.

Mr.

Frischkorn's

power

data

was

farsuperior to Floyd's;

Mr.

Frischkorn'sintensity, totalenergyexerted

and

distributionofintensityexceeded

Mr.

Landis.

Power,

however, does not

win

races;

Mr.

Frischkorn

ended

the stagein79th

1.

Mr.

Landis

1

Stage 17

Win

Was

The

Result of

Superior

Race

Tactics

and

Strategy

Mr.

Landis,

and

hiscoachingstaff,devised aspecificstrategy tosucceed

on

Stage

17. Thisstrategy

was

designed not simplyto

win

Stage17,buttoput

him

back

into

contentionto

win

theTour. Essentially,

Mr.

Landis decidedtochallengethepeloton

on

thefirstclimb

and

seeifthey

would

chase.

Mr.

Landis

assumed

thatthe three leaders

would

not chase

him

because they

would

thinkthathe could notsustainthepace throughouttheStage withouthisteam's support.

By

breaking outearly,

Mr.

Landis

createda"civil

war"

among

the leadersbecause

none ofthem wanted

to

expend

his

team'sresourcesto catchhim. Moreover,

Mr.

Landis

knew

thatif

he paced

himselfat

360

to

390

watts

on

the climbs,he

would be

able to sustain the leadduringthe Stage.

Additionally, since

Mr.

Landis

had broken

away

from

the peloton,he

was

able to

have

hissupportvehicle ridenextto

him

during

most

ofthe stage.

By

havinghissupport

vehicle insuchclose range,Mr. Landis received seventybottles

of

water, three to four

times

more

thanthecyclistsinthe peloton. In addition to thehydrationeffects,Stage17

was

a

warm

day and Mr.

Landis kepthis

body

cool

by

dosingitwithicecoldwater.

Accordingly,

Mr.

Landis'performance

on

Stage17

was

well within

Mr.

Landis' otherperformances

and

hissuccessduringtheStage

was

adirect result

of

superior strategy

and

tactics.

V.

ARGUMENT

A.

USADA'S

BURDEN

OF PROOF

The

standard

of

proofinananti-dopingcaseisa multi-stepprocess witha shifting

burden.

The

steps are as follows:

First, the

Anti-Doping

Organization, inthiscase

US

AD

A,

"shall

have

the

burden

of

establishingthanan anti-dopingruleviolationhasoccurred." See

UCI

Cycling

Regulations, Art. 16,exhibits

GDC0070,

see also the

World Anti-Doping

Code,Art.3.1,

exhibit

WADA0453-0496

(The

languageinboththe

WADA

Code

and

Art 16are identicalexceptfor the substitutionof

"UCI and

itsNational Federations"for

"Anti-Doping

Organizations). Inthiscase,

USADA

seeks to establishitsburden

by

thealleged

adverseanalytic findings

of

boththe

GC-MS

tests

and

the

GC-IRMS

tests

from

Stage 17 ofthe

2006

Tour.

Once

USADA

introducesevidenceof an adverseanalytic finding, the

resultsare

presumed

correctbecause"

_{WADA-accredited}

_{laboratories ... are}

presumed

to

have

conducted

Sample

Analysis

and

custodialproceduresinaccordance withthe

International

Standard

for laboratory analysis." See

UCI

Art. 18,exhibit

GDC0071.

10

10

USADA

asserts

-

without

any

authorityatall

-

thatthispresumptionis"supported

by

thefactthat

one of

WADA's

core responsibilitiesistomonitorthe labs..."

Because

itisunsupported

by any

citationorlogic,

USADA's

editorialshould

be

ignored.

Second,

Mr.

Landisisentitledto rebutthispresumption

by

establishing that a departure

from

the InternationalStandardoccurred. See

UCI

Art.18,exhibit

GDC0071

("The Rider

may

rebutthispresumption

by

establishing that a departure...occurred"),

see also

WADA

Code

Art.3.2.1,exhibit

GDC0453-0496.

The

standardof

proof

by

which Mr.

Landis

must meet

thisstandardis

by

a"balance ofprobability." Seeid. ("the

burden of proof

upon

theAthlete...shallbe

by

abalanceofprobability").

Third, oncethatpresumptionisrebutted

by

a

showing

of sucha departure,then

USADA

shall"havethe

burden

toestablishthatsuchdeparture didnotcausethe

Adverse

AnalyticalFinding...."

WADA

Code

Art.3.2.1,exhibit

GDC0453-0496.

In establishingitsburden,theapplicable rules require that

USADA

must

present

evidenceofadopingviolation to the"comfortablesatisfactionofthehearing

body

bearingin

mind

the seriousnessofthe allegation

which

ismade." See

UCI

Anti-Doping

Regulations, Article16,exhibit

GDC0070,

and

Article3.1 ofthe

World Anti-Doping

Code,exhibit

GDC0453-0496.

The

CourtforArbitrationof Sportin

USADA

v.

Montgomery (CAS

2004/O/645),atpp. 13-14, exhibit

GDC0148-0149,

has definedthe

"comfortablesatisfaction"

burden

asa sliding scale

of

probabilitydepending

on

the

seriousnessofthe allegation.

The

CourtforArbitrationofSport explicitly statedthat:

Inallcasesthedegreeofprobability

must be commensurate

with

and

proportionate tothoseallegations;the

more

seriousthe allegationthehigherthe

degree

of

probability,or'comfort',required.

Id.(emphasisadded). Thus,accordingly, inlight

of

the

UCI

and

WADA

rules,

and

the case law,

when

the allegationof dopingisminor,theanti-doping organization

must

presentevidencethat establishesthat,

more

likelythannot,thedopingviolationoccurred.

When

the allegationof dopingisserious,however, an evengreater probabilityofthe violation

must

beshown.

The

rationale forthisheightened burdenisthat"the

more

serious the allegation thelesslikelyitisthatthe allegedevent occurredand,hence,the stronger theevidence required beforetheoccurrenceoftheeventisdemonstratedto

be

more

probable thannot....

The

gravityofthe allegations

and

the related probability or

improbabilityoftheiroccurrence

become

ineffect part

and

parcel

of

thecircumstances

which must be weighed

indeciding whether,

on

balance,theyaretrue." Id.

Inthiscase,giventheseriousness

of

the allegations,

US

ADA

must be

heldtothe

most

stringentburden permitted

by

therules.

The

factorssupportingthe seriousness

and

gravity

of

the allegations are as follows:

1

.

the allegationsinvolvethe

crown

jewelofprofessional cycling, the

Tour

de

France;

2. the allegationsinvolvea sportingeventthatattractsworld-wideattention

and

participation;

3. the allegationsinvolvenotjusta participantinthe

Tour

deFrance,butthe

winner of

theTour;

4. thiscase involves thefirsttimeinhistory that thewinner

of

the

Tour

de France has

been

charged with a doping offensearisingduringtheTour;

5. the allegationsinvolvethe career, livelihood

and

reputationof

Mr.

Landis; 6. the allegations

have

verysubstantial financialimpact

on Mr.

Landis;

7. the allegations against

Mr.

Landis

have been accompanied by

a

media

campaign

inFrance, along withattendant leaksofthat information,see

GDC0324-0332,

that

have

attacked

Mr.

Landis' reputation; and,

8. the allegations

have

attracted international attention to the role

and

fairness

of

the anti-doping protocol.

To

establish the allegeddopingviolation here,giventheseriousnessofthe allegations,

US

ADA

should

be

heldto the

most

stringentburden permitted

by

therules.

No

othercasebroughtin theanti-doping case has

had

this

many

potential ramifications forthe athlete or for theanti-doping system. Pursuanttotherules,this

burden

must be

as

close to"proof

beyond

a reasonable doubt"as possible. See

Montgomery,

supra,atHI3,

exhibit

GDC0148

["From

thisperspective,

and

in

view

ofthenature

and

gravityofthe allegationsatissue in theseproceedings,thereis

no

practicaldistinction

between

the standardsof proof advocated

by

US

ADA

[comfortablesatisfaction]

and

the

Respondents

[beyondareasonable doubt]."]

Thus, although

US

ADA

isentitledtoaninitialpresumption,oncerebutted

by Mr.

Landis

showing any

deviation

from

any ISL

standard,

USADA

must

satisfyits

burden

to acomfortablesatisfaction,

which

in thiscaseisakintothat of

beyond

a reasonable doubt,thatthe deviationdidnot causethe

Adverse

AnalyticalFindingor that the

deviationdid not

change

theresult. Thisburdenisnoteasilysatisfied.

Inthiscase,as

Mr.

Landiswill

show

that there

were

numerous

suchdeviations,

none ofwhich

USADA

has

been

able todemonstrate

by any

standarddidnotcausethe

Landaluce,"[i]t isvirtuallyimpossibletoproveanegativefact."

CAS

2006/A/l119, p.

23,at1)1 11,exhibit

GDC0189

(translated

GDC0215).

B.

HOW

MANY

WAYS CAN LNDD BOTCH AN

ANTI-DOPING TEST?

The

testing for testosteroneisa

complex

procedurethatdoes notrely

upon

simply

identifying thepresence oftestosteroneinurine,butratherthe nature

of

the testosterone

inurine. See Ayotte,

C,

etal.,

GC/C/IRMS

and

GC/MS

in"NaturalSteroid Testing,

RADA(9)

(2001)("Testing for the administrationofnatural steroidsisa

complex

task requiring the identification

and

quantificationofa

number

of parameters

of

the steroid

profiles ")See Exhibit

GDC0024-0029.

LNDD

uses

two

differentteststodetermine whether aparticularsample

shows

evidence

of

testosteronedoping.

These two

testsare

the Testosterone/EpitestosteroneTest ("T/Etestor

GC/MS

test)

and

the

GC-C-IRMS

("IRMS")

test.

The T/E

testisconductedfirst,

and

onlyifthe

T/E

testisconsidered

positive, will the

IRMS

test

be

conducted.

LNDD,

however,failedtoconductthesetest

as required

by

the

WAD

A

rules.

Given

thetotalityofthe errors

and

WAD

A

rule

violations

committed by

LNDD,

USADA

can notsatisfyitssignificant ultimateburden

that these blatant deviations

and

failuresdid not,evenin theslightestfashion, affectits

test results.

1.

The Chain

Of

Custody

IsFatally

Flawed

Before

Mr.

Landis'addresses

LNDD's

failuresinthe administration

of

the

T/E and

CIR

testing, thispanelshould dismissthe anti-doping violation against

Mr.

Landis

because

LNDD

significantlydeviated

from

the

WADA

rulesconcerning chain

of

a.

Usada

Can

Not

Establish

Complete

Chain

Of

Custody

Beyond

A

Shadow

Of

A

Doubt

Thereareegregious

and

systematicbreaksinthechainof custodyinthehandling

of

Sample 995474

inboththe

A

and

B

samplebottleswhileat

LNDD

that significantly

undercutsthereliability

of

the

LNDD's

findings.

Having

an impeccable chain

of

custody

isnecessary"[t]oensurethatthe urine tested suffered

no

contamination, tampering,or mislabeling." Catlin,

Cowan, Donike

etal.,"TestingUrineforDrugs,"International

FederationofClinicalChemistry(1992),Exhibit

GDC0219-0232.

Indeed,pristinechain

of

custodyisof suchvitalimportancethat

WADA

ISL

5.2.2.2,exhibit

WADA

0079-0135,requires(1)thateachlaboratoryhaveinternalchain

of

custody proceduresto

maintaincontrol

of

and

accountforthesamples whileinthe laboratory

and

(2)thatthe

procedures

must

incorporateTechnical

Document 2003LCOC.

Exhibit

GDC0233.

Technical

Document

2003LCOC

requires, inpart,the following:

1• Thatthe laboratory

must

have documentationestablishinga

"continuous recordofindividualsinpossession

of

thesamples...

."

(emphasis added);

and

2. Thatthelaboratory

must

recordthatthe

sample

has

been

placedina

controlarea

whenever

thesampleisnotinpossession

of

a laboratory operator. Id.

Significantly,thechain

of

custody

must document

allintra-laboratorytransfers.

Catlin,

Cowan, Donike

etal.,"TestingUrineforDrugs,"InternationalFederation

of

ClinicalChemistry(1992),Exhibit

GDC0219-0232.

USADA

hasfailed toprovide

Mr.

Landis with

any

SOP

concerning

LNDD's

chain of custodyprocedures.

Given

that

no document

containing

LNDD's

chainof custody procedure

was

produced,

no

such chain of custody

document

can be used duringthe hearing. Procedural Order #2. Accordingly,

LNDD

isin direct violationof Technical

Document 2003LCOC.

Further,

USADA

hasfailed toprovidethe original

contemporaneous documents

that

would

supportthechain of custody

summary

reportprovidedindiscovery.

Without

those documents,the

summary

page

isnotsufficientto establishan "impeccable" chain ofcustody. Indeed,

USADA

admittedinitsPre-Hearing BriefthatExhibit

USADA0257,

a similarchainof custody

summary

reportregardingaliquots,isnotthe originalchain

of

custody

document and

was

prepared onlytoassistthe reader. See

USADA

Pre-Hearing BriefatExhibit

32A.

In addition toadmittingthatthis,

and

the other

summary

chain of custodyreports,

were

not

contemporaneous

chain

of

custody documents,

USADA

admits,

afterit

was

pointedout

by Mr.

Landisinhisdiscovery motion,thatthe

summary

report

containedseveralerrors.

Without

theunderlying supporting documentation,

USADA's

chain

of

custody

summary

report, Exhibits

USADA0253

and

0254, should

be

disregarded

as thereis

no

method

todetermineitsaccuracy.

Even

if

USADA's

non-contemporaneous

summary

reportisconsidered,

LNDD

systematically failed torecordintra-laboratory transfers

of

the

"A" and

"B"

sample

1

.

On

July21,2006,

LNDD

failedtorecord

who

removed

the"A"

sample

from

the refrigerator

and

when

heorshedidso. Exhibit

USADA0253.

2.

On

July21,.2006,

LNDD

failedtorecord

how

the

"A"

samplebottle

was

transferred

from

MartininSalle107toGarciainSalle 106,

when

thesample

was

transferred,

and where

it

was

transferred.

Exhibit

USADA0253.

3

.

On

July 22,2006,

LNDD

failedtorecord

who

removed

that

"A"

bottle

from

the refrigerator

and

when

it

was

removed. Exhibit

USADA0253.

4.

On

July 22,2006,

LNDD

failedtorecord

how

the

"A"

samplebottle

was

transferred

from

CerpoliniinS.103to

Mongongu

inS.104,

which

occurred

sometime between

10:50 to 11:20,

where

it

was

transferred,

and

when

it

was

transferred. Exhibit

USADA0253.

5.

On

July 22,2006,

LNDD

failedtorecord

how

the

"A"

samplebottle

was

transferred

from

Mongongu

in S. 104to Cerpolini

which

occurred

sometime between

11:20

and

12:45,

where

the transfer occurred,

and

when

it

was

transferred. Exhibit

USADA0253.

6.

On

July 23,2006,

LNDD

failedtorecord

who

removed

the

"A"

sample

bottle

from

the refrigerator,

and

when

the transfer occurred.

These

egregious

and

systematicerrorsoccurredinthehandling ofthe"B"sample

as well. Indeed, the

B

sample chain

of

custodyiseven

more

questionable.

1

.

On

July 28,2006,

LNDD

failed torecord

who

removed

the"B" samplebottle

from

the freezer,

and

where

thistransferoccurred.

Exhibit

USADA0254.

2.

On

August

3,2006,

LNDD

failed torecord

how,

where,

and

when

the"B"

sample

was

removed from

thefreezer.

And,

LNDD

failedto

recordthe transfersof

how, when, and where

the

B

samplebottle

was

transferred

from

Cerpoliniinan

unknown

location to Frelat in

S004,

which

occurred

somewhere between

9:12

and

11:03. Exhibit

USADA0254.

3.

On

August

3,2006,

LNDD

failed torecordthe transfer

of

the"B" samplebottle

from

Frelatin

S004

toBarlagneinS103. Exhibit

USADA0254.

The

severityof

LNDD's

systematicfailuretorecordintra-laboratory transfersis

apparent

when

compared

tothe

method of documenting

intra-laboratory transfersatthe

UCLA

and

Montreallaboratories. Exhibit

GDC0030-003

1isachain

of

custody

document from

theMontreallaboratory. This chain of custody

document

establishes the

time, date, person, or place,

who

had

the

sample

bottle,

and

the person, or place,

who

the

sample

bottle

was

given. Thisisin direct contrast to

LNDD,

which

simplyrecordsonly one-half

of

the intra-laboratorytransfer,i.e.,theperson

who

receivedthesamplebottle

and

nottheperson

who

providedthebottle.

LNDD's

chainof custody

documents

are in stark contrast to

UCLA's

chain of custody

documents

as well. Exhibit

GDC0032-0033,

contains

two

chainof custody

documents from

the

UCLA

laboratory. SimilartotheMontreallaboratory,

UCLA

recordsbothparties to the intra-laboratory transfer,which,unlike

LNDD,

createsa

continuous chain

of

custody.

In addition to thesystematicfailuretorecord bothparties to the intra-laboratory

transfers,

LNDD's

overallhandling ofthe

sample

bottles inthiscaseisdubious:

1

.

On

July21,2006,the

"A" sample

bottle

was removed from

the

refrigeratorat7:25

and

was

notreturneduntil9:25,

two

hourslater.

Infact,during those

two

hours, theonly

documented

taskcompleted

was

the creationofaliquots. See Exhibit

USADA0253.

2.

On

July 22,2006,the

"A" sample

bottle

was removed from

storage

at9:05

and

not returneduntil12:45,overthree

and

a halfhourslater.

During

these three

and

a half hoursthatthe

"A"

samplebottle

was

removed from

storage,the operators

who

purportedly

had

possession

of

the

"A"

bottle

were

conducting chemistryforboththe

T/E and

IRMS

tests. See Exhibits

USADA01

19-0120,0200.

3.

On

July 23,2006,the

"A" sample

bottle

was removed from

the refrigeratorat14:20

and

not returneduntil17:00,over2

and

half

hourslater.

During

thistime, the aliquot for thesecond confirmation

T/E

test,

which

was

theonly reasonfor

removing

the bottle

from

storage,

was

completedat15:00;yet,the bottle

was

not replaced

until

two

hourslater. SeeExhibits

USADA0079,

0253, 0256. There

is

no

explanationfor

why

the bottle

was

needlesslysittingaroundthe laboratory.

Breaksinthechainof custodyarefataltothereliabilityof

LNDD's

test results. In

fact,ina

1994

report tothe International

Amateur

AthleticFederation regarding

laboratoryprocedures,Prof.

Manfred Donike

stated that"[t]hechain

of

custody...

must

be impeccable beforea positive findingcanlead to sanctions." Thisdocumentation can

hardly

be

characterized asanimpeccable chain ofcustody. In addition tobeinglessthan

impeccable,

LNDD's

systematicfailureto include intra-laboratory transfersisin direct violation

of

the

WADA

regulation

and

WADA

Technical

Document

2003LCOC

concerning chainofcustody.

These

"breaks"inthechainofcustody, orcompletefailuretorecordthechainof

custody, constitute afatalflawinthe testingprocessthatcannotbe

overcome

by

USADA.

The

breaksinthechain

of

custody, asillustratedabove,obviate the

need

to

even

examine

thelaboratoryresults,asan impeccable chain

of

custodyisnecessary"[t]o ensurethatthe urine tested suffered

no

contamination, tampering,ormislabeling."

Catlin,

Cowan, Donike

etal.,"TestingUrineforDrugs,"InternationalFederationof

ClinicalChemistry(1992),Exhibit

GDC0219-0232.

Accordingly,thisPanel shouldfind that

USADA

has notsatisfiedits

burden of

establishingadopingviolation.

Furthermore,these errors didnot occurina

vacuum.

As

willbe discussedlaterin

this brief,giventhetotalityofthe errors that

LNDD

committed

whiletesting

Mr.

Landis'

that

Mr.

Landis

committed

ananti-doping violation. Here,itisimpossiblefor

USADA

to establish

by

a "comfortablesatisfaction,"giventhe blatant errors inthechainof custody

inconjunction with

LNDD's

other blunders, that these errors didnotaffect

Mr.

Landis'

test results.

2.

LNDD's

GC/MS

Testosterone/EpitestosteroneRatioTest:

A

Case

Study

In

Incompetence

a.

The Theory

of the

GC/MS

Test

The

initialtest

performed

by

LNDD

fortestosteroneistheTestosteroneto

Epitestosteroneratio test("T/Etestor

GC/MS

test").

The

theorybehindthe

T/E

testis thatthe urinary testosterone to epitestosteroneratioremainsrelativelyconstant

and

isnot

known

tobealtered

by

exercise. Exhibit

GDC0234.

The

administrationof

exogenous

testosteroneresults inanincrease intheconcentrationoftestosterone in the urine;

whereas,the epitestosterone levelsremain unchanged.

Id

Thus,the testosterone to epitestosteroneratioincreases.

Although

it

was

originallybelievedtheratioof

testosterone to epitestosteroneinurine in adultmales should

be

approximately1:1. In

fact,however,ratiosashighas 15:1 orhighercould

be

normal;conversely,

some

individuals naturally

have

low

urinary

T/E

ratiosthat

do

not

change

even withthe

administrationof

exogenous

testosterone.

See

exhibit

GDC0235-0246.

11

To

increase theaccuracy

of

the

T/E

test,thesample goes through aderivatization process. Derivatizationistheprocessin

which

the

hydroxy and

keto groupsofthe

compounds

tobetested

-

inthiscase,testosterone

and

epitestosterone

-

arereplaced withtrimethylsulfate.

The

purposeofderivatizationisto

make

themoleculeslarger

The

GC/MS

testis

performed

usinga

Gas Chromatography/Mass

Spectrometer

("GC/MS")

instrument,

which

identifiesdifferentsubstances withina urinesample.

The

GC/MS

instrumentcalculates the absolute levelsoftestosterone

and

epitestosterone

by

measuringthe areaundertheirrespectedpeaks.

The

ratio

of

testosterone

and

epitestosterone,however,is

measured

usingthe absolute values. Itshouldbe notedthat the

GC/MS

instrument cannotdistinguish

between

synthetic

and

natural testosterone

becausesynthetic

and

naturaltestosteronehasthe

same

retentiontime

and

mass.

b.

The

Operation

of the

GC/MS

Instrument

The

GC/MS

is

composed

of

two

major components:thegas

chromatograph

and

the

mass

spectrometer.

The

gas

chromatograph

isusedtoseparatemolecules

by

sendingthesemolecules throughatube coated witha

complex

hydrocarbons,a reactive substance.

Based on

the

chemicalproperties

of

eachindividualmolecule,themolecule

moves

throughthetubeat

differentspeeds.

The

amount

of time each moleculetakes to

move

thoughthegas

chromatograph

isconsideredthemolecule'sretentiontime. Separatingthemolecules permitsthe

mass

spectrometerportionofthe

machine

to evaluate themolecules

separately inorder to identifythem.

[Footnote continued

from

previous page]

and more

volatile,

which

allows

them

to

be

tested

more

easily

and

therefore

more

accurately. Incompletederivatization affectsthereliabilityofthetestresults.

The mass

spectrometer measuresthe individualmolecules

by

breaking each

moleculeintoionizedfragments.

Once

broken

intoionizedfragments,the

mass

spectrometer

measures

the

abundance

oftheions,alsocalleda response,using each

ionized fragment's

mass

tocharge (m/z)ratio.

Tregulated

mm

^^

Catena: Sector

r*i<fcr*

openiubaiBr

(capillary)

The

GC/MS

testproducesaseriesof

documents

calledchromatographs.

A

chromatographissimply a graph with time

on

theX-axis

and

abundance,or quantity,

on

the Y-axis.

Chromatographs

canbeparticularto

one

specificion ora spectrum, arange,

of

ions.

The

specific

GC/MS

testing

method

iswellillustrated at

http

://www

.unsol

vedmy

steries.oregonstate.

edu/GCMS_05

.shtml,see exhibit

GDC0247-0248. In pertinentpart,the

GC/MS

process

works

asfollows:

The

urine

sample

issent to chemistry. Chemistryserves several different

purposes, suchas, filteringthe urine to

remove

solids

and

other

unwanted

materials

and

The

preparedurine

sample

isinjected into the

GC/MS

and

the

sample

iscarried

by

inert(non-reactive)gas (suchashelium) throughthe instrument.

The

injection portis

heatedto300°

C

tocausethechemicalsto

become

gases.

The

outer partofthe

GC

isa veryspecializedoven.

The column

isheatedto

move

themolecules throughthecolumn. Typical

oven

temperaturesrange

from

40°

C

to320° C. Insidethe

oven

isthe

column which

isalong(i.e.,

30

meter)thintube witha special

polymer

coating

on

theinside.

Chemical

mixturesare separatedbased

on

theirvolatility

andare carriedthroughthe

column by

helium. Chemicals with highvolatilitytravel

throughthe

column

more

quicklythanchemicals with

low

volatility.

After passing throughthe

GC,

thechemicalpulsescontinuetothe

MS.

The

moleculesareblastedwithelectrons,

which

cause

them

tobreakinto pieces

and

turn into

positivelychargedparticles calledions. Thisisimportantbecausethe particles

must

be chargedtopass throughthefilter.

As

the ionscontinue throughthe

MS,

theytravelthroughan electromagneticfield

thatfiltersthe ionsbased

on

mass.

The

technicianusingtheinstrument chooses

what

range

of masses

should

be

allowed throughthefilter.

The

filtercontinuously scans throughtherange of

masses

asthestream

of

ions

come

from

the ion source.

A

detectorcountsthe

number

of

ionswitha specificmass. This informationissent toa

computer and

a

mass

spectrumiscreated.

The mass

spectrumisagraph

of

the

number

of

ionswithdifferent

masses

thattraveledthroughthefilter.

The

data

from

the

mass

spectrometerissent to a

computer and

plotted

on

agraph

Scientistscan

compare

the

mass

spectrum of an

unknown compound

toa libraryof

mass

spectraof

known

compounds.

A

"fullspectrum"analysis considersallthe"peaks"within a spectrum. Selective ionmonitoring

(SIM)

looks onlyata

few

characteristicpeaks12(but requireslookingat

more

than

one

characteristicpeak)associatedwithacandidatesubstance. Thisis

done on

theassumptionthatata givenretentiontime,asetofionsischaracteristicofa certain

compound.

When

the

amount

of informationcollectedaboutthe ionsina given gas chromatographic

peak

isreduced,thesensitivityofthe analysisgoesup. Therefore,

SIM

analysisallowsasmallerquantityofa

compound

tobedetected

and

measured, butthe

degreeofcertaintyaboutthe identityofthat

compound

isreducedas

compared

toafull spectrumanalysis.

c.

The

Difference

Between

the

Screening

and

Confirmation

Methods

Additionally, there are

two methods

usedat

LNDD

fordeterminingthe

T/E

ratio.

One

method

iscalled thescreen

and

theotheriscalledtheconfirmation method.

The

screen

and

confirmation

methods

differmaterially in severalways. First,the

confirmation usescalibrationcurvesfor the semi-quantification

of

T

and

E. Second,the

confirmationis

done

intriplicate,with a

mean

ofthe threesamplesusedasafinalresult

whereas

thescreen involvesonly asingle

workup and

injection. Finally,the

method

file

12

forthe

GC/MS

runisdifferent,including differencesin,

among

other things, thedwell times spent

on

eachion.

d.

The

A

Sample

Testing Results:

A

Summary

LNDD

conductedmultiple

GC/MS

tests

on Mr.

Landis'

A

samplesinthe

followingorder:

one

screentest,

two

confirmationtests,

and

lastly,another screentest.

On

July 21,2006,the

LNDD

performed

thefirstscreen

GC/MS

test

on

the

A

sample. Exhibit54.

On

July 24,2006,

LNDD

conductedaconfirmation

GC/MS

test. Exhibit

USADA0054.

This confirmation

GC/MS

test

was

rejected.

As

aresult,

on

July 22,

LNDD

conductedasecond

GC/MS

confirmationtest failed. Exhibit

USADA0101.

Despitehaving performed a screen

and

two

confirmation

GC/MS

tests,

LNDD

rather

curiouslyconductedasecond screentest

on

the

A

sample

on

July 25. Exhibit

USADA0057.

The

resultofthefirstscreen

GC/MS

testindicateda

T/E

ratioof4.9:1. See Exhibit

USADA0054.

Documents

associatedwiththis teststated thatthere

was

inhibited derivatization. SeeExhibits

USADA0054

-

0056.

The

results

of

thefirstconfirmation

GC/MS

test

measured

a

T/E

ratioof10.7:1. SeeExhibits

USADA0092,

0223).

According

to

USADA,

thefirstconfirmationtest

had

weak

measurements

forthe

methyltestosterone

and

was

disregarded. See

USADA

Pre-Hearing Briefat

page

7.

The

second confirmation

GC/MS

test

measured

a

T/E

ratioof11.4:1. Exhibit

USADA0101.

And,

thesecond screen

GC/MS

test

had

a

T/E

ratioof5.1:1. Exhibit

USADA0057.

Curiously, thefirstscreentest

and

second confirmation

T/E

test

show

testosterone

thesecond confirmation

T/E

testislessthan

one

halfofthat

measured

inthefirstscreen.

2.

LNDD

violatedthe

ISL

requirementtoconduct a confirmation

analysisusing

more

stringentmethods;

3.

LNDD

violatedthe

ISL by wrongly

identifyingdeuterated

androsteroneintheconfirmationprocess;

4.

LNDD

violatedthe

ISL

requirement

by

failingtoruntherequired

calibration controls;

5.

LNDD

violatedtherequirementtoverifytheaccuracyofcalibration curves;

6.

LNDD

violatedtherequirementthat

no

testingshould

be

done

on

degradedurinesamples;

and

7.

LNDD

violatedthe

ISL

requirementthatprohibitsmatrix

interferenceinthe

chromatograms;

Any

one of

these

ISL

violations

would

be

sufficient to invalidatethe

GC/MS

results,buttakentogether,these violationsdemonstratea consistent patternof

incompetencethat infectsthecredibility

of

allthetest results.

(i)

LNDDS LABORATORY DOCUMENTATION

ERRORS

LNDD's

GC/MS

testresultsareonlyas reliable as theoperators thatperform

them

personnelare required to

have

a "thorough

knowledge

ofthe[ir]responsibilities"to

ensurethatthetestresults are

performed

ina reliablemethod.

ISL

5.4.2.2,Exhibit

WADA0079-0135.

In addition,allsupervisory personnelare required to

have

a thorough understandingof, inter alia,quality controlprocedures, chain of custody procedures,

and

proper remedialactionsnecessarytorespondto analytical

problems

thatarise.

ISL

5.4.2.6,Exhibit

WADA0079-0135.

While

itisyet to

be

determinedifthe

LNDD

operatorsunderstoodtheirresponsibilities,thedocumentation provided

by

USADA

undoubtedly evidencestheir failure to

comply

withsimple, yetcritical,provisions in the

ISL,the

WADA

Technical

Documents

incorporatedinto theISL,

and

ISO

17025.

(ii)

LNDD'S

LABORATORY DOCUMENTATION

IS

RIDDLED

WITH

ERRORS

Proper documentationisessential to theaccuracy

and

integrityoftheanti-doping system. Thisisparticularlytrue

when

itrelatestoproper

sample

identification,chain of custody

and

forensic corrections. Stringent rules protecting theseinterestsare codified in

boththe

WADA

InternationalStandards

and

intheunderlyingInternationalOrganization

for Standardization rulesgoverninglaboratories.

WADA

Technical

Document 2003LCOC,

Exhibit

GDC0233,

providesspecific instructionsconcerningcorrections to laboratorydocuments.

The

technical

document

requires that "[a]ny forensic corrections that

need

to

be

made

to the

comment

should

be

done

witha singlelinethrough

and

the

change

shouldbeinitialedand dated

by

the

individual

making

thechange."

The

Technical

Document

continuesthat"[n]owhite out

ISO

similarlyprovidesthatmistakesinthe

documents

"shallbe crossedout,noterased,

made

illegibleor deleted,andthe correctvalueentered alongside."

But

furtheryet, "[a]ll suchalterationstorecordsshallbe signedorinitialed

by

theperson

making

the

correction." See Exhibit

GDC0304

(InternationalOrganizationforStandardization

ISO/EC

17025.4.3.2.3 (2005)).

LNDD

violatedboththe

WADA

technical

document

standard

and

the

ISO

standard

on

numerous

occasionsinconjunctionwiththistesting. SeeExhibits

GDC05

10-0513. Rather thanlistthe thirty-nine

WADA

and

ISO

violations

committed

by

LNDD,

Mr.

Landis has prepared a compilation ofthe errors as Exhibits

GDC0510-0513. Ifrequested

by

the Panel,

Mr.

Landiswillprovidefurtherbriefingconcerning each

individual violation.

The paradigm of

LNDD's

numerous

violations,anditsoverallineptperformance,

isExhibit200. InExhibit 200,there are

no

lessthansiximpropercross-outs,an orphanednotation, incorrect notations

of

reference solutions for epitestosterone,

and

a

likelyincorrect notation for the reference solution for testosterone. Exhibit

USADA0200

l>ttfr<^tf»mttofeKa«6MgyCRW',..J

XJSADAOCTO ^-f

Most

troubling,atleastfiveof

LNDD's

violations

of

the

ISO

andtechnical

documents

concernthe

sample

number

listed

on

thedocuments.

As

anexample,in

Exhibit

USADA0009,

LNDD

violated the

WADA

and

ISO

provisions inchangingthe

sample

number from

an

unknown number

to

995474

becausethe original

sample

number

was made

illegible

and

theoperatordidnotinitial

and

date thechange. Exhibit